Sharon Worcester

New guidelines highlight the role that integrative pain management techniques, such as massage, acupuncture, and music therapy, can play in relieving certain types of cancer pain in adults.

The recommendations, published in the Journal of Clinical Oncology, represent a joint effort between the American Society of Clinical Oncology (ASCO) and the Society of Integrative Oncology (SIO) to guide clinicians on how best to weave various nonpharmacologic pain management strategies into cancer care.

“Pain is a clinical challenge for many oncology patients and clinicians, and there’s a growing body of evidence showing that integrative therapies can be useful in pain management,” Heather Greenlee, ND, PhD, explained in a press release.

However, clear clinical guidance as to when and when not to use these approaches is lacking, said Dr. Greenlee, cochair of the SIO Clinical Practice Guideline Committee.

Previous guidelines from ASCO on managing chronic cancer-related pain largely focused on diagnosing pain and on pharmacologic interventions, and they touched only on evidence related to nonpharmacologic options.

The new guideline “takes a deeper dive on the use of integrative therapies, which is important because clinicians and patients need to have access to the latest evidence-based information to make clinical decisions,” noted Jun H. Mao, MD, SIO-ASCO panel cochair.

In the guidance, the expert panel addresses two core questions: What mind-body therapies are recommended for managing pain experienced by adult and pediatric patients diagnosed with cancer, and what natural products are recommended for managing pain experienced by adult and pediatric patients diagnosed with cancer?

The panel conducted a literature search and identified 277 relevant studies. They included systematic reviews and randomized controlled trials published between 1990 and 2021 that evaluated outcomes related to pain intensity, symptom relief, and adverse events. After reaching a consensus, the expert panel made recommendations on the basis of the strength of the available evidence.

Regarding modalities for which there was stronger evidence, the panel highlighted several recommendations regarding acupuncture, reflexology, hypnosis, and massage.

The panel determined, for instance, that acupuncture should be offered for aromatase-related joint pain in patients with breast cancer and that it can be offered for general or musculoskeletal pain from cancer. It recommended reflexology or acupressure for pain experienced during systemic therapy for cancer. Hypnosis is an option for patients experiencing procedural pain in cancer treatment or diagnostic workups, and massage is an option for pain experienced during palliative or hospice care or following breast cancer treatment.

These recommendations were considered moderate in strength and were based on intermediate levels of evidence that demonstrated that the benefits outweighed risks.

The panel added several recommendations it deemed to be weak in strength and that were based on low-quality evidence. These include Hatha yoga for patients experiencing pain after treatment for breast or head and neck cancers, and music therapy for patients experiencing pain from cancer surgery.

The experts also identified areas “potentially relevant to cancer care but needing more research,” such as the safety and efficacy of natural products, including omega-3 fatty acids and glutamine, and determined that there is insufficient or inconclusive evidence to make recommendations for pediatric patients.

“With improved oncology treatments such as immunotherapy and targeted therapy, more patients diagnosed with cancer are living longer; therefore, pain and symptom management is critical for improving quality of life,” Dr. Mao, chief of integrative medicine at Memorial Sloan Kettering Cancer Center, New York, said in an interview. “The SIO-ASCO clinical guideline will provide very timely recommendations for physicians to incorporate nonpharmacological treatments such as acupuncture and massage to improve pain management for patients impacted by cancer.”

However, clinical uptake of such treatments “is always a concern,” said panel cochair Eduardo Bruera, MD, of MD Anderson Cancer Center, Houston. “We are hoping that by showing the growing evidence that is out there, health care systems will start hiring these kinds of practitioners and insurance systems will start covering these treatments, because more and more, these are being shown to be effective at managing pain for cancer populations,” Dr. Bruera said.

The SIO-ASCO panel’s work was supported by a grant from the Samueli Foundation to the Society for Integrative Oncology.

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

New guidelines highlight the role that integrative pain management techniques, such as massage, acupuncture, and music therapy, can play in relieving certain types of cancer pain in adults.

The recommendations, published in the Journal of Clinical Oncology, represent a joint effort between the American Society of Clinical Oncology (ASCO) and the Society of Integrative Oncology (SIO) to guide clinicians on how best to weave various nonpharmacologic pain management strategies into cancer care.

“Pain is a clinical challenge for many oncology patients and clinicians, and there’s a growing body of evidence showing that integrative therapies can be useful in pain management,” Heather Greenlee, ND, PhD, explained in a press release.

However, clear clinical guidance as to when and when not to use these approaches is lacking, said Dr. Greenlee, cochair of the SIO Clinical Practice Guideline Committee.

Previous guidelines from ASCO on managing chronic cancer-related pain largely focused on diagnosing pain and on pharmacologic interventions, and they touched only on evidence related to nonpharmacologic options.

The new guideline “takes a deeper dive on the use of integrative therapies, which is important because clinicians and patients need to have access to the latest evidence-based information to make clinical decisions,” noted Jun H. Mao, MD, SIO-ASCO panel cochair.

In the guidance, the expert panel addresses two core questions: What mind-body therapies are recommended for managing pain experienced by adult and pediatric patients diagnosed with cancer, and what natural products are recommended for managing pain experienced by adult and pediatric patients diagnosed with cancer?

The panel conducted a literature search and identified 277 relevant studies. They included systematic reviews and randomized controlled trials published between 1990 and 2021 that evaluated outcomes related to pain intensity, symptom relief, and adverse events. After reaching a consensus, the expert panel made recommendations on the basis of the strength of the available evidence.

Regarding modalities for which there was stronger evidence, the panel highlighted several recommendations regarding acupuncture, reflexology, hypnosis, and massage.

The panel determined, for instance, that acupuncture should be offered for aromatase-related joint pain in patients with breast cancer and that it can be offered for general or musculoskeletal pain from cancer. It recommended reflexology or acupressure for pain experienced during systemic therapy for cancer. Hypnosis is an option for patients experiencing procedural pain in cancer treatment or diagnostic workups, and massage is an option for pain experienced during palliative or hospice care or following breast cancer treatment.

These recommendations were considered moderate in strength and were based on intermediate levels of evidence that demonstrated that the benefits outweighed risks.

The panel added several recommendations it deemed to be weak in strength and that were based on low-quality evidence. These include Hatha yoga for patients experiencing pain after treatment for breast or head and neck cancers, and music therapy for patients experiencing pain from cancer surgery.

The experts also identified areas “potentially relevant to cancer care but needing more research,” such as the safety and efficacy of natural products, including omega-3 fatty acids and glutamine, and determined that there is insufficient or inconclusive evidence to make recommendations for pediatric patients.

“With improved oncology treatments such as immunotherapy and targeted therapy, more patients diagnosed with cancer are living longer; therefore, pain and symptom management is critical for improving quality of life,” Dr. Mao, chief of integrative medicine at Memorial Sloan Kettering Cancer Center, New York, said in an interview. “The SIO-ASCO clinical guideline will provide very timely recommendations for physicians to incorporate nonpharmacological treatments such as acupuncture and massage to improve pain management for patients impacted by cancer.”

However, clinical uptake of such treatments “is always a concern,” said panel cochair Eduardo Bruera, MD, of MD Anderson Cancer Center, Houston. “We are hoping that by showing the growing evidence that is out there, health care systems will start hiring these kinds of practitioners and insurance systems will start covering these treatments, because more and more, these are being shown to be effective at managing pain for cancer populations,” Dr. Bruera said.

The SIO-ASCO panel’s work was supported by a grant from the Samueli Foundation to the Society for Integrative Oncology.

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

New guidelines highlight the role that integrative pain management techniques, such as massage, acupuncture, and music therapy, can play in relieving certain types of cancer pain in adults.

The recommendations, published in the Journal of Clinical Oncology, represent a joint effort between the American Society of Clinical Oncology (ASCO) and the Society of Integrative Oncology (SIO) to guide clinicians on how best to weave various nonpharmacologic pain management strategies into cancer care.

“Pain is a clinical challenge for many oncology patients and clinicians, and there’s a growing body of evidence showing that integrative therapies can be useful in pain management,” Heather Greenlee, ND, PhD, explained in a press release.

However, clear clinical guidance as to when and when not to use these approaches is lacking, said Dr. Greenlee, cochair of the SIO Clinical Practice Guideline Committee.

Previous guidelines from ASCO on managing chronic cancer-related pain largely focused on diagnosing pain and on pharmacologic interventions, and they touched only on evidence related to nonpharmacologic options.

The new guideline “takes a deeper dive on the use of integrative therapies, which is important because clinicians and patients need to have access to the latest evidence-based information to make clinical decisions,” noted Jun H. Mao, MD, SIO-ASCO panel cochair.

In the guidance, the expert panel addresses two core questions: What mind-body therapies are recommended for managing pain experienced by adult and pediatric patients diagnosed with cancer, and what natural products are recommended for managing pain experienced by adult and pediatric patients diagnosed with cancer?

The panel conducted a literature search and identified 277 relevant studies. They included systematic reviews and randomized controlled trials published between 1990 and 2021 that evaluated outcomes related to pain intensity, symptom relief, and adverse events. After reaching a consensus, the expert panel made recommendations on the basis of the strength of the available evidence.

Regarding modalities for which there was stronger evidence, the panel highlighted several recommendations regarding acupuncture, reflexology, hypnosis, and massage.

