Patricia McKnight

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m², and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.

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

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m², and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.

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

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m², and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.

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

Racial disparities in cancer care have been reduced by Medicaid expansion, suggest new nationwide data.

Across the United States, minority patients with cancer often have worse outcomes than White patients, with Black patients more likely to die sooner.

But new data suggest that these racial disparities are lessening. They come from a cross-sectional cohort study of patients with gastrointestinal cancers and show that the gap in mortality rates was reduced in Medicaid expansion states, compared with nonexpansion states.

The results were particularly notable for Black patients, for whom there was a consistent increase in receiving therapy (chemotherapy or surgery) and a decrease in mortality from stomach, colorectal, and pancreatic cancer, the investigators commented.

The study was highlighted at a press briefing held in advance of the annual meeting of the American Society of Clinical Oncology.

“The findings of this study provide a solid step for closing the gap, showing that the Medicaid expansion opportunity offered by the Affordable Care Act, which allows participating states to improve health care access for disadvantaged populations, results in better cancer outcomes and mitigation of racial disparities in cancer survival,” commented Julie Gralow, MD, chief medical officer and executive vice president of ASCO.

The study included 86,052 patients from the National Cancer Database who, from 2009 to 2019, were diagnosed with pancreatic cancer, colorectal cancer, or stomach cancer. Just over 22,000 patients (25.7%) were Black; the remainder 63,943 (74.3%) were White.

In Medicaid expansion states, there was a greater absolute reduction in 2-year mortality among Black patients with pancreatic cancer of –11.8%, compared with nonexpansion states, at –2.4%, a difference-in-difference (DID) of –9.4%. Additionally, there was an increase in treatment with chemotherapy for patients with stage III-IV pancreatic cancer (4.5% for Black patients and 3.2% for White), compared with patients in nonexpansion states (0.8% for Black patients and 0.4% for White; DID, 3.7% for Black patients and DID, 2.7% for White).

“We found similar results in colorectal cancer, but this effect is primarily observed among the stage IV patients,” commented lead author Naveen Manisundaram, MD, a research fellow at the University of Texas MD Anderson Cancer Center, Houston. “Black patients with advanced stage disease experienced a 12.6% reduction in mortality in expansion states.”

Among Black patients with stage IV colorectal cancer, there was an increase in rates of surgery in expansion states, compared with nonexpansion states (DID, 5.7%). However, there was no increase in treatment with chemotherapy (DID, 1%; P = .66).

Mortality rates for Black patients with stomach cancer also decreased. In expansion states, there was a –13% absolute decrease in mortality, compared with a –5.2% decrease in nonexpansion states.

The investigators noted that Medicaid coverage was a key component in access to care through the Affordable Care Act. About two-thirds (66.7%) of Black patients had Medicaid; 33.3% were uninsured. Coverage was similar among White patients; 64.1% had Medicaid and 35.9% were uninsured.

“Our study provides compelling data that show Medicaid expansion was associated with improvement in survival for both Black and White patients with gastrointestinal cancers. Additionally, it suggests that Medicaid expansion is one potential avenue to mitigate existing racial survival disparities among these patients,” Dr. Manisundaram concluded.

The study was funded by the National Institutes of Health. One coauthor reported an advisory role with Medicaroid. Dr. Gralow has had a consulting or advisory role with Genentech and Roche.

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

Racial disparities in cancer care have been reduced by Medicaid expansion, suggest new nationwide data.

Across the United States, minority patients with cancer often have worse outcomes than White patients, with Black patients more likely to die sooner.

But new data suggest that these racial disparities are lessening. They come from a cross-sectional cohort study of patients with gastrointestinal cancers and show that the gap in mortality rates was reduced in Medicaid expansion states, compared with nonexpansion states.

The results were particularly notable for Black patients, for whom there was a consistent increase in receiving therapy (chemotherapy or surgery) and a decrease in mortality from stomach, colorectal, and pancreatic cancer, the investigators commented.

The study was highlighted at a press briefing held in advance of the annual meeting of the American Society of Clinical Oncology.

“The findings of this study provide a solid step for closing the gap, showing that the Medicaid expansion opportunity offered by the Affordable Care Act, which allows participating states to improve health care access for disadvantaged populations, results in better cancer outcomes and mitigation of racial disparities in cancer survival,” commented Julie Gralow, MD, chief medical officer and executive vice president of ASCO.

The study included 86,052 patients from the National Cancer Database who, from 2009 to 2019, were diagnosed with pancreatic cancer, colorectal cancer, or stomach cancer. Just over 22,000 patients (25.7%) were Black; the remainder 63,943 (74.3%) were White.

In Medicaid expansion states, there was a greater absolute reduction in 2-year mortality among Black patients with pancreatic cancer of –11.8%, compared with nonexpansion states, at –2.4%, a difference-in-difference (DID) of –9.4%. Additionally, there was an increase in treatment with chemotherapy for patients with stage III-IV pancreatic cancer (4.5% for Black patients and 3.2% for White), compared with patients in nonexpansion states (0.8% for Black patients and 0.4% for White; DID, 3.7% for Black patients and DID, 2.7% for White).

“We found similar results in colorectal cancer, but this effect is primarily observed among the stage IV patients,” commented lead author Naveen Manisundaram, MD, a research fellow at the University of Texas MD Anderson Cancer Center, Houston. “Black patients with advanced stage disease experienced a 12.6% reduction in mortality in expansion states.”

Among Black patients with stage IV colorectal cancer, there was an increase in rates of surgery in expansion states, compared with nonexpansion states (DID, 5.7%). However, there was no increase in treatment with chemotherapy (DID, 1%; P = .66).

Mortality rates for Black patients with stomach cancer also decreased. In expansion states, there was a –13% absolute decrease in mortality, compared with a –5.2% decrease in nonexpansion states.

The investigators noted that Medicaid coverage was a key component in access to care through the Affordable Care Act. About two-thirds (66.7%) of Black patients had Medicaid; 33.3% were uninsured. Coverage was similar among White patients; 64.1% had Medicaid and 35.9% were uninsured.

“Our study provides compelling data that show Medicaid expansion was associated with improvement in survival for both Black and White patients with gastrointestinal cancers. Additionally, it suggests that Medicaid expansion is one potential avenue to mitigate existing racial survival disparities among these patients,” Dr. Manisundaram concluded.

The study was funded by the National Institutes of Health. One coauthor reported an advisory role with Medicaroid. Dr. Gralow has had a consulting or advisory role with Genentech and Roche.

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

Racial disparities in cancer care have been reduced by Medicaid expansion, suggest new nationwide data.

Across the United States, minority patients with cancer often have worse outcomes than White patients, with Black patients more likely to die sooner.

But new data suggest that these racial disparities are lessening. They come from a cross-sectional cohort study of patients with gastrointestinal cancers and show that the gap in mortality rates was reduced in Medicaid expansion states, compared with nonexpansion states.

The results were particularly notable for Black patients, for whom there was a consistent increase in receiving therapy (chemotherapy or surgery) and a decrease in mortality from stomach, colorectal, and pancreatic cancer, the investigators commented.

The study was highlighted at a press briefing held in advance of the annual meeting of the American Society of Clinical Oncology.

“The findings of this study provide a solid step for closing the gap, showing that the Medicaid expansion opportunity offered by the Affordable Care Act, which allows participating states to improve health care access for disadvantaged populations, results in better cancer outcomes and mitigation of racial disparities in cancer survival,” commented Julie Gralow, MD, chief medical officer and executive vice president of ASCO.

The study included 86,052 patients from the National Cancer Database who, from 2009 to 2019, were diagnosed with pancreatic cancer, colorectal cancer, or stomach cancer. Just over 22,000 patients (25.7%) were Black; the remainder 63,943 (74.3%) were White.

In Medicaid expansion states, there was a greater absolute reduction in 2-year mortality among Black patients with pancreatic cancer of –11.8%, compared with nonexpansion states, at –2.4%, a difference-in-difference (DID) of –9.4%. Additionally, there was an increase in treatment with chemotherapy for patients with stage III-IV pancreatic cancer (4.5% for Black patients and 3.2% for White), compared with patients in nonexpansion states (0.8% for Black patients and 0.4% for White; DID, 3.7% for Black patients and DID, 2.7% for White).

“We found similar results in colorectal cancer, but this effect is primarily observed among the stage IV patients,” commented lead author Naveen Manisundaram, MD, a research fellow at the University of Texas MD Anderson Cancer Center, Houston. “Black patients with advanced stage disease experienced a 12.6% reduction in mortality in expansion states.”

Among Black patients with stage IV colorectal cancer, there was an increase in rates of surgery in expansion states, compared with nonexpansion states (DID, 5.7%). However, there was no increase in treatment with chemotherapy (DID, 1%; P = .66).

Mortality rates for Black patients with stomach cancer also decreased. In expansion states, there was a –13% absolute decrease in mortality, compared with a –5.2% decrease in nonexpansion states.

The investigators noted that Medicaid coverage was a key component in access to care through the Affordable Care Act. About two-thirds (66.7%) of Black patients had Medicaid; 33.3% were uninsured. Coverage was similar among White patients; 64.1% had Medicaid and 35.9% were uninsured.

“Our study provides compelling data that show Medicaid expansion was associated with improvement in survival for both Black and White patients with gastrointestinal cancers. Additionally, it suggests that Medicaid expansion is one potential avenue to mitigate existing racial survival disparities among these patients,” Dr. Manisundaram concluded.

The study was funded by the National Institutes of Health. One coauthor reported an advisory role with Medicaroid. Dr. Gralow has had a consulting or advisory role with Genentech and Roche.

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

The American Society of Clinical Oncology has released updated guidelines for treating anxiety and depression in adult cancer survivors.

Since the last guidelines, published in 2014, screening and assessment for depression and anxiety have improved, and a large new evidence base has emerged. To ensure the most up-to-date recommendations, a group of experts spanning psychology, psychiatry, medical and surgical oncology, internal medicine, and nursing convened to review the current literature on managing depression and anxiety. The review included 61 studies – 16 meta-analyses, 44 randomized controlled trials, and one systematic review – published between 2013 and 2021.

“The purpose of this guideline update is to gather and examine the evidence published since the 2014 guideline ... [with a] focus on management and treatment only.” The overall goal is to provide “the most effective and least resource-intensive intervention based on symptom severity” for patients with cancer, the experts write.

The new clinical practice guideline addresses the following question: What are the recommended treatment approaches in the management of anxiety and/or depression in survivors of adult cancer?

After an extensive literature search and analysis, the study was published online in the Journal of Clinical Oncology.

The expert panel’s recommendations fell into three broad categories – general management principles, treatment and care options for depressive symptoms, and treatment and care options for anxiety symptoms – with the guidelines for managing depression and anxiety largely mirroring each other.

The authors caution, however, that the guidelines “were developed in the context of mental health care being available and may not be applicable within other resource settings.”
 

General management principals

All patients with cancer, along with their caregivers, family members, or trusted confidants, should be offered information and resources on depression and anxiety. The panel gave this a “strong” recommendation but provided the caveat that the “information should be culturally informed and linguistically appropriate and can include a conversation between clinician and patient.”

