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Colorectal cancer (CRC) remains the second most common cause of cancer-related death in the United States. Although the past several decades have seen significantly greater emphasis on screening and disease prevention for CRC, it has also become increasingly apparent that the age profile and associated risks for this cancer are rapidly changing.

Evidence of this can be found in recently released CRC statistics from the American Cancer Society, which are updated every 3 years using population-based cancer registries.

The incidence in CRC has shown a progressive decline over the past 4 decades. However, whereas in the 2000s there was an average decline of approximately 3%-4% annually, it slowed to 1% per year between 2011 and 2019. This effect is in part because of the trends among younger individuals (< 55 years), in whom the incidence of CRC has increased by 9% over the past 25 years.

The incidence of regional-stage disease also increased by 2%-3% per year for those younger than 65 years, with an additional increase in the incidence of more advanced/distant disease by 0.5%-3% per year. The latter finding represents a reversal of earlier trends observed for staged disease in the decade from 1995 to 2005.

These recent statistics reveal other notable changes that occurred in parallel with the increased incidence of younger-onset CRC. There was a significant shift to left-sided tumors, with a 4% increase in rectal cancers in the decades spanning 1995–2019.

Although the overall mortality declined 2% from 2011 to 2020, the reverse was seen in patients younger than 50 years, in whom there was an increase by 0.5%-3% annually.

Available incidence and mortality data for the current year are understandably lacking, as there is a 2- to 4-year lag for data collection and assimilation, and there have also been methodological changes for tracking and projections. Nonetheless, 2023 projections estimate that there will be 153,020 new cases in the United States, with 19,550 (13%) to occur in those younger than 50 years and 33% in those aged 50-64 years. Overall, 43% of cases are projected to occur in those aged 45-49 years, which is noteworthy given that these ages are now included in the most current CRC screening recommendations.

Further underscoring the risks posed by earlier-onset trends is the projection of 52,550 CRC-related deaths in 2023, with 7% estimated to occur in those younger than 50 years.
 

What’s behind the trend toward younger onset?

The specific factors contributing to increasing rates of CRC in younger individuals are not well known, but there are several plausible explanations. Notable possible contributing factors reported in the literature include obesity, smoking, alcohol, diet, and microbial changes, among other demographic variables. Exposure to high-fructose corn syrup, sugar-sweetened beverages, and processed meats has also recently received attention as contributing dietary risk factors.

The shifting trends toward the onset of CRC among younger patients are now clearly established, with approximately 20% of new cases occurring in those in their early 50s or younger and a higher rate of left-sided tumor development. Unfortunately, these shifts are also associated with a more advanced stage of disease.

There are unique clinical challenges when it comes to identifying younger-onset CRC. A low level of suspicion among primary care providers that their younger patients may have CRC can result in delays in their receiving clinically appropriate diagnostic testing (particularly for overt or occult bleeding/iron deficiency). Younger patients may also be less likely to know about or adhere to new recommendations that they undergo screening.

The landscape for age-related CRC is changing. Although there are many obstacles for implementing new practices, these recent findings from the ACS also highlight a clear path for improvement.

David A. Johnson, MD, is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, and a past president of the American College of Gastroenterology.

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

Colorectal cancer (CRC) remains the second most common cause of cancer-related death in the United States. Although the past several decades have seen significantly greater emphasis on screening and disease prevention for CRC, it has also become increasingly apparent that the age profile and associated risks for this cancer are rapidly changing.

Evidence of this can be found in recently released CRC statistics from the American Cancer Society, which are updated every 3 years using population-based cancer registries.

The incidence in CRC has shown a progressive decline over the past 4 decades. However, whereas in the 2000s there was an average decline of approximately 3%-4% annually, it slowed to 1% per year between 2011 and 2019. This effect is in part because of the trends among younger individuals (< 55 years), in whom the incidence of CRC has increased by 9% over the past 25 years.

The incidence of regional-stage disease also increased by 2%-3% per year for those younger than 65 years, with an additional increase in the incidence of more advanced/distant disease by 0.5%-3% per year. The latter finding represents a reversal of earlier trends observed for staged disease in the decade from 1995 to 2005.

These recent statistics reveal other notable changes that occurred in parallel with the increased incidence of younger-onset CRC. There was a significant shift to left-sided tumors, with a 4% increase in rectal cancers in the decades spanning 1995–2019.

Although the overall mortality declined 2% from 2011 to 2020, the reverse was seen in patients younger than 50 years, in whom there was an increase by 0.5%-3% annually.

Available incidence and mortality data for the current year are understandably lacking, as there is a 2- to 4-year lag for data collection and assimilation, and there have also been methodological changes for tracking and projections. Nonetheless, 2023 projections estimate that there will be 153,020 new cases in the United States, with 19,550 (13%) to occur in those younger than 50 years and 33% in those aged 50-64 years. Overall, 43% of cases are projected to occur in those aged 45-49 years, which is noteworthy given that these ages are now included in the most current CRC screening recommendations.

Further underscoring the risks posed by earlier-onset trends is the projection of 52,550 CRC-related deaths in 2023, with 7% estimated to occur in those younger than 50 years.
 

What’s behind the trend toward younger onset?

The specific factors contributing to increasing rates of CRC in younger individuals are not well known, but there are several plausible explanations. Notable possible contributing factors reported in the literature include obesity, smoking, alcohol, diet, and microbial changes, among other demographic variables. Exposure to high-fructose corn syrup, sugar-sweetened beverages, and processed meats has also recently received attention as contributing dietary risk factors.

The shifting trends toward the onset of CRC among younger patients are now clearly established, with approximately 20% of new cases occurring in those in their early 50s or younger and a higher rate of left-sided tumor development. Unfortunately, these shifts are also associated with a more advanced stage of disease.

There are unique clinical challenges when it comes to identifying younger-onset CRC. A low level of suspicion among primary care providers that their younger patients may have CRC can result in delays in their receiving clinically appropriate diagnostic testing (particularly for overt or occult bleeding/iron deficiency). Younger patients may also be less likely to know about or adhere to new recommendations that they undergo screening.

The landscape for age-related CRC is changing. Although there are many obstacles for implementing new practices, these recent findings from the ACS also highlight a clear path for improvement.

David A. Johnson, MD, is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, and a past president of the American College of Gastroenterology.

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

Colorectal cancer (CRC) remains the second most common cause of cancer-related death in the United States. Although the past several decades have seen significantly greater emphasis on screening and disease prevention for CRC, it has also become increasingly apparent that the age profile and associated risks for this cancer are rapidly changing.

Evidence of this can be found in recently released CRC statistics from the American Cancer Society, which are updated every 3 years using population-based cancer registries.

The incidence in CRC has shown a progressive decline over the past 4 decades. However, whereas in the 2000s there was an average decline of approximately 3%-4% annually, it slowed to 1% per year between 2011 and 2019. This effect is in part because of the trends among younger individuals (< 55 years), in whom the incidence of CRC has increased by 9% over the past 25 years.

The incidence of regional-stage disease also increased by 2%-3% per year for those younger than 65 years, with an additional increase in the incidence of more advanced/distant disease by 0.5%-3% per year. The latter finding represents a reversal of earlier trends observed for staged disease in the decade from 1995 to 2005.

These recent statistics reveal other notable changes that occurred in parallel with the increased incidence of younger-onset CRC. There was a significant shift to left-sided tumors, with a 4% increase in rectal cancers in the decades spanning 1995–2019.

Although the overall mortality declined 2% from 2011 to 2020, the reverse was seen in patients younger than 50 years, in whom there was an increase by 0.5%-3% annually.

Available incidence and mortality data for the current year are understandably lacking, as there is a 2- to 4-year lag for data collection and assimilation, and there have also been methodological changes for tracking and projections. Nonetheless, 2023 projections estimate that there will be 153,020 new cases in the United States, with 19,550 (13%) to occur in those younger than 50 years and 33% in those aged 50-64 years. Overall, 43% of cases are projected to occur in those aged 45-49 years, which is noteworthy given that these ages are now included in the most current CRC screening recommendations.

Further underscoring the risks posed by earlier-onset trends is the projection of 52,550 CRC-related deaths in 2023, with 7% estimated to occur in those younger than 50 years.
 

What’s behind the trend toward younger onset?

The specific factors contributing to increasing rates of CRC in younger individuals are not well known, but there are several plausible explanations. Notable possible contributing factors reported in the literature include obesity, smoking, alcohol, diet, and microbial changes, among other demographic variables. Exposure to high-fructose corn syrup, sugar-sweetened beverages, and processed meats has also recently received attention as contributing dietary risk factors.

The shifting trends toward the onset of CRC among younger patients are now clearly established, with approximately 20% of new cases occurring in those in their early 50s or younger and a higher rate of left-sided tumor development. Unfortunately, these shifts are also associated with a more advanced stage of disease.

There are unique clinical challenges when it comes to identifying younger-onset CRC. A low level of suspicion among primary care providers that their younger patients may have CRC can result in delays in their receiving clinically appropriate diagnostic testing (particularly for overt or occult bleeding/iron deficiency). Younger patients may also be less likely to know about or adhere to new recommendations that they undergo screening.

The landscape for age-related CRC is changing. Although there are many obstacles for implementing new practices, these recent findings from the ACS also highlight a clear path for improvement.

David A. Johnson, MD, is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, and a past president of the American College of Gastroenterology.

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

Radiotherapy followed by immunotherapy within 1-12 months – but not sooner or later – may boost progression-free survival in patients with metastatic non–small cell lung cancer, according to a new study. However, patients still fared poorly on average since overall survival remained low and didn’t change significantly.

While not conclusive, the new research – released at European Lung Cancer Congress 2023 – offers early insight into the best timing for the experimental combination treatment, study coauthor Yanyan Lou, MD, PhD, an oncologist at Mayo Clinic in Jacksonville, Fla., said in an interview.

The wide availability of radiation therapy could also allow the therapy to be administered even in regions with poor access to sophisticated medical care, she said. “Radiation is a very feasible approach that pretty much everybody in your community can get.”

Radiotherapy is typically not added to immunotherapy in patients with non–small cell lung cancer. But “there has been recent interest in the combination: Would tumor necrosis from radiation enhance the immunogenicity of the tumor and thus enhance the effect of immunotherapy?” oncologist Toby Campbell, MD, of University of Wisconsin–Madison, said in an interview.

Research has indeed suggested that the treatments may have a synergistic effect, he said, and it’s clear that “strategies to try and increase immunogenicity are an important area to investigate.”

But he cautioned that “we have a long way to go to understanding how immunogenicity works and how the gut microbiome, tumor, immunotherapy, and the immune system interact with one another.”

