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ALC/AMC prognostic in mantle cell lymphoma
The peripheral blood absolute lymphocyte-to-monocyte ratio (ALC/AMC) was prognostic for overall survival in mantle cell lymphoma patients who have undergone induction therapy, based on a retrospective review study of 96 patients by Andre Goy, MD, of John Theurer Cancer Center, Hackensack (NJ) University, and his colleagues.
Overall survival was better when ALC/AMC was 2 or greater following induction therapy, the researchers wrote in an abstract published in conjunction with the annual meeting of the American Society of Clinical Oncology.
The finding indicates that novel maintenance programs, including targeting the microenvironment or immune response, might be appropriate when patients with mantle cell lymphoma have low ALC/AMC.
The researchers examined data for 96 consecutive mantle cell lymphoma patients. The ALC/AMC was determined from peripheral blood counts obtained approximately 30 days following completion of initial therapy or immediately prior to stem cell mobilization in patients who had first line stem cell transplants.
The ALC/AMC was less than 2 in 67 patients and was 2 or greater in 29 patients. The two patient cohorts were similar in median age, ethnicities, stage distributions, elevated beta-2-microglobulin, elevated lactate dehydrogenate, and Mantle Cell Lymphoma International Prognostic Index scores.
ALC/AMC was less than 2 in 10 of 13 transplanted patients and in 57 of 83 patients who did not undergo transplants. At a median follow-up of 43 months, the median overall survival has not been reached in either cohort.
The 5-year survival rate was 90% among patients with an ALC/AMC of 2 or greater and 68% in those with an ALC/AMC less than 2 (log-rank P less than .05).
Similar ALC/AMC 5-year survival trends were noted when subsetting to the 25 patients with high risk Mantle Cell Lymphoma International Prognostic Index scores (72% vs. 45%; P = .07).
Dr. Goy disclosed honoraria from Acerta Pharma, Celgene, Pharmacyclics, and Takeda; a consulting or advisory role with Acerta Pharma, Celgene, Infinity Pharmaceuticals, Pharmacyclics, and Takeda; and speakers’ bureaus participation for Pharmacyclics and Takeda.
Prognostic value of the absolute lymphocyte-to-monocyte (ALC/AMC) ratio on overall survival among patients with mantle cell lymphoma. Published in conjunction with the 2017 ASCO Annual Meeting. Abstract No: e19030.
mdales@frontlinemedcom.com
On Twitter @maryjodales
The peripheral blood absolute lymphocyte-to-monocyte ratio (ALC/AMC) was prognostic for overall survival in mantle cell lymphoma patients who have undergone induction therapy, based on a retrospective review study of 96 patients by Andre Goy, MD, of John Theurer Cancer Center, Hackensack (NJ) University, and his colleagues.
Overall survival was better when ALC/AMC was 2 or greater following induction therapy, the researchers wrote in an abstract published in conjunction with the annual meeting of the American Society of Clinical Oncology.
The finding indicates that novel maintenance programs, including targeting the microenvironment or immune response, might be appropriate when patients with mantle cell lymphoma have low ALC/AMC.
The researchers examined data for 96 consecutive mantle cell lymphoma patients. The ALC/AMC was determined from peripheral blood counts obtained approximately 30 days following completion of initial therapy or immediately prior to stem cell mobilization in patients who had first line stem cell transplants.
The ALC/AMC was less than 2 in 67 patients and was 2 or greater in 29 patients. The two patient cohorts were similar in median age, ethnicities, stage distributions, elevated beta-2-microglobulin, elevated lactate dehydrogenate, and Mantle Cell Lymphoma International Prognostic Index scores.
ALC/AMC was less than 2 in 10 of 13 transplanted patients and in 57 of 83 patients who did not undergo transplants. At a median follow-up of 43 months, the median overall survival has not been reached in either cohort.
The 5-year survival rate was 90% among patients with an ALC/AMC of 2 or greater and 68% in those with an ALC/AMC less than 2 (log-rank P less than .05).
Similar ALC/AMC 5-year survival trends were noted when subsetting to the 25 patients with high risk Mantle Cell Lymphoma International Prognostic Index scores (72% vs. 45%; P = .07).
Dr. Goy disclosed honoraria from Acerta Pharma, Celgene, Pharmacyclics, and Takeda; a consulting or advisory role with Acerta Pharma, Celgene, Infinity Pharmaceuticals, Pharmacyclics, and Takeda; and speakers’ bureaus participation for Pharmacyclics and Takeda.
Prognostic value of the absolute lymphocyte-to-monocyte (ALC/AMC) ratio on overall survival among patients with mantle cell lymphoma. Published in conjunction with the 2017 ASCO Annual Meeting. Abstract No: e19030.
mdales@frontlinemedcom.com
On Twitter @maryjodales
The peripheral blood absolute lymphocyte-to-monocyte ratio (ALC/AMC) was prognostic for overall survival in mantle cell lymphoma patients who have undergone induction therapy, based on a retrospective review study of 96 patients by Andre Goy, MD, of John Theurer Cancer Center, Hackensack (NJ) University, and his colleagues.
Overall survival was better when ALC/AMC was 2 or greater following induction therapy, the researchers wrote in an abstract published in conjunction with the annual meeting of the American Society of Clinical Oncology.
The finding indicates that novel maintenance programs, including targeting the microenvironment or immune response, might be appropriate when patients with mantle cell lymphoma have low ALC/AMC.
The researchers examined data for 96 consecutive mantle cell lymphoma patients. The ALC/AMC was determined from peripheral blood counts obtained approximately 30 days following completion of initial therapy or immediately prior to stem cell mobilization in patients who had first line stem cell transplants.
The ALC/AMC was less than 2 in 67 patients and was 2 or greater in 29 patients. The two patient cohorts were similar in median age, ethnicities, stage distributions, elevated beta-2-microglobulin, elevated lactate dehydrogenate, and Mantle Cell Lymphoma International Prognostic Index scores.
ALC/AMC was less than 2 in 10 of 13 transplanted patients and in 57 of 83 patients who did not undergo transplants. At a median follow-up of 43 months, the median overall survival has not been reached in either cohort.
The 5-year survival rate was 90% among patients with an ALC/AMC of 2 or greater and 68% in those with an ALC/AMC less than 2 (log-rank P less than .05).
Similar ALC/AMC 5-year survival trends were noted when subsetting to the 25 patients with high risk Mantle Cell Lymphoma International Prognostic Index scores (72% vs. 45%; P = .07).
Dr. Goy disclosed honoraria from Acerta Pharma, Celgene, Pharmacyclics, and Takeda; a consulting or advisory role with Acerta Pharma, Celgene, Infinity Pharmaceuticals, Pharmacyclics, and Takeda; and speakers’ bureaus participation for Pharmacyclics and Takeda.
Prognostic value of the absolute lymphocyte-to-monocyte (ALC/AMC) ratio on overall survival among patients with mantle cell lymphoma. Published in conjunction with the 2017 ASCO Annual Meeting. Abstract No: e19030.
mdales@frontlinemedcom.com
On Twitter @maryjodales
IN CONJUNCTION WITH ASCO 2017
Key clinical point:
Major finding: The 5-year survival rate was 90% among patients with an ALC/AMC of 2 or greater and 68% in those with an ALC/AMC less than 2 (log-rank P less than .05).
Data source: A retrospective review study of 96 patients.
Disclosures: Dr. Goy disclosed honoraria from Acerta Pharma, Celgene, Pharmacyclics, and Takeda; a consulting or advisory role with Acerta Pharma, Celgene, Infinity Pharmaceuticals, Pharmacyclics, and Takeda; and speakers’ bureaus participation for Pharmacyclics and Takeda.
Citation: Prognostic value of the absolute lymphocyte-to-monocyte (ALC/AMC) ratio on overall survival among patients with mantle cell lymphoma. Published in conjunction with the 2017 ASCO Annual Meeting. Abstract No: e19030.
Smoldering myeloma progressed more rapidly in patients with elevated BMIs
An elevated body mass index appears to be a risk factor for progression of smoldering multiple myeloma, according to Wilson I. Gonsalves, MD, and his colleagues at Mayo Clinic, Rochester, Minn.
The findings, based on median follow up data of 106 months from 306 patients diagnosed with smoldering multiple myeloma from 2000-2010 at the Mayo Clinic, need to be confirmed in larger studies. Nevertheless, the results imply that patient weight is a potentially modifiable risk factor for progression from smoldering disease to multiple myeloma, Dr. Gonsalves and his colleagues wrote.
At initial evaluation, 28% of patients had myeloma defining events, such as a serum free light chain ratio greater than 100 or over 60% clonal bone marrow plasma cells. Myeloma defining events were present in 17% of patients with normal BMIs and 33% of patients with elevated BMIs, a statistically significant difference (P = .011).
