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Look Beyond BMI: Metabolic Factors’ Link to Cancer Explained
The new research finds that adults with persistent metabolic syndrome that worsens over time are at increased risk for any type of cancer.
The conditions that make up metabolic syndrome (high blood pressure, high blood sugar, increased abdominal adiposity, and high cholesterol and triglycerides) have been associated with an increased risk of diseases, including heart disease, stroke, and type 2 diabetes, wrote Li Deng, PhD, of Capital Medical University, Beijing, and colleagues.
However, a single assessment of metabolic syndrome at one point in time is inadequate to show an association with cancer risk over time, they said. In the current study, the researchers used models to examine the association between trajectory patterns of metabolic syndrome over time and the risk of overall and specific cancer types. They also examined the impact of chronic inflammation concurrent with metabolic syndrome.
What We Know About Metabolic Syndrome and Cancer Risk
A systematic review and meta-analysis published in Diabetes Care in 2012 showed an association between the presence of metabolic syndrome and an increased risk of various cancers including liver, bladder, pancreatic, breast, and colorectal.
More recently, a 2020 study published in Diabetes showed evidence of increased risk for certain cancers (pancreatic, kidney, uterine, cervical) but no increased risk for cancer overall.
In addition, a 2022 study by some of the current study researchers of the same Chinese cohort focused on the role of inflammation in combination with metabolic syndrome on colorectal cancer specifically, and found an increased risk for cancer when both metabolic syndrome and inflammation were present.
However, the reasons for this association between metabolic syndrome and cancer remain unclear, and the effect of the fluctuating nature of metabolic syndrome over time on long-term cancer risk has not been explored, the researchers wrote.
“There is emerging evidence that even normal weight individuals who are metabolically unhealthy may be at an elevated cancer risk, and we need better metrics to define the underlying metabolic dysfunction in obesity,” Sheetal Hardikar, MBBS, PhD, MPH, an investigator at the Huntsman Cancer Institute, University of Utah, said in an interview.
Dr. Hardikar, who serves as assistant professor in the department of population health sciences at the University of Utah, was not involved in the current study. She and her colleagues published a research paper on data from the National Health and Nutrition Examination Survey in 2023 that showed an increased risk of obesity-related cancer.
What New Study Adds to Related Research
Previous studies have consistently reported an approximately 30% increased risk of cancer with metabolic syndrome, Dr. Hardikar said. “What is unique about this study is the examination of metabolic syndrome trajectories over four years, and not just the presence of metabolic syndrome at one point in time,” she said.
In the new study, published in Cancer on March 11 (doi: 10.1002/cncr.35235), 44,115 adults in China were separated into four trajectories based on metabolic syndrome scores for the period from 2006 to 2010. The scores were based on clinical evidence of metabolic syndrome, defined using the International Diabetes Federation criteria of central obesity and the presence of at least two other factors including increased triglycerides, decreased HDL cholesterol, high blood pressure (or treatment for previously diagnosed hypertension), and increased fasting plasma glucose (or previous diagnosis of type 2 diabetes).
The average age of the participants was 49 years; the mean body mass index ranged from approximately 22 kg/m2 in the low-stable group to approximately 28 kg/m2 in the elevated-increasing group.
The four trajectories of metabolic syndrome were low-stable (10.56% of participants), moderate-low (40.84%), moderate-high (41.46%), and elevated-increasing (7.14%), based on trends from the individuals’ initial physical exams on entering the study.
Over a median follow-up period of 9.4 years (from 2010 to 2021), 2,271 cancer diagnoses were reported in the study population. Those with an elevated-increasing metabolic syndrome trajectory had 1.3 times the risk of any cancer compared with those in the low-stable group. Risk for breast cancer, endometrial cancer, kidney cancer, colorectal cancer, and liver cancer in the highest trajectory group were 2.1, 3.3, 4.5, 2.5, and 1.6 times higher, respectively, compared to the lowest group. The increased risk in the elevated-trajectory group for all cancer types persisted when the low-stable, moderate-low, and moderate-high trajectory pattern groups were combined.
The researchers also examined the impact of chronic inflammation and found that individuals with persistently high metabolic syndrome scores and concurrent chronic inflammation had the highest risks of breast, endometrial, colon, and liver cancer. However, individuals with persistently high metabolic syndrome scores and no concurrent chronic inflammation had the highest risk of kidney cancer.
What Are the Limitations of This Research?
The researchers of the current study acknowledged the lack of information on other causes of cancer, including dietary habits, hepatitis C infection, and Helicobacter pylori infection. Other limitations include the focus only on individuals from a single community of mainly middle-aged men in China that may not generalize to other populations.
Also, the metabolic syndrome trajectories did not change much over time, which may be related to the short 4-year study period.
Using the International Diabetes Federation criteria was another limitation, because it prevented the assessment of cancer risk in normal weight individuals with metabolic dysfunction, Dr. Hardikar noted.
Does Metabolic Syndrome Cause Cancer?
“This research suggests that proactive and continuous management of metabolic syndrome may serve as an essential strategy in preventing cancer,” senior author Han-Ping Shi, MD, PhD, of Capital Medical University in Beijing, noted in a statement on the study.
More research is needed to assess the impact of these interventions on cancer risk. However, the data from the current study can guide future research that may lead to more targeted treatments and more effective preventive strategies, he continued.
“Current evidence based on this study and many other reports strongly suggests an increased risk for cancer associated with metabolic syndrome,” Dr. Hardikar said in an interview. The data serve as a reminder to clinicians to look beyond BMI as the only measure of obesity, and to consider metabolic factors together to identify individuals at increased risk for cancer, she said.
“We must continue to educate patients about obesity and all the chronic conditions it may lead to, but we cannot ignore this emerging phenotype of being of normal weight but metabolically unhealthy,” Dr. Hardikar emphasized.
What Additional Research is Needed?
Looking ahead, “we need well-designed interventions to test causality for metabolic syndrome and cancer risk, though the evidence from the observational studies is very strong,” Dr. Hardikar said.
In addition, a consensus is needed to better define metabolic dysfunction,and to explore cancer risk in normal weight but metabolically unhealthy individuals, she said.
The study was supported by the National Key Research and Development Program of China. The researchers and Dr. Hardikar had no financial conflicts to disclose.
The new research finds that adults with persistent metabolic syndrome that worsens over time are at increased risk for any type of cancer.
The conditions that make up metabolic syndrome (high blood pressure, high blood sugar, increased abdominal adiposity, and high cholesterol and triglycerides) have been associated with an increased risk of diseases, including heart disease, stroke, and type 2 diabetes, wrote Li Deng, PhD, of Capital Medical University, Beijing, and colleagues.
However, a single assessment of metabolic syndrome at one point in time is inadequate to show an association with cancer risk over time, they said. In the current study, the researchers used models to examine the association between trajectory patterns of metabolic syndrome over time and the risk of overall and specific cancer types. They also examined the impact of chronic inflammation concurrent with metabolic syndrome.
What We Know About Metabolic Syndrome and Cancer Risk
A systematic review and meta-analysis published in Diabetes Care in 2012 showed an association between the presence of metabolic syndrome and an increased risk of various cancers including liver, bladder, pancreatic, breast, and colorectal.
More recently, a 2020 study published in Diabetes showed evidence of increased risk for certain cancers (pancreatic, kidney, uterine, cervical) but no increased risk for cancer overall.
In addition, a 2022 study by some of the current study researchers of the same Chinese cohort focused on the role of inflammation in combination with metabolic syndrome on colorectal cancer specifically, and found an increased risk for cancer when both metabolic syndrome and inflammation were present.
However, the reasons for this association between metabolic syndrome and cancer remain unclear, and the effect of the fluctuating nature of metabolic syndrome over time on long-term cancer risk has not been explored, the researchers wrote.
“There is emerging evidence that even normal weight individuals who are metabolically unhealthy may be at an elevated cancer risk, and we need better metrics to define the underlying metabolic dysfunction in obesity,” Sheetal Hardikar, MBBS, PhD, MPH, an investigator at the Huntsman Cancer Institute, University of Utah, said in an interview.
Dr. Hardikar, who serves as assistant professor in the department of population health sciences at the University of Utah, was not involved in the current study. She and her colleagues published a research paper on data from the National Health and Nutrition Examination Survey in 2023 that showed an increased risk of obesity-related cancer.
What New Study Adds to Related Research
Previous studies have consistently reported an approximately 30% increased risk of cancer with metabolic syndrome, Dr. Hardikar said. “What is unique about this study is the examination of metabolic syndrome trajectories over four years, and not just the presence of metabolic syndrome at one point in time,” she said.
In the new study, published in Cancer on March 11 (doi: 10.1002/cncr.35235), 44,115 adults in China were separated into four trajectories based on metabolic syndrome scores for the period from 2006 to 2010. The scores were based on clinical evidence of metabolic syndrome, defined using the International Diabetes Federation criteria of central obesity and the presence of at least two other factors including increased triglycerides, decreased HDL cholesterol, high blood pressure (or treatment for previously diagnosed hypertension), and increased fasting plasma glucose (or previous diagnosis of type 2 diabetes).
The average age of the participants was 49 years; the mean body mass index ranged from approximately 22 kg/m2 in the low-stable group to approximately 28 kg/m2 in the elevated-increasing group.
The four trajectories of metabolic syndrome were low-stable (10.56% of participants), moderate-low (40.84%), moderate-high (41.46%), and elevated-increasing (7.14%), based on trends from the individuals’ initial physical exams on entering the study.
Over a median follow-up period of 9.4 years (from 2010 to 2021), 2,271 cancer diagnoses were reported in the study population. Those with an elevated-increasing metabolic syndrome trajectory had 1.3 times the risk of any cancer compared with those in the low-stable group. Risk for breast cancer, endometrial cancer, kidney cancer, colorectal cancer, and liver cancer in the highest trajectory group were 2.1, 3.3, 4.5, 2.5, and 1.6 times higher, respectively, compared to the lowest group. The increased risk in the elevated-trajectory group for all cancer types persisted when the low-stable, moderate-low, and moderate-high trajectory pattern groups were combined.
The researchers also examined the impact of chronic inflammation and found that individuals with persistently high metabolic syndrome scores and concurrent chronic inflammation had the highest risks of breast, endometrial, colon, and liver cancer. However, individuals with persistently high metabolic syndrome scores and no concurrent chronic inflammation had the highest risk of kidney cancer.
What Are the Limitations of This Research?
The researchers of the current study acknowledged the lack of information on other causes of cancer, including dietary habits, hepatitis C infection, and Helicobacter pylori infection. Other limitations include the focus only on individuals from a single community of mainly middle-aged men in China that may not generalize to other populations.
Also, the metabolic syndrome trajectories did not change much over time, which may be related to the short 4-year study period.
Using the International Diabetes Federation criteria was another limitation, because it prevented the assessment of cancer risk in normal weight individuals with metabolic dysfunction, Dr. Hardikar noted.
Does Metabolic Syndrome Cause Cancer?
“This research suggests that proactive and continuous management of metabolic syndrome may serve as an essential strategy in preventing cancer,” senior author Han-Ping Shi, MD, PhD, of Capital Medical University in Beijing, noted in a statement on the study.
More research is needed to assess the impact of these interventions on cancer risk. However, the data from the current study can guide future research that may lead to more targeted treatments and more effective preventive strategies, he continued.
“Current evidence based on this study and many other reports strongly suggests an increased risk for cancer associated with metabolic syndrome,” Dr. Hardikar said in an interview. The data serve as a reminder to clinicians to look beyond BMI as the only measure of obesity, and to consider metabolic factors together to identify individuals at increased risk for cancer, she said.
“We must continue to educate patients about obesity and all the chronic conditions it may lead to, but we cannot ignore this emerging phenotype of being of normal weight but metabolically unhealthy,” Dr. Hardikar emphasized.
What Additional Research is Needed?
Looking ahead, “we need well-designed interventions to test causality for metabolic syndrome and cancer risk, though the evidence from the observational studies is very strong,” Dr. Hardikar said.
In addition, a consensus is needed to better define metabolic dysfunction,and to explore cancer risk in normal weight but metabolically unhealthy individuals, she said.
The study was supported by the National Key Research and Development Program of China. The researchers and Dr. Hardikar had no financial conflicts to disclose.
The new research finds that adults with persistent metabolic syndrome that worsens over time are at increased risk for any type of cancer.
The conditions that make up metabolic syndrome (high blood pressure, high blood sugar, increased abdominal adiposity, and high cholesterol and triglycerides) have been associated with an increased risk of diseases, including heart disease, stroke, and type 2 diabetes, wrote Li Deng, PhD, of Capital Medical University, Beijing, and colleagues.
However, a single assessment of metabolic syndrome at one point in time is inadequate to show an association with cancer risk over time, they said. In the current study, the researchers used models to examine the association between trajectory patterns of metabolic syndrome over time and the risk of overall and specific cancer types. They also examined the impact of chronic inflammation concurrent with metabolic syndrome.
What We Know About Metabolic Syndrome and Cancer Risk
A systematic review and meta-analysis published in Diabetes Care in 2012 showed an association between the presence of metabolic syndrome and an increased risk of various cancers including liver, bladder, pancreatic, breast, and colorectal.
More recently, a 2020 study published in Diabetes showed evidence of increased risk for certain cancers (pancreatic, kidney, uterine, cervical) but no increased risk for cancer overall.
In addition, a 2022 study by some of the current study researchers of the same Chinese cohort focused on the role of inflammation in combination with metabolic syndrome on colorectal cancer specifically, and found an increased risk for cancer when both metabolic syndrome and inflammation were present.
However, the reasons for this association between metabolic syndrome and cancer remain unclear, and the effect of the fluctuating nature of metabolic syndrome over time on long-term cancer risk has not been explored, the researchers wrote.