For the new study, researchers retrospectively analyzed cases of 225 patients with metastatic non–small cell lung cancer (male = 56%, median age = 68, 79% adenocarcinoma) who were treated with immunotherapy at Mayo Clinic–Jacksonville from 2011 to 2022. The study excluded those who received targeted therapy or prior concurrent chemoradiotherapy and durvalumab.

The most common metastases were bone and central nervous system types (41% and 25%, respectively). Fifty-six percent of patients received radiotherapy before or during immunotherapy. Another 27% never received radiotherapy, and 17% received it after immunotherapy was discontinued.

Common types of immunotherapy included pembrolizumab (78%), nivolumab (14%), and atezolizumab (12%).

Overall, the researchers found no statistically significant differences in various outcomes between patients who received radiotherapy before or during immunotherapy compared with those who didn’t get radiotherapy (progression-free survival: 5.9 vs. 5.5 months, P = .66; overall survival: 16.9 vs. 13.1 months, P = .84; immune-related adverse events: 26.2% vs. 34.4%, P = .24).

However, the researchers found that progression-free survival was significantly higher in one group: Those who received radiotherapy 1-12 months before immunotherapy vs. those who received it less than 1 month before (12.6 vs. 4.2 months, hazard ratio [HR], 0.46, 95% confidence interval [CI], 0.26-0.83, P = .005,) and those who never received radiotherapy (12.6 vs. 5.5 months, HR, 0.56, 95% CI, 0.36-0.89, P = .0197).

There wasn’t a statistically significant difference in overall survival.

The small number of subjects and the variation in treatment protocols may have prevented the study from revealing a survival benefit, Dr. Lou said.

As for adverse effects, she said a preliminary analysis didn’t turn up any.

It’s not clear why a 1- to 12-month gap between radiotherapy and immunotherapy may be most effective, she said. Moving forward, “we need validate this in a large cohort,” she noted.

In regard to cost, immunotherapy is notoriously expensive. Pembrolizumab, for example, has a list price of $10,897 per 200-mg dose given every 3 weeks, and patients may take the drug for a year or two.

Dr. Campbell, who didn’t take part in the new study, said it suggests that research into radiation-immunotherapy combination treatment may be worthwhile.

No funding was reported. The study authors and Dr. Campbell reported no disclosures.

Radiotherapy followed by immunotherapy within 1-12 months – but not sooner or later – may boost progression-free survival in patients with metastatic non–small cell lung cancer, according to a new study. However, patients still fared poorly on average since overall survival remained low and didn’t change significantly.

While not conclusive, the new research – released at European Lung Cancer Congress 2023 – offers early insight into the best timing for the experimental combination treatment, study coauthor Yanyan Lou, MD, PhD, an oncologist at Mayo Clinic in Jacksonville, Fla., said in an interview.

The wide availability of radiation therapy could also allow the therapy to be administered even in regions with poor access to sophisticated medical care, she said. “Radiation is a very feasible approach that pretty much everybody in your community can get.”

Radiotherapy is typically not added to immunotherapy in patients with non–small cell lung cancer. But “there has been recent interest in the combination: Would tumor necrosis from radiation enhance the immunogenicity of the tumor and thus enhance the effect of immunotherapy?” oncologist Toby Campbell, MD, of University of Wisconsin–Madison, said in an interview.

Research has indeed suggested that the treatments may have a synergistic effect, he said, and it’s clear that “strategies to try and increase immunogenicity are an important area to investigate.”

But he cautioned that “we have a long way to go to understanding how immunogenicity works and how the gut microbiome, tumor, immunotherapy, and the immune system interact with one another.”

For the new study, researchers retrospectively analyzed cases of 225 patients with metastatic non–small cell lung cancer (male = 56%, median age = 68, 79% adenocarcinoma) who were treated with immunotherapy at Mayo Clinic–Jacksonville from 2011 to 2022. The study excluded those who received targeted therapy or prior concurrent chemoradiotherapy and durvalumab.

The most common metastases were bone and central nervous system types (41% and 25%, respectively). Fifty-six percent of patients received radiotherapy before or during immunotherapy. Another 27% never received radiotherapy, and 17% received it after immunotherapy was discontinued.

Common types of immunotherapy included pembrolizumab (78%), nivolumab (14%), and atezolizumab (12%).

Overall, the researchers found no statistically significant differences in various outcomes between patients who received radiotherapy before or during immunotherapy compared with those who didn’t get radiotherapy (progression-free survival: 5.9 vs. 5.5 months, P = .66; overall survival: 16.9 vs. 13.1 months, P = .84; immune-related adverse events: 26.2% vs. 34.4%, P = .24).

However, the researchers found that progression-free survival was significantly higher in one group: Those who received radiotherapy 1-12 months before immunotherapy vs. those who received it less than 1 month before (12.6 vs. 4.2 months, hazard ratio [HR], 0.46, 95% confidence interval [CI], 0.26-0.83, P = .005,) and those who never received radiotherapy (12.6 vs. 5.5 months, HR, 0.56, 95% CI, 0.36-0.89, P = .0197).

There wasn’t a statistically significant difference in overall survival.

The small number of subjects and the variation in treatment protocols may have prevented the study from revealing a survival benefit, Dr. Lou said.

As for adverse effects, she said a preliminary analysis didn’t turn up any.

It’s not clear why a 1- to 12-month gap between radiotherapy and immunotherapy may be most effective, she said. Moving forward, “we need validate this in a large cohort,” she noted.

In regard to cost, immunotherapy is notoriously expensive. Pembrolizumab, for example, has a list price of $10,897 per 200-mg dose given every 3 weeks, and patients may take the drug for a year or two.

Dr. Campbell, who didn’t take part in the new study, said it suggests that research into radiation-immunotherapy combination treatment may be worthwhile.

No funding was reported. The study authors and Dr. Campbell reported no disclosures.

Radiotherapy followed by immunotherapy within 1-12 months – but not sooner or later – may boost progression-free survival in patients with metastatic non–small cell lung cancer, according to a new study. However, patients still fared poorly on average since overall survival remained low and didn’t change significantly.

While not conclusive, the new research – released at European Lung Cancer Congress 2023 – offers early insight into the best timing for the experimental combination treatment, study coauthor Yanyan Lou, MD, PhD, an oncologist at Mayo Clinic in Jacksonville, Fla., said in an interview.

The wide availability of radiation therapy could also allow the therapy to be administered even in regions with poor access to sophisticated medical care, she said. “Radiation is a very feasible approach that pretty much everybody in your community can get.”

Radiotherapy is typically not added to immunotherapy in patients with non–small cell lung cancer. But “there has been recent interest in the combination: Would tumor necrosis from radiation enhance the immunogenicity of the tumor and thus enhance the effect of immunotherapy?” oncologist Toby Campbell, MD, of University of Wisconsin–Madison, said in an interview.

Research has indeed suggested that the treatments may have a synergistic effect, he said, and it’s clear that “strategies to try and increase immunogenicity are an important area to investigate.”

But he cautioned that “we have a long way to go to understanding how immunogenicity works and how the gut microbiome, tumor, immunotherapy, and the immune system interact with one another.”

For the new study, researchers retrospectively analyzed cases of 225 patients with metastatic non–small cell lung cancer (male = 56%, median age = 68, 79% adenocarcinoma) who were treated with immunotherapy at Mayo Clinic–Jacksonville from 2011 to 2022. The study excluded those who received targeted therapy or prior concurrent chemoradiotherapy and durvalumab.

The most common metastases were bone and central nervous system types (41% and 25%, respectively). Fifty-six percent of patients received radiotherapy before or during immunotherapy. Another 27% never received radiotherapy, and 17% received it after immunotherapy was discontinued.

Common types of immunotherapy included pembrolizumab (78%), nivolumab (14%), and atezolizumab (12%).

Overall, the researchers found no statistically significant differences in various outcomes between patients who received radiotherapy before or during immunotherapy compared with those who didn’t get radiotherapy (progression-free survival: 5.9 vs. 5.5 months, P = .66; overall survival: 16.9 vs. 13.1 months, P = .84; immune-related adverse events: 26.2% vs. 34.4%, P = .24).

However, the researchers found that progression-free survival was significantly higher in one group: Those who received radiotherapy 1-12 months before immunotherapy vs. those who received it less than 1 month before (12.6 vs. 4.2 months, hazard ratio [HR], 0.46, 95% confidence interval [CI], 0.26-0.83, P = .005,) and those who never received radiotherapy (12.6 vs. 5.5 months, HR, 0.56, 95% CI, 0.36-0.89, P = .0197).

There wasn’t a statistically significant difference in overall survival.

The small number of subjects and the variation in treatment protocols may have prevented the study from revealing a survival benefit, Dr. Lou said.

As for adverse effects, she said a preliminary analysis didn’t turn up any.

It’s not clear why a 1- to 12-month gap between radiotherapy and immunotherapy may be most effective, she said. Moving forward, “we need validate this in a large cohort,” she noted.

In regard to cost, immunotherapy is notoriously expensive. Pembrolizumab, for example, has a list price of $10,897 per 200-mg dose given every 3 weeks, and patients may take the drug for a year or two.

Dr. Campbell, who didn’t take part in the new study, said it suggests that research into radiation-immunotherapy combination treatment may be worthwhile.

No funding was reported. The study authors and Dr. Campbell reported no disclosures.

Although people who survive a childhood cancer are at an increased risk of developing and dying from subsequent cancers, as well as heart disease and stroke, they can reduce this risk by following a healthy lifestyle, say U.S. investigators.

This message comes from a retrospective analysis of more than 34,000 childhood cancer survivors, which found that 40 years after the initial cancer diagnosis, the cumulative all-cause mortality rate was 23.3%, compared with less than 5% in the general population.

However, following a healthy lifestyle was associated with a 20% reduction in health-related mortality, independent of other factors, the analysis showed. This rose even further, up to a 30% reduction, among individuals who did not have hypertension or diabetes.

The study was published online  in The Lancet.

“We identified that long-term survivors of childhood cancer are experiencing a large number of deaths in excess of what would be expected for the general, aging population,” first author Stephanie Dixon, MD, MPH, oncology department, St. Jude Children’s Research Hospital, Memphis, Tenn., said in a press release.

“These excess deaths are predominantly due to the same leading causes of death as in the general population,” including subsequent cancers, heart disease, cerebrovascular disease/stroke, chronic liver and kidney disease, and infectious diseases, she noted. However, in these childhood cancer survivors they are occurring “at a younger age and higher rate.”

“What was most exciting to see,” Dr. Dixon added, “was that, independent of prior treatment exposures and sociodemographic factors, a healthy lifestyle and absence of hypertension or diabetes were each associated with a reduced risk of health-related mortality.”

“This is important because our goal is to extend the life span of survivors and to improve their ‘health span’ as well,” said senior author Greg Armstrong, MD, MSCE, chair of the department of epidemiology and cancer control at St. Jude.