Clinicians should select the most effective and least intensive intervention based on symptom severity when selecting treatment – what the panelists referred to as a stepped-care model. History of psychiatric diagnoses or substance use as well as prior responses to mental health treatment are some of the factors that may inform treatment choice.

For patients experiencing both depression and anxiety symptoms, treatment of depressive symptoms should be prioritized.

When referring a patient for further evaluation or care, clinicians “should make every effort to reduce barriers and facilitate patient follow-through,” the authors write. And health care professionals should regularly assess the treatment responses for patients receiving psychological or pharmacological interventions.

Overall, the treatments should be “supervised by a psychiatrist, and primary care or oncology providers work collaboratively with a nurse care manager to provide psychological interventions and monitor treatment compliance and outcomes,” the panelists write. “This type of collaborative care is found to be superior to usual care and is more cost-effective than face-to-face and pharmacologic treatment for depression.”
 

Treatment and care options for depressive and anxiety symptoms

For patients with moderate to severe depression symptoms, the panelists again stressed that clinicians should provide “culturally informed and linguistically appropriate information.” This information may include the frequency and symptoms of depression as well as signs these symptoms may be getting worse, with contact information for the medical team provided.

Among patients with moderate symptoms, clinicians can offer patients a range of individual or group therapy options, including cognitive-behavioral therapy (CBT), behavioral activation, mindfulness-based stress reduction, or structured physical activity and exercise. For patients with severe symptoms of depression, clinicians should offer individual therapy with one of these four treatment options: CBT, behavioral activation, mindfulness-based stress reduction, or interpersonal therapy.

The panelists offered almost identical recommendations for patients with anxiety, except mindfulness-based stress reduction was an option for patients with severe symptoms.

Clinicians can also provide pharmacologic options to treat depression or anxiety in certain patients, though the panelists provided the caveat that evidence for pharmacologic management is weak.

“These guidelines make no recommendations about any specific pharmacologic regimen being better than another,” the experts wrote. And “patients should be warned of potential harm or adverse effects.”

Overall, the panelists noted that, as highlighted in the 2014 ASCO guideline, the updated version continues to stress the importance of providing education on coping with stress, anxiety, and depression.

And “for individuals with elevated symptoms, validation and normalizing patients’ experiences is crucial,” the panelists write.

Although the timing of screening is not the focus of this updated review, the experts recognized that “how and when patients with cancer and survivors are screened are important determinants of timely management of anxiety and depression.”

And unlike the prior guideline, “pharmacotherapy is not recommended as a first-line treatment, neither alone nor in combination,” the authors say.

Overall, the panelists emphasize how widespread the mental health care crisis is and that problems accessing mental health care remain. “The choice of intervention to offer patients facing such obstacles should be based on shared decision-making, taking into account availability, accessibility, patient preference, likelihood of adverse events, adherence, and cost,” the experts conclude.

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

The American Society of Clinical Oncology has released updated guidelines for treating anxiety and depression in adult cancer survivors.

Since the last guidelines, published in 2014, screening and assessment for depression and anxiety have improved, and a large new evidence base has emerged. To ensure the most up-to-date recommendations, a group of experts spanning psychology, psychiatry, medical and surgical oncology, internal medicine, and nursing convened to review the current literature on managing depression and anxiety. The review included 61 studies – 16 meta-analyses, 44 randomized controlled trials, and one systematic review – published between 2013 and 2021.

“The purpose of this guideline update is to gather and examine the evidence published since the 2014 guideline ... [with a] focus on management and treatment only.” The overall goal is to provide “the most effective and least resource-intensive intervention based on symptom severity” for patients with cancer, the experts write.

The new clinical practice guideline addresses the following question: What are the recommended treatment approaches in the management of anxiety and/or depression in survivors of adult cancer?

After an extensive literature search and analysis, the study was published online in the Journal of Clinical Oncology.

The expert panel’s recommendations fell into three broad categories – general management principles, treatment and care options for depressive symptoms, and treatment and care options for anxiety symptoms – with the guidelines for managing depression and anxiety largely mirroring each other.

The authors caution, however, that the guidelines “were developed in the context of mental health care being available and may not be applicable within other resource settings.”
 

General management principals

All patients with cancer, along with their caregivers, family members, or trusted confidants, should be offered information and resources on depression and anxiety. The panel gave this a “strong” recommendation but provided the caveat that the “information should be culturally informed and linguistically appropriate and can include a conversation between clinician and patient.”

Clinicians should select the most effective and least intensive intervention based on symptom severity when selecting treatment – what the panelists referred to as a stepped-care model. History of psychiatric diagnoses or substance use as well as prior responses to mental health treatment are some of the factors that may inform treatment choice.

For patients experiencing both depression and anxiety symptoms, treatment of depressive symptoms should be prioritized.

When referring a patient for further evaluation or care, clinicians “should make every effort to reduce barriers and facilitate patient follow-through,” the authors write. And health care professionals should regularly assess the treatment responses for patients receiving psychological or pharmacological interventions.

Overall, the treatments should be “supervised by a psychiatrist, and primary care or oncology providers work collaboratively with a nurse care manager to provide psychological interventions and monitor treatment compliance and outcomes,” the panelists write. “This type of collaborative care is found to be superior to usual care and is more cost-effective than face-to-face and pharmacologic treatment for depression.”
 

Treatment and care options for depressive and anxiety symptoms

For patients with moderate to severe depression symptoms, the panelists again stressed that clinicians should provide “culturally informed and linguistically appropriate information.” This information may include the frequency and symptoms of depression as well as signs these symptoms may be getting worse, with contact information for the medical team provided.

Among patients with moderate symptoms, clinicians can offer patients a range of individual or group therapy options, including cognitive-behavioral therapy (CBT), behavioral activation, mindfulness-based stress reduction, or structured physical activity and exercise. For patients with severe symptoms of depression, clinicians should offer individual therapy with one of these four treatment options: CBT, behavioral activation, mindfulness-based stress reduction, or interpersonal therapy.

The panelists offered almost identical recommendations for patients with anxiety, except mindfulness-based stress reduction was an option for patients with severe symptoms.

Clinicians can also provide pharmacologic options to treat depression or anxiety in certain patients, though the panelists provided the caveat that evidence for pharmacologic management is weak.

“These guidelines make no recommendations about any specific pharmacologic regimen being better than another,” the experts wrote. And “patients should be warned of potential harm or adverse effects.”

Overall, the panelists noted that, as highlighted in the 2014 ASCO guideline, the updated version continues to stress the importance of providing education on coping with stress, anxiety, and depression.

And “for individuals with elevated symptoms, validation and normalizing patients’ experiences is crucial,” the panelists write.

Although the timing of screening is not the focus of this updated review, the experts recognized that “how and when patients with cancer and survivors are screened are important determinants of timely management of anxiety and depression.”

And unlike the prior guideline, “pharmacotherapy is not recommended as a first-line treatment, neither alone nor in combination,” the authors say.

Overall, the panelists emphasize how widespread the mental health care crisis is and that problems accessing mental health care remain. “The choice of intervention to offer patients facing such obstacles should be based on shared decision-making, taking into account availability, accessibility, patient preference, likelihood of adverse events, adherence, and cost,” the experts conclude.

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

The American Society of Clinical Oncology has released updated guidelines for treating anxiety and depression in adult cancer survivors.

Since the last guidelines, published in 2014, screening and assessment for depression and anxiety have improved, and a large new evidence base has emerged. To ensure the most up-to-date recommendations, a group of experts spanning psychology, psychiatry, medical and surgical oncology, internal medicine, and nursing convened to review the current literature on managing depression and anxiety. The review included 61 studies – 16 meta-analyses, 44 randomized controlled trials, and one systematic review – published between 2013 and 2021.

“The purpose of this guideline update is to gather and examine the evidence published since the 2014 guideline ... [with a] focus on management and treatment only.” The overall goal is to provide “the most effective and least resource-intensive intervention based on symptom severity” for patients with cancer, the experts write.

The new clinical practice guideline addresses the following question: What are the recommended treatment approaches in the management of anxiety and/or depression in survivors of adult cancer?

After an extensive literature search and analysis, the study was published online in the Journal of Clinical Oncology.

The expert panel’s recommendations fell into three broad categories – general management principles, treatment and care options for depressive symptoms, and treatment and care options for anxiety symptoms – with the guidelines for managing depression and anxiety largely mirroring each other.

The authors caution, however, that the guidelines “were developed in the context of mental health care being available and may not be applicable within other resource settings.”
 

General management principals

All patients with cancer, along with their caregivers, family members, or trusted confidants, should be offered information and resources on depression and anxiety. The panel gave this a “strong” recommendation but provided the caveat that the “information should be culturally informed and linguistically appropriate and can include a conversation between clinician and patient.”

Clinicians should select the most effective and least intensive intervention based on symptom severity when selecting treatment – what the panelists referred to as a stepped-care model. History of psychiatric diagnoses or substance use as well as prior responses to mental health treatment are some of the factors that may inform treatment choice.

For patients experiencing both depression and anxiety symptoms, treatment of depressive symptoms should be prioritized.

When referring a patient for further evaluation or care, clinicians “should make every effort to reduce barriers and facilitate patient follow-through,” the authors write. And health care professionals should regularly assess the treatment responses for patients receiving psychological or pharmacological interventions.

Overall, the treatments should be “supervised by a psychiatrist, and primary care or oncology providers work collaboratively with a nurse care manager to provide psychological interventions and monitor treatment compliance and outcomes,” the panelists write. “This type of collaborative care is found to be superior to usual care and is more cost-effective than face-to-face and pharmacologic treatment for depression.”
 

Treatment and care options for depressive and anxiety symptoms

For patients with moderate to severe depression symptoms, the panelists again stressed that clinicians should provide “culturally informed and linguistically appropriate information.” This information may include the frequency and symptoms of depression as well as signs these symptoms may be getting worse, with contact information for the medical team provided.

Among patients with moderate symptoms, clinicians can offer patients a range of individual or group therapy options, including cognitive-behavioral therapy (CBT), behavioral activation, mindfulness-based stress reduction, or structured physical activity and exercise. For patients with severe symptoms of depression, clinicians should offer individual therapy with one of these four treatment options: CBT, behavioral activation, mindfulness-based stress reduction, or interpersonal therapy.

The panelists offered almost identical recommendations for patients with anxiety, except mindfulness-based stress reduction was an option for patients with severe symptoms.

Clinicians can also provide pharmacologic options to treat depression or anxiety in certain patients, though the panelists provided the caveat that evidence for pharmacologic management is weak.

“These guidelines make no recommendations about any specific pharmacologic regimen being better than another,” the experts wrote. And “patients should be warned of potential harm or adverse effects.”

Overall, the panelists noted that, as highlighted in the 2014 ASCO guideline, the updated version continues to stress the importance of providing education on coping with stress, anxiety, and depression.

And “for individuals with elevated symptoms, validation and normalizing patients’ experiences is crucial,” the panelists write.

Although the timing of screening is not the focus of this updated review, the experts recognized that “how and when patients with cancer and survivors are screened are important determinants of timely management of anxiety and depression.”

And unlike the prior guideline, “pharmacotherapy is not recommended as a first-line treatment, neither alone nor in combination,” the authors say.