When the analysis was limited to the 187 patients without myeloma-defining events at initial evaluation, the 2-year rate of progression to symptomatic multiple myeloma was 15% in those with a normal BMI and 33% in those with an elevated BMI (P = .013).
In a multivariable model, only elevated BMI (P = .004) and increasing clonal bone marrow plasma cells (P = .001) were statistically significant in predicting 2-year progression to multiple myeloma.
At last follow-up, 66% of patients had progressed to symptomatic multiple myeloma.
Dr. Gonsalves had no relationships to disclose.
The impact of body mass index on the risk of early progression of smoldering multiple myeloma to symptomatic myeloma. 2017 ASCO annual meeting. Abstract No: 8032.
mdales@frontlinemedcom.com
On Twitter @maryjodales
An elevated body mass index appears to be a risk factor for progression of smoldering multiple myeloma, according to Wilson I. Gonsalves, MD, and his colleagues at Mayo Clinic, Rochester, Minn.
The findings, based on median follow up data of 106 months from 306 patients diagnosed with smoldering multiple myeloma from 2000-2010 at the Mayo Clinic, need to be confirmed in larger studies. Nevertheless, the results imply that patient weight is a potentially modifiable risk factor for progression from smoldering disease to multiple myeloma, Dr. Gonsalves and his colleagues wrote.
At initial evaluation, 28% of patients had myeloma defining events, such as a serum free light chain ratio greater than 100 or over 60% clonal bone marrow plasma cells. Myeloma defining events were present in 17% of patients with normal BMIs and 33% of patients with elevated BMIs, a statistically significant difference (P = .011).
When the analysis was limited to the 187 patients without myeloma-defining events at initial evaluation, the 2-year rate of progression to symptomatic multiple myeloma was 15% in those with a normal BMI and 33% in those with an elevated BMI (P = .013).
In a multivariable model, only elevated BMI (P = .004) and increasing clonal bone marrow plasma cells (P = .001) were statistically significant in predicting 2-year progression to multiple myeloma.
At last follow-up, 66% of patients had progressed to symptomatic multiple myeloma.
Dr. Gonsalves had no relationships to disclose.
The impact of body mass index on the risk of early progression of smoldering multiple myeloma to symptomatic myeloma. 2017 ASCO annual meeting. Abstract No: 8032.
mdales@frontlinemedcom.com
On Twitter @maryjodales
An elevated body mass index appears to be a risk factor for progression of smoldering multiple myeloma, according to Wilson I. Gonsalves, MD, and his colleagues at Mayo Clinic, Rochester, Minn.
The findings, based on median follow up data of 106 months from 306 patients diagnosed with smoldering multiple myeloma from 2000-2010 at the Mayo Clinic, need to be confirmed in larger studies. Nevertheless, the results imply that patient weight is a potentially modifiable risk factor for progression from smoldering disease to multiple myeloma, Dr. Gonsalves and his colleagues wrote.
At initial evaluation, 28% of patients had myeloma defining events, such as a serum free light chain ratio greater than 100 or over 60% clonal bone marrow plasma cells. Myeloma defining events were present in 17% of patients with normal BMIs and 33% of patients with elevated BMIs, a statistically significant difference (P = .011).
When the analysis was limited to the 187 patients without myeloma-defining events at initial evaluation, the 2-year rate of progression to symptomatic multiple myeloma was 15% in those with a normal BMI and 33% in those with an elevated BMI (P = .013).
In a multivariable model, only elevated BMI (P = .004) and increasing clonal bone marrow plasma cells (P = .001) were statistically significant in predicting 2-year progression to multiple myeloma.
At last follow-up, 66% of patients had progressed to symptomatic multiple myeloma.
Dr. Gonsalves had no relationships to disclose.
The impact of body mass index on the risk of early progression of smoldering multiple myeloma to symptomatic myeloma. 2017 ASCO annual meeting. Abstract No: 8032.
mdales@frontlinemedcom.com
On Twitter @maryjodales
FROM ASCO 2017
Key clinical point:
Major finding: The 2-year rate of progression from smoldering disease to symptomatic multiple myeloma was 16% in patients with a normal BMI and 42% in patients with an elevated BMI (P less than 0.0001).
Data source: Median follow up data of 106 months from 306 patients diagnosed with smoldering multiple myeloma during 2000-2010 at the Mayo Clinic.
Disclosures: Dr. Gonsalves had no relationships to disclose.
Citation: The impact of body mass index on the risk of early progression of smoldering multiple myeloma to symptomatic myeloma. 2017 ASCO annual meeting. Abstract No: 8032.
Myeloma patients who get solid tumor cancers do as well as other cancer patients
With improved treatment, patients with multiple myeloma are surviving long enough to develop other cancers, Jorge J. Castillo, MD, and Adam J. Olszewski, MD, reported in a poster to be presented at the annual meeting of the American Society of Clinical Oncology.
The good news is that myeloma patients, when diagnosed with a subsequent solid tumor, are just as likely to respond to treatment and do just as well as patients without myeloma, according to Dr. Castillo of Dana-Farber Cancer Institute, Boston, and Dr. Olszewski of Alpert Medical School of Brown University, Providence, R.I.
They based their conclusion on Surveillance, Epidemiology, and End Results (SEER) data for patients diagnosed with six common cancers from 2004-2013.
“Among them, we identified [nearly 1,300] myeloma survivors, and we matched each to 50 randomly sampled controls with the same cancer by age, sex, race, and year of diagnosis. We then compared [cancer specific survival], cumulative incidence function (CIF) for death from the non-myeloma index cancer, and whether patients had surgery for non-metastastic, stage-matched tumors only,” the researchers wrote in their abstract.
They did analyses for breast, lung, prostate, colorectal, melanoma, and bladder cancers. The median time from diagnosis of myeloma to diagnosis of the second ranged from 35 months (bladder [133 myeloma patients] and lung [286 myeloma patients] cancers) to 50 months (melanoma [140 myeloma patients]). The median time after myeloma diagnosis was 40 months for those patients who developed breast, prostate, or colorectal cancers.
In the comparisons, myeloma survivors were significantly older (P less than .001) than patients initially diagnosed with the same respective cancers. In the case-control analysis, breast (P = .002) and lung cancers (P = .003) were more often diagnosed at an early stage among myeloma survivors.
The hazard ratio (HR) for cancer-specific survival for 189 myeloma patients diagnosed with breast cancer as compared to other breast cancer patients, for example, was 0.99, 95% confidence interval (CI) 0.61-1.61. The HR for the cumulative incidence function of cancer death was 0.82, 95% CI 0.50-1.35.
Myeloma patients were no less likely than were case-control subjects to have surgery for their cancers, with the exception of the 330 myeloma patients who developed prostate cancer (odds ratio, 0.59, 95% CI, 0.44-0.81).
Cancer-specific survival significantly differed (P less than .05) only for lung cancer, and was better among the 286 myeloma patients with lung cancer even when stratified by stage (HR 0.64, 95% CI 0.54-0.75). For cumulative incidence function of cancer death for lung cancer, the hazard ratio was 0.52 (95% CI 0.44-0.61). Better outcomes in lung cancer are not fully explained by earlier detection, suggesting a biological difference, the researchers reported.
Cumulative incidence function of cancer death was significantly lower for myeloma patients with lung and colorectal cancers.
Dr. Castillo disclosed honoraria from Celgene and Janssen; a consulting or advisory role with Biogen, Otsuka, and Pharmacyclics; and institutional research funding from Abbvie, Gilead Sciences, Millennium, and Pharmacyclics. Dr. Olszewski disclosed institutional research funding from Genentech, Incyte, and TG Therapeutics.
Citation: Outcomes of secondary cancers among myeloma survivors. 2017 ASCO annual meeting. Abstract No. 8043.
mdales@frontlinemedcom.com
On Twitter @maryjodales
With improved treatment, patients with multiple myeloma are surviving long enough to develop other cancers, Jorge J. Castillo, MD, and Adam J. Olszewski, MD, reported in a poster to be presented at the annual meeting of the American Society of Clinical Oncology.
The good news is that myeloma patients, when diagnosed with a subsequent solid tumor, are just as likely to respond to treatment and do just as well as patients without myeloma, according to Dr. Castillo of Dana-Farber Cancer Institute, Boston, and Dr. Olszewski of Alpert Medical School of Brown University, Providence, R.I.
They based their conclusion on Surveillance, Epidemiology, and End Results (SEER) data for patients diagnosed with six common cancers from 2004-2013.
