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Study shows higher obesity-related cancer mortality in areas with more fast food

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Sun, 05/07/2023 - 00:56

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

 

 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

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Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

 

 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

 

 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

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Expert discusses which diets are best, based on the evidence

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Mon, 05/08/2023 - 08:36

– Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

 

 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.

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– Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

 

 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.

– Primary care providers can draw from a wide range of diets to give patients evidence-based advice on how to lose weight, prevent diabetes, and achieve other health goals, according to a speaker at the annual meeting of the American College of Physicians.

“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
 

Predominantly plant‐based diets

Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).

The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.

“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.

A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.

“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.

For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
 

Time‐restricted feeding

There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.

Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.

These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
 

 

 

Low‐carbohydrate and ketogenic diets

Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.

The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
 

Rating the level of scientific evidence behind different diet options

Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.

In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
 

Getting to know patients is essential to help them maintain diet modifications

When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”

In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.

“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.

When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.

Dr. Hauser and Dr. Bittleman report no relevant financial relationships.

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AT INTERNAL MEDICINE 2023

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Cancer pain declines with cannabis use

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Fri, 05/05/2023 - 10:15

Adults with cancer experienced significant reductions in pain after taking medicinal cannabis, in a study.

Physician-prescribed cannabis, particularly cannabinoids, has been shown to ease cancer-related pain in adult cancer patients, who often find inadequate pain relief from medications including opioids, Saro Aprikian, MSc, a medical student at the Royal College of Surgeons, Dublin, and colleagues, wrote in their paper.

However, real-world data on the safety and effectiveness of cannabis in the cancer population and the impact on use of other medications are lacking, the researchers said.

In the study, published in BMJ Supportive & Palliative Care, the researchers reviewed data from 358 adults with cancer who were part of a multicenter cannabis registry in Canada between May 2015 and October 2018.

The average age of the patients was 57.6 years, and 48% were men. The top three cancer diagnoses in the study population were genitorurinary, breast, and colorectal.

Pain was the most common reason for obtaining a medical cannabis prescription, cited by 72.4% of patients.

Data were collected at follow-up visits conducted every 3 months over 1 year. Pain was assessed via the Brief Pain Inventory (BPI) and revised Edmonton Symptom Assessment System (ESAS-r) questionnaires and compared to baseline values. Patients rated their pain intensity on a sliding scale of 0 (none) to 10 (worst possible). Pain relief was rated on a scale of 0% (none) to 100% (complete).

Compared to baseline scores, patients showed significant decreases at 3, 6 and 9 months for BPI worst pain (5.5 at baseline, 3.6 for 3, 6, and 9 months) average pain (4.1 at baseline, 2.4, 2.3, and 2.7 for 3, 6, and 9 months, respectively), overall pain severity (2.7 at baseline, 2.3, 2.3, and 2.4 at 3, 6, and 9 months, respectively), and pain interference with daily life (4.3 at baseline, 2.4, 2.2, and 2.4 at 3, 6, and 9 months, respectively; P less than .01 for all four pain measures).

“Pain severity as reported in the ESAS-r decreased significantly at 3-month, 6-month and 9-month follow-ups,” the researchers noted.

In addition, total medication burden based on the medication quantification scale (MQS) and morphine equivalent daily dose (MEDD) were recorded at 3, 6, 9, and 12 months. MQS scores decreased compared to baseline at 3, 6, 9, and 12 months in 10%, 23.5%, 26.2%, and 31.6% of patients, respectively. Also compared with baseline, 11.1%, 31.3%, and 14.3% of patients reported decreases in MEDD scores at 3, 6, and 9 months, respectively.

Overall, products with equal amounts of active ingredients tetrahydrocannabinol (THC) and cannabidiol (CBD) were more effective than were those with a predominance of either THC or CBD, the researchers wrote.

Medical cannabis was well-tolerated; a total of 15 moderate to severe side effects were reported by 11 patients, 13 of which were minor. The most common side effects were sleepiness and fatigue, and five patients discontinued their medical cannabis because of side effects. The two serious side effects reported during the study period – pneumonia and a cardiovascular event – were deemed unlikely related to the patients’ medicinal cannabis use.

The findings were limited by several factors, including the observational design, which prevented conclusions about causality, the researchers noted. Other limitations included the loss of many patients to follow-up and incomplete data on other prescription medications in many cases.

The results support the use of medical cannabis by cancer patients as an adjunct pain relief strategy and a way to potentially reduce the use of other medications such as opioids, the authors concluded.

The study was supported by the Canadian Consortium for the Investigation of Cannabinoids, Collège des Médecins du Québec, and the Canopy Growth Corporation. The researchers had no financial conflicts to disclose.

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Adults with cancer experienced significant reductions in pain after taking medicinal cannabis, in a study.

Physician-prescribed cannabis, particularly cannabinoids, has been shown to ease cancer-related pain in adult cancer patients, who often find inadequate pain relief from medications including opioids, Saro Aprikian, MSc, a medical student at the Royal College of Surgeons, Dublin, and colleagues, wrote in their paper.

However, real-world data on the safety and effectiveness of cannabis in the cancer population and the impact on use of other medications are lacking, the researchers said.

In the study, published in BMJ Supportive & Palliative Care, the researchers reviewed data from 358 adults with cancer who were part of a multicenter cannabis registry in Canada between May 2015 and October 2018.

The average age of the patients was 57.6 years, and 48% were men. The top three cancer diagnoses in the study population were genitorurinary, breast, and colorectal.

Pain was the most common reason for obtaining a medical cannabis prescription, cited by 72.4% of patients.

Data were collected at follow-up visits conducted every 3 months over 1 year. Pain was assessed via the Brief Pain Inventory (BPI) and revised Edmonton Symptom Assessment System (ESAS-r) questionnaires and compared to baseline values. Patients rated their pain intensity on a sliding scale of 0 (none) to 10 (worst possible). Pain relief was rated on a scale of 0% (none) to 100% (complete).

Compared to baseline scores, patients showed significant decreases at 3, 6 and 9 months for BPI worst pain (5.5 at baseline, 3.6 for 3, 6, and 9 months) average pain (4.1 at baseline, 2.4, 2.3, and 2.7 for 3, 6, and 9 months, respectively), overall pain severity (2.7 at baseline, 2.3, 2.3, and 2.4 at 3, 6, and 9 months, respectively), and pain interference with daily life (4.3 at baseline, 2.4, 2.2, and 2.4 at 3, 6, and 9 months, respectively; P less than .01 for all four pain measures).

“Pain severity as reported in the ESAS-r decreased significantly at 3-month, 6-month and 9-month follow-ups,” the researchers noted.

In addition, total medication burden based on the medication quantification scale (MQS) and morphine equivalent daily dose (MEDD) were recorded at 3, 6, 9, and 12 months. MQS scores decreased compared to baseline at 3, 6, 9, and 12 months in 10%, 23.5%, 26.2%, and 31.6% of patients, respectively. Also compared with baseline, 11.1%, 31.3%, and 14.3% of patients reported decreases in MEDD scores at 3, 6, and 9 months, respectively.

Overall, products with equal amounts of active ingredients tetrahydrocannabinol (THC) and cannabidiol (CBD) were more effective than were those with a predominance of either THC or CBD, the researchers wrote.

Medical cannabis was well-tolerated; a total of 15 moderate to severe side effects were reported by 11 patients, 13 of which were minor. The most common side effects were sleepiness and fatigue, and five patients discontinued their medical cannabis because of side effects. The two serious side effects reported during the study period – pneumonia and a cardiovascular event – were deemed unlikely related to the patients’ medicinal cannabis use.

The findings were limited by several factors, including the observational design, which prevented conclusions about causality, the researchers noted. Other limitations included the loss of many patients to follow-up and incomplete data on other prescription medications in many cases.

The results support the use of medical cannabis by cancer patients as an adjunct pain relief strategy and a way to potentially reduce the use of other medications such as opioids, the authors concluded.

The study was supported by the Canadian Consortium for the Investigation of Cannabinoids, Collège des Médecins du Québec, and the Canopy Growth Corporation. The researchers had no financial conflicts to disclose.

Adults with cancer experienced significant reductions in pain after taking medicinal cannabis, in a study.

Physician-prescribed cannabis, particularly cannabinoids, has been shown to ease cancer-related pain in adult cancer patients, who often find inadequate pain relief from medications including opioids, Saro Aprikian, MSc, a medical student at the Royal College of Surgeons, Dublin, and colleagues, wrote in their paper.

However, real-world data on the safety and effectiveness of cannabis in the cancer population and the impact on use of other medications are lacking, the researchers said.

In the study, published in BMJ Supportive & Palliative Care, the researchers reviewed data from 358 adults with cancer who were part of a multicenter cannabis registry in Canada between May 2015 and October 2018.

The average age of the patients was 57.6 years, and 48% were men. The top three cancer diagnoses in the study population were genitorurinary, breast, and colorectal.

Pain was the most common reason for obtaining a medical cannabis prescription, cited by 72.4% of patients.

Data were collected at follow-up visits conducted every 3 months over 1 year. Pain was assessed via the Brief Pain Inventory (BPI) and revised Edmonton Symptom Assessment System (ESAS-r) questionnaires and compared to baseline values. Patients rated their pain intensity on a sliding scale of 0 (none) to 10 (worst possible). Pain relief was rated on a scale of 0% (none) to 100% (complete).

Compared to baseline scores, patients showed significant decreases at 3, 6 and 9 months for BPI worst pain (5.5 at baseline, 3.6 for 3, 6, and 9 months) average pain (4.1 at baseline, 2.4, 2.3, and 2.7 for 3, 6, and 9 months, respectively), overall pain severity (2.7 at baseline, 2.3, 2.3, and 2.4 at 3, 6, and 9 months, respectively), and pain interference with daily life (4.3 at baseline, 2.4, 2.2, and 2.4 at 3, 6, and 9 months, respectively; P less than .01 for all four pain measures).

“Pain severity as reported in the ESAS-r decreased significantly at 3-month, 6-month and 9-month follow-ups,” the researchers noted.

In addition, total medication burden based on the medication quantification scale (MQS) and morphine equivalent daily dose (MEDD) were recorded at 3, 6, 9, and 12 months. MQS scores decreased compared to baseline at 3, 6, 9, and 12 months in 10%, 23.5%, 26.2%, and 31.6% of patients, respectively. Also compared with baseline, 11.1%, 31.3%, and 14.3% of patients reported decreases in MEDD scores at 3, 6, and 9 months, respectively.

Overall, products with equal amounts of active ingredients tetrahydrocannabinol (THC) and cannabidiol (CBD) were more effective than were those with a predominance of either THC or CBD, the researchers wrote.

Medical cannabis was well-tolerated; a total of 15 moderate to severe side effects were reported by 11 patients, 13 of which were minor. The most common side effects were sleepiness and fatigue, and five patients discontinued their medical cannabis because of side effects. The two serious side effects reported during the study period – pneumonia and a cardiovascular event – were deemed unlikely related to the patients’ medicinal cannabis use.

The findings were limited by several factors, including the observational design, which prevented conclusions about causality, the researchers noted. Other limitations included the loss of many patients to follow-up and incomplete data on other prescription medications in many cases.

The results support the use of medical cannabis by cancer patients as an adjunct pain relief strategy and a way to potentially reduce the use of other medications such as opioids, the authors concluded.

The study was supported by the Canadian Consortium for the Investigation of Cannabinoids, Collège des Médecins du Québec, and the Canopy Growth Corporation. The researchers had no financial conflicts to disclose.

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Outpatient costs top drug costs in some insured, working women with breast cancer

Article Type
Changed
Tue, 04/11/2023 - 08:03

Among a sample of younger women with invasive breast cancer and employer-sponsored insurance, outpatient-related out-of-pocket (OOP) costs were greater than drug costs.

For these same patients, prescriptions were largely for nonproprietary anticancer drugs and entailed limited OOP costs. For women with high-deductible health plans (HDHPs) and commercially driven health plans (CDHPs), OOP costs were higher, compared with coverage by more generous plans, according to the Research Letter published in JAMA Network Open.

“You would expect that people undergoing cancer treatment should not have to face very high out-of-pocket costs associated with care regardless of treatment modality because their treatment is largely guideline-indicated, and they have no choices,” stated corresponding author Rena Conti, PhD, associate professor with the school of business, Boston University, in an interview. “If you are diagnosed with cancer and undergoing treatment, you’re following the recommendation of your doctor, and your doctor is following standard protocols for treatment. In that scenario, Economics 101 suggests that people should not have to pay anything or [should pay] very little, especially for things that are cheap and are known to be effective, because there’s no overuse. Where normally we think that out-of-pocket costs are meant to control overuse, people with breast cancer are not opting to get more than indicated chemotherapy or radiation.”

The analysis of 25,224 women with invasive breast cancer diagnosis and claims for 1 or more of 14 oral anticancer drugs revealed that OOP costs for nondrug outpatient claims represented 79.0% of total costs. OOP drug costs were modest, with a 30-day supply ranging from $0.57-$0.60 for tamoxifen to $134.08-$141.07 for palbociclib.