The panel determined, for instance, that acupuncture should be offered for aromatase-related joint pain in patients with breast cancer and that it can be offered for general or musculoskeletal pain from cancer. It recommended reflexology or acupressure for pain experienced during systemic therapy for cancer. Hypnosis is an option for patients experiencing procedural pain in cancer treatment or diagnostic workups, and massage is an option for pain experienced during palliative or hospice care or following breast cancer treatment.

These recommendations were considered moderate in strength and were based on intermediate levels of evidence that demonstrated that the benefits outweighed risks.

The panel added several recommendations it deemed to be weak in strength and that were based on low-quality evidence. These include Hatha yoga for patients experiencing pain after treatment for breast or head and neck cancers, and music therapy for patients experiencing pain from cancer surgery.

The experts also identified areas “potentially relevant to cancer care but needing more research,” such as the safety and efficacy of natural products, including omega-3 fatty acids and glutamine, and determined that there is insufficient or inconclusive evidence to make recommendations for pediatric patients.

“With improved oncology treatments such as immunotherapy and targeted therapy, more patients diagnosed with cancer are living longer; therefore, pain and symptom management is critical for improving quality of life,” Dr. Mao, chief of integrative medicine at Memorial Sloan Kettering Cancer Center, New York, said in an interview. “The SIO-ASCO clinical guideline will provide very timely recommendations for physicians to incorporate nonpharmacological treatments such as acupuncture and massage to improve pain management for patients impacted by cancer.”

However, clinical uptake of such treatments “is always a concern,” said panel cochair Eduardo Bruera, MD, of MD Anderson Cancer Center, Houston. “We are hoping that by showing the growing evidence that is out there, health care systems will start hiring these kinds of practitioners and insurance systems will start covering these treatments, because more and more, these are being shown to be effective at managing pain for cancer populations,” Dr. Bruera said.

The SIO-ASCO panel’s work was supported by a grant from the Samueli Foundation to the Society for Integrative Oncology.

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

A sedentary lifestyle has already been linked with an increased risk for breast cancer based on data from observational studies, but a new study with different methodology  provides stronger evidence of causality.

The results of the new study suggest that greater overall physical activity levels, greater vigorous activity, and lower sedentary time are likely to reduce breast cancer risk, said the authors.

Viktor Cap/Thinkstock

“Increasing physical activity and reducing sedentary time are already recommended for cancer prevention. Our study adds further evidence that such behavioral changes are likely to lower the incidence of future breast cancer rates,” Suzanne C. Dixon-Suen, PhD, of Cancer Council Victoria, Melbourne, and colleagues reported on behalf of the Breast Cancer Association Consortium (BCAC).

The findings were published online in the British Journal of Sports Medicine.

The investigators used individual-level BCAC case-control data and performed two-sample Mendelian randomization – a study method that assesses causality by using genetic variants as proxies for particular risk factors. In this case, genetic variants were used as proxies for lifelong physical activity levels and sedentary behaviors.

“[Genetic] instruments were single-nucleotide polymorphisms (SNPs) associated in UK Biobank [genomewide association studies] with overall physical activity (all movement), vigorous physical activity, or sedentary time” as assessed by a wrist-worn accelerometer.

Patients with greater genetic predisposition to higher overall activity levels had a 41% lower overall breast cancer risk (odds ratio, 0.59), the team reported. Genetically predicted vigorous activity was associated with a 38% lower risk of premenopausal and perimenopausal breast cancer (OR, 0.62 for 3 or more days vs. 0 days of self-reported days per week).

Conversely, greater genetically predicted sedentary time was associated with a 77%  higher risk of hormone receptor–negative breast cancer risk (OR, 1.77), including triple-negative breast cancer, for which the risk was 104% higher (OR, 2.04).

The findings were generally consistent across disease types and stages, and were unchanged after factoring in “the production by a single gene of two or more apparently unrelated effects (pleiotropy), such as smoking and overweight, for example,” according to a press release from the journal.

The investigators included data from 130,957 women of European ancestry. Of those, 69,838 had invasive disease, 6,667 had in situ tumors, and 54,452 were controls without breast cancer. The case-control groups included 23,999 pre-/perimenopausal women with invasive breast cancer and 17,686 women without, and 45,839 postmenopausal women with breast cancer and 36,766 without.

A number of plausible biological explanations for the findings exist, the authors noted, adding that convincing evidence suggests there are causal pathways between physical activity and breast cancer risk, including overweight and obesity, disordered metabolism, sex hormones, and inflammation.

Furthermore, the researchers reported, “mechanisms linking sedentary time and cancer are likely to at least partially overlap with those underpinning the physical activity relationship.”

For the future, they suggested that “[a] stronger cancer-control focus on physical activity and sedentary time as modifiable cancer risk factors is warranted, given the heavy burden of disease attributed to the most common cancer in women.”

This study was funded by multiple international sources. Dr. Dixon-Suen reported no relevant financial relationships. Several coauthors disclosed relationships with industry.

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

A sedentary lifestyle has already been linked with an increased risk for breast cancer based on data from observational studies, but a new study with different methodology  provides stronger evidence of causality.

The results of the new study suggest that greater overall physical activity levels, greater vigorous activity, and lower sedentary time are likely to reduce breast cancer risk, said the authors.

Viktor Cap/Thinkstock

“Increasing physical activity and reducing sedentary time are already recommended for cancer prevention. Our study adds further evidence that such behavioral changes are likely to lower the incidence of future breast cancer rates,” Suzanne C. Dixon-Suen, PhD, of Cancer Council Victoria, Melbourne, and colleagues reported on behalf of the Breast Cancer Association Consortium (BCAC).

The findings were published online in the British Journal of Sports Medicine.

The investigators used individual-level BCAC case-control data and performed two-sample Mendelian randomization – a study method that assesses causality by using genetic variants as proxies for particular risk factors. In this case, genetic variants were used as proxies for lifelong physical activity levels and sedentary behaviors.

“[Genetic] instruments were single-nucleotide polymorphisms (SNPs) associated in UK Biobank [genomewide association studies] with overall physical activity (all movement), vigorous physical activity, or sedentary time” as assessed by a wrist-worn accelerometer.

Patients with greater genetic predisposition to higher overall activity levels had a 41% lower overall breast cancer risk (odds ratio, 0.59), the team reported. Genetically predicted vigorous activity was associated with a 38% lower risk of premenopausal and perimenopausal breast cancer (OR, 0.62 for 3 or more days vs. 0 days of self-reported days per week).

Conversely, greater genetically predicted sedentary time was associated with a 77%  higher risk of hormone receptor–negative breast cancer risk (OR, 1.77), including triple-negative breast cancer, for which the risk was 104% higher (OR, 2.04).

The findings were generally consistent across disease types and stages, and were unchanged after factoring in “the production by a single gene of two or more apparently unrelated effects (pleiotropy), such as smoking and overweight, for example,” according to a press release from the journal.

The investigators included data from 130,957 women of European ancestry. Of those, 69,838 had invasive disease, 6,667 had in situ tumors, and 54,452 were controls without breast cancer. The case-control groups included 23,999 pre-/perimenopausal women with invasive breast cancer and 17,686 women without, and 45,839 postmenopausal women with breast cancer and 36,766 without.

A number of plausible biological explanations for the findings exist, the authors noted, adding that convincing evidence suggests there are causal pathways between physical activity and breast cancer risk, including overweight and obesity, disordered metabolism, sex hormones, and inflammation.

Furthermore, the researchers reported, “mechanisms linking sedentary time and cancer are likely to at least partially overlap with those underpinning the physical activity relationship.”

For the future, they suggested that “[a] stronger cancer-control focus on physical activity and sedentary time as modifiable cancer risk factors is warranted, given the heavy burden of disease attributed to the most common cancer in women.”

This study was funded by multiple international sources. Dr. Dixon-Suen reported no relevant financial relationships. Several coauthors disclosed relationships with industry.

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

A sedentary lifestyle has already been linked with an increased risk for breast cancer based on data from observational studies, but a new study with different methodology  provides stronger evidence of causality.

The results of the new study suggest that greater overall physical activity levels, greater vigorous activity, and lower sedentary time are likely to reduce breast cancer risk, said the authors.

Viktor Cap/Thinkstock

“Increasing physical activity and reducing sedentary time are already recommended for cancer prevention. Our study adds further evidence that such behavioral changes are likely to lower the incidence of future breast cancer rates,” Suzanne C. Dixon-Suen, PhD, of Cancer Council Victoria, Melbourne, and colleagues reported on behalf of the Breast Cancer Association Consortium (BCAC).

The findings were published online in the British Journal of Sports Medicine.

The investigators used individual-level BCAC case-control data and performed two-sample Mendelian randomization – a study method that assesses causality by using genetic variants as proxies for particular risk factors. In this case, genetic variants were used as proxies for lifelong physical activity levels and sedentary behaviors.

“[Genetic] instruments were single-nucleotide polymorphisms (SNPs) associated in UK Biobank [genomewide association studies] with overall physical activity (all movement), vigorous physical activity, or sedentary time” as assessed by a wrist-worn accelerometer.

Patients with greater genetic predisposition to higher overall activity levels had a 41% lower overall breast cancer risk (odds ratio, 0.59), the team reported. Genetically predicted vigorous activity was associated with a 38% lower risk of premenopausal and perimenopausal breast cancer (OR, 0.62 for 3 or more days vs. 0 days of self-reported days per week).

