Roxanne Nelson, RN, BSN

Radiomics, a growing area of cancer research that extracts noninvasive biomarkers from medical imaging, may be able to improve lung cancer screening by identifying patients with early stage disease at high risk for poorer outcomes.

This is the conclusion from a group of researchers who used data from the National Lung Screening Trial (NLST) to develop and validate a model based on radiomics that could identify a vulnerable high-risk group of early stage patients associated with poor outcomes. These patients would generally require aggressive follow-up and/or adjuvant therapy.

The study was published June 29 in Nature Scientific Reports.

Radiomics, also known as quantitative image features, are noninvasive biomarkers that are generated from medical imaging. An emerging translational field of research, radiomics extracts large amounts of features from radiographic medical images using data-characterization algorithms, which reflect the underlying tumor pathophysiology and heterogeneity.

The authors note that radiomics has many advantages over circulating and tissue-based biomarkers, as these quantitative image features are rapidly calculated from standard-of-care imaging and reflect the entire tumor burden – and not just a sample as is the case with tissue-based biomarkers.

“We view radiomics as a decision support tool across the cancer control continuum, whether it be screening and early detection, diagnosis, prognostication, or treatment response,” said lead author Matthew B. Schabath, PhD, associate member in cancer epidemiology at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida.

“Radiomic features are generated from standard-of-care imaging and validated radiomic models can provide real-time decision support information to clinicians,” he explained.

Last year, another study showed that combining radiomics and imaging may be able to determine which patients with lung cancer were most likely to respond to chemotherapy. The researchers used CT imaging of radiomic features from within and outside the lung nodule and found it could predict time to progression and overall survival, as well as response to chemotherapy, in patients with non–small cell lung cancer (NSCLC).

Anant Madabhushi, PhD, a professor of biomedical engineering and director of the Center for Computational Imaging and Personalized Diagnostics at Case Western Reserve University, Cleveland, commented that the new study is “complementary and supports the premise that radiomics both from inside and outside the tumor can tell us about outcome and treatment response.”

Dr. Madabhushi also noted his group has released several other studies along similar lines, including a study showing how radiomics can predict the benefit of adjuvant therapy in lung cancer, a study showing how radiomics can predict recurrence in early stage NSCLC, and a study showing that radiomics can predict survival and response to immunotherapy in NSCLC.

Improving current lung cancer screening

The landmark NLST showed that, as compared with chest x-rays, low-dose helical computed tomography (LDCT) was associated with a 20% relative reduction in lung cancer mortality in high-risk individuals. However, LDCT screening can lead to overdiagnosis and subsequent overtreatment of slow-growing, indolent cancers.

“Current lung cancer screening inclusion criteria in the US are largely based on the criteria used in the NLST,” Dr. Schabath told Medscape Medical News. “Though the NLST clearly demonstrated that screening LDCT is a lifesaving tool, the NLST was not designed to create public policy.”

He pointed out that fewer than 30% of Americans diagnosed with lung cancer meet the current screening entry criteria and that subsequent trials (e.g., NELSON, LUSI, or MILD) used broader and more inclusive criteria and also showed the efficacy of LDCT for early detection of lung cancer. “Thus, there should be consideration in making the lung cancer screening guidelines more inclusive,” said Dr. Schabath.

“Additionally, adjunct risk-stratification tools, such as blood-based biomarkers, could be an important complement to determine who should be part of a lung cancer screening program,” he said. “This could be particularly salient for people who have no or very few risk factors, such as never smokers.”

Pinpointing poor outcomes

In the current study, Dr. Schabath and colleagues used publicly available data and LDCT images from the NLST to generate radiomic features from screen detected, incidentally-diagnosed lung cancers. Radiomic features describing size, shape, volume, and textural characteristics were then calculated from both the intratumoral and peritumoral regions.

Patients were divided into training and test cohorts, and an external cohort of non-screen-detected lung cancer patients was used for further validation. There were no statistically significant differences between training and test cohorts for most demographics, including age, sex, smoking status, number of pack-years smoked, treatment, stage, and baseline screening result. However, self-reported chronic obstructive pulmonary disease (COPD) was significantly higher in the test cohort compared with the training group (16% vs. 7%; P = .02).

A total of 91 stable and reproducible radiomics features (peritumoral and intratumoral) were identified and 40 (26 peritumoral and 14 intratumoral) were significantly associated with overall survival in the training cohort. The features were subsequently narrowed to four, and backward elimination analyses identified a single model. Patients were then stratified into three risk-groups: low risk, intermediate risk, and high risk.

According to their model, the high-risk group had worse overall survival (hazard ratio, 9.91; 25% 2.5-year and 0% 5-year OS) as compared with the low-risk group (HR, 1.00; 93% 2.5-year and 78% 5-year OS).

The final model was validated in the test group and then replicated in the non–screen-detected patients with adenocarcinoma patients. Since the disease stage differed significantly across the risk groups, the model was stratified by stage and the authors found “compelling” results among early-stage patients, who generally have good outcomes. In this subset, the high-risk group was associated with a worse overall survival (HR, 2.63; 56% 2.5-year and 42% 5-year OS) vs. the low-risk group (HR, 1.00; 75% 2.5-year and 75% 5-year OS).

“We have ongoing studies to determine if these results are consistent in the real-world setting of lung cancer screening across multiple centers,” said Dr. Schabath. “If the NELSON, LUSI, or MILD trial data become publicly available, we will certainly pursue validating our results in those clinical trials.”

The study was funded by the National Cancer Institute. Dr. Schabath and Dr. Madabhushi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Radiomics, a growing area of cancer research that extracts noninvasive biomarkers from medical imaging, may be able to improve lung cancer screening by identifying patients with early stage disease at high risk for poorer outcomes.

This is the conclusion from a group of researchers who used data from the National Lung Screening Trial (NLST) to develop and validate a model based on radiomics that could identify a vulnerable high-risk group of early stage patients associated with poor outcomes. These patients would generally require aggressive follow-up and/or adjuvant therapy.

The study was published June 29 in Nature Scientific Reports.

Radiomics, also known as quantitative image features, are noninvasive biomarkers that are generated from medical imaging. An emerging translational field of research, radiomics extracts large amounts of features from radiographic medical images using data-characterization algorithms, which reflect the underlying tumor pathophysiology and heterogeneity.

The authors note that radiomics has many advantages over circulating and tissue-based biomarkers, as these quantitative image features are rapidly calculated from standard-of-care imaging and reflect the entire tumor burden – and not just a sample as is the case with tissue-based biomarkers.

“We view radiomics as a decision support tool across the cancer control continuum, whether it be screening and early detection, diagnosis, prognostication, or treatment response,” said lead author Matthew B. Schabath, PhD, associate member in cancer epidemiology at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida.

“Radiomic features are generated from standard-of-care imaging and validated radiomic models can provide real-time decision support information to clinicians,” he explained.

Last year, another study showed that combining radiomics and imaging may be able to determine which patients with lung cancer were most likely to respond to chemotherapy. The researchers used CT imaging of radiomic features from within and outside the lung nodule and found it could predict time to progression and overall survival, as well as response to chemotherapy, in patients with non–small cell lung cancer (NSCLC).