“We were interested in understanding to what extent women who are insured with private insurance are exposed to out-of-pocket costs for standard breast cancer treatment, both in looking at drugs, but also the other aspects of the treatments they undergo.”

High OOP costs for the oral anticancer prescription drugs that are central to breast cancer treatment are associated with treatment nonadherence and discontinuation. Little has been known, however, about OOP costs of treatment associated with invasive breast cancer among employer-insured women younger than 65 years, the paper says.

“This population may face significant financial burdens related to long-term hormonal-based prevention and enrollment in high-deductible health plans and consumer-driven health plans,” the authors state in their paper.

In the cross-sectional study, which used the national 2018 Marative MarketScan database, 23.1% were HDHP- or CDHP-insured. Fifty-one percent had no OOP costs for drugs. The total mean estimated OOP cost, however, was $1,502.23 per patient, with inpatient costs representing only $112.41 (95% confidence interval, $112.40-$112.42); outpatient costs were $1,186.27 (95% CI, $1,185.67-$1,188.16). Pharmaceutical costs were $203.55 (95% CI, $203.34-$203.78).“We were surprised to find that the vast majority were getting breast cancer treatment with older, very effective, very safe, relatively inexpensive drugs and had limited out-of-pocket costs with some variation – higher costs for the few receiving newer, expensive drugs. The backbone of treatment is the older, generic drugs, which are cheap for both the insurers and the patients. But we found also that women are facing high out-of-pocket costs for nondrug-based therapy – specifically for doctor visits, getting check-ups, diagnostic scans, and maybe other types of treatment, as well. ... It’s a very different story than the one typically being told about the preponderance of out-of-pocket costs being drug-related,” Dr. Conti said.

 

 

The explanation may be that progress in breast cancer treatment over the last decades has led to effective treatments that are largely now inexpensive. The situation is different with ovarian cancer and many blood cancers such as chronic lymphocytic leukemia and multiple myeloma. For them, the new, innovative, safe, and effective drugs are very expensive, she noted.

“I think that insurers can modulate the out-of-pocket costs associated with drug treatment through formulary design and other tools they have. It’s less easy for them to modulate out-of-pocket costs associated with other modalties of care. Still, for medical care that is obviously necessary, there needs to be a cap on what women should have to pay,” Dr. Conti said.

A further concern raised by Dr. Conti is shrinking Medicaid coverage with the expiration of COVID-specific expanded Medicaid eligibility.

“Policy folks are closely watching the size of uninsured populations and also the growing importance of the high deductible and consumer-driven plans in which patients face high out-of-pocket first dollar coverage for care. With Medicaid rolls shrinking, we’ll see more people in low-premium, not well-insured plans. Americans’ exposure to higher costs for guideline-recommended care might grow, especially as more of them are independent contractors in the gig economy and not working for big corporations.”

“We worry that if and when they get a diagnosis of breast cancer, which is common among younger women, they are going to be faced with costs associated with their care that are going to have to be paid out-of-pocket – and it’s not going to be for the drug, it’s the other types of care. Doctors should know that the younger patient population that they are serving might be facing burdens associated with their care.”

Dr. Conti added, “Among women who are underinsured, there is a clear burden associated with cancer treatment. Reform efforts have largely focused on reducing out-of-pocket costs for seniors and have not focused much on guideline-consistent care for those under 65 who are working. Their burden can be quite onerous and cause financial harm for them and their families, resulting in worse health,” she continued, “Policy attention should go to unburdening people who have a serious diagnosis and who really have to be treated. There’s very good evidence that imposing additional out-of-pocket costs for guideline-consistent care causes people to make really hard decisions about paying rent versus paying for meds, about splitting pills and not doing all the things their physician is recommending, and about staying in jobs they don’t love but are locked into [because of health coverage].”

Dr. Conti concluded, “The good news is that, in breast cancer, the drugs work and are cheap. But the bad news is that there are many people who are underinsured and therefore, their care still has a high out-of-pocket burden. ACA radically changed working age people’s ability to qualify for insurance and be insured, but that didn’t mean that they are really well-covered when they become sick. They are still in peril over high out-of-pocket costs because of the proliferation of plans that are very skimpy. Women think they are insured until they get a diagnosis.”

Noting study limitations, Dr. Conti said that OOP costs cited are an underestimate, because many patients will also be treated for other comorbidities and complications related to treatment.

The authors disclosed no conflicts of interest. The study was funded by the American Cancer Society.

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Among a sample of younger women with invasive breast cancer and employer-sponsored insurance, outpatient-related out-of-pocket (OOP) costs were greater than drug costs.

For these same patients, prescriptions were largely for nonproprietary anticancer drugs and entailed limited OOP costs. For women with high-deductible health plans (HDHPs) and commercially driven health plans (CDHPs), OOP costs were higher, compared with coverage by more generous plans, according to the Research Letter published in JAMA Network Open.

“You would expect that people undergoing cancer treatment should not have to face very high out-of-pocket costs associated with care regardless of treatment modality because their treatment is largely guideline-indicated, and they have no choices,” stated corresponding author Rena Conti, PhD, associate professor with the school of business, Boston University, in an interview. “If you are diagnosed with cancer and undergoing treatment, you’re following the recommendation of your doctor, and your doctor is following standard protocols for treatment. In that scenario, Economics 101 suggests that people should not have to pay anything or [should pay] very little, especially for things that are cheap and are known to be effective, because there’s no overuse. Where normally we think that out-of-pocket costs are meant to control overuse, people with breast cancer are not opting to get more than indicated chemotherapy or radiation.”

The analysis of 25,224 women with invasive breast cancer diagnosis and claims for 1 or more of 14 oral anticancer drugs revealed that OOP costs for nondrug outpatient claims represented 79.0% of total costs. OOP drug costs were modest, with a 30-day supply ranging from $0.57-$0.60 for tamoxifen to $134.08-$141.07 for palbociclib.

“We were interested in understanding to what extent women who are insured with private insurance are exposed to out-of-pocket costs for standard breast cancer treatment, both in looking at drugs, but also the other aspects of the treatments they undergo.”

High OOP costs for the oral anticancer prescription drugs that are central to breast cancer treatment are associated with treatment nonadherence and discontinuation. Little has been known, however, about OOP costs of treatment associated with invasive breast cancer among employer-insured women younger than 65 years, the paper says.

“This population may face significant financial burdens related to long-term hormonal-based prevention and enrollment in high-deductible health plans and consumer-driven health plans,” the authors state in their paper.

In the cross-sectional study, which used the national 2018 Marative MarketScan database, 23.1% were HDHP- or CDHP-insured. Fifty-one percent had no OOP costs for drugs. The total mean estimated OOP cost, however, was $1,502.23 per patient, with inpatient costs representing only $112.41 (95% confidence interval, $112.40-$112.42); outpatient costs were $1,186.27 (95% CI, $1,185.67-$1,188.16). Pharmaceutical costs were $203.55 (95% CI, $203.34-$203.78).“We were surprised to find that the vast majority were getting breast cancer treatment with older, very effective, very safe, relatively inexpensive drugs and had limited out-of-pocket costs with some variation – higher costs for the few receiving newer, expensive drugs. The backbone of treatment is the older, generic drugs, which are cheap for both the insurers and the patients. But we found also that women are facing high out-of-pocket costs for nondrug-based therapy – specifically for doctor visits, getting check-ups, diagnostic scans, and maybe other types of treatment, as well. ... It’s a very different story than the one typically being told about the preponderance of out-of-pocket costs being drug-related,” Dr. Conti said.

 

 

The explanation may be that progress in breast cancer treatment over the last decades has led to effective treatments that are largely now inexpensive. The situation is different with ovarian cancer and many blood cancers such as chronic lymphocytic leukemia and multiple myeloma. For them, the new, innovative, safe, and effective drugs are very expensive, she noted.

“I think that insurers can modulate the out-of-pocket costs associated with drug treatment through formulary design and other tools they have. It’s less easy for them to modulate out-of-pocket costs associated with other modalties of care. Still, for medical care that is obviously necessary, there needs to be a cap on what women should have to pay,” Dr. Conti said.

A further concern raised by Dr. Conti is shrinking Medicaid coverage with the expiration of COVID-specific expanded Medicaid eligibility.

“Policy folks are closely watching the size of uninsured populations and also the growing importance of the high deductible and consumer-driven plans in which patients face high out-of-pocket first dollar coverage for care. With Medicaid rolls shrinking, we’ll see more people in low-premium, not well-insured plans. Americans’ exposure to higher costs for guideline-recommended care might grow, especially as more of them are independent contractors in the gig economy and not working for big corporations.”

“We worry that if and when they get a diagnosis of breast cancer, which is common among younger women, they are going to be faced with costs associated with their care that are going to have to be paid out-of-pocket – and it’s not going to be for the drug, it’s the other types of care. Doctors should know that the younger patient population that they are serving might be facing burdens associated with their care.”

Dr. Conti added, “Among women who are underinsured, there is a clear burden associated with cancer treatment. Reform efforts have largely focused on reducing out-of-pocket costs for seniors and have not focused much on guideline-consistent care for those under 65 who are working. Their burden can be quite onerous and cause financial harm for them and their families, resulting in worse health,” she continued, “Policy attention should go to unburdening people who have a serious diagnosis and who really have to be treated. There’s very good evidence that imposing additional out-of-pocket costs for guideline-consistent care causes people to make really hard decisions about paying rent versus paying for meds, about splitting pills and not doing all the things their physician is recommending, and about staying in jobs they don’t love but are locked into [because of health coverage].”

Dr. Conti concluded, “The good news is that, in breast cancer, the drugs work and are cheap. But the bad news is that there are many people who are underinsured and therefore, their care still has a high out-of-pocket burden. ACA radically changed working age people’s ability to qualify for insurance and be insured, but that didn’t mean that they are really well-covered when they become sick. They are still in peril over high out-of-pocket costs because of the proliferation of plans that are very skimpy. Women think they are insured until they get a diagnosis.”

Noting study limitations, Dr. Conti said that OOP costs cited are an underestimate, because many patients will also be treated for other comorbidities and complications related to treatment.

The authors disclosed no conflicts of interest. The study was funded by the American Cancer Society.

Among a sample of younger women with invasive breast cancer and employer-sponsored insurance, outpatient-related out-of-pocket (OOP) costs were greater than drug costs.

For these same patients, prescriptions were largely for nonproprietary anticancer drugs and entailed limited OOP costs. For women with high-deductible health plans (HDHPs) and commercially driven health plans (CDHPs), OOP costs were higher, compared with coverage by more generous plans, according to the Research Letter published in JAMA Network Open.

“You would expect that people undergoing cancer treatment should not have to face very high out-of-pocket costs associated with care regardless of treatment modality because their treatment is largely guideline-indicated, and they have no choices,” stated corresponding author Rena Conti, PhD, associate professor with the school of business, Boston University, in an interview. “If you are diagnosed with cancer and undergoing treatment, you’re following the recommendation of your doctor, and your doctor is following standard protocols for treatment. In that scenario, Economics 101 suggests that people should not have to pay anything or [should pay] very little, especially for things that are cheap and are known to be effective, because there’s no overuse. Where normally we think that out-of-pocket costs are meant to control overuse, people with breast cancer are not opting to get more than indicated chemotherapy or radiation.”

The analysis of 25,224 women with invasive breast cancer diagnosis and claims for 1 or more of 14 oral anticancer drugs revealed that OOP costs for nondrug outpatient claims represented 79.0% of total costs. OOP drug costs were modest, with a 30-day supply ranging from $0.57-$0.60 for tamoxifen to $134.08-$141.07 for palbociclib.

“We were interested in understanding to what extent women who are insured with private insurance are exposed to out-of-pocket costs for standard breast cancer treatment, both in looking at drugs, but also the other aspects of the treatments they undergo.”

High OOP costs for the oral anticancer prescription drugs that are central to breast cancer treatment are associated with treatment nonadherence and discontinuation. Little has been known, however, about OOP costs of treatment associated with invasive breast cancer among employer-insured women younger than 65 years, the paper says.

“This population may face significant financial burdens related to long-term hormonal-based prevention and enrollment in high-deductible health plans and consumer-driven health plans,” the authors state in their paper.

In the cross-sectional study, which used the national 2018 Marative MarketScan database, 23.1% were HDHP- or CDHP-insured. Fifty-one percent had no OOP costs for drugs. The total mean estimated OOP cost, however, was $1,502.23 per patient, with inpatient costs representing only $112.41 (95% confidence interval, $112.40-$112.42); outpatient costs were $1,186.27 (95% CI, $1,185.67-$1,188.16). Pharmaceutical costs were $203.55 (95% CI, $203.34-$203.78).“We were surprised to find that the vast majority were getting breast cancer treatment with older, very effective, very safe, relatively inexpensive drugs and had limited out-of-pocket costs with some variation – higher costs for the few receiving newer, expensive drugs. The backbone of treatment is the older, generic drugs, which are cheap for both the insurers and the patients. But we found also that women are facing high out-of-pocket costs for nondrug-based therapy – specifically for doctor visits, getting check-ups, diagnostic scans, and maybe other types of treatment, as well. ... It’s a very different story than the one typically being told about the preponderance of out-of-pocket costs being drug-related,” Dr. Conti said.