Conversely, greater genetically predicted sedentary time was associated with a 77%  higher risk of hormone receptor–negative breast cancer risk (OR, 1.77), including triple-negative breast cancer, for which the risk was 104% higher (OR, 2.04).

The findings were generally consistent across disease types and stages, and were unchanged after factoring in “the production by a single gene of two or more apparently unrelated effects (pleiotropy), such as smoking and overweight, for example,” according to a press release from the journal.

The investigators included data from 130,957 women of European ancestry. Of those, 69,838 had invasive disease, 6,667 had in situ tumors, and 54,452 were controls without breast cancer. The case-control groups included 23,999 pre-/perimenopausal women with invasive breast cancer and 17,686 women without, and 45,839 postmenopausal women with breast cancer and 36,766 without.

A number of plausible biological explanations for the findings exist, the authors noted, adding that convincing evidence suggests there are causal pathways between physical activity and breast cancer risk, including overweight and obesity, disordered metabolism, sex hormones, and inflammation.

Furthermore, the researchers reported, “mechanisms linking sedentary time and cancer are likely to at least partially overlap with those underpinning the physical activity relationship.”

For the future, they suggested that “[a] stronger cancer-control focus on physical activity and sedentary time as modifiable cancer risk factors is warranted, given the heavy burden of disease attributed to the most common cancer in women.”

This study was funded by multiple international sources. Dr. Dixon-Suen reported no relevant financial relationships. Several coauthors disclosed relationships with industry.

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

Intera Oncology has recalled 440 Intera 3000 Hepatic Artery Infusion Pumps following three reports of potentially life-threatening medication flow rates.

Although no injuries or deaths related to the pump malfunction have been reported yet, the U.S. Food and Drug Administration has deemed the recall Class I, the most serious category that indicates the device could cause injury or death.

Intera Oncology initiated the recall in July following reports from clinicians that the pumps, which are implanted to deliver chemotherapy to treat liver tumors, were delivering medications faster than expected. A fast flow rate can lead to life-threatening hematologic toxicity, neurotoxicity, or death. It also means patients will run out of medication too soon, potentially leading to disease progression or death.

The FDA notice states the company has advised customers to continue to monitor flow rate as per standard refill procedure as well as monitor for liver toxicity to adjust dosing as per standard protocols.

The company also said to consider pump replacement if altered flow can’t be adequately managed by dosing adjustments or having patients come in for medication refills and to verify the flow rate sooner than every 2 weeks if the pump appears to be flowing more than 15% outside its labeled specification.

Questions about the recall can be directed to Intera Oncology at (800) 660-2660 or support@interaoncol.

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

Intera Oncology has recalled 440 Intera 3000 Hepatic Artery Infusion Pumps following three reports of potentially life-threatening medication flow rates.

Although no injuries or deaths related to the pump malfunction have been reported yet, the U.S. Food and Drug Administration has deemed the recall Class I, the most serious category that indicates the device could cause injury or death.

Intera Oncology initiated the recall in July following reports from clinicians that the pumps, which are implanted to deliver chemotherapy to treat liver tumors, were delivering medications faster than expected. A fast flow rate can lead to life-threatening hematologic toxicity, neurotoxicity, or death. It also means patients will run out of medication too soon, potentially leading to disease progression or death.

The FDA notice states the company has advised customers to continue to monitor flow rate as per standard refill procedure as well as monitor for liver toxicity to adjust dosing as per standard protocols.

The company also said to consider pump replacement if altered flow can’t be adequately managed by dosing adjustments or having patients come in for medication refills and to verify the flow rate sooner than every 2 weeks if the pump appears to be flowing more than 15% outside its labeled specification.

Questions about the recall can be directed to Intera Oncology at (800) 660-2660 or support@interaoncol.

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

Intera Oncology has recalled 440 Intera 3000 Hepatic Artery Infusion Pumps following three reports of potentially life-threatening medication flow rates.

Although no injuries or deaths related to the pump malfunction have been reported yet, the U.S. Food and Drug Administration has deemed the recall Class I, the most serious category that indicates the device could cause injury or death.

Intera Oncology initiated the recall in July following reports from clinicians that the pumps, which are implanted to deliver chemotherapy to treat liver tumors, were delivering medications faster than expected. A fast flow rate can lead to life-threatening hematologic toxicity, neurotoxicity, or death. It also means patients will run out of medication too soon, potentially leading to disease progression or death.

The FDA notice states the company has advised customers to continue to monitor flow rate as per standard refill procedure as well as monitor for liver toxicity to adjust dosing as per standard protocols.

The company also said to consider pump replacement if altered flow can’t be adequately managed by dosing adjustments or having patients come in for medication refills and to verify the flow rate sooner than every 2 weeks if the pump appears to be flowing more than 15% outside its labeled specification.

Questions about the recall can be directed to Intera Oncology at (800) 660-2660 or support@interaoncol.

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

Alcohol is a major preventable risk factor for cancer. New data suggest that reducing alcohol intake reduces the risk of developing an alcohol-related cancer.

The findings, from a large population-based study conducted in Korea, underscore the importance of encouraging individuals to quit drinking or to reduce alcohol consumption to help reduce cancer risk, the authors noted.

The study was published online in JAMA Network Open.

It provides evidence “suggesting that cancer risk can be meaningfully altered by changing the amount of alcoholic beverages consumed,” wrote the authors of an accompanying editorial, Neal D. Freedman, PhD, and Christian C. Abnet, PhD, of the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

“Alcohol consumption is an important cancer risk factor,” they wrote, adding that a “well examined dose-response association has been reported, with highest risks observed among people who drink 3 alcoholic beverages per day and higher.”

The new study shows that a “reduction in use was associated with lower risk, particularly among participants who started drinking at a heavy level,” they noted.

Previous studies have estimated that alcohol use accounts for nearly 4% of newly diagnosed cancers worldwide and nearly 5% of U.S. cancer cases overall.

But the figures are much higher for some specific cancers. That same U.S. study found that alcohol accounts for at least 45% of oral cavity/pharyngeal cancers and at least 25% of laryngeal cancers, as well as 12.1% of female breast cancers, 11.1% of colorectal cancers, 10.5% of liver cancers, and 7.7% of esophageal cancers, as previously reported by this news organization.
 

New findings on reducing intake

This latest study involved an analysis of data on 4.5 million individuals who were adult beneficiaries of the Korean National Health Insurance Service. The median age of the participants was 53.6 years, and they underwent a national health screening in 2009 and 2011.

During median follow-up of 6.4 years, the cancer incidence rate was 7.7 per 1,000 person-years.

Information on alcohol consumption was collected from self-administered questionnaires completed during the health screenings. Participants were categorized on the basis of alcohol consumption: none (0 g/d), mild ( less than 15 g/d), moderate (15-29.9 g/d), and heavy (30 or more g/d).

Compared with those who sustained their alcohol consumption level during the study period, those who increased their level were at higher risk of alcohol-related cancers and all cancers, the investigators found.

The increase in alcohol-related cancer incidence was dose dependent: Those who changed from nondrinking to mild, moderate, or heavy drinking were at increasingly higher risk for alcohol-related cancer, compared with those who remained nondrinkers (adjusted hazard ratios [aHRs], 1.03, 1.10, and 1.34, respectively).

Participants who were mild drinkers at baseline and who quit drinking were at lower risk of alcohol-related cancer, compared with those whose drinking level was sustained (aHR, 0.96). Those with moderate or heavy drinking levels who quit drinking were at higher overall cancer risk than were those who sustained their drinking levels. However, this difference was negated when quitting was sustained, the authors noted.

For heavy drinkers who reduced their drinking levels, cancer incidence was reduced, compared with those who sustained heavy drinking levels. This was true for those who changed from heavy to moderate drinking (aHR, 0.91 for alcohol-related cancers; 0.96 for alcohol-related cancers) and those who changed from heavy to mild drinking (aHR, 0.92 for alcohol-related cancers and all cancers).

“Alcohol cessation and reduction should be reinforced for the prevention of cancer,” concluded the authors.
 

Implications and future directions

The editorialists noted that the study is limited by several factors, such as a short interval between assessments and relatively short follow-up. There is also no information on participants’ alcohol consumption earlier in life or about other healthy lifestyle changes during the study period. In addition, there is no mention of a genetic variant affecting aldehyde dehydrogenase that leads to alcohol-induced flushing, which is common among East Asians.

Despite of these limitations, the study provides “important new findings about the potential role of changes in alcohol consumption in cancer risk,” Dr. Freedman and Dr. Abnet noted. Future studies should examine the association between alcohol intake and cancer risk in other populations and use longer intervals between assessments, they suggested.

“Such studies are needed to move the field forward and inform public health guidance on cancer prevention,” the editorialists concluded.

The authors of the study and the editorialists have disclosed no relevant financial relationships.

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

Alcohol is a major preventable risk factor for cancer. New data suggest that reducing alcohol intake reduces the risk of developing an alcohol-related cancer.

The findings, from a large population-based study conducted in Korea, underscore the importance of encouraging individuals to quit drinking or to reduce alcohol consumption to help reduce cancer risk, the authors noted.

The study was published online in JAMA Network Open.