Anant Madabhushi, PhD, a professor of biomedical engineering and director of the Center for Computational Imaging and Personalized Diagnostics at Case Western Reserve University, Cleveland, commented that the new study is “complementary and supports the premise that radiomics both from inside and outside the tumor can tell us about outcome and treatment response.”

Dr. Madabhushi also noted his group has released several other studies along similar lines, including a study showing how radiomics can predict the benefit of adjuvant therapy in lung cancer, a study showing how radiomics can predict recurrence in early stage NSCLC, and a study showing that radiomics can predict survival and response to immunotherapy in NSCLC.

Improving current lung cancer screening

The landmark NLST showed that, as compared with chest x-rays, low-dose helical computed tomography (LDCT) was associated with a 20% relative reduction in lung cancer mortality in high-risk individuals. However, LDCT screening can lead to overdiagnosis and subsequent overtreatment of slow-growing, indolent cancers.

“Current lung cancer screening inclusion criteria in the US are largely based on the criteria used in the NLST,” Dr. Schabath told Medscape Medical News. “Though the NLST clearly demonstrated that screening LDCT is a lifesaving tool, the NLST was not designed to create public policy.”

He pointed out that fewer than 30% of Americans diagnosed with lung cancer meet the current screening entry criteria and that subsequent trials (e.g., NELSON, LUSI, or MILD) used broader and more inclusive criteria and also showed the efficacy of LDCT for early detection of lung cancer. “Thus, there should be consideration in making the lung cancer screening guidelines more inclusive,” said Dr. Schabath.

“Additionally, adjunct risk-stratification tools, such as blood-based biomarkers, could be an important complement to determine who should be part of a lung cancer screening program,” he said. “This could be particularly salient for people who have no or very few risk factors, such as never smokers.”

Pinpointing poor outcomes

In the current study, Dr. Schabath and colleagues used publicly available data and LDCT images from the NLST to generate radiomic features from screen detected, incidentally-diagnosed lung cancers. Radiomic features describing size, shape, volume, and textural characteristics were then calculated from both the intratumoral and peritumoral regions.

Patients were divided into training and test cohorts, and an external cohort of non-screen-detected lung cancer patients was used for further validation. There were no statistically significant differences between training and test cohorts for most demographics, including age, sex, smoking status, number of pack-years smoked, treatment, stage, and baseline screening result. However, self-reported chronic obstructive pulmonary disease (COPD) was significantly higher in the test cohort compared with the training group (16% vs. 7%; P = .02).

A total of 91 stable and reproducible radiomics features (peritumoral and intratumoral) were identified and 40 (26 peritumoral and 14 intratumoral) were significantly associated with overall survival in the training cohort. The features were subsequently narrowed to four, and backward elimination analyses identified a single model. Patients were then stratified into three risk-groups: low risk, intermediate risk, and high risk.

According to their model, the high-risk group had worse overall survival (hazard ratio, 9.91; 25% 2.5-year and 0% 5-year OS) as compared with the low-risk group (HR, 1.00; 93% 2.5-year and 78% 5-year OS).

The final model was validated in the test group and then replicated in the non–screen-detected patients with adenocarcinoma patients. Since the disease stage differed significantly across the risk groups, the model was stratified by stage and the authors found “compelling” results among early-stage patients, who generally have good outcomes. In this subset, the high-risk group was associated with a worse overall survival (HR, 2.63; 56% 2.5-year and 42% 5-year OS) vs. the low-risk group (HR, 1.00; 75% 2.5-year and 75% 5-year OS).

“We have ongoing studies to determine if these results are consistent in the real-world setting of lung cancer screening across multiple centers,” said Dr. Schabath. “If the NELSON, LUSI, or MILD trial data become publicly available, we will certainly pursue validating our results in those clinical trials.”

The study was funded by the National Cancer Institute. Dr. Schabath and Dr. Madabhushi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Radiomics, a growing area of cancer research that extracts noninvasive biomarkers from medical imaging, may be able to improve lung cancer screening by identifying patients with early stage disease at high risk for poorer outcomes.

This is the conclusion from a group of researchers who used data from the National Lung Screening Trial (NLST) to develop and validate a model based on radiomics that could identify a vulnerable high-risk group of early stage patients associated with poor outcomes. These patients would generally require aggressive follow-up and/or adjuvant therapy.

The study was published June 29 in Nature Scientific Reports.

Radiomics, also known as quantitative image features, are noninvasive biomarkers that are generated from medical imaging. An emerging translational field of research, radiomics extracts large amounts of features from radiographic medical images using data-characterization algorithms, which reflect the underlying tumor pathophysiology and heterogeneity.

The authors note that radiomics has many advantages over circulating and tissue-based biomarkers, as these quantitative image features are rapidly calculated from standard-of-care imaging and reflect the entire tumor burden – and not just a sample as is the case with tissue-based biomarkers.

“We view radiomics as a decision support tool across the cancer control continuum, whether it be screening and early detection, diagnosis, prognostication, or treatment response,” said lead author Matthew B. Schabath, PhD, associate member in cancer epidemiology at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida.

“Radiomic features are generated from standard-of-care imaging and validated radiomic models can provide real-time decision support information to clinicians,” he explained.

Last year, another study showed that combining radiomics and imaging may be able to determine which patients with lung cancer were most likely to respond to chemotherapy. The researchers used CT imaging of radiomic features from within and outside the lung nodule and found it could predict time to progression and overall survival, as well as response to chemotherapy, in patients with non–small cell lung cancer (NSCLC).

Anant Madabhushi, PhD, a professor of biomedical engineering and director of the Center for Computational Imaging and Personalized Diagnostics at Case Western Reserve University, Cleveland, commented that the new study is “complementary and supports the premise that radiomics both from inside and outside the tumor can tell us about outcome and treatment response.”

Dr. Madabhushi also noted his group has released several other studies along similar lines, including a study showing how radiomics can predict the benefit of adjuvant therapy in lung cancer, a study showing how radiomics can predict recurrence in early stage NSCLC, and a study showing that radiomics can predict survival and response to immunotherapy in NSCLC.

Improving current lung cancer screening

The landmark NLST showed that, as compared with chest x-rays, low-dose helical computed tomography (LDCT) was associated with a 20% relative reduction in lung cancer mortality in high-risk individuals. However, LDCT screening can lead to overdiagnosis and subsequent overtreatment of slow-growing, indolent cancers.

“Current lung cancer screening inclusion criteria in the US are largely based on the criteria used in the NLST,” Dr. Schabath told Medscape Medical News. “Though the NLST clearly demonstrated that screening LDCT is a lifesaving tool, the NLST was not designed to create public policy.”

He pointed out that fewer than 30% of Americans diagnosed with lung cancer meet the current screening entry criteria and that subsequent trials (e.g., NELSON, LUSI, or MILD) used broader and more inclusive criteria and also showed the efficacy of LDCT for early detection of lung cancer. “Thus, there should be consideration in making the lung cancer screening guidelines more inclusive,” said Dr. Schabath.