“There is emerging evidence that even normal weight individuals who are metabolically unhealthy may be at an elevated cancer risk, and we need better metrics to define the underlying metabolic dysfunction in obesity,” Sheetal Hardikar, MBBS, PhD, MPH, an investigator at the Huntsman Cancer Institute, University of Utah, said in an interview.
Dr. Hardikar, who serves as assistant professor in the department of population health sciences at the University of Utah, was not involved in the current study. She and her colleagues published a research paper on data from the National Health and Nutrition Examination Survey in 2023 that showed an increased risk of obesity-related cancer.
What New Study Adds to Related Research
Previous studies have consistently reported an approximately 30% increased risk of cancer with metabolic syndrome, Dr. Hardikar said. “What is unique about this study is the examination of metabolic syndrome trajectories over four years, and not just the presence of metabolic syndrome at one point in time,” she said.
In the new study, published in Cancer on March 11 (doi: 10.1002/cncr.35235), 44,115 adults in China were separated into four trajectories based on metabolic syndrome scores for the period from 2006 to 2010. The scores were based on clinical evidence of metabolic syndrome, defined using the International Diabetes Federation criteria of central obesity and the presence of at least two other factors including increased triglycerides, decreased HDL cholesterol, high blood pressure (or treatment for previously diagnosed hypertension), and increased fasting plasma glucose (or previous diagnosis of type 2 diabetes).
The average age of the participants was 49 years; the mean body mass index ranged from approximately 22 kg/m2 in the low-stable group to approximately 28 kg/m2 in the elevated-increasing group.
The four trajectories of metabolic syndrome were low-stable (10.56% of participants), moderate-low (40.84%), moderate-high (41.46%), and elevated-increasing (7.14%), based on trends from the individuals’ initial physical exams on entering the study.
Over a median follow-up period of 9.4 years (from 2010 to 2021), 2,271 cancer diagnoses were reported in the study population. Those with an elevated-increasing metabolic syndrome trajectory had 1.3 times the risk of any cancer compared with those in the low-stable group. Risk for breast cancer, endometrial cancer, kidney cancer, colorectal cancer, and liver cancer in the highest trajectory group were 2.1, 3.3, 4.5, 2.5, and 1.6 times higher, respectively, compared to the lowest group. The increased risk in the elevated-trajectory group for all cancer types persisted when the low-stable, moderate-low, and moderate-high trajectory pattern groups were combined.
The researchers also examined the impact of chronic inflammation and found that individuals with persistently high metabolic syndrome scores and concurrent chronic inflammation had the highest risks of breast, endometrial, colon, and liver cancer. However, individuals with persistently high metabolic syndrome scores and no concurrent chronic inflammation had the highest risk of kidney cancer.
What Are the Limitations of This Research?
The researchers of the current study acknowledged the lack of information on other causes of cancer, including dietary habits, hepatitis C infection, and Helicobacter pylori infection. Other limitations include the focus only on individuals from a single community of mainly middle-aged men in China that may not generalize to other populations.
Also, the metabolic syndrome trajectories did not change much over time, which may be related to the short 4-year study period.
Using the International Diabetes Federation criteria was another limitation, because it prevented the assessment of cancer risk in normal weight individuals with metabolic dysfunction, Dr. Hardikar noted.
Does Metabolic Syndrome Cause Cancer?
“This research suggests that proactive and continuous management of metabolic syndrome may serve as an essential strategy in preventing cancer,” senior author Han-Ping Shi, MD, PhD, of Capital Medical University in Beijing, noted in a statement on the study.
More research is needed to assess the impact of these interventions on cancer risk. However, the data from the current study can guide future research that may lead to more targeted treatments and more effective preventive strategies, he continued.
“Current evidence based on this study and many other reports strongly suggests an increased risk for cancer associated with metabolic syndrome,” Dr. Hardikar said in an interview. The data serve as a reminder to clinicians to look beyond BMI as the only measure of obesity, and to consider metabolic factors together to identify individuals at increased risk for cancer, she said.
“We must continue to educate patients about obesity and all the chronic conditions it may lead to, but we cannot ignore this emerging phenotype of being of normal weight but metabolically unhealthy,” Dr. Hardikar emphasized.
What Additional Research is Needed?
Looking ahead, “we need well-designed interventions to test causality for metabolic syndrome and cancer risk, though the evidence from the observational studies is very strong,” Dr. Hardikar said.
In addition, a consensus is needed to better define metabolic dysfunction,and to explore cancer risk in normal weight but metabolically unhealthy individuals, she said.
The study was supported by the National Key Research and Development Program of China. The researchers and Dr. Hardikar had no financial conflicts to disclose.
FROM CANCER
Does worsening metabolic syndrome increase the risk of developing cancer?
The conditions that comprise metabolic syndrome (high blood pressure, high blood sugar, increased abdominal adiposity, and high cholesterol and triglycerides) have been associated with an increased risk of diseases, including heart disease, stroke, and type 2 diabetes, wrote Li Deng, PhD, of Capital Medical University, Beijing, China, and colleagues.
A systematic review and meta-analysis published in Diabetes Care in 2012 showed an association between the presence of metabolic syndrome and an increased risk of various cancers including liver, bladder, pancreatic, breast, and colorectal.
More recently, a 2019 study published in Diabetes showed evidence of increased risk for certain cancers (pancreatic, kidney, uterine, cervical) but no increased risk for cancer overall.
However, the reasons for this association between metabolic syndrome and cancer remain unclear, and the effect of the fluctuating nature of metabolic syndrome over time on long-term cancer risk has not been explored, the researchers wrote.
What Does New Study Add to Other Research on Metabolic Syndrome and Cancer Risk?
In the new study, published in Cancer on March 11 (doi: 10.1002/cncr.35235), 44,115 adults in China were separated into four trajectories based on metabolic syndrome scores for the period from 2006 to 2010. The scores were based on clinical evidence of metabolic syndrome, defined using the International Diabetes Federation criteria of central obesity and the presence of at least two other factors including increased triglycerides, decreased HDL cholesterol, high blood pressure (or treatment for previously diagnosed hypertension), and increased fasting plasma glucose (or previous diagnosis of type 2 diabetes).
The average age of the participants was 49 years. The four trajectories of metabolic syndrome were low-stable (10.56% of participants), moderate-low (40.84%), moderate-high (41.46%), and elevated-increasing (7.14%), based on trends from the individuals’ initial physical exams on entering the study.
Over a median follow-up period of 9.4 years (from 2010 to 2021), 2,271 cancer diagnoses were reported in the study population. Those with an elevated-increasing metabolic syndrome trajectory had 1.3 times the risk of any cancer compared with those in the low-stable group. Risk for breast cancer, endometrial cancer, kidney cancer, colorectal cancer, and liver cancer in the highest trajectory group were 2.1, 3.3, 4.5, 2.5, and 1.6 times higher, respectively, compared to the lowest group. The increased risk in the elevated-trajectory group for all cancer types persisted when the low-stable, moderate-low, and moderate-high trajectory pattern groups were combined.
The researchers also examined the impact of chronic inflammation and found that individuals with persistently high metabolic syndrome scores and concurrent chronic inflammation had the highest risks of breast, endometrial, colon, and liver cancer. However, individuals with persistently high metabolic syndrome scores and no concurrent chronic inflammation had the highest risk of kidney cancer.
What Are the Limitations of This Research?
The researchers of the current study acknowledged the lack of information on other causes of cancer, including dietary habits, hepatitis C infection, and Helicobacter pylori infection. Other limitations include the focus only on individuals from a single community of mainly middle-aged men in China that may not generalize to other populations.
Also, the metabolic syndrome trajectories did not change much over time, which may be related to the short 4-year study period.
What Is the Takeaway Message for Clinical Practice?
The results suggest that monitoring and managing metabolic syndrome could help reduce cancer risk, the researchers concluded.
“This research suggests that proactive and continuous management of metabolic syndrome may serve as an essential strategy in preventing cancer,” senior author Han-Ping Shi, MD, PhD, of Capital Medical University in Beijing, said in a press release accompanying the study.
More research is needed to assess the impact of these interventions on cancer risk, he noted. However, the data from the current study can guide future research that may lead to more targeted treatments and more effective preventive strategies, he said in a statement.
The study was supported by the National Key Research and Development Program of China. The researchers had no financial conflicts to disclose.
The conditions that comprise metabolic syndrome (high blood pressure, high blood sugar, increased abdominal adiposity, and high cholesterol and triglycerides) have been associated with an increased risk of diseases, including heart disease, stroke, and type 2 diabetes, wrote Li Deng, PhD, of Capital Medical University, Beijing, China, and colleagues.
A systematic review and meta-analysis published in Diabetes Care in 2012 showed an association between the presence of metabolic syndrome and an increased risk of various cancers including liver, bladder, pancreatic, breast, and colorectal.
More recently, a 2019 study published in Diabetes showed evidence of increased risk for certain cancers (pancreatic, kidney, uterine, cervical) but no increased risk for cancer overall.
However, the reasons for this association between metabolic syndrome and cancer remain unclear, and the effect of the fluctuating nature of metabolic syndrome over time on long-term cancer risk has not been explored, the researchers wrote.
What Does New Study Add to Other Research on Metabolic Syndrome and Cancer Risk?
In the new study, published in Cancer on March 11 (doi: 10.1002/cncr.35235), 44,115 adults in China were separated into four trajectories based on metabolic syndrome scores for the period from 2006 to 2010. The scores were based on clinical evidence of metabolic syndrome, defined using the International Diabetes Federation criteria of central obesity and the presence of at least two other factors including increased triglycerides, decreased HDL cholesterol, high blood pressure (or treatment for previously diagnosed hypertension), and increased fasting plasma glucose (or previous diagnosis of type 2 diabetes).
The average age of the participants was 49 years. The four trajectories of metabolic syndrome were low-stable (10.56% of participants), moderate-low (40.84%), moderate-high (41.46%), and elevated-increasing (7.14%), based on trends from the individuals’ initial physical exams on entering the study.
Over a median follow-up period of 9.4 years (from 2010 to 2021), 2,271 cancer diagnoses were reported in the study population. Those with an elevated-increasing metabolic syndrome trajectory had 1.3 times the risk of any cancer compared with those in the low-stable group. Risk for breast cancer, endometrial cancer, kidney cancer, colorectal cancer, and liver cancer in the highest trajectory group were 2.1, 3.3, 4.5, 2.5, and 1.6 times higher, respectively, compared to the lowest group. The increased risk in the elevated-trajectory group for all cancer types persisted when the low-stable, moderate-low, and moderate-high trajectory pattern groups were combined.
The researchers also examined the impact of chronic inflammation and found that individuals with persistently high metabolic syndrome scores and concurrent chronic inflammation had the highest risks of breast, endometrial, colon, and liver cancer. However, individuals with persistently high metabolic syndrome scores and no concurrent chronic inflammation had the highest risk of kidney cancer.
What Are the Limitations of This Research?
The researchers of the current study acknowledged the lack of information on other causes of cancer, including dietary habits, hepatitis C infection, and Helicobacter pylori infection. Other limitations include the focus only on individuals from a single community of mainly middle-aged men in China that may not generalize to other populations.
Also, the metabolic syndrome trajectories did not change much over time, which may be related to the short 4-year study period.
What Is the Takeaway Message for Clinical Practice?
The results suggest that monitoring and managing metabolic syndrome could help reduce cancer risk, the researchers concluded.
“This research suggests that proactive and continuous management of metabolic syndrome may serve as an essential strategy in preventing cancer,” senior author Han-Ping Shi, MD, PhD, of Capital Medical University in Beijing, said in a press release accompanying the study.
More research is needed to assess the impact of these interventions on cancer risk, he noted. However, the data from the current study can guide future research that may lead to more targeted treatments and more effective preventive strategies, he said in a statement.
The study was supported by the National Key Research and Development Program of China. The researchers had no financial conflicts to disclose.
The conditions that comprise metabolic syndrome (high blood pressure, high blood sugar, increased abdominal adiposity, and high cholesterol and triglycerides) have been associated with an increased risk of diseases, including heart disease, stroke, and type 2 diabetes, wrote Li Deng, PhD, of Capital Medical University, Beijing, China, and colleagues.
A systematic review and meta-analysis published in Diabetes Care in 2012 showed an association between the presence of metabolic syndrome and an increased risk of various cancers including liver, bladder, pancreatic, breast, and colorectal.
More recently, a 2019 study published in Diabetes showed evidence of increased risk for certain cancers (pancreatic, kidney, uterine, cervical) but no increased risk for cancer overall.
However, the reasons for this association between metabolic syndrome and cancer remain unclear, and the effect of the fluctuating nature of metabolic syndrome over time on long-term cancer risk has not been explored, the researchers wrote.
What Does New Study Add to Other Research on Metabolic Syndrome and Cancer Risk?
In the new study, published in Cancer on March 11 (doi: 10.1002/cncr.35235), 44,115 adults in China were separated into four trajectories based on metabolic syndrome scores for the period from 2006 to 2010. The scores were based on clinical evidence of metabolic syndrome, defined using the International Diabetes Federation criteria of central obesity and the presence of at least two other factors including increased triglycerides, decreased HDL cholesterol, high blood pressure (or treatment for previously diagnosed hypertension), and increased fasting plasma glucose (or previous diagnosis of type 2 diabetes).
The average age of the participants was 49 years. The four trajectories of metabolic syndrome were low-stable (10.56% of participants), moderate-low (40.84%), moderate-high (41.46%), and elevated-increasing (7.14%), based on trends from the individuals’ initial physical exams on entering the study.
Over a median follow-up period of 9.4 years (from 2010 to 2021), 2,271 cancer diagnoses were reported in the study population. Those with an elevated-increasing metabolic syndrome trajectory had 1.3 times the risk of any cancer compared with those in the low-stable group. Risk for breast cancer, endometrial cancer, kidney cancer, colorectal cancer, and liver cancer in the highest trajectory group were 2.1, 3.3, 4.5, 2.5, and 1.6 times higher, respectively, compared to the lowest group. The increased risk in the elevated-trajectory group for all cancer types persisted when the low-stable, moderate-low, and moderate-high trajectory pattern groups were combined.