It provides evidence “suggesting that cancer risk can be meaningfully altered by changing the amount of alcoholic beverages consumed,” wrote the authors of an accompanying editorial, Neal D. Freedman, PhD, and Christian C. Abnet, PhD, of the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

“Alcohol consumption is an important cancer risk factor,” they wrote, adding that a “well examined dose-response association has been reported, with highest risks observed among people who drink 3 alcoholic beverages per day and higher.”

The new study shows that a “reduction in use was associated with lower risk, particularly among participants who started drinking at a heavy level,” they noted.

Previous studies have estimated that alcohol use accounts for nearly 4% of newly diagnosed cancers worldwide and nearly 5% of U.S. cancer cases overall.

But the figures are much higher for some specific cancers. That same U.S. study found that alcohol accounts for at least 45% of oral cavity/pharyngeal cancers and at least 25% of laryngeal cancers, as well as 12.1% of female breast cancers, 11.1% of colorectal cancers, 10.5% of liver cancers, and 7.7% of esophageal cancers, as previously reported by this news organization.
 

New findings on reducing intake

This latest study involved an analysis of data on 4.5 million individuals who were adult beneficiaries of the Korean National Health Insurance Service. The median age of the participants was 53.6 years, and they underwent a national health screening in 2009 and 2011.

During median follow-up of 6.4 years, the cancer incidence rate was 7.7 per 1,000 person-years.

Information on alcohol consumption was collected from self-administered questionnaires completed during the health screenings. Participants were categorized on the basis of alcohol consumption: none (0 g/d), mild ( less than 15 g/d), moderate (15-29.9 g/d), and heavy (30 or more g/d).

Compared with those who sustained their alcohol consumption level during the study period, those who increased their level were at higher risk of alcohol-related cancers and all cancers, the investigators found.

The increase in alcohol-related cancer incidence was dose dependent: Those who changed from nondrinking to mild, moderate, or heavy drinking were at increasingly higher risk for alcohol-related cancer, compared with those who remained nondrinkers (adjusted hazard ratios [aHRs], 1.03, 1.10, and 1.34, respectively).

Participants who were mild drinkers at baseline and who quit drinking were at lower risk of alcohol-related cancer, compared with those whose drinking level was sustained (aHR, 0.96). Those with moderate or heavy drinking levels who quit drinking were at higher overall cancer risk than were those who sustained their drinking levels. However, this difference was negated when quitting was sustained, the authors noted.

For heavy drinkers who reduced their drinking levels, cancer incidence was reduced, compared with those who sustained heavy drinking levels. This was true for those who changed from heavy to moderate drinking (aHR, 0.91 for alcohol-related cancers; 0.96 for alcohol-related cancers) and those who changed from heavy to mild drinking (aHR, 0.92 for alcohol-related cancers and all cancers).

“Alcohol cessation and reduction should be reinforced for the prevention of cancer,” concluded the authors.
 

Implications and future directions

The editorialists noted that the study is limited by several factors, such as a short interval between assessments and relatively short follow-up. There is also no information on participants’ alcohol consumption earlier in life or about other healthy lifestyle changes during the study period. In addition, there is no mention of a genetic variant affecting aldehyde dehydrogenase that leads to alcohol-induced flushing, which is common among East Asians.

Despite of these limitations, the study provides “important new findings about the potential role of changes in alcohol consumption in cancer risk,” Dr. Freedman and Dr. Abnet noted. Future studies should examine the association between alcohol intake and cancer risk in other populations and use longer intervals between assessments, they suggested.

“Such studies are needed to move the field forward and inform public health guidance on cancer prevention,” the editorialists concluded.

The authors of the study and the editorialists have disclosed no relevant financial relationships.

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

Alcohol is a major preventable risk factor for cancer. New data suggest that reducing alcohol intake reduces the risk of developing an alcohol-related cancer.

The findings, from a large population-based study conducted in Korea, underscore the importance of encouraging individuals to quit drinking or to reduce alcohol consumption to help reduce cancer risk, the authors noted.

The study was published online in JAMA Network Open.

It provides evidence “suggesting that cancer risk can be meaningfully altered by changing the amount of alcoholic beverages consumed,” wrote the authors of an accompanying editorial, Neal D. Freedman, PhD, and Christian C. Abnet, PhD, of the division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.

“Alcohol consumption is an important cancer risk factor,” they wrote, adding that a “well examined dose-response association has been reported, with highest risks observed among people who drink 3 alcoholic beverages per day and higher.”

The new study shows that a “reduction in use was associated with lower risk, particularly among participants who started drinking at a heavy level,” they noted.

Previous studies have estimated that alcohol use accounts for nearly 4% of newly diagnosed cancers worldwide and nearly 5% of U.S. cancer cases overall.

But the figures are much higher for some specific cancers. That same U.S. study found that alcohol accounts for at least 45% of oral cavity/pharyngeal cancers and at least 25% of laryngeal cancers, as well as 12.1% of female breast cancers, 11.1% of colorectal cancers, 10.5% of liver cancers, and 7.7% of esophageal cancers, as previously reported by this news organization.
 

New findings on reducing intake

This latest study involved an analysis of data on 4.5 million individuals who were adult beneficiaries of the Korean National Health Insurance Service. The median age of the participants was 53.6 years, and they underwent a national health screening in 2009 and 2011.

During median follow-up of 6.4 years, the cancer incidence rate was 7.7 per 1,000 person-years.

Information on alcohol consumption was collected from self-administered questionnaires completed during the health screenings. Participants were categorized on the basis of alcohol consumption: none (0 g/d), mild ( less than 15 g/d), moderate (15-29.9 g/d), and heavy (30 or more g/d).

Compared with those who sustained their alcohol consumption level during the study period, those who increased their level were at higher risk of alcohol-related cancers and all cancers, the investigators found.

The increase in alcohol-related cancer incidence was dose dependent: Those who changed from nondrinking to mild, moderate, or heavy drinking were at increasingly higher risk for alcohol-related cancer, compared with those who remained nondrinkers (adjusted hazard ratios [aHRs], 1.03, 1.10, and 1.34, respectively).

Participants who were mild drinkers at baseline and who quit drinking were at lower risk of alcohol-related cancer, compared with those whose drinking level was sustained (aHR, 0.96). Those with moderate or heavy drinking levels who quit drinking were at higher overall cancer risk than were those who sustained their drinking levels. However, this difference was negated when quitting was sustained, the authors noted.

For heavy drinkers who reduced their drinking levels, cancer incidence was reduced, compared with those who sustained heavy drinking levels. This was true for those who changed from heavy to moderate drinking (aHR, 0.91 for alcohol-related cancers; 0.96 for alcohol-related cancers) and those who changed from heavy to mild drinking (aHR, 0.92 for alcohol-related cancers and all cancers).

“Alcohol cessation and reduction should be reinforced for the prevention of cancer,” concluded the authors.
 

Implications and future directions

The editorialists noted that the study is limited by several factors, such as a short interval between assessments and relatively short follow-up. There is also no information on participants’ alcohol consumption earlier in life or about other healthy lifestyle changes during the study period. In addition, there is no mention of a genetic variant affecting aldehyde dehydrogenase that leads to alcohol-induced flushing, which is common among East Asians.

Despite of these limitations, the study provides “important new findings about the potential role of changes in alcohol consumption in cancer risk,” Dr. Freedman and Dr. Abnet noted. Future studies should examine the association between alcohol intake and cancer risk in other populations and use longer intervals between assessments, they suggested.

“Such studies are needed to move the field forward and inform public health guidance on cancer prevention,” the editorialists concluded.

The authors of the study and the editorialists have disclosed no relevant financial relationships.

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

The Food and Drug Administration issued a warning June 30 that the cancer drug duvelisib (Copiktra, Verastem Inc.), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.

Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.

However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.

“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.

More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).

Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.

Of note, in April, the FDA also announced it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib, following a voluntary request by the drug manufacturer, Secura Bio Inc.

A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.

This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”

As reported by Medscape, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.

“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.

The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.

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

The Food and Drug Administration issued a warning June 30 that the cancer drug duvelisib (Copiktra, Verastem Inc.), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.

Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.

However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.

“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.

More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).

Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.

Of note, in April, the FDA also announced it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib, following a voluntary request by the drug manufacturer, Secura Bio Inc.

A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.

This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”

As reported by Medscape, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.

“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.

The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.

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

The Food and Drug Administration issued a warning June 30 that the cancer drug duvelisib (Copiktra, Verastem Inc.), a PI3 kinase inhibitor, may increase the risk of death and serious side effects.

Duvelisib was approved in 2018 to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies that did not work or stopped working.

However, more recent 5-year overall survival results from the randomized phase 3 DUO clinical trial found a possible increased risk of death with duvelisib compared with another drug used to treat leukemia and lymphoma, according to an FDA Drug Safety Communication.

“The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood,” states the warning, which advises prescribers to weigh the risks and benefits of continued use versus use of other treatments.

More specifically, median 5-year overall survival among 319 patients with CLL or SLL in the DUO trial was 52.3 months with duvelisib versus 63.3 months with the monoclonal antibody ofatumumab (hazard ratio, 1.09 overall and 1.06 among patients who received at least two prior lines of therapy).

Serious adverse events of grade 3 or higher were also more common in those treated with duvelisib.

