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Tool Can Help Predict Futile Surgery in Pancreatic Cancer

Article Type
Changed
Wed, 08/07/2024 - 10:56

 

TOPLINE:

An easy-to-use web-based prognostic tool, MetroPancreas, may help predict the likelihood of futile pancreatectomy in patients with resectable pancreatic ductal adenocarcinoma and improve patient selection for upfront surgery.

METHODOLOGY:

  • Immediate resection is associated with a high incidence of postoperative complications and disease recurrence within a year of surgery in patients with pancreatic ductal adenocarcinoma. Predicting which patients likely won’t benefit from upfront pancreatectomy is important.
  • To identify preoperative risk factors for futile pancreatectomy, researchers evaluated 1426 patients (median age, 69 years; 53.2% men) with anatomically resectable pancreatic ductal adenocarcinoma who underwent pancreatic resection between January 2010 and December 2021.
  • The patients were divided into derivation (n = 885) and validation (n = 541) cohorts.
  • The primary outcome was the rate of futile upfront pancreatectomy, defined as death or disease recurrence within 6 months of surgery. Patients were divided into three risk categories — low, intermediate, and high risk — each with escalating likelihoods of futile resection, worse pathological features, and worse outcomes.
  • The secondary endpoint was to develop criteria for surgical candidacy, setting a futility likelihood threshold of < 20%. This threshold corresponds to the lower bound of the 95% confidence interval (CI) for postneoadjuvant resection rates (resection rate, 0.90; 95% CI, 0.80-1.01) from recent meta-analyses.

TAKEAWAY:

  • The futility rate for pancreatectomy was 18.9% — 19.2% in the development cohort and 18.6% in the validation cohort. Three independent risk factors for futile resection included American Society of Anesthesiologists (ASA) class (95% CI for coefficients, 0.68-0.87), preoperative cancer antigen 19.9 serum levels (95% CI for coefficients, 0.05-0.75), and radiologic tumor size (95% CI for coefficients, 0.28-0.46).
  • Using these independent risk factors, the predictive model demonstrated adequate calibration and discrimination in both the derivation and validation cohorts.
  • The researchers then identified three risk groups. In the derivation cohort, the rate of futile pancreatectomy was 9.2% in the low-risk group, 18.0% in the intermediate-risk group, and 28.7% in the high-risk group (P < .001 for trend). In the validation cohort, the futility rate was 10.9% in the low-risk group, 20.2% in the intermediate-risk group, and 29.2% in the high-risk group (P < .001 for trend).
  • Researchers identified four conditions associated with a futility likelihood below 20%, where larger tumor size is paired with lower cancer antigen 19.9 levels (defined as cancer antigen 19.9–adjusted-to-size). Patients who met these criteria experienced significantly longer disease-free survival (median 18.4 months vs 11.2 months) and overall survival (38.5 months vs 22.1 months).

IN PRACTICE:

“Although the study provides an easy-to-use calculator for clinical decision-making, there are some methodological limitations,” according to the authors of accompanying commentary. These limitations include failing to accurately describe how ASA class, cancer antigen 19.9 level, and tumor size were chosen for the model. “While we do not think the model is yet ready for standard clinical use, it may prove to be a viable tool if tested in future randomized trials comparing the neoadjuvant approach to upfront surgery in resectable pancreatic cancer,” the editorialists added.

 

 

SOURCE:

This study, led by Stefano Crippa, MD, PhD, Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy, and the accompanying commentary were published online in JAMA Surgery.

LIMITATIONS:

In addition to the limitations noted by the editorialists, others include the study’s retrospective design, which could introduce bias. Because preoperative imaging was not revised, the assigned resectability classes could show variability. Institutional differences existed in the selection process for upfront pancreatectomy. The model cannot be applied to cancer antigen 19.9 nonsecretors and was not externally validated.

DISCLOSURES:

The Italian Association for Cancer Research Special Program in Metastatic Disease and Italian Ministry of Health/Italian Foundation for the Research of Pancreatic Diseases supported the study in the form of a grant. Two authors reported receiving personal fees outside the submitted work. No other disclosures were reported.

A version of this article first appeared on Medscape.com.

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TOPLINE:

An easy-to-use web-based prognostic tool, MetroPancreas, may help predict the likelihood of futile pancreatectomy in patients with resectable pancreatic ductal adenocarcinoma and improve patient selection for upfront surgery.

METHODOLOGY:

  • Immediate resection is associated with a high incidence of postoperative complications and disease recurrence within a year of surgery in patients with pancreatic ductal adenocarcinoma. Predicting which patients likely won’t benefit from upfront pancreatectomy is important.
  • To identify preoperative risk factors for futile pancreatectomy, researchers evaluated 1426 patients (median age, 69 years; 53.2% men) with anatomically resectable pancreatic ductal adenocarcinoma who underwent pancreatic resection between January 2010 and December 2021.
  • The patients were divided into derivation (n = 885) and validation (n = 541) cohorts.
  • The primary outcome was the rate of futile upfront pancreatectomy, defined as death or disease recurrence within 6 months of surgery. Patients were divided into three risk categories — low, intermediate, and high risk — each with escalating likelihoods of futile resection, worse pathological features, and worse outcomes.
  • The secondary endpoint was to develop criteria for surgical candidacy, setting a futility likelihood threshold of < 20%. This threshold corresponds to the lower bound of the 95% confidence interval (CI) for postneoadjuvant resection rates (resection rate, 0.90; 95% CI, 0.80-1.01) from recent meta-analyses.

TAKEAWAY:

  • The futility rate for pancreatectomy was 18.9% — 19.2% in the development cohort and 18.6% in the validation cohort. Three independent risk factors for futile resection included American Society of Anesthesiologists (ASA) class (95% CI for coefficients, 0.68-0.87), preoperative cancer antigen 19.9 serum levels (95% CI for coefficients, 0.05-0.75), and radiologic tumor size (95% CI for coefficients, 0.28-0.46).
  • Using these independent risk factors, the predictive model demonstrated adequate calibration and discrimination in both the derivation and validation cohorts.
  • The researchers then identified three risk groups. In the derivation cohort, the rate of futile pancreatectomy was 9.2% in the low-risk group, 18.0% in the intermediate-risk group, and 28.7% in the high-risk group (P < .001 for trend). In the validation cohort, the futility rate was 10.9% in the low-risk group, 20.2% in the intermediate-risk group, and 29.2% in the high-risk group (P < .001 for trend).
  • Researchers identified four conditions associated with a futility likelihood below 20%, where larger tumor size is paired with lower cancer antigen 19.9 levels (defined as cancer antigen 19.9–adjusted-to-size). Patients who met these criteria experienced significantly longer disease-free survival (median 18.4 months vs 11.2 months) and overall survival (38.5 months vs 22.1 months).

IN PRACTICE:

“Although the study provides an easy-to-use calculator for clinical decision-making, there are some methodological limitations,” according to the authors of accompanying commentary. These limitations include failing to accurately describe how ASA class, cancer antigen 19.9 level, and tumor size were chosen for the model. “While we do not think the model is yet ready for standard clinical use, it may prove to be a viable tool if tested in future randomized trials comparing the neoadjuvant approach to upfront surgery in resectable pancreatic cancer,” the editorialists added.

 

 

SOURCE:

This study, led by Stefano Crippa, MD, PhD, Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy, and the accompanying commentary were published online in JAMA Surgery.

LIMITATIONS:

In addition to the limitations noted by the editorialists, others include the study’s retrospective design, which could introduce bias. Because preoperative imaging was not revised, the assigned resectability classes could show variability. Institutional differences existed in the selection process for upfront pancreatectomy. The model cannot be applied to cancer antigen 19.9 nonsecretors and was not externally validated.

DISCLOSURES:

The Italian Association for Cancer Research Special Program in Metastatic Disease and Italian Ministry of Health/Italian Foundation for the Research of Pancreatic Diseases supported the study in the form of a grant. Two authors reported receiving personal fees outside the submitted work. No other disclosures were reported.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

An easy-to-use web-based prognostic tool, MetroPancreas, may help predict the likelihood of futile pancreatectomy in patients with resectable pancreatic ductal adenocarcinoma and improve patient selection for upfront surgery.

METHODOLOGY:

  • Immediate resection is associated with a high incidence of postoperative complications and disease recurrence within a year of surgery in patients with pancreatic ductal adenocarcinoma. Predicting which patients likely won’t benefit from upfront pancreatectomy is important.
  • To identify preoperative risk factors for futile pancreatectomy, researchers evaluated 1426 patients (median age, 69 years; 53.2% men) with anatomically resectable pancreatic ductal adenocarcinoma who underwent pancreatic resection between January 2010 and December 2021.
  • The patients were divided into derivation (n = 885) and validation (n = 541) cohorts.
  • The primary outcome was the rate of futile upfront pancreatectomy, defined as death or disease recurrence within 6 months of surgery. Patients were divided into three risk categories — low, intermediate, and high risk — each with escalating likelihoods of futile resection, worse pathological features, and worse outcomes.
  • The secondary endpoint was to develop criteria for surgical candidacy, setting a futility likelihood threshold of < 20%. This threshold corresponds to the lower bound of the 95% confidence interval (CI) for postneoadjuvant resection rates (resection rate, 0.90; 95% CI, 0.80-1.01) from recent meta-analyses.

TAKEAWAY:

  • The futility rate for pancreatectomy was 18.9% — 19.2% in the development cohort and 18.6% in the validation cohort. Three independent risk factors for futile resection included American Society of Anesthesiologists (ASA) class (95% CI for coefficients, 0.68-0.87), preoperative cancer antigen 19.9 serum levels (95% CI for coefficients, 0.05-0.75), and radiologic tumor size (95% CI for coefficients, 0.28-0.46).
  • Using these independent risk factors, the predictive model demonstrated adequate calibration and discrimination in both the derivation and validation cohorts.
  • The researchers then identified three risk groups. In the derivation cohort, the rate of futile pancreatectomy was 9.2% in the low-risk group, 18.0% in the intermediate-risk group, and 28.7% in the high-risk group (P < .001 for trend). In the validation cohort, the futility rate was 10.9% in the low-risk group, 20.2% in the intermediate-risk group, and 29.2% in the high-risk group (P < .001 for trend).
  • Researchers identified four conditions associated with a futility likelihood below 20%, where larger tumor size is paired with lower cancer antigen 19.9 levels (defined as cancer antigen 19.9–adjusted-to-size). Patients who met these criteria experienced significantly longer disease-free survival (median 18.4 months vs 11.2 months) and overall survival (38.5 months vs 22.1 months).

IN PRACTICE:

“Although the study provides an easy-to-use calculator for clinical decision-making, there are some methodological limitations,” according to the authors of accompanying commentary. These limitations include failing to accurately describe how ASA class, cancer antigen 19.9 level, and tumor size were chosen for the model. “While we do not think the model is yet ready for standard clinical use, it may prove to be a viable tool if tested in future randomized trials comparing the neoadjuvant approach to upfront surgery in resectable pancreatic cancer,” the editorialists added.

 

 

SOURCE:

This study, led by Stefano Crippa, MD, PhD, Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy, and the accompanying commentary were published online in JAMA Surgery.

LIMITATIONS:

In addition to the limitations noted by the editorialists, others include the study’s retrospective design, which could introduce bias. Because preoperative imaging was not revised, the assigned resectability classes could show variability. Institutional differences existed in the selection process for upfront pancreatectomy. The model cannot be applied to cancer antigen 19.9 nonsecretors and was not externally validated.

DISCLOSURES:

The Italian Association for Cancer Research Special Program in Metastatic Disease and Italian Ministry of Health/Italian Foundation for the Research of Pancreatic Diseases supported the study in the form of a grant. Two authors reported receiving personal fees outside the submitted work. No other disclosures were reported.

A version of this article first appeared on Medscape.com.

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Could total mesometrial resection become a new standard treatment for cervical cancer?

Article Type
Changed
Fri, 07/19/2024 - 13:57

Total mesometrial resection (TMMR) is associated with significantly longer recurrence-free survival (RFS) and overall survival (OS) than standard treatment for patients with early-stage cervical cancer, while outcomes were not different among those with locally advanced disease, according to a new study.

These findings suggest that TMMR may be considered a primary treatment option for both early-stage and locally advanced cervical cancer confined to the Müllerian compartment, reported lead author Henrik Falconer, MD, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
 

What is the rationale behind TMMR?

“Current international guidelines [for cervical cancer] are primarily based on retrospective case series and a small number of outdated randomized controlled trials,” the investigators wrote in EClinicalMedicine, part of The Lancet publication platform. “The stage-dependent treatment recommendations, with surgery advised for early-stage and radiation therapy for locally advanced disease, may be considered too simplistic, suggesting that early stages of cervical cancer cannot be controlled with surgical resection alone or that locally advanced cervical cancer is inoperable.”

This mindset, they noted, overlooks the complexities of cancer spread. In contrast, TMMR and similar surgical approaches based on the cancer field model are mapped along routes of locoregional dissemination, leading to “excellent local control” in more than 600 cases at the University Hospital of Leipzig, Leipzig, Germany.

To date, however, TMMR’s adoption has been limited, and it has not been compared directly with current guideline treatments, prompting the present study.
 

What methods were used to compare TMMR with standard treatment?

The study compared TMMR plus therapeutic lymph node dissection (tLND) without adjuvant radiation versus standard treatment (ST) for early-stage (FIGO 2009 IB1, IIA1) and locally advanced (FIGO 2009 IB2, IIA2, IIB) cervical cancer. Standard treatment for patients with early-stage disease involved radical hysterectomy and pelvic lymphadenectomy, with adjuvant chemoradiation dependent upon final pathology. Those with locally advanced disease received definitive chemoradiation.

Data for the standard treatment group were drawn from population-based registries in Sweden, while those for the TMMR group came from the Leipzig Mesometrial Resection Study Database. The final dataset included 1,007 women treated between 2011 and 2020, with 733 undergoing standard treatment and 274 receiving TMMR.

Outcomes included RFS and OS, adjusted for clinical and tumor-related variables.
 

How did TMMR compare with standard treatment?

TMMR was associated with superior oncologic outcomes compared with standard treatment for early-stage cervical cancer.

Specifically, 5-year RFS was 91.2% for TMMR versus 81.8% for standard therapy (P = .002). In the adjusted analysis, TMMR was associated with a significantly lower hazard of recurrence (hazard ratio [HR], 0.39; 95% CI, 0.22–0.69) and death (HR, 0.42; 95% CI, 0.21-0.86). Also favoring TMMR, absolute difference in the risk of recurrence at 5 years was 9.4% (95% CI 3.2–15.7). In addition, 5-year OS was better in the TMMR group, at 93.3%, compared with 90.3% for standard treatment (P = .034).

Among patients with locally advanced disease, no significant differences in RFS or OS were observed.
 

Are these data strong enough to make TMMR the new standard treatment?

Dr. Falconer and colleagues concluded that TMMR with tLND “may replace the standard treatment approach in early-stage cervical cancer and furthermore be evaluated as an option in locally advanced cervical cancer confined to the Müllerian compartment.”

While the investigators anticipated demands for randomized controlled trials, they questioned the value of such studies, suggesting that any control arm would be “based on inconsistent or flawed concepts.”

Dr. Susan C. Modesitt


Susan C. Modesitt, MD, director of the gynecologic oncology division of Winship Cancer Institute of Emory University, Atlanta, offered a different perspective.

“They do show encouraging data in the early stage,” Dr. Modesitt said in an interview, “but I would still want to see a randomized controlled trial, because we’ve been burned before.”

She cited the LACC trial, which dispelled strong convictions about the alleged superiority of minimally invasive radical hysterectomy.

“We thought minimally invasive was so good, and we should be doing that to everybody, but we did a trial, and we found worse outcomes,” Dr. Modesitt said. “More of those early-stage women died.”

Dr. Modesitt also pointed out the lack of safety data in the present publication.

“TMMR is a bigger procedure, so I would expect more complications,” she said, noting that rates of urinary injury, nerve injury, and readmission need to be considered alongside efficacy outcomes.

How does TMMR fit into the current treatment landscape for cervical cancer?

“This is a very niche surgery that most places don’t do,” Dr. Modesitt said.

She pointed out that “multiple variations” on the standard radical hysterectomy have been proposed in the past, such as the laterally extended endopelvic resection.

“[TMMR] is not a new concept,” she said. “It’s just a question of how radical it is.”

Instead of developing new types of radical surgery, she said, the trend in the United States is toward de-escalation of surgical treatments altogether, with greater reliance upon medical options, such as immunotherapy.

“[This study] is thought provoking, and I applaud them for doing it,” Dr. Modesitt said. “But I’m not going to go out and do that on my next patient.”

This study was supported by grants from Centre for Clinical Research Sörmland (Sweden) and Region Stockholm (Sweden). Dr. Falconer is a board member of Surgical Science.

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Total mesometrial resection (TMMR) is associated with significantly longer recurrence-free survival (RFS) and overall survival (OS) than standard treatment for patients with early-stage cervical cancer, while outcomes were not different among those with locally advanced disease, according to a new study.