As such, “the study highlights the importance of encouraging survivors to practice healthy behaviors and maintain good control of cardiovascular disease risk factors,” emphasized coauthor Melissa M. Hudson, MD, director of the cancer survivorship division at St. Jude.

Future research should focus on interventions for modifiable lifestyle and cardiovascular risk factors that “may need to be specifically tailored to survivors, with the goal of reducing chronic disease development” and extending their lifespan, the researchers said.
 

Late effects of treatment

Childhood cancer has a tremendous success rate: In the United States, the 5-year survival rate is now more than 85%.

However, long-term survivors experience excess morbidity and late mortality compared with the general population, both of which are “attributable to late effects of treatment,” the team pointed out.

Their study focused on individuals who had been diagnosed with cancer before they were 21 years old and who had survived at least 5 years after the cancer diagnosis.

The median age at diagnosis was 6 years, and the most common diagnoses were acute lymphoblastic leukemia (36%), Hodgkin lymphoma (11%), astrocytoma (10%), and kidney tumors (8%).

The team identified 34,230 survivors who had been treated between Jan. 1, 1970, and Dec. 31, 1999, at 31 institutions in the United States and Canada.

They  represented approximately 20% of all childhood cancer survivors in the United States over the study period. The team noted that 56% of the survivors were male, and the majority (64%) were non-Hispanic White.

The date and causes of death through December 2017 were obtained via linkage to the National Death Index, and cancer treatment information was collated for 21,418 survivors who provided consent. Lifestyle factors – including smoking, alcohol use, physical activity, and unhealthy weight – were graded on a score of 0-4.

Over a median follow-up of 29.1 years, there were 5,916 deaths, with 34% attributable to the recurrence or progression of the primary cancer, and 51.2% attributable to other causes, such as subsequent neoplasms, and cardiac, pulmonary, and other health-related causes.

Overall, survivors were at an elevated risk of death compared with the general population, at a standardized mortality ratio of 5.6. This ratio peaked at 5-9 years after diagnosis at an 18.1-fold increased risk of death compared with the general population.

Forty years or more from the initial diagnosis, two-thirds of the 131 per 10,000 person-years excess deaths from health-related causes were due to the top three causes of health-related death in the general population, the team reported.

This included an absolute excess risk of death from cancer of 54 per 10,000 person-years, an excess risk of heart disease mortality of 27 per 10,000 person-years, and an excess risk of cerebrovascular disease mortality of 10 per 10,000 person-years.

The individual cases of death contributing the greatest excess risk were gastrointestinal cancers (11 per 10,000 person-years), cerebrovascular disease (10 per 10,000 person-years), ischemic heart disease (10 per 10,000 person-years), and valvular heart disease (9 per 10,000 person-years).

The good news is that following a healthy lifestyle was associated with a 20% reduction in health-related mortality versus an unhealthy lifestyle (P = .0020).

Moreover, following even a moderately healthy lifestyle was associated with a 10% reduction in health-related mortality, the researchers noted.

The study was supported by grants from the National Cancer Institute, St. Jude Children’s Research Hospital Cancer Center Support, and the American Lebanese-Syrian Associated Charities. The authors reported no relevant financial relationships.

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

Although people who survive a childhood cancer are at an increased risk of developing and dying from subsequent cancers, as well as heart disease and stroke, they can reduce this risk by following a healthy lifestyle, say U.S. investigators.

This message comes from a retrospective analysis of more than 34,000 childhood cancer survivors, which found that 40 years after the initial cancer diagnosis, the cumulative all-cause mortality rate was 23.3%, compared with less than 5% in the general population.

However, following a healthy lifestyle was associated with a 20% reduction in health-related mortality, independent of other factors, the analysis showed. This rose even further, up to a 30% reduction, among individuals who did not have hypertension or diabetes.

The study was published online  in The Lancet.

“We identified that long-term survivors of childhood cancer are experiencing a large number of deaths in excess of what would be expected for the general, aging population,” first author Stephanie Dixon, MD, MPH, oncology department, St. Jude Children’s Research Hospital, Memphis, Tenn., said in a press release.

“These excess deaths are predominantly due to the same leading causes of death as in the general population,” including subsequent cancers, heart disease, cerebrovascular disease/stroke, chronic liver and kidney disease, and infectious diseases, she noted. However, in these childhood cancer survivors they are occurring “at a younger age and higher rate.”

“What was most exciting to see,” Dr. Dixon added, “was that, independent of prior treatment exposures and sociodemographic factors, a healthy lifestyle and absence of hypertension or diabetes were each associated with a reduced risk of health-related mortality.”

“This is important because our goal is to extend the life span of survivors and to improve their ‘health span’ as well,” said senior author Greg Armstrong, MD, MSCE, chair of the department of epidemiology and cancer control at St. Jude.

As such, “the study highlights the importance of encouraging survivors to practice healthy behaviors and maintain good control of cardiovascular disease risk factors,” emphasized coauthor Melissa M. Hudson, MD, director of the cancer survivorship division at St. Jude.

Future research should focus on interventions for modifiable lifestyle and cardiovascular risk factors that “may need to be specifically tailored to survivors, with the goal of reducing chronic disease development” and extending their lifespan, the researchers said.
 

Late effects of treatment

Childhood cancer has a tremendous success rate: In the United States, the 5-year survival rate is now more than 85%.

However, long-term survivors experience excess morbidity and late mortality compared with the general population, both of which are “attributable to late effects of treatment,” the team pointed out.

Their study focused on individuals who had been diagnosed with cancer before they were 21 years old and who had survived at least 5 years after the cancer diagnosis.

The median age at diagnosis was 6 years, and the most common diagnoses were acute lymphoblastic leukemia (36%), Hodgkin lymphoma (11%), astrocytoma (10%), and kidney tumors (8%).

The team identified 34,230 survivors who had been treated between Jan. 1, 1970, and Dec. 31, 1999, at 31 institutions in the United States and Canada.

They  represented approximately 20% of all childhood cancer survivors in the United States over the study period. The team noted that 56% of the survivors were male, and the majority (64%) were non-Hispanic White.

The date and causes of death through December 2017 were obtained via linkage to the National Death Index, and cancer treatment information was collated for 21,418 survivors who provided consent. Lifestyle factors – including smoking, alcohol use, physical activity, and unhealthy weight – were graded on a score of 0-4.

Over a median follow-up of 29.1 years, there were 5,916 deaths, with 34% attributable to the recurrence or progression of the primary cancer, and 51.2% attributable to other causes, such as subsequent neoplasms, and cardiac, pulmonary, and other health-related causes.

Overall, survivors were at an elevated risk of death compared with the general population, at a standardized mortality ratio of 5.6. This ratio peaked at 5-9 years after diagnosis at an 18.1-fold increased risk of death compared with the general population.

Forty years or more from the initial diagnosis, two-thirds of the 131 per 10,000 person-years excess deaths from health-related causes were due to the top three causes of health-related death in the general population, the team reported.

This included an absolute excess risk of death from cancer of 54 per 10,000 person-years, an excess risk of heart disease mortality of 27 per 10,000 person-years, and an excess risk of cerebrovascular disease mortality of 10 per 10,000 person-years.

The individual cases of death contributing the greatest excess risk were gastrointestinal cancers (11 per 10,000 person-years), cerebrovascular disease (10 per 10,000 person-years), ischemic heart disease (10 per 10,000 person-years), and valvular heart disease (9 per 10,000 person-years).

The good news is that following a healthy lifestyle was associated with a 20% reduction in health-related mortality versus an unhealthy lifestyle (P = .0020).

Moreover, following even a moderately healthy lifestyle was associated with a 10% reduction in health-related mortality, the researchers noted.

The study was supported by grants from the National Cancer Institute, St. Jude Children’s Research Hospital Cancer Center Support, and the American Lebanese-Syrian Associated Charities. The authors reported no relevant financial relationships.

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

Although people who survive a childhood cancer are at an increased risk of developing and dying from subsequent cancers, as well as heart disease and stroke, they can reduce this risk by following a healthy lifestyle, say U.S. investigators.

This message comes from a retrospective analysis of more than 34,000 childhood cancer survivors, which found that 40 years after the initial cancer diagnosis, the cumulative all-cause mortality rate was 23.3%, compared with less than 5% in the general population.

However, following a healthy lifestyle was associated with a 20% reduction in health-related mortality, independent of other factors, the analysis showed. This rose even further, up to a 30% reduction, among individuals who did not have hypertension or diabetes.

The study was published online  in The Lancet.

“We identified that long-term survivors of childhood cancer are experiencing a large number of deaths in excess of what would be expected for the general, aging population,” first author Stephanie Dixon, MD, MPH, oncology department, St. Jude Children’s Research Hospital, Memphis, Tenn., said in a press release.

“These excess deaths are predominantly due to the same leading causes of death as in the general population,” including subsequent cancers, heart disease, cerebrovascular disease/stroke, chronic liver and kidney disease, and infectious diseases, she noted. However, in these childhood cancer survivors they are occurring “at a younger age and higher rate.”

“What was most exciting to see,” Dr. Dixon added, “was that, independent of prior treatment exposures and sociodemographic factors, a healthy lifestyle and absence of hypertension or diabetes were each associated with a reduced risk of health-related mortality.”

“This is important because our goal is to extend the life span of survivors and to improve their ‘health span’ as well,” said senior author Greg Armstrong, MD, MSCE, chair of the department of epidemiology and cancer control at St. Jude.

As such, “the study highlights the importance of encouraging survivors to practice healthy behaviors and maintain good control of cardiovascular disease risk factors,” emphasized coauthor Melissa M. Hudson, MD, director of the cancer survivorship division at St. Jude.

Future research should focus on interventions for modifiable lifestyle and cardiovascular risk factors that “may need to be specifically tailored to survivors, with the goal of reducing chronic disease development” and extending their lifespan, the researchers said.
 

Late effects of treatment

Childhood cancer has a tremendous success rate: In the United States, the 5-year survival rate is now more than 85%.

However, long-term survivors experience excess morbidity and late mortality compared with the general population, both of which are “attributable to late effects of treatment,” the team pointed out.

Their study focused on individuals who had been diagnosed with cancer before they were 21 years old and who had survived at least 5 years after the cancer diagnosis.

The median age at diagnosis was 6 years, and the most common diagnoses were acute lymphoblastic leukemia (36%), Hodgkin lymphoma (11%), astrocytoma (10%), and kidney tumors (8%).

The team identified 34,230 survivors who had been treated between Jan. 1, 1970, and Dec. 31, 1999, at 31 institutions in the United States and Canada.

They  represented approximately 20% of all childhood cancer survivors in the United States over the study period. The team noted that 56% of the survivors were male, and the majority (64%) were non-Hispanic White.