Of note, in April, the FDA also announced it was withdrawing approval of the relapsed or refractory follicular lymphoma indication for duvelisib, following a voluntary request by the drug manufacturer, Secura Bio Inc.

A public meeting will be scheduled to discuss the findings of the trial and whether the drug should continue to be prescribed.

This FDA warning follows the agency’s June 1 withdrawal of approval for umbralisib (Ukoniq), another PI3 kinase inhibitor, following an investigation into a “possible increased risk of death.”

As reported by Medscape, umbralisib had received accelerated approval in February 2021 to treat adults with relapsed or refractory marginal zone lymphoma following at least one prior therapy and those with relapsed or refractory follicular lymphoma who had received at least three prior therapies.

“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class, which were discussed at an advisory committee meeting of non-FDA experts in April 2022,” according to the FDA warning.

The FDA urges patients and health care professionals to report side effects involving duvelisib or other medicines to the FDA MedWatch program.

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

Lisocabtagene maraleucel, also known as liso-cel (Breyanzi), has been approved by the Food and Drug Administration for the second-line treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL).

This expanded indication is based on findings from the pivotal phase 3 TRANSFORM study, which showed significant and clinically meaningful improvements with CD19-directed chimeric antigen receptor T-cell immunotherapy over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant. The latter course of treatment had been the standard of care for more than 2 decades.

Data from the global, randomized, multicenter TRANSFORM study, as reported in December 2021 at the annual meeting of the American Society of Hematology, showed that second-line treatment with liso-cel in 92 patients with r/r LBCL within 12 months after first-line therapy, compared with 92 patient who received standard of care therapy, was associated with highly statistically significant and clinically meaningful improvement in event-free survival (10.1 vs. 2.3 months; hazard ratio, 0.349), complete response rate (66% vs. 39%), and progression-free survival (14.8 vs. 5.7 months; HR, 0.406).

A positive trend in overall survival was also observed (HR, 0.509 at median follow-up of 6.2 months). No new liso-cel safety signals were detected in the second-line setting.

Liso-cel was initially approved in February 2021 for the treatment of adults with LBCL, including diffuse LBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:

• Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy.
• Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant because of comorbidities or age.

Liso-cel is not indicated for the treatment of patients with primary central nervous system lymphoma.

In February 2022, the FDA granted Priority Review status for a Bristol-Myers Squibb supplemental Biologics License Application (sBLA), based on the TRANSFORM study data, to expand the indication to include use after the failure of first-line therapy.

The agent “now has the potential to be a new standard of care for patients after failure of first-line therapy, offering significantly improved outcomes beyond the current mainstay of care,” Anne Kerber, the BMS senior vice president of cell therapy development, said in a press release at that time.

The European Medicines Agency has also validated a type II variation application for extension of the indication for liso-cel in this setting. Validation of the application “confirms the submission is complete and begins the EMA’s centralized review procedure,” BMS announced in a June 20, 2022, press release.

Liso-cel, which has been available only through a restricted program under a Risk Evaluation and Mitigation Strategy, includes a boxed warning regarding the risk for cytokine release syndrome (CRS) and neurologic toxicities.

The warning states that liso-cel should not be administered to patients with active infection or inflammatory disorders, and that severe or life-threatening CRS should be treated with tocilizumab with or without corticosteroids.

Patients should also be monitored for neurologic events after treatment with liso-cel, and supportive care and/or corticosteroids should be administered as needed.

Lisocabtagene maraleucel, also known as liso-cel (Breyanzi), has been approved by the Food and Drug Administration for the second-line treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL).

This expanded indication is based on findings from the pivotal phase 3 TRANSFORM study, which showed significant and clinically meaningful improvements with CD19-directed chimeric antigen receptor T-cell immunotherapy over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant. The latter course of treatment had been the standard of care for more than 2 decades.

Data from the global, randomized, multicenter TRANSFORM study, as reported in December 2021 at the annual meeting of the American Society of Hematology, showed that second-line treatment with liso-cel in 92 patients with r/r LBCL within 12 months after first-line therapy, compared with 92 patient who received standard of care therapy, was associated with highly statistically significant and clinically meaningful improvement in event-free survival (10.1 vs. 2.3 months; hazard ratio, 0.349), complete response rate (66% vs. 39%), and progression-free survival (14.8 vs. 5.7 months; HR, 0.406).

A positive trend in overall survival was also observed (HR, 0.509 at median follow-up of 6.2 months). No new liso-cel safety signals were detected in the second-line setting.

Liso-cel was initially approved in February 2021 for the treatment of adults with LBCL, including diffuse LBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:

• Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy.
• Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant because of comorbidities or age.

Liso-cel is not indicated for the treatment of patients with primary central nervous system lymphoma.

In February 2022, the FDA granted Priority Review status for a Bristol-Myers Squibb supplemental Biologics License Application (sBLA), based on the TRANSFORM study data, to expand the indication to include use after the failure of first-line therapy.

The agent “now has the potential to be a new standard of care for patients after failure of first-line therapy, offering significantly improved outcomes beyond the current mainstay of care,” Anne Kerber, the BMS senior vice president of cell therapy development, said in a press release at that time.

The European Medicines Agency has also validated a type II variation application for extension of the indication for liso-cel in this setting. Validation of the application “confirms the submission is complete and begins the EMA’s centralized review procedure,” BMS announced in a June 20, 2022, press release.

Liso-cel, which has been available only through a restricted program under a Risk Evaluation and Mitigation Strategy, includes a boxed warning regarding the risk for cytokine release syndrome (CRS) and neurologic toxicities.

The warning states that liso-cel should not be administered to patients with active infection or inflammatory disorders, and that severe or life-threatening CRS should be treated with tocilizumab with or without corticosteroids.

Patients should also be monitored for neurologic events after treatment with liso-cel, and supportive care and/or corticosteroids should be administered as needed.

Lisocabtagene maraleucel, also known as liso-cel (Breyanzi), has been approved by the Food and Drug Administration for the second-line treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL).

This expanded indication is based on findings from the pivotal phase 3 TRANSFORM study, which showed significant and clinically meaningful improvements with CD19-directed chimeric antigen receptor T-cell immunotherapy over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant. The latter course of treatment had been the standard of care for more than 2 decades.

Data from the global, randomized, multicenter TRANSFORM study, as reported in December 2021 at the annual meeting of the American Society of Hematology, showed that second-line treatment with liso-cel in 92 patients with r/r LBCL within 12 months after first-line therapy, compared with 92 patient who received standard of care therapy, was associated with highly statistically significant and clinically meaningful improvement in event-free survival (10.1 vs. 2.3 months; hazard ratio, 0.349), complete response rate (66% vs. 39%), and progression-free survival (14.8 vs. 5.7 months; HR, 0.406).

A positive trend in overall survival was also observed (HR, 0.509 at median follow-up of 6.2 months). No new liso-cel safety signals were detected in the second-line setting.

Liso-cel was initially approved in February 2021 for the treatment of adults with LBCL, including diffuse LBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:

• Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy.
• Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant because of comorbidities or age.

Liso-cel is not indicated for the treatment of patients with primary central nervous system lymphoma.

In February 2022, the FDA granted Priority Review status for a Bristol-Myers Squibb supplemental Biologics License Application (sBLA), based on the TRANSFORM study data, to expand the indication to include use after the failure of first-line therapy.

The agent “now has the potential to be a new standard of care for patients after failure of first-line therapy, offering significantly improved outcomes beyond the current mainstay of care,” Anne Kerber, the BMS senior vice president of cell therapy development, said in a press release at that time.

The European Medicines Agency has also validated a type II variation application for extension of the indication for liso-cel in this setting. Validation of the application “confirms the submission is complete and begins the EMA’s centralized review procedure,” BMS announced in a June 20, 2022, press release.

Liso-cel, which has been available only through a restricted program under a Risk Evaluation and Mitigation Strategy, includes a boxed warning regarding the risk for cytokine release syndrome (CRS) and neurologic toxicities.

The warning states that liso-cel should not be administered to patients with active infection or inflammatory disorders, and that severe or life-threatening CRS should be treated with tocilizumab with or without corticosteroids.

Patients should also be monitored for neurologic events after treatment with liso-cel, and supportive care and/or corticosteroids should be administered as needed.

CHICAGO -- High-dose ifosfamide has shown superior survival benefit over three other chemotherapy regimens for patients with recurring or refractory primary Ewing sarcoma (RR-ES) in the practice-changing rEECur trial.

This international trial is the first randomized head-to-head comparison of commonly used chemotherapy regimens in patients with the rare and deadly disease.

The study results are expected to change the standard of care and be practice-changing on a global scale, commented Julie Gralow, MD, chief medical officer at the annual meeting of the American Society of Clinical Oncology, where the results were presented June 5 during a plenary session.

Ewing sarcoma is a very rare cancer of the bone and soft tissue that mainly affects children and young adults, particularly in the second decade of life, explained lead author Martin McCabe, MD, clinical senior lecturer in pediatric, teenage, and young adult cancer at the University of Manchester (England). The incidence rate is 3.2 per million people under age 25 years, he said.

Dr. Gralow explained in an interview that treatment of Ewing sarcoma differs from one cancer center to another. Several different chemotherapy regimens are being used, all based on single-arm trials, with no consensus on which is best.

This international trial set out to answer that question and compared four different regimens. Participating centers were “able to solve a question by partnering, coming together, and even in a very rare population get enough patients to define the winner,” she said.