“Among them, we identified [nearly 1,300] myeloma survivors, and we matched each to 50 randomly sampled controls with the same cancer by age, sex, race, and year of diagnosis. We then compared [cancer specific survival], cumulative incidence function (CIF) for death from the non-myeloma index cancer, and whether patients had surgery for non-metastastic, stage-matched tumors only,” the researchers wrote in their abstract.
They did analyses for breast, lung, prostate, colorectal, melanoma, and bladder cancers. The median time from diagnosis of myeloma to diagnosis of the second ranged from 35 months (bladder [133 myeloma patients] and lung [286 myeloma patients] cancers) to 50 months (melanoma [140 myeloma patients]). The median time after myeloma diagnosis was 40 months for those patients who developed breast, prostate, or colorectal cancers.
In the comparisons, myeloma survivors were significantly older (P less than .001) than patients initially diagnosed with the same respective cancers. In the case-control analysis, breast (P = .002) and lung cancers (P = .003) were more often diagnosed at an early stage among myeloma survivors.
The hazard ratio (HR) for cancer-specific survival for 189 myeloma patients diagnosed with breast cancer as compared to other breast cancer patients, for example, was 0.99, 95% confidence interval (CI) 0.61-1.61. The HR for the cumulative incidence function of cancer death was 0.82, 95% CI 0.50-1.35.
Myeloma patients were no less likely than were case-control subjects to have surgery for their cancers, with the exception of the 330 myeloma patients who developed prostate cancer (odds ratio, 0.59, 95% CI, 0.44-0.81).
Cancer-specific survival significantly differed (P less than .05) only for lung cancer, and was better among the 286 myeloma patients with lung cancer even when stratified by stage (HR 0.64, 95% CI 0.54-0.75). For cumulative incidence function of cancer death for lung cancer, the hazard ratio was 0.52 (95% CI 0.44-0.61). Better outcomes in lung cancer are not fully explained by earlier detection, suggesting a biological difference, the researchers reported.
Cumulative incidence function of cancer death was significantly lower for myeloma patients with lung and colorectal cancers.
Dr. Castillo disclosed honoraria from Celgene and Janssen; a consulting or advisory role with Biogen, Otsuka, and Pharmacyclics; and institutional research funding from Abbvie, Gilead Sciences, Millennium, and Pharmacyclics. Dr. Olszewski disclosed institutional research funding from Genentech, Incyte, and TG Therapeutics.
Citation: Outcomes of secondary cancers among myeloma survivors. 2017 ASCO annual meeting. Abstract No. 8043.
mdales@frontlinemedcom.com
On Twitter @maryjodales
With improved treatment, patients with multiple myeloma are surviving long enough to develop other cancers, Jorge J. Castillo, MD, and Adam J. Olszewski, MD, reported in a poster to be presented at the annual meeting of the American Society of Clinical Oncology.
The good news is that myeloma patients, when diagnosed with a subsequent solid tumor, are just as likely to respond to treatment and do just as well as patients without myeloma, according to Dr. Castillo of Dana-Farber Cancer Institute, Boston, and Dr. Olszewski of Alpert Medical School of Brown University, Providence, R.I.
They based their conclusion on Surveillance, Epidemiology, and End Results (SEER) data for patients diagnosed with six common cancers from 2004-2013.
“Among them, we identified [nearly 1,300] myeloma survivors, and we matched each to 50 randomly sampled controls with the same cancer by age, sex, race, and year of diagnosis. We then compared [cancer specific survival], cumulative incidence function (CIF) for death from the non-myeloma index cancer, and whether patients had surgery for non-metastastic, stage-matched tumors only,” the researchers wrote in their abstract.
They did analyses for breast, lung, prostate, colorectal, melanoma, and bladder cancers. The median time from diagnosis of myeloma to diagnosis of the second ranged from 35 months (bladder [133 myeloma patients] and lung [286 myeloma patients] cancers) to 50 months (melanoma [140 myeloma patients]). The median time after myeloma diagnosis was 40 months for those patients who developed breast, prostate, or colorectal cancers.
In the comparisons, myeloma survivors were significantly older (P less than .001) than patients initially diagnosed with the same respective cancers. In the case-control analysis, breast (P = .002) and lung cancers (P = .003) were more often diagnosed at an early stage among myeloma survivors.
The hazard ratio (HR) for cancer-specific survival for 189 myeloma patients diagnosed with breast cancer as compared to other breast cancer patients, for example, was 0.99, 95% confidence interval (CI) 0.61-1.61. The HR for the cumulative incidence function of cancer death was 0.82, 95% CI 0.50-1.35.
Myeloma patients were no less likely than were case-control subjects to have surgery for their cancers, with the exception of the 330 myeloma patients who developed prostate cancer (odds ratio, 0.59, 95% CI, 0.44-0.81).
Cancer-specific survival significantly differed (P less than .05) only for lung cancer, and was better among the 286 myeloma patients with lung cancer even when stratified by stage (HR 0.64, 95% CI 0.54-0.75). For cumulative incidence function of cancer death for lung cancer, the hazard ratio was 0.52 (95% CI 0.44-0.61). Better outcomes in lung cancer are not fully explained by earlier detection, suggesting a biological difference, the researchers reported.
Cumulative incidence function of cancer death was significantly lower for myeloma patients with lung and colorectal cancers.
Dr. Castillo disclosed honoraria from Celgene and Janssen; a consulting or advisory role with Biogen, Otsuka, and Pharmacyclics; and institutional research funding from Abbvie, Gilead Sciences, Millennium, and Pharmacyclics. Dr. Olszewski disclosed institutional research funding from Genentech, Incyte, and TG Therapeutics.
Citation: Outcomes of secondary cancers among myeloma survivors. 2017 ASCO annual meeting. Abstract No. 8043.
mdales@frontlinemedcom.com
On Twitter @maryjodales
FROM 2017 ASCO ANNUAL MEETING
Key clinical point:
Major finding: Cancer-specific survival significantly differed (P less than .05) only for lung cancer, and was better among the 286 myeloma patients with lung cancer even when stratified by stage (HR, 0.64, 95% CI 0.54-0.75).
Data source: Surveillance, Epidemiology, and End Results (SEER) data for patients diagnosed with six common cancers from 2004-2013.
Disclosures: Dr. Castillo disclosed honoraria from Celgene and Janssen; a consulting or advisory role with Biogen, Otsuka, and Pharmacyclics; and institutional research funding from Abbvie, Gilead Sciences, Millennium, and Pharmacyclics. Dr. Olszewski disclosed institutional research funding from Genentech, Incyte, and TG Therapeutics.
Citation: Outcomes of secondary cancers among myeloma survivors. 2017 ASCO annual meeting. Abstract No. 8043.
Gefitinib bests chemo as adjuvant therapy for early EGFR-mutant NSCLC
The targeted agent gefitinib is superior to the standard of care chemotherapy for treating resected early non–small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) activating mutation, finds the phase III randomized Chinese ADJUVANT trial.
Gefitinib, an oral tyrosine kinase inhibitor that targets the EGFR kinase among others, is already approved by the Food and Drug Administration for treatment of locally advanced or metastatic disease having mutations in the gene for this receptor.
Trial results reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology showed that compared with vinorelbine and cisplatin combination chemotherapy, 2 years of gefitinib prolonged the time to recurrence or death by more than 10 months, reducing risk of these events by a significant 40%. Gefitinib also was better tolerated: The rate of grade 3 or worse adverse events with the targeted agent was one-fourth that seen with the chemotherapy.
“Targeted therapy can delay recurrence of intermediate-stage lung cancer after surgery. Two-year treatment duration of gefitinib is efficacious and tolerated well,” said lead study author Yi-Long Wu, MD, director of the Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China. “Adjuvant gefitinib should be considered as an important option for stage II to IIIA lung cancer patients with an activating EGFR mutation.”
Clinical implications
The improved disease-free survival seen with gefitinib in ADJUVANT is “encouraging,” according to ASCO President-Elect Bruce E. Johnson, MD, chief clinical research officer and an Institute Physician at the Dana-Farber Cancer Institute in Boston.
Longer follow-up will be needed to obtain a full picture as the horizon for events in the adjuvant setting is more on the order of years, and the disease-free survival curves began converging over time, he noted. “We will ultimately be interested in seeing whether this actually prolongs survival in a longer follow-up study, which Dr. Wu’s group is planning to do.
“I haven’t changed my approach yet for the patients with EGFR-mutant lung cancer,” Dr. Johnson concluded. “But I will be following this [trial] very closely to see what happens to the survival.”
The new data from ADJUVANT will likely have several effects on the clinical management of NSCLC, according to presscast moderator and ASCO Chief Medical Officer Richard L. Schilsky, MD.
“I suspect that many doctors will begin testing these lung cancer tumors right after surgery, to see if they actually have an EGFR mutation. That is not currently standard of care in the U.S.; typically the testing doesn’t take place until the cancer recurs or becomes metastatic,” he said. “So that way, doctors and patients will know whether or not treatment with an EGFR inhibitor is even an option.