The date and causes of death through December 2017 were obtained via linkage to the National Death Index, and cancer treatment information was collated for 21,418 survivors who provided consent. Lifestyle factors – including smoking, alcohol use, physical activity, and unhealthy weight – were graded on a score of 0-4.

Over a median follow-up of 29.1 years, there were 5,916 deaths, with 34% attributable to the recurrence or progression of the primary cancer, and 51.2% attributable to other causes, such as subsequent neoplasms, and cardiac, pulmonary, and other health-related causes.

Overall, survivors were at an elevated risk of death compared with the general population, at a standardized mortality ratio of 5.6. This ratio peaked at 5-9 years after diagnosis at an 18.1-fold increased risk of death compared with the general population.

Forty years or more from the initial diagnosis, two-thirds of the 131 per 10,000 person-years excess deaths from health-related causes were due to the top three causes of health-related death in the general population, the team reported.

This included an absolute excess risk of death from cancer of 54 per 10,000 person-years, an excess risk of heart disease mortality of 27 per 10,000 person-years, and an excess risk of cerebrovascular disease mortality of 10 per 10,000 person-years.

The individual cases of death contributing the greatest excess risk were gastrointestinal cancers (11 per 10,000 person-years), cerebrovascular disease (10 per 10,000 person-years), ischemic heart disease (10 per 10,000 person-years), and valvular heart disease (9 per 10,000 person-years).

The good news is that following a healthy lifestyle was associated with a 20% reduction in health-related mortality versus an unhealthy lifestyle (P = .0020).

Moreover, following even a moderately healthy lifestyle was associated with a 10% reduction in health-related mortality, the researchers noted.

The study was supported by grants from the National Cancer Institute, St. Jude Children’s Research Hospital Cancer Center Support, and the American Lebanese-Syrian Associated Charities. The authors reported no relevant financial relationships.

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

A new analysis suggests that the initial target of therapy – lung or brain – doesn’t affect overall survival rates in patients with non–small cell lung cancer that has spread to the brain.

“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

The study was released at European Lung Cancer Congress 2023.

According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.

“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”

However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”

For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.

There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)

“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.

He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”

Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”

He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”

No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.

A new analysis suggests that the initial target of therapy – lung or brain – doesn’t affect overall survival rates in patients with non–small cell lung cancer that has spread to the brain.

“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

The study was released at European Lung Cancer Congress 2023.

According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.

“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”

However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”

For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.

There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)

“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.

He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”

Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”

He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”

No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.

A new analysis suggests that the initial target of therapy – lung or brain – doesn’t affect overall survival rates in patients with non–small cell lung cancer that has spread to the brain.

“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.

The study was released at European Lung Cancer Congress 2023.

According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.

“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”

However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”

For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.

There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)

“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.

He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”

Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”

He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”

No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.

At a single robotic-assisted pulmonary lobectomy center, patients with public insurance or combined public and private insurance fared worse than those with private insurance, according to a new retrospective analysis.

The study used public insurance status as a marker for low socioeconomic status (SES) and suggests that patients with combined insurance may constitute a separate population that deserves more attention.

Lower SES has been linked to later stage diagnoses and worse outcomes in NSCLC. Private insurance is a generally-accepted indicator of higher SES, while public insurance like Medicare or Medicaid, alone or in combination with private supplementary insurance, is an indicator of lower SES.

Although previous studies have found associations between patients having public health insurance and experiencing later-stage diagnoses and worse overall survival, there have been few studies of surgical outcomes, and almost no research has examined combination health insurance, according to Allison O. Dumitriu Carcoana, who presented the research during a poster session at the European Lung Cancer Congress 2023.

“This is an important insurance subgroup for us because the majority of our patients fall into this subgroup by being over 65 years old and thus qualifying for Medicare while also paying for a private supplement,” said Ms. Dumitriu Carcoana, who is a medical student at University of South Florida Health Morsani College of Medicine, Tampa.

A previous analysis by the group found an association between private insurance status and better discharge status, as well as higher 5-year overall survival. After accumulating an additional 278 patients, the researchers examined 10-year survival outcomes.

In the new analysis, 52% of 711 participants had combination insurance, while 28% had private insurance, and 20% had public insurance. The subgroups all had similar demographic and histological characteristics. The study was unique in that it found no between-group differences in higher stage at diagnosis, whereas previous studies have found a greater risk of higher stage diagnosis among individuals with public insurance. As expected, patients in the combined insurance group had a higher mean age (P less than .0001) and higher Charlson comorbidity index scores (P = .0014), which in turn was associated with lower 10-year survival. The group also had the highest percentage of former smokers, while the public insurance group had the highest percentage of current smokers (P = .0003).

At both 5 and 10 years, the private insurance group had better OS than the group with public (P less than .001) and the combination insurance group (P = .08). Public health insurance was associated with worse OS at 5 years (hazard ratio, 1.83; P less than .005) but not at 10 years (HR, 1.18; P = .51), while combination insurance was associated with worse OS at 10 years (HR, 1.72; P = .02).

“We think that patients with public health insurance having the worst 5-year overall survival, despite their lower ages and fewer comorbid conditions, compared with patients with combination insurance, highlights the impact of lower socioeconomic status on health outcomes. These patients had the same tumor characteristics, BMI, sex, and race as our patients in the other two insurance groups. The only other significant risk factor [the group had besides having a higher proportion of patients with lower socioeconomic status was that it had a higher proportion of current smokers]. But the multivariate analyses showed that insurance status was an independent predictor of survival, regardless of smoking status or other comorbidities,” said Ms. Dumitriu Carcoana.

“At 10 years post-operatively, the survival curves have shifted and the combination patients had the worst 10-year overall survival. We attribute this to their higher number of comorbid conditions and increased age. In practice, [this means that] the group of patients with public insurance type, but no supplement, should be identified clinically, and the clinical team can initiate a discussion,” Ms. Dumitriu Carcoana said.

“Do these patients feel that they can make follow-up appointments, keep up with medication costs, and make the right lifestyle decisions postoperatively on their current insurance plan? If not, can they afford a private supplement? In our cohort specifically, it may also be important to do more preoperative counseling on the importance of smoking cessation,” she added.

The study is interesting, but it has some important limitations, according to Raja Flores, MD, who was not involved with the study. The authors stated that there was no difference between the insurance groups with respect to mortality or cancer stage, which is the most important predictor of survival. However, the poster didn't include details of the authors' analysis, making it difficult to interpret, Dr. Flores said.

The fact that the study includes a single surgeon has some disadvantages in terms of broader applicability, but it also controls for surgical technique. “Different surgeons have different ways of doing things, so if you had the same surgeon doing it the same way every time, you can look at other variables like insurance (status) and stage,” said Dr. Flores.

The results may also provide an argument against using robotic surgery in patients who do not have insurance, especially since they have not been proven to be better than standard minimally invasive surgery with no robotic assistance. With uninsured patients, “you’re using taxpayer money for a more expensive procedure that isn’t proving to be any better,” Dr. Flores explained.

The study was performed at a single center and cannot prove causation due to its retrospective nature.

Ms. Dumitriu Carcoana and Dr. Flores have no relevant financial disclosures.

*This article was updated on 4/13/2023.

At a single robotic-assisted pulmonary lobectomy center, patients with public insurance or combined public and private insurance fared worse than those with private insurance, according to a new retrospective analysis.

The study used public insurance status as a marker for low socioeconomic status (SES) and suggests that patients with combined insurance may constitute a separate population that deserves more attention.

Lower SES has been linked to later stage diagnoses and worse outcomes in NSCLC. Private insurance is a generally-accepted indicator of higher SES, while public insurance like Medicare or Medicaid, alone or in combination with private supplementary insurance, is an indicator of lower SES.

Although previous studies have found associations between patients having public health insurance and experiencing later-stage diagnoses and worse overall survival, there have been few studies of surgical outcomes, and almost no research has examined combination health insurance, according to Allison O. Dumitriu Carcoana, who presented the research during a poster session at the European Lung Cancer Congress 2023.

“This is an important insurance subgroup for us because the majority of our patients fall into this subgroup by being over 65 years old and thus qualifying for Medicare while also paying for a private supplement,” said Ms. Dumitriu Carcoana, who is a medical student at University of South Florida Health Morsani College of Medicine, Tampa.

A previous analysis by the group found an association between private insurance status and better discharge status, as well as higher 5-year overall survival. After accumulating an additional 278 patients, the researchers examined 10-year survival outcomes.

In the new analysis, 52% of 711 participants had combination insurance, while 28% had private insurance, and 20% had public insurance. The subgroups all had similar demographic and histological characteristics. The study was unique in that it found no between-group differences in higher stage at diagnosis, whereas previous studies have found a greater risk of higher stage diagnosis among individuals with public insurance. As expected, patients in the combined insurance group had a higher mean age (P less than .0001) and higher Charlson comorbidity index scores (P = .0014), which in turn was associated with lower 10-year survival. The group also had the highest percentage of former smokers, while the public insurance group had the highest percentage of current smokers (P = .0003).

At both 5 and 10 years, the private insurance group had better OS than the group with public (P less than .001) and the combination insurance group (P = .08). Public health insurance was associated with worse OS at 5 years (hazard ratio, 1.83; P less than .005) but not at 10 years (HR, 1.18; P = .51), while combination insurance was associated with worse OS at 10 years (HR, 1.72; P = .02).

“We think that patients with public health insurance having the worst 5-year overall survival, despite their lower ages and fewer comorbid conditions, compared with patients with combination insurance, highlights the impact of lower socioeconomic status on health outcomes. These patients had the same tumor characteristics, BMI, sex, and race as our patients in the other two insurance groups. The only other significant risk factor [the group had besides having a higher proportion of patients with lower socioeconomic status was that it had a higher proportion of current smokers]. But the multivariate analyses showed that insurance status was an independent predictor of survival, regardless of smoking status or other comorbidities,” said Ms. Dumitriu Carcoana.

“At 10 years post-operatively, the survival curves have shifted and the combination patients had the worst 10-year overall survival. We attribute this to their higher number of comorbid conditions and increased age. In practice, [this means that] the group of patients with public insurance type, but no supplement, should be identified clinically, and the clinical team can initiate a discussion,” Ms. Dumitriu Carcoana said.

“Do these patients feel that they can make follow-up appointments, keep up with medication costs, and make the right lifestyle decisions postoperatively on their current insurance plan? If not, can they afford a private supplement? In our cohort specifically, it may also be important to do more preoperative counseling on the importance of smoking cessation,” she added.

The study is interesting, but it has some important limitations, according to Raja Flores, MD, who was not involved with the study. The authors stated that there was no difference between the insurance groups with respect to mortality or cancer stage, which is the most important predictor of survival. However, the poster didn't include details of the authors' analysis, making it difficult to interpret, Dr. Flores said.