“Additionally, adjunct risk-stratification tools, such as blood-based biomarkers, could be an important complement to determine who should be part of a lung cancer screening program,” he said. “This could be particularly salient for people who have no or very few risk factors, such as never smokers.”

Pinpointing poor outcomes

In the current study, Dr. Schabath and colleagues used publicly available data and LDCT images from the NLST to generate radiomic features from screen detected, incidentally-diagnosed lung cancers. Radiomic features describing size, shape, volume, and textural characteristics were then calculated from both the intratumoral and peritumoral regions.

Patients were divided into training and test cohorts, and an external cohort of non-screen-detected lung cancer patients was used for further validation. There were no statistically significant differences between training and test cohorts for most demographics, including age, sex, smoking status, number of pack-years smoked, treatment, stage, and baseline screening result. However, self-reported chronic obstructive pulmonary disease (COPD) was significantly higher in the test cohort compared with the training group (16% vs. 7%; P = .02).

A total of 91 stable and reproducible radiomics features (peritumoral and intratumoral) were identified and 40 (26 peritumoral and 14 intratumoral) were significantly associated with overall survival in the training cohort. The features were subsequently narrowed to four, and backward elimination analyses identified a single model. Patients were then stratified into three risk-groups: low risk, intermediate risk, and high risk.

According to their model, the high-risk group had worse overall survival (hazard ratio, 9.91; 25% 2.5-year and 0% 5-year OS) as compared with the low-risk group (HR, 1.00; 93% 2.5-year and 78% 5-year OS).

The final model was validated in the test group and then replicated in the non–screen-detected patients with adenocarcinoma patients. Since the disease stage differed significantly across the risk groups, the model was stratified by stage and the authors found “compelling” results among early-stage patients, who generally have good outcomes. In this subset, the high-risk group was associated with a worse overall survival (HR, 2.63; 56% 2.5-year and 42% 5-year OS) vs. the low-risk group (HR, 1.00; 75% 2.5-year and 75% 5-year OS).

“We have ongoing studies to determine if these results are consistent in the real-world setting of lung cancer screening across multiple centers,” said Dr. Schabath. “If the NELSON, LUSI, or MILD trial data become publicly available, we will certainly pursue validating our results in those clinical trials.”

The study was funded by the National Cancer Institute. Dr. Schabath and Dr. Madabhushi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The incidence of colorectal cancer (CRC) in adults younger than 55 years has been increasing in recent years ― a “dramatic increase” was noted in the United States in 2017, and an increase in incidence has subsequently been seen in many other countries across Europe, as well as Australia, New Zealand, and Canada.

A new study has identified geographic hot spots across the United States, characterized by distinct patterns of early-onset CRC with worse survival among men. The hot spots primarily include counties in the lower Mississippi Delta, west-central Appalachia, and eastern Virginia/North Carolina.

In these hot spots, young adult non-Hispanic black men were specifically at risk and were more likely to die of the disease as compared to persons of other racial groups.

The study was published online on May 15 in the American Journal of Cancer Research.

These data can help to identify some of the risk factors associated with early-onset CRC/mortality, commented lead author Charles Rogers, PhD, MPH, a researcher at the Huntsman Cancer Institute and assistant professor of public health at the University of Utah, Salt Lake City.

“We noted potential explanations for the hot spots,” he told Medscape Medical News. “These include an enduring history of unique challenges, such as inadequate access to care, poor health literacy, and low educational attainment.”

Within hot-spot counties there were also higher rates of poverty, a lack of health insurance, and fewer primary care physicians.

“The disproportionate burden of early-onset colorectal cancer among non-Hispanic black men may result from distinctive stressors coupled with cultural and social expectations that impact screening and care behaviors,” said Rogers. “And while it’s estimated that approximately 14% of all US adults are current smokers, we observed that 24% of the adult population residing in hot-spot counties reported currently smoking and having smoked at least 100 cigarettes in their lifetime.”
 

Lifestyle and screening

Elements relating to the increase in early-onset CRC include environmental and geographical factors, as well as lifestyle factors, such as diet, obesity, and sedentary behaviors, Rogers commented.

“I think lifestyle factors are huge,” he said. “Consumption of high-fructose corn syrup and charred meat, for example, are worth considering and deserve more attention.”

He emphasized the importance of screening. Most health organizations in the United States recommend that screening start at age 50 years, but the American Cancer Society lowered this to 45 years, and the issue has been hotly debated. Rogers said that adults younger than 50 should be having conversations with their clinicians about screening for CRC. He noted that this is particularly important if they have any symptoms of CRC, have a family history of the disease, or reside in one of the hot spots that were identified in their study.

An expert who was approached for outside comment agreed. Chyke Doubeni, MBBS, MPH, director of the Center for Health Equity and Community Engagement Research at the Mayo Clinic in Rochester, Minnesota, said that anyone with health concerns should discuss preventive measures with their primary care physician.

“Screening for people younger than the age of 50 is currently controversial, as it is not recommended by some guidelines,” he said. “Recommendations for screening are different for people with a family history or certain genetic conditions.”

Such people include those younger than 50 years who have a family history of CRC or advanced adenomas. These patients should share that history with their primary care physician in order to determine when to begin screening and how often to be screened.

“People under the age of 50 who have symptoms such as unexplained rectal bleeding or iron deficiency anemia that may suggest the presence of colorectal cancer should be promptly evaluated for that possibility,” Doubeni added.
 

Hot spots versus other counties

The goal of the study was to identify mortality hot spots specific to men with early-onset CRC and to evaluate disparities while controlling for sex-specific differences. Rogers and colleagues identified counties with high early-onset CRC mortality rates using data from the Centers for Disease Control and Prevention (1999–2017) and linked them to data from the Surveillance, Epidemiology, and End Results (SEER) for men aged 15 to 49 years.

The team identified 232 US counties (7% of the total) as hot spots. The majority (214 of 232, 92%) were located in the South, and the remainder (18 of 232, 8%) were in the Midwest P < .01).

As compared to men living in other counties, those residing in hot-spot counties were more likely to be non-Hispanic blacks (30.82% vs 13.06%), less likely to be Hispanic (1.68% vs 16.65%; P < .01), and more likely to be diagnosed with metastatic disease (stage IV CRC) (2.58% vs 1.94%; P < .01).

Among men who lived in hot spots, CRC survival was poorer than was seen elsewhere (113.76 vs 129.04 months, respectively; P < .001). Among those with early-onset CRC, the risk for CRC-specific death was 24% higher (hazard ratio [HR], 1.24) than for men living outside of the hot-spot counties. However, that figure dropped to 12% after adjustment for county-level smoking (HR, 1.12).

With respect to racial/ethnic differences, non-Hispanic black (HR, 1.31) and Hispanic (HR, 1.12) patients had a 31% and 12% increased risk for CRC-specific death as compared to non-Hispanic white men (HR, 1.01) after adjusting for smoking status.

The authors note that among all determinants, “clinical stage explained the largest proportion of the variance” in early-onset CRC survival for men living in hot spots and other locations combined.

In the hot-spot counties, severe tumor grade was associated with greater CRC-specific mortality risk. Among patients with poorly differentiated tumors (HR, 1.87) and undifferentiated tumors (HR, 2.60), the mortality risk was nearly 2 times and 2.6 times greater, respectively, than those with well-differentiated tumors.