“If it is an option, then many factors will likely come into play, and most importantly we will be waiting for the survival data,” said Dr. Schilsky, professor emeritus at the University of Chicago. Another consideration is that the trial compared 12 weeks of chemotherapy with 2 years of continuous gefitinib therapy, the latter of which requires a long-term commitment to adherence by patients and carries much greater cost.
“At the end of the day, I think that once the survival data is known in particular, doctors and patients are going to have to have very thoughtful discussions about what is the magnitude of the survival benefit; what is the burden on the patient to take either cytotoxic chemotherapy for 12 weeks or 2 years of an oral treatment, which, while it is less toxic, is not without toxicity; and what’s the financial burden of that treatment choice going to be for the patient,” he concluded.
Study details
Eligibility for the ADJUVANT trial required completely resected pathological stage II-IIIA (N1-N2) NSCLC with an EGFR-activating mutation. In all, 220 patients were randomized evenly to receive gefitinib (Iressa) once daily for 24 months or vinorelbine plus cisplatin every 3 weeks for 4 cycles.
Results showed that median disease-free survival – the trial’s primary endpoint—was 28.7 months with gefitinib compared with 18.0 months with chemotherapy (hazard ratio, 0.60; P = .005), Dr. Wu reported in the presscast. Corresponding 3-year disease-free survival rates were 34% and 27%.
The rate of grade 3 or worse adverse events was 12.3% in the gefitinib group, compared with 48.3% in the chemotherapy group. Most types of events were less common with the tyrosine kinase inhibitor, with the exception of rash, diarrhea, and elevation of liver enzymes.
Dr. Wu disclosed ties with AstraZeneca, Roche, Merck, Boehringer Ingelheim; Lilly, Pierre Fabre, Pfizer, and Sanofi. The Chinese Thoracic Oncology Group and AstraZeneca Chin funded the trial.
The targeted agent gefitinib is superior to the standard of care chemotherapy for treating resected early non–small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) activating mutation, finds the phase III randomized Chinese ADJUVANT trial.
Gefitinib, an oral tyrosine kinase inhibitor that targets the EGFR kinase among others, is already approved by the Food and Drug Administration for treatment of locally advanced or metastatic disease having mutations in the gene for this receptor.
Trial results reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology showed that compared with vinorelbine and cisplatin combination chemotherapy, 2 years of gefitinib prolonged the time to recurrence or death by more than 10 months, reducing risk of these events by a significant 40%. Gefitinib also was better tolerated: The rate of grade 3 or worse adverse events with the targeted agent was one-fourth that seen with the chemotherapy.
“Targeted therapy can delay recurrence of intermediate-stage lung cancer after surgery. Two-year treatment duration of gefitinib is efficacious and tolerated well,” said lead study author Yi-Long Wu, MD, director of the Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China. “Adjuvant gefitinib should be considered as an important option for stage II to IIIA lung cancer patients with an activating EGFR mutation.”
Clinical implications
The improved disease-free survival seen with gefitinib in ADJUVANT is “encouraging,” according to ASCO President-Elect Bruce E. Johnson, MD, chief clinical research officer and an Institute Physician at the Dana-Farber Cancer Institute in Boston.
Longer follow-up will be needed to obtain a full picture as the horizon for events in the adjuvant setting is more on the order of years, and the disease-free survival curves began converging over time, he noted. “We will ultimately be interested in seeing whether this actually prolongs survival in a longer follow-up study, which Dr. Wu’s group is planning to do.
“I haven’t changed my approach yet for the patients with EGFR-mutant lung cancer,” Dr. Johnson concluded. “But I will be following this [trial] very closely to see what happens to the survival.”
The new data from ADJUVANT will likely have several effects on the clinical management of NSCLC, according to presscast moderator and ASCO Chief Medical Officer Richard L. Schilsky, MD.
“I suspect that many doctors will begin testing these lung cancer tumors right after surgery, to see if they actually have an EGFR mutation. That is not currently standard of care in the U.S.; typically the testing doesn’t take place until the cancer recurs or becomes metastatic,” he said. “So that way, doctors and patients will know whether or not treatment with an EGFR inhibitor is even an option.
“If it is an option, then many factors will likely come into play, and most importantly we will be waiting for the survival data,” said Dr. Schilsky, professor emeritus at the University of Chicago. Another consideration is that the trial compared 12 weeks of chemotherapy with 2 years of continuous gefitinib therapy, the latter of which requires a long-term commitment to adherence by patients and carries much greater cost.
“At the end of the day, I think that once the survival data is known in particular, doctors and patients are going to have to have very thoughtful discussions about what is the magnitude of the survival benefit; what is the burden on the patient to take either cytotoxic chemotherapy for 12 weeks or 2 years of an oral treatment, which, while it is less toxic, is not without toxicity; and what’s the financial burden of that treatment choice going to be for the patient,” he concluded.
Study details
Eligibility for the ADJUVANT trial required completely resected pathological stage II-IIIA (N1-N2) NSCLC with an EGFR-activating mutation. In all, 220 patients were randomized evenly to receive gefitinib (Iressa) once daily for 24 months or vinorelbine plus cisplatin every 3 weeks for 4 cycles.
Results showed that median disease-free survival – the trial’s primary endpoint—was 28.7 months with gefitinib compared with 18.0 months with chemotherapy (hazard ratio, 0.60; P = .005), Dr. Wu reported in the presscast. Corresponding 3-year disease-free survival rates were 34% and 27%.
The rate of grade 3 or worse adverse events was 12.3% in the gefitinib group, compared with 48.3% in the chemotherapy group. Most types of events were less common with the tyrosine kinase inhibitor, with the exception of rash, diarrhea, and elevation of liver enzymes.
Dr. Wu disclosed ties with AstraZeneca, Roche, Merck, Boehringer Ingelheim; Lilly, Pierre Fabre, Pfizer, and Sanofi. The Chinese Thoracic Oncology Group and AstraZeneca Chin funded the trial.
The targeted agent gefitinib is superior to the standard of care chemotherapy for treating resected early non–small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) activating mutation, finds the phase III randomized Chinese ADJUVANT trial.
Gefitinib, an oral tyrosine kinase inhibitor that targets the EGFR kinase among others, is already approved by the Food and Drug Administration for treatment of locally advanced or metastatic disease having mutations in the gene for this receptor.
Trial results reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology showed that compared with vinorelbine and cisplatin combination chemotherapy, 2 years of gefitinib prolonged the time to recurrence or death by more than 10 months, reducing risk of these events by a significant 40%. Gefitinib also was better tolerated: The rate of grade 3 or worse adverse events with the targeted agent was one-fourth that seen with the chemotherapy.
“Targeted therapy can delay recurrence of intermediate-stage lung cancer after surgery. Two-year treatment duration of gefitinib is efficacious and tolerated well,” said lead study author Yi-Long Wu, MD, director of the Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China. “Adjuvant gefitinib should be considered as an important option for stage II to IIIA lung cancer patients with an activating EGFR mutation.”
Clinical implications
The improved disease-free survival seen with gefitinib in ADJUVANT is “encouraging,” according to ASCO President-Elect Bruce E. Johnson, MD, chief clinical research officer and an Institute Physician at the Dana-Farber Cancer Institute in Boston.
Longer follow-up will be needed to obtain a full picture as the horizon for events in the adjuvant setting is more on the order of years, and the disease-free survival curves began converging over time, he noted. “We will ultimately be interested in seeing whether this actually prolongs survival in a longer follow-up study, which Dr. Wu’s group is planning to do.
“I haven’t changed my approach yet for the patients with EGFR-mutant lung cancer,” Dr. Johnson concluded. “But I will be following this [trial] very closely to see what happens to the survival.”
The new data from ADJUVANT will likely have several effects on the clinical management of NSCLC, according to presscast moderator and ASCO Chief Medical Officer Richard L. Schilsky, MD.
“I suspect that many doctors will begin testing these lung cancer tumors right after surgery, to see if they actually have an EGFR mutation. That is not currently standard of care in the U.S.; typically the testing doesn’t take place until the cancer recurs or becomes metastatic,” he said. “So that way, doctors and patients will know whether or not treatment with an EGFR inhibitor is even an option.
“If it is an option, then many factors will likely come into play, and most importantly we will be waiting for the survival data,” said Dr. Schilsky, professor emeritus at the University of Chicago. Another consideration is that the trial compared 12 weeks of chemotherapy with 2 years of continuous gefitinib therapy, the latter of which requires a long-term commitment to adherence by patients and carries much greater cost.