The fact that the study includes a single surgeon has some disadvantages in terms of broader applicability, but it also controls for surgical technique. “Different surgeons have different ways of doing things, so if you had the same surgeon doing it the same way every time, you can look at other variables like insurance (status) and stage,” said Dr. Flores.

The results may also provide an argument against using robotic surgery in patients who do not have insurance, especially since they have not been proven to be better than standard minimally invasive surgery with no robotic assistance. With uninsured patients, “you’re using taxpayer money for a more expensive procedure that isn’t proving to be any better,” Dr. Flores explained.

The study was performed at a single center and cannot prove causation due to its retrospective nature.

Ms. Dumitriu Carcoana and Dr. Flores have no relevant financial disclosures.

*This article was updated on 4/13/2023.

At a single robotic-assisted pulmonary lobectomy center, patients with public insurance or combined public and private insurance fared worse than those with private insurance, according to a new retrospective analysis.

The study used public insurance status as a marker for low socioeconomic status (SES) and suggests that patients with combined insurance may constitute a separate population that deserves more attention.

Lower SES has been linked to later stage diagnoses and worse outcomes in NSCLC. Private insurance is a generally-accepted indicator of higher SES, while public insurance like Medicare or Medicaid, alone or in combination with private supplementary insurance, is an indicator of lower SES.

Although previous studies have found associations between patients having public health insurance and experiencing later-stage diagnoses and worse overall survival, there have been few studies of surgical outcomes, and almost no research has examined combination health insurance, according to Allison O. Dumitriu Carcoana, who presented the research during a poster session at the European Lung Cancer Congress 2023.

“This is an important insurance subgroup for us because the majority of our patients fall into this subgroup by being over 65 years old and thus qualifying for Medicare while also paying for a private supplement,” said Ms. Dumitriu Carcoana, who is a medical student at University of South Florida Health Morsani College of Medicine, Tampa.

A previous analysis by the group found an association between private insurance status and better discharge status, as well as higher 5-year overall survival. After accumulating an additional 278 patients, the researchers examined 10-year survival outcomes.

In the new analysis, 52% of 711 participants had combination insurance, while 28% had private insurance, and 20% had public insurance. The subgroups all had similar demographic and histological characteristics. The study was unique in that it found no between-group differences in higher stage at diagnosis, whereas previous studies have found a greater risk of higher stage diagnosis among individuals with public insurance. As expected, patients in the combined insurance group had a higher mean age (P less than .0001) and higher Charlson comorbidity index scores (P = .0014), which in turn was associated with lower 10-year survival. The group also had the highest percentage of former smokers, while the public insurance group had the highest percentage of current smokers (P = .0003).

At both 5 and 10 years, the private insurance group had better OS than the group with public (P less than .001) and the combination insurance group (P = .08). Public health insurance was associated with worse OS at 5 years (hazard ratio, 1.83; P less than .005) but not at 10 years (HR, 1.18; P = .51), while combination insurance was associated with worse OS at 10 years (HR, 1.72; P = .02).

“We think that patients with public health insurance having the worst 5-year overall survival, despite their lower ages and fewer comorbid conditions, compared with patients with combination insurance, highlights the impact of lower socioeconomic status on health outcomes. These patients had the same tumor characteristics, BMI, sex, and race as our patients in the other two insurance groups. The only other significant risk factor [the group had besides having a higher proportion of patients with lower socioeconomic status was that it had a higher proportion of current smokers]. But the multivariate analyses showed that insurance status was an independent predictor of survival, regardless of smoking status or other comorbidities,” said Ms. Dumitriu Carcoana.

“At 10 years post-operatively, the survival curves have shifted and the combination patients had the worst 10-year overall survival. We attribute this to their higher number of comorbid conditions and increased age. In practice, [this means that] the group of patients with public insurance type, but no supplement, should be identified clinically, and the clinical team can initiate a discussion,” Ms. Dumitriu Carcoana said.

“Do these patients feel that they can make follow-up appointments, keep up with medication costs, and make the right lifestyle decisions postoperatively on their current insurance plan? If not, can they afford a private supplement? In our cohort specifically, it may also be important to do more preoperative counseling on the importance of smoking cessation,” she added.

The study is interesting, but it has some important limitations, according to Raja Flores, MD, who was not involved with the study. The authors stated that there was no difference between the insurance groups with respect to mortality or cancer stage, which is the most important predictor of survival. However, the poster didn't include details of the authors' analysis, making it difficult to interpret, Dr. Flores said.

The fact that the study includes a single surgeon has some disadvantages in terms of broader applicability, but it also controls for surgical technique. “Different surgeons have different ways of doing things, so if you had the same surgeon doing it the same way every time, you can look at other variables like insurance (status) and stage,” said Dr. Flores.

The results may also provide an argument against using robotic surgery in patients who do not have insurance, especially since they have not been proven to be better than standard minimally invasive surgery with no robotic assistance. With uninsured patients, “you’re using taxpayer money for a more expensive procedure that isn’t proving to be any better,” Dr. Flores explained.

The study was performed at a single center and cannot prove causation due to its retrospective nature.

Ms. Dumitriu Carcoana and Dr. Flores have no relevant financial disclosures.

*This article was updated on 4/13/2023.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A comparison of Food and Drug Administration and European Medicines Agency approvals of immune checkpoint inhibitors in the field of thoracic cancer found significantly longer approval times at the European agency, as well as some examples of different perspectives on biomarkers.

The findings of this new study suggest that patients in Europe may face delayed access to new therapies, the authors wrote in a poster presentation at the European Lung Cancer Congress 2023.

They also noted that some FDA approvals occurred before pivotal trial data became available, which can leave doubt about efficacy.

“Effective cancer management relies on availability of therapies which improve patient outcomes, such as immunotherapy. The two largest regulators involved in approving immunotherapies are the FDA and the EMA and therefore we aimed to compare the approval timings between both to see if a difference in approval timings was present,” coauthor Aakash Desai, MD, said in an interview.

Previously, the researchers conducted a study of cancer approval patterns at the FDA and EMA between 2010 and 2019, and found U.S. patients gain access to new cancer therapeutics more quickly than do European patients. Of 89 new therapies approved in that time span, the FDA approval occurred first in 85 cases (95%), though just 72% were submitted to FDA first. The median increased time it took for EMA approval compared with the FDA was 241 days. Thirty-nine percent of U.S. approvals came before the publication of the pivotal clinical trial, versus 9% of EMA approvals.

The new study focuses on thoracic oncology, where lung cancer is the leading cause of death. “As such, prompt approval timings for immunotherapies are crucial for effective treatment. Furthermore, lung cancer immunotherapies target certain biomarkers, of which, PD1 and PD-L1 are key,” said Dr. Desai, a fellow at Mayo Clinic, Rochester, Minn.

Still, Dr. Desai sounded a note of caution. “Just because a therapy is approved more quickly does not necessarily mean it is efficacious, as the clinical trials involving these drugs may not have been completed or fully reported at the time of authorization. [Drug developers] need to have a more global and coordinated approach to evaluating evidence and approval of drugs so the care received by a particular patient is not a factor of where they live,” he said.

The researchers surveyed approvals of seven immune checkpoint inhibitors (ICIs) approved by both the FDA and the EMA for thoracic malignancies, including non–small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and mesothelioma. The FDA approved 22 indications for the novel ICIs in thoracic malignancies, compared with 16 indications at the EMA. The difference in median approval times was larger for SCLC (179 versus 308 days) and mesothelioma (39 versus 280 days) than for NSCLC (242 versus 272 days).

“There are two discrepancies in biomarker requirements between the FDA and EMA, whereby the FDA has a broader requirement, despite these being ranked fairly consistently in terms of evidence of benefit by [European Society for Medical Oncology Magnitude of Clinical Benefit Scale and National Comprehensive Cancer Network] frameworks,” said Dr. Desai. In the case of atezolizumab for adjuvant NSCLC, the FDA required PDL1 levels of 1% or higher, while the EMA required 50% or higher. For durvalumab in unresectable NSCLC, the FDA had no PDL1 requirement, while the EMA required 1% or higher.

Dr. Desai suggested a need for further investigation into the differences between the two agencies. Asked why the two agencies might have different views on the biomarkers, Dr. Desai responded: “That is the million-dollar question. My guess is [the] EMA weighs subgroup data more than [the] FDA.”

Dr. Desai has no relevant financial disclosures.

A comparison of Food and Drug Administration and European Medicines Agency approvals of immune checkpoint inhibitors in the field of thoracic cancer found significantly longer approval times at the European agency, as well as some examples of different perspectives on biomarkers.

The findings of this new study suggest that patients in Europe may face delayed access to new therapies, the authors wrote in a poster presentation at the European Lung Cancer Congress 2023.

They also noted that some FDA approvals occurred before pivotal trial data became available, which can leave doubt about efficacy.

“Effective cancer management relies on availability of therapies which improve patient outcomes, such as immunotherapy. The two largest regulators involved in approving immunotherapies are the FDA and the EMA and therefore we aimed to compare the approval timings between both to see if a difference in approval timings was present,” coauthor Aakash Desai, MD, said in an interview.

Previously, the researchers conducted a study of cancer approval patterns at the FDA and EMA between 2010 and 2019, and found U.S. patients gain access to new cancer therapeutics more quickly than do European patients. Of 89 new therapies approved in that time span, the FDA approval occurred first in 85 cases (95%), though just 72% were submitted to FDA first. The median increased time it took for EMA approval compared with the FDA was 241 days. Thirty-nine percent of U.S. approvals came before the publication of the pivotal clinical trial, versus 9% of EMA approvals.

The new study focuses on thoracic oncology, where lung cancer is the leading cause of death. “As such, prompt approval timings for immunotherapies are crucial for effective treatment. Furthermore, lung cancer immunotherapies target certain biomarkers, of which, PD1 and PD-L1 are key,” said Dr. Desai, a fellow at Mayo Clinic, Rochester, Minn.

Still, Dr. Desai sounded a note of caution. “Just because a therapy is approved more quickly does not necessarily mean it is efficacious, as the clinical trials involving these drugs may not have been completed or fully reported at the time of authorization. [Drug developers] need to have a more global and coordinated approach to evaluating evidence and approval of drugs so the care received by a particular patient is not a factor of where they live,” he said.

The researchers surveyed approvals of seven immune checkpoint inhibitors (ICIs) approved by both the FDA and the EMA for thoracic malignancies, including non–small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and mesothelioma. The FDA approved 22 indications for the novel ICIs in thoracic malignancies, compared with 16 indications at the EMA. The difference in median approval times was larger for SCLC (179 versus 308 days) and mesothelioma (39 versus 280 days) than for NSCLC (242 versus 272 days).