 

 

The explanation may be that progress in breast cancer treatment over the last decades has led to effective treatments that are largely now inexpensive. The situation is different with ovarian cancer and many blood cancers such as chronic lymphocytic leukemia and multiple myeloma. For them, the new, innovative, safe, and effective drugs are very expensive, she noted.

“I think that insurers can modulate the out-of-pocket costs associated with drug treatment through formulary design and other tools they have. It’s less easy for them to modulate out-of-pocket costs associated with other modalties of care. Still, for medical care that is obviously necessary, there needs to be a cap on what women should have to pay,” Dr. Conti said.

A further concern raised by Dr. Conti is shrinking Medicaid coverage with the expiration of COVID-specific expanded Medicaid eligibility.

“Policy folks are closely watching the size of uninsured populations and also the growing importance of the high deductible and consumer-driven plans in which patients face high out-of-pocket first dollar coverage for care. With Medicaid rolls shrinking, we’ll see more people in low-premium, not well-insured plans. Americans’ exposure to higher costs for guideline-recommended care might grow, especially as more of them are independent contractors in the gig economy and not working for big corporations.”

“We worry that if and when they get a diagnosis of breast cancer, which is common among younger women, they are going to be faced with costs associated with their care that are going to have to be paid out-of-pocket – and it’s not going to be for the drug, it’s the other types of care. Doctors should know that the younger patient population that they are serving might be facing burdens associated with their care.”

Dr. Conti added, “Among women who are underinsured, there is a clear burden associated with cancer treatment. Reform efforts have largely focused on reducing out-of-pocket costs for seniors and have not focused much on guideline-consistent care for those under 65 who are working. Their burden can be quite onerous and cause financial harm for them and their families, resulting in worse health,” she continued, “Policy attention should go to unburdening people who have a serious diagnosis and who really have to be treated. There’s very good evidence that imposing additional out-of-pocket costs for guideline-consistent care causes people to make really hard decisions about paying rent versus paying for meds, about splitting pills and not doing all the things their physician is recommending, and about staying in jobs they don’t love but are locked into [because of health coverage].”

Dr. Conti concluded, “The good news is that, in breast cancer, the drugs work and are cheap. But the bad news is that there are many people who are underinsured and therefore, their care still has a high out-of-pocket burden. ACA radically changed working age people’s ability to qualify for insurance and be insured, but that didn’t mean that they are really well-covered when they become sick. They are still in peril over high out-of-pocket costs because of the proliferation of plans that are very skimpy. Women think they are insured until they get a diagnosis.”

Noting study limitations, Dr. Conti said that OOP costs cited are an underestimate, because many patients will also be treated for other comorbidities and complications related to treatment.

The authors disclosed no conflicts of interest. The study was funded by the American Cancer Society.

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Survival improved for some patients with metastatic cancers

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Fri, 04/07/2023 - 18:26

 

Over the past 30 years, more than 80 new systemic therapies for cancer have been approved, and many patients diagnosed with localized disease have benefited with improved progression-free and overall survival. The same can be said for some – but by no means all – patients with metastatic disease at diagnosis, a new study indicates.

“Our results show that the survival of patients with de novo metastatic cancer improved slowly over 30 years but that these gains were typically modest and unevenly distributed among cancers,” comment the authors, led by Marianne Luyendijk, MSc, from the Netherlands Comprehensive Cancer Organization, Utrecht.

The study was published online  in the Journal of the National Cancer Institute.

The retrospective study compared survival data of patients with de novo metastatic disease diagnosed from 1989 through 1993 with those of patients diagnosed from 2014 to 2018.

The results show that 5-year survival increased by 15% or more among patients with metastatic gastrointestinal stromal tumors; neuroendocrine tumors; melanoma; and cancers of the prostate, breast, thyroid, and testes.

For patients with other cancers, however, the gains in survival were more modest. For example, over the study period, 5-year survival of patients with metastatic non–small cell lung cancer increased by only 6%, a disappointing finding, given the advent of targeted therapies and immunotherapy during the most recent period, the authors note.

In contrast, there was a 16% improvement in long-term survival of patients with metastatic melanoma, likely owing to the introduction of immune checkpoint inhibitors and targeted therapies, such as tyrosine kinase inhibitors.

The data also showed differences over time in the proportion of patients diagnosed with de novo metastatic disease; some cancers, such as NSCLC and small cell lung cancer, were more frequently diagnosed at late stages in the more recent era, possibly owing to increased screening and the use of technology such as FDG-PET imaging.

On the other end of the spectrum, cancers of the prostate, rectum, uterine cervix, breast, gallbladder, and bile ducts were more likely to be caught at an earlier stage during later years of the study period.

The authors say that among the possible explanations for a less than robust reduction over time in metastatic disease is that new drugs do not always translate into improved survival. They cite a 2017 study showing that among 53 new cancer drugs approved by U.S., European, or Australian drug regulators, fewer than half improved overall survival by at least 3 months, and an additional 26% offered survival advantages that were either shorter than 3 months or of unknown benefit.

“This may also explain why the 1- and 5-year survival rates of some cancers have changed little in the last 30 years,” they write. “Nevertheless, even minor benefits in survival or other outcomes (for example, quality of life) may represent progress in treating patients with metastatic cancer.”

The investigators recommend that to improve understanding of the effect of new therapies on survival of metastatic disease, cancer registries include data on therapies used beyond the first line, as well as comorbidities and quality-of-life measures.

The authors did not report a study funding source. Ms. Luyendijk has disclosed no relevant financial relationships. Several co-authors reported financial relationships with pharmaceutical companies.

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

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Over the past 30 years, more than 80 new systemic therapies for cancer have been approved, and many patients diagnosed with localized disease have benefited with improved progression-free and overall survival. The same can be said for some – but by no means all – patients with metastatic disease at diagnosis, a new study indicates.

“Our results show that the survival of patients with de novo metastatic cancer improved slowly over 30 years but that these gains were typically modest and unevenly distributed among cancers,” comment the authors, led by Marianne Luyendijk, MSc, from the Netherlands Comprehensive Cancer Organization, Utrecht.

The study was published online  in the Journal of the National Cancer Institute.

The retrospective study compared survival data of patients with de novo metastatic disease diagnosed from 1989 through 1993 with those of patients diagnosed from 2014 to 2018.

The results show that 5-year survival increased by 15% or more among patients with metastatic gastrointestinal stromal tumors; neuroendocrine tumors; melanoma; and cancers of the prostate, breast, thyroid, and testes.

For patients with other cancers, however, the gains in survival were more modest. For example, over the study period, 5-year survival of patients with metastatic non–small cell lung cancer increased by only 6%, a disappointing finding, given the advent of targeted therapies and immunotherapy during the most recent period, the authors note.

In contrast, there was a 16% improvement in long-term survival of patients with metastatic melanoma, likely owing to the introduction of immune checkpoint inhibitors and targeted therapies, such as tyrosine kinase inhibitors.

The data also showed differences over time in the proportion of patients diagnosed with de novo metastatic disease; some cancers, such as NSCLC and small cell lung cancer, were more frequently diagnosed at late stages in the more recent era, possibly owing to increased screening and the use of technology such as FDG-PET imaging.

On the other end of the spectrum, cancers of the prostate, rectum, uterine cervix, breast, gallbladder, and bile ducts were more likely to be caught at an earlier stage during later years of the study period.

The authors say that among the possible explanations for a less than robust reduction over time in metastatic disease is that new drugs do not always translate into improved survival. They cite a 2017 study showing that among 53 new cancer drugs approved by U.S., European, or Australian drug regulators, fewer than half improved overall survival by at least 3 months, and an additional 26% offered survival advantages that were either shorter than 3 months or of unknown benefit.

“This may also explain why the 1- and 5-year survival rates of some cancers have changed little in the last 30 years,” they write. “Nevertheless, even minor benefits in survival or other outcomes (for example, quality of life) may represent progress in treating patients with metastatic cancer.”

The investigators recommend that to improve understanding of the effect of new therapies on survival of metastatic disease, cancer registries include data on therapies used beyond the first line, as well as comorbidities and quality-of-life measures.

The authors did not report a study funding source. Ms. Luyendijk has disclosed no relevant financial relationships. Several co-authors reported financial relationships with pharmaceutical companies.

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

 

Over the past 30 years, more than 80 new systemic therapies for cancer have been approved, and many patients diagnosed with localized disease have benefited with improved progression-free and overall survival. The same can be said for some – but by no means all – patients with metastatic disease at diagnosis, a new study indicates.

“Our results show that the survival of patients with de novo metastatic cancer improved slowly over 30 years but that these gains were typically modest and unevenly distributed among cancers,” comment the authors, led by Marianne Luyendijk, MSc, from the Netherlands Comprehensive Cancer Organization, Utrecht.

The study was published online  in the Journal of the National Cancer Institute.

The retrospective study compared survival data of patients with de novo metastatic disease diagnosed from 1989 through 1993 with those of patients diagnosed from 2014 to 2018.

The results show that 5-year survival increased by 15% or more among patients with metastatic gastrointestinal stromal tumors; neuroendocrine tumors; melanoma; and cancers of the prostate, breast, thyroid, and testes.

For patients with other cancers, however, the gains in survival were more modest. For example, over the study period, 5-year survival of patients with metastatic non–small cell lung cancer increased by only 6%, a disappointing finding, given the advent of targeted therapies and immunotherapy during the most recent period, the authors note.

In contrast, there was a 16% improvement in long-term survival of patients with metastatic melanoma, likely owing to the introduction of immune checkpoint inhibitors and targeted therapies, such as tyrosine kinase inhibitors.

The data also showed differences over time in the proportion of patients diagnosed with de novo metastatic disease; some cancers, such as NSCLC and small cell lung cancer, were more frequently diagnosed at late stages in the more recent era, possibly owing to increased screening and the use of technology such as FDG-PET imaging.

On the other end of the spectrum, cancers of the prostate, rectum, uterine cervix, breast, gallbladder, and bile ducts were more likely to be caught at an earlier stage during later years of the study period.

The authors say that among the possible explanations for a less than robust reduction over time in metastatic disease is that new drugs do not always translate into improved survival. They cite a 2017 study showing that among 53 new cancer drugs approved by U.S., European, or Australian drug regulators, fewer than half improved overall survival by at least 3 months, and an additional 26% offered survival advantages that were either shorter than 3 months or of unknown benefit.

“This may also explain why the 1- and 5-year survival rates of some cancers have changed little in the last 30 years,” they write. “Nevertheless, even minor benefits in survival or other outcomes (for example, quality of life) may represent progress in treating patients with metastatic cancer.”

The investigators recommend that to improve understanding of the effect of new therapies on survival of metastatic disease, cancer registries include data on therapies used beyond the first line, as well as comorbidities and quality-of-life measures.

The authors did not report a study funding source. Ms. Luyendijk has disclosed no relevant financial relationships. Several co-authors reported financial relationships with pharmaceutical companies.

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

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Few women identify breast density as a breast cancer risk

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Changed
Thu, 03/16/2023 - 11:35

A qualitative study of breast cancer screening–age women finds that few women identified breast density as a risk factor for breast cancer.

Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.

The study was published earlier this year in JAMA Network Open.

“Forty [percent] to 50% of women who undergo mammography fall into the two highest breast density categories,” said the study’s lead author Christine Gunn, PhD, of the Dartmouth Institute for Health Policy and Clinical Practice, N.H. “Breast cancer risk increases from 1.2-4.0 times depending on the level of breast density. By comparison, a first-degree family history of breast cancer, particularly in premenopausal women, confers a two-fold higher breast cancer risk.”

Dr. Gunn’s study is based on a survey of 2,306 women (between 40 and 76 years old) that was conducted between 2019 and 2020. The goal was to determine how well women understood cancer risks associated with dense breast tissue. The final analysis included 1,858 women (9% Asian, 27% Black, 14% Hispanic, 43% White, and 7% other race or ethnicity).

Breast density was thought to be a greater risk than not having children, drinking daily, and having had a prior breast biopsy, according to 52%, 53%, and 48% of respondents, respectively. Breast density was believed to be a lesser breast cancer risk than having a first-degree relative with breast cancer by 93% of women, and 65% of women felt it was a lesser risk than being overweight or obese.

Of the 61 women who completed follow-up interviews, 6 described breast density as a contributing factor to breast cancer risk. And, 17 women did not know whether it was possible to reduce their breast cancer risk.
 

Doctors must notify patients in writing

Breast tissue falls under one of four categories: fatty tissue, scattered areas of dense fibroglandular tissue, many areas of glandular and connective tissue, or extremely dense tissue. The tissue is considered dense if it falls under heterogeneously dense or extremely dense, and in those cases, follow-up testing with ultrasound or MRI may be necessary. This is important, Dr. Gunn said, because dense tissue can make “it harder to find cancers because connective tissue appears white on the mammogram, potentially masking tumors.”