The researchers also examined the impact of chronic inflammation and found that individuals with persistently high metabolic syndrome scores and concurrent chronic inflammation had the highest risks of breast, endometrial, colon, and liver cancer. However, individuals with persistently high metabolic syndrome scores and no concurrent chronic inflammation had the highest risk of kidney cancer.
What Are the Limitations of This Research?
The researchers of the current study acknowledged the lack of information on other causes of cancer, including dietary habits, hepatitis C infection, and Helicobacter pylori infection. Other limitations include the focus only on individuals from a single community of mainly middle-aged men in China that may not generalize to other populations.
Also, the metabolic syndrome trajectories did not change much over time, which may be related to the short 4-year study period.
What Is the Takeaway Message for Clinical Practice?
The results suggest that monitoring and managing metabolic syndrome could help reduce cancer risk, the researchers concluded.
“This research suggests that proactive and continuous management of metabolic syndrome may serve as an essential strategy in preventing cancer,” senior author Han-Ping Shi, MD, PhD, of Capital Medical University in Beijing, said in a press release accompanying the study.
More research is needed to assess the impact of these interventions on cancer risk, he noted. However, the data from the current study can guide future research that may lead to more targeted treatments and more effective preventive strategies, he said in a statement.
The study was supported by the National Key Research and Development Program of China. The researchers had no financial conflicts to disclose.
FROM CANCER
Sulfites Selected as ACDS Allergen of the Year
by the American Contact Dermatitis Society (ACDS).
Sulfites are currently not found in most screening patch test series, so may be missed as a relevant contact allergen, Donald V. Belsito, MD, emeritus professor in the Department of Dermatology at Columbia University, New York City, said in his presentation on the Allergen of the Year on March 7 at the annual meeting of the American Contact Dermatitis Society in San Diego. Sulfites, he noted, are distinct from sulfates, and the groups do not cross-react with each other.
Sodium disulfite, an inorganic compound, belongs to a group of sulfiting agents, which contain the sulfite ion SO32− and include ammonium sulfite, potassium sulfite, and sodium sulfite, Dr. Belsito said. Sulfites function as antioxidants and preservatives in a range of products including food and beverages, personal care products, and pharmaceuticals.
The type of sulfite allergy diagnosed by patch testing is type IV hypersensitivity or delayed-type hypersensitivity, where patients present with pruritic, red, scaling macules, papulovesicles, and patches, Dr. Belsito told this news organization. “It is not the type I, immediate hypersensitivity that causes hives and, in some cases, anaphylaxis,” he said. Sulfites also can cause these side effects, so correct labeling of food and beverages is important, he noted.
Some common nonoccupational sulfite sources include hair coloring and bleach products, hairspray, tanning lotions, makeup, sunscreens, and deodorants, Dr. Belsito said in his presentation. Medications including topical antifungals, topical corticosteroids, and nasal solutions can be culprits, as can water in swimming pools, he noted.
In occupational settings, sulfites may be present not only in food and drink products but also can be used in production of products, such as those used for sterilization during beer and wine fermentation, Dr. Belsito said. Other potential occupational sources of sulfite exposure include healthcare settings and textile, chemical, rubber, and pharmaceutical manufacturing.
High-sulfite food products (> 100 ppm) to be aware of include dried fruit (raisins and prunes are exceptions), bottled lemon or lime juice (but not frozen products), wine, molasses, grape juice (white, or white, pink, and red sparkling), and pickled cocktail onions, Dr. Belsito said.
“Like other contact allergens, the clinical presentation correlates with exposure,” he added. A study by the North American Contact Dermatitis Group (NACDG) found that 28.8% of patients positive for sulfite allergy on patch testing presented with facial dermatitis, which was not only related to cosmetics and medications used on the face but also from products, such as shampoo, used on the scalp that dripped onto the face. “The scalp is relatively resistant to the expression of contact allergy and may not be involved at all,” he said.
According to the NACDG study, the hands were the second most common site of dermatitis associated with sulfites (20.5%) followed by generalized distribution (13.6%). These sites are to be expected, given the sources of food and beverage, personal care products, and occupational materials, Dr. Belsito said.
“Eczematous dermatitis of the lips is also common in patients with ingested food sources of sulfites,” he said.
Systemic contact dermatitis to sulfites has been documented following oral, rectal, and parental exposure, Dr. Belsito told this news organization. “Systemic dermatitis may present as a scattered/generalized dermatitis, symmetrical drug-related intertriginous and flexural exanthema (also referred to as baboon syndrome), or erythroderma,” he said.
How to Spot Sulfite Allergies
The exclusion of sulfites from most patch test series means that sulfite allergy diagnoses are often missed, despite the wide range of potential exposures, Dr. Belsito said.
“Most cases of allergic contact dermatitis occur at the site of application of the allergen,” he noted. Depending on the location of the dermatitis, a detailed history of exposures that includes cosmetics and topical medications, work-related materials, and foods and beverages might suggest a sulfite allergy, he said.
Given the range of potential clinical presentations and the many and varied exposures to sulfites, Dr. Belsito’s best tip for clinicians is to routinely screen for them and evaluate the many avenues of exposure if a patch test is positive, he said.
For now, he said he does not think additional research is needed on sulfites as allergens; instead, sulfites, such as sodium metabisulfite/sodium disulfite, should be included in all clinicians’ baseline screening series, he said.
The Allergen of the Year was also recently announced in the journal Dermatitis. Authors Samuel F. Ekstein, MS, and Erin M. Warshaw, MD, from the Department of Dermatology, Park Nicollet Health Services, Minneapolis, Minnesota, noted that the ACDS hoped to raise awareness of sulfites as a “significant allergen” and called for their increased inclusion in screening patch test series.
Patients identified with sulfite allergies can find alternative products on the ACDS CAMP (Contact Allergen Management Program) website, Dr. Warshaw said in an interview.
She also highlighted some examples of sulfites as allergens in healthcare settings in particular. She described one patient who presented with dermatitis at the site of three previous hand orthopedic procedures.
“Although surgical cleansers were suspected, the patient reacted to sodium metabisulfite. Review of the operating room contactants confirmed sulfites as preservatives in an injectable anesthetic and antibiotic used for wound irrigation,” she said. Another patient who had been treated for recurrent otitis externa and seborrheic dermatitis was found to be allergic to sulfites in an otic antibiotic suspension as well as in a ketoconazole cream product, she added.
In the paper, Dr. Warshaw and Mr. Ekstein called for the addition of sulfites to the test series. Although the NACDG added sodium metabisulfite to the series in 2017, sulfites are not part of the American Contact Dermatitis Core Series, they wrote. Sodium metabisulfite, they said, was added to the European baseline standard series after review of the 2019-2020 patch test reactivity and clinical relevance data.
The ACDS meeting is held every year the day before the annual meeting of the American Academy of Dermatology.
Dr. Belsito and Dr. Warshaw had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
by the American Contact Dermatitis Society (ACDS).
Sulfites are currently not found in most screening patch test series, so may be missed as a relevant contact allergen, Donald V. Belsito, MD, emeritus professor in the Department of Dermatology at Columbia University, New York City, said in his presentation on the Allergen of the Year on March 7 at the annual meeting of the American Contact Dermatitis Society in San Diego. Sulfites, he noted, are distinct from sulfates, and the groups do not cross-react with each other.
Sodium disulfite, an inorganic compound, belongs to a group of sulfiting agents, which contain the sulfite ion SO32− and include ammonium sulfite, potassium sulfite, and sodium sulfite, Dr. Belsito said. Sulfites function as antioxidants and preservatives in a range of products including food and beverages, personal care products, and pharmaceuticals.
The type of sulfite allergy diagnosed by patch testing is type IV hypersensitivity or delayed-type hypersensitivity, where patients present with pruritic, red, scaling macules, papulovesicles, and patches, Dr. Belsito told this news organization. “It is not the type I, immediate hypersensitivity that causes hives and, in some cases, anaphylaxis,” he said. Sulfites also can cause these side effects, so correct labeling of food and beverages is important, he noted.
Some common nonoccupational sulfite sources include hair coloring and bleach products, hairspray, tanning lotions, makeup, sunscreens, and deodorants, Dr. Belsito said in his presentation. Medications including topical antifungals, topical corticosteroids, and nasal solutions can be culprits, as can water in swimming pools, he noted.
In occupational settings, sulfites may be present not only in food and drink products but also can be used in production of products, such as those used for sterilization during beer and wine fermentation, Dr. Belsito said. Other potential occupational sources of sulfite exposure include healthcare settings and textile, chemical, rubber, and pharmaceutical manufacturing.
High-sulfite food products (> 100 ppm) to be aware of include dried fruit (raisins and prunes are exceptions), bottled lemon or lime juice (but not frozen products), wine, molasses, grape juice (white, or white, pink, and red sparkling), and pickled cocktail onions, Dr. Belsito said.
“Like other contact allergens, the clinical presentation correlates with exposure,” he added. A study by the North American Contact Dermatitis Group (NACDG) found that 28.8% of patients positive for sulfite allergy on patch testing presented with facial dermatitis, which was not only related to cosmetics and medications used on the face but also from products, such as shampoo, used on the scalp that dripped onto the face. “The scalp is relatively resistant to the expression of contact allergy and may not be involved at all,” he said.
According to the NACDG study, the hands were the second most common site of dermatitis associated with sulfites (20.5%) followed by generalized distribution (13.6%). These sites are to be expected, given the sources of food and beverage, personal care products, and occupational materials, Dr. Belsito said.
“Eczematous dermatitis of the lips is also common in patients with ingested food sources of sulfites,” he said.
Systemic contact dermatitis to sulfites has been documented following oral, rectal, and parental exposure, Dr. Belsito told this news organization. “Systemic dermatitis may present as a scattered/generalized dermatitis, symmetrical drug-related intertriginous and flexural exanthema (also referred to as baboon syndrome), or erythroderma,” he said.
How to Spot Sulfite Allergies
The exclusion of sulfites from most patch test series means that sulfite allergy diagnoses are often missed, despite the wide range of potential exposures, Dr. Belsito said.
“Most cases of allergic contact dermatitis occur at the site of application of the allergen,” he noted. Depending on the location of the dermatitis, a detailed history of exposures that includes cosmetics and topical medications, work-related materials, and foods and beverages might suggest a sulfite allergy, he said.
Given the range of potential clinical presentations and the many and varied exposures to sulfites, Dr. Belsito’s best tip for clinicians is to routinely screen for them and evaluate the many avenues of exposure if a patch test is positive, he said.
For now, he said he does not think additional research is needed on sulfites as allergens; instead, sulfites, such as sodium metabisulfite/sodium disulfite, should be included in all clinicians’ baseline screening series, he said.
The Allergen of the Year was also recently announced in the journal Dermatitis. Authors Samuel F. Ekstein, MS, and Erin M. Warshaw, MD, from the Department of Dermatology, Park Nicollet Health Services, Minneapolis, Minnesota, noted that the ACDS hoped to raise awareness of sulfites as a “significant allergen” and called for their increased inclusion in screening patch test series.
Patients identified with sulfite allergies can find alternative products on the ACDS CAMP (Contact Allergen Management Program) website, Dr. Warshaw said in an interview.
She also highlighted some examples of sulfites as allergens in healthcare settings in particular. She described one patient who presented with dermatitis at the site of three previous hand orthopedic procedures.
“Although surgical cleansers were suspected, the patient reacted to sodium metabisulfite. Review of the operating room contactants confirmed sulfites as preservatives in an injectable anesthetic and antibiotic used for wound irrigation,” she said. Another patient who had been treated for recurrent otitis externa and seborrheic dermatitis was found to be allergic to sulfites in an otic antibiotic suspension as well as in a ketoconazole cream product, she added.
In the paper, Dr. Warshaw and Mr. Ekstein called for the addition of sulfites to the test series. Although the NACDG added sodium metabisulfite to the series in 2017, sulfites are not part of the American Contact Dermatitis Core Series, they wrote. Sodium metabisulfite, they said, was added to the European baseline standard series after review of the 2019-2020 patch test reactivity and clinical relevance data.
The ACDS meeting is held every year the day before the annual meeting of the American Academy of Dermatology.
Dr. Belsito and Dr. Warshaw had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
by the American Contact Dermatitis Society (ACDS).
Sulfites are currently not found in most screening patch test series, so may be missed as a relevant contact allergen, Donald V. Belsito, MD, emeritus professor in the Department of Dermatology at Columbia University, New York City, said in his presentation on the Allergen of the Year on March 7 at the annual meeting of the American Contact Dermatitis Society in San Diego. Sulfites, he noted, are distinct from sulfates, and the groups do not cross-react with each other.
Sodium disulfite, an inorganic compound, belongs to a group of sulfiting agents, which contain the sulfite ion SO32− and include ammonium sulfite, potassium sulfite, and sodium sulfite, Dr. Belsito said. Sulfites function as antioxidants and preservatives in a range of products including food and beverages, personal care products, and pharmaceuticals.
The type of sulfite allergy diagnosed by patch testing is type IV hypersensitivity or delayed-type hypersensitivity, where patients present with pruritic, red, scaling macules, papulovesicles, and patches, Dr. Belsito told this news organization. “It is not the type I, immediate hypersensitivity that causes hives and, in some cases, anaphylaxis,” he said. Sulfites also can cause these side effects, so correct labeling of food and beverages is important, he noted.
Some common nonoccupational sulfite sources include hair coloring and bleach products, hairspray, tanning lotions, makeup, sunscreens, and deodorants, Dr. Belsito said in his presentation. Medications including topical antifungals, topical corticosteroids, and nasal solutions can be culprits, as can water in swimming pools, he noted.