“There are two discrepancies in biomarker requirements between the FDA and EMA, whereby the FDA has a broader requirement, despite these being ranked fairly consistently in terms of evidence of benefit by [European Society for Medical Oncology Magnitude of Clinical Benefit Scale and National Comprehensive Cancer Network] frameworks,” said Dr. Desai. In the case of atezolizumab for adjuvant NSCLC, the FDA required PDL1 levels of 1% or higher, while the EMA required 50% or higher. For durvalumab in unresectable NSCLC, the FDA had no PDL1 requirement, while the EMA required 1% or higher.

Dr. Desai suggested a need for further investigation into the differences between the two agencies. Asked why the two agencies might have different views on the biomarkers, Dr. Desai responded: “That is the million-dollar question. My guess is [the] EMA weighs subgroup data more than [the] FDA.”

Dr. Desai has no relevant financial disclosures.

A comparison of Food and Drug Administration and European Medicines Agency approvals of immune checkpoint inhibitors in the field of thoracic cancer found significantly longer approval times at the European agency, as well as some examples of different perspectives on biomarkers.

The findings of this new study suggest that patients in Europe may face delayed access to new therapies, the authors wrote in a poster presentation at the European Lung Cancer Congress 2023.

They also noted that some FDA approvals occurred before pivotal trial data became available, which can leave doubt about efficacy.

“Effective cancer management relies on availability of therapies which improve patient outcomes, such as immunotherapy. The two largest regulators involved in approving immunotherapies are the FDA and the EMA and therefore we aimed to compare the approval timings between both to see if a difference in approval timings was present,” coauthor Aakash Desai, MD, said in an interview.

Previously, the researchers conducted a study of cancer approval patterns at the FDA and EMA between 2010 and 2019, and found U.S. patients gain access to new cancer therapeutics more quickly than do European patients. Of 89 new therapies approved in that time span, the FDA approval occurred first in 85 cases (95%), though just 72% were submitted to FDA first. The median increased time it took for EMA approval compared with the FDA was 241 days. Thirty-nine percent of U.S. approvals came before the publication of the pivotal clinical trial, versus 9% of EMA approvals.

The new study focuses on thoracic oncology, where lung cancer is the leading cause of death. “As such, prompt approval timings for immunotherapies are crucial for effective treatment. Furthermore, lung cancer immunotherapies target certain biomarkers, of which, PD1 and PD-L1 are key,” said Dr. Desai, a fellow at Mayo Clinic, Rochester, Minn.

Still, Dr. Desai sounded a note of caution. “Just because a therapy is approved more quickly does not necessarily mean it is efficacious, as the clinical trials involving these drugs may not have been completed or fully reported at the time of authorization. [Drug developers] need to have a more global and coordinated approach to evaluating evidence and approval of drugs so the care received by a particular patient is not a factor of where they live,” he said.

The researchers surveyed approvals of seven immune checkpoint inhibitors (ICIs) approved by both the FDA and the EMA for thoracic malignancies, including non–small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and mesothelioma. The FDA approved 22 indications for the novel ICIs in thoracic malignancies, compared with 16 indications at the EMA. The difference in median approval times was larger for SCLC (179 versus 308 days) and mesothelioma (39 versus 280 days) than for NSCLC (242 versus 272 days).

“There are two discrepancies in biomarker requirements between the FDA and EMA, whereby the FDA has a broader requirement, despite these being ranked fairly consistently in terms of evidence of benefit by [European Society for Medical Oncology Magnitude of Clinical Benefit Scale and National Comprehensive Cancer Network] frameworks,” said Dr. Desai. In the case of atezolizumab for adjuvant NSCLC, the FDA required PDL1 levels of 1% or higher, while the EMA required 50% or higher. For durvalumab in unresectable NSCLC, the FDA had no PDL1 requirement, while the EMA required 1% or higher.

Dr. Desai suggested a need for further investigation into the differences between the two agencies. Asked why the two agencies might have different views on the biomarkers, Dr. Desai responded: “That is the million-dollar question. My guess is [the] EMA weighs subgroup data more than [the] FDA.”

Dr. Desai has no relevant financial disclosures.

A large, systematic review of phase III randomized, controlled trials in metastatic non–small cell lung cancer found quality of life (QoL) improvements in progression-free survival (PFS), but not overall survival (OS), among patients treated with targeted therapy.

The authors, including Fabio Salomone of the University of Naples Federico II, department of clinical medicine and surgery, also observed trends toward an association between QoL improvement and PFS among patients treated with chemotherapy and immunotherapy.

The new research was presented during a poster session at European Lung Cancer Congress 2023.

“The findings of the study support the thesis that QoL and survival in patients with NSCLC are linked. Although this is documented in the literature, this study sums up the evidence of a large number of RCTs, and provides detail in the QoL/survival relationship by treatment type. The subgroup analysis by treatment type is a key strength of the study showing that the QoL/survival link is stronger and more reliable in target(ed) therapies,” George Kypriotakis, PhD, who was not involved with the study, said in an interview.

Combining efficacy and quality of life improvement is an important consideration in clinical practice. “It is important that clinicians provide therapies that are also palliative and improve QoL,” said Dr. Kypriotakis, assistant professor of behavioral sciences at University of Texas MD Anderson Cancer Center, Houston. He noted that the finding of a PFS benefit is a good indicator of overall benefit, which is important since OS outcomes require a larger number of patients and longer follow-up to determine.

“PFS can still be a valid surrogate for OS, especially when it is positively associated with QoL,” noted Dr. Kypriotakis.

The study included 81 trials. Sixteen of the studies investigated immunotherapy, 50 investigated targeted therapy, and 17 investigated chemotherapy regimens. Thirty-seven percent of the trials found an improvement in QoL in the treatment arm compared with the control arm, 59.3% found no difference between arms, and 3.7% found a worse QoL in the treatment arm. There was no statistically significant association between an improvement in OS and QoL among the trials (P = .368).
 

Improved QoL tied to improved PFS

The researchers found an association between improved QoL and improved PFS. Among 60 trials that showed improved PFS, 43.3% found a superior QoL in the treatment arm, 53.3% showed no difference, and 3.3% showed reduced QoL. Among 20 trials that found no improvement in PFS, 20% demonstrated an improved QoL, 75% found no change, and 5% showed worse QoL (P = .0473).

A subanalysis of 48 targeted therapy trials found a correlation between PFS and QoL improvement (P = .0196). Among 25 trials involving patients receiving epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors showing an improved PFS, 60% showed improved QoL, 36% showed no difference, and 4% showed worsening (P = .0077). Seven of these trials showed no PFS benefit and no change in QoL.
 

Industry sponsorship may affect QOL results

The researchers found potential evidence that industry sponsorship may lead to a spin on QoL outcomes. Among 51 trials that showed no QoL benefit associated with treatment, the description of the QoL outcome in 37 industry-sponsored was judged to be neutral and coherent with the study findings in 26 cases, but unjustifiably favorable in 11 cases. Among 14 with nonprofit support, descriptions of QoL results were found to be neutral in all cases (P = .0232).

“Obviously, industry may be motivated to overemphasize treatment benefits, especially in measures that also have a qualitative/subjective dimension such as QoL. Assuming that the authors used a reliable criterion to evaluate “inappropriateness,” industry may be more likely to emphasize QoL improvements as a surrogate for OS, especially when seeking drug approval,” Dr. Kypriotakis said.

The study is retrospective and cannot prove causation.

Dr. Salomone and Dr. Kypriotakis have no relevant financial disclosures.

A large, systematic review of phase III randomized, controlled trials in metastatic non–small cell lung cancer found quality of life (QoL) improvements in progression-free survival (PFS), but not overall survival (OS), among patients treated with targeted therapy.

The authors, including Fabio Salomone of the University of Naples Federico II, department of clinical medicine and surgery, also observed trends toward an association between QoL improvement and PFS among patients treated with chemotherapy and immunotherapy.

The new research was presented during a poster session at European Lung Cancer Congress 2023.

“The findings of the study support the thesis that QoL and survival in patients with NSCLC are linked. Although this is documented in the literature, this study sums up the evidence of a large number of RCTs, and provides detail in the QoL/survival relationship by treatment type. The subgroup analysis by treatment type is a key strength of the study showing that the QoL/survival link is stronger and more reliable in target(ed) therapies,” George Kypriotakis, PhD, who was not involved with the study, said in an interview.

Combining efficacy and quality of life improvement is an important consideration in clinical practice. “It is important that clinicians provide therapies that are also palliative and improve QoL,” said Dr. Kypriotakis, assistant professor of behavioral sciences at University of Texas MD Anderson Cancer Center, Houston. He noted that the finding of a PFS benefit is a good indicator of overall benefit, which is important since OS outcomes require a larger number of patients and longer follow-up to determine.

“PFS can still be a valid surrogate for OS, especially when it is positively associated with QoL,” noted Dr. Kypriotakis.

The study included 81 trials. Sixteen of the studies investigated immunotherapy, 50 investigated targeted therapy, and 17 investigated chemotherapy regimens. Thirty-seven percent of the trials found an improvement in QoL in the treatment arm compared with the control arm, 59.3% found no difference between arms, and 3.7% found a worse QoL in the treatment arm. There was no statistically significant association between an improvement in OS and QoL among the trials (P = .368).
 

Improved QoL tied to improved PFS

The researchers found an association between improved QoL and improved PFS. Among 60 trials that showed improved PFS, 43.3% found a superior QoL in the treatment arm, 53.3% showed no difference, and 3.3% showed reduced QoL. Among 20 trials that found no improvement in PFS, 20% demonstrated an improved QoL, 75% found no change, and 5% showed worse QoL (P = .0473).

A subanalysis of 48 targeted therapy trials found a correlation between PFS and QoL improvement (P = .0196). Among 25 trials involving patients receiving epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors showing an improved PFS, 60% showed improved QoL, 36% showed no difference, and 4% showed worsening (P = .0077). Seven of these trials showed no PFS benefit and no change in QoL.
 

Industry sponsorship may affect QOL results

The researchers found potential evidence that industry sponsorship may lead to a spin on QoL outcomes. Among 51 trials that showed no QoL benefit associated with treatment, the description of the QoL outcome in 37 industry-sponsored was judged to be neutral and coherent with the study findings in 26 cases, but unjustifiably favorable in 11 cases. Among 14 with nonprofit support, descriptions of QoL results were found to be neutral in all cases (P = .0232).

“Obviously, industry may be motivated to overemphasize treatment benefits, especially in measures that also have a qualitative/subjective dimension such as QoL. Assuming that the authors used a reliable criterion to evaluate “inappropriateness,” industry may be more likely to emphasize QoL improvements as a surrogate for OS, especially when seeking drug approval,” Dr. Kypriotakis said.