Prior studies have found that many clinicians are uncomfortable counseling patients on the implications of breast density and cancer risk, the authors wrote.

However, under the Mammography Quality Standards Act, which was updated on March 10, the Food and Drug Administration requires that patients be provided with a mammography report summary that “identifies whether the patient has dense or nondense breast tissue.” The report, which should be written in lay language, should also specify the “significance” of the dense tissue.

While some states mandate notification regardless of the density level, most only notify women if heterogeneously dense or extremely dense tissue has been identified, Dr. Gunn said. But the rules are inconsistent, she said. In some facilities in Massachusetts, for example, women may receive a mammography report letter and a separate breast density letter. “For some, it has been really confusing. They received a letter saying that their mammography was normal and then another one saying that they have dense breasts – resulting in a lot of uncertainty and anxiety. We don’t want to overly alarm people. We want them to understand their risk,” she said.

Breast density can be considered among other risk factors, including alcohol use, obesity, diet, parity, prior breast biopsy, and inherited unfavorable genetic mutations. “If the total lifetime risk is above 20%, that opens up further screening options, such as a breast MRI, which will catch more cancers than a breast mammogram by itself,” Dr. Gunn said.

“The challenges for physicians and patients around collecting and understanding breast density information in the context of other risk factors can potentially lead to disparities in who gets to know their risk and who doesn’t,” Dr. Gunn said. It would be possible, she speculated, to create or use existing risk calculators integrated into medical records and populated with information gathered in premammography visit questionnaires. Ideally, a radiologist could hand the patient results in real time at the end of the mammography visit, integrating risk estimates with mammography findings to make recommendations.

This study was supported by grant RSG-133017-CPHPS from the American Cancer Society.
 

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A qualitative study of breast cancer screening–age women finds that few women identified breast density as a risk factor for breast cancer.

Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.

The study was published earlier this year in JAMA Network Open.

“Forty [percent] to 50% of women who undergo mammography fall into the two highest breast density categories,” said the study’s lead author Christine Gunn, PhD, of the Dartmouth Institute for Health Policy and Clinical Practice, N.H. “Breast cancer risk increases from 1.2-4.0 times depending on the level of breast density. By comparison, a first-degree family history of breast cancer, particularly in premenopausal women, confers a two-fold higher breast cancer risk.”

Dr. Gunn’s study is based on a survey of 2,306 women (between 40 and 76 years old) that was conducted between 2019 and 2020. The goal was to determine how well women understood cancer risks associated with dense breast tissue. The final analysis included 1,858 women (9% Asian, 27% Black, 14% Hispanic, 43% White, and 7% other race or ethnicity).

Breast density was thought to be a greater risk than not having children, drinking daily, and having had a prior breast biopsy, according to 52%, 53%, and 48% of respondents, respectively. Breast density was believed to be a lesser breast cancer risk than having a first-degree relative with breast cancer by 93% of women, and 65% of women felt it was a lesser risk than being overweight or obese.

Of the 61 women who completed follow-up interviews, 6 described breast density as a contributing factor to breast cancer risk. And, 17 women did not know whether it was possible to reduce their breast cancer risk.
 

Doctors must notify patients in writing

Breast tissue falls under one of four categories: fatty tissue, scattered areas of dense fibroglandular tissue, many areas of glandular and connective tissue, or extremely dense tissue. The tissue is considered dense if it falls under heterogeneously dense or extremely dense, and in those cases, follow-up testing with ultrasound or MRI may be necessary. This is important, Dr. Gunn said, because dense tissue can make “it harder to find cancers because connective tissue appears white on the mammogram, potentially masking tumors.”

Prior studies have found that many clinicians are uncomfortable counseling patients on the implications of breast density and cancer risk, the authors wrote.

However, under the Mammography Quality Standards Act, which was updated on March 10, the Food and Drug Administration requires that patients be provided with a mammography report summary that “identifies whether the patient has dense or nondense breast tissue.” The report, which should be written in lay language, should also specify the “significance” of the dense tissue.

While some states mandate notification regardless of the density level, most only notify women if heterogeneously dense or extremely dense tissue has been identified, Dr. Gunn said. But the rules are inconsistent, she said. In some facilities in Massachusetts, for example, women may receive a mammography report letter and a separate breast density letter. “For some, it has been really confusing. They received a letter saying that their mammography was normal and then another one saying that they have dense breasts – resulting in a lot of uncertainty and anxiety. We don’t want to overly alarm people. We want them to understand their risk,” she said.

Breast density can be considered among other risk factors, including alcohol use, obesity, diet, parity, prior breast biopsy, and inherited unfavorable genetic mutations. “If the total lifetime risk is above 20%, that opens up further screening options, such as a breast MRI, which will catch more cancers than a breast mammogram by itself,” Dr. Gunn said.

“The challenges for physicians and patients around collecting and understanding breast density information in the context of other risk factors can potentially lead to disparities in who gets to know their risk and who doesn’t,” Dr. Gunn said. It would be possible, she speculated, to create or use existing risk calculators integrated into medical records and populated with information gathered in premammography visit questionnaires. Ideally, a radiologist could hand the patient results in real time at the end of the mammography visit, integrating risk estimates with mammography findings to make recommendations.

This study was supported by grant RSG-133017-CPHPS from the American Cancer Society.
 

A qualitative study of breast cancer screening–age women finds that few women identified breast density as a risk factor for breast cancer.

Most women did not feel confident they knew what actions could mitigate breast cancer risk, leading researchers to the conclusion that comprehensive education about breast cancer risks and prevention strategies is needed.

The study was published earlier this year in JAMA Network Open.

“Forty [percent] to 50% of women who undergo mammography fall into the two highest breast density categories,” said the study’s lead author Christine Gunn, PhD, of the Dartmouth Institute for Health Policy and Clinical Practice, N.H. “Breast cancer risk increases from 1.2-4.0 times depending on the level of breast density. By comparison, a first-degree family history of breast cancer, particularly in premenopausal women, confers a two-fold higher breast cancer risk.”

Dr. Gunn’s study is based on a survey of 2,306 women (between 40 and 76 years old) that was conducted between 2019 and 2020. The goal was to determine how well women understood cancer risks associated with dense breast tissue. The final analysis included 1,858 women (9% Asian, 27% Black, 14% Hispanic, 43% White, and 7% other race or ethnicity).

Breast density was thought to be a greater risk than not having children, drinking daily, and having had a prior breast biopsy, according to 52%, 53%, and 48% of respondents, respectively. Breast density was believed to be a lesser breast cancer risk than having a first-degree relative with breast cancer by 93% of women, and 65% of women felt it was a lesser risk than being overweight or obese.

Of the 61 women who completed follow-up interviews, 6 described breast density as a contributing factor to breast cancer risk. And, 17 women did not know whether it was possible to reduce their breast cancer risk.
 

Doctors must notify patients in writing

Breast tissue falls under one of four categories: fatty tissue, scattered areas of dense fibroglandular tissue, many areas of glandular and connective tissue, or extremely dense tissue. The tissue is considered dense if it falls under heterogeneously dense or extremely dense, and in those cases, follow-up testing with ultrasound or MRI may be necessary. This is important, Dr. Gunn said, because dense tissue can make “it harder to find cancers because connective tissue appears white on the mammogram, potentially masking tumors.”

Prior studies have found that many clinicians are uncomfortable counseling patients on the implications of breast density and cancer risk, the authors wrote.

However, under the Mammography Quality Standards Act, which was updated on March 10, the Food and Drug Administration requires that patients be provided with a mammography report summary that “identifies whether the patient has dense or nondense breast tissue.” The report, which should be written in lay language, should also specify the “significance” of the dense tissue.

While some states mandate notification regardless of the density level, most only notify women if heterogeneously dense or extremely dense tissue has been identified, Dr. Gunn said. But the rules are inconsistent, she said. In some facilities in Massachusetts, for example, women may receive a mammography report letter and a separate breast density letter. “For some, it has been really confusing. They received a letter saying that their mammography was normal and then another one saying that they have dense breasts – resulting in a lot of uncertainty and anxiety. We don’t want to overly alarm people. We want them to understand their risk,” she said.

Breast density can be considered among other risk factors, including alcohol use, obesity, diet, parity, prior breast biopsy, and inherited unfavorable genetic mutations. “If the total lifetime risk is above 20%, that opens up further screening options, such as a breast MRI, which will catch more cancers than a breast mammogram by itself,” Dr. Gunn said.

“The challenges for physicians and patients around collecting and understanding breast density information in the context of other risk factors can potentially lead to disparities in who gets to know their risk and who doesn’t,” Dr. Gunn said. It would be possible, she speculated, to create or use existing risk calculators integrated into medical records and populated with information gathered in premammography visit questionnaires. Ideally, a radiologist could hand the patient results in real time at the end of the mammography visit, integrating risk estimates with mammography findings to make recommendations.

This study was supported by grant RSG-133017-CPHPS from the American Cancer Society.
 

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Use of diagnostic mammograms is inconsistent, survey finds

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Wed, 02/08/2023 - 08:40

A survey of physicians treating breast cancer patients finds that many use diagnostic mammograms for surveillance rather than screening mammograms, despite lack of evidence for a clinical difference.

Existing guidelines offer little help, according to Pavani Chalasani, MD, MPH, who presented the study at the San Antonio Breast Cancer Symposium. “They just say [do an] annual mammogram, but they don’t say, ‘Do we need to do screening? Do we need to do breast MRIs?’”

Her personal experience also reflected a general confusion. “I asked my colleagues and got different answers from seven colleagues,” said Dr. Chalasani, who is an oncologist at the University of Arizona Cancer Center, Tucson.

She noted that diagnostic mammograms are generally similar to screening mammograms, but the radiologist is viewing the images in real time and can take additional views as needed while the patient is still present. “That is the biggest difference,” said Dr. Chalasani. No studies have been conducted to determine which method produces better results.

To get a snapshot of current practice, she and her colleagues developed a survey, which the American Society of Clinical Oncology sent to 1,000 randomly selected members between Oct. 19 and Nov. 22, 2021. 244 individuals responded; 93.5% were physicians, and half identified as female. A total of 174 respondents were medical oncologists, 31 were radiation oncologists, and 20 were surgical oncologists. The imbalance among respondents is a limitation of the study. That “may or may not be reflective of our real-time practices (among surgeons), but we do think that since a lot of times patients are seen by medical oncologists, there could be overlap,” said Dr. Chalasani.

About 50% of respondents said that they use breast MRI in the diagnosis of 25% or fewer patients. Approximately 64% of respondents said they used diagnostic mammograms versus about 31% who used imaging mammograms at first imaging. About 53% said they ordered mammograms within the first 6 months after treatment.

38% of those who ordered diagnostic mammograms for surveillance used it for 3-5 years, while 29% continued it for 5 years or more. One-quarter employed additional imaging during follow-up, most commonly breast ultrasound. About 65% said they had no stop date for screening mammograms, as long as the patient remained healthy. The choice of screening or diagnostic mammography was about 50:50, though about 55% said they use screening mammography for patients 80 years of age or older.

Dr. Chalasani pointed out that both screening and diagnostic mammograms provide similar imaging quality. Screening mammograms are completely covered by insurance, while diagnostic mammograms typically require a copay. “We’re doing this [diagnostic mammography] with no guidelines, but there is this out of pocket cost, without knowing if it’s the right thing to do,” she said.

National Comprehensive Cancer Network guidelines indicate that diagnostic mammograms can be conducted for 5 years after a ductal carcinoma in situ diagnosis, but it doesn’t provide guidance for invasive cancers. Some past studies suggested that doing diagnostic mammograms for 3 years may increase diagnosis, but it isn’t clear if any such advantage would actually result in a clinical difference, according to Dr. Chalasani. “With the treatments we have, we still might cure [the cancer]. So what endpoints are we looking for? Are we changing care to add on toxicity to the patient, and stress to the patient and also for the health care system?”

She hopes that physicians will look at the results and understand that diagnostic mammograms, while they intuitively feel superior, are not supported by guidelines, and patients must incur an extra cost.

Her team also plans to conduct cost-effectiveness analysis of diagnostic mammograms.

Dr. Chalasani has no relevant financial disclosures.

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A survey of physicians treating breast cancer patients finds that many use diagnostic mammograms for surveillance rather than screening mammograms, despite lack of evidence for a clinical difference.

Existing guidelines offer little help, according to Pavani Chalasani, MD, MPH, who presented the study at the San Antonio Breast Cancer Symposium. “They just say [do an] annual mammogram, but they don’t say, ‘Do we need to do screening? Do we need to do breast MRIs?’”

Her personal experience also reflected a general confusion. “I asked my colleagues and got different answers from seven colleagues,” said Dr. Chalasani, who is an oncologist at the University of Arizona Cancer Center, Tucson.

She noted that diagnostic mammograms are generally similar to screening mammograms, but the radiologist is viewing the images in real time and can take additional views as needed while the patient is still present. “That is the biggest difference,” said Dr. Chalasani. No studies have been conducted to determine which method produces better results.