These findings suggest that TMMR may be considered a primary treatment option for both early-stage and locally advanced cervical cancer confined to the Müllerian compartment, reported lead author Henrik Falconer, MD, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
 

What is the rationale behind TMMR?

“Current international guidelines [for cervical cancer] are primarily based on retrospective case series and a small number of outdated randomized controlled trials,” the investigators wrote in EClinicalMedicine, part of The Lancet publication platform. “The stage-dependent treatment recommendations, with surgery advised for early-stage and radiation therapy for locally advanced disease, may be considered too simplistic, suggesting that early stages of cervical cancer cannot be controlled with surgical resection alone or that locally advanced cervical cancer is inoperable.”

This mindset, they noted, overlooks the complexities of cancer spread. In contrast, TMMR and similar surgical approaches based on the cancer field model are mapped along routes of locoregional dissemination, leading to “excellent local control” in more than 600 cases at the University Hospital of Leipzig, Leipzig, Germany.

To date, however, TMMR’s adoption has been limited, and it has not been compared directly with current guideline treatments, prompting the present study.
 

What methods were used to compare TMMR with standard treatment?

The study compared TMMR plus therapeutic lymph node dissection (tLND) without adjuvant radiation versus standard treatment (ST) for early-stage (FIGO 2009 IB1, IIA1) and locally advanced (FIGO 2009 IB2, IIA2, IIB) cervical cancer. Standard treatment for patients with early-stage disease involved radical hysterectomy and pelvic lymphadenectomy, with adjuvant chemoradiation dependent upon final pathology. Those with locally advanced disease received definitive chemoradiation.

Data for the standard treatment group were drawn from population-based registries in Sweden, while those for the TMMR group came from the Leipzig Mesometrial Resection Study Database. The final dataset included 1,007 women treated between 2011 and 2020, with 733 undergoing standard treatment and 274 receiving TMMR.

Outcomes included RFS and OS, adjusted for clinical and tumor-related variables.
 

How did TMMR compare with standard treatment?

TMMR was associated with superior oncologic outcomes compared with standard treatment for early-stage cervical cancer.

Specifically, 5-year RFS was 91.2% for TMMR versus 81.8% for standard therapy (P = .002). In the adjusted analysis, TMMR was associated with a significantly lower hazard of recurrence (hazard ratio [HR], 0.39; 95% CI, 0.22–0.69) and death (HR, 0.42; 95% CI, 0.21-0.86). Also favoring TMMR, absolute difference in the risk of recurrence at 5 years was 9.4% (95% CI 3.2–15.7). In addition, 5-year OS was better in the TMMR group, at 93.3%, compared with 90.3% for standard treatment (P = .034).

Among patients with locally advanced disease, no significant differences in RFS or OS were observed.
 

Are these data strong enough to make TMMR the new standard treatment?

Dr. Falconer and colleagues concluded that TMMR with tLND “may replace the standard treatment approach in early-stage cervical cancer and furthermore be evaluated as an option in locally advanced cervical cancer confined to the Müllerian compartment.”

While the investigators anticipated demands for randomized controlled trials, they questioned the value of such studies, suggesting that any control arm would be “based on inconsistent or flawed concepts.”

Dr. Susan C. Modesitt


Susan C. Modesitt, MD, director of the gynecologic oncology division of Winship Cancer Institute of Emory University, Atlanta, offered a different perspective.

“They do show encouraging data in the early stage,” Dr. Modesitt said in an interview, “but I would still want to see a randomized controlled trial, because we’ve been burned before.”

She cited the LACC trial, which dispelled strong convictions about the alleged superiority of minimally invasive radical hysterectomy.

“We thought minimally invasive was so good, and we should be doing that to everybody, but we did a trial, and we found worse outcomes,” Dr. Modesitt said. “More of those early-stage women died.”

Dr. Modesitt also pointed out the lack of safety data in the present publication.

“TMMR is a bigger procedure, so I would expect more complications,” she said, noting that rates of urinary injury, nerve injury, and readmission need to be considered alongside efficacy outcomes.

How does TMMR fit into the current treatment landscape for cervical cancer?

“This is a very niche surgery that most places don’t do,” Dr. Modesitt said.

She pointed out that “multiple variations” on the standard radical hysterectomy have been proposed in the past, such as the laterally extended endopelvic resection.

“[TMMR] is not a new concept,” she said. “It’s just a question of how radical it is.”

Instead of developing new types of radical surgery, she said, the trend in the United States is toward de-escalation of surgical treatments altogether, with greater reliance upon medical options, such as immunotherapy.

“[This study] is thought provoking, and I applaud them for doing it,” Dr. Modesitt said. “But I’m not going to go out and do that on my next patient.”

This study was supported by grants from Centre for Clinical Research Sörmland (Sweden) and Region Stockholm (Sweden). Dr. Falconer is a board member of Surgical Science.

Total mesometrial resection (TMMR) is associated with significantly longer recurrence-free survival (RFS) and overall survival (OS) than standard treatment for patients with early-stage cervical cancer, while outcomes were not different among those with locally advanced disease, according to a new study.

These findings suggest that TMMR may be considered a primary treatment option for both early-stage and locally advanced cervical cancer confined to the Müllerian compartment, reported lead author Henrik Falconer, MD, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
 

What is the rationale behind TMMR?

“Current international guidelines [for cervical cancer] are primarily based on retrospective case series and a small number of outdated randomized controlled trials,” the investigators wrote in EClinicalMedicine, part of The Lancet publication platform. “The stage-dependent treatment recommendations, with surgery advised for early-stage and radiation therapy for locally advanced disease, may be considered too simplistic, suggesting that early stages of cervical cancer cannot be controlled with surgical resection alone or that locally advanced cervical cancer is inoperable.”

This mindset, they noted, overlooks the complexities of cancer spread. In contrast, TMMR and similar surgical approaches based on the cancer field model are mapped along routes of locoregional dissemination, leading to “excellent local control” in more than 600 cases at the University Hospital of Leipzig, Leipzig, Germany.

To date, however, TMMR’s adoption has been limited, and it has not been compared directly with current guideline treatments, prompting the present study.
 

What methods were used to compare TMMR with standard treatment?

The study compared TMMR plus therapeutic lymph node dissection (tLND) without adjuvant radiation versus standard treatment (ST) for early-stage (FIGO 2009 IB1, IIA1) and locally advanced (FIGO 2009 IB2, IIA2, IIB) cervical cancer. Standard treatment for patients with early-stage disease involved radical hysterectomy and pelvic lymphadenectomy, with adjuvant chemoradiation dependent upon final pathology. Those with locally advanced disease received definitive chemoradiation.

Data for the standard treatment group were drawn from population-based registries in Sweden, while those for the TMMR group came from the Leipzig Mesometrial Resection Study Database. The final dataset included 1,007 women treated between 2011 and 2020, with 733 undergoing standard treatment and 274 receiving TMMR.

Outcomes included RFS and OS, adjusted for clinical and tumor-related variables.
 

How did TMMR compare with standard treatment?

TMMR was associated with superior oncologic outcomes compared with standard treatment for early-stage cervical cancer.

Specifically, 5-year RFS was 91.2% for TMMR versus 81.8% for standard therapy (P = .002). In the adjusted analysis, TMMR was associated with a significantly lower hazard of recurrence (hazard ratio [HR], 0.39; 95% CI, 0.22–0.69) and death (HR, 0.42; 95% CI, 0.21-0.86). Also favoring TMMR, absolute difference in the risk of recurrence at 5 years was 9.4% (95% CI 3.2–15.7). In addition, 5-year OS was better in the TMMR group, at 93.3%, compared with 90.3% for standard treatment (P = .034).

Among patients with locally advanced disease, no significant differences in RFS or OS were observed.
 

Are these data strong enough to make TMMR the new standard treatment?

Dr. Falconer and colleagues concluded that TMMR with tLND “may replace the standard treatment approach in early-stage cervical cancer and furthermore be evaluated as an option in locally advanced cervical cancer confined to the Müllerian compartment.”

While the investigators anticipated demands for randomized controlled trials, they questioned the value of such studies, suggesting that any control arm would be “based on inconsistent or flawed concepts.”

Dr. Susan C. Modesitt


Susan C. Modesitt, MD, director of the gynecologic oncology division of Winship Cancer Institute of Emory University, Atlanta, offered a different perspective.

“They do show encouraging data in the early stage,” Dr. Modesitt said in an interview, “but I would still want to see a randomized controlled trial, because we’ve been burned before.”

She cited the LACC trial, which dispelled strong convictions about the alleged superiority of minimally invasive radical hysterectomy.

“We thought minimally invasive was so good, and we should be doing that to everybody, but we did a trial, and we found worse outcomes,” Dr. Modesitt said. “More of those early-stage women died.”

Dr. Modesitt also pointed out the lack of safety data in the present publication.

“TMMR is a bigger procedure, so I would expect more complications,” she said, noting that rates of urinary injury, nerve injury, and readmission need to be considered alongside efficacy outcomes.

How does TMMR fit into the current treatment landscape for cervical cancer?

“This is a very niche surgery that most places don’t do,” Dr. Modesitt said.

She pointed out that “multiple variations” on the standard radical hysterectomy have been proposed in the past, such as the laterally extended endopelvic resection.

“[TMMR] is not a new concept,” she said. “It’s just a question of how radical it is.”

Instead of developing new types of radical surgery, she said, the trend in the United States is toward de-escalation of surgical treatments altogether, with greater reliance upon medical options, such as immunotherapy.

“[This study] is thought provoking, and I applaud them for doing it,” Dr. Modesitt said. “But I’m not going to go out and do that on my next patient.”

This study was supported by grants from Centre for Clinical Research Sörmland (Sweden) and Region Stockholm (Sweden). Dr. Falconer is a board member of Surgical Science.

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Does Extended Postop Follow-Up Improve Survival in Gastric Cancer?

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Changed
Wed, 07/17/2024 - 15:24

 

TOPLINE:

For patients with gastric cancer, extending regular follow-up beyond the typical 5 years after gastrectomy was associated with improved overall and post-recurrence survival rates, new data from a retrospective analysis showed.

METHODOLOGY:

  • Currently, postgastrectomy cancer surveillance typically lasts 5 years, although some centers now monitor patients beyond this point.
  • To investigate the potential benefit of extended surveillance, researchers used Korean National Health Insurance claims data to identify 40,468 patients with gastric cancer who were disease free 5 years after gastrectomy — 14,294 received extended regular follow-up visits and 26,174 did not.
  • The extended regular follow-up group was defined as having endoscopy or abdominopelvic CT between 2 months and 2 years before diagnosis of late recurrence or gastric remnant cancer and having two or more examinations between 5.5 and 8.5 years after gastrectomy. Late recurrence was a recurrence diagnosed 5 years after gastrectomy.
  • Researchers used Cox proportional hazards regression to evaluate the independent association between follow-up and overall and postrecurrence survival rates.

TAKEAWAY:

  • Overall, 5 years postgastrectomy, the incidence of late recurrence or gastric remnant cancer was 7.8% — 4.0% between 5 and 10 years (1610 of 40,468 patients) and 9.4% after 10 years (1528 of 16,287 patients).
  • Regular follow-up beyond 5 years was associated with a significant reduction in overall mortality — from 49.4% to 36.9% at 15 years (P < .001). Overall survival after late recurrence or gastric remnant cancer also improved significantly with extended regular follow-up, with the 5-year postrecurrence survival rate increasing from 32.7% to 71.1% (P < .001).
  • The combination of endoscopy and abdominopelvic CT provided the highest 5-year postrecurrence survival rate (74.5%), compared with endoscopy alone (54.5%) or CT alone (47.1%).
  • A time interval of more than 2 years between a previous endoscopy or abdominopelvic CT and diagnosis of late recurrence or gastric remnant cancer significantly decreased postrecurrence survival (hazard ratio [HR], 1.72 for endoscopy and HR, 1.48 for abdominopelvic CT).

IN PRACTICE:

“These findings suggest that extended regular follow-up after 5 years post gastrectomy should be implemented clinically and that current practice and value of follow-up protocols in postoperative care of patients with gastric cancer be reconsidered,” the authors concluded.

The authors of an accompanying commentary cautioned that, while the study “successfully establishes groundwork for extending surveillance of gastric cancer in high-risk populations, more work is needed to strategically identify those who would benefit most from extended surveillance.”
 

SOURCE:

The study, with first author Ju-Hee Lee, MD, PhD, Department of Surgery, Hanyang University College of Medicine, Seoul, South Korea, and accompanying commentary were published online on June 18 in JAMA Surgery.

LIMITATIONS:

Recurrent cancer and gastric remnant cancer could not be distinguished from each other because clinical records were not analyzed. The claims database lacked detailed clinical information on individual patients, including cancer stages, and a separate analysis of tumor markers could not be performed.

DISCLOSURES:

The study was funded by a grant from the Korean Gastric Cancer Association. The study authors and commentary authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

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TOPLINE:

For patients with gastric cancer, extending regular follow-up beyond the typical 5 years after gastrectomy was associated with improved overall and post-recurrence survival rates, new data from a retrospective analysis showed.

METHODOLOGY:

  • Currently, postgastrectomy cancer surveillance typically lasts 5 years, although some centers now monitor patients beyond this point.
  • To investigate the potential benefit of extended surveillance, researchers used Korean National Health Insurance claims data to identify 40,468 patients with gastric cancer who were disease free 5 years after gastrectomy — 14,294 received extended regular follow-up visits and 26,174 did not.
  • The extended regular follow-up group was defined as having endoscopy or abdominopelvic CT between 2 months and 2 years before diagnosis of late recurrence or gastric remnant cancer and having two or more examinations between 5.5 and 8.5 years after gastrectomy. Late recurrence was a recurrence diagnosed 5 years after gastrectomy.
  • Researchers used Cox proportional hazards regression to evaluate the independent association between follow-up and overall and postrecurrence survival rates.

TAKEAWAY:

  • Overall, 5 years postgastrectomy, the incidence of late recurrence or gastric remnant cancer was 7.8% — 4.0% between 5 and 10 years (1610 of 40,468 patients) and 9.4% after 10 years (1528 of 16,287 patients).
  • Regular follow-up beyond 5 years was associated with a significant reduction in overall mortality — from 49.4% to 36.9% at 15 years (P < .001). Overall survival after late recurrence or gastric remnant cancer also improved significantly with extended regular follow-up, with the 5-year postrecurrence survival rate increasing from 32.7% to 71.1% (P < .001).
  • The combination of endoscopy and abdominopelvic CT provided the highest 5-year postrecurrence survival rate (74.5%), compared with endoscopy alone (54.5%) or CT alone (47.1%).
  • A time interval of more than 2 years between a previous endoscopy or abdominopelvic CT and diagnosis of late recurrence or gastric remnant cancer significantly decreased postrecurrence survival (hazard ratio [HR], 1.72 for endoscopy and HR, 1.48 for abdominopelvic CT).

IN PRACTICE:

“These findings suggest that extended regular follow-up after 5 years post gastrectomy should be implemented clinically and that current practice and value of follow-up protocols in postoperative care of patients with gastric cancer be reconsidered,” the authors concluded.

The authors of an accompanying commentary cautioned that, while the study “successfully establishes groundwork for extending surveillance of gastric cancer in high-risk populations, more work is needed to strategically identify those who would benefit most from extended surveillance.”
 

SOURCE:

The study, with first author Ju-Hee Lee, MD, PhD, Department of Surgery, Hanyang University College of Medicine, Seoul, South Korea, and accompanying commentary were published online on June 18 in JAMA Surgery.

LIMITATIONS:

Recurrent cancer and gastric remnant cancer could not be distinguished from each other because clinical records were not analyzed. The claims database lacked detailed clinical information on individual patients, including cancer stages, and a separate analysis of tumor markers could not be performed.

DISCLOSURES:

The study was funded by a grant from the Korean Gastric Cancer Association. The study authors and commentary authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

 

TOPLINE:

For patients with gastric cancer, extending regular follow-up beyond the typical 5 years after gastrectomy was associated with improved overall and post-recurrence survival rates, new data from a retrospective analysis showed.

METHODOLOGY:

  • Currently, postgastrectomy cancer surveillance typically lasts 5 years, although some centers now monitor patients beyond this point.
  • To investigate the potential benefit of extended surveillance, researchers used Korean National Health Insurance claims data to identify 40,468 patients with gastric cancer who were disease free 5 years after gastrectomy — 14,294 received extended regular follow-up visits and 26,174 did not.
  • The extended regular follow-up group was defined as having endoscopy or abdominopelvic CT between 2 months and 2 years before diagnosis of late recurrence or gastric remnant cancer and having two or more examinations between 5.5 and 8.5 years after gastrectomy. Late recurrence was a recurrence diagnosed 5 years after gastrectomy.
  • Researchers used Cox proportional hazards regression to evaluate the independent association between follow-up and overall and postrecurrence survival rates.