Earlier findings from this trial had shown that ifosfamide had improved survival, compared with gemcitabine and docetaxel and compared with irinotecan and temozolomide.

At the meeting, results of the comparison of ifosfamide versus a combination of topotecan and cyclophosphamide (TC) were presented.

Median overall survival was 15.4 versus 10.5 months with ifosfamide versus TC, and 1-year overall survival was 55% versus 45%, respectively, for a 94% probability that ifosfamide is better than TC for overall survival, Dr. McCabe reported.  

Median event-free survival was 16.8 months in 73 patients in the ifosfamide group versus 10.4 months for 73 patients in the TC group. Six-month event-free survival was 47% versus 37%, respectively. “Given the observed data, there is a 96% probability that ifosfamide is better than TC for event-free survival,” he said.   

High-dose ifosfamide prolonged median event-free survival by 5.7 months, compared with 3.7 months for TC.

Notably, greater event-free survival and overall survival differences were observed for patients under age 14 years, compared with those aged 14 and older, Dr. McCabe noted.

As for toxicity, similar rates of neutropenic infections were seen in the two groups, but more severe renal and brain toxicity were observed with ifosfamide, with both occurring in less than 10% of patients, he said.

Despite the practice-changing results, Dr. McCabe stressed that the “differences [between treatments] are quite small, and what we actually need is better drugs to cure more patients.”

The rEEcur trial is continuing to recruit patients to the ifosfamide group, and a fifth chemotherapy group of carboplatin and etoposide has been added.

Later this year, investigators also plan to add a new group with a molecular targeted therapeutic.
 

Important global collaboration

Dr. Gralow emphasized the global collaboration that was behind this trial, which set out to answer important questions about how best to treat a rare disease. “In this really terrific collaboration ... there was an agreement to test all these regimens that are commonly used, and so we now have data on efficacy and toxicity.”

“It’s a really important concept in rare diseases: If we all work together, we actually can study them and get answers,” she said.

“I think pediatricians and oncologists are [now] better able to talk about the risks and benefits [of the regimens],” she added.

Vicki L. Keedy, MD, an ASCO Expert in sarcoma, concurred. The findings from the rEECur trial “could help physicians talk with patients and their families about the likelihood of response, survival, and toxicity for each regimen available for relapsed Ewing sarcoma based on objective, randomized data,” she commented in an ASCO press release. 

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

CHICAGO -- High-dose ifosfamide has shown superior survival benefit over three other chemotherapy regimens for patients with recurring or refractory primary Ewing sarcoma (RR-ES) in the practice-changing rEECur trial.

This international trial is the first randomized head-to-head comparison of commonly used chemotherapy regimens in patients with the rare and deadly disease.

The study results are expected to change the standard of care and be practice-changing on a global scale, commented Julie Gralow, MD, chief medical officer at the annual meeting of the American Society of Clinical Oncology, where the results were presented June 5 during a plenary session.

Ewing sarcoma is a very rare cancer of the bone and soft tissue that mainly affects children and young adults, particularly in the second decade of life, explained lead author Martin McCabe, MD, clinical senior lecturer in pediatric, teenage, and young adult cancer at the University of Manchester (England). The incidence rate is 3.2 per million people under age 25 years, he said.

Dr. Gralow explained in an interview that treatment of Ewing sarcoma differs from one cancer center to another. Several different chemotherapy regimens are being used, all based on single-arm trials, with no consensus on which is best.

This international trial set out to answer that question and compared four different regimens. Participating centers were “able to solve a question by partnering, coming together, and even in a very rare population get enough patients to define the winner,” she said.

Earlier findings from this trial had shown that ifosfamide had improved survival, compared with gemcitabine and docetaxel and compared with irinotecan and temozolomide.

At the meeting, results of the comparison of ifosfamide versus a combination of topotecan and cyclophosphamide (TC) were presented.

Median overall survival was 15.4 versus 10.5 months with ifosfamide versus TC, and 1-year overall survival was 55% versus 45%, respectively, for a 94% probability that ifosfamide is better than TC for overall survival, Dr. McCabe reported.  

Median event-free survival was 16.8 months in 73 patients in the ifosfamide group versus 10.4 months for 73 patients in the TC group. Six-month event-free survival was 47% versus 37%, respectively. “Given the observed data, there is a 96% probability that ifosfamide is better than TC for event-free survival,” he said.   

High-dose ifosfamide prolonged median event-free survival by 5.7 months, compared with 3.7 months for TC.

Notably, greater event-free survival and overall survival differences were observed for patients under age 14 years, compared with those aged 14 and older, Dr. McCabe noted.

As for toxicity, similar rates of neutropenic infections were seen in the two groups, but more severe renal and brain toxicity were observed with ifosfamide, with both occurring in less than 10% of patients, he said.

Despite the practice-changing results, Dr. McCabe stressed that the “differences [between treatments] are quite small, and what we actually need is better drugs to cure more patients.”

The rEEcur trial is continuing to recruit patients to the ifosfamide group, and a fifth chemotherapy group of carboplatin and etoposide has been added.

Later this year, investigators also plan to add a new group with a molecular targeted therapeutic.
 

Important global collaboration

Dr. Gralow emphasized the global collaboration that was behind this trial, which set out to answer important questions about how best to treat a rare disease. “In this really terrific collaboration ... there was an agreement to test all these regimens that are commonly used, and so we now have data on efficacy and toxicity.”

“It’s a really important concept in rare diseases: If we all work together, we actually can study them and get answers,” she said.

“I think pediatricians and oncologists are [now] better able to talk about the risks and benefits [of the regimens],” she added.

Vicki L. Keedy, MD, an ASCO Expert in sarcoma, concurred. The findings from the rEECur trial “could help physicians talk with patients and their families about the likelihood of response, survival, and toxicity for each regimen available for relapsed Ewing sarcoma based on objective, randomized data,” she commented in an ASCO press release. 

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

CHICAGO -- High-dose ifosfamide has shown superior survival benefit over three other chemotherapy regimens for patients with recurring or refractory primary Ewing sarcoma (RR-ES) in the practice-changing rEECur trial.

This international trial is the first randomized head-to-head comparison of commonly used chemotherapy regimens in patients with the rare and deadly disease.

The study results are expected to change the standard of care and be practice-changing on a global scale, commented Julie Gralow, MD, chief medical officer at the annual meeting of the American Society of Clinical Oncology, where the results were presented June 5 during a plenary session.

Ewing sarcoma is a very rare cancer of the bone and soft tissue that mainly affects children and young adults, particularly in the second decade of life, explained lead author Martin McCabe, MD, clinical senior lecturer in pediatric, teenage, and young adult cancer at the University of Manchester (England). The incidence rate is 3.2 per million people under age 25 years, he said.

Dr. Gralow explained in an interview that treatment of Ewing sarcoma differs from one cancer center to another. Several different chemotherapy regimens are being used, all based on single-arm trials, with no consensus on which is best.

This international trial set out to answer that question and compared four different regimens. Participating centers were “able to solve a question by partnering, coming together, and even in a very rare population get enough patients to define the winner,” she said.

Earlier findings from this trial had shown that ifosfamide had improved survival, compared with gemcitabine and docetaxel and compared with irinotecan and temozolomide.

At the meeting, results of the comparison of ifosfamide versus a combination of topotecan and cyclophosphamide (TC) were presented.

Median overall survival was 15.4 versus 10.5 months with ifosfamide versus TC, and 1-year overall survival was 55% versus 45%, respectively, for a 94% probability that ifosfamide is better than TC for overall survival, Dr. McCabe reported.  

Median event-free survival was 16.8 months in 73 patients in the ifosfamide group versus 10.4 months for 73 patients in the TC group. Six-month event-free survival was 47% versus 37%, respectively. “Given the observed data, there is a 96% probability that ifosfamide is better than TC for event-free survival,” he said.   

High-dose ifosfamide prolonged median event-free survival by 5.7 months, compared with 3.7 months for TC.

Notably, greater event-free survival and overall survival differences were observed for patients under age 14 years, compared with those aged 14 and older, Dr. McCabe noted.

As for toxicity, similar rates of neutropenic infections were seen in the two groups, but more severe renal and brain toxicity were observed with ifosfamide, with both occurring in less than 10% of patients, he said.

Despite the practice-changing results, Dr. McCabe stressed that the “differences [between treatments] are quite small, and what we actually need is better drugs to cure more patients.”

The rEEcur trial is continuing to recruit patients to the ifosfamide group, and a fifth chemotherapy group of carboplatin and etoposide has been added.

Later this year, investigators also plan to add a new group with a molecular targeted therapeutic.
 

Important global collaboration

Dr. Gralow emphasized the global collaboration that was behind this trial, which set out to answer important questions about how best to treat a rare disease. “In this really terrific collaboration ... there was an agreement to test all these regimens that are commonly used, and so we now have data on efficacy and toxicity.”

“It’s a really important concept in rare diseases: If we all work together, we actually can study them and get answers,” she said.

“I think pediatricians and oncologists are [now] better able to talk about the risks and benefits [of the regimens],” she added.

Vicki L. Keedy, MD, an ASCO Expert in sarcoma, concurred. The findings from the rEECur trial “could help physicians talk with patients and their families about the likelihood of response, survival, and toxicity for each regimen available for relapsed Ewing sarcoma based on objective, randomized data,” she commented in an ASCO press release. 