To get a snapshot of current practice, she and her colleagues developed a survey, which the American Society of Clinical Oncology sent to 1,000 randomly selected members between Oct. 19 and Nov. 22, 2021. 244 individuals responded; 93.5% were physicians, and half identified as female. A total of 174 respondents were medical oncologists, 31 were radiation oncologists, and 20 were surgical oncologists. The imbalance among respondents is a limitation of the study. That “may or may not be reflective of our real-time practices (among surgeons), but we do think that since a lot of times patients are seen by medical oncologists, there could be overlap,” said Dr. Chalasani.

About 50% of respondents said that they use breast MRI in the diagnosis of 25% or fewer patients. Approximately 64% of respondents said they used diagnostic mammograms versus about 31% who used imaging mammograms at first imaging. About 53% said they ordered mammograms within the first 6 months after treatment.

38% of those who ordered diagnostic mammograms for surveillance used it for 3-5 years, while 29% continued it for 5 years or more. One-quarter employed additional imaging during follow-up, most commonly breast ultrasound. About 65% said they had no stop date for screening mammograms, as long as the patient remained healthy. The choice of screening or diagnostic mammography was about 50:50, though about 55% said they use screening mammography for patients 80 years of age or older.

Dr. Chalasani pointed out that both screening and diagnostic mammograms provide similar imaging quality. Screening mammograms are completely covered by insurance, while diagnostic mammograms typically require a copay. “We’re doing this [diagnostic mammography] with no guidelines, but there is this out of pocket cost, without knowing if it’s the right thing to do,” she said.

National Comprehensive Cancer Network guidelines indicate that diagnostic mammograms can be conducted for 5 years after a ductal carcinoma in situ diagnosis, but it doesn’t provide guidance for invasive cancers. Some past studies suggested that doing diagnostic mammograms for 3 years may increase diagnosis, but it isn’t clear if any such advantage would actually result in a clinical difference, according to Dr. Chalasani. “With the treatments we have, we still might cure [the cancer]. So what endpoints are we looking for? Are we changing care to add on toxicity to the patient, and stress to the patient and also for the health care system?”

She hopes that physicians will look at the results and understand that diagnostic mammograms, while they intuitively feel superior, are not supported by guidelines, and patients must incur an extra cost.

Her team also plans to conduct cost-effectiveness analysis of diagnostic mammograms.

Dr. Chalasani has no relevant financial disclosures.

A survey of physicians treating breast cancer patients finds that many use diagnostic mammograms for surveillance rather than screening mammograms, despite lack of evidence for a clinical difference.

Existing guidelines offer little help, according to Pavani Chalasani, MD, MPH, who presented the study at the San Antonio Breast Cancer Symposium. “They just say [do an] annual mammogram, but they don’t say, ‘Do we need to do screening? Do we need to do breast MRIs?’”

Her personal experience also reflected a general confusion. “I asked my colleagues and got different answers from seven colleagues,” said Dr. Chalasani, who is an oncologist at the University of Arizona Cancer Center, Tucson.

She noted that diagnostic mammograms are generally similar to screening mammograms, but the radiologist is viewing the images in real time and can take additional views as needed while the patient is still present. “That is the biggest difference,” said Dr. Chalasani. No studies have been conducted to determine which method produces better results.

To get a snapshot of current practice, she and her colleagues developed a survey, which the American Society of Clinical Oncology sent to 1,000 randomly selected members between Oct. 19 and Nov. 22, 2021. 244 individuals responded; 93.5% were physicians, and half identified as female. A total of 174 respondents were medical oncologists, 31 were radiation oncologists, and 20 were surgical oncologists. The imbalance among respondents is a limitation of the study. That “may or may not be reflective of our real-time practices (among surgeons), but we do think that since a lot of times patients are seen by medical oncologists, there could be overlap,” said Dr. Chalasani.

About 50% of respondents said that they use breast MRI in the diagnosis of 25% or fewer patients. Approximately 64% of respondents said they used diagnostic mammograms versus about 31% who used imaging mammograms at first imaging. About 53% said they ordered mammograms within the first 6 months after treatment.

38% of those who ordered diagnostic mammograms for surveillance used it for 3-5 years, while 29% continued it for 5 years or more. One-quarter employed additional imaging during follow-up, most commonly breast ultrasound. About 65% said they had no stop date for screening mammograms, as long as the patient remained healthy. The choice of screening or diagnostic mammography was about 50:50, though about 55% said they use screening mammography for patients 80 years of age or older.

Dr. Chalasani pointed out that both screening and diagnostic mammograms provide similar imaging quality. Screening mammograms are completely covered by insurance, while diagnostic mammograms typically require a copay. “We’re doing this [diagnostic mammography] with no guidelines, but there is this out of pocket cost, without knowing if it’s the right thing to do,” she said.

National Comprehensive Cancer Network guidelines indicate that diagnostic mammograms can be conducted for 5 years after a ductal carcinoma in situ diagnosis, but it doesn’t provide guidance for invasive cancers. Some past studies suggested that doing diagnostic mammograms for 3 years may increase diagnosis, but it isn’t clear if any such advantage would actually result in a clinical difference, according to Dr. Chalasani. “With the treatments we have, we still might cure [the cancer]. So what endpoints are we looking for? Are we changing care to add on toxicity to the patient, and stress to the patient and also for the health care system?”

She hopes that physicians will look at the results and understand that diagnostic mammograms, while they intuitively feel superior, are not supported by guidelines, and patients must incur an extra cost.

Her team also plans to conduct cost-effectiveness analysis of diagnostic mammograms.

Dr. Chalasani has no relevant financial disclosures.

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FDA OKs elacestrant for ESR1+ advanced, metastatic breast cancer

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Thu, 02/02/2023 - 15:47

The Food and Drug Administration approved elacestrant (Orserdu, Stemline Therapeutics) for postmenopausal women or men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that progressed on at least one line of endocrine therapy.

The agency also approved the Guardant360 CDx assay as a companion diagnostic to identify breast cancer patients who meet the treatment requirements, according to the agency’s press release announcing the approval.

The novel oral selective estrogen receptor degrader was approved based on the phase 3 EMERALD trial, which included 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer, about half of whom had ESR1 mutations. Patients had progressed on one or two prior lines of endocrine therapy, including one containing a CDK4/6 inhibitor. Participants could also have had one prior line of chemotherapy in the advanced or metastatic setting.

Participants were randomized 1:1 to either elacestrant 345 mg orally once daily or investigator’s choice of endocrine therapy, which included fulvestrant or an aromatase inhibitor.

In the 228 patients (48%) with ESR1 mutations, median progression-free survival (PFS) was 3.8 months with elacestrant versus 1.9 months in the fulvestrant or aromatase inhibitor arm (hazard ratio, 0.55; P = .0005). Investigators observed no statistically significant PFS difference between the treatment arms in patients who didn’t have the mutation.
 

Fair comparison?

In June, experts raised concerns about the adequacy of the “standard of care” control arm in EMERALD, particularly that single agents were used at a time when combination therapy is becoming more common.

“The expression ‘standard of care’ is applied generously, as the control arm is restricted” to single agents and no combinations, which “may have led to a substandard” comparison group, Timothée Olivier, MD, Geneva University Hospital, and Vinay Prasad, MD, MPH, University of California, San Francisco, said in an editorial quoted in the piece.

EMERALD investigators acknowledged that there were issues with the control group, noting that in the “United States and Europe, combination therapy with fulvestrant” – instead of single agents – “is increasingly being used as the second-line [standard of care] treatment.”

However, the goal of the study “was to compare a novel endocrine therapy vs. currently available endocrine therapies,” not combination regimens, the investigators said.

Also, “the benefit of elacestrant over fulvestrant and AIs [aromatase inhibitors] in our monotherapy trial ... suggests that incorporating elacestrant as the preferred endocrine therapy backbone in future earlier-line combination studies is a promising strategy.”
 

Lipid monitoring necessary

The most common adverse events with elacestrant, occurring in 10% or more of patients, are musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia, according to labeling.

Labeling warns that elacestrant “may cause hypercholesterolemia and hypertriglyceridemia. Monitor lipid profile prior to starting treatment and periodically thereafter.”

The recommended elacestrant dose is the trial dose, 345 mg orally with food once daily until disease progression or unacceptable toxicity.

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

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The Food and Drug Administration approved elacestrant (Orserdu, Stemline Therapeutics) for postmenopausal women or men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that progressed on at least one line of endocrine therapy.

The agency also approved the Guardant360 CDx assay as a companion diagnostic to identify breast cancer patients who meet the treatment requirements, according to the agency’s press release announcing the approval.

The novel oral selective estrogen receptor degrader was approved based on the phase 3 EMERALD trial, which included 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer, about half of whom had ESR1 mutations. Patients had progressed on one or two prior lines of endocrine therapy, including one containing a CDK4/6 inhibitor. Participants could also have had one prior line of chemotherapy in the advanced or metastatic setting.

Participants were randomized 1:1 to either elacestrant 345 mg orally once daily or investigator’s choice of endocrine therapy, which included fulvestrant or an aromatase inhibitor.

In the 228 patients (48%) with ESR1 mutations, median progression-free survival (PFS) was 3.8 months with elacestrant versus 1.9 months in the fulvestrant or aromatase inhibitor arm (hazard ratio, 0.55; P = .0005). Investigators observed no statistically significant PFS difference between the treatment arms in patients who didn’t have the mutation.
 

Fair comparison?

In June, experts raised concerns about the adequacy of the “standard of care” control arm in EMERALD, particularly that single agents were used at a time when combination therapy is becoming more common.

“The expression ‘standard of care’ is applied generously, as the control arm is restricted” to single agents and no combinations, which “may have led to a substandard” comparison group, Timothée Olivier, MD, Geneva University Hospital, and Vinay Prasad, MD, MPH, University of California, San Francisco, said in an editorial quoted in the piece.

EMERALD investigators acknowledged that there were issues with the control group, noting that in the “United States and Europe, combination therapy with fulvestrant” – instead of single agents – “is increasingly being used as the second-line [standard of care] treatment.”

However, the goal of the study “was to compare a novel endocrine therapy vs. currently available endocrine therapies,” not combination regimens, the investigators said.

Also, “the benefit of elacestrant over fulvestrant and AIs [aromatase inhibitors] in our monotherapy trial ... suggests that incorporating elacestrant as the preferred endocrine therapy backbone in future earlier-line combination studies is a promising strategy.”
 

Lipid monitoring necessary

The most common adverse events with elacestrant, occurring in 10% or more of patients, are musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia, according to labeling.

Labeling warns that elacestrant “may cause hypercholesterolemia and hypertriglyceridemia. Monitor lipid profile prior to starting treatment and periodically thereafter.”

The recommended elacestrant dose is the trial dose, 345 mg orally with food once daily until disease progression or unacceptable toxicity.

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

The Food and Drug Administration approved elacestrant (Orserdu, Stemline Therapeutics) for postmenopausal women or men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that progressed on at least one line of endocrine therapy.

The agency also approved the Guardant360 CDx assay as a companion diagnostic to identify breast cancer patients who meet the treatment requirements, according to the agency’s press release announcing the approval.

The novel oral selective estrogen receptor degrader was approved based on the phase 3 EMERALD trial, which included 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer, about half of whom had ESR1 mutations. Patients had progressed on one or two prior lines of endocrine therapy, including one containing a CDK4/6 inhibitor. Participants could also have had one prior line of chemotherapy in the advanced or metastatic setting.

Participants were randomized 1:1 to either elacestrant 345 mg orally once daily or investigator’s choice of endocrine therapy, which included fulvestrant or an aromatase inhibitor.

In the 228 patients (48%) with ESR1 mutations, median progression-free survival (PFS) was 3.8 months with elacestrant versus 1.9 months in the fulvestrant or aromatase inhibitor arm (hazard ratio, 0.55; P = .0005). Investigators observed no statistically significant PFS difference between the treatment arms in patients who didn’t have the mutation.
 

Fair comparison?

In June, experts raised concerns about the adequacy of the “standard of care” control arm in EMERALD, particularly that single agents were used at a time when combination therapy is becoming more common.

“The expression ‘standard of care’ is applied generously, as the control arm is restricted” to single agents and no combinations, which “may have led to a substandard” comparison group, Timothée Olivier, MD, Geneva University Hospital, and Vinay Prasad, MD, MPH, University of California, San Francisco, said in an editorial quoted in the piece.

EMERALD investigators acknowledged that there were issues with the control group, noting that in the “United States and Europe, combination therapy with fulvestrant” – instead of single agents – “is increasingly being used as the second-line [standard of care] treatment.”

However, the goal of the study “was to compare a novel endocrine therapy vs. currently available endocrine therapies,” not combination regimens, the investigators said.

Also, “the benefit of elacestrant over fulvestrant and AIs [aromatase inhibitors] in our monotherapy trial ... suggests that incorporating elacestrant as the preferred endocrine therapy backbone in future earlier-line combination studies is a promising strategy.”
 