TAKEAWAY:

  • Overall, 5 years postgastrectomy, the incidence of late recurrence or gastric remnant cancer was 7.8% — 4.0% between 5 and 10 years (1610 of 40,468 patients) and 9.4% after 10 years (1528 of 16,287 patients).
  • Regular follow-up beyond 5 years was associated with a significant reduction in overall mortality — from 49.4% to 36.9% at 15 years (P < .001). Overall survival after late recurrence or gastric remnant cancer also improved significantly with extended regular follow-up, with the 5-year postrecurrence survival rate increasing from 32.7% to 71.1% (P < .001).
  • The combination of endoscopy and abdominopelvic CT provided the highest 5-year postrecurrence survival rate (74.5%), compared with endoscopy alone (54.5%) or CT alone (47.1%).
  • A time interval of more than 2 years between a previous endoscopy or abdominopelvic CT and diagnosis of late recurrence or gastric remnant cancer significantly decreased postrecurrence survival (hazard ratio [HR], 1.72 for endoscopy and HR, 1.48 for abdominopelvic CT).

IN PRACTICE:

“These findings suggest that extended regular follow-up after 5 years post gastrectomy should be implemented clinically and that current practice and value of follow-up protocols in postoperative care of patients with gastric cancer be reconsidered,” the authors concluded.

The authors of an accompanying commentary cautioned that, while the study “successfully establishes groundwork for extending surveillance of gastric cancer in high-risk populations, more work is needed to strategically identify those who would benefit most from extended surveillance.”
 

SOURCE:

The study, with first author Ju-Hee Lee, MD, PhD, Department of Surgery, Hanyang University College of Medicine, Seoul, South Korea, and accompanying commentary were published online on June 18 in JAMA Surgery.

LIMITATIONS:

Recurrent cancer and gastric remnant cancer could not be distinguished from each other because clinical records were not analyzed. The claims database lacked detailed clinical information on individual patients, including cancer stages, and a separate analysis of tumor markers could not be performed.

DISCLOSURES:

The study was funded by a grant from the Korean Gastric Cancer Association. The study authors and commentary authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

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Time Warp: Fax Machines Still Common in Oncology Practice. Why?

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Wed, 07/03/2024 - 10:03

On any given day, oncologist Mark Lewis, MD, feels like he’s seesawing between two eras of technology. 

One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine. 

“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”

Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers. 

According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found. 

Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained. 

“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.” 

If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.

Or is it?

Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently. 

“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”

And when information is lost, patient care can be compromised. 

Slower Workflows, Care Concerns

Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum. 

Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices. 

“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.” 

Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said. 

Insurers and third-party laboratories often send test results back by fax as well.

“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.

“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”

Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened. 

As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added. 

“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.” 

Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients. 

Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend. 

“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said. 

Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said. 

“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”

 

 

Broader Health Policy Impacts

The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say. 

Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.

Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.

Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always. 

“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said. 

Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said. 

“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”

But, she said, “we didn’t have the level of systems in place to do it well.”

Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said. 

Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.

“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’” 

Slow, but Steady, Improvements

Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.

Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.

According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data. 

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.

Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape. 

Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care. 

EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said. 

“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”

Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology. 

But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.” 

“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
 

A version of this article appeared on Medscape.com.

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On any given day, oncologist Mark Lewis, MD, feels like he’s seesawing between two eras of technology. 

One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine. 

“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”

Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers. 

According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found. 

Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained. 

“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.” 

If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.

Or is it?

Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently. 

“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”

And when information is lost, patient care can be compromised. 

Slower Workflows, Care Concerns

Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum. 

Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices. 

“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.” 

Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said. 

Insurers and third-party laboratories often send test results back by fax as well.

“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.

“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”

Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened. 

As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added. 

“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.” 

Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients. 

Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend. 

“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said. 

Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said. 

“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”

 

 

Broader Health Policy Impacts

The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say. 

Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.

Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.

Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always. 

“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said. 

Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said. 

“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”

But, she said, “we didn’t have the level of systems in place to do it well.”

Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said. 

Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.

“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’” 

Slow, but Steady, Improvements

Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.

Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.

According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data. 

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.

Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape. 

Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care. 

EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said. 

“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”

Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology. 

But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.” 

“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
 

A version of this article appeared on Medscape.com.

On any given day, oncologist Mark Lewis, MD, feels like he’s seesawing between two eras of technology. 

One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine. 

“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”

Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers. 

According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found. 

Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained. 

“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.” 

If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.

Or is it?

Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently. 

“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”

And when information is lost, patient care can be compromised. 

Slower Workflows, Care Concerns

Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum. 

Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices. 

“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.” 

Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said. 

Insurers and third-party laboratories often send test results back by fax as well.

“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.

“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”

Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened. 

As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added. 

“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.” 

Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients. 

Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend. 

“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said. 

Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said. 

“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”

 

 

Broader Health Policy Impacts

The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say. 

Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.

Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.

Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always. 

“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said. 

Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said. 

“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”

But, she said, “we didn’t have the level of systems in place to do it well.”

Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said. 

Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.

“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’” 

Slow, but Steady, Improvements

Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.

Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.

According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data. 

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.

Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape. 

Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care. 

EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said. 

“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”

Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology. 

But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.” 

“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
 

A version of this article appeared on Medscape.com.

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Liver Resection Beats Out Alternatives in Early Multinodular HCC

Article Type
Changed
Tue, 06/25/2024 - 16:33

 

TOPLINE:

For patients with early multinodular hepatocellular carcinoma (HCC) who are ineligible for liver transplant, liver resection provides a survival advantage over percutaneous radiofrequency ablation and transarterial chemoembolization (TACE).

METHODOLOGY:

  • The presentation of HCC is often multinodular — meaning patients have two or three nodules measuring ≤ 3 cm each. Although liver resection is considered the gold standard curative treatment for early-stage disease, experts debate its efficacy in multinodular HCC, researchers explained.
  • Using two large Italian registries with data from multiple centers, researchers compared the efficacy of liver resection, percutaneous radiofrequency ablation, and TACE in 720 patients with early multinodular HCC. Overall, 296 patients underwent liver resection, 240 had percutaneous radiofrequency ablation, and 184 underwent TACE.
  • To avoid crossovers between groups, the researchers considered liver resection, percutaneous radiofrequency ablation, and TACE the main treatments in each population in a hierarchical order. That meant, in the liver resection group, researchers excluded patients undergoing a superior treatment during the follow-up, such as liver transplant. In the ablation group, patients undergoing surgery to treat HCC recurrences were excluded.
  • The primary outcome was overall survival at 1, 3, and 5 years. The researchers used a matching-adjusted indirect comparison (MAIC) to balance data and control for confounding factors between the three treatment groups.

TAKEAWAY:

  • After MAIC adjustment, the survival rate at 1 year was slightly lower in the liver resection group — 89% vs 94% in the ablation group and 91% in the TACE group. However, at 3 and 5 years, survival rates were better in the liver resection group — 71% at 3 years and 56% at 5 years vs 65% and 40%, respectively, in the ablation group and 49% and 29%, respectively, in the TACE group.
  • Median overall survival was 69 months with liver resection, 54 months with ablation, and 34 months with TACE. Multivariable Cox survival analysis confirmed a significantly higher mortality risk with ablation (hazard ratio [HR], 1.41; P = .01) and TACE (HR, 1.86; P = .001) than with liver resection.
  • In competing risk analyses, patients who underwent liver resection had a lower risk for HCC-related death than peers who had ablation (HR, 1.38; P = .07) or TACE (HR, 1.91; P = .006).
  • In a subgroup survival analysis of patients with Child-Pugh class B cirrhosis, liver resection provided significantly better overall survival than TACE (HR, 2.79; P = .001) and higher overall survival than ablation (HR, 1.44; P = .21), but these findings were not statistically significant.

IN PRACTICE:

“The main result of the current study is the indisputable superiority” of liver resection over percutaneous radiofrequency ablation and TACE in patients with multinodular HCC, the researchers concluded. “For patients with early multinodular HCC who are ineligible for transplant, LR [liver resection] should be prioritized as the primary therapeutic option,” followed by percutaneous radiofrequency ablation and TACE, when resection is not feasible.

The authors of an invited commentary said the analysis provides “convincing” data that liver resection leads to superior 3- and 5-year survival. “All of our local therapies are getting better. Making each available under different clinical circumstances and combining these when appropriate provides patients with the best chance at cure with the least invasiveness,” the editorialists added.
 

SOURCE:

The study, with first author Alessandro Vitale, MD, PhD, with the Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Padua, Italy, and the accompanying commentary were published online last month in JAMA Surgery.

LIMITATIONS:

Selection bias cannot be ruled out due to potential hidden variables that were not collected in the centers’ databases. Not all patients included in the study were potentially treatable with all three proposed approaches. The study population was derived from Italian centers, which may have limited the generalizability of the results.

DISCLOSURES:

The study reported no specific funding. The authors reported various disclosures during the conduct of the study, including ties to AstraZeneca, AbbVie, Bayer, MSD, Roche, and Eisai. An editorialist reported ties to Medtronic, Theromics, Vergent Bioscience, Imugene, Sovato Health, XDemics, and Imugene.

A version of this article first appeared on Medscape.com.

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TOPLINE:

For patients with early multinodular hepatocellular carcinoma (HCC) who are ineligible for liver transplant, liver resection provides a survival advantage over percutaneous radiofrequency ablation and transarterial chemoembolization (TACE).

METHODOLOGY:

  • The presentation of HCC is often multinodular — meaning patients have two or three nodules measuring ≤ 3 cm each. Although liver resection is considered the gold standard curative treatment for early-stage disease, experts debate its efficacy in multinodular HCC, researchers explained.
  • Using two large Italian registries with data from multiple centers, researchers compared the efficacy of liver resection, percutaneous radiofrequency ablation, and TACE in 720 patients with early multinodular HCC. Overall, 296 patients underwent liver resection, 240 had percutaneous radiofrequency ablation, and 184 underwent TACE.
  • To avoid crossovers between groups, the researchers considered liver resection, percutaneous radiofrequency ablation, and TACE the main treatments in each population in a hierarchical order. That meant, in the liver resection group, researchers excluded patients undergoing a superior treatment during the follow-up, such as liver transplant. In the ablation group, patients undergoing surgery to treat HCC recurrences were excluded.
  • The primary outcome was overall survival at 1, 3, and 5 years. The researchers used a matching-adjusted indirect comparison (MAIC) to balance data and control for confounding factors between the three treatment groups.

TAKEAWAY:

  • After MAIC adjustment, the survival rate at 1 year was slightly lower in the liver resection group — 89% vs 94% in the ablation group and 91% in the TACE group. However, at 3 and 5 years, survival rates were better in the liver resection group — 71% at 3 years and 56% at 5 years vs 65% and 40%, respectively, in the ablation group and 49% and 29%, respectively, in the TACE group.
  • Median overall survival was 69 months with liver resection, 54 months with ablation, and 34 months with TACE. Multivariable Cox survival analysis confirmed a significantly higher mortality risk with ablation (hazard ratio [HR], 1.41; P = .01) and TACE (HR, 1.86; P = .001) than with liver resection.
  • In competing risk analyses, patients who underwent liver resection had a lower risk for HCC-related death than peers who had ablation (HR, 1.38; P = .07) or TACE (HR, 1.91; P = .006).
  • In a subgroup survival analysis of patients with Child-Pugh class B cirrhosis, liver resection provided significantly better overall survival than TACE (HR, 2.79; P = .001) and higher overall survival than ablation (HR, 1.44; P = .21), but these findings were not statistically significant.

IN PRACTICE:

“The main result of the current study is the indisputable superiority” of liver resection over percutaneous radiofrequency ablation and TACE in patients with multinodular HCC, the researchers concluded. “For patients with early multinodular HCC who are ineligible for transplant, LR [liver resection] should be prioritized as the primary therapeutic option,” followed by percutaneous radiofrequency ablation and TACE, when resection is not feasible.

The authors of an invited commentary said the analysis provides “convincing” data that liver resection leads to superior 3- and 5-year survival. “All of our local therapies are getting better. Making each available under different clinical circumstances and combining these when appropriate provides patients with the best chance at cure with the least invasiveness,” the editorialists added.
 

SOURCE:

The study, with first author Alessandro Vitale, MD, PhD, with the Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Padua, Italy, and the accompanying commentary were published online last month in JAMA Surgery.

LIMITATIONS:

Selection bias cannot be ruled out due to potential hidden variables that were not collected in the centers’ databases. Not all patients included in the study were potentially treatable with all three proposed approaches. The study population was derived from Italian centers, which may have limited the generalizability of the results.

DISCLOSURES:

The study reported no specific funding. The authors reported various disclosures during the conduct of the study, including ties to AstraZeneca, AbbVie, Bayer, MSD, Roche, and Eisai. An editorialist reported ties to Medtronic, Theromics, Vergent Bioscience, Imugene, Sovato Health, XDemics, and Imugene.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

For patients with early multinodular hepatocellular carcinoma (HCC) who are ineligible for liver transplant, liver resection provides a survival advantage over percutaneous radiofrequency ablation and transarterial chemoembolization (TACE).

METHODOLOGY:

  • The presentation of HCC is often multinodular — meaning patients have two or three nodules measuring ≤ 3 cm each. Although liver resection is considered the gold standard curative treatment for early-stage disease, experts debate its efficacy in multinodular HCC, researchers explained.
  • Using two large Italian registries with data from multiple centers, researchers compared the efficacy of liver resection, percutaneous radiofrequency ablation, and TACE in 720 patients with early multinodular HCC. Overall, 296 patients underwent liver resection, 240 had percutaneous radiofrequency ablation, and 184 underwent TACE.
  • To avoid crossovers between groups, the researchers considered liver resection, percutaneous radiofrequency ablation, and TACE the main treatments in each population in a hierarchical order. That meant, in the liver resection group, researchers excluded patients undergoing a superior treatment during the follow-up, such as liver transplant. In the ablation group, patients undergoing surgery to treat HCC recurrences were excluded.
  • The primary outcome was overall survival at 1, 3, and 5 years. The researchers used a matching-adjusted indirect comparison (MAIC) to balance data and control for confounding factors between the three treatment groups.

TAKEAWAY:

  • After MAIC adjustment, the survival rate at 1 year was slightly lower in the liver resection group — 89% vs 94% in the ablation group and 91% in the TACE group. However, at 3 and 5 years, survival rates were better in the liver resection group — 71% at 3 years and 56% at 5 years vs 65% and 40%, respectively, in the ablation group and 49% and 29%, respectively, in the TACE group.
  • Median overall survival was 69 months with liver resection, 54 months with ablation, and 34 months with TACE. Multivariable Cox survival analysis confirmed a significantly higher mortality risk with ablation (hazard ratio [HR], 1.41; P = .01) and TACE (HR, 1.86; P = .001) than with liver resection.
  • In competing risk analyses, patients who underwent liver resection had a lower risk for HCC-related death than peers who had ablation (HR, 1.38; P = .07) or TACE (HR, 1.91; P = .006).
  • In a subgroup survival analysis of patients with Child-Pugh class B cirrhosis, liver resection provided significantly better overall survival than TACE (HR, 2.79; P = .001) and higher overall survival than ablation (HR, 1.44; P = .21), but these findings were not statistically significant.

IN PRACTICE:

“The main result of the current study is the indisputable superiority” of liver resection over percutaneous radiofrequency ablation and TACE in patients with multinodular HCC, the researchers concluded. “For patients with early multinodular HCC who are ineligible for transplant, LR [liver resection] should be prioritized as the primary therapeutic option,” followed by percutaneous radiofrequency ablation and TACE, when resection is not feasible.

The authors of an invited commentary said the analysis provides “convincing” data that liver resection leads to superior 3- and 5-year survival. “All of our local therapies are getting better. Making each available under different clinical circumstances and combining these when appropriate provides patients with the best chance at cure with the least invasiveness,” the editorialists added.
 

SOURCE:

The study, with first author Alessandro Vitale, MD, PhD, with the Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Padua, Italy, and the accompanying commentary were published online last month in JAMA Surgery.

LIMITATIONS:

Selection bias cannot be ruled out due to potential hidden variables that were not collected in the centers’ databases. Not all patients included in the study were potentially treatable with all three proposed approaches. The study population was derived from Italian centers, which may have limited the generalizability of the results.

DISCLOSURES:

The study reported no specific funding. The authors reported various disclosures during the conduct of the study, including ties to AstraZeneca, AbbVie, Bayer, MSD, Roche, and Eisai. An editorialist reported ties to Medtronic, Theromics, Vergent Bioscience, Imugene, Sovato Health, XDemics, and Imugene.

A version of this article first appeared on Medscape.com.

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Oncology Mergers Are on the Rise. How Can Independent Practices Survive?

Article Type
Changed
Tue, 06/25/2024 - 13:51

When he completed his fellowship at Fox Chase Cancer Center in Philadelphia, Moshe Chasky, MD, joined a small five-person practice that rented space from the city’s Jefferson Hospital in Philadelphia. The arrangement seemed to work well for the hospital and the small practice, which remained independent.

Within 10 years, the hospital sought to buy the practice, Alliance Cancer Specialists.

But the oncologists at Alliance did not want to join Jefferson.