“At the end of the day, I think that once the survival data is known in particular, doctors and patients are going to have to have very thoughtful discussions about what is the magnitude of the survival benefit; what is the burden on the patient to take either cytotoxic chemotherapy for 12 weeks or 2 years of an oral treatment, which, while it is less toxic, is not without toxicity; and what’s the financial burden of that treatment choice going to be for the patient,” he concluded.
Study details
Eligibility for the ADJUVANT trial required completely resected pathological stage II-IIIA (N1-N2) NSCLC with an EGFR-activating mutation. In all, 220 patients were randomized evenly to receive gefitinib (Iressa) once daily for 24 months or vinorelbine plus cisplatin every 3 weeks for 4 cycles.
Results showed that median disease-free survival – the trial’s primary endpoint—was 28.7 months with gefitinib compared with 18.0 months with chemotherapy (hazard ratio, 0.60; P = .005), Dr. Wu reported in the presscast. Corresponding 3-year disease-free survival rates were 34% and 27%.
The rate of grade 3 or worse adverse events was 12.3% in the gefitinib group, compared with 48.3% in the chemotherapy group. Most types of events were less common with the tyrosine kinase inhibitor, with the exception of rash, diarrhea, and elevation of liver enzymes.
Dr. Wu disclosed ties with AstraZeneca, Roche, Merck, Boehringer Ingelheim; Lilly, Pierre Fabre, Pfizer, and Sanofi. The Chinese Thoracic Oncology Group and AstraZeneca Chin funded the trial.
FROM THE 2017 ASCO ANNUAL MEETING
Key clinical point:
Major finding: Patients in the gefitinib group had a sharply reduced risk of recurrence or death relative to peers in the vinorelbine-cisplatin group (hazard ratio, 0.60; P = .005).
Data source: ADJUVANT, a phase III randomized controlled study of 220 patients with completely resected EGFR-mutant pathological stage II-IIIA (N1-N2) NSCLC.
Disclosures: Dr. Wu disclosed ties with AstraZeneca, Roche, Merck, Boehringer Ingelheim; Lilly, Pierre Fabre, Pfizer, and Sanofi. The Chinese Thoracic Oncology Group and AstraZeneca Chin funded the trial.
Lenalidomide maintenance boosted depth of response in myeloma patients
Lenalidomide maintenance therapy further improved depth of response in newly diagnosed, transplant-eligible patients with multiple myeloma in the EMN02/HO95 trial, based on the abstract of a poster to be presented at the annual meeting of the American Society of Clinical Oncology.
The study results also show that using multiparameter flow cytometry to monitor minimal residual disease (MRD) was predictive of patient outcome. A high-risk cytogenetic profile – defined as having del17, translocation (4;14), or translocation (14;16) – was the most important prognostic factor in MRD-positive patients, according to Stefania Oliva, MD, of the University of Torino [Italy] and her colleagues.
At 3 years, progression-free survival was 50% in MRD-positive patients and 77% in MRD-negative patients (hazard ratio, 2.87; P less than .001). High-risk cytogenetics was the most important risk factor (HR, 9.87; interaction-P = .001). Further, 48% of patients who had MRD before maintenance therapy and had a second evaluation for minimal residual disease after at least 1 year of lenalidomide therapy became MRD negative.
The trial (NCT01208766) participants were no older than age 65 years and received received bortezomib-cyclophosphamide-dexamethasone (VCD) induction therapy, then bortezomib-melphalan-prednisone (VMP) or high-dose melphalan intensification therapy followed by stem cell transplant, and subsequently bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy or no consolidation therapy, followed by lenalidomide maintenance therapy.
Of 316 patients who were evaluable before maintenance therapy, 18% had International Staging System stage III disease (beta-2 microglobulin of 5.5 mg/L or greater) and 22% had a high-risk cytogenetic profile.
For intensification therapy, 63% had received high-dose melphalan and 37% got VMP; thereafter 51% had received VRD. Nearly two-thirds of the 76% of patients who were MRD negative got high-dose melphalan, with a median follow-up of 30 months from MRD enrollment.
Patients who had at least a very good partial response underwent minimal residual disease evaluation before starting maintenance therapy and then every 6-12 months during maintenance therapy. Multiparameter flow cytometry was performed on bone marrow according to Euroflow-based methods (eight colors, two tubes) with a sensitivity of 10-5, and quality checks were performed to compare sensitivity and to show correlation between protocols.
Dr. Oliva disclosed receiving honoraria from Celgene and Takeda.
Citation: Minimal residual disease (MRD) monitoring by multiparameter flow cytometry (MFC) in newly diagnosed transplant eligible multiple myeloma (MM) patients: Results from the EMN02/HO95 phase 3 trial. 2017 ASCO annual meeting. Abstract No: 8011
mdales@frontlinemedcom.com
On Twitter @maryjodales
Lenalidomide maintenance therapy further improved depth of response in newly diagnosed, transplant-eligible patients with multiple myeloma in the EMN02/HO95 trial, based on the abstract of a poster to be presented at the annual meeting of the American Society of Clinical Oncology.
The study results also show that using multiparameter flow cytometry to monitor minimal residual disease (MRD) was predictive of patient outcome. A high-risk cytogenetic profile – defined as having del17, translocation (4;14), or translocation (14;16) – was the most important prognostic factor in MRD-positive patients, according to Stefania Oliva, MD, of the University of Torino [Italy] and her colleagues.
At 3 years, progression-free survival was 50% in MRD-positive patients and 77% in MRD-negative patients (hazard ratio, 2.87; P less than .001). High-risk cytogenetics was the most important risk factor (HR, 9.87; interaction-P = .001). Further, 48% of patients who had MRD before maintenance therapy and had a second evaluation for minimal residual disease after at least 1 year of lenalidomide therapy became MRD negative.
The trial (NCT01208766) participants were no older than age 65 years and received received bortezomib-cyclophosphamide-dexamethasone (VCD) induction therapy, then bortezomib-melphalan-prednisone (VMP) or high-dose melphalan intensification therapy followed by stem cell transplant, and subsequently bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy or no consolidation therapy, followed by lenalidomide maintenance therapy.
Of 316 patients who were evaluable before maintenance therapy, 18% had International Staging System stage III disease (beta-2 microglobulin of 5.5 mg/L or greater) and 22% had a high-risk cytogenetic profile.
For intensification therapy, 63% had received high-dose melphalan and 37% got VMP; thereafter 51% had received VRD. Nearly two-thirds of the 76% of patients who were MRD negative got high-dose melphalan, with a median follow-up of 30 months from MRD enrollment.
Patients who had at least a very good partial response underwent minimal residual disease evaluation before starting maintenance therapy and then every 6-12 months during maintenance therapy. Multiparameter flow cytometry was performed on bone marrow according to Euroflow-based methods (eight colors, two tubes) with a sensitivity of 10-5, and quality checks were performed to compare sensitivity and to show correlation between protocols.
Dr. Oliva disclosed receiving honoraria from Celgene and Takeda.
Citation: Minimal residual disease (MRD) monitoring by multiparameter flow cytometry (MFC) in newly diagnosed transplant eligible multiple myeloma (MM) patients: Results from the EMN02/HO95 phase 3 trial. 2017 ASCO annual meeting. Abstract No: 8011
mdales@frontlinemedcom.com
On Twitter @maryjodales
Lenalidomide maintenance therapy further improved depth of response in newly diagnosed, transplant-eligible patients with multiple myeloma in the EMN02/HO95 trial, based on the abstract of a poster to be presented at the annual meeting of the American Society of Clinical Oncology.
The study results also show that using multiparameter flow cytometry to monitor minimal residual disease (MRD) was predictive of patient outcome. A high-risk cytogenetic profile – defined as having del17, translocation (4;14), or translocation (14;16) – was the most important prognostic factor in MRD-positive patients, according to Stefania Oliva, MD, of the University of Torino [Italy] and her colleagues.
At 3 years, progression-free survival was 50% in MRD-positive patients and 77% in MRD-negative patients (hazard ratio, 2.87; P less than .001). High-risk cytogenetics was the most important risk factor (HR, 9.87; interaction-P = .001). Further, 48% of patients who had MRD before maintenance therapy and had a second evaluation for minimal residual disease after at least 1 year of lenalidomide therapy became MRD negative.
The trial (NCT01208766) participants were no older than age 65 years and received received bortezomib-cyclophosphamide-dexamethasone (VCD) induction therapy, then bortezomib-melphalan-prednisone (VMP) or high-dose melphalan intensification therapy followed by stem cell transplant, and subsequently bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy or no consolidation therapy, followed by lenalidomide maintenance therapy.
Of 316 patients who were evaluable before maintenance therapy, 18% had International Staging System stage III disease (beta-2 microglobulin of 5.5 mg/L or greater) and 22% had a high-risk cytogenetic profile.