Compared to other counties, hot-spot counties were characterized by demographics that have been linked to poorer health outcomes, such as higher poverty rates (26.57% vs 16.77%), greater prevalence of adult obesity (34.94% vs 25.89%), higher adult smoking rates (23.97% vs 15.44%), higher uninsured rates (20.06% vs 17.91%), and fewer primary care physicians (58.28 vs 75.45 per 100,000 population).
 

Geographic distribution of CRC

Commenting to Medscape Medical News, Doubeni pointed out that the identified hot spots are similar to previously reported overall CRC hot spots.

“It shows the same patterns of geographic distribution of colorectal cancer in the United States,” he said. “These patterns tend to be associated with areas with high levels of poverty, as is the case with other chronic diseases, and may be related to clustering of risk factors and limited access to care in those areas.”

The research was supported by the National Cancer Institute of the National Institutes of Health, the Huntsman Cancer Foundation, and the Health Studies Fund of the Department of Family and Preventative Medicine at the University of Utah. The authors and Doubeni have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The incidence of colorectal cancer (CRC) in adults younger than 55 years has been increasing in recent years ― a “dramatic increase” was noted in the United States in 2017, and an increase in incidence has subsequently been seen in many other countries across Europe, as well as Australia, New Zealand, and Canada.

A new study has identified geographic hot spots across the United States, characterized by distinct patterns of early-onset CRC with worse survival among men. The hot spots primarily include counties in the lower Mississippi Delta, west-central Appalachia, and eastern Virginia/North Carolina.

In these hot spots, young adult non-Hispanic black men were specifically at risk and were more likely to die of the disease as compared to persons of other racial groups.

The study was published online on May 15 in the American Journal of Cancer Research.

These data can help to identify some of the risk factors associated with early-onset CRC/mortality, commented lead author Charles Rogers, PhD, MPH, a researcher at the Huntsman Cancer Institute and assistant professor of public health at the University of Utah, Salt Lake City.

“We noted potential explanations for the hot spots,” he told Medscape Medical News. “These include an enduring history of unique challenges, such as inadequate access to care, poor health literacy, and low educational attainment.”

Within hot-spot counties there were also higher rates of poverty, a lack of health insurance, and fewer primary care physicians.

“The disproportionate burden of early-onset colorectal cancer among non-Hispanic black men may result from distinctive stressors coupled with cultural and social expectations that impact screening and care behaviors,” said Rogers. “And while it’s estimated that approximately 14% of all US adults are current smokers, we observed that 24% of the adult population residing in hot-spot counties reported currently smoking and having smoked at least 100 cigarettes in their lifetime.”
 

Lifestyle and screening

Elements relating to the increase in early-onset CRC include environmental and geographical factors, as well as lifestyle factors, such as diet, obesity, and sedentary behaviors, Rogers commented.

“I think lifestyle factors are huge,” he said. “Consumption of high-fructose corn syrup and charred meat, for example, are worth considering and deserve more attention.”

He emphasized the importance of screening. Most health organizations in the United States recommend that screening start at age 50 years, but the American Cancer Society lowered this to 45 years, and the issue has been hotly debated. Rogers said that adults younger than 50 should be having conversations with their clinicians about screening for CRC. He noted that this is particularly important if they have any symptoms of CRC, have a family history of the disease, or reside in one of the hot spots that were identified in their study.

An expert who was approached for outside comment agreed. Chyke Doubeni, MBBS, MPH, director of the Center for Health Equity and Community Engagement Research at the Mayo Clinic in Rochester, Minnesota, said that anyone with health concerns should discuss preventive measures with their primary care physician.

“Screening for people younger than the age of 50 is currently controversial, as it is not recommended by some guidelines,” he said. “Recommendations for screening are different for people with a family history or certain genetic conditions.”

Such people include those younger than 50 years who have a family history of CRC or advanced adenomas. These patients should share that history with their primary care physician in order to determine when to begin screening and how often to be screened.

“People under the age of 50 who have symptoms such as unexplained rectal bleeding or iron deficiency anemia that may suggest the presence of colorectal cancer should be promptly evaluated for that possibility,” Doubeni added.
 

Hot spots versus other counties

The goal of the study was to identify mortality hot spots specific to men with early-onset CRC and to evaluate disparities while controlling for sex-specific differences. Rogers and colleagues identified counties with high early-onset CRC mortality rates using data from the Centers for Disease Control and Prevention (1999–2017) and linked them to data from the Surveillance, Epidemiology, and End Results (SEER) for men aged 15 to 49 years.

The team identified 232 US counties (7% of the total) as hot spots. The majority (214 of 232, 92%) were located in the South, and the remainder (18 of 232, 8%) were in the Midwest P < .01).

As compared to men living in other counties, those residing in hot-spot counties were more likely to be non-Hispanic blacks (30.82% vs 13.06%), less likely to be Hispanic (1.68% vs 16.65%; P < .01), and more likely to be diagnosed with metastatic disease (stage IV CRC) (2.58% vs 1.94%; P < .01).

Among men who lived in hot spots, CRC survival was poorer than was seen elsewhere (113.76 vs 129.04 months, respectively; P < .001). Among those with early-onset CRC, the risk for CRC-specific death was 24% higher (hazard ratio [HR], 1.24) than for men living outside of the hot-spot counties. However, that figure dropped to 12% after adjustment for county-level smoking (HR, 1.12).

With respect to racial/ethnic differences, non-Hispanic black (HR, 1.31) and Hispanic (HR, 1.12) patients had a 31% and 12% increased risk for CRC-specific death as compared to non-Hispanic white men (HR, 1.01) after adjusting for smoking status.

The authors note that among all determinants, “clinical stage explained the largest proportion of the variance” in early-onset CRC survival for men living in hot spots and other locations combined.

In the hot-spot counties, severe tumor grade was associated with greater CRC-specific mortality risk. Among patients with poorly differentiated tumors (HR, 1.87) and undifferentiated tumors (HR, 2.60), the mortality risk was nearly 2 times and 2.6 times greater, respectively, than those with well-differentiated tumors.

Compared to other counties, hot-spot counties were characterized by demographics that have been linked to poorer health outcomes, such as higher poverty rates (26.57% vs 16.77%), greater prevalence of adult obesity (34.94% vs 25.89%), higher adult smoking rates (23.97% vs 15.44%), higher uninsured rates (20.06% vs 17.91%), and fewer primary care physicians (58.28 vs 75.45 per 100,000 population).
 

Geographic distribution of CRC

Commenting to Medscape Medical News, Doubeni pointed out that the identified hot spots are similar to previously reported overall CRC hot spots.

“It shows the same patterns of geographic distribution of colorectal cancer in the United States,” he said. “These patterns tend to be associated with areas with high levels of poverty, as is the case with other chronic diseases, and may be related to clustering of risk factors and limited access to care in those areas.”

The research was supported by the National Cancer Institute of the National Institutes of Health, the Huntsman Cancer Foundation, and the Health Studies Fund of the Department of Family and Preventative Medicine at the University of Utah. The authors and Doubeni have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The incidence of colorectal cancer (CRC) in adults younger than 55 years has been increasing in recent years ― a “dramatic increase” was noted in the United States in 2017, and an increase in incidence has subsequently been seen in many other countries across Europe, as well as Australia, New Zealand, and Canada.