Lipid monitoring necessary

The most common adverse events with elacestrant, occurring in 10% or more of patients, are musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia, according to labeling.

Labeling warns that elacestrant “may cause hypercholesterolemia and hypertriglyceridemia. Monitor lipid profile prior to starting treatment and periodically thereafter.”

The recommended elacestrant dose is the trial dose, 345 mg orally with food once daily until disease progression or unacceptable toxicity.

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

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3D-printed tumor models could advance new cancer therapies

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Mon, 01/23/2023 - 13:44

Scientists have made big strides in the fight against cancer. A person’s risk of dying of cancer in the U.S. fell by 27% in the past 2 decades, thanks in large part to researchers who continue to uncover the complex details of how cancer works and to make advances in treatment. 

Now the emerging technology of 3D bioprinting – like 3D printing for the human body, using actual human cells – promises to speed up research by enabling scientists to develop 3D tumor models that better represent samples from patients.   

The impact could be “huge,” says Y. Shrike Zhang, PhD, an assistant professor of medicine at Harvard Medical School and associate bioengineer at Brigham and Women’s Hospital, both in Boston, who studies 3D bioprinting. “It is not the only technology that may allow modeling of tumors in vitro, but it certainly is one of the most capable.” 

Why does that matter? Because the 2D cell cultures that scientists often use now may not capture all the complexities of how cancer grows, spreads, and responds to treatment. It’s one reason why so few potential new cancer drugs – 3.4%, according to one estimate – can pass all clinical trials. Results may not carry over from the culture dish to the patient

Researchers say these 3D-printed blood vessels may treat certain dangerous health problems that affect your veins, arteries, or capillaries.

A 3D-bioprinted model, on the other hand, may be better at copying a tumor’s “microenvironment” – all the parts (cells, molecules, blood vessels) that surround a tumor. 

“The tumor microenvironment plays an integral role in defining how cancer progresses,” says Madhuri Dey, a PhD candidate and researcher at Penn State University. “In vitro 3D models are an attempt at reconstituting a [cancer] microenvironment, which sheds light on how tumors respond to chemo or immunotherapeutic treatments when they are present in a native-like microenvironment.”

Ms. Dey is the lead author of a study funded by the National Science Foundation in which breast cancer tumors were 3D-bioprinted and successfully treated. Unlike some previous 3D models of cancer cells, this model did a better job of imitating that microenvironment, she explains. 

So far, “3D bioprinting of cancer models has been limited to bioprinting of individual cancer cells laden in hydrogels,” she says. But she and her colleagues developed a technique called aspiration-assisted bioprinting that lets them control where blood vessels are located relative to the tumor. “This model lays the foundation for studying these nuances of cancer,” Ms. Dey says. 

“This is a quite cool work,” Dr. Zhang says of the Penn State study (which he was not involved in). “Vascularization is always a key component in [a] majority of the tumor types.” A model that incorporates blood vessels provides a “critical niche” to help tumor models reach their full potential in cancer research. 
 

A 3D printer for your body

Chances are you’ve heard of 3D printing and may even own (or know someone who owns) a 3D printer. The concept is like regular printing, but instead of spewing ink onto paper, a 3D printer releases layers of plastic or other materials, hundreds or thousands of times, to build an object from the ground up

Three-dimensional bioprinting works much the same way, except those layers are made of living cells to create biological structures like skin, vessels, organs, or bone. 

Bioprinting has been around since 1988. So far, it’s mainly used in research settings, such as in the field of regenerative medicine. Research is underway for ear reconstruction, nerve regeneration, and skin regeneration. The technology was also recently used to create eye tissue to help researchers study eye diseases. 

The technology’s potential for use in cancer research has yet to be fully realized, Ms. Dey says. But that may be changing. 

“The use of 3D-bioprinted tumor models is getting close to translations in cancer research,” says Dr. Zhang. “They are being increasingly adopted by the research field, and [the technology] has started to be explored by the pharma industry for use towards cancer drug development.” 

Because bioprinting can be automated, it could allow researchers to create high-quality, complex tumor models at scale, Dr. Zhang says.

Such 3D models also have the potential to replace or reduce the use of animals in tumor drug testing, Ms. Dey notes. They “are expected to provide a more accurate drug response, compared [with] animal models, as animal physiology does not match humans’.” 

The FDA Modernization Act 2.0, a new U.S. law eliminating the requirement that drugs be tested in animals before humans, has “further paved the way for such technologies in the drug development pipeline,” Dr. Zhang says.
 

What if we could build a custom tumor model for each patient? 

Possible uses for bioprinting go beyond the lab, Ms. Dey says. Imagine if we could customize 3D tumor models based on biopsies from individual patients. Doctors could test many treatments on these patient-specific models, letting them more accurately predict how each patient would respond to different therapies. This would help doctors decide which course of treatment is best. 

In Ms. Dey’s study, the 3D model was treated with chemotherapy and with immunotherapy, and it responded to both. This highlights the potential for such 3D models to reveal the body’s immune response and be used to screen therapies, she says. “We hope is that in the future, this technique can be adapted in the hospital, which would speed up the course of cancer treatment.”

To that end, she and her colleagues are now working with real breast cancer tumors removed from patients, re-creating them in the lab in 3D to use for chemo and immunotherapy screening.

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

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Scientists have made big strides in the fight against cancer. A person’s risk of dying of cancer in the U.S. fell by 27% in the past 2 decades, thanks in large part to researchers who continue to uncover the complex details of how cancer works and to make advances in treatment. 

Now the emerging technology of 3D bioprinting – like 3D printing for the human body, using actual human cells – promises to speed up research by enabling scientists to develop 3D tumor models that better represent samples from patients.   

The impact could be “huge,” says Y. Shrike Zhang, PhD, an assistant professor of medicine at Harvard Medical School and associate bioengineer at Brigham and Women’s Hospital, both in Boston, who studies 3D bioprinting. “It is not the only technology that may allow modeling of tumors in vitro, but it certainly is one of the most capable.” 

Why does that matter? Because the 2D cell cultures that scientists often use now may not capture all the complexities of how cancer grows, spreads, and responds to treatment. It’s one reason why so few potential new cancer drugs – 3.4%, according to one estimate – can pass all clinical trials. Results may not carry over from the culture dish to the patient

Researchers say these 3D-printed blood vessels may treat certain dangerous health problems that affect your veins, arteries, or capillaries.

A 3D-bioprinted model, on the other hand, may be better at copying a tumor’s “microenvironment” – all the parts (cells, molecules, blood vessels) that surround a tumor. 

“The tumor microenvironment plays an integral role in defining how cancer progresses,” says Madhuri Dey, a PhD candidate and researcher at Penn State University. “In vitro 3D models are an attempt at reconstituting a [cancer] microenvironment, which sheds light on how tumors respond to chemo or immunotherapeutic treatments when they are present in a native-like microenvironment.”

Ms. Dey is the lead author of a study funded by the National Science Foundation in which breast cancer tumors were 3D-bioprinted and successfully treated. Unlike some previous 3D models of cancer cells, this model did a better job of imitating that microenvironment, she explains. 

So far, “3D bioprinting of cancer models has been limited to bioprinting of individual cancer cells laden in hydrogels,” she says. But she and her colleagues developed a technique called aspiration-assisted bioprinting that lets them control where blood vessels are located relative to the tumor. “This model lays the foundation for studying these nuances of cancer,” Ms. Dey says. 

“This is a quite cool work,” Dr. Zhang says of the Penn State study (which he was not involved in). “Vascularization is always a key component in [a] majority of the tumor types.” A model that incorporates blood vessels provides a “critical niche” to help tumor models reach their full potential in cancer research. 
 

A 3D printer for your body

Chances are you’ve heard of 3D printing and may even own (or know someone who owns) a 3D printer. The concept is like regular printing, but instead of spewing ink onto paper, a 3D printer releases layers of plastic or other materials, hundreds or thousands of times, to build an object from the ground up

Three-dimensional bioprinting works much the same way, except those layers are made of living cells to create biological structures like skin, vessels, organs, or bone. 

Bioprinting has been around since 1988. So far, it’s mainly used in research settings, such as in the field of regenerative medicine. Research is underway for ear reconstruction, nerve regeneration, and skin regeneration. The technology was also recently used to create eye tissue to help researchers study eye diseases. 

The technology’s potential for use in cancer research has yet to be fully realized, Ms. Dey says. But that may be changing. 

“The use of 3D-bioprinted tumor models is getting close to translations in cancer research,” says Dr. Zhang. “They are being increasingly adopted by the research field, and [the technology] has started to be explored by the pharma industry for use towards cancer drug development.” 

Because bioprinting can be automated, it could allow researchers to create high-quality, complex tumor models at scale, Dr. Zhang says.

Such 3D models also have the potential to replace or reduce the use of animals in tumor drug testing, Ms. Dey notes. They “are expected to provide a more accurate drug response, compared [with] animal models, as animal physiology does not match humans’.” 

The FDA Modernization Act 2.0, a new U.S. law eliminating the requirement that drugs be tested in animals before humans, has “further paved the way for such technologies in the drug development pipeline,” Dr. Zhang says.
 

What if we could build a custom tumor model for each patient? 

Possible uses for bioprinting go beyond the lab, Ms. Dey says. Imagine if we could customize 3D tumor models based on biopsies from individual patients. Doctors could test many treatments on these patient-specific models, letting them more accurately predict how each patient would respond to different therapies. This would help doctors decide which course of treatment is best. 

In Ms. Dey’s study, the 3D model was treated with chemotherapy and with immunotherapy, and it responded to both. This highlights the potential for such 3D models to reveal the body’s immune response and be used to screen therapies, she says. “We hope is that in the future, this technique can be adapted in the hospital, which would speed up the course of cancer treatment.”

To that end, she and her colleagues are now working with real breast cancer tumors removed from patients, re-creating them in the lab in 3D to use for chemo and immunotherapy screening.

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

Scientists have made big strides in the fight against cancer. A person’s risk of dying of cancer in the U.S. fell by 27% in the past 2 decades, thanks in large part to researchers who continue to uncover the complex details of how cancer works and to make advances in treatment. 

Now the emerging technology of 3D bioprinting – like 3D printing for the human body, using actual human cells – promises to speed up research by enabling scientists to develop 3D tumor models that better represent samples from patients.   

The impact could be “huge,” says Y. Shrike Zhang, PhD, an assistant professor of medicine at Harvard Medical School and associate bioengineer at Brigham and Women’s Hospital, both in Boston, who studies 3D bioprinting. “It is not the only technology that may allow modeling of tumors in vitro, but it certainly is one of the most capable.” 

Why does that matter? Because the 2D cell cultures that scientists often use now may not capture all the complexities of how cancer grows, spreads, and responds to treatment. It’s one reason why so few potential new cancer drugs – 3.4%, according to one estimate – can pass all clinical trials. Results may not carry over from the culture dish to the patient

Researchers say these 3D-printed blood vessels may treat certain dangerous health problems that affect your veins, arteries, or capillaries.

A 3D-bioprinted model, on the other hand, may be better at copying a tumor’s “microenvironment” – all the parts (cells, molecules, blood vessels) that surround a tumor. 

“The tumor microenvironment plays an integral role in defining how cancer progresses,” says Madhuri Dey, a PhD candidate and researcher at Penn State University. “In vitro 3D models are an attempt at reconstituting a [cancer] microenvironment, which sheds light on how tumors respond to chemo or immunotherapeutic treatments when they are present in a native-like microenvironment.”

Ms. Dey is the lead author of a study funded by the National Science Foundation in which breast cancer tumors were 3D-bioprinted and successfully treated. Unlike some previous 3D models of cancer cells, this model did a better job of imitating that microenvironment, she explains. 

So far, “3D bioprinting of cancer models has been limited to bioprinting of individual cancer cells laden in hydrogels,” she says. But she and her colleagues developed a technique called aspiration-assisted bioprinting that lets them control where blood vessels are located relative to the tumor. “This model lays the foundation for studying these nuances of cancer,” Ms. Dey says. 

“This is a quite cool work,” Dr. Zhang says of the Penn State study (which he was not involved in). “Vascularization is always a key component in [a] majority of the tumor types.” A model that incorporates blood vessels provides a “critical niche” to help tumor models reach their full potential in cancer research. 
 

A 3D printer for your body

Chances are you’ve heard of 3D printing and may even own (or know someone who owns) a 3D printer. The concept is like regular printing, but instead of spewing ink onto paper, a 3D printer releases layers of plastic or other materials, hundreds or thousands of times, to build an object from the ground up

Three-dimensional bioprinting works much the same way, except those layers are made of living cells to create biological structures like skin, vessels, organs, or bone. 

Bioprinting has been around since 1988. So far, it’s mainly used in research settings, such as in the field of regenerative medicine. Research is underway for ear reconstruction, nerve regeneration, and skin regeneration. The technology was also recently used to create eye tissue to help researchers study eye diseases. 

The technology’s potential for use in cancer research has yet to be fully realized, Ms. Dey says. But that may be changing. 