Overall, the panelists emphasize how widespread the mental health care crisis is and that problems accessing mental health care remain. “The choice of intervention to offer patients facing such obstacles should be based on shared decision-making, taking into account availability, accessibility, patient preference, likelihood of adverse events, adherence, and cost,” the experts conclude.

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

Cancer research has made big strides over the past few decades, leading to better prevention efforts, improved treatment options, and longer survival. Despite the significant progress, there is still a lot of work to do. 

In an article published in Cell, cancer specialists from across the globe provided their take on the big questions worth exploring in research over the coming years.

More sex-specific research

Sherene Loi, MBBS, PhD, head of the Translational Breast Cancer Genomics and Therapeutics Laboratory at the MacCallum Cancer Centre in Melbourne, said there needs to be more research on the differences in immune-related adverse events and immune responses between the sexes.

Dr. Loi’s recent research in mouse models has revealed that immune checkpoint inhibitors can lead to reduced oocyte reserves, and if those insights are validated in humans, it could have big implications for women of childbearing age who may face premature menopause and infertility.

“It is astonishing to realize that very little research has been done to investigate the long-term reproductive or fertility consequences of new agents we investigate in the phase 3 setting and then prescribe routinely in the curative setting,” Dr. Loi said. 
 

The global cancer community

C. S. Pramesh, MMBS, MS, FRCS, director of Tata Memorial Hospital in Mumbai, India, said that cancer research should prioritize global experiences, instead of focusing so heavily on high-income countries such as the United States.

“With much of the cancer burden likely to fall on low- and middle-income countries, it seems incongruous that almost 90% of cancer research currently takes place in high-income countries,” Dr. Pramesh said. “Neither the discordance between the cancer burden and research funding in high-income countries nor the types of problems or solutions addressed in these countries are relevant to the majority of patients with cancer in the world.”

Bishal Gyawali, MD, PhD, has discussed a similar need to prioritize cancer care in low- and middle-income countries, what he has dubbed “cancer groundshot.”

Dr. Pramesh described a brainstorming session among colleagues with global cancer expertise in which they identified five broad themes especially relevant to a global community. These themes include reducing the burden of patients presenting with advanced disease as well as improving access, affordability, and outcomes through solution-oriented research – goals that are critical but often not prioritized by high-income countries or industry, he said.

“Now is the time for the global community to wake up, take notice, and change the direction of cancer research for the larger public good,” Dr. Pramesh said.
 

Prioritizing combination therapies

The next big focus in cancer research should be to develop effective combination therapies, according to René Bernards, PhD, of The Netherlands Cancer Institute.

“Resistance to therapy remains a major obstacle in the treatment of cancer,” Dr. Bernards said. But, as the AIDS pandemic has taught us, the use of multiple drugs with “nonoverlapping resistance mechanisms can make a deadly disease with a high mutation rate chronic.”

A growing body of evidence highlights the relevance of this strategy to oncology. A recent study, for instance, highlighted the effectiveness of dual immune checkpoint inhibitors to treat advanced melanoma. 

“I believe that academic researchers can deliver more clinical benefit to patients by focusing on finding highly effective combinations of existing drugs than by searching for more drug targets,” he said. “Over time, this would also contribute to affordable health care through use of more generic drugs.”
 

Cancer drugs and the heart

Cardiologist Javid Moslehi, MD, who specializes in the cardiovascular health of patients with cancer, believes cardio-oncology should be the next frontier. During his research fellowship, Dr. Moslehi discovered that “many novel cancer therapies were leading to cardiovascular adverse effects, both during treatment and survivorship.”

But, Dr. Moslehi explained, “we are entering [uncharted] waters.”

Patients who receive immune checkpoint inhibitors may, for instance, develop fulminant myocarditis. Dr. Moslehi and colleagues have also found in preclinical models that abatacept (CTLA4-Ig) may be an effective treatment for myocarditis.

“Because of the targeted nature of new cancer therapies, cardiovascular sequelae may provide insights into cardiac biology, making cardio-oncology a novel platform for cardiovascular investigation,” Dr. Moslehi explained.
 

Inside rare cancers

William Sellers, MD, director of the Broad Institute of MIT’s Cancer Program, Cambridge, Mass., said rare cancers should be the next focus.

After all, “rare cancers are only rare in isolation,” Dr. Sellers said, noting that these cancers make up 20%-24% of all cancer diagnoses.

Although funding for rare cancer research remains limited, investing more could benefit patients in the long run. In early 2023, Pfizer announced plans to explore more options for early stage treatments for rare diseases and cancers. 

“New initiatives supporting direct-to-patient cohort enrollment bridging geographic fragmentation and rare cancer model development, enabling preclinical research to accelerate, are the first steps along a path toward curing these diseases,” he said. 

The researchers reported numerous relationships with pharmaceutical companies.
 

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

Cancer research has made big strides over the past few decades, leading to better prevention efforts, improved treatment options, and longer survival. Despite the significant progress, there is still a lot of work to do. 

In an article published in Cell, cancer specialists from across the globe provided their take on the big questions worth exploring in research over the coming years.

More sex-specific research

Sherene Loi, MBBS, PhD, head of the Translational Breast Cancer Genomics and Therapeutics Laboratory at the MacCallum Cancer Centre in Melbourne, said there needs to be more research on the differences in immune-related adverse events and immune responses between the sexes.

Dr. Loi’s recent research in mouse models has revealed that immune checkpoint inhibitors can lead to reduced oocyte reserves, and if those insights are validated in humans, it could have big implications for women of childbearing age who may face premature menopause and infertility.

“It is astonishing to realize that very little research has been done to investigate the long-term reproductive or fertility consequences of new agents we investigate in the phase 3 setting and then prescribe routinely in the curative setting,” Dr. Loi said. 
 

The global cancer community

C. S. Pramesh, MMBS, MS, FRCS, director of Tata Memorial Hospital in Mumbai, India, said that cancer research should prioritize global experiences, instead of focusing so heavily on high-income countries such as the United States.

“With much of the cancer burden likely to fall on low- and middle-income countries, it seems incongruous that almost 90% of cancer research currently takes place in high-income countries,” Dr. Pramesh said. “Neither the discordance between the cancer burden and research funding in high-income countries nor the types of problems or solutions addressed in these countries are relevant to the majority of patients with cancer in the world.”

Bishal Gyawali, MD, PhD, has discussed a similar need to prioritize cancer care in low- and middle-income countries, what he has dubbed “cancer groundshot.”

Dr. Pramesh described a brainstorming session among colleagues with global cancer expertise in which they identified five broad themes especially relevant to a global community. These themes include reducing the burden of patients presenting with advanced disease as well as improving access, affordability, and outcomes through solution-oriented research – goals that are critical but often not prioritized by high-income countries or industry, he said.

“Now is the time for the global community to wake up, take notice, and change the direction of cancer research for the larger public good,” Dr. Pramesh said.
 

Prioritizing combination therapies

The next big focus in cancer research should be to develop effective combination therapies, according to René Bernards, PhD, of The Netherlands Cancer Institute.

“Resistance to therapy remains a major obstacle in the treatment of cancer,” Dr. Bernards said. But, as the AIDS pandemic has taught us, the use of multiple drugs with “nonoverlapping resistance mechanisms can make a deadly disease with a high mutation rate chronic.”

A growing body of evidence highlights the relevance of this strategy to oncology. A recent study, for instance, highlighted the effectiveness of dual immune checkpoint inhibitors to treat advanced melanoma. 

“I believe that academic researchers can deliver more clinical benefit to patients by focusing on finding highly effective combinations of existing drugs than by searching for more drug targets,” he said. “Over time, this would also contribute to affordable health care through use of more generic drugs.”
 

Cancer drugs and the heart

Cardiologist Javid Moslehi, MD, who specializes in the cardiovascular health of patients with cancer, believes cardio-oncology should be the next frontier. During his research fellowship, Dr. Moslehi discovered that “many novel cancer therapies were leading to cardiovascular adverse effects, both during treatment and survivorship.”

But, Dr. Moslehi explained, “we are entering [uncharted] waters.”

Patients who receive immune checkpoint inhibitors may, for instance, develop fulminant myocarditis. Dr. Moslehi and colleagues have also found in preclinical models that abatacept (CTLA4-Ig) may be an effective treatment for myocarditis.

“Because of the targeted nature of new cancer therapies, cardiovascular sequelae may provide insights into cardiac biology, making cardio-oncology a novel platform for cardiovascular investigation,” Dr. Moslehi explained.
 

Inside rare cancers

William Sellers, MD, director of the Broad Institute of MIT’s Cancer Program, Cambridge, Mass., said rare cancers should be the next focus.

After all, “rare cancers are only rare in isolation,” Dr. Sellers said, noting that these cancers make up 20%-24% of all cancer diagnoses.

Although funding for rare cancer research remains limited, investing more could benefit patients in the long run. In early 2023, Pfizer announced plans to explore more options for early stage treatments for rare diseases and cancers. 

“New initiatives supporting direct-to-patient cohort enrollment bridging geographic fragmentation and rare cancer model development, enabling preclinical research to accelerate, are the first steps along a path toward curing these diseases,” he said. 

The researchers reported numerous relationships with pharmaceutical companies.
 

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

Cancer research has made big strides over the past few decades, leading to better prevention efforts, improved treatment options, and longer survival. Despite the significant progress, there is still a lot of work to do. 

In an article published in Cell, cancer specialists from across the globe provided their take on the big questions worth exploring in research over the coming years.

More sex-specific research

Sherene Loi, MBBS, PhD, head of the Translational Breast Cancer Genomics and Therapeutics Laboratory at the MacCallum Cancer Centre in Melbourne, said there needs to be more research on the differences in immune-related adverse events and immune responses between the sexes.

Dr. Loi’s recent research in mouse models has revealed that immune checkpoint inhibitors can lead to reduced oocyte reserves, and if those insights are validated in humans, it could have big implications for women of childbearing age who may face premature menopause and infertility.

“It is astonishing to realize that very little research has been done to investigate the long-term reproductive or fertility consequences of new agents we investigate in the phase 3 setting and then prescribe routinely in the curative setting,” Dr. Loi said. 
 

The global cancer community

C. S. Pramesh, MMBS, MS, FRCS, director of Tata Memorial Hospital in Mumbai, India, said that cancer research should prioritize global experiences, instead of focusing so heavily on high-income countries such as the United States.

“With much of the cancer burden likely to fall on low- and middle-income countries, it seems incongruous that almost 90% of cancer research currently takes place in high-income countries,” Dr. Pramesh said. “Neither the discordance between the cancer burden and research funding in high-income countries nor the types of problems or solutions addressed in these countries are relevant to the majority of patients with cancer in the world.”

Bishal Gyawali, MD, PhD, has discussed a similar need to prioritize cancer care in low- and middle-income countries, what he has dubbed “cancer groundshot.”

Dr. Pramesh described a brainstorming session among colleagues with global cancer expertise in which they identified five broad themes especially relevant to a global community. These themes include reducing the burden of patients presenting with advanced disease as well as improving access, affordability, and outcomes through solution-oriented research – goals that are critical but often not prioritized by high-income countries or industry, he said.

“Now is the time for the global community to wake up, take notice, and change the direction of cancer research for the larger public good,” Dr. Pramesh said.
 