In occupational settings, sulfites may be present not only in food and drink products but also can be used in production of products, such as those used for sterilization during beer and wine fermentation, Dr. Belsito said. Other potential occupational sources of sulfite exposure include healthcare settings and textile, chemical, rubber, and pharmaceutical manufacturing.
High-sulfite food products (> 100 ppm) to be aware of include dried fruit (raisins and prunes are exceptions), bottled lemon or lime juice (but not frozen products), wine, molasses, grape juice (white, or white, pink, and red sparkling), and pickled cocktail onions, Dr. Belsito said.
“Like other contact allergens, the clinical presentation correlates with exposure,” he added. A study by the North American Contact Dermatitis Group (NACDG) found that 28.8% of patients positive for sulfite allergy on patch testing presented with facial dermatitis, which was not only related to cosmetics and medications used on the face but also from products, such as shampoo, used on the scalp that dripped onto the face. “The scalp is relatively resistant to the expression of contact allergy and may not be involved at all,” he said.
According to the NACDG study, the hands were the second most common site of dermatitis associated with sulfites (20.5%) followed by generalized distribution (13.6%). These sites are to be expected, given the sources of food and beverage, personal care products, and occupational materials, Dr. Belsito said.
“Eczematous dermatitis of the lips is also common in patients with ingested food sources of sulfites,” he said.
Systemic contact dermatitis to sulfites has been documented following oral, rectal, and parental exposure, Dr. Belsito told this news organization. “Systemic dermatitis may present as a scattered/generalized dermatitis, symmetrical drug-related intertriginous and flexural exanthema (also referred to as baboon syndrome), or erythroderma,” he said.
How to Spot Sulfite Allergies
The exclusion of sulfites from most patch test series means that sulfite allergy diagnoses are often missed, despite the wide range of potential exposures, Dr. Belsito said.
“Most cases of allergic contact dermatitis occur at the site of application of the allergen,” he noted. Depending on the location of the dermatitis, a detailed history of exposures that includes cosmetics and topical medications, work-related materials, and foods and beverages might suggest a sulfite allergy, he said.
Given the range of potential clinical presentations and the many and varied exposures to sulfites, Dr. Belsito’s best tip for clinicians is to routinely screen for them and evaluate the many avenues of exposure if a patch test is positive, he said.
For now, he said he does not think additional research is needed on sulfites as allergens; instead, sulfites, such as sodium metabisulfite/sodium disulfite, should be included in all clinicians’ baseline screening series, he said.
The Allergen of the Year was also recently announced in the journal Dermatitis. Authors Samuel F. Ekstein, MS, and Erin M. Warshaw, MD, from the Department of Dermatology, Park Nicollet Health Services, Minneapolis, Minnesota, noted that the ACDS hoped to raise awareness of sulfites as a “significant allergen” and called for their increased inclusion in screening patch test series.
Patients identified with sulfite allergies can find alternative products on the ACDS CAMP (Contact Allergen Management Program) website, Dr. Warshaw said in an interview.
She also highlighted some examples of sulfites as allergens in healthcare settings in particular. She described one patient who presented with dermatitis at the site of three previous hand orthopedic procedures.
“Although surgical cleansers were suspected, the patient reacted to sodium metabisulfite. Review of the operating room contactants confirmed sulfites as preservatives in an injectable anesthetic and antibiotic used for wound irrigation,” she said. Another patient who had been treated for recurrent otitis externa and seborrheic dermatitis was found to be allergic to sulfites in an otic antibiotic suspension as well as in a ketoconazole cream product, she added.
In the paper, Dr. Warshaw and Mr. Ekstein called for the addition of sulfites to the test series. Although the NACDG added sodium metabisulfite to the series in 2017, sulfites are not part of the American Contact Dermatitis Core Series, they wrote. Sodium metabisulfite, they said, was added to the European baseline standard series after review of the 2019-2020 patch test reactivity and clinical relevance data.
The ACDS meeting is held every year the day before the annual meeting of the American Academy of Dermatology.
Dr. Belsito and Dr. Warshaw had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
FROM ACDS 2024
TIL for Melanoma: What Are the Costs and Other Challenges to Getting It to Patients?
The US Food and Drug Administration (FDA) recently approved the tumor-infiltrating lymphocyte cell therapy (TIL) for use in certain adults with unresectable or metastatic melanoma. This marks the first time the FDA has allowed a cellular therapy to be marketed for a solid tumor cancer.
Lifileucel is made from a patient’s surgically removed tumor. Tissue from that tumor is then sent to a manufacturing center. Turnaround time to when the drug is ready to be sent back to the cancer center for use is approximately 34 days, according to the drug’s manufacturer, Iovance.
Insurance Adjustments
The cost of the one-time lifileucel treatment is $515,000, according to the manufacturer.
Two investigators in the clinical trials of lifileucel, Allison Betof Warner, MD, of Stanford University, Stanford, California, and Igor Puzanov, MD, of Roswell Park Comprehensive Cancer Center, Buffalo, New York, shared their expectations regarding factors that would contribute to how much a patient paid for the drug.
Given the drug’s recent approval, the logistical details are still being worked out between cancer centers and insurers regarding how much patients will pay out of pocket for lifileucel, said Dr. Betof Warner, who is assistant professor in the Department of Medicine, Division of Medical Oncology at Stanford University.
The associated costs, including the surgery that is needed to procure the TIL cells for expansion into the final drug product, will be different for each patient, she told this publication.
Patients’ costs for lifileucel will vary based on their insurance, explained Dr. Puzanov, chief of melanoma and professor of oncology at Roswell Park Comprehensive Cancer Center.
At Roswell Park, “we will work with our regionally-based payers on a case-by-case basis to seek approval for those patients we believe can most benefit from lifileucel,” he said in an interview. Preauthorization will be required, as is standard for many cancer treatments, he added.
Once payer approval is in place, Dr. Puzanov said, he did not anticipate significant delays in access for patients.
Certified centers such as the multidisciplinary team at Roswell Park are ready to treat patients now. Other centers are similarly prepared, especially those involved in the clinical trials of lifileucel, he said.
Logistics and Infrastructure
A position article and guidelines on the management of and best practices for TIL was published in the Journal for ImmunoTherapy of Cancer on February 29. The paper, of which both Dr. Betof Warner and Dr. Puzanov served as authors, noted that one of the barriers to the use of TIL cell therapy in clinical practice is the need for state-of-the art infrastructure at centers that want to offer the treatment. Scheduling, patient referrals, and surgery, as well as the production and infusion of TIL, must be organized and streamlined for successful treatment, the authors wrote.
The two supply chains involved in TIL — the transportation of the tumor tissue from the treatment center to the manufacturer and transport of the TIL infusion product back to the treatment center — must be timely and precise, they emphasized.
Docs Hope TIL Improves in Several Ways
Although the TIL technology is a breakthrough, “we hope to see even better efficacy and lower toxicity as further research looks at ways to improve on the current TIL standard,” Dr. Puzanov said.
More research and dose adjustments may impact patient costs and side effects, he noted. “I am looking to see TILs used in the front line, with or without checkpoint inhibitors.”
Research is needed to explore how to lower the chemotherapy doses and possibly the associated toxicity, he added. Finally, researchers must consider whether high-dose IL-2 therapy — given as part of the TIL cell therapy — could be replaced with other cytokines, or whether the number of doses could be lowered. Another avenue of exploration is engineering genes for cytokines into TILs, he said.
“The key is to think about TIL therapy before you need it — ideally, when the patient is still doing well on their frontline checkpoint inhibition immunotherapy,” Dr. Puzanov said in an interview. That is the time for evaluation, and specialty centers can provide an expert assessment, he said.
“We are constantly working to improve TIL therapy,” Dr. Betof Warner told this publication. More research is needed optimize the regimen to reduce side effects, which would not only make treatment easier for currently eligible patients, but might allow treatment for patients not currently eligible.
“For example, we are looking for ways to reduce the dose of preparative chemotherapy, which prepares the body for the cells to maximize their longevity and efficacy, and to reduce or eliminate the need to give IL-2 after the cell administration,” continued Dr. Betof Warner, who is also Director of Melanoma Medical Oncology, Director of Solid Tumor Cellular Therapy, and Codirector of the Pigmented Lesion and Melanoma Program at Stanford University. “We are also actively studying next-generation TIL therapies to try to increase the efficacy.”
“Lifileucel has about a 30% success rate for melanoma that has progressed after standard therapy; we are working hard to do better than that,” she noted.
In a press release, Iovance summarized the results of the trial that supported the FDA’s accelerated approval of lifileucel. In an open-label single-arm study, including multiple sites worldwide, 73 adults with unresectable or metastatic melanoma who had received at least one previous systemic therapy underwent a lymphodepleting regimen followed by treatments with fludarabine and aldesleukin. Patients then received lifileucel at a median dose of 21.1 x 109 viable cells; the recommended dose ranges from 7.5 x 109 to 72 x 109 cells.
The primary efficacy outcome was objective response rate (ORR). The ORR in the study was 31.5%, and the median time to initial lifileucel response was 1.5 months.
The clinical trials of lifileucel for which Dr. Betof Warner and Dr. Puzanov served as investigators were sponsored by Iovance.
The US Food and Drug Administration (FDA) recently approved the tumor-infiltrating lymphocyte cell therapy (TIL) for use in certain adults with unresectable or metastatic melanoma. This marks the first time the FDA has allowed a cellular therapy to be marketed for a solid tumor cancer.
Lifileucel is made from a patient’s surgically removed tumor. Tissue from that tumor is then sent to a manufacturing center. Turnaround time to when the drug is ready to be sent back to the cancer center for use is approximately 34 days, according to the drug’s manufacturer, Iovance.
Insurance Adjustments
The cost of the one-time lifileucel treatment is $515,000, according to the manufacturer.
Two investigators in the clinical trials of lifileucel, Allison Betof Warner, MD, of Stanford University, Stanford, California, and Igor Puzanov, MD, of Roswell Park Comprehensive Cancer Center, Buffalo, New York, shared their expectations regarding factors that would contribute to how much a patient paid for the drug.
Given the drug’s recent approval, the logistical details are still being worked out between cancer centers and insurers regarding how much patients will pay out of pocket for lifileucel, said Dr. Betof Warner, who is assistant professor in the Department of Medicine, Division of Medical Oncology at Stanford University.
The associated costs, including the surgery that is needed to procure the TIL cells for expansion into the final drug product, will be different for each patient, she told this publication.
Patients’ costs for lifileucel will vary based on their insurance, explained Dr. Puzanov, chief of melanoma and professor of oncology at Roswell Park Comprehensive Cancer Center.
At Roswell Park, “we will work with our regionally-based payers on a case-by-case basis to seek approval for those patients we believe can most benefit from lifileucel,” he said in an interview. Preauthorization will be required, as is standard for many cancer treatments, he added.
Once payer approval is in place, Dr. Puzanov said, he did not anticipate significant delays in access for patients.
Certified centers such as the multidisciplinary team at Roswell Park are ready to treat patients now. Other centers are similarly prepared, especially those involved in the clinical trials of lifileucel, he said.
Logistics and Infrastructure
A position article and guidelines on the management of and best practices for TIL was published in the Journal for ImmunoTherapy of Cancer on February 29. The paper, of which both Dr. Betof Warner and Dr. Puzanov served as authors, noted that one of the barriers to the use of TIL cell therapy in clinical practice is the need for state-of-the art infrastructure at centers that want to offer the treatment. Scheduling, patient referrals, and surgery, as well as the production and infusion of TIL, must be organized and streamlined for successful treatment, the authors wrote.
The two supply chains involved in TIL — the transportation of the tumor tissue from the treatment center to the manufacturer and transport of the TIL infusion product back to the treatment center — must be timely and precise, they emphasized.
Docs Hope TIL Improves in Several Ways
Although the TIL technology is a breakthrough, “we hope to see even better efficacy and lower toxicity as further research looks at ways to improve on the current TIL standard,” Dr. Puzanov said.
More research and dose adjustments may impact patient costs and side effects, he noted. “I am looking to see TILs used in the front line, with or without checkpoint inhibitors.”
Research is needed to explore how to lower the chemotherapy doses and possibly the associated toxicity, he added. Finally, researchers must consider whether high-dose IL-2 therapy — given as part of the TIL cell therapy — could be replaced with other cytokines, or whether the number of doses could be lowered. Another avenue of exploration is engineering genes for cytokines into TILs, he said.
“The key is to think about TIL therapy before you need it — ideally, when the patient is still doing well on their frontline checkpoint inhibition immunotherapy,” Dr. Puzanov said in an interview. That is the time for evaluation, and specialty centers can provide an expert assessment, he said.
“We are constantly working to improve TIL therapy,” Dr. Betof Warner told this publication. More research is needed optimize the regimen to reduce side effects, which would not only make treatment easier for currently eligible patients, but might allow treatment for patients not currently eligible.
“For example, we are looking for ways to reduce the dose of preparative chemotherapy, which prepares the body for the cells to maximize their longevity and efficacy, and to reduce or eliminate the need to give IL-2 after the cell administration,” continued Dr. Betof Warner, who is also Director of Melanoma Medical Oncology, Director of Solid Tumor Cellular Therapy, and Codirector of the Pigmented Lesion and Melanoma Program at Stanford University. “We are also actively studying next-generation TIL therapies to try to increase the efficacy.”
“Lifileucel has about a 30% success rate for melanoma that has progressed after standard therapy; we are working hard to do better than that,” she noted.
In a press release, Iovance summarized the results of the trial that supported the FDA’s accelerated approval of lifileucel. In an open-label single-arm study, including multiple sites worldwide, 73 adults with unresectable or metastatic melanoma who had received at least one previous systemic therapy underwent a lymphodepleting regimen followed by treatments with fludarabine and aldesleukin. Patients then received lifileucel at a median dose of 21.1 x 109 viable cells; the recommended dose ranges from 7.5 x 109 to 72 x 109 cells.
The primary efficacy outcome was objective response rate (ORR). The ORR in the study was 31.5%, and the median time to initial lifileucel response was 1.5 months.