A new study has identified geographic hot spots across the United States, characterized by distinct patterns of early-onset CRC with worse survival among men. The hot spots primarily include counties in the lower Mississippi Delta, west-central Appalachia, and eastern Virginia/North Carolina.

In these hot spots, young adult non-Hispanic black men were specifically at risk and were more likely to die of the disease as compared to persons of other racial groups.

The study was published online on May 15 in the American Journal of Cancer Research.

These data can help to identify some of the risk factors associated with early-onset CRC/mortality, commented lead author Charles Rogers, PhD, MPH, a researcher at the Huntsman Cancer Institute and assistant professor of public health at the University of Utah, Salt Lake City.

“We noted potential explanations for the hot spots,” he told Medscape Medical News. “These include an enduring history of unique challenges, such as inadequate access to care, poor health literacy, and low educational attainment.”

Within hot-spot counties there were also higher rates of poverty, a lack of health insurance, and fewer primary care physicians.

“The disproportionate burden of early-onset colorectal cancer among non-Hispanic black men may result from distinctive stressors coupled with cultural and social expectations that impact screening and care behaviors,” said Rogers. “And while it’s estimated that approximately 14% of all US adults are current smokers, we observed that 24% of the adult population residing in hot-spot counties reported currently smoking and having smoked at least 100 cigarettes in their lifetime.”
 

Lifestyle and screening

Elements relating to the increase in early-onset CRC include environmental and geographical factors, as well as lifestyle factors, such as diet, obesity, and sedentary behaviors, Rogers commented.

“I think lifestyle factors are huge,” he said. “Consumption of high-fructose corn syrup and charred meat, for example, are worth considering and deserve more attention.”

He emphasized the importance of screening. Most health organizations in the United States recommend that screening start at age 50 years, but the American Cancer Society lowered this to 45 years, and the issue has been hotly debated. Rogers said that adults younger than 50 should be having conversations with their clinicians about screening for CRC. He noted that this is particularly important if they have any symptoms of CRC, have a family history of the disease, or reside in one of the hot spots that were identified in their study.

An expert who was approached for outside comment agreed. Chyke Doubeni, MBBS, MPH, director of the Center for Health Equity and Community Engagement Research at the Mayo Clinic in Rochester, Minnesota, said that anyone with health concerns should discuss preventive measures with their primary care physician.

“Screening for people younger than the age of 50 is currently controversial, as it is not recommended by some guidelines,” he said. “Recommendations for screening are different for people with a family history or certain genetic conditions.”

Such people include those younger than 50 years who have a family history of CRC or advanced adenomas. These patients should share that history with their primary care physician in order to determine when to begin screening and how often to be screened.

“People under the age of 50 who have symptoms such as unexplained rectal bleeding or iron deficiency anemia that may suggest the presence of colorectal cancer should be promptly evaluated for that possibility,” Doubeni added.
 

Hot spots versus other counties

The goal of the study was to identify mortality hot spots specific to men with early-onset CRC and to evaluate disparities while controlling for sex-specific differences. Rogers and colleagues identified counties with high early-onset CRC mortality rates using data from the Centers for Disease Control and Prevention (1999–2017) and linked them to data from the Surveillance, Epidemiology, and End Results (SEER) for men aged 15 to 49 years.

The team identified 232 US counties (7% of the total) as hot spots. The majority (214 of 232, 92%) were located in the South, and the remainder (18 of 232, 8%) were in the Midwest P < .01).

As compared to men living in other counties, those residing in hot-spot counties were more likely to be non-Hispanic blacks (30.82% vs 13.06%), less likely to be Hispanic (1.68% vs 16.65%; P < .01), and more likely to be diagnosed with metastatic disease (stage IV CRC) (2.58% vs 1.94%; P < .01).

Among men who lived in hot spots, CRC survival was poorer than was seen elsewhere (113.76 vs 129.04 months, respectively; P < .001). Among those with early-onset CRC, the risk for CRC-specific death was 24% higher (hazard ratio [HR], 1.24) than for men living outside of the hot-spot counties. However, that figure dropped to 12% after adjustment for county-level smoking (HR, 1.12).

With respect to racial/ethnic differences, non-Hispanic black (HR, 1.31) and Hispanic (HR, 1.12) patients had a 31% and 12% increased risk for CRC-specific death as compared to non-Hispanic white men (HR, 1.01) after adjusting for smoking status.

The authors note that among all determinants, “clinical stage explained the largest proportion of the variance” in early-onset CRC survival for men living in hot spots and other locations combined.

In the hot-spot counties, severe tumor grade was associated with greater CRC-specific mortality risk. Among patients with poorly differentiated tumors (HR, 1.87) and undifferentiated tumors (HR, 2.60), the mortality risk was nearly 2 times and 2.6 times greater, respectively, than those with well-differentiated tumors.

Compared to other counties, hot-spot counties were characterized by demographics that have been linked to poorer health outcomes, such as higher poverty rates (26.57% vs 16.77%), greater prevalence of adult obesity (34.94% vs 25.89%), higher adult smoking rates (23.97% vs 15.44%), higher uninsured rates (20.06% vs 17.91%), and fewer primary care physicians (58.28 vs 75.45 per 100,000 population).
 

Geographic distribution of CRC

Commenting to Medscape Medical News, Doubeni pointed out that the identified hot spots are similar to previously reported overall CRC hot spots.

“It shows the same patterns of geographic distribution of colorectal cancer in the United States,” he said. “These patterns tend to be associated with areas with high levels of poverty, as is the case with other chronic diseases, and may be related to clustering of risk factors and limited access to care in those areas.”

The research was supported by the National Cancer Institute of the National Institutes of Health, the Huntsman Cancer Foundation, and the Health Studies Fund of the Department of Family and Preventative Medicine at the University of Utah. The authors and Doubeni have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Treating hypertension with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) was associated with a reduced risk for colorectal cancer, according to findings from a large retrospective study.

However, another study reported just over a year ago suggested that ACE inhibitors, but not ARBs, are associated with an increased risk for lung cancer. An expert approached for comment emphasized that both studies are observational, and, as such, they only show an association, not causation.

In this latest study, published online July 6 in the journal Hypertension, the use of ACE inhibitors/ARBs was associated with a 22% lower risk for colorectal cancer developing within 3 years after a negative baseline colonoscopy.

This is the largest study to date, with a cohort of more than 185,000 patients, to suggest a significant protective effect for these two common antihypertensive medications, the authors note. The risk of developing colorectal cancer decreased with longer duration of ACE inhibitor/ARB use, with a 5% reduction in adjusted hazard ratio risk for each year of use. However, this effect was limited to patients who had negative colonoscopies within a 3-year period and did not extend beyond that point.

Lead author Wai K. Leung, MD, clinical professor of medicine at the University of Hong Kong, explained that they are not advising patients to take ACE inhibitors simply to prevent cancer. “Unlike aspirin and statins, the potential chemopreventive role of ACE inhibitors on cancer has never been established,” he said in an interview. “The study findings may favor the use of ACE inhibitors in the treatment of hypertension, over many other antihypertensives, in some patients for preventing colorectal cancer.”