Prioritizing combination therapies

The next big focus in cancer research should be to develop effective combination therapies, according to René Bernards, PhD, of The Netherlands Cancer Institute.

“Resistance to therapy remains a major obstacle in the treatment of cancer,” Dr. Bernards said. But, as the AIDS pandemic has taught us, the use of multiple drugs with “nonoverlapping resistance mechanisms can make a deadly disease with a high mutation rate chronic.”

A growing body of evidence highlights the relevance of this strategy to oncology. A recent study, for instance, highlighted the effectiveness of dual immune checkpoint inhibitors to treat advanced melanoma. 

“I believe that academic researchers can deliver more clinical benefit to patients by focusing on finding highly effective combinations of existing drugs than by searching for more drug targets,” he said. “Over time, this would also contribute to affordable health care through use of more generic drugs.”
 

Cancer drugs and the heart

Cardiologist Javid Moslehi, MD, who specializes in the cardiovascular health of patients with cancer, believes cardio-oncology should be the next frontier. During his research fellowship, Dr. Moslehi discovered that “many novel cancer therapies were leading to cardiovascular adverse effects, both during treatment and survivorship.”

But, Dr. Moslehi explained, “we are entering [uncharted] waters.”

Patients who receive immune checkpoint inhibitors may, for instance, develop fulminant myocarditis. Dr. Moslehi and colleagues have also found in preclinical models that abatacept (CTLA4-Ig) may be an effective treatment for myocarditis.

“Because of the targeted nature of new cancer therapies, cardiovascular sequelae may provide insights into cardiac biology, making cardio-oncology a novel platform for cardiovascular investigation,” Dr. Moslehi explained.
 

Inside rare cancers

William Sellers, MD, director of the Broad Institute of MIT’s Cancer Program, Cambridge, Mass., said rare cancers should be the next focus.

After all, “rare cancers are only rare in isolation,” Dr. Sellers said, noting that these cancers make up 20%-24% of all cancer diagnoses.

Although funding for rare cancer research remains limited, investing more could benefit patients in the long run. In early 2023, Pfizer announced plans to explore more options for early stage treatments for rare diseases and cancers. 

“New initiatives supporting direct-to-patient cohort enrollment bridging geographic fragmentation and rare cancer model development, enabling preclinical research to accelerate, are the first steps along a path toward curing these diseases,” he said. 

The researchers reported numerous relationships with pharmaceutical companies.
 

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

Cisplatin is one of the most commonly used chemotherapeutic agents for treating a variety of cancers, such as lung, bladder, and ovarian cancers. But the therapy comes with a drawback – ototoxicity.

“More than half of adult and pediatric patients with cancer treated with cisplatin developed hearing impairment with major impact on patients’ health-related quality of life,” researchers noted in a clinical review published in JCO Oncology Practice.

It is estimated that 36% of adult patients and 40%-60% of pediatric patients experience cisplatin-induced ototoxicity. It can present as tinnitus (ringing in the ears), loss of hearing in the high-frequency range (4000 – 8000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The incidence of cisplatin-induced ototoxicity is estimated to be 36% of adult patients and 40% to 60% of pediatric patients. Ototoxicity can present as tinnitus, loss of hearing in the high-frequency range (4,000-8,000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The risk of developing cisplatin-induced ototoxicity depends on various factors, including the cumulative dose of cisplatin, the duration of treatment, and individual patient factors, such as age and preexisting hearing problems.

The lack of real-world practice patterns for monitoring ototoxicity makes identifying effective prevention and intervention strategies challenging, say the authors, led by Asmi Chattaraj, MD, of the University of Pittsburgh Medical Center (UPMC), McKeesport, Pa.

The team conducted a survey of oncologists with the UPMC Hillman Cancer Center network regarding patterns for monitoring and reducing the risk of ototoxicity.

Of the 35 responding oncologists, the majority (97%) indicated that they regularly discuss the risk of ototoxicity with all patients before they receive cisplatin. However, only 18% of the respondents said they obtain audiograms for patients before administering cisplatin, 69% order audiograms only if patients complain of hearing loss or tinnitus, and 35% of respondents do not perform regular monitoring for ototoxicity.

“This heterogeneity of practice within a single network highlights the need for high-quality evidence to guide clinical practice and the urgent need to standardize the necessary diagnostic steps to monitor for ototoxicity and its effect on the quality of life in the adult oncology practice, similar to the current practice in the pediatric patient population,” the researchers determined.
 

Proactive rather than reactive

Managing cisplatin-induced ototoxicity “must be viewed as a proactive measure rather than a reactive measure,” Nisha A. Mohindra, MD, wrote in an accompanying editorial.

Dr. Mohindra noted that although it is recommended that audiology assessments be conducted before, during, and after administration of ototoxicity drugs, the monitoring for ototoxicity remains underutilized in clinical practice. The path to better outcomes begins with implementing testing into clinical practice, she suggested.

“The most effective mechanism to manage ototoxicity currently is to identify patients at risk and implement programs to support ongoing monitoring,” Dr. Mohindra wrote.

“Even if ototoxicity cannot be prevented in some patients, providing treating oncologists with a timely opportunity to alter therapy or providing patients with support, guidance, and earlier access to rehabilitation services may mitigate long-term effects of hearing loss,” she concluded.

The researchers have disclosed numerous relationships with industry, a full listing of which is available with the original article.

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

Cisplatin is one of the most commonly used chemotherapeutic agents for treating a variety of cancers, such as lung, bladder, and ovarian cancers. But the therapy comes with a drawback – ototoxicity.

“More than half of adult and pediatric patients with cancer treated with cisplatin developed hearing impairment with major impact on patients’ health-related quality of life,” researchers noted in a clinical review published in JCO Oncology Practice.

It is estimated that 36% of adult patients and 40%-60% of pediatric patients experience cisplatin-induced ototoxicity. It can present as tinnitus (ringing in the ears), loss of hearing in the high-frequency range (4000 – 8000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The incidence of cisplatin-induced ototoxicity is estimated to be 36% of adult patients and 40% to 60% of pediatric patients. Ototoxicity can present as tinnitus, loss of hearing in the high-frequency range (4,000-8,000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The risk of developing cisplatin-induced ototoxicity depends on various factors, including the cumulative dose of cisplatin, the duration of treatment, and individual patient factors, such as age and preexisting hearing problems.

The lack of real-world practice patterns for monitoring ototoxicity makes identifying effective prevention and intervention strategies challenging, say the authors, led by Asmi Chattaraj, MD, of the University of Pittsburgh Medical Center (UPMC), McKeesport, Pa.

The team conducted a survey of oncologists with the UPMC Hillman Cancer Center network regarding patterns for monitoring and reducing the risk of ototoxicity.

Of the 35 responding oncologists, the majority (97%) indicated that they regularly discuss the risk of ototoxicity with all patients before they receive cisplatin. However, only 18% of the respondents said they obtain audiograms for patients before administering cisplatin, 69% order audiograms only if patients complain of hearing loss or tinnitus, and 35% of respondents do not perform regular monitoring for ototoxicity.

“This heterogeneity of practice within a single network highlights the need for high-quality evidence to guide clinical practice and the urgent need to standardize the necessary diagnostic steps to monitor for ototoxicity and its effect on the quality of life in the adult oncology practice, similar to the current practice in the pediatric patient population,” the researchers determined.
 

Proactive rather than reactive

Managing cisplatin-induced ototoxicity “must be viewed as a proactive measure rather than a reactive measure,” Nisha A. Mohindra, MD, wrote in an accompanying editorial.

Dr. Mohindra noted that although it is recommended that audiology assessments be conducted before, during, and after administration of ototoxicity drugs, the monitoring for ototoxicity remains underutilized in clinical practice. The path to better outcomes begins with implementing testing into clinical practice, she suggested.

“The most effective mechanism to manage ototoxicity currently is to identify patients at risk and implement programs to support ongoing monitoring,” Dr. Mohindra wrote.

“Even if ototoxicity cannot be prevented in some patients, providing treating oncologists with a timely opportunity to alter therapy or providing patients with support, guidance, and earlier access to rehabilitation services may mitigate long-term effects of hearing loss,” she concluded.

The researchers have disclosed numerous relationships with industry, a full listing of which is available with the original article.

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

Cisplatin is one of the most commonly used chemotherapeutic agents for treating a variety of cancers, such as lung, bladder, and ovarian cancers. But the therapy comes with a drawback – ototoxicity.

“More than half of adult and pediatric patients with cancer treated with cisplatin developed hearing impairment with major impact on patients’ health-related quality of life,” researchers noted in a clinical review published in JCO Oncology Practice.

It is estimated that 36% of adult patients and 40%-60% of pediatric patients experience cisplatin-induced ototoxicity. It can present as tinnitus (ringing in the ears), loss of hearing in the high-frequency range (4000 – 8000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The incidence of cisplatin-induced ototoxicity is estimated to be 36% of adult patients and 40% to 60% of pediatric patients. Ototoxicity can present as tinnitus, loss of hearing in the high-frequency range (4,000-8,000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The risk of developing cisplatin-induced ototoxicity depends on various factors, including the cumulative dose of cisplatin, the duration of treatment, and individual patient factors, such as age and preexisting hearing problems.

The lack of real-world practice patterns for monitoring ototoxicity makes identifying effective prevention and intervention strategies challenging, say the authors, led by Asmi Chattaraj, MD, of the University of Pittsburgh Medical Center (UPMC), McKeesport, Pa.

The team conducted a survey of oncologists with the UPMC Hillman Cancer Center network regarding patterns for monitoring and reducing the risk of ototoxicity.

Of the 35 responding oncologists, the majority (97%) indicated that they regularly discuss the risk of ototoxicity with all patients before they receive cisplatin. However, only 18% of the respondents said they obtain audiograms for patients before administering cisplatin, 69% order audiograms only if patients complain of hearing loss or tinnitus, and 35% of respondents do not perform regular monitoring for ototoxicity.

“This heterogeneity of practice within a single network highlights the need for high-quality evidence to guide clinical practice and the urgent need to standardize the necessary diagnostic steps to monitor for ototoxicity and its effect on the quality of life in the adult oncology practice, similar to the current practice in the pediatric patient population,” the researchers determined.
 

Proactive rather than reactive

Managing cisplatin-induced ototoxicity “must be viewed as a proactive measure rather than a reactive measure,” Nisha A. Mohindra, MD, wrote in an accompanying editorial.

Dr. Mohindra noted that although it is recommended that audiology assessments be conducted before, during, and after administration of ototoxicity drugs, the monitoring for ototoxicity remains underutilized in clinical practice. The path to better outcomes begins with implementing testing into clinical practice, she suggested.

“The most effective mechanism to manage ototoxicity currently is to identify patients at risk and implement programs to support ongoing monitoring,” Dr. Mohindra wrote.

“Even if ototoxicity cannot be prevented in some patients, providing treating oncologists with a timely opportunity to alter therapy or providing patients with support, guidance, and earlier access to rehabilitation services may mitigate long-term effects of hearing loss,” she concluded.

The researchers have disclosed numerous relationships with industry, a full listing of which is available with the original article.

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

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

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

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

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

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

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

Radiation dermatitis is one of the most common side effects of radiotherapy for women with breast cancer. Results from a phase 3 trial add to previous evidence from smaller trials that show that a silicone-based film can protect skin from this side effect. 