“The use of 3D-bioprinted tumor models is getting close to translations in cancer research,” says Dr. Zhang. “They are being increasingly adopted by the research field, and [the technology] has started to be explored by the pharma industry for use towards cancer drug development.” 

Because bioprinting can be automated, it could allow researchers to create high-quality, complex tumor models at scale, Dr. Zhang says.

Such 3D models also have the potential to replace or reduce the use of animals in tumor drug testing, Ms. Dey notes. They “are expected to provide a more accurate drug response, compared [with] animal models, as animal physiology does not match humans’.” 

The FDA Modernization Act 2.0, a new U.S. law eliminating the requirement that drugs be tested in animals before humans, has “further paved the way for such technologies in the drug development pipeline,” Dr. Zhang says.
 

What if we could build a custom tumor model for each patient? 

Possible uses for bioprinting go beyond the lab, Ms. Dey says. Imagine if we could customize 3D tumor models based on biopsies from individual patients. Doctors could test many treatments on these patient-specific models, letting them more accurately predict how each patient would respond to different therapies. This would help doctors decide which course of treatment is best. 

In Ms. Dey’s study, the 3D model was treated with chemotherapy and with immunotherapy, and it responded to both. This highlights the potential for such 3D models to reveal the body’s immune response and be used to screen therapies, she says. “We hope is that in the future, this technique can be adapted in the hospital, which would speed up the course of cancer treatment.”

To that end, she and her colleagues are now working with real breast cancer tumors removed from patients, re-creating them in the lab in 3D to use for chemo and immunotherapy screening.

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

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People with cancer should be wary of taking dietary supplements

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Tue, 01/24/2023 - 14:09

Cancer dietitian Lisa Cianciotta often finds herself sitting across from a patient who suddenly fishes a bottle of antioxidant supplements from their bag and says, “My friend told me this works really well,” or “I read on the Internet that this is supposed to be really good for cancer.” 

Although taking an antioxidant pill sounds harmless, Ms. Cianciotta, a clinical dietitian who works with cancer patients at New York–Presbyterian Hospital, knows well that this popular dietary supplement can interfere with a patient’s radiation or chemotherapy.

But many patients with cancer believe these over-the-counter vitamins, minerals, or herbal remedies will help them, and most use at least one dietary supplement alongside their cancer treatment.

And that leaves Ms. Cianciotta with a delicate conversation ahead of her. 

Drug-supplement interactions are complex, often varying by supplement, cancer, and treatment type, and can do more harm than good. Popular dietary supplements may, for instance, cancel the effects of a cancer treatment, making it less effective, or increase serious side effects, such as liver toxicity. But in other cases, supplementation, such as vitamin D for patients who lack the vitamin, may be beneficial, Ms. Cianciotta said. 

These drug-supplement interactions can be hard to pinpoint, given that more than two-thirds of doctors don’t know their patients are using supplements.

Here’s what patients need to know about the potential risks of supplement use during treatment, and how oncologists can address this thorny, often poorly understood topic with patients.
 

The complex drug-supplement landscape

The list of dietary supplements and how they can interact with different treatments and cancer types is long and nuanced. 

But certain supplements appear to affect cancer treatments regardless of other things and should be avoided. Any supplement that strongly alters the body’s levels of the protein cytochromes P450 is one example. This group of enzymes plays a key role in metabolizing drugs, including chemotherapy and immunotherapy agents. 

Certain supplements – most notably St. John’s wort extract – may decrease or increase the activity of cytochrome P450, which can then  affect the concentrations of anticancer drugs in the blood, said William Figg, PharmD, an associate director of the Center for Cancer Research at the National Cancer Institute in Bethesda, Md. Studies show, for instance, that this common herbal supplement can increase the activity of cytochrome P450, resulting in lower levels of cancer drugs.

Outside of drug metabolism, patients with hormone-related cancers, such as breast and prostate cancers, should steer clear of dietary supplements that can alter levels of testosterone or estrogen, Dr. Figg said. The evergreen shrub ashwagandha, for example, is marketed to reduce stress and fatigue, but can also increase testosterone levels – a potential problem for those with prostate cancer receiving androgen deprivation therapy, which lowers testosterone levels. 

Many oncologists counsel patients against using antioxidant-based dietary supplements – particularly turmeric and green tea extract – while they have radiation therapy and certain chemotherapies. These therapies work by creating an abundance of highly reactive molecules called free radicals in tumor cells, which increase stress within these cells, ultimately killing them off. Antioxidants, in theory, can neutralize this effect, said Skyler Johnson, MD, a radiation oncologist at Huntsman Cancer Institute at the University of Utah, Salt Lake City.  Some studies suggest that antioxidant supplements may lessen the effects of radiation and chemotherapy, although the evidence is mixed.

Some dietary supplements, including high-dose green tea extract and vitamin A, can cause kidney or liver toxicity, and “many cancer patients already have compromised kidney or liver function,” said Jun J. Mao, MD, chief of integrative medicine at Memorial Sloan Kettering Cancer Center in New York. Even herbs that don’t interfere with how well a cancer drug works, such as stevia, can increase treatment-related side effects, such as nausea and vomiting. 

Another potential problem with dietary supplements: It’s nearly impossible to know exactly what’s in them. For instance, just last year, the Food and Drug Administration sent nearly 50 warning letters to companies marketing dietary supplements. The issue is that federal regulations governing production are less strict for supplements than for medications. As a result, some supplements contain ingredients not listed on the label. 

One historical example was the supplement PC-SPES, a mix of eight herbs, marketed to men with prostate cancer. The supplement was recalled in 2002 after certain batches were found to contain traces of prescription drugs, including diethylstilbestrol, ethinyl estradiol, warfarin, and alprazolam.

To further complicate matters, some dietary supplements can be helpful. Most patients with cancer “are malnourished and missing out on nutrients they could be getting from food,” said Ms. Cianciotta.

Patients are tested routinely for vitamin deficiencies and receive supplements as needed, she said. Vitamin D and folic acid are two of the most common deficiencies in this patient population. Vitamin D supplementation can improve outcomes in patients who have received a stem cell transplant by aiding engraftment and rebuilding the immune system, while folic acid supplementation can help to raise low red blood cell counts and hemoglobin levels. 

Although she rarely sees vitamin toxicity, Ms. Cianciotta stressed that more is not always better and supplement use, even when it seems safe or warranted due to a deficiency, should be taken under supervision, and monitored carefully by the patient’s care team. 
 

 

 

Bringing supplement use into the light

Too often, providers are unaware of a patient’s supplement use. 

A core reason: Dietary supplements are often touted as natural, which many patients equate with safety, said Samantha Heller, a senior clinical nutritionist at New York (N.Y.) University Langone Health. 

That means patients may not know a supplement can act like a drug and interfere with their cancer treatment, and thus may not see the importance of telling their doctors.

Still, the promise of herbs, vitamins, and minerals can be alluring, and there are many reasons patients decide to partake. One major appeal: Dietary supplements can help some patients feel empowered.

“Cancer is a disease that takes away a lot of control from the individual. Taking supplements or herbs is a way to regain some sense of control,” said Dr. Mao. 

The phenomenon can also be cultural, he said. Some people grow up taking herbs and supplements to stay healthy or combat health woes.

Pressure or advice from family or friends who may think they are helping a loved one with their dietary recommendations may play a role as well. Friends and family “cannot prescribe chemo, but they can buy herbs and supplements,” Dr. Mao said. 

Patients seeking greater control over their health or who feel high levels of anxiety may be more likely to take suggestions from friends and family or more likely to believe false or misleading claims about the efficacy or safety of supplements, explained  medical oncologist William Dahut, MD, chief scientific officer for the American Cancer Society. 

Plus, social media often amplifies and normalizes this misinformation, noted Dr. Johnson. In a 2021 study published in the Journal of the National Cancer Institute, he and colleagues found that one-third of the most popular articles on cancer treatment posted to social media in 2018 and 2019 contained false, inaccurate, or misleading information that was often harmful. 

Some of the false claims centered on unproven, potentially unsafe herbal remedies, according to Dr. Johnson. These included “lung cancer can be cured with cannabis oil” and “golden berries cure and prevent cancer.” 

Given exaggerated claims of “cures,” some patients may keep their supplement use under the radar out of fear they will be judged or criticized. 

“Clinicians should avoid making patients feel judged or telling people not to go online to do their own research,” Dr. Johnson said.

Guiding patients, instead, to accurate sources of online information may be one way to help patients feel empowered, he said. Cancer.gov and the Memorial Sloan Kettering Cancer Center’s About Herbs database provide accessible and accurate information on dietary supplements and cancer treatment for both health care professionals and patients, he noted. 

If a particular supplement is not safe during treatment, providers should be able to explain why, said  Ms. Cianciotta. In a recent study, 80% of health care providers surveyed believed that interactions between herbals and medications could be problematic, but only 15% could explain why. 

“Being able to explain why we are discouraging a particular supplement right now tends to be much better received than just telling a patient not to take something, because it is bad,” she said. 

Another key is listening closely to patients to understand why they may be taking a particular supplement. Does the patient feel out of control? Is nausea a problem? 

“Allowing patients to tell you why they are using a particular supplement will often reveal unmet needs or psychosocial challenges,” Dr. Mao said. This information can allow providers to suggest an evidence-based alternative, such as mindfulness meditation or acupuncture, to manage stress.

And if a patient has received a dietary supplement from well-meaning family and friends?

“Simply telling a patient that a given supplement is useless or harmful could create family tension,” said  Dr. Mao. 

Instead, he recommends reframing the issue. 

“We want to have a better understanding of how patients are tolerating chemo or immunotherapy before throwing other things on top of it. Let them know that now may just not be the right time to add a supplement to the mix,” Dr. Mao said. 

The bottom line: “Patients want to play an active role in their own care, and we want to help them do that in a safe way,” he said. 

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

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Cancer dietitian Lisa Cianciotta often finds herself sitting across from a patient who suddenly fishes a bottle of antioxidant supplements from their bag and says, “My friend told me this works really well,” or “I read on the Internet that this is supposed to be really good for cancer.” 

Although taking an antioxidant pill sounds harmless, Ms. Cianciotta, a clinical dietitian who works with cancer patients at New York–Presbyterian Hospital, knows well that this popular dietary supplement can interfere with a patient’s radiation or chemotherapy.

But many patients with cancer believe these over-the-counter vitamins, minerals, or herbal remedies will help them, and most use at least one dietary supplement alongside their cancer treatment.

And that leaves Ms. Cianciotta with a delicate conversation ahead of her. 

Drug-supplement interactions are complex, often varying by supplement, cancer, and treatment type, and can do more harm than good. Popular dietary supplements may, for instance, cancel the effects of a cancer treatment, making it less effective, or increase serious side effects, such as liver toxicity. But in other cases, supplementation, such as vitamin D for patients who lack the vitamin, may be beneficial, Ms. Cianciotta said. 

These drug-supplement interactions can be hard to pinpoint, given that more than two-thirds of doctors don’t know their patients are using supplements.

Here’s what patients need to know about the potential risks of supplement use during treatment, and how oncologists can address this thorny, often poorly understood topic with patients.
 

The complex drug-supplement landscape

The list of dietary supplements and how they can interact with different treatments and cancer types is long and nuanced. 

But certain supplements appear to affect cancer treatments regardless of other things and should be avoided. Any supplement that strongly alters the body’s levels of the protein cytochromes P450 is one example. This group of enzymes plays a key role in metabolizing drugs, including chemotherapy and immunotherapy agents. 

Certain supplements – most notably St. John’s wort extract – may decrease or increase the activity of cytochrome P450, which can then  affect the concentrations of anticancer drugs in the blood, said William Figg, PharmD, an associate director of the Center for Cancer Research at the National Cancer Institute in Bethesda, Md. Studies show, for instance, that this common herbal supplement can increase the activity of cytochrome P450, resulting in lower levels of cancer drugs.

Outside of drug metabolism, patients with hormone-related cancers, such as breast and prostate cancers, should steer clear of dietary supplements that can alter levels of testosterone or estrogen, Dr. Figg said. The evergreen shrub ashwagandha, for example, is marketed to reduce stress and fatigue, but can also increase testosterone levels – a potential problem for those with prostate cancer receiving androgen deprivation therapy, which lowers testosterone levels. 

Many oncologists counsel patients against using antioxidant-based dietary supplements – particularly turmeric and green tea extract – while they have radiation therapy and certain chemotherapies. These therapies work by creating an abundance of highly reactive molecules called free radicals in tumor cells, which increase stress within these cells, ultimately killing them off. Antioxidants, in theory, can neutralize this effect, said Skyler Johnson, MD, a radiation oncologist at Huntsman Cancer Institute at the University of Utah, Salt Lake City.  Some studies suggest that antioxidant supplements may lessen the effects of radiation and chemotherapy, although the evidence is mixed.

Some dietary supplements, including high-dose green tea extract and vitamin A, can cause kidney or liver toxicity, and “many cancer patients already have compromised kidney or liver function,” said Jun J. Mao, MD, chief of integrative medicine at Memorial Sloan Kettering Cancer Center in New York. Even herbs that don’t interfere with how well a cancer drug works, such as stevia, can increase treatment-related side effects, such as nausea and vomiting. 