The study is retrospective and cannot prove causation.

Dr. Salomone and Dr. Kypriotakis have no relevant financial disclosures.

A large, systematic review of phase III randomized, controlled trials in metastatic non–small cell lung cancer found quality of life (QoL) improvements in progression-free survival (PFS), but not overall survival (OS), among patients treated with targeted therapy.

The authors, including Fabio Salomone of the University of Naples Federico II, department of clinical medicine and surgery, also observed trends toward an association between QoL improvement and PFS among patients treated with chemotherapy and immunotherapy.

The new research was presented during a poster session at European Lung Cancer Congress 2023.

“The findings of the study support the thesis that QoL and survival in patients with NSCLC are linked. Although this is documented in the literature, this study sums up the evidence of a large number of RCTs, and provides detail in the QoL/survival relationship by treatment type. The subgroup analysis by treatment type is a key strength of the study showing that the QoL/survival link is stronger and more reliable in target(ed) therapies,” George Kypriotakis, PhD, who was not involved with the study, said in an interview.

Combining efficacy and quality of life improvement is an important consideration in clinical practice. “It is important that clinicians provide therapies that are also palliative and improve QoL,” said Dr. Kypriotakis, assistant professor of behavioral sciences at University of Texas MD Anderson Cancer Center, Houston. He noted that the finding of a PFS benefit is a good indicator of overall benefit, which is important since OS outcomes require a larger number of patients and longer follow-up to determine.

“PFS can still be a valid surrogate for OS, especially when it is positively associated with QoL,” noted Dr. Kypriotakis.

The study included 81 trials. Sixteen of the studies investigated immunotherapy, 50 investigated targeted therapy, and 17 investigated chemotherapy regimens. Thirty-seven percent of the trials found an improvement in QoL in the treatment arm compared with the control arm, 59.3% found no difference between arms, and 3.7% found a worse QoL in the treatment arm. There was no statistically significant association between an improvement in OS and QoL among the trials (P = .368).
 

Improved QoL tied to improved PFS

The researchers found an association between improved QoL and improved PFS. Among 60 trials that showed improved PFS, 43.3% found a superior QoL in the treatment arm, 53.3% showed no difference, and 3.3% showed reduced QoL. Among 20 trials that found no improvement in PFS, 20% demonstrated an improved QoL, 75% found no change, and 5% showed worse QoL (P = .0473).

A subanalysis of 48 targeted therapy trials found a correlation between PFS and QoL improvement (P = .0196). Among 25 trials involving patients receiving epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors showing an improved PFS, 60% showed improved QoL, 36% showed no difference, and 4% showed worsening (P = .0077). Seven of these trials showed no PFS benefit and no change in QoL.
 

Industry sponsorship may affect QOL results

The researchers found potential evidence that industry sponsorship may lead to a spin on QoL outcomes. Among 51 trials that showed no QoL benefit associated with treatment, the description of the QoL outcome in 37 industry-sponsored was judged to be neutral and coherent with the study findings in 26 cases, but unjustifiably favorable in 11 cases. Among 14 with nonprofit support, descriptions of QoL results were found to be neutral in all cases (P = .0232).

“Obviously, industry may be motivated to overemphasize treatment benefits, especially in measures that also have a qualitative/subjective dimension such as QoL. Assuming that the authors used a reliable criterion to evaluate “inappropriateness,” industry may be more likely to emphasize QoL improvements as a surrogate for OS, especially when seeking drug approval,” Dr. Kypriotakis said.

The study is retrospective and cannot prove causation.

Dr. Salomone and Dr. Kypriotakis have no relevant financial disclosures.

Hepatocellular carcinoma (HCC) is relatively common among patients with alcohol-associated cirrhosis, reaching a cumulative incidence of 9% at the 10-year mark, shows a large pooled analysis.

Incidence rates were higher for cohorts that underwent HCC surveillance versus those that did not undergo surveillance, suggesting that such programs offer significant benefit, lead author Daniel Q. Huang, MBBS, of the University of California, San Diego, and colleagues reported.

National University of Singapore

“A systematic review of the incidence of HCC among patients with alcohol-associated cirrhosis has not been reported,” the investigators wrote in Clinical Gastroenterology and Hepatology, prompting the present research.

Previous studies have described a broad range of annual incidence findings for HCC in this population, from 0.6% to 5.6%, suggesting that a systematic approach was needed.

To this end, Dr. Huang and colleagues analyzed data from 18 studies that involved 148,333 patients with alcohol-associated cirrhosis. The primary analysis aimed to determine cumulative incidence rates over time, while the secondary analysis characterized the impact of participation in HCC surveillance programs.

“This meta-analysis used reconstructed individual participant data, which is considered to be the gold standard for reporting survival data because it accounts for censoring of events,” the investigators noted. “The current study provides important data that are useful for clinical practice and clinical trial design.”

The cumulative incidence rates of HCC were 1%, 3%, and 9% at 1 year, 5 years, and 10 years, respectively. Among 12 of the risk factors studied, smoking, diabetes, and decompensation were all significantly associated with rate of HCC.

“Therefore, patients with alcohol-associated cirrhosis should be screened for diabetes to identify the patients at high risk for HCC development,” the investigators wrote. “In addition, patients with alcohol-associated cirrhosis should be advised to stop smoking, while patients with hepatic decompensation should be monitored carefully for the development of HCC if clinically appropriate.”

The secondary analysis showed that HCC incidence rates were higher among patients participating in HCC surveillance programs than those who did not participate (18.6 vs. 4.8 per 1,000 person-years; P = .001).

“Patients with alcohol-associated cirrhosis are known to have lower HCC surveillance rates, which may be related to poor disease awareness, clinic time constraints caused by other active medical issues, and provider beliefs regarding the likelihood of adherence,” the investigators noted.

Increased efforts are needed to promote surveillance in this population, they added, suggesting a range of communication pathways, including social media, traditional news outlets, and direct mailing.

Dr. Huang and colleagues also suggested that the findings should be validated in large prospective studies.

The study was funded by the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Environmental Health Sciences, the National Center for Advancing Translational Sciences, and others. Dr. Huang disclosed funding from the Singapore Ministry of Health’s National Medical Research Council.

Hepatocellular carcinoma (HCC) is relatively common among patients with alcohol-associated cirrhosis, reaching a cumulative incidence of 9% at the 10-year mark, shows a large pooled analysis.

Incidence rates were higher for cohorts that underwent HCC surveillance versus those that did not undergo surveillance, suggesting that such programs offer significant benefit, lead author Daniel Q. Huang, MBBS, of the University of California, San Diego, and colleagues reported.

National University of Singapore

“A systematic review of the incidence of HCC among patients with alcohol-associated cirrhosis has not been reported,” the investigators wrote in Clinical Gastroenterology and Hepatology, prompting the present research.

Previous studies have described a broad range of annual incidence findings for HCC in this population, from 0.6% to 5.6%, suggesting that a systematic approach was needed.

To this end, Dr. Huang and colleagues analyzed data from 18 studies that involved 148,333 patients with alcohol-associated cirrhosis. The primary analysis aimed to determine cumulative incidence rates over time, while the secondary analysis characterized the impact of participation in HCC surveillance programs.

“This meta-analysis used reconstructed individual participant data, which is considered to be the gold standard for reporting survival data because it accounts for censoring of events,” the investigators noted. “The current study provides important data that are useful for clinical practice and clinical trial design.”

The cumulative incidence rates of HCC were 1%, 3%, and 9% at 1 year, 5 years, and 10 years, respectively. Among 12 of the risk factors studied, smoking, diabetes, and decompensation were all significantly associated with rate of HCC.

“Therefore, patients with alcohol-associated cirrhosis should be screened for diabetes to identify the patients at high risk for HCC development,” the investigators wrote. “In addition, patients with alcohol-associated cirrhosis should be advised to stop smoking, while patients with hepatic decompensation should be monitored carefully for the development of HCC if clinically appropriate.”

The secondary analysis showed that HCC incidence rates were higher among patients participating in HCC surveillance programs than those who did not participate (18.6 vs. 4.8 per 1,000 person-years; P = .001).

“Patients with alcohol-associated cirrhosis are known to have lower HCC surveillance rates, which may be related to poor disease awareness, clinic time constraints caused by other active medical issues, and provider beliefs regarding the likelihood of adherence,” the investigators noted.

Increased efforts are needed to promote surveillance in this population, they added, suggesting a range of communication pathways, including social media, traditional news outlets, and direct mailing.

Dr. Huang and colleagues also suggested that the findings should be validated in large prospective studies.

The study was funded by the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Environmental Health Sciences, the National Center for Advancing Translational Sciences, and others. Dr. Huang disclosed funding from the Singapore Ministry of Health’s National Medical Research Council.

Hepatocellular carcinoma (HCC) is relatively common among patients with alcohol-associated cirrhosis, reaching a cumulative incidence of 9% at the 10-year mark, shows a large pooled analysis.

Incidence rates were higher for cohorts that underwent HCC surveillance versus those that did not undergo surveillance, suggesting that such programs offer significant benefit, lead author Daniel Q. Huang, MBBS, of the University of California, San Diego, and colleagues reported.

National University of Singapore

“A systematic review of the incidence of HCC among patients with alcohol-associated cirrhosis has not been reported,” the investigators wrote in Clinical Gastroenterology and Hepatology, prompting the present research.

Previous studies have described a broad range of annual incidence findings for HCC in this population, from 0.6% to 5.6%, suggesting that a systematic approach was needed.

To this end, Dr. Huang and colleagues analyzed data from 18 studies that involved 148,333 patients with alcohol-associated cirrhosis. The primary analysis aimed to determine cumulative incidence rates over time, while the secondary analysis characterized the impact of participation in HCC surveillance programs.

“This meta-analysis used reconstructed individual participant data, which is considered to be the gold standard for reporting survival data because it accounts for censoring of events,” the investigators noted. “The current study provides important data that are useful for clinical practice and clinical trial design.”

The cumulative incidence rates of HCC were 1%, 3%, and 9% at 1 year, 5 years, and 10 years, respectively. Among 12 of the risk factors studied, smoking, diabetes, and decompensation were all significantly associated with rate of HCC.

“Therefore, patients with alcohol-associated cirrhosis should be screened for diabetes to identify the patients at high risk for HCC development,” the investigators wrote. “In addition, patients with alcohol-associated cirrhosis should be advised to stop smoking, while patients with hepatic decompensation should be monitored carefully for the development of HCC if clinically appropriate.”

The secondary analysis showed that HCC incidence rates were higher among patients participating in HCC surveillance programs than those who did not participate (18.6 vs. 4.8 per 1,000 person-years; P = .001).