But it is not being used much in clinical practice. Instead, radiation dermatitis is usually treated after the fact, most often with aqueous creams.

The product is Mepitel film, from Swedish medical device company Mölnlycke Health Care.

It should be used for women who are at high risk for developing radiation dermatitis, said Edward Chow, MBBS, PhD, of the department of radiation oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, who was the senior author of the phase 3 study published recently in the Journal of Clinical Oncology.

“Other doctors think that because radiation dermatitis isn’t life-threatening it isn’t as important, but the condition does affect the quality of life for patients,” Dr. Chow said. “If we can lessen the pain and discomfort, why wouldn’t we as physicians?”

Dr. Chow’s open-label, multicenter trial was conducted in 376 women with large breasts (bra cup size C or larger) who were undergoing radiotherapy after lumpectomy or mastectomy. The primary endpoint was grade 2 or 3 radiation dermatitis using the Common Terminology Criteria for Adverse Events. (Grade 2 is described as moderate, whereas grade 3 is severe.) 

The film significantly reduced the incidence of grade 2 or 3 radiation dermatitis, down to  15.5% compared with 45.6% in patients receiving standard care (odds ratio, 0.20, 95% confidence interval, 0.12-0.34, P < .0001). 

There was also a significant reduction in grade 3 radiation dermatitis (2.8% vs. 13.6%; OR, 0.19; P < .0002) and moist desquamation (8% vs. 19.2%; OR, 0.36; P = .002).

“The film was remarkably effective and helped protect patients from potentially debilitating side effects,” commented Corey Speers, MD, PhD, a radiation oncologist with University Hospitals, Cleveland, who saw the study data presented during a plenary session at the annual meeting of the American Society of Clinical Oncology.

He believes that preventing radiation dermatitis before it develops is the best way to care for patients. 

“[Radiation dermatitis] is usually associated with pain and discomfort and can lead to more serious issues like infection or delayed wound healing, and unfortunately, there aren’t effective treatments for it once it’s developed, so preventing it is our most effective strategy,” Dr. Speers said. 

One reason for the film not being used much could be that it takes time apply the film, suggested Patries Herst, PhD, department of radiation therapy, University of Otago, Wellington, New Zealand. She was the lead author of a study published in 2014 that also analyzed the effectiveness of the film in preventing radiation dermatitis.

In their trial, a research radiation therapist applied the film to women when they were starting their radiotherapy. The film is applied to a portion of the breast or chest wall, and Dr. Herst emphasized the importance of applying the film correctly, making sure the film is not stretched during application and not overlapping other pieces of the film, while also making sure that it conforms to the breast shape. The film was replaced when it would curl too much around the sides, approximately every 1 or 2 weeks. 

“Radiation therapy itself is very short. And so you have about 10 minutes for every patient,” she explained.

“But applying the film adds 20-30 minutes and it’s really awkward to apply properly,” Dr. Herst said. “You have to tap it in and then have to maybe cut it so that it fits better. And hospitals say, ‘We don’t have the time’ and that is still the biggest issue that we’re seeing right now.”

In Dr. Chow’s study, the average time spent applying the film on lumpectomy patients was 55 minutes and was slightly shorter at 45 minutes for mastectomy patients. He acknowledged that it does take time that staff at most hospitals and clinics simply don’t have.

Dr. Chow suggested that perhaps a family member or other caregiver could apply the film, and he referenced an educational video from the manufacturer that provides in-depth instructions on the correct way to apply the film for radiotherapy patients. However, this could lead to errors and a waste of product if not the film was not applied properly. 

The cost of Mepitel film may also be a deterrent. Dr. Chow’s study noted that, during the entire course of radiotherapy, the cost for the film was about $80-$100 per patient. However, he believes the benefits outweigh the cost. 

In addition, there have been issues with supplies, and it has been difficult for people to get their hands on the actual product.

Currently, the Mayo Clinic is also conducting a study testing Mepitel Film for radiation dermatitis in breast cancer patients following mastectomy. Mayo Clinic principal investigator Kimberly Corbin, MD, could not go into great detail about the ongoing trial, but she said it has been difficult to get the product. 

“We have been using the film at Mayo for a number of years,” Dr. Corbin said, but we “have found that it is challenging to get supplies.”

“While we have generally been able to have some supply established through our store here, we know that is not typical and it is difficult for patients to access,” she said. In addition, “there are not a ton of centers with experience in application.”

A representative with Mölnlycke Health Care, Allyson Bower-Willner, could not comment on the distribution of Mepitel film in the United States or if the company plans to increase the amount of product shipped. The film is available “to a limited set of customers,” she said.

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

Radiation dermatitis is one of the most common side effects of radiotherapy for women with breast cancer. Results from a phase 3 trial add to previous evidence from smaller trials that show that a silicone-based film can protect skin from this side effect. 

But it is not being used much in clinical practice. Instead, radiation dermatitis is usually treated after the fact, most often with aqueous creams.

The product is Mepitel film, from Swedish medical device company Mölnlycke Health Care.

It should be used for women who are at high risk for developing radiation dermatitis, said Edward Chow, MBBS, PhD, of the department of radiation oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, who was the senior author of the phase 3 study published recently in the Journal of Clinical Oncology.

“Other doctors think that because radiation dermatitis isn’t life-threatening it isn’t as important, but the condition does affect the quality of life for patients,” Dr. Chow said. “If we can lessen the pain and discomfort, why wouldn’t we as physicians?”

Dr. Chow’s open-label, multicenter trial was conducted in 376 women with large breasts (bra cup size C or larger) who were undergoing radiotherapy after lumpectomy or mastectomy. The primary endpoint was grade 2 or 3 radiation dermatitis using the Common Terminology Criteria for Adverse Events. (Grade 2 is described as moderate, whereas grade 3 is severe.) 

The film significantly reduced the incidence of grade 2 or 3 radiation dermatitis, down to  15.5% compared with 45.6% in patients receiving standard care (odds ratio, 0.20, 95% confidence interval, 0.12-0.34, P < .0001). 

There was also a significant reduction in grade 3 radiation dermatitis (2.8% vs. 13.6%; OR, 0.19; P < .0002) and moist desquamation (8% vs. 19.2%; OR, 0.36; P = .002).

“The film was remarkably effective and helped protect patients from potentially debilitating side effects,” commented Corey Speers, MD, PhD, a radiation oncologist with University Hospitals, Cleveland, who saw the study data presented during a plenary session at the annual meeting of the American Society of Clinical Oncology.

He believes that preventing radiation dermatitis before it develops is the best way to care for patients. 

“[Radiation dermatitis] is usually associated with pain and discomfort and can lead to more serious issues like infection or delayed wound healing, and unfortunately, there aren’t effective treatments for it once it’s developed, so preventing it is our most effective strategy,” Dr. Speers said. 

One reason for the film not being used much could be that it takes time apply the film, suggested Patries Herst, PhD, department of radiation therapy, University of Otago, Wellington, New Zealand. She was the lead author of a study published in 2014 that also analyzed the effectiveness of the film in preventing radiation dermatitis.

In their trial, a research radiation therapist applied the film to women when they were starting their radiotherapy. The film is applied to a portion of the breast or chest wall, and Dr. Herst emphasized the importance of applying the film correctly, making sure the film is not stretched during application and not overlapping other pieces of the film, while also making sure that it conforms to the breast shape. The film was replaced when it would curl too much around the sides, approximately every 1 or 2 weeks. 

“Radiation therapy itself is very short. And so you have about 10 minutes for every patient,” she explained.

“But applying the film adds 20-30 minutes and it’s really awkward to apply properly,” Dr. Herst said. “You have to tap it in and then have to maybe cut it so that it fits better. And hospitals say, ‘We don’t have the time’ and that is still the biggest issue that we’re seeing right now.”

In Dr. Chow’s study, the average time spent applying the film on lumpectomy patients was 55 minutes and was slightly shorter at 45 minutes for mastectomy patients. He acknowledged that it does take time that staff at most hospitals and clinics simply don’t have.

Dr. Chow suggested that perhaps a family member or other caregiver could apply the film, and he referenced an educational video from the manufacturer that provides in-depth instructions on the correct way to apply the film for radiotherapy patients. However, this could lead to errors and a waste of product if not the film was not applied properly. 

The cost of Mepitel film may also be a deterrent. Dr. Chow’s study noted that, during the entire course of radiotherapy, the cost for the film was about $80-$100 per patient. However, he believes the benefits outweigh the cost. 

In addition, there have been issues with supplies, and it has been difficult for people to get their hands on the actual product.

Currently, the Mayo Clinic is also conducting a study testing Mepitel Film for radiation dermatitis in breast cancer patients following mastectomy. Mayo Clinic principal investigator Kimberly Corbin, MD, could not go into great detail about the ongoing trial, but she said it has been difficult to get the product. 

“We have been using the film at Mayo for a number of years,” Dr. Corbin said, but we “have found that it is challenging to get supplies.”

“While we have generally been able to have some supply established through our store here, we know that is not typical and it is difficult for patients to access,” she said. In addition, “there are not a ton of centers with experience in application.”

A representative with Mölnlycke Health Care, Allyson Bower-Willner, could not comment on the distribution of Mepitel film in the United States or if the company plans to increase the amount of product shipped. The film is available “to a limited set of customers,” she said.

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

Radiation dermatitis is one of the most common side effects of radiotherapy for women with breast cancer. Results from a phase 3 trial add to previous evidence from smaller trials that show that a silicone-based film can protect skin from this side effect. 

But it is not being used much in clinical practice. Instead, radiation dermatitis is usually treated after the fact, most often with aqueous creams.

The product is Mepitel film, from Swedish medical device company Mölnlycke Health Care.

It should be used for women who are at high risk for developing radiation dermatitis, said Edward Chow, MBBS, PhD, of the department of radiation oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, who was the senior author of the phase 3 study published recently in the Journal of Clinical Oncology.

“Other doctors think that because radiation dermatitis isn’t life-threatening it isn’t as important, but the condition does affect the quality of life for patients,” Dr. Chow said. “If we can lessen the pain and discomfort, why wouldn’t we as physicians?”

Dr. Chow’s open-label, multicenter trial was conducted in 376 women with large breasts (bra cup size C or larger) who were undergoing radiotherapy after lumpectomy or mastectomy. The primary endpoint was grade 2 or 3 radiation dermatitis using the Common Terminology Criteria for Adverse Events. (Grade 2 is described as moderate, whereas grade 3 is severe.) 

The film significantly reduced the incidence of grade 2 or 3 radiation dermatitis, down to  15.5% compared with 45.6% in patients receiving standard care (odds ratio, 0.20, 95% confidence interval, 0.12-0.34, P < .0001). 

There was also a significant reduction in grade 3 radiation dermatitis (2.8% vs. 13.6%; OR, 0.19; P < .0002) and moist desquamation (8% vs. 19.2%; OR, 0.36; P = .002).

“The film was remarkably effective and helped protect patients from potentially debilitating side effects,” commented Corey Speers, MD, PhD, a radiation oncologist with University Hospitals, Cleveland, who saw the study data presented during a plenary session at the annual meeting of the American Society of Clinical Oncology.

He believes that preventing radiation dermatitis before it develops is the best way to care for patients. 