The hospital eventually entered into an exclusive agreement with its own medical group to provide inpatient oncology/hematology services at three Jefferson Health–Northeast hospitals and stripped Dr. Chasky and his colleagues of their privileges at those facilities, Medscape Medical News reported last year.

The Alliance story is a familiar one for independent community oncology practices, said Jeff Patton, MD, CEO of OneOncology, a management services organization.

A 2020 report from the Community Oncology Alliance (COA), for instance, tracked mergers, acquisitions, and closures in the community oncology setting and found the number of practices acquired by hospitals, known as vertical integration, nearly tripled from 2010 to 2020.

“Some hospitals are pretty predatory in their approach,” Dr. Patton said. If hospitals have their own oncology program, “they’ll employ the referring doctors and then discourage them or prevent them from referring patients to our independent practices that are not owned by the hospital.”

Still, in the face of growing pressure to join hospitals, some community oncology practices are finding ways to survive and maintain their independence.
 

A Growing Trend

The latest data continue to show a clear trend: Consolidation in oncology is on the rise.

A 2024 study revealed that the pace of consolidation seems to be increasing.

The analysis found that, between 2015 and 2022, the number of medical oncologists increased by 14% and the number of medical oncologists per practice increased by 40%, while the number of practices decreased by 18%.

While about 44% of practices remain independent, the percentage of medical oncologists working in practices with more than 25 clinicians has increased from 34% in 2015 to 44% in 2022. By 2022, the largest 102 practices in the United States employed more than 40% of all medical oncologists.

“The rate of consolidation seems to be rapid,” study coauthor Parsa Erfani, MD, an internal medicine resident at Brigham & Women’s Hospital, Boston, explained.

Consolidation appears to breed more consolidation. The researchers found, for instance, that markets with greater hospital consolidation and more hospital beds per capita were more likely to undergo consolidation in oncology.

Consolidation may be higher in these markets “because hospitals or health systems are buying up oncology practices or conversely because oncology practices are merging to compete more effectively with larger hospitals in the area,” Dr. Erfani told this news organization.

Mergers among independent practices, known as horizontal integration, have also been on the rise, according to the 2020 COA report. These mergers can help counter pressures from hospitals seeking to acquire community practices as well as prevent practices and their clinics from closing.

Although Dr. Erfani’s research wasn’t designed to determine the factors behind consolidation, he and his colleagues point to the Affordable Care Act (ACA) and the federal 340B Drug Pricing Program as potential drivers of this trend.

The ACA encouraged consolidation as a way to improve efficiency and created the need for ever-larger information systems to collect and report quality data. But these data collection and reporting requirements have become increasingly difficult for smaller practices to take on.

The 340B Program, however, may be a bigger contributing factor to consolidation. Created in 1992, the 340B Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a 25%-50% discount.

Hospitals seeking to capitalize on the margins possible under the 340B Program will “buy all the referring physicians in a market so that the medical oncology group is left with little choice but to sell to the hospital,” said Dr. Patton.

“Those 340B dollars are worth a lot to hospitals,” said David A. Eagle, MD, a hematologist/oncologist with New York Cancer & Blood Specialists and past president of COA. The program “creates an appetite for nonprofit hospitals to want to grow their medical oncology programs,” he told this news organization.

Declining Medicare reimbursement has also hit independent practices hard.

Over the past 15 years, compared with inflation, physicians have gotten “a pay rate decrease from Medicare,” said Dr. Patton. Payers have followed that lead and tried to cut pay for clinicians, especially those who do not have market share, he said. Paying them less is “disingenuous knowing that our costs of providing care are going up,” he said.
 

 

 

Less Access, Higher Costs, Worse Care?

Many studies have demonstrated that, when hospitals become behemoths in a given market, healthcare costs go up.

“There are robust data showing that consolidation increases healthcare costs by reducing competition, including in oncology,” wrote Dr. Erfani and colleagues.

Oncology practices that are owned by hospitals bill facility fees for outpatient chemotherapy treatment, adding another layer of cost, the researchers explained, citing a 2019 Health Economics study.

Another analysis, published in 2020, found that hospital prices for the top 37 infused cancer drugs averaged 86% more per unit than the price charged by physician offices. Hospital outpatient departments charged even more, on average, for drugs — 128% more for nivolumab and 428% more for fluorouracil, for instance.

In their 2024 analysis, Dr. Erfani and colleagues also found that increased hospital market concentration was associated with worse quality of care, across all assessed patient satisfaction measures, and may result in worse access to care as well.

Overall, these consolidation “trends have important implications for cancer care cost, quality, and access,” the authors concluded.
 

Navigating the Consolidation Trend

In the face of mounting pressure to join hospitals, community oncology practices have typically relied on horizontal mergers to maintain their independence. An increasing number of practices, however, are now turning to another strategy: Management services organizations.

According to some oncologists, a core benefit of joining a management services organization is their community practices can maintain autonomy, hold on to referrals, and benefit from access to a wider network of peers and recently approved treatments such as chimeric antigen receptor T-cell therapies.

In these arrangements, the management company also provides business assistance to practices, including help with billing and collection, payer negotiations, supply chain issues, and credentialing, as well as recruiting, hiring, and marketing.

These management organizations, which include American Oncology Network, Integrated Oncology Network, OneOncology, and Verdi Oncology, are, however, backed by private equity. According to a 2022 report, private equity–backed management organizations have ramped up arrangements with community oncology practices over the past few years — a trend that has concerned some experts.

The authors of a recent analysis in JAMA Internal Medicine explained that, although private equity involvement in physician practices may enable operational efficiencies, “critics point to potential conflicts of interest” and highlight concerns that patients “may face additional barriers to both accessibility and affordability of care.”

The difference, according to some oncologists, is their practices are not owned by the management services organization; instead, the practices enter contracts that outline the boundaries of the relationship and stipulate fees to the management organizations.

In 2020, Dr. Chasky’s practice, Alliance Cancer Specialists, joined The US Oncology Network, a management services organization wholly owned by McKesson. The organization provides the practice with capital and other resources, as well as access to the Sarah Cannon Research Institute, so patients can participate in clinical trials.

“We totally function as an independent practice,” said Dr. Chasky. “We make our own management decisions,” he said. For instance, if Alliance wants to hire a new clinician, US Oncology helps with the recruitment. “But at the end of the day, it’s our practice,” he said.

Davey Daniel, MD — whose community practice joined the management services organization OneOncology — has seen the benefits of being part of a larger network. For instance, bispecific therapies for leukemias, lymphomas, and multiple myeloma are typically administered at academic centers because of the risk for cytokine release syndrome.

However, physician leaders in the OneOncology network “came up with a playbook on how to do it safely” in the community setting, said Dr. Daniel. “It meant that we were adopting FDA newly approved therapies in a very short course.”

Being able to draw from a wider pool of expertise has had other advantages. Dr. Daniel can lean on pathologists and research scientists in the network for advice on targeted therapy use. “We’re actually bringing precision medicine expertise to the community,” Dr. Daniel said.

Dr. Chasky and Dr. Eagle, whose practice is also part of OneOncology, said that continuing to work in the community setting has allowed them greater flexibility.

Dr. Eagle explained that New York Cancer & Blood Specialists tries to offer patients an appointment within 2 days of a referral, and it allows walk-in visits.

Dr. Chasky leans into the flexibility by having staff stay late, when needed, to ensure that all patients are seen. “We’re there for our patients at all hours,” Dr. Chasky said, adding that often “you don’t have that flexibility when you work for a big hospital system.”

The bottom line is community oncology can still thrive, said Nick Ferreyros, managing director of COA, “as long as we have a healthy competitive ecosystem where [we] are valued and seen as an important part of our cancer care system.”

A version of this article first appeared on Medscape.com.

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When he completed his fellowship at Fox Chase Cancer Center in Philadelphia, Moshe Chasky, MD, joined a small five-person practice that rented space from the city’s Jefferson Hospital in Philadelphia. The arrangement seemed to work well for the hospital and the small practice, which remained independent.

Within 10 years, the hospital sought to buy the practice, Alliance Cancer Specialists.

But the oncologists at Alliance did not want to join Jefferson.

The hospital eventually entered into an exclusive agreement with its own medical group to provide inpatient oncology/hematology services at three Jefferson Health–Northeast hospitals and stripped Dr. Chasky and his colleagues of their privileges at those facilities, Medscape Medical News reported last year.

The Alliance story is a familiar one for independent community oncology practices, said Jeff Patton, MD, CEO of OneOncology, a management services organization.

A 2020 report from the Community Oncology Alliance (COA), for instance, tracked mergers, acquisitions, and closures in the community oncology setting and found the number of practices acquired by hospitals, known as vertical integration, nearly tripled from 2010 to 2020.

“Some hospitals are pretty predatory in their approach,” Dr. Patton said. If hospitals have their own oncology program, “they’ll employ the referring doctors and then discourage them or prevent them from referring patients to our independent practices that are not owned by the hospital.”

Still, in the face of growing pressure to join hospitals, some community oncology practices are finding ways to survive and maintain their independence.
 

A Growing Trend

The latest data continue to show a clear trend: Consolidation in oncology is on the rise.

A 2024 study revealed that the pace of consolidation seems to be increasing.

The analysis found that, between 2015 and 2022, the number of medical oncologists increased by 14% and the number of medical oncologists per practice increased by 40%, while the number of practices decreased by 18%.

While about 44% of practices remain independent, the percentage of medical oncologists working in practices with more than 25 clinicians has increased from 34% in 2015 to 44% in 2022. By 2022, the largest 102 practices in the United States employed more than 40% of all medical oncologists.

“The rate of consolidation seems to be rapid,” study coauthor Parsa Erfani, MD, an internal medicine resident at Brigham & Women’s Hospital, Boston, explained.

Consolidation appears to breed more consolidation. The researchers found, for instance, that markets with greater hospital consolidation and more hospital beds per capita were more likely to undergo consolidation in oncology.

Consolidation may be higher in these markets “because hospitals or health systems are buying up oncology practices or conversely because oncology practices are merging to compete more effectively with larger hospitals in the area,” Dr. Erfani told this news organization.

Mergers among independent practices, known as horizontal integration, have also been on the rise, according to the 2020 COA report. These mergers can help counter pressures from hospitals seeking to acquire community practices as well as prevent practices and their clinics from closing.

Although Dr. Erfani’s research wasn’t designed to determine the factors behind consolidation, he and his colleagues point to the Affordable Care Act (ACA) and the federal 340B Drug Pricing Program as potential drivers of this trend.

The ACA encouraged consolidation as a way to improve efficiency and created the need for ever-larger information systems to collect and report quality data. But these data collection and reporting requirements have become increasingly difficult for smaller practices to take on.

The 340B Program, however, may be a bigger contributing factor to consolidation. Created in 1992, the 340B Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a 25%-50% discount.

Hospitals seeking to capitalize on the margins possible under the 340B Program will “buy all the referring physicians in a market so that the medical oncology group is left with little choice but to sell to the hospital,” said Dr. Patton.

“Those 340B dollars are worth a lot to hospitals,” said David A. Eagle, MD, a hematologist/oncologist with New York Cancer & Blood Specialists and past president of COA. The program “creates an appetite for nonprofit hospitals to want to grow their medical oncology programs,” he told this news organization.

Declining Medicare reimbursement has also hit independent practices hard.

Over the past 15 years, compared with inflation, physicians have gotten “a pay rate decrease from Medicare,” said Dr. Patton. Payers have followed that lead and tried to cut pay for clinicians, especially those who do not have market share, he said. Paying them less is “disingenuous knowing that our costs of providing care are going up,” he said.
 

 

 

Less Access, Higher Costs, Worse Care?

Many studies have demonstrated that, when hospitals become behemoths in a given market, healthcare costs go up.

“There are robust data showing that consolidation increases healthcare costs by reducing competition, including in oncology,” wrote Dr. Erfani and colleagues.

Oncology practices that are owned by hospitals bill facility fees for outpatient chemotherapy treatment, adding another layer of cost, the researchers explained, citing a 2019 Health Economics study.

Another analysis, published in 2020, found that hospital prices for the top 37 infused cancer drugs averaged 86% more per unit than the price charged by physician offices. Hospital outpatient departments charged even more, on average, for drugs — 128% more for nivolumab and 428% more for fluorouracil, for instance.

In their 2024 analysis, Dr. Erfani and colleagues also found that increased hospital market concentration was associated with worse quality of care, across all assessed patient satisfaction measures, and may result in worse access to care as well.

Overall, these consolidation “trends have important implications for cancer care cost, quality, and access,” the authors concluded.
 

Navigating the Consolidation Trend

In the face of mounting pressure to join hospitals, community oncology practices have typically relied on horizontal mergers to maintain their independence. An increasing number of practices, however, are now turning to another strategy: Management services organizations.

According to some oncologists, a core benefit of joining a management services organization is their community practices can maintain autonomy, hold on to referrals, and benefit from access to a wider network of peers and recently approved treatments such as chimeric antigen receptor T-cell therapies.

In these arrangements, the management company also provides business assistance to practices, including help with billing and collection, payer negotiations, supply chain issues, and credentialing, as well as recruiting, hiring, and marketing.

These management organizations, which include American Oncology Network, Integrated Oncology Network, OneOncology, and Verdi Oncology, are, however, backed by private equity. According to a 2022 report, private equity–backed management organizations have ramped up arrangements with community oncology practices over the past few years — a trend that has concerned some experts.

The authors of a recent analysis in JAMA Internal Medicine explained that, although private equity involvement in physician practices may enable operational efficiencies, “critics point to potential conflicts of interest” and highlight concerns that patients “may face additional barriers to both accessibility and affordability of care.”

The difference, according to some oncologists, is their practices are not owned by the management services organization; instead, the practices enter contracts that outline the boundaries of the relationship and stipulate fees to the management organizations.

In 2020, Dr. Chasky’s practice, Alliance Cancer Specialists, joined The US Oncology Network, a management services organization wholly owned by McKesson. The organization provides the practice with capital and other resources, as well as access to the Sarah Cannon Research Institute, so patients can participate in clinical trials.

“We totally function as an independent practice,” said Dr. Chasky. “We make our own management decisions,” he said. For instance, if Alliance wants to hire a new clinician, US Oncology helps with the recruitment. “But at the end of the day, it’s our practice,” he said.

Davey Daniel, MD — whose community practice joined the management services organization OneOncology — has seen the benefits of being part of a larger network. For instance, bispecific therapies for leukemias, lymphomas, and multiple myeloma are typically administered at academic centers because of the risk for cytokine release syndrome.

However, physician leaders in the OneOncology network “came up with a playbook on how to do it safely” in the community setting, said Dr. Daniel. “It meant that we were adopting FDA newly approved therapies in a very short course.”

Being able to draw from a wider pool of expertise has had other advantages. Dr. Daniel can lean on pathologists and research scientists in the network for advice on targeted therapy use. “We’re actually bringing precision medicine expertise to the community,” Dr. Daniel said.

Dr. Chasky and Dr. Eagle, whose practice is also part of OneOncology, said that continuing to work in the community setting has allowed them greater flexibility.

Dr. Eagle explained that New York Cancer & Blood Specialists tries to offer patients an appointment within 2 days of a referral, and it allows walk-in visits.

Dr. Chasky leans into the flexibility by having staff stay late, when needed, to ensure that all patients are seen. “We’re there for our patients at all hours,” Dr. Chasky said, adding that often “you don’t have that flexibility when you work for a big hospital system.”

The bottom line is community oncology can still thrive, said Nick Ferreyros, managing director of COA, “as long as we have a healthy competitive ecosystem where [we] are valued and seen as an important part of our cancer care system.”

A version of this article first appeared on Medscape.com.

When he completed his fellowship at Fox Chase Cancer Center in Philadelphia, Moshe Chasky, MD, joined a small five-person practice that rented space from the city’s Jefferson Hospital in Philadelphia. The arrangement seemed to work well for the hospital and the small practice, which remained independent.

Within 10 years, the hospital sought to buy the practice, Alliance Cancer Specialists.

But the oncologists at Alliance did not want to join Jefferson.

The hospital eventually entered into an exclusive agreement with its own medical group to provide inpatient oncology/hematology services at three Jefferson Health–Northeast hospitals and stripped Dr. Chasky and his colleagues of their privileges at those facilities, Medscape Medical News reported last year.

The Alliance story is a familiar one for independent community oncology practices, said Jeff Patton, MD, CEO of OneOncology, a management services organization.

A 2020 report from the Community Oncology Alliance (COA), for instance, tracked mergers, acquisitions, and closures in the community oncology setting and found the number of practices acquired by hospitals, known as vertical integration, nearly tripled from 2010 to 2020.

“Some hospitals are pretty predatory in their approach,” Dr. Patton said. If hospitals have their own oncology program, “they’ll employ the referring doctors and then discourage them or prevent them from referring patients to our independent practices that are not owned by the hospital.”

Still, in the face of growing pressure to join hospitals, some community oncology practices are finding ways to survive and maintain their independence.
 