“Patients with alcohol-associated cirrhosis are known to have lower HCC surveillance rates, which may be related to poor disease awareness, clinic time constraints caused by other active medical issues, and provider beliefs regarding the likelihood of adherence,” the investigators noted.

Increased efforts are needed to promote surveillance in this population, they added, suggesting a range of communication pathways, including social media, traditional news outlets, and direct mailing.

Dr. Huang and colleagues also suggested that the findings should be validated in large prospective studies.

The study was funded by the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Environmental Health Sciences, the National Center for Advancing Translational Sciences, and others. Dr. Huang disclosed funding from the Singapore Ministry of Health’s National Medical Research Council.

Results of a study recently published in Nature Communications suggests that radiation from ultraviolet nail polish dryers could induce cell death and trigger molecular changes linked to cancer in human cells. According to two experts, these findings raise concerns regarding the safety of frequent use of these nail dryers.

In the study, human and mouse cells were exposed to radiation from UV nail dryers. Exposing human and mice skin cells to UVA light for 20 minutes resulted in the death of 20%-30% of cells; three consecutive 20-minute sessions resulted in the death of 65%-70% of cells. Additionally, surviving cells suffered oxidative damage to their DNA and mitochondria, with mutational patterns similar to those seen in skin cancer, study investigator Maria Zhivagui, PhD, of the University of California, San Diego, and associates reported.  

“This study showed that irradiation of human and mouse cell lines using UV nail polish dryers resulted in DNA damage and genome mutations,” Shari Lipner, MD, PhD, director of the nail division at New York–Presbyterian Hospital/Weill Cornell Medicine, New York, said in an interview. The study “ties together exposure to UV light from nail polish dryers and genetic mutations that are associated with skin cancers,” added Dr. Lipner, who was not involved with the study.

UV nail lamps are commonly used to dry and harden gel nail polish formulas. Often referred to as “mini tanning beds,” these devices emit UVA radiation, classified as a Group 1 Carcinogen by the International Agency for Research on Cancer.

“Both UVA and UVB are main drivers of both melanoma and keratinocyte carcinomas (basal cell carcinoma and squamous cell carcinoma),” said Anthony Rossi, MD, a dermatologic surgeon at Memorial Sloan Kettering Cancer Center, New York, who was also not a study investigator. UV irradiance “produces DNA mutations that are specific to forming types of skin cancer,” he said in an interview.

UVA wavelengths commonly used in nail dryers can penetrate all layers of the epidermis, the top layer of the skin, potentially affecting stem cells in the skin, according to the study.

Dr. Lipner noted that “there have been several case reports of patients with histories of gel manicures using UV nail polish dryers who later developed squamous cell carcinomas on the dorsal hands, fingers, and nails, and articles describing high UV emissions from nail polish dryers, but the direct connection between UV dryers and skin cancer development was tenuous.” The first of its kind, the new study investigated the impact of UV nail drying devices at a cellular level.

The results of this study, in combination with previous case reports suggesting the development of skin cancers following UVA dryer use, raise concern regarding the safety of these commonly used devices. The study, the authors wrote, “does not provide direct evidence for an increased cancer risk in human beings,” but their findings and “prior evidence strongly suggest that radiation emitted by UV nail polish dryers may cause cancers of the hand and that UV nail polish dryers, similar to tanning beds, may increase the risk of early onset skin cancer.”

Courtesy MSKCC

Dr. Rossi said that, “while this study shows that the UV exposure does affect human cells and causes mutations, the study was not done in vivo in human beings, so further studies are needed to know at what dose and frequency gel manicures would be needed to cause detrimental effects.” However, for people who regularly receive gel manicures involving UV nail dryers, both Dr. Lipner and Dr. Rossi recommend applying a broad-spectrum sunscreen to protect the dorsal hands, fingertips, and skin surrounding the nails, or wearing UV-protective gloves.

The study was supported by an Alfred B. Sloan Research Fellowship to one of the authors and grants from the National Institutes of Health to two authors. One author reported being a compensated consultant and having an equity interest in io9. Dr. Lipner and Dr. Rossi reported no relevant financial relationships.

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

Results of a study recently published in Nature Communications suggests that radiation from ultraviolet nail polish dryers could induce cell death and trigger molecular changes linked to cancer in human cells. According to two experts, these findings raise concerns regarding the safety of frequent use of these nail dryers.

In the study, human and mouse cells were exposed to radiation from UV nail dryers. Exposing human and mice skin cells to UVA light for 20 minutes resulted in the death of 20%-30% of cells; three consecutive 20-minute sessions resulted in the death of 65%-70% of cells. Additionally, surviving cells suffered oxidative damage to their DNA and mitochondria, with mutational patterns similar to those seen in skin cancer, study investigator Maria Zhivagui, PhD, of the University of California, San Diego, and associates reported.  

“This study showed that irradiation of human and mouse cell lines using UV nail polish dryers resulted in DNA damage and genome mutations,” Shari Lipner, MD, PhD, director of the nail division at New York–Presbyterian Hospital/Weill Cornell Medicine, New York, said in an interview. The study “ties together exposure to UV light from nail polish dryers and genetic mutations that are associated with skin cancers,” added Dr. Lipner, who was not involved with the study.

UV nail lamps are commonly used to dry and harden gel nail polish formulas. Often referred to as “mini tanning beds,” these devices emit UVA radiation, classified as a Group 1 Carcinogen by the International Agency for Research on Cancer.

“Both UVA and UVB are main drivers of both melanoma and keratinocyte carcinomas (basal cell carcinoma and squamous cell carcinoma),” said Anthony Rossi, MD, a dermatologic surgeon at Memorial Sloan Kettering Cancer Center, New York, who was also not a study investigator. UV irradiance “produces DNA mutations that are specific to forming types of skin cancer,” he said in an interview.

UVA wavelengths commonly used in nail dryers can penetrate all layers of the epidermis, the top layer of the skin, potentially affecting stem cells in the skin, according to the study.

Dr. Lipner noted that “there have been several case reports of patients with histories of gel manicures using UV nail polish dryers who later developed squamous cell carcinomas on the dorsal hands, fingers, and nails, and articles describing high UV emissions from nail polish dryers, but the direct connection between UV dryers and skin cancer development was tenuous.” The first of its kind, the new study investigated the impact of UV nail drying devices at a cellular level.

The results of this study, in combination with previous case reports suggesting the development of skin cancers following UVA dryer use, raise concern regarding the safety of these commonly used devices. The study, the authors wrote, “does not provide direct evidence for an increased cancer risk in human beings,” but their findings and “prior evidence strongly suggest that radiation emitted by UV nail polish dryers may cause cancers of the hand and that UV nail polish dryers, similar to tanning beds, may increase the risk of early onset skin cancer.”

Courtesy MSKCC

Dr. Rossi said that, “while this study shows that the UV exposure does affect human cells and causes mutations, the study was not done in vivo in human beings, so further studies are needed to know at what dose and frequency gel manicures would be needed to cause detrimental effects.” However, for people who regularly receive gel manicures involving UV nail dryers, both Dr. Lipner and Dr. Rossi recommend applying a broad-spectrum sunscreen to protect the dorsal hands, fingertips, and skin surrounding the nails, or wearing UV-protective gloves.

The study was supported by an Alfred B. Sloan Research Fellowship to one of the authors and grants from the National Institutes of Health to two authors. One author reported being a compensated consultant and having an equity interest in io9. Dr. Lipner and Dr. Rossi reported no relevant financial relationships.

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

Results of a study recently published in Nature Communications suggests that radiation from ultraviolet nail polish dryers could induce cell death and trigger molecular changes linked to cancer in human cells. According to two experts, these findings raise concerns regarding the safety of frequent use of these nail dryers.

In the study, human and mouse cells were exposed to radiation from UV nail dryers. Exposing human and mice skin cells to UVA light for 20 minutes resulted in the death of 20%-30% of cells; three consecutive 20-minute sessions resulted in the death of 65%-70% of cells. Additionally, surviving cells suffered oxidative damage to their DNA and mitochondria, with mutational patterns similar to those seen in skin cancer, study investigator Maria Zhivagui, PhD, of the University of California, San Diego, and associates reported.  

“This study showed that irradiation of human and mouse cell lines using UV nail polish dryers resulted in DNA damage and genome mutations,” Shari Lipner, MD, PhD, director of the nail division at New York–Presbyterian Hospital/Weill Cornell Medicine, New York, said in an interview. The study “ties together exposure to UV light from nail polish dryers and genetic mutations that are associated with skin cancers,” added Dr. Lipner, who was not involved with the study.

UV nail lamps are commonly used to dry and harden gel nail polish formulas. Often referred to as “mini tanning beds,” these devices emit UVA radiation, classified as a Group 1 Carcinogen by the International Agency for Research on Cancer.

“Both UVA and UVB are main drivers of both melanoma and keratinocyte carcinomas (basal cell carcinoma and squamous cell carcinoma),” said Anthony Rossi, MD, a dermatologic surgeon at Memorial Sloan Kettering Cancer Center, New York, who was also not a study investigator. UV irradiance “produces DNA mutations that are specific to forming types of skin cancer,” he said in an interview.

UVA wavelengths commonly used in nail dryers can penetrate all layers of the epidermis, the top layer of the skin, potentially affecting stem cells in the skin, according to the study.

Dr. Lipner noted that “there have been several case reports of patients with histories of gel manicures using UV nail polish dryers who later developed squamous cell carcinomas on the dorsal hands, fingers, and nails, and articles describing high UV emissions from nail polish dryers, but the direct connection between UV dryers and skin cancer development was tenuous.” The first of its kind, the new study investigated the impact of UV nail drying devices at a cellular level.

The results of this study, in combination with previous case reports suggesting the development of skin cancers following UVA dryer use, raise concern regarding the safety of these commonly used devices. The study, the authors wrote, “does not provide direct evidence for an increased cancer risk in human beings,” but their findings and “prior evidence strongly suggest that radiation emitted by UV nail polish dryers may cause cancers of the hand and that UV nail polish dryers, similar to tanning beds, may increase the risk of early onset skin cancer.”

Courtesy MSKCC

Dr. Rossi said that, “while this study shows that the UV exposure does affect human cells and causes mutations, the study was not done in vivo in human beings, so further studies are needed to know at what dose and frequency gel manicures would be needed to cause detrimental effects.” However, for people who regularly receive gel manicures involving UV nail dryers, both Dr. Lipner and Dr. Rossi recommend applying a broad-spectrum sunscreen to protect the dorsal hands, fingertips, and skin surrounding the nails, or wearing UV-protective gloves.

The study was supported by an Alfred B. Sloan Research Fellowship to one of the authors and grants from the National Institutes of Health to two authors. One author reported being a compensated consultant and having an equity interest in io9. Dr. Lipner and Dr. Rossi reported no relevant financial relationships.

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