“[Radiation dermatitis] is usually associated with pain and discomfort and can lead to more serious issues like infection or delayed wound healing, and unfortunately, there aren’t effective treatments for it once it’s developed, so preventing it is our most effective strategy,” Dr. Speers said. 

One reason for the film not being used much could be that it takes time apply the film, suggested Patries Herst, PhD, department of radiation therapy, University of Otago, Wellington, New Zealand. She was the lead author of a study published in 2014 that also analyzed the effectiveness of the film in preventing radiation dermatitis.

In their trial, a research radiation therapist applied the film to women when they were starting their radiotherapy. The film is applied to a portion of the breast or chest wall, and Dr. Herst emphasized the importance of applying the film correctly, making sure the film is not stretched during application and not overlapping other pieces of the film, while also making sure that it conforms to the breast shape. The film was replaced when it would curl too much around the sides, approximately every 1 or 2 weeks. 

“Radiation therapy itself is very short. And so you have about 10 minutes for every patient,” she explained.

“But applying the film adds 20-30 minutes and it’s really awkward to apply properly,” Dr. Herst said. “You have to tap it in and then have to maybe cut it so that it fits better. And hospitals say, ‘We don’t have the time’ and that is still the biggest issue that we’re seeing right now.”

In Dr. Chow’s study, the average time spent applying the film on lumpectomy patients was 55 minutes and was slightly shorter at 45 minutes for mastectomy patients. He acknowledged that it does take time that staff at most hospitals and clinics simply don’t have.

Dr. Chow suggested that perhaps a family member or other caregiver could apply the film, and he referenced an educational video from the manufacturer that provides in-depth instructions on the correct way to apply the film for radiotherapy patients. However, this could lead to errors and a waste of product if not the film was not applied properly. 

The cost of Mepitel film may also be a deterrent. Dr. Chow’s study noted that, during the entire course of radiotherapy, the cost for the film was about $80-$100 per patient. However, he believes the benefits outweigh the cost. 

In addition, there have been issues with supplies, and it has been difficult for people to get their hands on the actual product.

Currently, the Mayo Clinic is also conducting a study testing Mepitel Film for radiation dermatitis in breast cancer patients following mastectomy. Mayo Clinic principal investigator Kimberly Corbin, MD, could not go into great detail about the ongoing trial, but she said it has been difficult to get the product. 

“We have been using the film at Mayo for a number of years,” Dr. Corbin said, but we “have found that it is challenging to get supplies.”

“While we have generally been able to have some supply established through our store here, we know that is not typical and it is difficult for patients to access,” she said. In addition, “there are not a ton of centers with experience in application.”

A representative with Mölnlycke Health Care, Allyson Bower-Willner, could not comment on the distribution of Mepitel film in the United States or if the company plans to increase the amount of product shipped. The film is available “to a limited set of customers,” she said.

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

The Food and Drug Administration has expanded the indication for adjuvant abemaciclib (Verzenio) in combination with endocrine therapy for patients with hormone receptor–positive, HER2-negative, node-positive early breast cancer who are at high risk for recurrence.

Abemaciclib was previously approved for this group of high-risk patients with the requirement that they have a Ki-67 score of at least 20%. The new expansion removes the Ki-67 testing requirement, meaning more patients are now eligible to receive this drug. High-risk patients eligible for the CDK4/6 inhibitor can now be identified solely on the basis of nodal status, tumor size, and tumor grade.

The FDA’s decision to expand the approval was based on 4-year data from the phase 3 monarchE trial of adjuvant abemaciclib, which showed benefit in invasive disease-free survival beyond the 2-year treatment course.

At 4 years, 85.5% of patients remained recurrence free with abemaciclib plus endocrine therapy, compared with 78.6% who received endocrine therapy alone, an absolute difference in invasive disease-free survival of 6.9%.

“The initial Verzenio FDA approval in early breast cancer was practice changing and now, through this indication expansion, we have the potential to reduce the risk of breast cancer recurrence for many more patients, relying solely on commonly utilized clinicopathologic features to identify them,” Erika P. Hamilton, MD, an investigator on the monarchE clinical trial, said in a press release.

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

The Food and Drug Administration has expanded the indication for adjuvant abemaciclib (Verzenio) in combination with endocrine therapy for patients with hormone receptor–positive, HER2-negative, node-positive early breast cancer who are at high risk for recurrence.

Abemaciclib was previously approved for this group of high-risk patients with the requirement that they have a Ki-67 score of at least 20%. The new expansion removes the Ki-67 testing requirement, meaning more patients are now eligible to receive this drug. High-risk patients eligible for the CDK4/6 inhibitor can now be identified solely on the basis of nodal status, tumor size, and tumor grade.

The FDA’s decision to expand the approval was based on 4-year data from the phase 3 monarchE trial of adjuvant abemaciclib, which showed benefit in invasive disease-free survival beyond the 2-year treatment course.

At 4 years, 85.5% of patients remained recurrence free with abemaciclib plus endocrine therapy, compared with 78.6% who received endocrine therapy alone, an absolute difference in invasive disease-free survival of 6.9%.

“The initial Verzenio FDA approval in early breast cancer was practice changing and now, through this indication expansion, we have the potential to reduce the risk of breast cancer recurrence for many more patients, relying solely on commonly utilized clinicopathologic features to identify them,” Erika P. Hamilton, MD, an investigator on the monarchE clinical trial, said in a press release.

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

The Food and Drug Administration has expanded the indication for adjuvant abemaciclib (Verzenio) in combination with endocrine therapy for patients with hormone receptor–positive, HER2-negative, node-positive early breast cancer who are at high risk for recurrence.

Abemaciclib was previously approved for this group of high-risk patients with the requirement that they have a Ki-67 score of at least 20%. The new expansion removes the Ki-67 testing requirement, meaning more patients are now eligible to receive this drug. High-risk patients eligible for the CDK4/6 inhibitor can now be identified solely on the basis of nodal status, tumor size, and tumor grade.

The FDA’s decision to expand the approval was based on 4-year data from the phase 3 monarchE trial of adjuvant abemaciclib, which showed benefit in invasive disease-free survival beyond the 2-year treatment course.

At 4 years, 85.5% of patients remained recurrence free with abemaciclib plus endocrine therapy, compared with 78.6% who received endocrine therapy alone, an absolute difference in invasive disease-free survival of 6.9%.

“The initial Verzenio FDA approval in early breast cancer was practice changing and now, through this indication expansion, we have the potential to reduce the risk of breast cancer recurrence for many more patients, relying solely on commonly utilized clinicopathologic features to identify them,” Erika P. Hamilton, MD, an investigator on the monarchE clinical trial, said in a press release.

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

An investigational, once-weekly prophylactic treatment provided “superior bleeding prevention” as well as normal or near-normal factor VIII activity in patients with severe hemophilia A, according to a recent phase 3 study.

One injection of efanesoctocog alfa, a factor VIII therapy, resolved almost all bleeding episodes (97%) in the overall patient population, and weekly prophylaxis provided mean factor VIII activity in the normal or near-normal range (> 40 IU/dL) for most of the week.

Efanesoctocog alfa is currently under priority review by the U.S. Food and Drug Administration, and the target action date for the approval decision was set for Tuesday, February 28.

“Currently, [patients] often need to make trade-offs between bleed protection and dosing frequency,” study researcher Angela Weyand, MD, of Michigan Medicine, said in a press release. The current phase 3 XTEND-1 results assessing efanesoctocog alfa demonstrate that “we have the opportunity to provide near normal factor activity levels for an extended period of time (the majority of a week) with a single dose, which is a first for hemophilia A.”

According to the researchers, efanesoctocog alfa is also the first investigational treatment for hemophilia A to surpass the von Willebrand factor half-life ceiling, which imposes a half-life limitation on current factor VIII therapies.

The study, which was funded by drugmakers Sanofi and Sobi, was published online in the New England Journal of Medicine.

Hemophilia A is a rare genetic disorder caused by a lack of blood clotting factor VIII. Normalizing factor VIII levels can help protect patients from spontaneous and traumatic bleeding but maintaining factor VIII levels in the normal (50-150 IU/dL) or close-to-normal range (> 40 to < 50 IU/dL) with currently available factor VIII therapies requires frequent administration, the study authors explained.

In the phase 3, open-label trial, the authors evaluated the efficacy, safety, and pharmacokinetics of efanesoctocog alfa for routine prophylaxis, treatment of bleeding episodes, and perioperative management in previously treated patients with severe hemophilia A.

Patients were 12 years of age or older with endogenous factor VIII activity of less than 1 IU/dL or a genotype known to produce severe hemophilia A. Patients were required to have had at least 150 previous exposure days to recombinant or plasma-derived factor VIII concentrates or cryoprecipitate.

Overall, 133 patients received once-weekly prophylaxis doses of 50 IU per kg of intravenous efanesoctocog alfa for 52 weeks (group A), and 26 patients received on-demand efanesoctocog alfa treatment for 26 weeks, followed by once-weekly prophylaxis with the medication for 26 weeks at the same 50 IU per kg dosage (group B). The primary endpoint was the mean annualized bleeding rate in group A.

Among those in group A, the annualized bleeding rate was 0 (interquartile range, 0-1.04) and the estimated mean annualized bleeding rate was 0.71. Overall, 65% of these patients (86 of 133) had no bleeding episodes and 93% had 0-2 bleeding episodes.

As for spontaneous bleeding, no episodes were reported in 80% of patients in group A (107 of 133) and 85% of patients (22 of 26) during the prophylaxis period in group B.

A total of 362 bleeding events occurred during the study, with most (268 of 362, or 74%) occurring in group B during the on-demand treatment period.

Among those in group A, switching from the prestudy standard of care to efanesoctocog alfa prophylaxis reduced the mean annualized bleeding rate from 2.96 to 0.69, a decrease of 77%. In group B, the mean annualized bleeding rate also decreased when patients switched from on-demand efanesoctocog alfa to prophylaxis (21.42 vs. 0.69).

Scores of physical health, joint health, and pain intensity were significantly improved within the 52 weeks. In patients with target joints at baseline, 100% of the target joints were resolved after at least 12 months of continuous prophylaxis.

In other words, not only did the treatment stop bleeding, but efanesoctocog alfa also improved the overall quality of life for patients, said lead author Annette von Drygalski MD, PharmD, of the University of California, San Diego. 

“[Efanesoctocog] alfa’s half-life and clotting factor activity levels truly translated into a number of other patient outcomes,” Dr. von Drygalski told this news organization. “All these reductions in parameters, pain improvement, improvement in joint health, reduction in pain, and of course reduction of infusions really resulted in improved quality of life for most patients, and so that’s remarkable.”

In addition, no patients developed inhibitors to factor VIII and there were no reports of serious allergic reactions, anaphylaxis, or vascular thrombotic events.

Of the 159 patients who received at least one dose of efanesoctocog alfa, 123 (77%) had at least one adverse event that developed or worsened during the treatment period. The most common adverse events were headache, arthralgia, fall, and back pain.

In an accompanying editorial, Cindy Leissinger, MD, called efanesoctocog alfa a “victory” for patients with hemophilia A.