A Growing Trend

The latest data continue to show a clear trend: Consolidation in oncology is on the rise.

A 2024 study revealed that the pace of consolidation seems to be increasing.

The analysis found that, between 2015 and 2022, the number of medical oncologists increased by 14% and the number of medical oncologists per practice increased by 40%, while the number of practices decreased by 18%.

While about 44% of practices remain independent, the percentage of medical oncologists working in practices with more than 25 clinicians has increased from 34% in 2015 to 44% in 2022. By 2022, the largest 102 practices in the United States employed more than 40% of all medical oncologists.

“The rate of consolidation seems to be rapid,” study coauthor Parsa Erfani, MD, an internal medicine resident at Brigham & Women’s Hospital, Boston, explained.

Consolidation appears to breed more consolidation. The researchers found, for instance, that markets with greater hospital consolidation and more hospital beds per capita were more likely to undergo consolidation in oncology.

Consolidation may be higher in these markets “because hospitals or health systems are buying up oncology practices or conversely because oncology practices are merging to compete more effectively with larger hospitals in the area,” Dr. Erfani told this news organization.

Mergers among independent practices, known as horizontal integration, have also been on the rise, according to the 2020 COA report. These mergers can help counter pressures from hospitals seeking to acquire community practices as well as prevent practices and their clinics from closing.

Although Dr. Erfani’s research wasn’t designed to determine the factors behind consolidation, he and his colleagues point to the Affordable Care Act (ACA) and the federal 340B Drug Pricing Program as potential drivers of this trend.

The ACA encouraged consolidation as a way to improve efficiency and created the need for ever-larger information systems to collect and report quality data. But these data collection and reporting requirements have become increasingly difficult for smaller practices to take on.

The 340B Program, however, may be a bigger contributing factor to consolidation. Created in 1992, the 340B Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a 25%-50% discount.

Hospitals seeking to capitalize on the margins possible under the 340B Program will “buy all the referring physicians in a market so that the medical oncology group is left with little choice but to sell to the hospital,” said Dr. Patton.

“Those 340B dollars are worth a lot to hospitals,” said David A. Eagle, MD, a hematologist/oncologist with New York Cancer & Blood Specialists and past president of COA. The program “creates an appetite for nonprofit hospitals to want to grow their medical oncology programs,” he told this news organization.

Declining Medicare reimbursement has also hit independent practices hard.

Over the past 15 years, compared with inflation, physicians have gotten “a pay rate decrease from Medicare,” said Dr. Patton. Payers have followed that lead and tried to cut pay for clinicians, especially those who do not have market share, he said. Paying them less is “disingenuous knowing that our costs of providing care are going up,” he said.
 

 

 

Less Access, Higher Costs, Worse Care?

Many studies have demonstrated that, when hospitals become behemoths in a given market, healthcare costs go up.

“There are robust data showing that consolidation increases healthcare costs by reducing competition, including in oncology,” wrote Dr. Erfani and colleagues.

Oncology practices that are owned by hospitals bill facility fees for outpatient chemotherapy treatment, adding another layer of cost, the researchers explained, citing a 2019 Health Economics study.

Another analysis, published in 2020, found that hospital prices for the top 37 infused cancer drugs averaged 86% more per unit than the price charged by physician offices. Hospital outpatient departments charged even more, on average, for drugs — 128% more for nivolumab and 428% more for fluorouracil, for instance.

In their 2024 analysis, Dr. Erfani and colleagues also found that increased hospital market concentration was associated with worse quality of care, across all assessed patient satisfaction measures, and may result in worse access to care as well.

Overall, these consolidation “trends have important implications for cancer care cost, quality, and access,” the authors concluded.
 

Navigating the Consolidation Trend

In the face of mounting pressure to join hospitals, community oncology practices have typically relied on horizontal mergers to maintain their independence. An increasing number of practices, however, are now turning to another strategy: Management services organizations.

According to some oncologists, a core benefit of joining a management services organization is their community practices can maintain autonomy, hold on to referrals, and benefit from access to a wider network of peers and recently approved treatments such as chimeric antigen receptor T-cell therapies.

In these arrangements, the management company also provides business assistance to practices, including help with billing and collection, payer negotiations, supply chain issues, and credentialing, as well as recruiting, hiring, and marketing.

These management organizations, which include American Oncology Network, Integrated Oncology Network, OneOncology, and Verdi Oncology, are, however, backed by private equity. According to a 2022 report, private equity–backed management organizations have ramped up arrangements with community oncology practices over the past few years — a trend that has concerned some experts.

The authors of a recent analysis in JAMA Internal Medicine explained that, although private equity involvement in physician practices may enable operational efficiencies, “critics point to potential conflicts of interest” and highlight concerns that patients “may face additional barriers to both accessibility and affordability of care.”

The difference, according to some oncologists, is their practices are not owned by the management services organization; instead, the practices enter contracts that outline the boundaries of the relationship and stipulate fees to the management organizations.

In 2020, Dr. Chasky’s practice, Alliance Cancer Specialists, joined The US Oncology Network, a management services organization wholly owned by McKesson. The organization provides the practice with capital and other resources, as well as access to the Sarah Cannon Research Institute, so patients can participate in clinical trials.

“We totally function as an independent practice,” said Dr. Chasky. “We make our own management decisions,” he said. For instance, if Alliance wants to hire a new clinician, US Oncology helps with the recruitment. “But at the end of the day, it’s our practice,” he said.

Davey Daniel, MD — whose community practice joined the management services organization OneOncology — has seen the benefits of being part of a larger network. For instance, bispecific therapies for leukemias, lymphomas, and multiple myeloma are typically administered at academic centers because of the risk for cytokine release syndrome.

However, physician leaders in the OneOncology network “came up with a playbook on how to do it safely” in the community setting, said Dr. Daniel. “It meant that we were adopting FDA newly approved therapies in a very short course.”

Being able to draw from a wider pool of expertise has had other advantages. Dr. Daniel can lean on pathologists and research scientists in the network for advice on targeted therapy use. “We’re actually bringing precision medicine expertise to the community,” Dr. Daniel said.

Dr. Chasky and Dr. Eagle, whose practice is also part of OneOncology, said that continuing to work in the community setting has allowed them greater flexibility.

Dr. Eagle explained that New York Cancer & Blood Specialists tries to offer patients an appointment within 2 days of a referral, and it allows walk-in visits.

Dr. Chasky leans into the flexibility by having staff stay late, when needed, to ensure that all patients are seen. “We’re there for our patients at all hours,” Dr. Chasky said, adding that often “you don’t have that flexibility when you work for a big hospital system.”

The bottom line is community oncology can still thrive, said Nick Ferreyros, managing director of COA, “as long as we have a healthy competitive ecosystem where [we] are valued and seen as an important part of our cancer care system.”

A version of this article first appeared on Medscape.com.

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Suicide in Surgeons: The Heavy Toll of a High-Stakes Career

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Fri, 05/24/2024 - 13:44

For those outside the medical profession, it took a global pandemic to finally understand how pervasive distress and suicide are among medical professionals, particularly surgeons.

For James Harrop, MD, it was made real years earlier by a colleague he’d trained alongside and worked with for decades — “one of the best surgeons I’ve ever seen” who, one day, just wasn’t there.

Lost in his own work, it wasn’t until Dr. Harrop, a professor of neurological and orthopedic surgery at Thomas Jefferson University, Philadelphia, read an article in The New England Journal of Medicine and realized his friend Michael Weinstein, MD, MPH, had been profoundly depressed for years and was hospitalized for his own safety.

Dr. Weinstein recovered and later gave grand rounds at Thomas Jefferson University, where he is an associate professor of surgery in the Acute Care Surgery Division. But the story stuck with Dr. Harrop.

“I said to Mike afterward, I’ve known you for 20 years and, retrospectively, going back, I never saw a single sign that you were depressed, sad, or had any issues, and he said to me ‘that’s because I did everything I could to make sure no one knew I had a problem,’ ” Dr. Harrop said during a talk on physician suicide on May 4 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.

“And that scared me because we need to help these people, we need to identify who they are.”

Surgeons at Greater Risk

Studies have reported that suicide and suicidal ideation are nearly twice as common among physicians, compared with among the general population. Among 9175 physicians surveyed in the 2023 Medscape Physician Suicide Report, 9% had considered suicide, and 1% had attempted it. The average for US adults is 4.9% and 0.5%, respectively.

Surgeons are at particularly high risk. A 2011 survey of 7905 US surgeons found that 1 in 16 (6.3%) had considered suicide in the previous year. A post-pandemic survey of more than 600 surgeons and surgical trainees reported that one in seven had suicidal ideation.

It’s often estimated that between 300 and 400 physicians die by suicide each year in the United States, but exact numbers are not known. Recent updated estimates from the National Violent Death Reporting System put the number at 119 physician suicides annually.

Notably, that’s no better than data reported more than 50 years ago in the landmark policy paper The Sick Physician: Impairment by Psychiatric Disorders, Including Alcoholism and Drug Dependence. It sounded the alarm on poor mental health in physicians and reported that 100 doctors died by suicide annually — the equivalent of the average medical school graduating class at the time.

“If I take my med school class and double it, that’s how many physicians die each year,” Dr. Harrop said. “And here’s the bad news, it starts in medical school.”

Research shows higher rates of depression and suicidal ideation in medical students and residents than in other graduates, with rates varying by stage of training, he noted.

In a multischool study, 12% of medical students and residents had probable major depression, 9.2% mild/moderate depression, and suicidal ideation jumped from 6.6% in the first year of medical school to 9.4% in year 4.

A recent AANS survey of 346 neurosurgery residents revealed 67% had burnout, and 41% seriously considered quitting. Burnout rose to a high of 76% in the second year and decreased to 49% and 54% in years 3 and 4, respectively.

Inadequate operating room exposure, hostile faculty, and stressors outside work were tied to burnout, whereas mentorship was linked to a threefold lower likelihood of burnout.

Notably, a 2019 study conservatively estimated that the annual cost of burnout-related physician turnover and reduced clinical hours was $4.6 billion nationally and $7600 per employed physician for an organization.

“We need to be kinder to each other, to look out for each other, and to talk to each other,” Dr. Harrop told conference attendees.

 

 

‘Death by a 1000 Cuts’

A host of factors are associated with physician suicide including long work hours, delayed gratification, difficulty balancing work and home life, changing healthcare systems, lawsuits, and the unique ability to prescribe medications, said Dr. Harrop.

“In my life, I think of it as death by 1000 cuts. Every day I come in, you’ve got another person attacking you,” he said, referencing Death by 1000 Cuts: Medscape National Physician Burnout & Suicide Report 2021.

Dr. Harrop told this news organization that talking with numerous experts in this field has made him appreciate that anyone is at a risk for suicide.

“The problem is an overload of external resources crushing your existence to the point that you become paralyzed and make the irrational thought that the best solution is to end your life,” he said.

Ann Stroink, MD, immediate past president of the AANS, said in an interview that one potential trigger for burnout is the current shortage of neurosurgeons in the United States, which has led to increased workloads and potential sleep deprivation among existing neurosurgeons.

“To address this critical issue, we’ve been advocating through legislative channels for additional Medicare[-funded] slots” to train more neurosurgeons, she said. “It’s imperative that we take proactive steps to ensure that our healthcare system can sustainably meet the needs of patients, while also supporting the well-being of our neurosurgical professionals.”

The AANS is also advocating for decreased regulatory burdens associated with Medicare and insurance coverage, such as prior authorization, to help alleviate the administrative burdens that often contribute to burnout among its members, Dr. Stroink said.

A Model for Suicide Prevention

Dr. Harrop emphasized that suicide is preventable and that there is “some good news.” Turning to another high-risk profession, he noted that the US Air Force was able to reduce its suicide rate by 42.7% between 1994 and 1998 by doing three basic things.

The agency established a central surveillance database, restructured prevention services, and, more importantly, began conducting annual suicide prevention and awareness training, using gatekeepers to channel at-risk personnel to appropriate agencies and performing mental health questionnaires at enrollment and annually.

Similarly, education, screening, and access to mental health treatment are core recommendations for a national response to depression and suicide in physician trainees, said Dr. Harrop, who noted that his own hospital has started using the Patient Health Questionnaire 9-item for its staff.

Asked by this news organization how much progress has been made since The Sick Physician report, Dr. Harrop said, “we are probably doing worse” in terms of the number of physician suicides, but “on a positive note, we are better with resources and acknowledgment that a problem exists.”

He noted that the AANS, which has published a physician burnout series on its Neurosurgery Blog, has shown great interest in this topic and is working to spread the word to help neurosurgeons. “My simple talk has led to me being approached by numerous people and healthcare organizations on how to further focus resources and prevention of this problem.”

Asked the one thing he would tell his friend, Michael Weinstein, a fellow surgeon, or trainee who’s struggling, Dr. Harrop said, “I am here for you, and we will get over these temporary problems, which are not significant in the big picture of what you mean to the world.”

Dr. Harrop reported serving as an adviser for Ethicon and Spiderwort.

A version of this article appeared on Medscape.com.

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For those outside the medical profession, it took a global pandemic to finally understand how pervasive distress and suicide are among medical professionals, particularly surgeons.

For James Harrop, MD, it was made real years earlier by a colleague he’d trained alongside and worked with for decades — “one of the best surgeons I’ve ever seen” who, one day, just wasn’t there.

Lost in his own work, it wasn’t until Dr. Harrop, a professor of neurological and orthopedic surgery at Thomas Jefferson University, Philadelphia, read an article in The New England Journal of Medicine and realized his friend Michael Weinstein, MD, MPH, had been profoundly depressed for years and was hospitalized for his own safety.

Dr. Weinstein recovered and later gave grand rounds at Thomas Jefferson University, where he is an associate professor of surgery in the Acute Care Surgery Division. But the story stuck with Dr. Harrop.

“I said to Mike afterward, I’ve known you for 20 years and, retrospectively, going back, I never saw a single sign that you were depressed, sad, or had any issues, and he said to me ‘that’s because I did everything I could to make sure no one knew I had a problem,’ ” Dr. Harrop said during a talk on physician suicide on May 4 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.

“And that scared me because we need to help these people, we need to identify who they are.”

Surgeons at Greater Risk

Studies have reported that suicide and suicidal ideation are nearly twice as common among physicians, compared with among the general population. Among 9175 physicians surveyed in the 2023 Medscape Physician Suicide Report, 9% had considered suicide, and 1% had attempted it. The average for US adults is 4.9% and 0.5%, respectively.

Surgeons are at particularly high risk. A 2011 survey of 7905 US surgeons found that 1 in 16 (6.3%) had considered suicide in the previous year. A post-pandemic survey of more than 600 surgeons and surgical trainees reported that one in seven had suicidal ideation.

It’s often estimated that between 300 and 400 physicians die by suicide each year in the United States, but exact numbers are not known. Recent updated estimates from the National Violent Death Reporting System put the number at 119 physician suicides annually.

Notably, that’s no better than data reported more than 50 years ago in the landmark policy paper The Sick Physician: Impairment by Psychiatric Disorders, Including Alcoholism and Drug Dependence. It sounded the alarm on poor mental health in physicians and reported that 100 doctors died by suicide annually — the equivalent of the average medical school graduating class at the time.

“If I take my med school class and double it, that’s how many physicians die each year,” Dr. Harrop said. “And here’s the bad news, it starts in medical school.”

Research shows higher rates of depression and suicidal ideation in medical students and residents than in other graduates, with rates varying by stage of training, he noted.

In a multischool study, 12% of medical students and residents had probable major depression, 9.2% mild/moderate depression, and suicidal ideation jumped from 6.6% in the first year of medical school to 9.4% in year 4.

A recent AANS survey of 346 neurosurgery residents revealed 67% had burnout, and 41% seriously considered quitting. Burnout rose to a high of 76% in the second year and decreased to 49% and 54% in years 3 and 4, respectively.

Inadequate operating room exposure, hostile faculty, and stressors outside work were tied to burnout, whereas mentorship was linked to a threefold lower likelihood of burnout.

Notably, a 2019 study conservatively estimated that the annual cost of burnout-related physician turnover and reduced clinical hours was $4.6 billion nationally and $7600 per employed physician for an organization.

“We need to be kinder to each other, to look out for each other, and to talk to each other,” Dr. Harrop told conference attendees.

 

 

‘Death by a 1000 Cuts’

A host of factors are associated with physician suicide including long work hours, delayed gratification, difficulty balancing work and home life, changing healthcare systems, lawsuits, and the unique ability to prescribe medications, said Dr. Harrop.

“In my life, I think of it as death by 1000 cuts. Every day I come in, you’ve got another person attacking you,” he said, referencing Death by 1000 Cuts: Medscape National Physician Burnout & Suicide Report 2021.

Dr. Harrop told this news organization that talking with numerous experts in this field has made him appreciate that anyone is at a risk for suicide.

“The problem is an overload of external resources crushing your existence to the point that you become paralyzed and make the irrational thought that the best solution is to end your life,” he said.