The clinical trials of lifileucel for which Dr. Betof Warner and Dr. Puzanov served as investigators were sponsored by Iovance.
The US Food and Drug Administration (FDA) recently approved the tumor-infiltrating lymphocyte cell therapy (TIL) for use in certain adults with unresectable or metastatic melanoma. This marks the first time the FDA has allowed a cellular therapy to be marketed for a solid tumor cancer.
Lifileucel is made from a patient’s surgically removed tumor. Tissue from that tumor is then sent to a manufacturing center. Turnaround time to when the drug is ready to be sent back to the cancer center for use is approximately 34 days, according to the drug’s manufacturer, Iovance.
Insurance Adjustments
The cost of the one-time lifileucel treatment is $515,000, according to the manufacturer.
Two investigators in the clinical trials of lifileucel, Allison Betof Warner, MD, of Stanford University, Stanford, California, and Igor Puzanov, MD, of Roswell Park Comprehensive Cancer Center, Buffalo, New York, shared their expectations regarding factors that would contribute to how much a patient paid for the drug.
Given the drug’s recent approval, the logistical details are still being worked out between cancer centers and insurers regarding how much patients will pay out of pocket for lifileucel, said Dr. Betof Warner, who is assistant professor in the Department of Medicine, Division of Medical Oncology at Stanford University.
The associated costs, including the surgery that is needed to procure the TIL cells for expansion into the final drug product, will be different for each patient, she told this publication.
Patients’ costs for lifileucel will vary based on their insurance, explained Dr. Puzanov, chief of melanoma and professor of oncology at Roswell Park Comprehensive Cancer Center.
At Roswell Park, “we will work with our regionally-based payers on a case-by-case basis to seek approval for those patients we believe can most benefit from lifileucel,” he said in an interview. Preauthorization will be required, as is standard for many cancer treatments, he added.
Once payer approval is in place, Dr. Puzanov said, he did not anticipate significant delays in access for patients.
Certified centers such as the multidisciplinary team at Roswell Park are ready to treat patients now. Other centers are similarly prepared, especially those involved in the clinical trials of lifileucel, he said.
Logistics and Infrastructure
A position article and guidelines on the management of and best practices for TIL was published in the Journal for ImmunoTherapy of Cancer on February 29. The paper, of which both Dr. Betof Warner and Dr. Puzanov served as authors, noted that one of the barriers to the use of TIL cell therapy in clinical practice is the need for state-of-the art infrastructure at centers that want to offer the treatment. Scheduling, patient referrals, and surgery, as well as the production and infusion of TIL, must be organized and streamlined for successful treatment, the authors wrote.
The two supply chains involved in TIL — the transportation of the tumor tissue from the treatment center to the manufacturer and transport of the TIL infusion product back to the treatment center — must be timely and precise, they emphasized.
Docs Hope TIL Improves in Several Ways
Although the TIL technology is a breakthrough, “we hope to see even better efficacy and lower toxicity as further research looks at ways to improve on the current TIL standard,” Dr. Puzanov said.
More research and dose adjustments may impact patient costs and side effects, he noted. “I am looking to see TILs used in the front line, with or without checkpoint inhibitors.”
Research is needed to explore how to lower the chemotherapy doses and possibly the associated toxicity, he added. Finally, researchers must consider whether high-dose IL-2 therapy — given as part of the TIL cell therapy — could be replaced with other cytokines, or whether the number of doses could be lowered. Another avenue of exploration is engineering genes for cytokines into TILs, he said.
“The key is to think about TIL therapy before you need it — ideally, when the patient is still doing well on their frontline checkpoint inhibition immunotherapy,” Dr. Puzanov said in an interview. That is the time for evaluation, and specialty centers can provide an expert assessment, he said.
“We are constantly working to improve TIL therapy,” Dr. Betof Warner told this publication. More research is needed optimize the regimen to reduce side effects, which would not only make treatment easier for currently eligible patients, but might allow treatment for patients not currently eligible.
“For example, we are looking for ways to reduce the dose of preparative chemotherapy, which prepares the body for the cells to maximize their longevity and efficacy, and to reduce or eliminate the need to give IL-2 after the cell administration,” continued Dr. Betof Warner, who is also Director of Melanoma Medical Oncology, Director of Solid Tumor Cellular Therapy, and Codirector of the Pigmented Lesion and Melanoma Program at Stanford University. “We are also actively studying next-generation TIL therapies to try to increase the efficacy.”
“Lifileucel has about a 30% success rate for melanoma that has progressed after standard therapy; we are working hard to do better than that,” she noted.
In a press release, Iovance summarized the results of the trial that supported the FDA’s accelerated approval of lifileucel. In an open-label single-arm study, including multiple sites worldwide, 73 adults with unresectable or metastatic melanoma who had received at least one previous systemic therapy underwent a lymphodepleting regimen followed by treatments with fludarabine and aldesleukin. Patients then received lifileucel at a median dose of 21.1 x 109 viable cells; the recommended dose ranges from 7.5 x 109 to 72 x 109 cells.
The primary efficacy outcome was objective response rate (ORR). The ORR in the study was 31.5%, and the median time to initial lifileucel response was 1.5 months.
The clinical trials of lifileucel for which Dr. Betof Warner and Dr. Puzanov served as investigators were sponsored by Iovance.
Study Finds No Increased Cancer Risk With Spironolactone
TOPLINE:
than that of unexposed women.
METHODOLOGY:
- Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
- The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
- Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.
TAKEAWAY:
- A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
- After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
- The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).
IN PRACTICE:
“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.
SOURCE:
The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.
A version of this article appeared on Medscape.com.
TOPLINE:
than that of unexposed women.
METHODOLOGY:
- Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
- The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
- Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.
TAKEAWAY:
- A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
- After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
- The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).
IN PRACTICE:
“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.
SOURCE:
The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.
A version of this article appeared on Medscape.com.
TOPLINE:
than that of unexposed women.
METHODOLOGY:
- Spironolactone, used off-label for several skin conditions in women, carries a warning about an increased tumor risk associated with high doses in rat models, and its antiandrogen properties have prompted hypotheses about a possible increased risk for breast or gynecologic cancers.
- The researchers reviewed data on 420 women with a history of spironolactone use for acne, hair loss, and hirsutism and 3272 women with no spironolactone use at the authors› institution. Their mean age ranged from 42 to 63 years; the majority were White, and 38% were non-White.
- Median spironolactone doses ranged from 25 mg to 225 mg; chart reviews included 5-year follow-up data from the first spironolactone exposure to allow time for tumor development.
TAKEAWAY:
- A total of 37 of the 420 women exposed to spironolactone developed any tumors, as did 546 of the 3272 with no spironolactone exposure.
- After the researchers controlled for age and race, women exposed to spironolactone were no more likely to develop a malignant tumor than a benign tumor, compared with unexposed women (odds ratio [OR], 0.48, P = .2).
- The risk for breast or uterine cancer was not significantly different in the spironolactone and non-spironolactone groups (OR, 0.95, P > .9).
IN PRACTICE:
“Women taking spironolactone for acne, hair loss, and hirsutism and who are at low risk of breast or gynecologic cancers may be counseled to have regular gynecology follow-up, but no more frequently than the general population,” but more studies are needed to evaluate risk over longer periods of time, the researchers wrote.
SOURCE:
The lead author of the study was Rachel C. Hill, BS, a student at Weill Cornell Medical College, New York City, and Shari R. Lipner, MD, PhD, of the department of dermatology at Weill Cornell Medical College, was the corresponding author. The study was published online in The Journal of the American Academy of Dermatology.
LIMITATIONS:
The findings were limited by the retrospective design, as well as the small number of spironolactone patients analyzed, the short follow-up period, the lack of information about spironolactone courses, and the inability to control for family history of malignancy.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences and a grant from the Clinical and Translational Science Center at Weill Cornell Medical College awarded to Ms. Hill. None of the authors had relevant disclosures; Dr. Lipner disclosed serving as a consultant for Ortho-Dermatologics, Eli Lilly, Moberg Pharmaceuticals, and BelleTorus Corporation.
A version of this article appeared on Medscape.com.
What Is the Long-Term Mortality Risk for Men With HR+ Breast Cancer?
Breast cancer-specific mortality risk in men with hormone receptor–positive breast cancer persists for at least 20 years, but patterns of breast cancer–specific mortality (BCSM) are distinct from those in women, a new study finds.
Previous studies in women with hormone receptor–positive (HR+) breast cancer have shown a risk of distant recurrence and death for at least 20 years after diagnosis, but data for men are limited, wrote Julieta Leone, MD, of the Dana Farber Cancer Institute, Boston, and colleagues.
What is Known About Hormone Receptor–Positive Breast Cancer Mortality in Men vs. Women?
Invasive breast cancer in men is rare and consequently understudied, the researchers wrote. Previous studies of BCSM in men with more than 5 years’ follow-up consist mainly of case series at single institutions, the researchers wrote in JAMA Oncology (2024 Feb 29. doi: 10.1001/jamaoncol.2023.7194).
“We believed it would be important to study this issue to help inform the management of men with breast cancer,” corresponding author, José P. Leone, MD, said in an interview.
In 2021, Dr. J.P. Leone and colleagues published a study in Breast Cancer Research and Treatment that examined the 20-year risk of BCSM in women that included more than 36,000 individuals who had survived for 5 years, with a median of 14 years’ follow-up.
In that study of women, the BCSM risk at 20 years was significantly higher for those with HR-negative tumors, but the risk was still elevated for both types. Patients with stage IIIC HR-positive disease had four times the risk of BCSM over 20 years and those with stage IIIC HR-negative disease had seven times the risk of BCSM over 20 years compared with the risk of death not related to breast cancer, the researchers wrote.
Another study of nearly 2,400 men with breast cancer (mainly HR+) by Dr. J.P. Leone and colleagues showed that cancer stage, tumor subtype, and race were associated with overall survival and breast cancer-specific survival.
What Does the New Study Add?
The current study included 2,836 men diagnosed with stage I to stage III HR+ breast cancer between 1990 and 2008, using data from the Surveillance, Epidemiology, and End Results (SEER) database.
“We found that in men with breast cancer, the risk of breast cancer mortality persists for at least 20 years and that [the risk] depends on traditional clinicopathologic factors, such as age, tumor size, nodal status and tumor grade,” Dr. J.P. Leone said in an interview.
“The prolonged risk [of breast-cancer specific mortality] over 20 years that we observed in our study is similar to that previously reported in women; however, the kinetics of the risk over the 20-year period appears different in men,” he emphasized.
The men in the study, especially those with a higher stage of disease, appeared to have a bimodal distribution of the BRCA mortality risk, he said.
Two peaks were identified, he explained; an early peak in mortality risk at approximately 4 years from diagnosis and another at approximately 11 years after diagnosis.
Although women with breast cancer had a prolonged risk of breast cancer mortality, “the kinetics of the risk does not include 2 peaks, even in women with higher stage of disease.” In women with higher stage breast cancer, the peak mortality risk occurs approximately 5 years after diagnosis, he said.
The reasons for the later peak in men remain unclear, the researchers wrote in the study, but possible explanations include nonadherence to endocrine therapy, differences in tumor biologic factors, and differences in the tumor microenvironment between men and women, they noted, in the discussion section.
What Drives the Risk?
Key factors for breast cancer-specific mortality were age, tumor stage, and tumor grade.
The cumulative 20-year risk of BCSM in the current study was 12.4%, 26.2%, and 46.0% for stage I, II, and III, respectively. The adjusted BCSM risk was increased in patients younger than 50 years, those with grade II or III/IV tumors, and those with stage II or III disease.
What Are the Limitations?
The current study by Leone and colleagues was limited by the relatively small subgroup sample of men with stage III and N3 disease, lack of data on the use of systemic therapies, and lack of data on human epidermal growth factor receptor 2 gene (ERBB2), the researchers wrote. However, the long-term follow-up strengthened the results, and the study is the first known to assess 20-year BCSM risk in men with nonmetastatic HR+ breast cancer.
What Do Oncologists Need to Know About the Study?
The study findings indicate that the risk of breast cancer mortality persists for 20 years in men with hormone receptor–positive breast cancer, Dr. J.P. Leone said in an interview. As in women, the risk depends on traditional clinicopathologic factors, he noted.
“However, the kinetics of that risk appears to be different between men and women. In order to reduce the breast cancer mortality risk in men with hormone receptor–positive breast cancer, it will be important for men to consider the benefits of the treatment options that may be indicated for their specific situation,” he said.
“I think early detection is also very important,” he emphasized. To that end, increased awareness of the possibility for breast cancer in men, as well as prompt intervention when breast cancer is suspected, will help to improve early detection when the risk of breast cancer mortality is lower, he added.
What Are the Next Steps for Research?
“I think our study underscores the need for additional research to improve our adjuvant therapy options in both men and women with hormone receptor-positive breast cancer, to reduce the risk of long-term mortality,” he said.
The study received no outside funding. Lead author Julieta Leone had no financial conflicts to disclose. Dr. José P. Leone disclosed receiving institutional grants from Kazia Therapeutics and Seagen unrelated to the current study.
Breast cancer-specific mortality risk in men with hormone receptor–positive breast cancer persists for at least 20 years, but patterns of breast cancer–specific mortality (BCSM) are distinct from those in women, a new study finds.
Previous studies in women with hormone receptor–positive (HR+) breast cancer have shown a risk of distant recurrence and death for at least 20 years after diagnosis, but data for men are limited, wrote Julieta Leone, MD, of the Dana Farber Cancer Institute, Boston, and colleagues.
What is Known About Hormone Receptor–Positive Breast Cancer Mortality in Men vs. Women?
Invasive breast cancer in men is rare and consequently understudied, the researchers wrote. Previous studies of BCSM in men with more than 5 years’ follow-up consist mainly of case series at single institutions, the researchers wrote in JAMA Oncology (2024 Feb 29. doi: 10.1001/jamaoncol.2023.7194).