Increased or reduced risk?

There has been considerable debate about the potential carcinogenic effects of ACE inhibitors and ARBs, and the relationship with “various solid organ cancer risks have been unsettled,” the authors note. Studies have produced conflicting results – showing no overall cancer risk and a modestly increased overall cancer risk – associated with these agents.

A recent study reported that ACE inhibitors, as compared with ARBs, increased risk for lung cancer by 14%. The risk for lung cancer increased by 22% among those using ACE inhibitors for 5 years, and the risk peaked at 31% for patients who took ACE inhibitors for 10 years or longer.

The lead author of that lung cancer study, Laurent Azoulay, PhD, of McGill University in Montreal, offered some thoughts on the seemingly conflicting data now being reported showing a reduction in the risk of colorectal cancer.

“In a nutshell, this study has important methodologic issues that can explain the observed findings,” he said in an interview.

Dr. Azoulay pointed out that, in the univariate model, the use of ACE inhibitors/ARBs was associated with a 26% increased risk of colorectal cancer. “It is only after propensity score adjustment that the effect estimate reversed in the protective direction,” he pointed out. “However, the variables included in the propensity score model were measured in the same time window as the exposure, which can lead to an overadjustment bias and generate spurious findings.”

Another issue is that the study period did not begin at the time of the exposure, but rather at a distant point after treatment initiation – in this case, colorectal cancer screening. “As such, the authors excluded patients who were previously diagnosed with colorectal cancer prior to that point, which likely included patients exposed to ACE inhibitors/ARBs,” he said. “This approach can lead to the inclusion of the ‘survivors’ for whom the risk of developing colorectal cancer is lower.

“But certainly,” Dr. Azoulay added, “this possible association should be investigated using methodologically sound approaches.”

Take-home message for physicians

Another expert emphasized the observational nature of both studies. Raymond Townsend, MD, director of the Hypertension Program and a professor of medicine at the Hospital of the University of Pennsylvania, Philadelphia, said: “First and foremost, these are observational studies and cannot make inference about causality; they can only show associations.”

He pointed out that, sometimes, associations are truly present, whereas at other times, there is bias or confounding that cannot be controlled for statistically because it is “unknown.” That said, the size of this latest study is a plus, and there is a reasonable follow-up period.

“The take-home [message] for practitioners is that there may be a benefit in keeping older people on ACE inhibitors on the likelihood of developing colorectal cancer if your last colonoscopy was negative,” Dr. Townsend, who was not involved in the study, said in an interview.

But there are some questions that remain unanswered regarding characteristics of the cohort, Dr. Townsend noted. “Who were the people having the colonoscopy in the first place? Were they a group at higher risk? Why were some on an ACE inhibitors/ARBs and many others not?” 

There are other conclusions that clinicians can glean from this. “Make a choice of treatment for a patient based on your best estimate of what will lower their blood pressure and prevent hypertension-mediated organ damage,” said Dr. Townsend, who is also an American Heart Association volunteer expert. “Keep in mind that patients hear about these studies and read unreviewed blogs on the web and so have questions.”

He emphasized that it always comes back to two things. “One is that every treatment decision is inherently a risk-benefit scenario,” he said. “And second is that most of our patients are adults, and if they choose to not be treated for their hypertension despite our best advice and reasoning with them, relinquish control and let them proceed as they wish, offering to renegotiate in the future when and if they reconsider.”

Study details

In the latest study, Dr. Leung and colleagues conducted a retrospective cohort study and used data from an electronic health care database of the Hong Kong Hospital Authority. A total of 187,897 individuals aged 40 years and older had undergone colonoscopy between 2005 and 2013 with a negative result and were included in the analysis.

The study’s primary outcome was colorectal cancer that was diagnosed between 6 and 36 months after undergoing colonoscopy, and the median age at colonoscopy was 60.6 years. Within this population, 30,856 patients (16.4%) used ACE inhibitors/ARBs.

Between 6 months and 3 years after undergoing colonoscopy, 854 cases of colorectal cancer were diagnosed, with an incidence rate of 15.2 per 10,000 person-years. The median time between colonoscopy and diagnosis was 1.2 years.

ACE inhibitor/ARB users had a median duration of 3.3 years of use within the 5-year period before their colonoscopy. Within this group, there were 169 (0.55%) cases of colorectal cancer. On univariate analysis, the crude hazard ratio (HR) of colorectal cancer and ACE inhibitor/ARB use was 1.26 (P = .008), but on propensity score regression adjustment, the adjusted HR became 0.78.

The propensity score absolute reduction in risk for users was 3.2 per 10,000 person-years versus nonusers, and stratification by subsite showed an HR of 0.77 for distal cancers and 0.83 for proximal cancers.

In a subgroup analysis, the benefits of ACE inhibitors and ARBs were seen in patients aged 55 years or older (adjusted HR, 0.79) and in those with a history of colonic polyps (adjusted HR, 0.71).

The authors also assessed if there was an association between these medications and other types of cancer. On univariate analysis, usage was associated with an increased risk of lung and prostate cancer but lower risk of breast cancer. But after propensity score regression adjustment, the associations were no longer there.

The study was funded by the Health and Medical Research Fund of the Hong Kong SAR Government. Dr. Leung has received honorarium for attending advisory board meetings of AbbVie, Takeda, and Abbott Laboratories; coauthor Esther W. Chan has received funding support from Pfizer, Bristol-Myers Squibb, Bayer, Takeda, Janssen (a division of Johnson & Johnson); Research Grants Council of Hong Kong; Narcotics Division, Security Bureau; and the National Natural Science Foundation of China, all for work unrelated to the current study. None of the other authors have disclosed relevant financial relationships. Dr. Azoulay has disclosed no relevant financial relationships. Dr. Townsend is employed by Penn Medicine.

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

Treating hypertension with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) was associated with a reduced risk for colorectal cancer, according to findings from a large retrospective study.

However, another study reported just over a year ago suggested that ACE inhibitors, but not ARBs, are associated with an increased risk for lung cancer. An expert approached for comment emphasized that both studies are observational, and, as such, they only show an association, not causation.

In this latest study, published online July 6 in the journal Hypertension, the use of ACE inhibitors/ARBs was associated with a 22% lower risk for colorectal cancer developing within 3 years after a negative baseline colonoscopy.

This is the largest study to date, with a cohort of more than 185,000 patients, to suggest a significant protective effect for these two common antihypertensive medications, the authors note. The risk of developing colorectal cancer decreased with longer duration of ACE inhibitor/ARB use, with a 5% reduction in adjusted hazard ratio risk for each year of use. However, this effect was limited to patients who had negative colonoscopies within a 3-year period and did not extend beyond that point.

Lead author Wai K. Leung, MD, clinical professor of medicine at the University of Hong Kong, explained that they are not advising patients to take ACE inhibitors simply to prevent cancer. “Unlike aspirin and statins, the potential chemopreventive role of ACE inhibitors on cancer has never been established,” he said in an interview. “The study findings may favor the use of ACE inhibitors in the treatment of hypertension, over many other antihypertensives, in some patients for preventing colorectal cancer.”