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

CHICAGO – The COVID pandemic pushed telemedicine forward as a safe, accessible, and more widely reimbursed approach to care delivery for patients with cancer, but uptake of telemedicine was plagued by inequities, a retrospective study suggests.

Before March 2020, only a very small percentage of patients with cancer used telemedicine services.

By November 2021, nearly 16% of patients initiating cancer treatment were using this approach.

However, certain groups were less likely to use telemedicine, in particular, patients who were Black, uninsured, did not live in cities, and were less affluent, noted lead author Jenny S. Guadamuz, PhD, a quantitative scientist at Flatiron Health and a postdoctoral research associate at the University of Southern California, Los Angeles.

The results are concerning because they suggest that telemedicine expansion could widen cancer care disparities, Dr. Guadamuz said. Previous studies found racial disparities in care access and outcomes early on in the pandemic.

“These findings are critically important considering recent efforts to make coverage of telemedicine services permanent, instead of tied to the [Health and Human Services] public health emergency declaration,” she said. “There are also efforts to increase reimbursement rates for telemedicine services by Medicare, several Medicaid programs, and private insurers.”

This study was highlighted at a press briefing held in advance of the American Society of Clinical Oncology annual meeting, where it will be presented at a poster session (abstract 6511).

ASCO President Everett E. Vokes, MD, said telemedicine is “an important tool to communicate with patients” but that it is important to consider the “digital divide.”

He also emphasized the need “to expand and learn to use telehealth not in a crisis but as part of our regular care moving forward.” In July 2021, as telemedicine services were expanding, ASCO released practice recommendations specific to telehealth and oncology.

“Telemedicine can improve access to timely cancer care, but, as this study points out, telemedicine must be available equitably, so that every patient can access the care they need and deserve,” he said in a press statement.
 

Study details

For the study, Dr. Guadamuz and colleagues assessed telemedicine uptake by nearly 27,000 patients in a Flatiron electronic health record–derived deidentified database of patients who initiated treatment for any of 21 common cancers at about 280 community oncology clinics between March 2020 and November 2021.

They found that Black patients were significantly less likely than were White patients to use telemedicine (13.2% vs. 15.6%; odds ratio [OR], 0.82), as were patients without documented insurance, compared with those who were well insured (11.6% vs. 16.4%; OR, 0.68).

Those in rural and suburban areas were less likely than were those in urban areas to use telemedicine (9.7% and 13.0% vs. 17.7%; ORs, 0.50 and 0.69, respectively), and those in less affluent vs. more affluent areas were also less likely to use telemedicine (10.6% vs. 23.6%, OR, 0.39).

Dr. Guadamuz noted that the differences remained statistically significant after adjustment for clinical characteristics and that racial inequities were seen across cancer types and over time.

Future work should assess other potential characteristics associated with telemedicine inequities, evaluate whether health care delivered via telemedicine is of similar quality as in-person services, and determine the types of practice that are providing telemedicine more equitably to their patients, she concluded.

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

CHICAGO – The COVID pandemic pushed telemedicine forward as a safe, accessible, and more widely reimbursed approach to care delivery for patients with cancer, but uptake of telemedicine was plagued by inequities, a retrospective study suggests.

Before March 2020, only a very small percentage of patients with cancer used telemedicine services.

By November 2021, nearly 16% of patients initiating cancer treatment were using this approach.

However, certain groups were less likely to use telemedicine, in particular, patients who were Black, uninsured, did not live in cities, and were less affluent, noted lead author Jenny S. Guadamuz, PhD, a quantitative scientist at Flatiron Health and a postdoctoral research associate at the University of Southern California, Los Angeles.

The results are concerning because they suggest that telemedicine expansion could widen cancer care disparities, Dr. Guadamuz said. Previous studies found racial disparities in care access and outcomes early on in the pandemic.

“These findings are critically important considering recent efforts to make coverage of telemedicine services permanent, instead of tied to the [Health and Human Services] public health emergency declaration,” she said. “There are also efforts to increase reimbursement rates for telemedicine services by Medicare, several Medicaid programs, and private insurers.”

This study was highlighted at a press briefing held in advance of the American Society of Clinical Oncology annual meeting, where it will be presented at a poster session (abstract 6511).

ASCO President Everett E. Vokes, MD, said telemedicine is “an important tool to communicate with patients” but that it is important to consider the “digital divide.”

He also emphasized the need “to expand and learn to use telehealth not in a crisis but as part of our regular care moving forward.” In July 2021, as telemedicine services were expanding, ASCO released practice recommendations specific to telehealth and oncology.

“Telemedicine can improve access to timely cancer care, but, as this study points out, telemedicine must be available equitably, so that every patient can access the care they need and deserve,” he said in a press statement.
 

Study details

For the study, Dr. Guadamuz and colleagues assessed telemedicine uptake by nearly 27,000 patients in a Flatiron electronic health record–derived deidentified database of patients who initiated treatment for any of 21 common cancers at about 280 community oncology clinics between March 2020 and November 2021.

They found that Black patients were significantly less likely than were White patients to use telemedicine (13.2% vs. 15.6%; odds ratio [OR], 0.82), as were patients without documented insurance, compared with those who were well insured (11.6% vs. 16.4%; OR, 0.68).

Those in rural and suburban areas were less likely than were those in urban areas to use telemedicine (9.7% and 13.0% vs. 17.7%; ORs, 0.50 and 0.69, respectively), and those in less affluent vs. more affluent areas were also less likely to use telemedicine (10.6% vs. 23.6%, OR, 0.39).

Dr. Guadamuz noted that the differences remained statistically significant after adjustment for clinical characteristics and that racial inequities were seen across cancer types and over time.

Future work should assess other potential characteristics associated with telemedicine inequities, evaluate whether health care delivered via telemedicine is of similar quality as in-person services, and determine the types of practice that are providing telemedicine more equitably to their patients, she concluded.

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

CHICAGO – The COVID pandemic pushed telemedicine forward as a safe, accessible, and more widely reimbursed approach to care delivery for patients with cancer, but uptake of telemedicine was plagued by inequities, a retrospective study suggests.

Before March 2020, only a very small percentage of patients with cancer used telemedicine services.

By November 2021, nearly 16% of patients initiating cancer treatment were using this approach.

However, certain groups were less likely to use telemedicine, in particular, patients who were Black, uninsured, did not live in cities, and were less affluent, noted lead author Jenny S. Guadamuz, PhD, a quantitative scientist at Flatiron Health and a postdoctoral research associate at the University of Southern California, Los Angeles.

The results are concerning because they suggest that telemedicine expansion could widen cancer care disparities, Dr. Guadamuz said. Previous studies found racial disparities in care access and outcomes early on in the pandemic.

“These findings are critically important considering recent efforts to make coverage of telemedicine services permanent, instead of tied to the [Health and Human Services] public health emergency declaration,” she said. “There are also efforts to increase reimbursement rates for telemedicine services by Medicare, several Medicaid programs, and private insurers.”

This study was highlighted at a press briefing held in advance of the American Society of Clinical Oncology annual meeting, where it will be presented at a poster session (abstract 6511).

ASCO President Everett E. Vokes, MD, said telemedicine is “an important tool to communicate with patients” but that it is important to consider the “digital divide.”

He also emphasized the need “to expand and learn to use telehealth not in a crisis but as part of our regular care moving forward.” In July 2021, as telemedicine services were expanding, ASCO released practice recommendations specific to telehealth and oncology.

“Telemedicine can improve access to timely cancer care, but, as this study points out, telemedicine must be available equitably, so that every patient can access the care they need and deserve,” he said in a press statement.
 

Study details

For the study, Dr. Guadamuz and colleagues assessed telemedicine uptake by nearly 27,000 patients in a Flatiron electronic health record–derived deidentified database of patients who initiated treatment for any of 21 common cancers at about 280 community oncology clinics between March 2020 and November 2021.

They found that Black patients were significantly less likely than were White patients to use telemedicine (13.2% vs. 15.6%; odds ratio [OR], 0.82), as were patients without documented insurance, compared with those who were well insured (11.6% vs. 16.4%; OR, 0.68).

Those in rural and suburban areas were less likely than were those in urban areas to use telemedicine (9.7% and 13.0% vs. 17.7%; ORs, 0.50 and 0.69, respectively), and those in less affluent vs. more affluent areas were also less likely to use telemedicine (10.6% vs. 23.6%, OR, 0.39).

Dr. Guadamuz noted that the differences remained statistically significant after adjustment for clinical characteristics and that racial inequities were seen across cancer types and over time.

Future work should assess other potential characteristics associated with telemedicine inequities, evaluate whether health care delivered via telemedicine is of similar quality as in-person services, and determine the types of practice that are providing telemedicine more equitably to their patients, she concluded.

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

Learning that a family member has cancer can be devastating enough. Waiting to find out whether a loved one can afford their treatment takes the concern to another level.

That was the case for health policy expert Stacie B. Dusetzina, PhD, when her mother was diagnosed with metastatic breast cancer.

“There is this period where you are waiting to learn more about the cancer type and treatment options, and, of course, what might be covered by your health plan,” Dr. Dusetzina, an associate professor at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. “Knowing as much as I do about coverage for prescription drugs in Medicare Part D, I was worried we would be in a situation where my mom had to spend over $15,000 out-of-pocket every year for one of these drugs.”