“In a crowded field of transformative therapies for hemophilia, efanesoctocog alfa stands out as a winner – a major therapeutic advance that achieves highly protective factor VIII levels with a once-weekly infusion,” writes Dr. Leissinger, director of the Louisiana Center for Bleeding and Clotting Disorders at Tulane University, New Orleans.

The study was supported by Sanofi and Sobi. Both Dr. von Drygalski and Dr. Leissinger disclosed serving as consultants for Sanofi, among other disclosures. Other authors provided a range of disclosures, including serving as consultants for Sanofi and Sobi.

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

An investigational, once-weekly prophylactic treatment provided “superior bleeding prevention” as well as normal or near-normal factor VIII activity in patients with severe hemophilia A, according to a recent phase 3 study.

One injection of efanesoctocog alfa, a factor VIII therapy, resolved almost all bleeding episodes (97%) in the overall patient population, and weekly prophylaxis provided mean factor VIII activity in the normal or near-normal range (> 40 IU/dL) for most of the week.

Efanesoctocog alfa is currently under priority review by the U.S. Food and Drug Administration, and the target action date for the approval decision was set for Tuesday, February 28.

“Currently, [patients] often need to make trade-offs between bleed protection and dosing frequency,” study researcher Angela Weyand, MD, of Michigan Medicine, said in a press release. The current phase 3 XTEND-1 results assessing efanesoctocog alfa demonstrate that “we have the opportunity to provide near normal factor activity levels for an extended period of time (the majority of a week) with a single dose, which is a first for hemophilia A.”

According to the researchers, efanesoctocog alfa is also the first investigational treatment for hemophilia A to surpass the von Willebrand factor half-life ceiling, which imposes a half-life limitation on current factor VIII therapies.

The study, which was funded by drugmakers Sanofi and Sobi, was published online in the New England Journal of Medicine.

Hemophilia A is a rare genetic disorder caused by a lack of blood clotting factor VIII. Normalizing factor VIII levels can help protect patients from spontaneous and traumatic bleeding but maintaining factor VIII levels in the normal (50-150 IU/dL) or close-to-normal range (> 40 to < 50 IU/dL) with currently available factor VIII therapies requires frequent administration, the study authors explained.

In the phase 3, open-label trial, the authors evaluated the efficacy, safety, and pharmacokinetics of efanesoctocog alfa for routine prophylaxis, treatment of bleeding episodes, and perioperative management in previously treated patients with severe hemophilia A.

Patients were 12 years of age or older with endogenous factor VIII activity of less than 1 IU/dL or a genotype known to produce severe hemophilia A. Patients were required to have had at least 150 previous exposure days to recombinant or plasma-derived factor VIII concentrates or cryoprecipitate.

Overall, 133 patients received once-weekly prophylaxis doses of 50 IU per kg of intravenous efanesoctocog alfa for 52 weeks (group A), and 26 patients received on-demand efanesoctocog alfa treatment for 26 weeks, followed by once-weekly prophylaxis with the medication for 26 weeks at the same 50 IU per kg dosage (group B). The primary endpoint was the mean annualized bleeding rate in group A.

Among those in group A, the annualized bleeding rate was 0 (interquartile range, 0-1.04) and the estimated mean annualized bleeding rate was 0.71. Overall, 65% of these patients (86 of 133) had no bleeding episodes and 93% had 0-2 bleeding episodes.

As for spontaneous bleeding, no episodes were reported in 80% of patients in group A (107 of 133) and 85% of patients (22 of 26) during the prophylaxis period in group B.

A total of 362 bleeding events occurred during the study, with most (268 of 362, or 74%) occurring in group B during the on-demand treatment period.

Among those in group A, switching from the prestudy standard of care to efanesoctocog alfa prophylaxis reduced the mean annualized bleeding rate from 2.96 to 0.69, a decrease of 77%. In group B, the mean annualized bleeding rate also decreased when patients switched from on-demand efanesoctocog alfa to prophylaxis (21.42 vs. 0.69).

Scores of physical health, joint health, and pain intensity were significantly improved within the 52 weeks. In patients with target joints at baseline, 100% of the target joints were resolved after at least 12 months of continuous prophylaxis.

In other words, not only did the treatment stop bleeding, but efanesoctocog alfa also improved the overall quality of life for patients, said lead author Annette von Drygalski MD, PharmD, of the University of California, San Diego. 

“[Efanesoctocog] alfa’s half-life and clotting factor activity levels truly translated into a number of other patient outcomes,” Dr. von Drygalski told this news organization. “All these reductions in parameters, pain improvement, improvement in joint health, reduction in pain, and of course reduction of infusions really resulted in improved quality of life for most patients, and so that’s remarkable.”

In addition, no patients developed inhibitors to factor VIII and there were no reports of serious allergic reactions, anaphylaxis, or vascular thrombotic events.

Of the 159 patients who received at least one dose of efanesoctocog alfa, 123 (77%) had at least one adverse event that developed or worsened during the treatment period. The most common adverse events were headache, arthralgia, fall, and back pain.

In an accompanying editorial, Cindy Leissinger, MD, called efanesoctocog alfa a “victory” for patients with hemophilia A.

“In a crowded field of transformative therapies for hemophilia, efanesoctocog alfa stands out as a winner – a major therapeutic advance that achieves highly protective factor VIII levels with a once-weekly infusion,” writes Dr. Leissinger, director of the Louisiana Center for Bleeding and Clotting Disorders at Tulane University, New Orleans.

The study was supported by Sanofi and Sobi. Both Dr. von Drygalski and Dr. Leissinger disclosed serving as consultants for Sanofi, among other disclosures. Other authors provided a range of disclosures, including serving as consultants for Sanofi and Sobi.

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

An investigational, once-weekly prophylactic treatment provided “superior bleeding prevention” as well as normal or near-normal factor VIII activity in patients with severe hemophilia A, according to a recent phase 3 study.

One injection of efanesoctocog alfa, a factor VIII therapy, resolved almost all bleeding episodes (97%) in the overall patient population, and weekly prophylaxis provided mean factor VIII activity in the normal or near-normal range (> 40 IU/dL) for most of the week.

Efanesoctocog alfa is currently under priority review by the U.S. Food and Drug Administration, and the target action date for the approval decision was set for Tuesday, February 28.

“Currently, [patients] often need to make trade-offs between bleed protection and dosing frequency,” study researcher Angela Weyand, MD, of Michigan Medicine, said in a press release. The current phase 3 XTEND-1 results assessing efanesoctocog alfa demonstrate that “we have the opportunity to provide near normal factor activity levels for an extended period of time (the majority of a week) with a single dose, which is a first for hemophilia A.”

According to the researchers, efanesoctocog alfa is also the first investigational treatment for hemophilia A to surpass the von Willebrand factor half-life ceiling, which imposes a half-life limitation on current factor VIII therapies.

The study, which was funded by drugmakers Sanofi and Sobi, was published online in the New England Journal of Medicine.

Hemophilia A is a rare genetic disorder caused by a lack of blood clotting factor VIII. Normalizing factor VIII levels can help protect patients from spontaneous and traumatic bleeding but maintaining factor VIII levels in the normal (50-150 IU/dL) or close-to-normal range (> 40 to < 50 IU/dL) with currently available factor VIII therapies requires frequent administration, the study authors explained.

In the phase 3, open-label trial, the authors evaluated the efficacy, safety, and pharmacokinetics of efanesoctocog alfa for routine prophylaxis, treatment of bleeding episodes, and perioperative management in previously treated patients with severe hemophilia A.

Patients were 12 years of age or older with endogenous factor VIII activity of less than 1 IU/dL or a genotype known to produce severe hemophilia A. Patients were required to have had at least 150 previous exposure days to recombinant or plasma-derived factor VIII concentrates or cryoprecipitate.

Overall, 133 patients received once-weekly prophylaxis doses of 50 IU per kg of intravenous efanesoctocog alfa for 52 weeks (group A), and 26 patients received on-demand efanesoctocog alfa treatment for 26 weeks, followed by once-weekly prophylaxis with the medication for 26 weeks at the same 50 IU per kg dosage (group B). The primary endpoint was the mean annualized bleeding rate in group A.

Among those in group A, the annualized bleeding rate was 0 (interquartile range, 0-1.04) and the estimated mean annualized bleeding rate was 0.71. Overall, 65% of these patients (86 of 133) had no bleeding episodes and 93% had 0-2 bleeding episodes.

As for spontaneous bleeding, no episodes were reported in 80% of patients in group A (107 of 133) and 85% of patients (22 of 26) during the prophylaxis period in group B.

A total of 362 bleeding events occurred during the study, with most (268 of 362, or 74%) occurring in group B during the on-demand treatment period.

Among those in group A, switching from the prestudy standard of care to efanesoctocog alfa prophylaxis reduced the mean annualized bleeding rate from 2.96 to 0.69, a decrease of 77%. In group B, the mean annualized bleeding rate also decreased when patients switched from on-demand efanesoctocog alfa to prophylaxis (21.42 vs. 0.69).

Scores of physical health, joint health, and pain intensity were significantly improved within the 52 weeks. In patients with target joints at baseline, 100% of the target joints were resolved after at least 12 months of continuous prophylaxis.

In other words, not only did the treatment stop bleeding, but efanesoctocog alfa also improved the overall quality of life for patients, said lead author Annette von Drygalski MD, PharmD, of the University of California, San Diego. 

“[Efanesoctocog] alfa’s half-life and clotting factor activity levels truly translated into a number of other patient outcomes,” Dr. von Drygalski told this news organization. “All these reductions in parameters, pain improvement, improvement in joint health, reduction in pain, and of course reduction of infusions really resulted in improved quality of life for most patients, and so that’s remarkable.”

In addition, no patients developed inhibitors to factor VIII and there were no reports of serious allergic reactions, anaphylaxis, or vascular thrombotic events.

Of the 159 patients who received at least one dose of efanesoctocog alfa, 123 (77%) had at least one adverse event that developed or worsened during the treatment period. The most common adverse events were headache, arthralgia, fall, and back pain.

In an accompanying editorial, Cindy Leissinger, MD, called efanesoctocog alfa a “victory” for patients with hemophilia A.

“In a crowded field of transformative therapies for hemophilia, efanesoctocog alfa stands out as a winner – a major therapeutic advance that achieves highly protective factor VIII levels with a once-weekly infusion,” writes Dr. Leissinger, director of the Louisiana Center for Bleeding and Clotting Disorders at Tulane University, New Orleans.

The study was supported by Sanofi and Sobi. Both Dr. von Drygalski and Dr. Leissinger disclosed serving as consultants for Sanofi, among other disclosures. Other authors provided a range of disclosures, including serving as consultants for Sanofi and Sobi.

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

Opioids are widely regarded as a linchpin in the treatment of moderate to severe cancer-related pain and end-of-life symptoms; however, there are persistent racial and ethnic inequities in opioid access among older cancer patients, with Black patients being disproportionately affected, a new study suggests.

Black patients were more likely to undergo urine drug screening (UDS) despite being less likely to receive any opioids for pain management and receiving lower daily doses of opioids in comparison with White patients, the study found.