Increased or reduced risk?

There has been considerable debate about the potential carcinogenic effects of ACE inhibitors and ARBs, and the relationship with “various solid organ cancer risks have been unsettled,” the authors note. Studies have produced conflicting results – showing no overall cancer risk and a modestly increased overall cancer risk – associated with these agents.

A recent study reported that ACE inhibitors, as compared with ARBs, increased risk for lung cancer by 14%. The risk for lung cancer increased by 22% among those using ACE inhibitors for 5 years, and the risk peaked at 31% for patients who took ACE inhibitors for 10 years or longer.

The lead author of that lung cancer study, Laurent Azoulay, PhD, of McGill University in Montreal, offered some thoughts on the seemingly conflicting data now being reported showing a reduction in the risk of colorectal cancer.

“In a nutshell, this study has important methodologic issues that can explain the observed findings,” he said in an interview.

Dr. Azoulay pointed out that, in the univariate model, the use of ACE inhibitors/ARBs was associated with a 26% increased risk of colorectal cancer. “It is only after propensity score adjustment that the effect estimate reversed in the protective direction,” he pointed out. “However, the variables included in the propensity score model were measured in the same time window as the exposure, which can lead to an overadjustment bias and generate spurious findings.”

Another issue is that the study period did not begin at the time of the exposure, but rather at a distant point after treatment initiation – in this case, colorectal cancer screening. “As such, the authors excluded patients who were previously diagnosed with colorectal cancer prior to that point, which likely included patients exposed to ACE inhibitors/ARBs,” he said. “This approach can lead to the inclusion of the ‘survivors’ for whom the risk of developing colorectal cancer is lower.

“But certainly,” Dr. Azoulay added, “this possible association should be investigated using methodologically sound approaches.”

Take-home message for physicians

Another expert emphasized the observational nature of both studies. Raymond Townsend, MD, director of the Hypertension Program and a professor of medicine at the Hospital of the University of Pennsylvania, Philadelphia, said: “First and foremost, these are observational studies and cannot make inference about causality; they can only show associations.”

He pointed out that, sometimes, associations are truly present, whereas at other times, there is bias or confounding that cannot be controlled for statistically because it is “unknown.” That said, the size of this latest study is a plus, and there is a reasonable follow-up period.

“The take-home [message] for practitioners is that there may be a benefit in keeping older people on ACE inhibitors on the likelihood of developing colorectal cancer if your last colonoscopy was negative,” Dr. Townsend, who was not involved in the study, said in an interview.

But there are some questions that remain unanswered regarding characteristics of the cohort, Dr. Townsend noted. “Who were the people having the colonoscopy in the first place? Were they a group at higher risk? Why were some on an ACE inhibitors/ARBs and many others not?” 

There are other conclusions that clinicians can glean from this. “Make a choice of treatment for a patient based on your best estimate of what will lower their blood pressure and prevent hypertension-mediated organ damage,” said Dr. Townsend, who is also an American Heart Association volunteer expert. “Keep in mind that patients hear about these studies and read unreviewed blogs on the web and so have questions.”

He emphasized that it always comes back to two things. “One is that every treatment decision is inherently a risk-benefit scenario,” he said. “And second is that most of our patients are adults, and if they choose to not be treated for their hypertension despite our best advice and reasoning with them, relinquish control and let them proceed as they wish, offering to renegotiate in the future when and if they reconsider.”

Study details

In the latest study, Dr. Leung and colleagues conducted a retrospective cohort study and used data from an electronic health care database of the Hong Kong Hospital Authority. A total of 187,897 individuals aged 40 years and older had undergone colonoscopy between 2005 and 2013 with a negative result and were included in the analysis.

The study’s primary outcome was colorectal cancer that was diagnosed between 6 and 36 months after undergoing colonoscopy, and the median age at colonoscopy was 60.6 years. Within this population, 30,856 patients (16.4%) used ACE inhibitors/ARBs.

Between 6 months and 3 years after undergoing colonoscopy, 854 cases of colorectal cancer were diagnosed, with an incidence rate of 15.2 per 10,000 person-years. The median time between colonoscopy and diagnosis was 1.2 years.

ACE inhibitor/ARB users had a median duration of 3.3 years of use within the 5-year period before their colonoscopy. Within this group, there were 169 (0.55%) cases of colorectal cancer. On univariate analysis, the crude hazard ratio (HR) of colorectal cancer and ACE inhibitor/ARB use was 1.26 (P = .008), but on propensity score regression adjustment, the adjusted HR became 0.78.

The propensity score absolute reduction in risk for users was 3.2 per 10,000 person-years versus nonusers, and stratification by subsite showed an HR of 0.77 for distal cancers and 0.83 for proximal cancers.

In a subgroup analysis, the benefits of ACE inhibitors and ARBs were seen in patients aged 55 years or older (adjusted HR, 0.79) and in those with a history of colonic polyps (adjusted HR, 0.71).

The authors also assessed if there was an association between these medications and other types of cancer. On univariate analysis, usage was associated with an increased risk of lung and prostate cancer but lower risk of breast cancer. But after propensity score regression adjustment, the associations were no longer there.

The study was funded by the Health and Medical Research Fund of the Hong Kong SAR Government. Dr. Leung has received honorarium for attending advisory board meetings of AbbVie, Takeda, and Abbott Laboratories; coauthor Esther W. Chan has received funding support from Pfizer, Bristol-Myers Squibb, Bayer, Takeda, Janssen (a division of Johnson & Johnson); Research Grants Council of Hong Kong; Narcotics Division, Security Bureau; and the National Natural Science Foundation of China, all for work unrelated to the current study. None of the other authors have disclosed relevant financial relationships. Dr. Azoulay has disclosed no relevant financial relationships. Dr. Townsend is employed by Penn Medicine.

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

Treating hypertension with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) was associated with a reduced risk for colorectal cancer, according to findings from a large retrospective study.

However, another study reported just over a year ago suggested that ACE inhibitors, but not ARBs, are associated with an increased risk for lung cancer. An expert approached for comment emphasized that both studies are observational, and, as such, they only show an association, not causation.

In this latest study, published online July 6 in the journal Hypertension, the use of ACE inhibitors/ARBs was associated with a 22% lower risk for colorectal cancer developing within 3 years after a negative baseline colonoscopy.

This is the largest study to date, with a cohort of more than 185,000 patients, to suggest a significant protective effect for these two common antihypertensive medications, the authors note. The risk of developing colorectal cancer decreased with longer duration of ACE inhibitor/ARB use, with a 5% reduction in adjusted hazard ratio risk for each year of use. However, this effect was limited to patients who had negative colonoscopies within a 3-year period and did not extend beyond that point.

Lead author Wai K. Leung, MD, clinical professor of medicine at the University of Hong Kong, explained that they are not advising patients to take ACE inhibitors simply to prevent cancer. “Unlike aspirin and statins, the potential chemopreventive role of ACE inhibitors on cancer has never been established,” he said in an interview. “The study findings may favor the use of ACE inhibitors in the treatment of hypertension, over many other antihypertensives, in some patients for preventing colorectal cancer.”