“We believed it would be important to study this issue to help inform the management of men with breast cancer,” corresponding author, José P. Leone, MD, said in an interview.
In 2021, Dr. J.P. Leone and colleagues published a study in Breast Cancer Research and Treatment that examined the 20-year risk of BCSM in women that included more than 36,000 individuals who had survived for 5 years, with a median of 14 years’ follow-up.
In that study of women, the BCSM risk at 20 years was significantly higher for those with HR-negative tumors, but the risk was still elevated for both types. Patients with stage IIIC HR-positive disease had four times the risk of BCSM over 20 years and those with stage IIIC HR-negative disease had seven times the risk of BCSM over 20 years compared with the risk of death not related to breast cancer, the researchers wrote.
Another study of nearly 2,400 men with breast cancer (mainly HR+) by Dr. J.P. Leone and colleagues showed that cancer stage, tumor subtype, and race were associated with overall survival and breast cancer-specific survival.
What Does the New Study Add?
The current study included 2,836 men diagnosed with stage I to stage III HR+ breast cancer between 1990 and 2008, using data from the Surveillance, Epidemiology, and End Results (SEER) database.
“We found that in men with breast cancer, the risk of breast cancer mortality persists for at least 20 years and that [the risk] depends on traditional clinicopathologic factors, such as age, tumor size, nodal status and tumor grade,” Dr. J.P. Leone said in an interview.
“The prolonged risk [of breast-cancer specific mortality] over 20 years that we observed in our study is similar to that previously reported in women; however, the kinetics of the risk over the 20-year period appears different in men,” he emphasized.
The men in the study, especially those with a higher stage of disease, appeared to have a bimodal distribution of the BRCA mortality risk, he said.
Two peaks were identified, he explained; an early peak in mortality risk at approximately 4 years from diagnosis and another at approximately 11 years after diagnosis.
Although women with breast cancer had a prolonged risk of breast cancer mortality, “the kinetics of the risk does not include 2 peaks, even in women with higher stage of disease.” In women with higher stage breast cancer, the peak mortality risk occurs approximately 5 years after diagnosis, he said.
The reasons for the later peak in men remain unclear, the researchers wrote in the study, but possible explanations include nonadherence to endocrine therapy, differences in tumor biologic factors, and differences in the tumor microenvironment between men and women, they noted, in the discussion section.
What Drives the Risk?
Key factors for breast cancer-specific mortality were age, tumor stage, and tumor grade.
The cumulative 20-year risk of BCSM in the current study was 12.4%, 26.2%, and 46.0% for stage I, II, and III, respectively. The adjusted BCSM risk was increased in patients younger than 50 years, those with grade II or III/IV tumors, and those with stage II or III disease.
What Are the Limitations?
The current study by Leone and colleagues was limited by the relatively small subgroup sample of men with stage III and N3 disease, lack of data on the use of systemic therapies, and lack of data on human epidermal growth factor receptor 2 gene (ERBB2), the researchers wrote. However, the long-term follow-up strengthened the results, and the study is the first known to assess 20-year BCSM risk in men with nonmetastatic HR+ breast cancer.
What Do Oncologists Need to Know About the Study?
The study findings indicate that the risk of breast cancer mortality persists for 20 years in men with hormone receptor–positive breast cancer, Dr. J.P. Leone said in an interview. As in women, the risk depends on traditional clinicopathologic factors, he noted.
“However, the kinetics of that risk appears to be different between men and women. In order to reduce the breast cancer mortality risk in men with hormone receptor–positive breast cancer, it will be important for men to consider the benefits of the treatment options that may be indicated for their specific situation,” he said.
“I think early detection is also very important,” he emphasized. To that end, increased awareness of the possibility for breast cancer in men, as well as prompt intervention when breast cancer is suspected, will help to improve early detection when the risk of breast cancer mortality is lower, he added.
What Are the Next Steps for Research?
“I think our study underscores the need for additional research to improve our adjuvant therapy options in both men and women with hormone receptor-positive breast cancer, to reduce the risk of long-term mortality,” he said.
The study received no outside funding. Lead author Julieta Leone had no financial conflicts to disclose. Dr. José P. Leone disclosed receiving institutional grants from Kazia Therapeutics and Seagen unrelated to the current study.
Breast cancer-specific mortality risk in men with hormone receptor–positive breast cancer persists for at least 20 years, but patterns of breast cancer–specific mortality (BCSM) are distinct from those in women, a new study finds.
Previous studies in women with hormone receptor–positive (HR+) breast cancer have shown a risk of distant recurrence and death for at least 20 years after diagnosis, but data for men are limited, wrote Julieta Leone, MD, of the Dana Farber Cancer Institute, Boston, and colleagues.
What is Known About Hormone Receptor–Positive Breast Cancer Mortality in Men vs. Women?
Invasive breast cancer in men is rare and consequently understudied, the researchers wrote. Previous studies of BCSM in men with more than 5 years’ follow-up consist mainly of case series at single institutions, the researchers wrote in JAMA Oncology (2024 Feb 29. doi: 10.1001/jamaoncol.2023.7194).
“We believed it would be important to study this issue to help inform the management of men with breast cancer,” corresponding author, José P. Leone, MD, said in an interview.
In 2021, Dr. J.P. Leone and colleagues published a study in Breast Cancer Research and Treatment that examined the 20-year risk of BCSM in women that included more than 36,000 individuals who had survived for 5 years, with a median of 14 years’ follow-up.
In that study of women, the BCSM risk at 20 years was significantly higher for those with HR-negative tumors, but the risk was still elevated for both types. Patients with stage IIIC HR-positive disease had four times the risk of BCSM over 20 years and those with stage IIIC HR-negative disease had seven times the risk of BCSM over 20 years compared with the risk of death not related to breast cancer, the researchers wrote.
Another study of nearly 2,400 men with breast cancer (mainly HR+) by Dr. J.P. Leone and colleagues showed that cancer stage, tumor subtype, and race were associated with overall survival and breast cancer-specific survival.
What Does the New Study Add?
The current study included 2,836 men diagnosed with stage I to stage III HR+ breast cancer between 1990 and 2008, using data from the Surveillance, Epidemiology, and End Results (SEER) database.
“We found that in men with breast cancer, the risk of breast cancer mortality persists for at least 20 years and that [the risk] depends on traditional clinicopathologic factors, such as age, tumor size, nodal status and tumor grade,” Dr. J.P. Leone said in an interview.
“The prolonged risk [of breast-cancer specific mortality] over 20 years that we observed in our study is similar to that previously reported in women; however, the kinetics of the risk over the 20-year period appears different in men,” he emphasized.
The men in the study, especially those with a higher stage of disease, appeared to have a bimodal distribution of the BRCA mortality risk, he said.
Two peaks were identified, he explained; an early peak in mortality risk at approximately 4 years from diagnosis and another at approximately 11 years after diagnosis.
Although women with breast cancer had a prolonged risk of breast cancer mortality, “the kinetics of the risk does not include 2 peaks, even in women with higher stage of disease.” In women with higher stage breast cancer, the peak mortality risk occurs approximately 5 years after diagnosis, he said.
The reasons for the later peak in men remain unclear, the researchers wrote in the study, but possible explanations include nonadherence to endocrine therapy, differences in tumor biologic factors, and differences in the tumor microenvironment between men and women, they noted, in the discussion section.
What Drives the Risk?
Key factors for breast cancer-specific mortality were age, tumor stage, and tumor grade.
The cumulative 20-year risk of BCSM in the current study was 12.4%, 26.2%, and 46.0% for stage I, II, and III, respectively. The adjusted BCSM risk was increased in patients younger than 50 years, those with grade II or III/IV tumors, and those with stage II or III disease.
What Are the Limitations?
The current study by Leone and colleagues was limited by the relatively small subgroup sample of men with stage III and N3 disease, lack of data on the use of systemic therapies, and lack of data on human epidermal growth factor receptor 2 gene (ERBB2), the researchers wrote. However, the long-term follow-up strengthened the results, and the study is the first known to assess 20-year BCSM risk in men with nonmetastatic HR+ breast cancer.
What Do Oncologists Need to Know About the Study?
The study findings indicate that the risk of breast cancer mortality persists for 20 years in men with hormone receptor–positive breast cancer, Dr. J.P. Leone said in an interview. As in women, the risk depends on traditional clinicopathologic factors, he noted.
“However, the kinetics of that risk appears to be different between men and women. In order to reduce the breast cancer mortality risk in men with hormone receptor–positive breast cancer, it will be important for men to consider the benefits of the treatment options that may be indicated for their specific situation,” he said.
“I think early detection is also very important,” he emphasized. To that end, increased awareness of the possibility for breast cancer in men, as well as prompt intervention when breast cancer is suspected, will help to improve early detection when the risk of breast cancer mortality is lower, he added.
What Are the Next Steps for Research?
“I think our study underscores the need for additional research to improve our adjuvant therapy options in both men and women with hormone receptor-positive breast cancer, to reduce the risk of long-term mortality,” he said.
The study received no outside funding. Lead author Julieta Leone had no financial conflicts to disclose. Dr. José P. Leone disclosed receiving institutional grants from Kazia Therapeutics and Seagen unrelated to the current study.
FROM JAMA ONCOLOGY
How Good are Tools to Screen for Spondyloarthritis in Patients With Psoriasis, Uveitis, IBD?
Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.
Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.
“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.
In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.
Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.
All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.
All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.
Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.
Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.
Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
The Case for a Generic Tool
The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.
The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.
The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
Streamlining to Increase Screening
“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.
In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.
“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
Need for Early Identification and Closer Collaboration
A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.
The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.
The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.
“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.
“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.
Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.
More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.
The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.
Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.
“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.
In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.
Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.
All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.
All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.
Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.
Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.
Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
The Case for a Generic Tool
The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.
The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.
The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
Streamlining to Increase Screening
“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.
In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.
“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
Need for Early Identification and Closer Collaboration
A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.
The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.
The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.
“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.
“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.
Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.
More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.
The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.
Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.
“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.
In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.
Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.
All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.
All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.
Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.
Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.
Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
The Case for a Generic Tool
The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.
The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.
The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
Streamlining to Increase Screening
“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.
In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.
“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
Need for Early Identification and Closer Collaboration
A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.
The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.
The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.
“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.
“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.
Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.
More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.
The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
What Happens to Surgery Candidates with BHDs and Cancer?
based on data from a new study of nearly 700,000 individuals.
The reason for this association remains unclear, and highlights the need to address existing behavioral health disorders (BHDs), which can be exacerbated after a patient is diagnosed with cancer, wrote Timothy M. Pawlik, MD, of The Ohio State University, Columbus, and colleagues. A cancer diagnosis can cause not only physical stress, but mental, emotional, social, and economic stress that can prompt a new BHD, cause relapse of a previous BHD, or exacerbate a current BHD, the researchers noted.
What is Known About BHDs and Cancer?
Although previous studies have shown a possible association between BHDs and increased cancer risk, as well as reduced compliance with care, the effect of BHDs on outcomes in cancer patients undergoing surgical resection has not been examined, wrote Dr. Pawlik and colleagues.
Previous research has focused on the impact of having a preexisting serious mental illness (SMI) such as schizophrenia and bipolar disorder on cancer care.
A 2023 literature review of 27 studies published in the Journal of Medical Imaging and Radiation Sciences showed that patients with preexisting severe mental illness (such as schizophrenia or bipolar disorder) had greater cancer-related mortality. In that study, the researchers also found that patients with severe mental illness were more likely to have metastatic disease at diagnosis, but less likely to receive optimal treatments, than individuals without SMIs.
Many studies also have focused on patients developing mental health problems (including BHDs) after a cancer diagnosis, but the current study is the first known to examine outcomes in those with BHDs before cancer.
Why Was It Important to Conduct This Study?
“BHDs are a diverse set of mental illnesses that affect an individual’s psychosocial wellbeing, potentially resulting in maladaptive behaviors,” Dr. Pawlik said in an interview. BHDs, which include substance abuse, eating disorders, and sleep disorders, are less common than anxiety/depression, but have an estimated prevalence of 1.3%-3.1% among adults in the United States, he said.
What Does the New Study Add?
In the new review by Dr. Pawlik and colleagues, published in the Journal of the American College of Surgeons (Katayama ES. J Am Coll Surg. 2024 Feb 29. doi: 2024. 10.1097/XCS.0000000000000954), BHDs were defined as substance abuse, eating disorders, or sleep disorders, which had not been the focus of previous studies. The researchers reviewed data from 694,836 adult patients with lung, esophageal, gastric, liver, pancreatic, or colorectal cancer between 2018-2021 using the Medicare Standard Analytic files. A total of 46,719 patients (6.7%) had at least one BHD.
Overall, patients with a BHD were significantly less likely than those without a BHD to undergo surgical resection (20.3% vs. 23.4%). Patients with a BHD also had significantly worse long-term postoperative survival than those without BHDs (median 37.1 months vs. 46.6 months) and significantly higher in-hospital costs ($17,432 vs. 16,159, P less than .001 for all).
Among patients who underwent cancer surgery, the odds of any complication were significantly higher for those with a BHD compared to those with no BHD (odds ratio 1.32), as were the odds of a prolonged length of stay (OR 1.67) and 90-day readmission (OR 1.57).
Dr. Pawlik said he was surprised by several of the findings, including that 1 in 15 Medicare beneficiaries had a BHD diagnosis, “with male sex and minority racial status, as well as higher social vulnerability, being associated with a higher prevalence of BHD.”
Also, the independent association of having a BHD with 30%-50% higher odds of a complication, prolonged length of stay, and 90-day readmission was higher than Dr. Pawlik had anticipated.
Why Do Patients With BHDs Have Fewer Surgeries and Worse Outcomes?
The reasons for this association were likely multifactorial and may reflect the greater burden of medical comorbidity and chronic illness in many patients with BHDs because of maladaptive lifestyles or poor nutrition status, Dr. Pawlik said.