For intensification therapy, 63% had received high-dose melphalan and 37% got VMP; thereafter 51% had received VRD. Nearly two-thirds of the 76% of patients who were MRD negative got high-dose melphalan, with a median follow-up of 30 months from MRD enrollment.
Patients who had at least a very good partial response underwent minimal residual disease evaluation before starting maintenance therapy and then every 6-12 months during maintenance therapy. Multiparameter flow cytometry was performed on bone marrow according to Euroflow-based methods (eight colors, two tubes) with a sensitivity of 10-5, and quality checks were performed to compare sensitivity and to show correlation between protocols.
Dr. Oliva disclosed receiving honoraria from Celgene and Takeda.
Citation: Minimal residual disease (MRD) monitoring by multiparameter flow cytometry (MFC) in newly diagnosed transplant eligible multiple myeloma (MM) patients: Results from the EMN02/HO95 phase 3 trial. 2017 ASCO annual meeting. Abstract No: 8011
mdales@frontlinemedcom.com
On Twitter @maryjodales
FROM 2017 ASCO ANNUAL MEETING
Key clinical point:
Major finding: 48% of patients who had minimal residual disease before maintenance therapy and had a second evaluation for MRD after at least 1 year of lenalidomide therapy became MRD negative.
Data source: A 3-year study of 316 patients who were evaluable before maintenance therapy in the EMN02/HO95 trial.
Disclosures: Dr. Oliva disclosed receiving honoraria from Celgene and Takeda.
Citation: Minimal residual disease (MRD) monitoring by multiparameter flow cytometry (MFC) in newly diagnosed transplant eligible multiple myeloma (MM) patients: Results from the EMN02/HO95 phase 3 trial. 2017 ASCO annual meeting. Abstract No: 8011
BILCAP: adjuvant capecitabine boosts overall survival of biliary tract cancers
Patients who have undergone complete resection of biliary tract cancers live longer if they receive the oral chemotherapy agent capecitabine instead of simple observation, according to findings of the phase III randomized controlled BILCAP trial.
“The only curative treatment [for these cancers] is surgical resection, but even in that circumstance, most patients will ultimately succumb to the disease,” lead study author John N. Primrose, MD, professor of surgery at the University of Southampton (England), said in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.
Results of the trial showed that compared with observation, capecitabine prolonged survival by a nonsignificant 15 months in the intention-to-treat population but by a significant 17 months in the per-protocol population. The drug had modest toxicity consistent with past experience and little impact on quality of life.
“On this basis, we believe that capecitabine should now become the standard of care for patients following curative resection of biliary tract cancer,” Dr. Primrose maintained.
The trial took place in a U.K. population, noted ASCO President Daniel F. Hayes, MD, clinical director of the breast oncology program and Stuart B. Padnos Professor in Breast Cancer Research at the University of Michigan Comprehensive Cancer Center in Ann Arbor.
“This is a cancer that is much more common in Asia than it is in the western world, and I think that will be one of the questions that will be raised, as to whether these [results] apply to patients from Asia with the same cancer,” he said. “Otherwise, this is an impressive study, an enormous amount of work, and a very important finding.”
Study coauthor John A. Bridgewater, PhD, a professor at University College Hospital in London, said that he was not concerned that the trial missed its primary endpoint.
“It would of course have been much nicer if it had been significant, but I don’t think there is any doubt that there is a genuine effect here,” he maintained, agreeing that capecitabine should be standard of care going forward.
Other chemotherapies have made their way into similar adjuvant trials since BILCAP began, including the combination of cisplatin and gemcitabine being tested in the randomized ACTICCA-1 trial, Dr. Bridgewater acknowledged. “We’ve been discussing the possible permutations if BILCAP turned out to be positive with [those investigators], and that study, cisplatin-gemcitabine compared to surveillance, will now be modified to cisplatin-gemcitabine versus capecitabine. We came to that agreement some time ago.”
The BILCAP investigators are undertaking biomarker analyses of patients’ tumors. “The genotype of a bile duct cancer that will do well with fluoropyrimidine [such as capecitabine] is unknown, and that is exactly what we’ll be looking at when we look at the material. That surely will be one of the most important questions,” he said.
At present, there is no evidence to suggest that biliary tract cancers arising in Asian populations, which are mainly due to chronic infection with liver flukes, will differ in their response to capecitabine, according to Dr. Bridgewater.
“Certainly, you’ll be able to see in the clinical subgroup analyses, the long and the short of it is that it’s actually very difficult to distinguish, certainly on clinical grounds, any group that benefits more than other groups,” he said. “So the short answer is, there shouldn’t be any difference. But do we really know? Not yet.”
Study details
Patients enrolled in BILCAP had macroscopically completely resected cholangiocarcinoma or gallbladder cancer (including liver and pancreatic resection, as appropriate). They were randomized evenly to eight cycles of capecitabine (Xeloda) at a conventional dose or observation (Capecitabine is approved by the Food and Drug Administration for treatment of breast and colorectal cancers).
With more than 80% of patients having at least 3 years of follow-up, median overall survival in the intention-to-treat population – the trial’s primary endpoint – was 51 months with capecitabine and 36 months with observation (hazard ratio [HR], 0.81; P = .097), Dr. Primrose reported. The benefit became significant in a sensitivity analysis that adjusted for prognostic factors (HR, 0.70; P = .007).
In addition, median overall survival in the per-protocol population was significantly longer with capecitabine, at 53 months, than with observation, at 36 months (HR, 0.75; P = .028).
Median recurrence-free survival in the intention-to-treat population was 25 months for the capecitabine group and 18 months for the observation group.
“The toxicity associated with chemotherapy was relatively modest and in fact very similar to what has been observed in other studies,” Dr. Primrose said. The predominant grade 3 or 4 toxicity seen with capecitabine was plantar-palmar erythema, which occurred in 20.7% of patients who received the drug. There were no capecitabine-related deaths.
“Our quality of life analysis showed that there was very little difference in quality of life related to chemotherapy over those who did not have chemotherapy,” he added.
Dr. Primrose reported that he had no disclosures. Dr. Bridgewater disclosed ties with Merck Serono, Servier, Roche, Celgene, and MSD Oncology.
Patients who have undergone complete resection of biliary tract cancers live longer if they receive the oral chemotherapy agent capecitabine instead of simple observation, according to findings of the phase III randomized controlled BILCAP trial.
“The only curative treatment [for these cancers] is surgical resection, but even in that circumstance, most patients will ultimately succumb to the disease,” lead study author John N. Primrose, MD, professor of surgery at the University of Southampton (England), said in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.
Results of the trial showed that compared with observation, capecitabine prolonged survival by a nonsignificant 15 months in the intention-to-treat population but by a significant 17 months in the per-protocol population. The drug had modest toxicity consistent with past experience and little impact on quality of life.
“On this basis, we believe that capecitabine should now become the standard of care for patients following curative resection of biliary tract cancer,” Dr. Primrose maintained.
The trial took place in a U.K. population, noted ASCO President Daniel F. Hayes, MD, clinical director of the breast oncology program and Stuart B. Padnos Professor in Breast Cancer Research at the University of Michigan Comprehensive Cancer Center in Ann Arbor.
“This is a cancer that is much more common in Asia than it is in the western world, and I think that will be one of the questions that will be raised, as to whether these [results] apply to patients from Asia with the same cancer,” he said. “Otherwise, this is an impressive study, an enormous amount of work, and a very important finding.”
Study coauthor John A. Bridgewater, PhD, a professor at University College Hospital in London, said that he was not concerned that the trial missed its primary endpoint.
“It would of course have been much nicer if it had been significant, but I don’t think there is any doubt that there is a genuine effect here,” he maintained, agreeing that capecitabine should be standard of care going forward.
Other chemotherapies have made their way into similar adjuvant trials since BILCAP began, including the combination of cisplatin and gemcitabine being tested in the randomized ACTICCA-1 trial, Dr. Bridgewater acknowledged. “We’ve been discussing the possible permutations if BILCAP turned out to be positive with [those investigators], and that study, cisplatin-gemcitabine compared to surveillance, will now be modified to cisplatin-gemcitabine versus capecitabine. We came to that agreement some time ago.”
The BILCAP investigators are undertaking biomarker analyses of patients’ tumors. “The genotype of a bile duct cancer that will do well with fluoropyrimidine [such as capecitabine] is unknown, and that is exactly what we’ll be looking at when we look at the material. That surely will be one of the most important questions,” he said.
At present, there is no evidence to suggest that biliary tract cancers arising in Asian populations, which are mainly due to chronic infection with liver flukes, will differ in their response to capecitabine, according to Dr. Bridgewater.