The inequities were particularly stark for Black men. “We found that Black men were far less likely to be prescribed reasonable doses than White men were,” said the study’s senior author, Alexi Wright, MD, MPH, a gynecologic oncologist and a researcher in the division of population sciences at Dana-Farber Cancer Institute, Boston. “And Black men were less likely to receive long-acting opioids, which are essential for many patients dying of cancer. Our findings are startling because everyone should agree that cancer patients should have equal access to pain relief at the end of life.”

The study was published on in the Journal of Clinical Oncology.

The researchers gathered data on 318,549 Medicare beneficiaries older than 65 years with poor-prognosis cancers who died between 2007 and 2019. During this time frame, for all groups, access to opioids declined and urine drug testing expanded, owing to the overall opioid epidemic in the United States. Overall, the proportion of patients near end of life (EOL) who received any opioid or long-acting opioids decreased from 42.2% to 32.7% and from 17.9% to 9.4%, respectively.

The investigators used National Drug Codes to identify all Medicare Part D claims for outpatient opioid prescriptions, excluding addiction treatments, cough suppressants, and parenteral opioids. They focused on prescriptions that were filled at least 30 days before death or hospice enrollment.

Among the study participants, the majority (85.5%) of patients were White, 29,555 patients (9.3%) were Black, and 16,636 patients (5.2%) were Hispanic.

Black and Hispanic patients were statistically less likely than White patients to receive opioid prescriptions near EOL (Black, –4.3 percentage points; Hispanic, –3.6 percentage points). They were also less likely to receive long-acting opioid prescriptions (Black, –3.1 percentage points; Hispanic, –2.2 percentage points).

“It’s not just that patients of color are less likely to get opioids, but when they do get them, they get lower doses, and they also are less likely to get long-acting opioids, which a lot of people view as sort of more potential for addiction, which isn’t necessarily true but kind of viewed with heightened concern or suspicion,” the study’s lead author, Andrea Enzinger, MD, a gastrointestinal oncologist and a researcher in Dana-Farber’s division of population sciences, said in an interview.

Dr. Enzinger added that she believes systemic racism and preconceived biases toward minorities and drug addiction may be contributing to these trends.

When Black patients did receive at least one opioid prescription, they received daily doses that were 10.5 morphine milligram equivalents (MMEs) lower than doses given to White patients. Compared with the total opioid dose filled per White decedent near EOL, the total dose filled per Black decedent was 210 MMEs lower.

“We all need to be worried about the potential for misuse or addiction, but this is the one setting that is very low on my priority list when somebody is dying. I mean, we’re looking at the last month of life, so nobody has the potential to become addicted,” Dr. Enzinger commented.

The team also evaluated rates or urine drug screening (UDS), but as these rates were relatively low, they expanded the time frame to 180 days before death or hospice. They found that disparities in UDS disproportionately affected Black men.

From 2007 to 2019, the proportion of patients who underwent UDS increased from 0.6% to 6.7% in the 180 days before death or hospice; however, Black decedents were tested more often than White or Hispanic decedents.

Black decedents were 0.5 percentage points more likely than White decedents to undergo UDS near EOL.

“The disparities in urine drug screening are modest but important, because they hint at underlying systematic racism in recommending patients for screening,” Dr. Wright said. “Screening needs to either be applied uniformly or not at all for patients in this situation.”

The researchers acknowledged that their findings likely do not represent the full spectrum of prescribing disparities and believe that the work should be expanded among younger populations. Nevertheless, the investigators believe the work highlights the persistent racial and ethnic disparities in opioid access.

The study was supported by a grant from the Agency for Healthcare Research and Policy.

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

Opioids are widely regarded as a linchpin in the treatment of moderate to severe cancer-related pain and end-of-life symptoms; however, there are persistent racial and ethnic inequities in opioid access among older cancer patients, with Black patients being disproportionately affected, a new study suggests.

Black patients were more likely to undergo urine drug screening (UDS) despite being less likely to receive any opioids for pain management and receiving lower daily doses of opioids in comparison with White patients, the study found.

The inequities were particularly stark for Black men. “We found that Black men were far less likely to be prescribed reasonable doses than White men were,” said the study’s senior author, Alexi Wright, MD, MPH, a gynecologic oncologist and a researcher in the division of population sciences at Dana-Farber Cancer Institute, Boston. “And Black men were less likely to receive long-acting opioids, which are essential for many patients dying of cancer. Our findings are startling because everyone should agree that cancer patients should have equal access to pain relief at the end of life.”

The study was published on in the Journal of Clinical Oncology.

The researchers gathered data on 318,549 Medicare beneficiaries older than 65 years with poor-prognosis cancers who died between 2007 and 2019. During this time frame, for all groups, access to opioids declined and urine drug testing expanded, owing to the overall opioid epidemic in the United States. Overall, the proportion of patients near end of life (EOL) who received any opioid or long-acting opioids decreased from 42.2% to 32.7% and from 17.9% to 9.4%, respectively.

The investigators used National Drug Codes to identify all Medicare Part D claims for outpatient opioid prescriptions, excluding addiction treatments, cough suppressants, and parenteral opioids. They focused on prescriptions that were filled at least 30 days before death or hospice enrollment.

Among the study participants, the majority (85.5%) of patients were White, 29,555 patients (9.3%) were Black, and 16,636 patients (5.2%) were Hispanic.

Black and Hispanic patients were statistically less likely than White patients to receive opioid prescriptions near EOL (Black, –4.3 percentage points; Hispanic, –3.6 percentage points). They were also less likely to receive long-acting opioid prescriptions (Black, –3.1 percentage points; Hispanic, –2.2 percentage points).

“It’s not just that patients of color are less likely to get opioids, but when they do get them, they get lower doses, and they also are less likely to get long-acting opioids, which a lot of people view as sort of more potential for addiction, which isn’t necessarily true but kind of viewed with heightened concern or suspicion,” the study’s lead author, Andrea Enzinger, MD, a gastrointestinal oncologist and a researcher in Dana-Farber’s division of population sciences, said in an interview.

Dr. Enzinger added that she believes systemic racism and preconceived biases toward minorities and drug addiction may be contributing to these trends.

When Black patients did receive at least one opioid prescription, they received daily doses that were 10.5 morphine milligram equivalents (MMEs) lower than doses given to White patients. Compared with the total opioid dose filled per White decedent near EOL, the total dose filled per Black decedent was 210 MMEs lower.

“We all need to be worried about the potential for misuse or addiction, but this is the one setting that is very low on my priority list when somebody is dying. I mean, we’re looking at the last month of life, so nobody has the potential to become addicted,” Dr. Enzinger commented.

The team also evaluated rates or urine drug screening (UDS), but as these rates were relatively low, they expanded the time frame to 180 days before death or hospice. They found that disparities in UDS disproportionately affected Black men.

From 2007 to 2019, the proportion of patients who underwent UDS increased from 0.6% to 6.7% in the 180 days before death or hospice; however, Black decedents were tested more often than White or Hispanic decedents.

Black decedents were 0.5 percentage points more likely than White decedents to undergo UDS near EOL.

“The disparities in urine drug screening are modest but important, because they hint at underlying systematic racism in recommending patients for screening,” Dr. Wright said. “Screening needs to either be applied uniformly or not at all for patients in this situation.”

The researchers acknowledged that their findings likely do not represent the full spectrum of prescribing disparities and believe that the work should be expanded among younger populations. Nevertheless, the investigators believe the work highlights the persistent racial and ethnic disparities in opioid access.

The study was supported by a grant from the Agency for Healthcare Research and Policy.

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

Opioids are widely regarded as a linchpin in the treatment of moderate to severe cancer-related pain and end-of-life symptoms; however, there are persistent racial and ethnic inequities in opioid access among older cancer patients, with Black patients being disproportionately affected, a new study suggests.

Black patients were more likely to undergo urine drug screening (UDS) despite being less likely to receive any opioids for pain management and receiving lower daily doses of opioids in comparison with White patients, the study found.

The inequities were particularly stark for Black men. “We found that Black men were far less likely to be prescribed reasonable doses than White men were,” said the study’s senior author, Alexi Wright, MD, MPH, a gynecologic oncologist and a researcher in the division of population sciences at Dana-Farber Cancer Institute, Boston. “And Black men were less likely to receive long-acting opioids, which are essential for many patients dying of cancer. Our findings are startling because everyone should agree that cancer patients should have equal access to pain relief at the end of life.”

The study was published on in the Journal of Clinical Oncology.

The researchers gathered data on 318,549 Medicare beneficiaries older than 65 years with poor-prognosis cancers who died between 2007 and 2019. During this time frame, for all groups, access to opioids declined and urine drug testing expanded, owing to the overall opioid epidemic in the United States. Overall, the proportion of patients near end of life (EOL) who received any opioid or long-acting opioids decreased from 42.2% to 32.7% and from 17.9% to 9.4%, respectively.

The investigators used National Drug Codes to identify all Medicare Part D claims for outpatient opioid prescriptions, excluding addiction treatments, cough suppressants, and parenteral opioids. They focused on prescriptions that were filled at least 30 days before death or hospice enrollment.

Among the study participants, the majority (85.5%) of patients were White, 29,555 patients (9.3%) were Black, and 16,636 patients (5.2%) were Hispanic.

Black and Hispanic patients were statistically less likely than White patients to receive opioid prescriptions near EOL (Black, –4.3 percentage points; Hispanic, –3.6 percentage points). They were also less likely to receive long-acting opioid prescriptions (Black, –3.1 percentage points; Hispanic, –2.2 percentage points).

“It’s not just that patients of color are less likely to get opioids, but when they do get them, they get lower doses, and they also are less likely to get long-acting opioids, which a lot of people view as sort of more potential for addiction, which isn’t necessarily true but kind of viewed with heightened concern or suspicion,” the study’s lead author, Andrea Enzinger, MD, a gastrointestinal oncologist and a researcher in Dana-Farber’s division of population sciences, said in an interview.

Dr. Enzinger added that she believes systemic racism and preconceived biases toward minorities and drug addiction may be contributing to these trends.

When Black patients did receive at least one opioid prescription, they received daily doses that were 10.5 morphine milligram equivalents (MMEs) lower than doses given to White patients. Compared with the total opioid dose filled per White decedent near EOL, the total dose filled per Black decedent was 210 MMEs lower.

“We all need to be worried about the potential for misuse or addiction, but this is the one setting that is very low on my priority list when somebody is dying. I mean, we’re looking at the last month of life, so nobody has the potential to become addicted,” Dr. Enzinger commented.

The team also evaluated rates or urine drug screening (UDS), but as these rates were relatively low, they expanded the time frame to 180 days before death or hospice. They found that disparities in UDS disproportionately affected Black men.

From 2007 to 2019, the proportion of patients who underwent UDS increased from 0.6% to 6.7% in the 180 days before death or hospice; however, Black decedents were tested more often than White or Hispanic decedents.

Black decedents were 0.5 percentage points more likely than White decedents to undergo UDS near EOL.

“The disparities in urine drug screening are modest but important, because they hint at underlying systematic racism in recommending patients for screening,” Dr. Wright said. “Screening needs to either be applied uniformly or not at all for patients in this situation.”

The researchers acknowledged that their findings likely do not represent the full spectrum of prescribing disparities and believe that the work should be expanded among younger populations. Nevertheless, the investigators believe the work highlights the persistent racial and ethnic disparities in opioid access.

The study was supported by a grant from the Agency for Healthcare Research and Policy.

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