“Patients with BHDs also likely face barriers to accessing care, which was noted particularly among patients with BHDs who lived in socially vulnerable areas,” he said. BHD patients also were more likely to be treated at low-volume rather than high-volume hospitals, “which undoubtedly contributed in part to worse outcomes in this cohort of patients,” he added.
What Can Oncologists Do to Help?
The take-home message for clinicians is that BHDs are linked to worse surgical outcomes and higher health care costs in cancer patients, Dr. Pawlik said in an interview.
“Enhanced accessibility to behavioral healthcare, as well as comprehensive policy reform related to mental health services are needed to improve care of patients with BHDs,” he said. “For example, implementing psychiatry compensation programs may encourage practice in vulnerable areas,” he said.
Other strategies include a following a collaborative care model involving mental health professionals working in tandem with primary care and mid-level practitioners and increasing use and establishment of telehealth systems to improve patient access to BHD services, he said.
What Are the Limitations?
The study by Dr. Pawlik and colleagues was limited by several factors, including the lack of data on younger patients and the full range of BHDs, as well as underreporting of BHDs and the high copays for mental health care, the researchers noted. However, the results suggest that concomitant BHDs are associated with worse cancer outcomes and higher in-hospital costs, and illustrate the need to screen for and target these conditions in cancer patients, the researchers concluded.
What Are the Next Steps for Research?
The current study involved Medicare beneficiaries aged 65 years or older, and more research is needed to investigate the impact of BHDs among younger cancer patients in whom the prevalence may be higher and the impact of BHDs may be different, Dr. Pawlik said in an interview. In addition, the analysis of BHDs as a composite of substance abuse, eating disorders, and sleep disorders (because the numbers were too small to break out data for each disorder, separately) prevented investigation of potential differences and unique challenges faced by distinct subpopulations of BHD patients, he said.
“Future studies should examine the individual impact of substance abuse, eating disorders, and sleep disorders on access to surgery, as well as the potential different impact that each one of these different BHDs may have on postoperative outcomes,” Dr. Pawlik suggested.
The study was supported by The Ohio State University College of Medicine Roessler Summer Research Scholarship. The researchers had no financial conflicts to disclose.
based on data from a new study of nearly 700,000 individuals.
The reason for this association remains unclear, and highlights the need to address existing behavioral health disorders (BHDs), which can be exacerbated after a patient is diagnosed with cancer, wrote Timothy M. Pawlik, MD, of The Ohio State University, Columbus, and colleagues. A cancer diagnosis can cause not only physical stress, but mental, emotional, social, and economic stress that can prompt a new BHD, cause relapse of a previous BHD, or exacerbate a current BHD, the researchers noted.
What is Known About BHDs and Cancer?
Although previous studies have shown a possible association between BHDs and increased cancer risk, as well as reduced compliance with care, the effect of BHDs on outcomes in cancer patients undergoing surgical resection has not been examined, wrote Dr. Pawlik and colleagues.
Previous research has focused on the impact of having a preexisting serious mental illness (SMI) such as schizophrenia and bipolar disorder on cancer care.
A 2023 literature review of 27 studies published in the Journal of Medical Imaging and Radiation Sciences showed that patients with preexisting severe mental illness (such as schizophrenia or bipolar disorder) had greater cancer-related mortality. In that study, the researchers also found that patients with severe mental illness were more likely to have metastatic disease at diagnosis, but less likely to receive optimal treatments, than individuals without SMIs.
Many studies also have focused on patients developing mental health problems (including BHDs) after a cancer diagnosis, but the current study is the first known to examine outcomes in those with BHDs before cancer.
Why Was It Important to Conduct This Study?
“BHDs are a diverse set of mental illnesses that affect an individual’s psychosocial wellbeing, potentially resulting in maladaptive behaviors,” Dr. Pawlik said in an interview. BHDs, which include substance abuse, eating disorders, and sleep disorders, are less common than anxiety/depression, but have an estimated prevalence of 1.3%-3.1% among adults in the United States, he said.
What Does the New Study Add?
In the new review by Dr. Pawlik and colleagues, published in the Journal of the American College of Surgeons (Katayama ES. J Am Coll Surg. 2024 Feb 29. doi: 2024. 10.1097/XCS.0000000000000954), BHDs were defined as substance abuse, eating disorders, or sleep disorders, which had not been the focus of previous studies. The researchers reviewed data from 694,836 adult patients with lung, esophageal, gastric, liver, pancreatic, or colorectal cancer between 2018-2021 using the Medicare Standard Analytic files. A total of 46,719 patients (6.7%) had at least one BHD.
Overall, patients with a BHD were significantly less likely than those without a BHD to undergo surgical resection (20.3% vs. 23.4%). Patients with a BHD also had significantly worse long-term postoperative survival than those without BHDs (median 37.1 months vs. 46.6 months) and significantly higher in-hospital costs ($17,432 vs. 16,159, P less than .001 for all).
Among patients who underwent cancer surgery, the odds of any complication were significantly higher for those with a BHD compared to those with no BHD (odds ratio 1.32), as were the odds of a prolonged length of stay (OR 1.67) and 90-day readmission (OR 1.57).
Dr. Pawlik said he was surprised by several of the findings, including that 1 in 15 Medicare beneficiaries had a BHD diagnosis, “with male sex and minority racial status, as well as higher social vulnerability, being associated with a higher prevalence of BHD.”
Also, the independent association of having a BHD with 30%-50% higher odds of a complication, prolonged length of stay, and 90-day readmission was higher than Dr. Pawlik had anticipated.
Why Do Patients With BHDs Have Fewer Surgeries and Worse Outcomes?
The reasons for this association were likely multifactorial and may reflect the greater burden of medical comorbidity and chronic illness in many patients with BHDs because of maladaptive lifestyles or poor nutrition status, Dr. Pawlik said.
“Patients with BHDs also likely face barriers to accessing care, which was noted particularly among patients with BHDs who lived in socially vulnerable areas,” he said. BHD patients also were more likely to be treated at low-volume rather than high-volume hospitals, “which undoubtedly contributed in part to worse outcomes in this cohort of patients,” he added.
What Can Oncologists Do to Help?
The take-home message for clinicians is that BHDs are linked to worse surgical outcomes and higher health care costs in cancer patients, Dr. Pawlik said in an interview.
“Enhanced accessibility to behavioral healthcare, as well as comprehensive policy reform related to mental health services are needed to improve care of patients with BHDs,” he said. “For example, implementing psychiatry compensation programs may encourage practice in vulnerable areas,” he said.
Other strategies include a following a collaborative care model involving mental health professionals working in tandem with primary care and mid-level practitioners and increasing use and establishment of telehealth systems to improve patient access to BHD services, he said.
What Are the Limitations?
The study by Dr. Pawlik and colleagues was limited by several factors, including the lack of data on younger patients and the full range of BHDs, as well as underreporting of BHDs and the high copays for mental health care, the researchers noted. However, the results suggest that concomitant BHDs are associated with worse cancer outcomes and higher in-hospital costs, and illustrate the need to screen for and target these conditions in cancer patients, the researchers concluded.
What Are the Next Steps for Research?
The current study involved Medicare beneficiaries aged 65 years or older, and more research is needed to investigate the impact of BHDs among younger cancer patients in whom the prevalence may be higher and the impact of BHDs may be different, Dr. Pawlik said in an interview. In addition, the analysis of BHDs as a composite of substance abuse, eating disorders, and sleep disorders (because the numbers were too small to break out data for each disorder, separately) prevented investigation of potential differences and unique challenges faced by distinct subpopulations of BHD patients, he said.
“Future studies should examine the individual impact of substance abuse, eating disorders, and sleep disorders on access to surgery, as well as the potential different impact that each one of these different BHDs may have on postoperative outcomes,” Dr. Pawlik suggested.
The study was supported by The Ohio State University College of Medicine Roessler Summer Research Scholarship. The researchers had no financial conflicts to disclose.
based on data from a new study of nearly 700,000 individuals.
The reason for this association remains unclear, and highlights the need to address existing behavioral health disorders (BHDs), which can be exacerbated after a patient is diagnosed with cancer, wrote Timothy M. Pawlik, MD, of The Ohio State University, Columbus, and colleagues. A cancer diagnosis can cause not only physical stress, but mental, emotional, social, and economic stress that can prompt a new BHD, cause relapse of a previous BHD, or exacerbate a current BHD, the researchers noted.
What is Known About BHDs and Cancer?
Although previous studies have shown a possible association between BHDs and increased cancer risk, as well as reduced compliance with care, the effect of BHDs on outcomes in cancer patients undergoing surgical resection has not been examined, wrote Dr. Pawlik and colleagues.
Previous research has focused on the impact of having a preexisting serious mental illness (SMI) such as schizophrenia and bipolar disorder on cancer care.
A 2023 literature review of 27 studies published in the Journal of Medical Imaging and Radiation Sciences showed that patients with preexisting severe mental illness (such as schizophrenia or bipolar disorder) had greater cancer-related mortality. In that study, the researchers also found that patients with severe mental illness were more likely to have metastatic disease at diagnosis, but less likely to receive optimal treatments, than individuals without SMIs.
Many studies also have focused on patients developing mental health problems (including BHDs) after a cancer diagnosis, but the current study is the first known to examine outcomes in those with BHDs before cancer.
Why Was It Important to Conduct This Study?
“BHDs are a diverse set of mental illnesses that affect an individual’s psychosocial wellbeing, potentially resulting in maladaptive behaviors,” Dr. Pawlik said in an interview. BHDs, which include substance abuse, eating disorders, and sleep disorders, are less common than anxiety/depression, but have an estimated prevalence of 1.3%-3.1% among adults in the United States, he said.
What Does the New Study Add?
In the new review by Dr. Pawlik and colleagues, published in the Journal of the American College of Surgeons (Katayama ES. J Am Coll Surg. 2024 Feb 29. doi: 2024. 10.1097/XCS.0000000000000954), BHDs were defined as substance abuse, eating disorders, or sleep disorders, which had not been the focus of previous studies. The researchers reviewed data from 694,836 adult patients with lung, esophageal, gastric, liver, pancreatic, or colorectal cancer between 2018-2021 using the Medicare Standard Analytic files. A total of 46,719 patients (6.7%) had at least one BHD.
Overall, patients with a BHD were significantly less likely than those without a BHD to undergo surgical resection (20.3% vs. 23.4%). Patients with a BHD also had significantly worse long-term postoperative survival than those without BHDs (median 37.1 months vs. 46.6 months) and significantly higher in-hospital costs ($17,432 vs. 16,159, P less than .001 for all).
Among patients who underwent cancer surgery, the odds of any complication were significantly higher for those with a BHD compared to those with no BHD (odds ratio 1.32), as were the odds of a prolonged length of stay (OR 1.67) and 90-day readmission (OR 1.57).
Dr. Pawlik said he was surprised by several of the findings, including that 1 in 15 Medicare beneficiaries had a BHD diagnosis, “with male sex and minority racial status, as well as higher social vulnerability, being associated with a higher prevalence of BHD.”
Also, the independent association of having a BHD with 30%-50% higher odds of a complication, prolonged length of stay, and 90-day readmission was higher than Dr. Pawlik had anticipated.
Why Do Patients With BHDs Have Fewer Surgeries and Worse Outcomes?
The reasons for this association were likely multifactorial and may reflect the greater burden of medical comorbidity and chronic illness in many patients with BHDs because of maladaptive lifestyles or poor nutrition status, Dr. Pawlik said.
“Patients with BHDs also likely face barriers to accessing care, which was noted particularly among patients with BHDs who lived in socially vulnerable areas,” he said. BHD patients also were more likely to be treated at low-volume rather than high-volume hospitals, “which undoubtedly contributed in part to worse outcomes in this cohort of patients,” he added.
What Can Oncologists Do to Help?
The take-home message for clinicians is that BHDs are linked to worse surgical outcomes and higher health care costs in cancer patients, Dr. Pawlik said in an interview.
“Enhanced accessibility to behavioral healthcare, as well as comprehensive policy reform related to mental health services are needed to improve care of patients with BHDs,” he said. “For example, implementing psychiatry compensation programs may encourage practice in vulnerable areas,” he said.
Other strategies include a following a collaborative care model involving mental health professionals working in tandem with primary care and mid-level practitioners and increasing use and establishment of telehealth systems to improve patient access to BHD services, he said.
What Are the Limitations?
The study by Dr. Pawlik and colleagues was limited by several factors, including the lack of data on younger patients and the full range of BHDs, as well as underreporting of BHDs and the high copays for mental health care, the researchers noted. However, the results suggest that concomitant BHDs are associated with worse cancer outcomes and higher in-hospital costs, and illustrate the need to screen for and target these conditions in cancer patients, the researchers concluded.
What Are the Next Steps for Research?
The current study involved Medicare beneficiaries aged 65 years or older, and more research is needed to investigate the impact of BHDs among younger cancer patients in whom the prevalence may be higher and the impact of BHDs may be different, Dr. Pawlik said in an interview. In addition, the analysis of BHDs as a composite of substance abuse, eating disorders, and sleep disorders (because the numbers were too small to break out data for each disorder, separately) prevented investigation of potential differences and unique challenges faced by distinct subpopulations of BHD patients, he said.
“Future studies should examine the individual impact of substance abuse, eating disorders, and sleep disorders on access to surgery, as well as the potential different impact that each one of these different BHDs may have on postoperative outcomes,” Dr. Pawlik suggested.
The study was supported by The Ohio State University College of Medicine Roessler Summer Research Scholarship. The researchers had no financial conflicts to disclose.
FROM JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Dupilumab Earns FDA Priority Review for Add-On COPD Care
The Food and Drug Administration (FDA) has accepted an application for Priority Review for dupilumab as an add-on therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD), according to a press release from manufacturer Regeneron.
If approved, dupilumab would be the only biologic option for COPD and the first new treatment option in approximately 10 years, according to the company.