That $15,000 would have taken a large chunk of her retirement income and could make treatment unaffordable down the line.

This situation is hardly unique.

Many patients with cancer who rely on Medicare Part D face an impossible choice: “Your money or your life,” Dr. Dusetzina said.

In a recent perspective in the New England Journal of Medicine, Dr. Dusetzina detailed how subtle variations in people’s cancer type can have major implications for their out-of-pocket drug costs.

The difference in cost comes down to whether drugs are delivered as pills or infusions. Oral agents are almost always covered under a health plan’s pharmacy benefit (Medicare Part D), while physician-administered drugs are covered under the medical benefit (Medicare Part B).

According to Dr. Dusetzina, Medicare beneficiaries can face substantial, possibly “unlimited,” out-of-pocket costs for drugs covered under Part D if they don’t qualify for low-income subsidies. On the other hand, most beneficiaries receiving physician-administered drugs covered under Part B have supplemental coverage, which reduces or eliminates out-of-pocket costs.

Dr. Dusetzina broke down the expected first fill and yearly out-of-pocket costs associated with 10 oral cancer drugs covered under Part D. These costs ranged from $3,100 to $3,392 for a first fill and $10,592 to $14,067 for one year.

In a candid Twitter thread, Dr. Dusetzina opened up more about the issues highlighted in her piece: “This paper is about #PartD and Cancer. It is also about #pharmacoequity ... This is about how screwed you are if you need cancer treatment and your treatment happens to be covered by #PartD and not #PartB.”

“This is ARBITRARY and INEQUITABLE,” she added.

What’s “arbitrary,” Dr. Dusetzina explains, is that a rather small, chance distinction in cancer type or subtype can be the difference between affording and not affording treatment – and potentially between life and death.

Take the drug costs for two similar patients with breast cancer.

Patient A has hormone receptor–positive, human epidermal growth factor receptor type 2 (HER2)–negative breast cancer and thus would likely receive first-line therapy with two oral agents: an aromatase inhibitor and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, most often palbociclib (Ibrance).

For palbociclib alone, out-of-pocket costs would come to $3,100 for the first fill and nearly $10,600 over a year for a Part D beneficiary who doesn’t qualify for low-income subsidies.

Now take patient B who has HER2–positive metastatic breast cancer. This person would likely receive first-line treatment with trastuzumab (Herceptin), pertuzumab (Perjeta), and a taxane – a combination covered under Part B, which would be subject to an out-of-pocket cap or covered with limited or no cost sharing.

This difference in cancer subtype leaves some patients “paying substantially more for their cancer treatment than others, despite the same goal of extending or improving their lives,” Dr. Dusetzina writes.

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

Learning that a family member has cancer can be devastating enough. Waiting to find out whether a loved one can afford their treatment takes the concern to another level.

That was the case for health policy expert Stacie B. Dusetzina, PhD, when her mother was diagnosed with metastatic breast cancer.

“There is this period where you are waiting to learn more about the cancer type and treatment options, and, of course, what might be covered by your health plan,” Dr. Dusetzina, an associate professor at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. “Knowing as much as I do about coverage for prescription drugs in Medicare Part D, I was worried we would be in a situation where my mom had to spend over $15,000 out-of-pocket every year for one of these drugs.”

That $15,000 would have taken a large chunk of her retirement income and could make treatment unaffordable down the line.

This situation is hardly unique.

Many patients with cancer who rely on Medicare Part D face an impossible choice: “Your money or your life,” Dr. Dusetzina said.

In a recent perspective in the New England Journal of Medicine, Dr. Dusetzina detailed how subtle variations in people’s cancer type can have major implications for their out-of-pocket drug costs.

The difference in cost comes down to whether drugs are delivered as pills or infusions. Oral agents are almost always covered under a health plan’s pharmacy benefit (Medicare Part D), while physician-administered drugs are covered under the medical benefit (Medicare Part B).

According to Dr. Dusetzina, Medicare beneficiaries can face substantial, possibly “unlimited,” out-of-pocket costs for drugs covered under Part D if they don’t qualify for low-income subsidies. On the other hand, most beneficiaries receiving physician-administered drugs covered under Part B have supplemental coverage, which reduces or eliminates out-of-pocket costs.

Dr. Dusetzina broke down the expected first fill and yearly out-of-pocket costs associated with 10 oral cancer drugs covered under Part D. These costs ranged from $3,100 to $3,392 for a first fill and $10,592 to $14,067 for one year.

In a candid Twitter thread, Dr. Dusetzina opened up more about the issues highlighted in her piece: “This paper is about #PartD and Cancer. It is also about #pharmacoequity ... This is about how screwed you are if you need cancer treatment and your treatment happens to be covered by #PartD and not #PartB.”

“This is ARBITRARY and INEQUITABLE,” she added.

What’s “arbitrary,” Dr. Dusetzina explains, is that a rather small, chance distinction in cancer type or subtype can be the difference between affording and not affording treatment – and potentially between life and death.

Take the drug costs for two similar patients with breast cancer.

Patient A has hormone receptor–positive, human epidermal growth factor receptor type 2 (HER2)–negative breast cancer and thus would likely receive first-line therapy with two oral agents: an aromatase inhibitor and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, most often palbociclib (Ibrance).

For palbociclib alone, out-of-pocket costs would come to $3,100 for the first fill and nearly $10,600 over a year for a Part D beneficiary who doesn’t qualify for low-income subsidies.

Now take patient B who has HER2–positive metastatic breast cancer. This person would likely receive first-line treatment with trastuzumab (Herceptin), pertuzumab (Perjeta), and a taxane – a combination covered under Part B, which would be subject to an out-of-pocket cap or covered with limited or no cost sharing.

This difference in cancer subtype leaves some patients “paying substantially more for their cancer treatment than others, despite the same goal of extending or improving their lives,” Dr. Dusetzina writes.

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

Learning that a family member has cancer can be devastating enough. Waiting to find out whether a loved one can afford their treatment takes the concern to another level.

That was the case for health policy expert Stacie B. Dusetzina, PhD, when her mother was diagnosed with metastatic breast cancer.

“There is this period where you are waiting to learn more about the cancer type and treatment options, and, of course, what might be covered by your health plan,” Dr. Dusetzina, an associate professor at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview. “Knowing as much as I do about coverage for prescription drugs in Medicare Part D, I was worried we would be in a situation where my mom had to spend over $15,000 out-of-pocket every year for one of these drugs.”

That $15,000 would have taken a large chunk of her retirement income and could make treatment unaffordable down the line.

This situation is hardly unique.

Many patients with cancer who rely on Medicare Part D face an impossible choice: “Your money or your life,” Dr. Dusetzina said.

In a recent perspective in the New England Journal of Medicine, Dr. Dusetzina detailed how subtle variations in people’s cancer type can have major implications for their out-of-pocket drug costs.

The difference in cost comes down to whether drugs are delivered as pills or infusions. Oral agents are almost always covered under a health plan’s pharmacy benefit (Medicare Part D), while physician-administered drugs are covered under the medical benefit (Medicare Part B).

According to Dr. Dusetzina, Medicare beneficiaries can face substantial, possibly “unlimited,” out-of-pocket costs for drugs covered under Part D if they don’t qualify for low-income subsidies. On the other hand, most beneficiaries receiving physician-administered drugs covered under Part B have supplemental coverage, which reduces or eliminates out-of-pocket costs.

Dr. Dusetzina broke down the expected first fill and yearly out-of-pocket costs associated with 10 oral cancer drugs covered under Part D. These costs ranged from $3,100 to $3,392 for a first fill and $10,592 to $14,067 for one year.

In a candid Twitter thread, Dr. Dusetzina opened up more about the issues highlighted in her piece: “This paper is about #PartD and Cancer. It is also about #pharmacoequity ... This is about how screwed you are if you need cancer treatment and your treatment happens to be covered by #PartD and not #PartB.”

“This is ARBITRARY and INEQUITABLE,” she added.

What’s “arbitrary,” Dr. Dusetzina explains, is that a rather small, chance distinction in cancer type or subtype can be the difference between affording and not affording treatment – and potentially between life and death.

Take the drug costs for two similar patients with breast cancer.

Patient A has hormone receptor–positive, human epidermal growth factor receptor type 2 (HER2)–negative breast cancer and thus would likely receive first-line therapy with two oral agents: an aromatase inhibitor and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, most often palbociclib (Ibrance).

For palbociclib alone, out-of-pocket costs would come to $3,100 for the first fill and nearly $10,600 over a year for a Part D beneficiary who doesn’t qualify for low-income subsidies.

Now take patient B who has HER2–positive metastatic breast cancer. This person would likely receive first-line treatment with trastuzumab (Herceptin), pertuzumab (Perjeta), and a taxane – a combination covered under Part B, which would be subject to an out-of-pocket cap or covered with limited or no cost sharing.

This difference in cancer subtype leaves some patients “paying substantially more for their cancer treatment than others, despite the same goal of extending or improving their lives,” Dr. Dusetzina writes.

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

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

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

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

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

Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.

The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.

“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.

The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.

The study was published online in The Lancet.

The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
 

First head-to-head trial

For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.

The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.

Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.

The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.

Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.

“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.

Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.

They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.

“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.

The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.

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