Ann Stroink, MD, immediate past president of the AANS, said in an interview that one potential trigger for burnout is the current shortage of neurosurgeons in the United States, which has led to increased workloads and potential sleep deprivation among existing neurosurgeons.

“To address this critical issue, we’ve been advocating through legislative channels for additional Medicare[-funded] slots” to train more neurosurgeons, she said. “It’s imperative that we take proactive steps to ensure that our healthcare system can sustainably meet the needs of patients, while also supporting the well-being of our neurosurgical professionals.”

The AANS is also advocating for decreased regulatory burdens associated with Medicare and insurance coverage, such as prior authorization, to help alleviate the administrative burdens that often contribute to burnout among its members, Dr. Stroink said.

A Model for Suicide Prevention

Dr. Harrop emphasized that suicide is preventable and that there is “some good news.” Turning to another high-risk profession, he noted that the US Air Force was able to reduce its suicide rate by 42.7% between 1994 and 1998 by doing three basic things.

The agency established a central surveillance database, restructured prevention services, and, more importantly, began conducting annual suicide prevention and awareness training, using gatekeepers to channel at-risk personnel to appropriate agencies and performing mental health questionnaires at enrollment and annually.

Similarly, education, screening, and access to mental health treatment are core recommendations for a national response to depression and suicide in physician trainees, said Dr. Harrop, who noted that his own hospital has started using the Patient Health Questionnaire 9-item for its staff.

Asked by this news organization how much progress has been made since The Sick Physician report, Dr. Harrop said, “we are probably doing worse” in terms of the number of physician suicides, but “on a positive note, we are better with resources and acknowledgment that a problem exists.”

He noted that the AANS, which has published a physician burnout series on its Neurosurgery Blog, has shown great interest in this topic and is working to spread the word to help neurosurgeons. “My simple talk has led to me being approached by numerous people and healthcare organizations on how to further focus resources and prevention of this problem.”

Asked the one thing he would tell his friend, Michael Weinstein, a fellow surgeon, or trainee who’s struggling, Dr. Harrop said, “I am here for you, and we will get over these temporary problems, which are not significant in the big picture of what you mean to the world.”

Dr. Harrop reported serving as an adviser for Ethicon and Spiderwort.

A version of this article appeared on Medscape.com.

For those outside the medical profession, it took a global pandemic to finally understand how pervasive distress and suicide are among medical professionals, particularly surgeons.

For James Harrop, MD, it was made real years earlier by a colleague he’d trained alongside and worked with for decades — “one of the best surgeons I’ve ever seen” who, one day, just wasn’t there.

Lost in his own work, it wasn’t until Dr. Harrop, a professor of neurological and orthopedic surgery at Thomas Jefferson University, Philadelphia, read an article in The New England Journal of Medicine and realized his friend Michael Weinstein, MD, MPH, had been profoundly depressed for years and was hospitalized for his own safety.

Dr. Weinstein recovered and later gave grand rounds at Thomas Jefferson University, where he is an associate professor of surgery in the Acute Care Surgery Division. But the story stuck with Dr. Harrop.

“I said to Mike afterward, I’ve known you for 20 years and, retrospectively, going back, I never saw a single sign that you were depressed, sad, or had any issues, and he said to me ‘that’s because I did everything I could to make sure no one knew I had a problem,’ ” Dr. Harrop said during a talk on physician suicide on May 4 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.

“And that scared me because we need to help these people, we need to identify who they are.”

Surgeons at Greater Risk

Studies have reported that suicide and suicidal ideation are nearly twice as common among physicians, compared with among the general population. Among 9175 physicians surveyed in the 2023 Medscape Physician Suicide Report, 9% had considered suicide, and 1% had attempted it. The average for US adults is 4.9% and 0.5%, respectively.

Surgeons are at particularly high risk. A 2011 survey of 7905 US surgeons found that 1 in 16 (6.3%) had considered suicide in the previous year. A post-pandemic survey of more than 600 surgeons and surgical trainees reported that one in seven had suicidal ideation.

It’s often estimated that between 300 and 400 physicians die by suicide each year in the United States, but exact numbers are not known. Recent updated estimates from the National Violent Death Reporting System put the number at 119 physician suicides annually.

Notably, that’s no better than data reported more than 50 years ago in the landmark policy paper The Sick Physician: Impairment by Psychiatric Disorders, Including Alcoholism and Drug Dependence. It sounded the alarm on poor mental health in physicians and reported that 100 doctors died by suicide annually — the equivalent of the average medical school graduating class at the time.

“If I take my med school class and double it, that’s how many physicians die each year,” Dr. Harrop said. “And here’s the bad news, it starts in medical school.”

Research shows higher rates of depression and suicidal ideation in medical students and residents than in other graduates, with rates varying by stage of training, he noted.

In a multischool study, 12% of medical students and residents had probable major depression, 9.2% mild/moderate depression, and suicidal ideation jumped from 6.6% in the first year of medical school to 9.4% in year 4.

A recent AANS survey of 346 neurosurgery residents revealed 67% had burnout, and 41% seriously considered quitting. Burnout rose to a high of 76% in the second year and decreased to 49% and 54% in years 3 and 4, respectively.

Inadequate operating room exposure, hostile faculty, and stressors outside work were tied to burnout, whereas mentorship was linked to a threefold lower likelihood of burnout.

Notably, a 2019 study conservatively estimated that the annual cost of burnout-related physician turnover and reduced clinical hours was $4.6 billion nationally and $7600 per employed physician for an organization.

“We need to be kinder to each other, to look out for each other, and to talk to each other,” Dr. Harrop told conference attendees.

 

 

‘Death by a 1000 Cuts’

A host of factors are associated with physician suicide including long work hours, delayed gratification, difficulty balancing work and home life, changing healthcare systems, lawsuits, and the unique ability to prescribe medications, said Dr. Harrop.

“In my life, I think of it as death by 1000 cuts. Every day I come in, you’ve got another person attacking you,” he said, referencing Death by 1000 Cuts: Medscape National Physician Burnout & Suicide Report 2021.

Dr. Harrop told this news organization that talking with numerous experts in this field has made him appreciate that anyone is at a risk for suicide.

“The problem is an overload of external resources crushing your existence to the point that you become paralyzed and make the irrational thought that the best solution is to end your life,” he said.

Ann Stroink, MD, immediate past president of the AANS, said in an interview that one potential trigger for burnout is the current shortage of neurosurgeons in the United States, which has led to increased workloads and potential sleep deprivation among existing neurosurgeons.

“To address this critical issue, we’ve been advocating through legislative channels for additional Medicare[-funded] slots” to train more neurosurgeons, she said. “It’s imperative that we take proactive steps to ensure that our healthcare system can sustainably meet the needs of patients, while also supporting the well-being of our neurosurgical professionals.”

The AANS is also advocating for decreased regulatory burdens associated with Medicare and insurance coverage, such as prior authorization, to help alleviate the administrative burdens that often contribute to burnout among its members, Dr. Stroink said.

A Model for Suicide Prevention

Dr. Harrop emphasized that suicide is preventable and that there is “some good news.” Turning to another high-risk profession, he noted that the US Air Force was able to reduce its suicide rate by 42.7% between 1994 and 1998 by doing three basic things.

The agency established a central surveillance database, restructured prevention services, and, more importantly, began conducting annual suicide prevention and awareness training, using gatekeepers to channel at-risk personnel to appropriate agencies and performing mental health questionnaires at enrollment and annually.

Similarly, education, screening, and access to mental health treatment are core recommendations for a national response to depression and suicide in physician trainees, said Dr. Harrop, who noted that his own hospital has started using the Patient Health Questionnaire 9-item for its staff.

Asked by this news organization how much progress has been made since The Sick Physician report, Dr. Harrop said, “we are probably doing worse” in terms of the number of physician suicides, but “on a positive note, we are better with resources and acknowledgment that a problem exists.”

He noted that the AANS, which has published a physician burnout series on its Neurosurgery Blog, has shown great interest in this topic and is working to spread the word to help neurosurgeons. “My simple talk has led to me being approached by numerous people and healthcare organizations on how to further focus resources and prevention of this problem.”

Asked the one thing he would tell his friend, Michael Weinstein, a fellow surgeon, or trainee who’s struggling, Dr. Harrop said, “I am here for you, and we will get over these temporary problems, which are not significant in the big picture of what you mean to the world.”

Dr. Harrop reported serving as an adviser for Ethicon and Spiderwort.

A version of this article appeared on Medscape.com.

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Is Axillary Surgery in Early Breast Cancer on Its Way Out?

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Tue, 04/16/2024 - 12:04

 

TOPLINE:

Omitting axillary lymph node dissection does not increase the risk for recurrence or compromise 5-year overall survival outcomes in patients with early-stage, node-negative breast cancer with sentinel-node metastases undergoing surgery and radiation therapy.

METHODOLOGY:

  • A growing body of evidence has indicated that patients with one or two positive sentinel nodes undergoing breast-conserving surgery and radiation therapy can skip axillary lymph node dissection and achieve similar outcomes compared with patients receiving axillary dissection.
  • However, these earlier studies had notable limitations, such as limited statistical power, uncertain nodal radiotherapy target volumes, and minimal data on relevant clinical subgroups.
  • To fill the gaps in the literature, the researchers conducted a trial with a large, inclusive cohort of patients with node-negative stage T1-T3 breast cancer who had one or two sentinel-node macrometastases and had undergone a mastectomy or breast-conserving surgery.
  • The trial randomized 2540 patients to either completion axillary lymph node dissection (n = 1205) or sentinel-node biopsy only (n = 1335). Nearly 90% of patients received adjuvant radiation therapy, and the majority also received systematic therapy.
  • Earlier recurrence-free survival findings and patient-reported outcomes were reported last December. The researchers now reported overall survival findings as well as secondary endpoints of breast cancer-specific survival.

TAKEAWAY:

  • The researchers reported 191 recurrences or deaths over a median follow-up of 46.8 months; 62 patients (4.6%) in the sentinel-node biopsy–only group died, and 69 patients (5.7%) in the dissection group died.
  • The biopsy-only group had an estimated 5-year overall survival of 92.9% compared with 92.0% in the dissection group and an estimated 5-year breast cancer-specific survival of 97.1% vs 96.6% in the dissection group.
  • The estimated 5-year recurrence-free survival was 89.7% in the biopsy-only group vs 88.7% in the dissection group (hazard ratio [HR], 0.89; 95% CI, 0.66-1.19).
  • This non-inferior difference held across all prespecified patient subgroups, except in patients with estrogen receptor-positive, human epidermal growth factor receptor 2–positive disease, in which sentinel biopsy alone appeared to be better (HR, 0.26).

IN PRACTICE:

“This trial provides robust evidence that the omission of completion axillary-lymph-node dissection was safe in patients with clinically node-negative T1, T2, or T3 breast cancer and one or two sentinel-node macrometastases who received adjuvant systemic treatment and radiation therapy according to national guidelines,” the authors concluded.

“It is clear that the role of axillary dissection is rapidly disappearing,” Kandace P. McGuire, MD, of Virginia Commonwealth University, Richmond, wrote in an accompanying editorial. “However, axillary staging continues to be vital with regard to decisions about appropriate breast cancer therapy.”

SOURCE:

This work, led by Jana de Boniface, MD, PhD, from Karolinska Institute, Stockholm, was published online in The New England Journal of Medicine, alongside the accompanying editorial by Dr. McGuire.

LIMITATIONS:

The study limitations include unavailable radiation therapy details for comparison, low male recruitment hindering sex-based analysis, short follow-up for luminal subtype breast cancer, unmet enrollment targets, and higher withdrawal rates in the dissection group.

DISCLOSURES:

This study was supported by the Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, and Swedish Breast Cancer Association. One coauthor reported receiving consultancy fees from various pharmaceutical companies outside this work.

A version of this article appeared on Medscape.com.

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TOPLINE:

Omitting axillary lymph node dissection does not increase the risk for recurrence or compromise 5-year overall survival outcomes in patients with early-stage, node-negative breast cancer with sentinel-node metastases undergoing surgery and radiation therapy.

METHODOLOGY:

  • A growing body of evidence has indicated that patients with one or two positive sentinel nodes undergoing breast-conserving surgery and radiation therapy can skip axillary lymph node dissection and achieve similar outcomes compared with patients receiving axillary dissection.
  • However, these earlier studies had notable limitations, such as limited statistical power, uncertain nodal radiotherapy target volumes, and minimal data on relevant clinical subgroups.
  • To fill the gaps in the literature, the researchers conducted a trial with a large, inclusive cohort of patients with node-negative stage T1-T3 breast cancer who had one or two sentinel-node macrometastases and had undergone a mastectomy or breast-conserving surgery.
  • The trial randomized 2540 patients to either completion axillary lymph node dissection (n = 1205) or sentinel-node biopsy only (n = 1335). Nearly 90% of patients received adjuvant radiation therapy, and the majority also received systematic therapy.
  • Earlier recurrence-free survival findings and patient-reported outcomes were reported last December. The researchers now reported overall survival findings as well as secondary endpoints of breast cancer-specific survival.

TAKEAWAY:

  • The researchers reported 191 recurrences or deaths over a median follow-up of 46.8 months; 62 patients (4.6%) in the sentinel-node biopsy–only group died, and 69 patients (5.7%) in the dissection group died.
  • The biopsy-only group had an estimated 5-year overall survival of 92.9% compared with 92.0% in the dissection group and an estimated 5-year breast cancer-specific survival of 97.1% vs 96.6% in the dissection group.
  • The estimated 5-year recurrence-free survival was 89.7% in the biopsy-only group vs 88.7% in the dissection group (hazard ratio [HR], 0.89; 95% CI, 0.66-1.19).
  • This non-inferior difference held across all prespecified patient subgroups, except in patients with estrogen receptor-positive, human epidermal growth factor receptor 2–positive disease, in which sentinel biopsy alone appeared to be better (HR, 0.26).

IN PRACTICE:

“This trial provides robust evidence that the omission of completion axillary-lymph-node dissection was safe in patients with clinically node-negative T1, T2, or T3 breast cancer and one or two sentinel-node macrometastases who received adjuvant systemic treatment and radiation therapy according to national guidelines,” the authors concluded.

“It is clear that the role of axillary dissection is rapidly disappearing,” Kandace P. McGuire, MD, of Virginia Commonwealth University, Richmond, wrote in an accompanying editorial. “However, axillary staging continues to be vital with regard to decisions about appropriate breast cancer therapy.”

SOURCE:

This work, led by Jana de Boniface, MD, PhD, from Karolinska Institute, Stockholm, was published online in The New England Journal of Medicine, alongside the accompanying editorial by Dr. McGuire.

LIMITATIONS:

The study limitations include unavailable radiation therapy details for comparison, low male recruitment hindering sex-based analysis, short follow-up for luminal subtype breast cancer, unmet enrollment targets, and higher withdrawal rates in the dissection group.

DISCLOSURES:

This study was supported by the Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, and Swedish Breast Cancer Association. One coauthor reported receiving consultancy fees from various pharmaceutical companies outside this work.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Omitting axillary lymph node dissection does not increase the risk for recurrence or compromise 5-year overall survival outcomes in patients with early-stage, node-negative breast cancer with sentinel-node metastases undergoing surgery and radiation therapy.

METHODOLOGY:

  • A growing body of evidence has indicated that patients with one or two positive sentinel nodes undergoing breast-conserving surgery and radiation therapy can skip axillary lymph node dissection and achieve similar outcomes compared with patients receiving axillary dissection.
  • However, these earlier studies had notable limitations, such as limited statistical power, uncertain nodal radiotherapy target volumes, and minimal data on relevant clinical subgroups.
  • To fill the gaps in the literature, the researchers conducted a trial with a large, inclusive cohort of patients with node-negative stage T1-T3 breast cancer who had one or two sentinel-node macrometastases and had undergone a mastectomy or breast-conserving surgery.
  • The trial randomized 2540 patients to either completion axillary lymph node dissection (n = 1205) or sentinel-node biopsy only (n = 1335). Nearly 90% of patients received adjuvant radiation therapy, and the majority also received systematic therapy.
  • Earlier recurrence-free survival findings and patient-reported outcomes were reported last December. The researchers now reported overall survival findings as well as secondary endpoints of breast cancer-specific survival.

TAKEAWAY:

  • The researchers reported 191 recurrences or deaths over a median follow-up of 46.8 months; 62 patients (4.6%) in the sentinel-node biopsy–only group died, and 69 patients (5.7%) in the dissection group died.
  • The biopsy-only group had an estimated 5-year overall survival of 92.9% compared with 92.0% in the dissection group and an estimated 5-year breast cancer-specific survival of 97.1% vs 96.6% in the dissection group.
  • The estimated 5-year recurrence-free survival was 89.7% in the biopsy-only group vs 88.7% in the dissection group (hazard ratio [HR], 0.89; 95% CI, 0.66-1.19).
  • This non-inferior difference held across all prespecified patient subgroups, except in patients with estrogen receptor-positive, human epidermal growth factor receptor 2–positive disease, in which sentinel biopsy alone appeared to be better (HR, 0.26).