Dupilumab works by blocking signaling by the interleukin (IL) 4 and IL-13 pathways, and Regeneron’s development program focuses on a population of COPD patients who also have type 2 inflammation.
The supplemental Biologics License Application was based on data from a pair of clinical trials in the company’s phase 3 COPD clinical research program.
In the studies, known as BOREAS and NOTUS, adults with uncontrolled COPD and type 2 inflammation who were current or former smokers were randomized to 300 mg of subcutaneous dupilumab or placebo once every 2 weeks. Type 2 inflammation was defined as blood eosinophil counts of at least 300 cells per microliter.
All patients received standard-of-care therapy. The primary endpoint of reduced annualized moderate or severe acute COPD exacerbations was 30% and 34% greater in the dupilumab groups in the two studies, respectively, compared with the placebo groups, and the significant differences in improvement persisted at 52 weeks.
Safety data were similar to previous studies of dupilumab for its approved indications. The most common adverse events seen in 5% or more of dupilumab patients compared with placebo patients across the two studies included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.
Priority Review status is granted to applications for approval for therapies that may offer significant improvements, although the therapies are still in clinical development. The target action date for the FDA decision is June 27, 2024, and regulatory submissions for dupilumab for COPD are under consideration in China and Europe in addition to the United States, according to the company.
A version of this article appeared on Medscape.com.
The Food and Drug Administration (FDA) has accepted an application for Priority Review for dupilumab as an add-on therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD), according to a press release from manufacturer Regeneron.
If approved, dupilumab would be the only biologic option for COPD and the first new treatment option in approximately 10 years, according to the company.
Dupilumab works by blocking signaling by the interleukin (IL) 4 and IL-13 pathways, and Regeneron’s development program focuses on a population of COPD patients who also have type 2 inflammation.
The supplemental Biologics License Application was based on data from a pair of clinical trials in the company’s phase 3 COPD clinical research program.
In the studies, known as BOREAS and NOTUS, adults with uncontrolled COPD and type 2 inflammation who were current or former smokers were randomized to 300 mg of subcutaneous dupilumab or placebo once every 2 weeks. Type 2 inflammation was defined as blood eosinophil counts of at least 300 cells per microliter.
All patients received standard-of-care therapy. The primary endpoint of reduced annualized moderate or severe acute COPD exacerbations was 30% and 34% greater in the dupilumab groups in the two studies, respectively, compared with the placebo groups, and the significant differences in improvement persisted at 52 weeks.
Safety data were similar to previous studies of dupilumab for its approved indications. The most common adverse events seen in 5% or more of dupilumab patients compared with placebo patients across the two studies included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.
Priority Review status is granted to applications for approval for therapies that may offer significant improvements, although the therapies are still in clinical development. The target action date for the FDA decision is June 27, 2024, and regulatory submissions for dupilumab for COPD are under consideration in China and Europe in addition to the United States, according to the company.
A version of this article appeared on Medscape.com.
The Food and Drug Administration (FDA) has accepted an application for Priority Review for dupilumab as an add-on therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD), according to a press release from manufacturer Regeneron.
If approved, dupilumab would be the only biologic option for COPD and the first new treatment option in approximately 10 years, according to the company.
Dupilumab works by blocking signaling by the interleukin (IL) 4 and IL-13 pathways, and Regeneron’s development program focuses on a population of COPD patients who also have type 2 inflammation.
The supplemental Biologics License Application was based on data from a pair of clinical trials in the company’s phase 3 COPD clinical research program.
In the studies, known as BOREAS and NOTUS, adults with uncontrolled COPD and type 2 inflammation who were current or former smokers were randomized to 300 mg of subcutaneous dupilumab or placebo once every 2 weeks. Type 2 inflammation was defined as blood eosinophil counts of at least 300 cells per microliter.
All patients received standard-of-care therapy. The primary endpoint of reduced annualized moderate or severe acute COPD exacerbations was 30% and 34% greater in the dupilumab groups in the two studies, respectively, compared with the placebo groups, and the significant differences in improvement persisted at 52 weeks.
Safety data were similar to previous studies of dupilumab for its approved indications. The most common adverse events seen in 5% or more of dupilumab patients compared with placebo patients across the two studies included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.
Priority Review status is granted to applications for approval for therapies that may offer significant improvements, although the therapies are still in clinical development. The target action date for the FDA decision is June 27, 2024, and regulatory submissions for dupilumab for COPD are under consideration in China and Europe in addition to the United States, according to the company.
A version of this article appeared on Medscape.com.
FDA Clears Medical Grade Over-the-Counter Pulse Oximeter
The MightySat Medical, an over-the-counter medical fingertip pulse oximeter, has received clearance from the US Food and Drug Administration (FDA) for use without a prescription, according to a press release from manufacturer Masimo.
The device is the first medical fingertip pulse oximeter available directly to consumers without a prescription that includes the same technology used by many hospitals, according to the company.
According to the FDA, home pulse oximeters are currently generally of two classes: hospital-grade prescription devices which have been vetted for accuracy through clinical trials, and over-the-counter devices which are sold direct to consumers but often estimate oxygen saturation. FDA communication on pulse oximeter accuracy states "OTC oximeters that are sold as either general wellness or sporting/aviation products are not intended for medical purposes, so they do not undergo FDA review."
Pulse oximeter use is important for patients diagnosed with breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, flu, pneumonia, or COVID-19 to collect accurate data on arterial blood oxygen saturation that they can share with their healthcare providers, according to the company. Patients with cardiac conditions, including pulmonary hypertension and heart failure may also benefit from pulse oximeter monitoring.
However, challenges of pulse oximeter use include measuring accuracy when patients are moving, measuring patients with poor circulation, and measuring patients with cool, thick, or darker skin. The MightySat Medical is designed to provide reliable measures of oxygen saturation and pulse rate across all patient groups, the manufacturers wrote in the press release.
Asked for additional comment, Diego J. Maselli, MD, FCCP, Professor and Chief in the division of Pulmonary Diseases and Critical Care at UT Health at San Antonio, noted, "Over the past decades, there has been an increased interest in home monitoring of medical conditions, particulrly with the development of more portable and accessible technology."
"This was heightended by the COVID-19 pandemic where telemedicine was frequently required as a means of delivering care," Dr. Maselli continued. "One of the important characteristics to monitor was the oxgen saturation in patients that had an active COVID-19 infection as it would dictate management and was part of the protocol for monitoring the clinical course of infection. Because of this need, many companies developed portable pulse oximeters for home use. This resulted in widespread use of pulse oximeters at home and other places outside clinic or hospital."
Other over-the-counter pulse oximeters that are not cleared by the FDA may create confusion among patients about the accuracy of their measurements, according to the company.
Dr. Maselli also commented that pulse oximeters' value can vary. "Unfortunately, these devices vary in quality and reliability and patients may not be fully aware of this. Most recently, the FDA approved a hospital-grade pulse oximeter that requires no prescription. This device may provide a more accurate reading in a wide range of clinical situations outside the healthcare setting. Patients should be aware that there are different grades of pulse oximeter before selecting one for home use. In addition, patients should work closely with their providers to better select the monitoring modaility that best fits their clinical situation," he said.
MightySat Medical is indicated for individuals aged 18 years and older who are well or poorly perfused under no motion conditions and is not intended as a diagnostic or screening tool for lung disease, according to the release. Treatment decisions based on data from the device should be made only in consultation with a healthcare provider, the company said. Dr. Maselli serves as a member of the CHEST Physician editorial board.
The FDA’s website offers further guidance related to at-home pulse oximeter use, with recommendations and limitations, as well as information on initiatives to ensure accurate and equitable pulse oximetry for all patients.
A version of this article appeared on Medscape.com.
The MightySat Medical, an over-the-counter medical fingertip pulse oximeter, has received clearance from the US Food and Drug Administration (FDA) for use without a prescription, according to a press release from manufacturer Masimo.
The device is the first medical fingertip pulse oximeter available directly to consumers without a prescription that includes the same technology used by many hospitals, according to the company.
According to the FDA, home pulse oximeters are currently generally of two classes: hospital-grade prescription devices which have been vetted for accuracy through clinical trials, and over-the-counter devices which are sold direct to consumers but often estimate oxygen saturation. FDA communication on pulse oximeter accuracy states "OTC oximeters that are sold as either general wellness or sporting/aviation products are not intended for medical purposes, so they do not undergo FDA review."
Pulse oximeter use is important for patients diagnosed with breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, flu, pneumonia, or COVID-19 to collect accurate data on arterial blood oxygen saturation that they can share with their healthcare providers, according to the company. Patients with cardiac conditions, including pulmonary hypertension and heart failure may also benefit from pulse oximeter monitoring.
However, challenges of pulse oximeter use include measuring accuracy when patients are moving, measuring patients with poor circulation, and measuring patients with cool, thick, or darker skin. The MightySat Medical is designed to provide reliable measures of oxygen saturation and pulse rate across all patient groups, the manufacturers wrote in the press release.
Asked for additional comment, Diego J. Maselli, MD, FCCP, Professor and Chief in the division of Pulmonary Diseases and Critical Care at UT Health at San Antonio, noted, "Over the past decades, there has been an increased interest in home monitoring of medical conditions, particulrly with the development of more portable and accessible technology."
"This was heightended by the COVID-19 pandemic where telemedicine was frequently required as a means of delivering care," Dr. Maselli continued. "One of the important characteristics to monitor was the oxgen saturation in patients that had an active COVID-19 infection as it would dictate management and was part of the protocol for monitoring the clinical course of infection. Because of this need, many companies developed portable pulse oximeters for home use. This resulted in widespread use of pulse oximeters at home and other places outside clinic or hospital."
Other over-the-counter pulse oximeters that are not cleared by the FDA may create confusion among patients about the accuracy of their measurements, according to the company.
Dr. Maselli also commented that pulse oximeters' value can vary. "Unfortunately, these devices vary in quality and reliability and patients may not be fully aware of this. Most recently, the FDA approved a hospital-grade pulse oximeter that requires no prescription. This device may provide a more accurate reading in a wide range of clinical situations outside the healthcare setting. Patients should be aware that there are different grades of pulse oximeter before selecting one for home use. In addition, patients should work closely with their providers to better select the monitoring modaility that best fits their clinical situation," he said.
MightySat Medical is indicated for individuals aged 18 years and older who are well or poorly perfused under no motion conditions and is not intended as a diagnostic or screening tool for lung disease, according to the release. Treatment decisions based on data from the device should be made only in consultation with a healthcare provider, the company said. Dr. Maselli serves as a member of the CHEST Physician editorial board.
The FDA’s website offers further guidance related to at-home pulse oximeter use, with recommendations and limitations, as well as information on initiatives to ensure accurate and equitable pulse oximetry for all patients.
A version of this article appeared on Medscape.com.
The MightySat Medical, an over-the-counter medical fingertip pulse oximeter, has received clearance from the US Food and Drug Administration (FDA) for use without a prescription, according to a press release from manufacturer Masimo.
The device is the first medical fingertip pulse oximeter available directly to consumers without a prescription that includes the same technology used by many hospitals, according to the company.
According to the FDA, home pulse oximeters are currently generally of two classes: hospital-grade prescription devices which have been vetted for accuracy through clinical trials, and over-the-counter devices which are sold direct to consumers but often estimate oxygen saturation. FDA communication on pulse oximeter accuracy states "OTC oximeters that are sold as either general wellness or sporting/aviation products are not intended for medical purposes, so they do not undergo FDA review."
Pulse oximeter use is important for patients diagnosed with breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, flu, pneumonia, or COVID-19 to collect accurate data on arterial blood oxygen saturation that they can share with their healthcare providers, according to the company. Patients with cardiac conditions, including pulmonary hypertension and heart failure may also benefit from pulse oximeter monitoring.
However, challenges of pulse oximeter use include measuring accuracy when patients are moving, measuring patients with poor circulation, and measuring patients with cool, thick, or darker skin. The MightySat Medical is designed to provide reliable measures of oxygen saturation and pulse rate across all patient groups, the manufacturers wrote in the press release.
Asked for additional comment, Diego J. Maselli, MD, FCCP, Professor and Chief in the division of Pulmonary Diseases and Critical Care at UT Health at San Antonio, noted, "Over the past decades, there has been an increased interest in home monitoring of medical conditions, particulrly with the development of more portable and accessible technology."
"This was heightended by the COVID-19 pandemic where telemedicine was frequently required as a means of delivering care," Dr. Maselli continued. "One of the important characteristics to monitor was the oxgen saturation in patients that had an active COVID-19 infection as it would dictate management and was part of the protocol for monitoring the clinical course of infection. Because of this need, many companies developed portable pulse oximeters for home use. This resulted in widespread use of pulse oximeters at home and other places outside clinic or hospital."
Other over-the-counter pulse oximeters that are not cleared by the FDA may create confusion among patients about the accuracy of their measurements, according to the company.
Dr. Maselli also commented that pulse oximeters' value can vary. "Unfortunately, these devices vary in quality and reliability and patients may not be fully aware of this. Most recently, the FDA approved a hospital-grade pulse oximeter that requires no prescription. This device may provide a more accurate reading in a wide range of clinical situations outside the healthcare setting. Patients should be aware that there are different grades of pulse oximeter before selecting one for home use. In addition, patients should work closely with their providers to better select the monitoring modaility that best fits their clinical situation," he said.
MightySat Medical is indicated for individuals aged 18 years and older who are well or poorly perfused under no motion conditions and is not intended as a diagnostic or screening tool for lung disease, according to the release. Treatment decisions based on data from the device should be made only in consultation with a healthcare provider, the company said. Dr. Maselli serves as a member of the CHEST Physician editorial board.
The FDA’s website offers further guidance related to at-home pulse oximeter use, with recommendations and limitations, as well as information on initiatives to ensure accurate and equitable pulse oximetry for all patients.
A version of this article appeared on Medscape.com.