“Certainly, you’ll be able to see in the clinical subgroup analyses, the long and the short of it is that it’s actually very difficult to distinguish, certainly on clinical grounds, any group that benefits more than other groups,” he said. “So the short answer is, there shouldn’t be any difference. But do we really know? Not yet.”
Study details
Patients enrolled in BILCAP had macroscopically completely resected cholangiocarcinoma or gallbladder cancer (including liver and pancreatic resection, as appropriate). They were randomized evenly to eight cycles of capecitabine (Xeloda) at a conventional dose or observation (Capecitabine is approved by the Food and Drug Administration for treatment of breast and colorectal cancers).
With more than 80% of patients having at least 3 years of follow-up, median overall survival in the intention-to-treat population – the trial’s primary endpoint – was 51 months with capecitabine and 36 months with observation (hazard ratio [HR], 0.81; P = .097), Dr. Primrose reported. The benefit became significant in a sensitivity analysis that adjusted for prognostic factors (HR, 0.70; P = .007).
In addition, median overall survival in the per-protocol population was significantly longer with capecitabine, at 53 months, than with observation, at 36 months (HR, 0.75; P = .028).
Median recurrence-free survival in the intention-to-treat population was 25 months for the capecitabine group and 18 months for the observation group.
“The toxicity associated with chemotherapy was relatively modest and in fact very similar to what has been observed in other studies,” Dr. Primrose said. The predominant grade 3 or 4 toxicity seen with capecitabine was plantar-palmar erythema, which occurred in 20.7% of patients who received the drug. There were no capecitabine-related deaths.
“Our quality of life analysis showed that there was very little difference in quality of life related to chemotherapy over those who did not have chemotherapy,” he added.
Dr. Primrose reported that he had no disclosures. Dr. Bridgewater disclosed ties with Merck Serono, Servier, Roche, Celgene, and MSD Oncology.
Patients who have undergone complete resection of biliary tract cancers live longer if they receive the oral chemotherapy agent capecitabine instead of simple observation, according to findings of the phase III randomized controlled BILCAP trial.
“The only curative treatment [for these cancers] is surgical resection, but even in that circumstance, most patients will ultimately succumb to the disease,” lead study author John N. Primrose, MD, professor of surgery at the University of Southampton (England), said in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.
Results of the trial showed that compared with observation, capecitabine prolonged survival by a nonsignificant 15 months in the intention-to-treat population but by a significant 17 months in the per-protocol population. The drug had modest toxicity consistent with past experience and little impact on quality of life.
“On this basis, we believe that capecitabine should now become the standard of care for patients following curative resection of biliary tract cancer,” Dr. Primrose maintained.
The trial took place in a U.K. population, noted ASCO President Daniel F. Hayes, MD, clinical director of the breast oncology program and Stuart B. Padnos Professor in Breast Cancer Research at the University of Michigan Comprehensive Cancer Center in Ann Arbor.
“This is a cancer that is much more common in Asia than it is in the western world, and I think that will be one of the questions that will be raised, as to whether these [results] apply to patients from Asia with the same cancer,” he said. “Otherwise, this is an impressive study, an enormous amount of work, and a very important finding.”
Study coauthor John A. Bridgewater, PhD, a professor at University College Hospital in London, said that he was not concerned that the trial missed its primary endpoint.
“It would of course have been much nicer if it had been significant, but I don’t think there is any doubt that there is a genuine effect here,” he maintained, agreeing that capecitabine should be standard of care going forward.
Other chemotherapies have made their way into similar adjuvant trials since BILCAP began, including the combination of cisplatin and gemcitabine being tested in the randomized ACTICCA-1 trial, Dr. Bridgewater acknowledged. “We’ve been discussing the possible permutations if BILCAP turned out to be positive with [those investigators], and that study, cisplatin-gemcitabine compared to surveillance, will now be modified to cisplatin-gemcitabine versus capecitabine. We came to that agreement some time ago.”
The BILCAP investigators are undertaking biomarker analyses of patients’ tumors. “The genotype of a bile duct cancer that will do well with fluoropyrimidine [such as capecitabine] is unknown, and that is exactly what we’ll be looking at when we look at the material. That surely will be one of the most important questions,” he said.
At present, there is no evidence to suggest that biliary tract cancers arising in Asian populations, which are mainly due to chronic infection with liver flukes, will differ in their response to capecitabine, according to Dr. Bridgewater.
“Certainly, you’ll be able to see in the clinical subgroup analyses, the long and the short of it is that it’s actually very difficult to distinguish, certainly on clinical grounds, any group that benefits more than other groups,” he said. “So the short answer is, there shouldn’t be any difference. But do we really know? Not yet.”
Study details
Patients enrolled in BILCAP had macroscopically completely resected cholangiocarcinoma or gallbladder cancer (including liver and pancreatic resection, as appropriate). They were randomized evenly to eight cycles of capecitabine (Xeloda) at a conventional dose or observation (Capecitabine is approved by the Food and Drug Administration for treatment of breast and colorectal cancers).
With more than 80% of patients having at least 3 years of follow-up, median overall survival in the intention-to-treat population – the trial’s primary endpoint – was 51 months with capecitabine and 36 months with observation (hazard ratio [HR], 0.81; P = .097), Dr. Primrose reported. The benefit became significant in a sensitivity analysis that adjusted for prognostic factors (HR, 0.70; P = .007).
In addition, median overall survival in the per-protocol population was significantly longer with capecitabine, at 53 months, than with observation, at 36 months (HR, 0.75; P = .028).
Median recurrence-free survival in the intention-to-treat population was 25 months for the capecitabine group and 18 months for the observation group.
“The toxicity associated with chemotherapy was relatively modest and in fact very similar to what has been observed in other studies,” Dr. Primrose said. The predominant grade 3 or 4 toxicity seen with capecitabine was plantar-palmar erythema, which occurred in 20.7% of patients who received the drug. There were no capecitabine-related deaths.
“Our quality of life analysis showed that there was very little difference in quality of life related to chemotherapy over those who did not have chemotherapy,” he added.
Dr. Primrose reported that he had no disclosures. Dr. Bridgewater disclosed ties with Merck Serono, Servier, Roche, Celgene, and MSD Oncology.
FROM THE 2017 ASCO ANNUAL MEETING
Key clinical point:
Major finding: Compared with observation, capecitabine prolonged median overall survival by 15 months in the intention-to-treat population (P = .097) and by 17 months in the per-protocol population (P = .028).
Data source: BILCAP, a phase III randomized controlled trial among 447 patients who had undergone complete resection of biliary tract cancers.
Disclosures: Dr. Primrose reported that he had no disclosures. Dr. Bridgewater disclosed ties with Merck Serono, Servier, Roche, Celgene, and MSD Oncology.
More early-stage cancer diagnosis since ACA implementation
Implementation of the Affordable Care Act (ACA) has been associated with a shift toward earlier stage at diagnosis for common screenable cancers, finds an analysis of nearly 273,000 patients reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.
“Extensive evidence has shown that people without insurance are more likely to be diagnosed at later stage, especially for the cancers that can be detected earlier through screening or symptoms,” said lead study author Xuesong Han, PhD, strategic director of health policy and health care delivery research at the American Cancer Society in Atlanta. “In 2014, two major components of the Affordable Care Act – Medicaid expansion and marketplace exchange – were implemented. As a result, insurance coverage has substantially increased for nonelderly Americans.”
Study findings showed that, for four of five screenable cancers – breast and cervical cancer in women and lung and colorectal cancer in both sexes combined – the proportion of cancers that were stage I at diagnosis, and hence most curable, increased by an absolute 1% or so after the ACA was implemented. Prostate cancer was the outlier: the value for this malignancy decreased by 1%.
“The increases for the first four cancers were consistent with our hypothesis, with more people gaining insurance and access to screening services or access to physicians to detect early symptoms,” Dr. Han summarized. “But what about prostate cancer? We think [that pattern] may reflect the recent USPSTF recommendations against routine prostate cancer screening.”
“We think that this is an important study,” commented ASCO president-elect Bruce E. Johnson, MD, who is also chief clinical research officer and an institute physician at the Dana-Farber Cancer Institute in Boston. “Obviously, the changes are not enormous; they are not dramatic. But … because the uptake of screening is relatively slow, this is certainly consistent with the idea that, by doing additional screening, you can potentially find more stage I patients, and, the earlier the stage, the more likely one is to be cured.”
“The other important thing is that ASCO strongly supports the relative ease of access to screening capabilities, and that’s one of the characteristics of the Affordable Care Act, that most of the cancer screening is covered,” he further stated. “Whatever form our health care takes over the next several years, we advocate for patients to have early access to screening, which can identify cancers at an earlier stage in their more curable forms.”