Another potential problem with dietary supplements: It’s nearly impossible to know exactly what’s in them. For instance, just last year, the Food and Drug Administration sent nearly 50 warning letters to companies marketing dietary supplements. The issue is that federal regulations governing production are less strict for supplements than for medications. As a result, some supplements contain ingredients not listed on the label. 

One historical example was the supplement PC-SPES, a mix of eight herbs, marketed to men with prostate cancer. The supplement was recalled in 2002 after certain batches were found to contain traces of prescription drugs, including diethylstilbestrol, ethinyl estradiol, warfarin, and alprazolam.

To further complicate matters, some dietary supplements can be helpful. Most patients with cancer “are malnourished and missing out on nutrients they could be getting from food,” said Ms. Cianciotta.

Patients are tested routinely for vitamin deficiencies and receive supplements as needed, she said. Vitamin D and folic acid are two of the most common deficiencies in this patient population. Vitamin D supplementation can improve outcomes in patients who have received a stem cell transplant by aiding engraftment and rebuilding the immune system, while folic acid supplementation can help to raise low red blood cell counts and hemoglobin levels. 

Although she rarely sees vitamin toxicity, Ms. Cianciotta stressed that more is not always better and supplement use, even when it seems safe or warranted due to a deficiency, should be taken under supervision, and monitored carefully by the patient’s care team. 
 

 

 

Bringing supplement use into the light

Too often, providers are unaware of a patient’s supplement use. 

A core reason: Dietary supplements are often touted as natural, which many patients equate with safety, said Samantha Heller, a senior clinical nutritionist at New York (N.Y.) University Langone Health. 

That means patients may not know a supplement can act like a drug and interfere with their cancer treatment, and thus may not see the importance of telling their doctors.

Still, the promise of herbs, vitamins, and minerals can be alluring, and there are many reasons patients decide to partake. One major appeal: Dietary supplements can help some patients feel empowered.

“Cancer is a disease that takes away a lot of control from the individual. Taking supplements or herbs is a way to regain some sense of control,” said Dr. Mao. 

The phenomenon can also be cultural, he said. Some people grow up taking herbs and supplements to stay healthy or combat health woes.

Pressure or advice from family or friends who may think they are helping a loved one with their dietary recommendations may play a role as well. Friends and family “cannot prescribe chemo, but they can buy herbs and supplements,” Dr. Mao said. 

Patients seeking greater control over their health or who feel high levels of anxiety may be more likely to take suggestions from friends and family or more likely to believe false or misleading claims about the efficacy or safety of supplements, explained  medical oncologist William Dahut, MD, chief scientific officer for the American Cancer Society. 

Plus, social media often amplifies and normalizes this misinformation, noted Dr. Johnson. In a 2021 study published in the Journal of the National Cancer Institute, he and colleagues found that one-third of the most popular articles on cancer treatment posted to social media in 2018 and 2019 contained false, inaccurate, or misleading information that was often harmful. 

Some of the false claims centered on unproven, potentially unsafe herbal remedies, according to Dr. Johnson. These included “lung cancer can be cured with cannabis oil” and “golden berries cure and prevent cancer.” 

Given exaggerated claims of “cures,” some patients may keep their supplement use under the radar out of fear they will be judged or criticized. 

“Clinicians should avoid making patients feel judged or telling people not to go online to do their own research,” Dr. Johnson said.

Guiding patients, instead, to accurate sources of online information may be one way to help patients feel empowered, he said. Cancer.gov and the Memorial Sloan Kettering Cancer Center’s About Herbs database provide accessible and accurate information on dietary supplements and cancer treatment for both health care professionals and patients, he noted. 

If a particular supplement is not safe during treatment, providers should be able to explain why, said  Ms. Cianciotta. In a recent study, 80% of health care providers surveyed believed that interactions between herbals and medications could be problematic, but only 15% could explain why. 

“Being able to explain why we are discouraging a particular supplement right now tends to be much better received than just telling a patient not to take something, because it is bad,” she said. 

Another key is listening closely to patients to understand why they may be taking a particular supplement. Does the patient feel out of control? Is nausea a problem? 

“Allowing patients to tell you why they are using a particular supplement will often reveal unmet needs or psychosocial challenges,” Dr. Mao said. This information can allow providers to suggest an evidence-based alternative, such as mindfulness meditation or acupuncture, to manage stress.

And if a patient has received a dietary supplement from well-meaning family and friends?

“Simply telling a patient that a given supplement is useless or harmful could create family tension,” said  Dr. Mao. 

Instead, he recommends reframing the issue. 

“We want to have a better understanding of how patients are tolerating chemo or immunotherapy before throwing other things on top of it. Let them know that now may just not be the right time to add a supplement to the mix,” Dr. Mao said. 

The bottom line: “Patients want to play an active role in their own care, and we want to help them do that in a safe way,” he said. 

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

Cancer dietitian Lisa Cianciotta often finds herself sitting across from a patient who suddenly fishes a bottle of antioxidant supplements from their bag and says, “My friend told me this works really well,” or “I read on the Internet that this is supposed to be really good for cancer.” 

Although taking an antioxidant pill sounds harmless, Ms. Cianciotta, a clinical dietitian who works with cancer patients at New York–Presbyterian Hospital, knows well that this popular dietary supplement can interfere with a patient’s radiation or chemotherapy.

But many patients with cancer believe these over-the-counter vitamins, minerals, or herbal remedies will help them, and most use at least one dietary supplement alongside their cancer treatment.

And that leaves Ms. Cianciotta with a delicate conversation ahead of her. 

Drug-supplement interactions are complex, often varying by supplement, cancer, and treatment type, and can do more harm than good. Popular dietary supplements may, for instance, cancel the effects of a cancer treatment, making it less effective, or increase serious side effects, such as liver toxicity. But in other cases, supplementation, such as vitamin D for patients who lack the vitamin, may be beneficial, Ms. Cianciotta said. 

These drug-supplement interactions can be hard to pinpoint, given that more than two-thirds of doctors don’t know their patients are using supplements.

Here’s what patients need to know about the potential risks of supplement use during treatment, and how oncologists can address this thorny, often poorly understood topic with patients.
 

The complex drug-supplement landscape

The list of dietary supplements and how they can interact with different treatments and cancer types is long and nuanced. 

But certain supplements appear to affect cancer treatments regardless of other things and should be avoided. Any supplement that strongly alters the body’s levels of the protein cytochromes P450 is one example. This group of enzymes plays a key role in metabolizing drugs, including chemotherapy and immunotherapy agents. 

Certain supplements – most notably St. John’s wort extract – may decrease or increase the activity of cytochrome P450, which can then  affect the concentrations of anticancer drugs in the blood, said William Figg, PharmD, an associate director of the Center for Cancer Research at the National Cancer Institute in Bethesda, Md. Studies show, for instance, that this common herbal supplement can increase the activity of cytochrome P450, resulting in lower levels of cancer drugs.

Outside of drug metabolism, patients with hormone-related cancers, such as breast and prostate cancers, should steer clear of dietary supplements that can alter levels of testosterone or estrogen, Dr. Figg said. The evergreen shrub ashwagandha, for example, is marketed to reduce stress and fatigue, but can also increase testosterone levels – a potential problem for those with prostate cancer receiving androgen deprivation therapy, which lowers testosterone levels. 

Many oncologists counsel patients against using antioxidant-based dietary supplements – particularly turmeric and green tea extract – while they have radiation therapy and certain chemotherapies. These therapies work by creating an abundance of highly reactive molecules called free radicals in tumor cells, which increase stress within these cells, ultimately killing them off. Antioxidants, in theory, can neutralize this effect, said Skyler Johnson, MD, a radiation oncologist at Huntsman Cancer Institute at the University of Utah, Salt Lake City.  Some studies suggest that antioxidant supplements may lessen the effects of radiation and chemotherapy, although the evidence is mixed.

Some dietary supplements, including high-dose green tea extract and vitamin A, can cause kidney or liver toxicity, and “many cancer patients already have compromised kidney or liver function,” said Jun J. Mao, MD, chief of integrative medicine at Memorial Sloan Kettering Cancer Center in New York. Even herbs that don’t interfere with how well a cancer drug works, such as stevia, can increase treatment-related side effects, such as nausea and vomiting. 

Another potential problem with dietary supplements: It’s nearly impossible to know exactly what’s in them. For instance, just last year, the Food and Drug Administration sent nearly 50 warning letters to companies marketing dietary supplements. The issue is that federal regulations governing production are less strict for supplements than for medications. As a result, some supplements contain ingredients not listed on the label. 

One historical example was the supplement PC-SPES, a mix of eight herbs, marketed to men with prostate cancer. The supplement was recalled in 2002 after certain batches were found to contain traces of prescription drugs, including diethylstilbestrol, ethinyl estradiol, warfarin, and alprazolam.

To further complicate matters, some dietary supplements can be helpful. Most patients with cancer “are malnourished and missing out on nutrients they could be getting from food,” said Ms. Cianciotta.

Patients are tested routinely for vitamin deficiencies and receive supplements as needed, she said. Vitamin D and folic acid are two of the most common deficiencies in this patient population. Vitamin D supplementation can improve outcomes in patients who have received a stem cell transplant by aiding engraftment and rebuilding the immune system, while folic acid supplementation can help to raise low red blood cell counts and hemoglobin levels. 

Although she rarely sees vitamin toxicity, Ms. Cianciotta stressed that more is not always better and supplement use, even when it seems safe or warranted due to a deficiency, should be taken under supervision, and monitored carefully by the patient’s care team. 
 

 

 

Bringing supplement use into the light

Too often, providers are unaware of a patient’s supplement use. 

A core reason: Dietary supplements are often touted as natural, which many patients equate with safety, said Samantha Heller, a senior clinical nutritionist at New York (N.Y.) University Langone Health. 

That means patients may not know a supplement can act like a drug and interfere with their cancer treatment, and thus may not see the importance of telling their doctors.

Still, the promise of herbs, vitamins, and minerals can be alluring, and there are many reasons patients decide to partake. One major appeal: Dietary supplements can help some patients feel empowered.

“Cancer is a disease that takes away a lot of control from the individual. Taking supplements or herbs is a way to regain some sense of control,” said Dr. Mao. 

The phenomenon can also be cultural, he said. Some people grow up taking herbs and supplements to stay healthy or combat health woes.

Pressure or advice from family or friends who may think they are helping a loved one with their dietary recommendations may play a role as well. Friends and family “cannot prescribe chemo, but they can buy herbs and supplements,” Dr. Mao said. 

Patients seeking greater control over their health or who feel high levels of anxiety may be more likely to take suggestions from friends and family or more likely to believe false or misleading claims about the efficacy or safety of supplements, explained  medical oncologist William Dahut, MD, chief scientific officer for the American Cancer Society. 

Plus, social media often amplifies and normalizes this misinformation, noted Dr. Johnson. In a 2021 study published in the Journal of the National Cancer Institute, he and colleagues found that one-third of the most popular articles on cancer treatment posted to social media in 2018 and 2019 contained false, inaccurate, or misleading information that was often harmful. 

Some of the false claims centered on unproven, potentially unsafe herbal remedies, according to Dr. Johnson. These included “lung cancer can be cured with cannabis oil” and “golden berries cure and prevent cancer.” 

Given exaggerated claims of “cures,” some patients may keep their supplement use under the radar out of fear they will be judged or criticized. 

“Clinicians should avoid making patients feel judged or telling people not to go online to do their own research,” Dr. Johnson said.

Guiding patients, instead, to accurate sources of online information may be one way to help patients feel empowered, he said. Cancer.gov and the Memorial Sloan Kettering Cancer Center’s About Herbs database provide accessible and accurate information on dietary supplements and cancer treatment for both health care professionals and patients, he noted. 

If a particular supplement is not safe during treatment, providers should be able to explain why, said  Ms. Cianciotta. In a recent study, 80% of health care providers surveyed believed that interactions between herbals and medications could be problematic, but only 15% could explain why. 

“Being able to explain why we are discouraging a particular supplement right now tends to be much better received than just telling a patient not to take something, because it is bad,” she said. 

Another key is listening closely to patients to understand why they may be taking a particular supplement. Does the patient feel out of control? Is nausea a problem? 

“Allowing patients to tell you why they are using a particular supplement will often reveal unmet needs or psychosocial challenges,” Dr. Mao said. This information can allow providers to suggest an evidence-based alternative, such as mindfulness meditation or acupuncture, to manage stress.

And if a patient has received a dietary supplement from well-meaning family and friends?

“Simply telling a patient that a given supplement is useless or harmful could create family tension,” said  Dr. Mao. 

Instead, he recommends reframing the issue. 

“We want to have a better understanding of how patients are tolerating chemo or immunotherapy before throwing other things on top of it. Let them know that now may just not be the right time to add a supplement to the mix,” Dr. Mao said. 

The bottom line: “Patients want to play an active role in their own care, and we want to help them do that in a safe way,” he said. 

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

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