IN PRACTICE:

“This trial provides robust evidence that the omission of completion axillary-lymph-node dissection was safe in patients with clinically node-negative T1, T2, or T3 breast cancer and one or two sentinel-node macrometastases who received adjuvant systemic treatment and radiation therapy according to national guidelines,” the authors concluded.

“It is clear that the role of axillary dissection is rapidly disappearing,” Kandace P. McGuire, MD, of Virginia Commonwealth University, Richmond, wrote in an accompanying editorial. “However, axillary staging continues to be vital with regard to decisions about appropriate breast cancer therapy.”

SOURCE:

This work, led by Jana de Boniface, MD, PhD, from Karolinska Institute, Stockholm, was published online in The New England Journal of Medicine, alongside the accompanying editorial by Dr. McGuire.

LIMITATIONS:

The study limitations include unavailable radiation therapy details for comparison, low male recruitment hindering sex-based analysis, short follow-up for luminal subtype breast cancer, unmet enrollment targets, and higher withdrawal rates in the dissection group.

DISCLOSURES:

This study was supported by the Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, and Swedish Breast Cancer Association. One coauthor reported receiving consultancy fees from various pharmaceutical companies outside this work.

A version of this article appeared on Medscape.com.

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How Medicare Reimbursement Trends Could Affect Breast Surgeries

Article Type
Changed
Mon, 04/15/2024 - 16:02

Medicare reimbursement for common breast cancer surgeries decreased significantly over the past two decades, and the resulting shortage of funds could affect quality of care and access to services, especially for vulnerable patient populations.

These were findings of new research presented by Terry P. Gao, MD, at the American Society of Breast Surgeons annual meeting.

Medicare reimbursements often set a benchmark that is followed by private insurers, and the impact of changes on various breast surgeries have not been examined, Dr. Gao, a research resident at Temple University Hospital, Philadelphia, said during a press briefing in advance of the meeting.

“This study is important because it is the first to analyze trends in Medicare reimbursement for breast cancer surgery over a long period,” Dr. Gao said during an interview. The findings highlight a critical issue that could impact access to quality care, especially for vulnerable populations, she said.
 

How Were the Data Analyzed?

Dr. Gao and colleagues reviewed percent changes in reimbursement procedures over a 20-year period and compared them to changes in the consumer price index (CPI) to show the real-life impact of inflation.

The study examined reimbursements based on the Medicare Physician Fee Schedule Look-Up Tool from 2003 to 2023 for 10 procedures. The procedures were core needle biopsy, open incisional breast biopsy, open excisional breast biopsy, lumpectomy, lumpectomy with axillary lymph node dissection (ALND), simple mastectomy, radical mastectomy, modified radical mastectomy, biopsy/removal of lymph nodes, and sentinel lymph node biopsy.
 

What Does the New Study Show?

“Reimbursements did not keep pace with the price of goods and services,” Dr. Gao said during the press briefing.

After the researchers corrected data for inflation, the overall mean Medicare reimbursement for breast cancer surgeries decreased by approximately 21%, based in part on the 69% increase in the CPI over the study period, Dr. Gao said. The greatest change was in core needle biopsy, for which reimbursement decreased by 36%.

After inflation adjustment, reimbursement increases were seen for only two procedures, lumpectomy and simple mastectomy, of 0.37% and 3.58%, respectively, but these do not represent meaningful gains, Dr. Gao said.

The researchers also used a model to estimate the real-life impact of decreased reimbursement on clinicians. They subtracted the actual 2023 compensation from expected 2023 compensation based on inflation for a breast cancer case incidence of 297,790 patients who underwent axillary surgery, breast lumpectomy, or simple mastectomy. The calculated potential real-world compensation loss for that year was $107,604,444.
 

What are the Clinical Implications? 

The current study is the first to put specific numbers on the trend in declining breast cancer payments, and the findings should encourage physicians to advocate for equitable policies, Dr. Gao noted during the briefing.

The substantial decrease in inflation-adjusted reimbursement rates was significant, she said during the interview. Although the decrease reflects similar trends seen in other specialties, the magnitude is a potential cause for concern, she said.

Declining reimbursements could disproportionately hurt safety-net hospitals serving vulnerable populations by limiting their ability to invest in better care and potentially worsening existing racial disparities, Dr. Gao told this publication. “Additionally, surgeons may opt out of Medicare networks due to low rates, leading to access issues and longer wait times. Finally, these trends could discourage future generations from specializing in breast cancer surgery.”

The study findings should be considered in the context of the complex and rapidly changing clinical landscape in which breast cancer care is evolving, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said during an interview.

“Surgery remains a critically important aspect to curative treatment,” Dr. Teshome said.

Surgical decision-making tailored to each patient’s goals involves coordination from a multidisciplinary team as well as skill and attention from surgeons, she added.

“This degree of specialization and nuance is not always captured in reimbursement models for breast surgery,” Dr. Teshome emphasized. The policy implications of any changes in Medicare reimbursement will be important given the American Cancer Society reports breast cancer as the most commonly diagnosed cancer in women in the United States, and as the second leading cause of cancer death in US women, she noted.
 

What Additional Research Is Needed?

Research is needed to understand how declining reimbursements affect patients’ access to care, treatment choices, and long-term outcomes, Dr. Gao said in the interview. Future studies also are needed to examine provider overhead costs, staffing structures, and profit margins to offer a more comprehensive understanding of financial sustainability.

Dr. Gao and Dr. Teshome had no financial conflicts to disclose.

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Medicare reimbursement for common breast cancer surgeries decreased significantly over the past two decades, and the resulting shortage of funds could affect quality of care and access to services, especially for vulnerable patient populations.

These were findings of new research presented by Terry P. Gao, MD, at the American Society of Breast Surgeons annual meeting.

Medicare reimbursements often set a benchmark that is followed by private insurers, and the impact of changes on various breast surgeries have not been examined, Dr. Gao, a research resident at Temple University Hospital, Philadelphia, said during a press briefing in advance of the meeting.

“This study is important because it is the first to analyze trends in Medicare reimbursement for breast cancer surgery over a long period,” Dr. Gao said during an interview. The findings highlight a critical issue that could impact access to quality care, especially for vulnerable populations, she said.
 

How Were the Data Analyzed?

Dr. Gao and colleagues reviewed percent changes in reimbursement procedures over a 20-year period and compared them to changes in the consumer price index (CPI) to show the real-life impact of inflation.

The study examined reimbursements based on the Medicare Physician Fee Schedule Look-Up Tool from 2003 to 2023 for 10 procedures. The procedures were core needle biopsy, open incisional breast biopsy, open excisional breast biopsy, lumpectomy, lumpectomy with axillary lymph node dissection (ALND), simple mastectomy, radical mastectomy, modified radical mastectomy, biopsy/removal of lymph nodes, and sentinel lymph node biopsy.
 

What Does the New Study Show?

“Reimbursements did not keep pace with the price of goods and services,” Dr. Gao said during the press briefing.

After the researchers corrected data for inflation, the overall mean Medicare reimbursement for breast cancer surgeries decreased by approximately 21%, based in part on the 69% increase in the CPI over the study period, Dr. Gao said. The greatest change was in core needle biopsy, for which reimbursement decreased by 36%.

After inflation adjustment, reimbursement increases were seen for only two procedures, lumpectomy and simple mastectomy, of 0.37% and 3.58%, respectively, but these do not represent meaningful gains, Dr. Gao said.

The researchers also used a model to estimate the real-life impact of decreased reimbursement on clinicians. They subtracted the actual 2023 compensation from expected 2023 compensation based on inflation for a breast cancer case incidence of 297,790 patients who underwent axillary surgery, breast lumpectomy, or simple mastectomy. The calculated potential real-world compensation loss for that year was $107,604,444.
 

What are the Clinical Implications? 

The current study is the first to put specific numbers on the trend in declining breast cancer payments, and the findings should encourage physicians to advocate for equitable policies, Dr. Gao noted during the briefing.

The substantial decrease in inflation-adjusted reimbursement rates was significant, she said during the interview. Although the decrease reflects similar trends seen in other specialties, the magnitude is a potential cause for concern, she said.

Declining reimbursements could disproportionately hurt safety-net hospitals serving vulnerable populations by limiting their ability to invest in better care and potentially worsening existing racial disparities, Dr. Gao told this publication. “Additionally, surgeons may opt out of Medicare networks due to low rates, leading to access issues and longer wait times. Finally, these trends could discourage future generations from specializing in breast cancer surgery.”

The study findings should be considered in the context of the complex and rapidly changing clinical landscape in which breast cancer care is evolving, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said during an interview.

“Surgery remains a critically important aspect to curative treatment,” Dr. Teshome said.

Surgical decision-making tailored to each patient’s goals involves coordination from a multidisciplinary team as well as skill and attention from surgeons, she added.

“This degree of specialization and nuance is not always captured in reimbursement models for breast surgery,” Dr. Teshome emphasized. The policy implications of any changes in Medicare reimbursement will be important given the American Cancer Society reports breast cancer as the most commonly diagnosed cancer in women in the United States, and as the second leading cause of cancer death in US women, she noted.
 

What Additional Research Is Needed?

Research is needed to understand how declining reimbursements affect patients’ access to care, treatment choices, and long-term outcomes, Dr. Gao said in the interview. Future studies also are needed to examine provider overhead costs, staffing structures, and profit margins to offer a more comprehensive understanding of financial sustainability.

Dr. Gao and Dr. Teshome had no financial conflicts to disclose.

Medicare reimbursement for common breast cancer surgeries decreased significantly over the past two decades, and the resulting shortage of funds could affect quality of care and access to services, especially for vulnerable patient populations.

These were findings of new research presented by Terry P. Gao, MD, at the American Society of Breast Surgeons annual meeting.

Medicare reimbursements often set a benchmark that is followed by private insurers, and the impact of changes on various breast surgeries have not been examined, Dr. Gao, a research resident at Temple University Hospital, Philadelphia, said during a press briefing in advance of the meeting.

“This study is important because it is the first to analyze trends in Medicare reimbursement for breast cancer surgery over a long period,” Dr. Gao said during an interview. The findings highlight a critical issue that could impact access to quality care, especially for vulnerable populations, she said.
 

How Were the Data Analyzed?

Dr. Gao and colleagues reviewed percent changes in reimbursement procedures over a 20-year period and compared them to changes in the consumer price index (CPI) to show the real-life impact of inflation.

The study examined reimbursements based on the Medicare Physician Fee Schedule Look-Up Tool from 2003 to 2023 for 10 procedures. The procedures were core needle biopsy, open incisional breast biopsy, open excisional breast biopsy, lumpectomy, lumpectomy with axillary lymph node dissection (ALND), simple mastectomy, radical mastectomy, modified radical mastectomy, biopsy/removal of lymph nodes, and sentinel lymph node biopsy.
 

What Does the New Study Show?

“Reimbursements did not keep pace with the price of goods and services,” Dr. Gao said during the press briefing.

After the researchers corrected data for inflation, the overall mean Medicare reimbursement for breast cancer surgeries decreased by approximately 21%, based in part on the 69% increase in the CPI over the study period, Dr. Gao said. The greatest change was in core needle biopsy, for which reimbursement decreased by 36%.

After inflation adjustment, reimbursement increases were seen for only two procedures, lumpectomy and simple mastectomy, of 0.37% and 3.58%, respectively, but these do not represent meaningful gains, Dr. Gao said.

The researchers also used a model to estimate the real-life impact of decreased reimbursement on clinicians. They subtracted the actual 2023 compensation from expected 2023 compensation based on inflation for a breast cancer case incidence of 297,790 patients who underwent axillary surgery, breast lumpectomy, or simple mastectomy. The calculated potential real-world compensation loss for that year was $107,604,444.
 

What are the Clinical Implications? 

The current study is the first to put specific numbers on the trend in declining breast cancer payments, and the findings should encourage physicians to advocate for equitable policies, Dr. Gao noted during the briefing.

The substantial decrease in inflation-adjusted reimbursement rates was significant, she said during the interview. Although the decrease reflects similar trends seen in other specialties, the magnitude is a potential cause for concern, she said.

Declining reimbursements could disproportionately hurt safety-net hospitals serving vulnerable populations by limiting their ability to invest in better care and potentially worsening existing racial disparities, Dr. Gao told this publication. “Additionally, surgeons may opt out of Medicare networks due to low rates, leading to access issues and longer wait times. Finally, these trends could discourage future generations from specializing in breast cancer surgery.”

The study findings should be considered in the context of the complex and rapidly changing clinical landscape in which breast cancer care is evolving, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said during an interview.

“Surgery remains a critically important aspect to curative treatment,” Dr. Teshome said.

Surgical decision-making tailored to each patient’s goals involves coordination from a multidisciplinary team as well as skill and attention from surgeons, she added.

“This degree of specialization and nuance is not always captured in reimbursement models for breast surgery,” Dr. Teshome emphasized. The policy implications of any changes in Medicare reimbursement will be important given the American Cancer Society reports breast cancer as the most commonly diagnosed cancer in women in the United States, and as the second leading cause of cancer death in US women, she noted.
 

What Additional Research Is Needed?

Research is needed to understand how declining reimbursements affect patients’ access to care, treatment choices, and long-term outcomes, Dr. Gao said in the interview. Future studies also are needed to examine provider overhead costs, staffing structures, and profit margins to offer a more comprehensive understanding of financial sustainability.

Dr. Gao and Dr. Teshome had no financial conflicts to disclose.

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FROM THE AMERICAN SOCIETY OF BREAST SURGEONS ANNUAL MEETING

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Minimally Invasive Cytoreductive Approach Comparable to Open Surgery for Ovarian Cancer

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Mon, 03/25/2024 - 16:09

Minimally invasive cytoreductive surgery for epithelial ovarian cancer appears to be safe and does not compromise survival, compared with open surgery, when patients have completely resected tumors.

This was a finding of a retrospective study presented by Judy Hayek, MD, during an oral abstract session at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, in San Diego.

Among 2,412 women in the National Cancer Database with tumor-free surgical margins (R0 resections) after interval debulking surgery (IDS), the median overall survival (OS) was 46 months for those who had undergone an open procedure or minimally invasive surgery (MIS) that was converted to an open procedure. In contrast, the median OS was 51 months for patients who underwent laparoscopic or robot-assisted minimally invasive surgery, reported Dr. Hayek, a gynecologic oncology fellow at SUNY Downstate Health Sciences University in Brooklyn, New York.

“R0 resection at the time of interval debulking surgery has similar survival outcomes by minimally invasive surgery versus laparotomy, while R0 resection via laparotomy is associated with higher perioperative mortality. There is no interaction between the extent of surgery and the impact of MIS on survival,” she said during her presentation.

The session included a debate on the pros and cons of minimally invasive vs. open surgery in this population.
 

Growing Use of MIS

Over the last decade, minimally invasive surgery for interval debulking was shown to be safe and feasible. More recently, two studies using National Cancer Database cohorts showed that survival was similar and perioperative outcomes were better with a minimally invasive approach at the time of IDS for patients with early disease, Dr. Hayek said (Obstet Gynecol 2017 Jul;130(1):71-79; and Gynecol Oncol 2023 May:172:130-137).

Potential limitations of MIS include the absence of haptic feedback compared with open surgery, and the possibility that limited visualization of the surgical field could lead to missed residual disease and subsequent poor outcomes for patients who were presumed to have complete gross resections, she said.
 

Outcomes Compared

Dr. Hayek and colleagues conducted their study to evaluate survival outcomes after R0 resections by MIS or laparotomy in IDS for patients with advanced epithelial ovarian cancer.

As noted before, they looked at outcomes for 2,412 women with stage IIIC or IV cancers of all histology types who were diagnosed from 2010 through 2019. A total of 624 patients (25.9%) had minimally invasive procedures, and 1,788 (74.1%) had open surgery or MIS that had been converted to open procedures.

Of the minimally invasive procedures, 48.7% were robot-assisted, and the remainder were laparoscopic.

Over the decade of the study, the frequency of minimally invasive surgery steadily increased, from 11.9% of all procedures in 2010 to 36.5% in 2019.

Also as noted, there was no difference in median overall survival, at 46 months for open/converted procedures vs. 51 months for minimally invasive procedures.

As might be expected, the mean length of stay was shorter with the less invasive surgery: 3.3 days compared with 5.3 days with open surgery (P less than .001). In addition, 30-day and 90-day mortality rates were also lower with MIS, at 0.8% and 1.9%, respectively, compared with 1.6% and 3.5% with laparotomy (P = .006 for 30-day mortality, and .003 for 90-day).

There were also no differences in overall survival between the procedure types when the cases were stratified according to extent of surgery. Within the minimally invasive surgery groups there were no differences in median OS for patients whose surgery was performed laparoscopically or with robotic assistance.

The study was limited by a lack of data on either patient-specific tumor burden, neoadjuvant chemotherapy use, progression-free survival, cause of death, or surgical morbidity, Dr. Hayek acknowledged.
 

 

 

MIS Use Debatable: CON

Despite the good outcomes with minimally invasive techniques in this favorable-risk population, critics contend that MIS interval cytoreduction is too risky in the majority of cases.