Study details
For the study, the investigators used the National Cancer Database – which captures 70% of newly diagnosed cases in the United States – to identify patients younger than 65 who were eligible for cancer screening and who received a diagnosis of any of the five screenable cancers in 2013 or 2014. They compared stage distribution before ACA implementation (first nine months of 2013) and afterward (last nine months of 2014).
Analyses were based on data from 121,402 female breast cancer patients aged 40-64 years, 39,418 colorectal cancer patients aged 50-64 years, 11,190 cervical cancer patients aged 21-64 years, 59,210 prostate cancer patients aged 50-64 years, and 41,436 lung cancer patients aged 55-64 years.
Results showed that the proportion of cancers that were stage I at diagnosis increased after ACA implementation from 47.8% to 48.9% for breast cancer (adjusted prevalence ratio, 1.02) and from 47.3% to 48.8% for cervical cancer (APR, 1.02) in women, and from 16.6% to 17.7% for lung cancer (APR, 1.07) and from 22.8% to 23.7% for colorectal cancer (APR, 1.04) in men and women combined, Dr. Han reported.
Prostate cancer was the exception, with the proportion of cases that were stage I at diagnosis falling from 18.5% to 17.2% (APR, 0.93).
In a stratified analysis, the significant downshift in lung and colorectal cancer stage were seen only in states that had actually adopted the Medicaid expansion component of the ACA, which covers low-income individuals, according to Dr. Han. The downshift in female breast cancer stage and upshift in prostate cancer stage occurred regardless of whether states had done so.
Implementation of the Affordable Care Act (ACA) has been associated with a shift toward earlier stage at diagnosis for common screenable cancers, finds an analysis of nearly 273,000 patients reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.
“Extensive evidence has shown that people without insurance are more likely to be diagnosed at later stage, especially for the cancers that can be detected earlier through screening or symptoms,” said lead study author Xuesong Han, PhD, strategic director of health policy and health care delivery research at the American Cancer Society in Atlanta. “In 2014, two major components of the Affordable Care Act – Medicaid expansion and marketplace exchange – were implemented. As a result, insurance coverage has substantially increased for nonelderly Americans.”
Study findings showed that, for four of five screenable cancers – breast and cervical cancer in women and lung and colorectal cancer in both sexes combined – the proportion of cancers that were stage I at diagnosis, and hence most curable, increased by an absolute 1% or so after the ACA was implemented. Prostate cancer was the outlier: the value for this malignancy decreased by 1%.
“The increases for the first four cancers were consistent with our hypothesis, with more people gaining insurance and access to screening services or access to physicians to detect early symptoms,” Dr. Han summarized. “But what about prostate cancer? We think [that pattern] may reflect the recent USPSTF recommendations against routine prostate cancer screening.”
“We think that this is an important study,” commented ASCO president-elect Bruce E. Johnson, MD, who is also chief clinical research officer and an institute physician at the Dana-Farber Cancer Institute in Boston. “Obviously, the changes are not enormous; they are not dramatic. But … because the uptake of screening is relatively slow, this is certainly consistent with the idea that, by doing additional screening, you can potentially find more stage I patients, and, the earlier the stage, the more likely one is to be cured.”
“The other important thing is that ASCO strongly supports the relative ease of access to screening capabilities, and that’s one of the characteristics of the Affordable Care Act, that most of the cancer screening is covered,” he further stated. “Whatever form our health care takes over the next several years, we advocate for patients to have early access to screening, which can identify cancers at an earlier stage in their more curable forms.”
Study details
For the study, the investigators used the National Cancer Database – which captures 70% of newly diagnosed cases in the United States – to identify patients younger than 65 who were eligible for cancer screening and who received a diagnosis of any of the five screenable cancers in 2013 or 2014. They compared stage distribution before ACA implementation (first nine months of 2013) and afterward (last nine months of 2014).
Analyses were based on data from 121,402 female breast cancer patients aged 40-64 years, 39,418 colorectal cancer patients aged 50-64 years, 11,190 cervical cancer patients aged 21-64 years, 59,210 prostate cancer patients aged 50-64 years, and 41,436 lung cancer patients aged 55-64 years.
Results showed that the proportion of cancers that were stage I at diagnosis increased after ACA implementation from 47.8% to 48.9% for breast cancer (adjusted prevalence ratio, 1.02) and from 47.3% to 48.8% for cervical cancer (APR, 1.02) in women, and from 16.6% to 17.7% for lung cancer (APR, 1.07) and from 22.8% to 23.7% for colorectal cancer (APR, 1.04) in men and women combined, Dr. Han reported.
Prostate cancer was the exception, with the proportion of cases that were stage I at diagnosis falling from 18.5% to 17.2% (APR, 0.93).
In a stratified analysis, the significant downshift in lung and colorectal cancer stage were seen only in states that had actually adopted the Medicaid expansion component of the ACA, which covers low-income individuals, according to Dr. Han. The downshift in female breast cancer stage and upshift in prostate cancer stage occurred regardless of whether states had done so.
Implementation of the Affordable Care Act (ACA) has been associated with a shift toward earlier stage at diagnosis for common screenable cancers, finds an analysis of nearly 273,000 patients reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.
“Extensive evidence has shown that people without insurance are more likely to be diagnosed at later stage, especially for the cancers that can be detected earlier through screening or symptoms,” said lead study author Xuesong Han, PhD, strategic director of health policy and health care delivery research at the American Cancer Society in Atlanta. “In 2014, two major components of the Affordable Care Act – Medicaid expansion and marketplace exchange – were implemented. As a result, insurance coverage has substantially increased for nonelderly Americans.”
Study findings showed that, for four of five screenable cancers – breast and cervical cancer in women and lung and colorectal cancer in both sexes combined – the proportion of cancers that were stage I at diagnosis, and hence most curable, increased by an absolute 1% or so after the ACA was implemented. Prostate cancer was the outlier: the value for this malignancy decreased by 1%.
“The increases for the first four cancers were consistent with our hypothesis, with more people gaining insurance and access to screening services or access to physicians to detect early symptoms,” Dr. Han summarized. “But what about prostate cancer? We think [that pattern] may reflect the recent USPSTF recommendations against routine prostate cancer screening.”
“We think that this is an important study,” commented ASCO president-elect Bruce E. Johnson, MD, who is also chief clinical research officer and an institute physician at the Dana-Farber Cancer Institute in Boston. “Obviously, the changes are not enormous; they are not dramatic. But … because the uptake of screening is relatively slow, this is certainly consistent with the idea that, by doing additional screening, you can potentially find more stage I patients, and, the earlier the stage, the more likely one is to be cured.”
“The other important thing is that ASCO strongly supports the relative ease of access to screening capabilities, and that’s one of the characteristics of the Affordable Care Act, that most of the cancer screening is covered,” he further stated. “Whatever form our health care takes over the next several years, we advocate for patients to have early access to screening, which can identify cancers at an earlier stage in their more curable forms.”
Study details
For the study, the investigators used the National Cancer Database – which captures 70% of newly diagnosed cases in the United States – to identify patients younger than 65 who were eligible for cancer screening and who received a diagnosis of any of the five screenable cancers in 2013 or 2014. They compared stage distribution before ACA implementation (first nine months of 2013) and afterward (last nine months of 2014).
Analyses were based on data from 121,402 female breast cancer patients aged 40-64 years, 39,418 colorectal cancer patients aged 50-64 years, 11,190 cervical cancer patients aged 21-64 years, 59,210 prostate cancer patients aged 50-64 years, and 41,436 lung cancer patients aged 55-64 years.
Results showed that the proportion of cancers that were stage I at diagnosis increased after ACA implementation from 47.8% to 48.9% for breast cancer (adjusted prevalence ratio, 1.02) and from 47.3% to 48.8% for cervical cancer (APR, 1.02) in women, and from 16.6% to 17.7% for lung cancer (APR, 1.07) and from 22.8% to 23.7% for colorectal cancer (APR, 1.04) in men and women combined, Dr. Han reported.
Prostate cancer was the exception, with the proportion of cases that were stage I at diagnosis falling from 18.5% to 17.2% (APR, 0.93).
In a stratified analysis, the significant downshift in lung and colorectal cancer stage were seen only in states that had actually adopted the Medicaid expansion component of the ACA, which covers low-income individuals, according to Dr. Han. The downshift in female breast cancer stage and upshift in prostate cancer stage occurred regardless of whether states had done so.
FROM THE 2017 ASCO ANNUAL MEETING
Key clinical point:
Major finding: The proportion of cancers that were stage I when diagnosed increased by about 1% after ACA implementation for breast, cervical, lung, and colorectal cancer, while it decreased by 1% for prostate cancer.
Data source: A cohort study of 272,656 patients with these five cancers from the National Cancer Database.
Disclosures: Dr. Han reported that she had no disclosures.