In the debate portion of the session, Kara Long Roche, MD, an associate attending in the section of ovarian cancer surgery at Memorial Sloan Kettering Cancer Center in New York, argued that the potential for MIS missing residual disease is too great.

“We know from almost every retrospective and prospective study done that the volume of residual disease after debulking, whether primary or interval, is the most important prognostic factor for our patients that we can modify,” she said.

Rather than debating morbidity, mortality, or criteria for resection, “I would argue that the question we need to debate is can MIS interval debulking achieve a completeness of resection, i.e., volume of residual disease?” she said.

Dr. Roche contended that retrospective studies such as that reported by Dr. Hayek cannot adequately answer this question because of selection bias. Patients selected for MIS have better responses to neoadjuvant chemotherapy and more favorable tumor biology; and, therefore, overall survival may not be the optimal endpoint for retrospective studies.

In addition, neoadjuvant chemotherapy does not automatically preclude the need for extensive upper abdominal surgery since almost half of patients who receive neoadjuvant chemotherapy are found to have bulky upper abdominal disease at the time of debulking.

Dr. Roche especially cautioned against what she called the WNL or “We Never Looked” phenomenon, in which patients are found on open surgery and organ mobilization to have disease that was not evident on presurgical imaging.

She acknowledged that for some patients the risks of laparotomy are likely to outweigh the benefit of a radical resection, and stressed that for such patients forgoing surgery or optimizing perioperative care may be more important than the size of the incision.

MIS IDS should be the exception, not the rule. We need prospective data with appropriate endpoints. We need surgical quality control in both arms, and we need to continue to focus on surgical education and training so that our trainees can graduate doing these procedures via any approach,” she concluded.
 

Debate: PRO

Arguing in favor of MIS for ovarian cancer, J. Alejandro Rauh-Hain, MD, MPH, associate professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center in Houston, told attendees “the only bias I have is that I actually love doing open surgery, but I’m going to try to convince you that there is a potential role for minimally invasive surgery in the future for selected patients with ovarian cancer after neoadjuvant chemotherapy.”

He noted that several studies have convincingly shown that neoadjuvant chemotherapy does not adversely affect oncologic outcomes for patients with advanced-stage ovarian cancer, and decreases perioperative morbidity in patients who receive it, including reductions in serious adverse events, risk of stoma, and 30-day postoperative mortality.

In addition, low use of neoadjuvant chemotherapy is associated with increased risks for 90-day postoperative deaths in both low- and high surgical volume centers in the US, according to unpublished National Cancer Database data.

Dr. Rauh-Hain noted that neoadjuvant chemotherapy use has steadily increased from 2010 through 2020, and added that in 2022, 32% of interval cytoreductive surgeries in the United States were performed with a minimally invasive approach.

To get a better handle on the MIS vs. open-surgery question, Dr. Rauh-Hain and colleagues at MD Anderson and 13 other centers in the United States, Canada, and Europe are currently recruiting patients for the Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy (LANCE) trial. In this phase 3 noninferiority study, patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who have complete or partial responses and CA125 normalization after three or four cycles of neoadjuvant chemotherapy will be randomized to laparotomy or MIS, followed by adjuvant platinum- and taxane-based chemotherapy.

The study by Hayek et al. was internally supported. Dr. Hayek and Dr. Roche reported having no conflicts of interest. Dr. Rauh-Hain disclosed financial relationships with Guidepoint Consulting, and the Schlesinger Group.

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Minimally invasive cytoreductive surgery for epithelial ovarian cancer appears to be safe and does not compromise survival, compared with open surgery, when patients have completely resected tumors.

This was a finding of a retrospective study presented by Judy Hayek, MD, during an oral abstract session at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, in San Diego.

Among 2,412 women in the National Cancer Database with tumor-free surgical margins (R0 resections) after interval debulking surgery (IDS), the median overall survival (OS) was 46 months for those who had undergone an open procedure or minimally invasive surgery (MIS) that was converted to an open procedure. In contrast, the median OS was 51 months for patients who underwent laparoscopic or robot-assisted minimally invasive surgery, reported Dr. Hayek, a gynecologic oncology fellow at SUNY Downstate Health Sciences University in Brooklyn, New York.

“R0 resection at the time of interval debulking surgery has similar survival outcomes by minimally invasive surgery versus laparotomy, while R0 resection via laparotomy is associated with higher perioperative mortality. There is no interaction between the extent of surgery and the impact of MIS on survival,” she said during her presentation.

The session included a debate on the pros and cons of minimally invasive vs. open surgery in this population.
 

Growing Use of MIS

Over the last decade, minimally invasive surgery for interval debulking was shown to be safe and feasible. More recently, two studies using National Cancer Database cohorts showed that survival was similar and perioperative outcomes were better with a minimally invasive approach at the time of IDS for patients with early disease, Dr. Hayek said (Obstet Gynecol 2017 Jul;130(1):71-79; and Gynecol Oncol 2023 May:172:130-137).

Potential limitations of MIS include the absence of haptic feedback compared with open surgery, and the possibility that limited visualization of the surgical field could lead to missed residual disease and subsequent poor outcomes for patients who were presumed to have complete gross resections, she said.
 

Outcomes Compared

Dr. Hayek and colleagues conducted their study to evaluate survival outcomes after R0 resections by MIS or laparotomy in IDS for patients with advanced epithelial ovarian cancer.

As noted before, they looked at outcomes for 2,412 women with stage IIIC or IV cancers of all histology types who were diagnosed from 2010 through 2019. A total of 624 patients (25.9%) had minimally invasive procedures, and 1,788 (74.1%) had open surgery or MIS that had been converted to open procedures.

Of the minimally invasive procedures, 48.7% were robot-assisted, and the remainder were laparoscopic.

Over the decade of the study, the frequency of minimally invasive surgery steadily increased, from 11.9% of all procedures in 2010 to 36.5% in 2019.

Also as noted, there was no difference in median overall survival, at 46 months for open/converted procedures vs. 51 months for minimally invasive procedures.

As might be expected, the mean length of stay was shorter with the less invasive surgery: 3.3 days compared with 5.3 days with open surgery (P less than .001). In addition, 30-day and 90-day mortality rates were also lower with MIS, at 0.8% and 1.9%, respectively, compared with 1.6% and 3.5% with laparotomy (P = .006 for 30-day mortality, and .003 for 90-day).

There were also no differences in overall survival between the procedure types when the cases were stratified according to extent of surgery. Within the minimally invasive surgery groups there were no differences in median OS for patients whose surgery was performed laparoscopically or with robotic assistance.

The study was limited by a lack of data on either patient-specific tumor burden, neoadjuvant chemotherapy use, progression-free survival, cause of death, or surgical morbidity, Dr. Hayek acknowledged.
 

 

 

MIS Use Debatable: CON

Despite the good outcomes with minimally invasive techniques in this favorable-risk population, critics contend that MIS interval cytoreduction is too risky in the majority of cases.

In the debate portion of the session, Kara Long Roche, MD, an associate attending in the section of ovarian cancer surgery at Memorial Sloan Kettering Cancer Center in New York, argued that the potential for MIS missing residual disease is too great.

“We know from almost every retrospective and prospective study done that the volume of residual disease after debulking, whether primary or interval, is the most important prognostic factor for our patients that we can modify,” she said.

Rather than debating morbidity, mortality, or criteria for resection, “I would argue that the question we need to debate is can MIS interval debulking achieve a completeness of resection, i.e., volume of residual disease?” she said.

Dr. Roche contended that retrospective studies such as that reported by Dr. Hayek cannot adequately answer this question because of selection bias. Patients selected for MIS have better responses to neoadjuvant chemotherapy and more favorable tumor biology; and, therefore, overall survival may not be the optimal endpoint for retrospective studies.

In addition, neoadjuvant chemotherapy does not automatically preclude the need for extensive upper abdominal surgery since almost half of patients who receive neoadjuvant chemotherapy are found to have bulky upper abdominal disease at the time of debulking.

Dr. Roche especially cautioned against what she called the WNL or “We Never Looked” phenomenon, in which patients are found on open surgery and organ mobilization to have disease that was not evident on presurgical imaging.

She acknowledged that for some patients the risks of laparotomy are likely to outweigh the benefit of a radical resection, and stressed that for such patients forgoing surgery or optimizing perioperative care may be more important than the size of the incision.

MIS IDS should be the exception, not the rule. We need prospective data with appropriate endpoints. We need surgical quality control in both arms, and we need to continue to focus on surgical education and training so that our trainees can graduate doing these procedures via any approach,” she concluded.
 

Debate: PRO

Arguing in favor of MIS for ovarian cancer, J. Alejandro Rauh-Hain, MD, MPH, associate professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center in Houston, told attendees “the only bias I have is that I actually love doing open surgery, but I’m going to try to convince you that there is a potential role for minimally invasive surgery in the future for selected patients with ovarian cancer after neoadjuvant chemotherapy.”

He noted that several studies have convincingly shown that neoadjuvant chemotherapy does not adversely affect oncologic outcomes for patients with advanced-stage ovarian cancer, and decreases perioperative morbidity in patients who receive it, including reductions in serious adverse events, risk of stoma, and 30-day postoperative mortality.

In addition, low use of neoadjuvant chemotherapy is associated with increased risks for 90-day postoperative deaths in both low- and high surgical volume centers in the US, according to unpublished National Cancer Database data.

Dr. Rauh-Hain noted that neoadjuvant chemotherapy use has steadily increased from 2010 through 2020, and added that in 2022, 32% of interval cytoreductive surgeries in the United States were performed with a minimally invasive approach.

To get a better handle on the MIS vs. open-surgery question, Dr. Rauh-Hain and colleagues at MD Anderson and 13 other centers in the United States, Canada, and Europe are currently recruiting patients for the Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy (LANCE) trial. In this phase 3 noninferiority study, patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who have complete or partial responses and CA125 normalization after three or four cycles of neoadjuvant chemotherapy will be randomized to laparotomy or MIS, followed by adjuvant platinum- and taxane-based chemotherapy.

The study by Hayek et al. was internally supported. Dr. Hayek and Dr. Roche reported having no conflicts of interest. Dr. Rauh-Hain disclosed financial relationships with Guidepoint Consulting, and the Schlesinger Group.

Minimally invasive cytoreductive surgery for epithelial ovarian cancer appears to be safe and does not compromise survival, compared with open surgery, when patients have completely resected tumors.

This was a finding of a retrospective study presented by Judy Hayek, MD, during an oral abstract session at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, in San Diego.

Among 2,412 women in the National Cancer Database with tumor-free surgical margins (R0 resections) after interval debulking surgery (IDS), the median overall survival (OS) was 46 months for those who had undergone an open procedure or minimally invasive surgery (MIS) that was converted to an open procedure. In contrast, the median OS was 51 months for patients who underwent laparoscopic or robot-assisted minimally invasive surgery, reported Dr. Hayek, a gynecologic oncology fellow at SUNY Downstate Health Sciences University in Brooklyn, New York.

“R0 resection at the time of interval debulking surgery has similar survival outcomes by minimally invasive surgery versus laparotomy, while R0 resection via laparotomy is associated with higher perioperative mortality. There is no interaction between the extent of surgery and the impact of MIS on survival,” she said during her presentation.

The session included a debate on the pros and cons of minimally invasive vs. open surgery in this population.
 

Growing Use of MIS

Over the last decade, minimally invasive surgery for interval debulking was shown to be safe and feasible. More recently, two studies using National Cancer Database cohorts showed that survival was similar and perioperative outcomes were better with a minimally invasive approach at the time of IDS for patients with early disease, Dr. Hayek said (Obstet Gynecol 2017 Jul;130(1):71-79; and Gynecol Oncol 2023 May:172:130-137).

Potential limitations of MIS include the absence of haptic feedback compared with open surgery, and the possibility that limited visualization of the surgical field could lead to missed residual disease and subsequent poor outcomes for patients who were presumed to have complete gross resections, she said.
 

Outcomes Compared

Dr. Hayek and colleagues conducted their study to evaluate survival outcomes after R0 resections by MIS or laparotomy in IDS for patients with advanced epithelial ovarian cancer.

As noted before, they looked at outcomes for 2,412 women with stage IIIC or IV cancers of all histology types who were diagnosed from 2010 through 2019. A total of 624 patients (25.9%) had minimally invasive procedures, and 1,788 (74.1%) had open surgery or MIS that had been converted to open procedures.

Of the minimally invasive procedures, 48.7% were robot-assisted, and the remainder were laparoscopic.

Over the decade of the study, the frequency of minimally invasive surgery steadily increased, from 11.9% of all procedures in 2010 to 36.5% in 2019.

Also as noted, there was no difference in median overall survival, at 46 months for open/converted procedures vs. 51 months for minimally invasive procedures.

As might be expected, the mean length of stay was shorter with the less invasive surgery: 3.3 days compared with 5.3 days with open surgery (P less than .001). In addition, 30-day and 90-day mortality rates were also lower with MIS, at 0.8% and 1.9%, respectively, compared with 1.6% and 3.5% with laparotomy (P = .006 for 30-day mortality, and .003 for 90-day).

There were also no differences in overall survival between the procedure types when the cases were stratified according to extent of surgery. Within the minimally invasive surgery groups there were no differences in median OS for patients whose surgery was performed laparoscopically or with robotic assistance.

The study was limited by a lack of data on either patient-specific tumor burden, neoadjuvant chemotherapy use, progression-free survival, cause of death, or surgical morbidity, Dr. Hayek acknowledged.
 

 

 

MIS Use Debatable: CON

Despite the good outcomes with minimally invasive techniques in this favorable-risk population, critics contend that MIS interval cytoreduction is too risky in the majority of cases.

In the debate portion of the session, Kara Long Roche, MD, an associate attending in the section of ovarian cancer surgery at Memorial Sloan Kettering Cancer Center in New York, argued that the potential for MIS missing residual disease is too great.

“We know from almost every retrospective and prospective study done that the volume of residual disease after debulking, whether primary or interval, is the most important prognostic factor for our patients that we can modify,” she said.

Rather than debating morbidity, mortality, or criteria for resection, “I would argue that the question we need to debate is can MIS interval debulking achieve a completeness of resection, i.e., volume of residual disease?” she said.

Dr. Roche contended that retrospective studies such as that reported by Dr. Hayek cannot adequately answer this question because of selection bias. Patients selected for MIS have better responses to neoadjuvant chemotherapy and more favorable tumor biology; and, therefore, overall survival may not be the optimal endpoint for retrospective studies.

In addition, neoadjuvant chemotherapy does not automatically preclude the need for extensive upper abdominal surgery since almost half of patients who receive neoadjuvant chemotherapy are found to have bulky upper abdominal disease at the time of debulking.

Dr. Roche especially cautioned against what she called the WNL or “We Never Looked” phenomenon, in which patients are found on open surgery and organ mobilization to have disease that was not evident on presurgical imaging.

She acknowledged that for some patients the risks of laparotomy are likely to outweigh the benefit of a radical resection, and stressed that for such patients forgoing surgery or optimizing perioperative care may be more important than the size of the incision.

MIS IDS should be the exception, not the rule. We need prospective data with appropriate endpoints. We need surgical quality control in both arms, and we need to continue to focus on surgical education and training so that our trainees can graduate doing these procedures via any approach,” she concluded.
 

Debate: PRO

Arguing in favor of MIS for ovarian cancer, J. Alejandro Rauh-Hain, MD, MPH, associate professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center in Houston, told attendees “the only bias I have is that I actually love doing open surgery, but I’m going to try to convince you that there is a potential role for minimally invasive surgery in the future for selected patients with ovarian cancer after neoadjuvant chemotherapy.”

He noted that several studies have convincingly shown that neoadjuvant chemotherapy does not adversely affect oncologic outcomes for patients with advanced-stage ovarian cancer, and decreases perioperative morbidity in patients who receive it, including reductions in serious adverse events, risk of stoma, and 30-day postoperative mortality.

In addition, low use of neoadjuvant chemotherapy is associated with increased risks for 90-day postoperative deaths in both low- and high surgical volume centers in the US, according to unpublished National Cancer Database data.

Dr. Rauh-Hain noted that neoadjuvant chemotherapy use has steadily increased from 2010 through 2020, and added that in 2022, 32% of interval cytoreductive surgeries in the United States were performed with a minimally invasive approach.

To get a better handle on the MIS vs. open-surgery question, Dr. Rauh-Hain and colleagues at MD Anderson and 13 other centers in the United States, Canada, and Europe are currently recruiting patients for the Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy (LANCE) trial. In this phase 3 noninferiority study, patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who have complete or partial responses and CA125 normalization after three or four cycles of neoadjuvant chemotherapy will be randomized to laparotomy or MIS, followed by adjuvant platinum- and taxane-based chemotherapy.

The study by Hayek et al. was internally supported. Dr. Hayek and Dr. Roche reported having no conflicts of interest. Dr. Rauh-Hain disclosed financial relationships with Guidepoint Consulting, and the Schlesinger Group.

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