Increased or reduced risk?

There has been considerable debate about the potential carcinogenic effects of ACE inhibitors and ARBs, and the relationship with “various solid organ cancer risks have been unsettled,” the authors note. Studies have produced conflicting results – showing no overall cancer risk and a modestly increased overall cancer risk – associated with these agents.

A recent study reported that ACE inhibitors, as compared with ARBs, increased risk for lung cancer by 14%. The risk for lung cancer increased by 22% among those using ACE inhibitors for 5 years, and the risk peaked at 31% for patients who took ACE inhibitors for 10 years or longer.

The lead author of that lung cancer study, Laurent Azoulay, PhD, of McGill University in Montreal, offered some thoughts on the seemingly conflicting data now being reported showing a reduction in the risk of colorectal cancer.

“In a nutshell, this study has important methodologic issues that can explain the observed findings,” he said in an interview.

Dr. Azoulay pointed out that, in the univariate model, the use of ACE inhibitors/ARBs was associated with a 26% increased risk of colorectal cancer. “It is only after propensity score adjustment that the effect estimate reversed in the protective direction,” he pointed out. “However, the variables included in the propensity score model were measured in the same time window as the exposure, which can lead to an overadjustment bias and generate spurious findings.”

Another issue is that the study period did not begin at the time of the exposure, but rather at a distant point after treatment initiation – in this case, colorectal cancer screening. “As such, the authors excluded patients who were previously diagnosed with colorectal cancer prior to that point, which likely included patients exposed to ACE inhibitors/ARBs,” he said. “This approach can lead to the inclusion of the ‘survivors’ for whom the risk of developing colorectal cancer is lower.

“But certainly,” Dr. Azoulay added, “this possible association should be investigated using methodologically sound approaches.”

Take-home message for physicians

Another expert emphasized the observational nature of both studies. Raymond Townsend, MD, director of the Hypertension Program and a professor of medicine at the Hospital of the University of Pennsylvania, Philadelphia, said: “First and foremost, these are observational studies and cannot make inference about causality; they can only show associations.”

He pointed out that, sometimes, associations are truly present, whereas at other times, there is bias or confounding that cannot be controlled for statistically because it is “unknown.” That said, the size of this latest study is a plus, and there is a reasonable follow-up period.

“The take-home [message] for practitioners is that there may be a benefit in keeping older people on ACE inhibitors on the likelihood of developing colorectal cancer if your last colonoscopy was negative,” Dr. Townsend, who was not involved in the study, said in an interview.

But there are some questions that remain unanswered regarding characteristics of the cohort, Dr. Townsend noted. “Who were the people having the colonoscopy in the first place? Were they a group at higher risk? Why were some on an ACE inhibitors/ARBs and many others not?” 

There are other conclusions that clinicians can glean from this. “Make a choice of treatment for a patient based on your best estimate of what will lower their blood pressure and prevent hypertension-mediated organ damage,” said Dr. Townsend, who is also an American Heart Association volunteer expert. “Keep in mind that patients hear about these studies and read unreviewed blogs on the web and so have questions.”

He emphasized that it always comes back to two things. “One is that every treatment decision is inherently a risk-benefit scenario,” he said. “And second is that most of our patients are adults, and if they choose to not be treated for their hypertension despite our best advice and reasoning with them, relinquish control and let them proceed as they wish, offering to renegotiate in the future when and if they reconsider.”

Study details

In the latest study, Dr. Leung and colleagues conducted a retrospective cohort study and used data from an electronic health care database of the Hong Kong Hospital Authority. A total of 187,897 individuals aged 40 years and older had undergone colonoscopy between 2005 and 2013 with a negative result and were included in the analysis.

The study’s primary outcome was colorectal cancer that was diagnosed between 6 and 36 months after undergoing colonoscopy, and the median age at colonoscopy was 60.6 years. Within this population, 30,856 patients (16.4%) used ACE inhibitors/ARBs.

Between 6 months and 3 years after undergoing colonoscopy, 854 cases of colorectal cancer were diagnosed, with an incidence rate of 15.2 per 10,000 person-years. The median time between colonoscopy and diagnosis was 1.2 years.

ACE inhibitor/ARB users had a median duration of 3.3 years of use within the 5-year period before their colonoscopy. Within this group, there were 169 (0.55%) cases of colorectal cancer. On univariate analysis, the crude hazard ratio (HR) of colorectal cancer and ACE inhibitor/ARB use was 1.26 (P = .008), but on propensity score regression adjustment, the adjusted HR became 0.78.

The propensity score absolute reduction in risk for users was 3.2 per 10,000 person-years versus nonusers, and stratification by subsite showed an HR of 0.77 for distal cancers and 0.83 for proximal cancers.

In a subgroup analysis, the benefits of ACE inhibitors and ARBs were seen in patients aged 55 years or older (adjusted HR, 0.79) and in those with a history of colonic polyps (adjusted HR, 0.71).

The authors also assessed if there was an association between these medications and other types of cancer. On univariate analysis, usage was associated with an increased risk of lung and prostate cancer but lower risk of breast cancer. But after propensity score regression adjustment, the associations were no longer there.

The study was funded by the Health and Medical Research Fund of the Hong Kong SAR Government. Dr. Leung has received honorarium for attending advisory board meetings of AbbVie, Takeda, and Abbott Laboratories; coauthor Esther W. Chan has received funding support from Pfizer, Bristol-Myers Squibb, Bayer, Takeda, Janssen (a division of Johnson & Johnson); Research Grants Council of Hong Kong; Narcotics Division, Security Bureau; and the National Natural Science Foundation of China, all for work unrelated to the current study. None of the other authors have disclosed relevant financial relationships. Dr. Azoulay has disclosed no relevant financial relationships. Dr. Townsend is employed by Penn Medicine.

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

The US Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda, Merck) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer.

This is the first time that an immunotherapy agent has been approved in this setting and as monotherapy, without added chemotherapy.

“Metastatic colorectal cancer is a serious and life-threatening disease with a poor prognosis,” said Richard Pazdur, MD, director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases at the FDA Center for Drug Evaluation and Research, in a statement. “Available current therapy with chemotherapy combinations and other biologics are associated with substantial toxicity.”

“Having a nonchemotherapy option available for selected patients is a noteworthy paradigm shift in treatment,” he commented.

Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and has demonstrated robust antitumor activity and a favorable safety profile in multiple tumor types.

The current approval is based on data from the multicenter, randomized KEYNOTE-177 trial, which found that pembrolizumab more than doubled median progression-free survival (PFS) compared with chemotherapy, the current standard of care. The study results were presented earlier this year at the American Society of Clinical Oncology (ASCO) virtual scientific program, as reported by Medscape Medical News. In a commentary about that study, David Kerr, MD, professor of cancer medicine at the Oxford Cancer Centre, UK, said: “We know that MSI-H/dMMR tumors occur in only 4% or 5% of all patients in the advanced setting. Nevertheless, for that small but important subgroup, we now have a well-tolerated new treatment.”

New standard of care

The KEYNOTE-177 trial involved 307 patients with previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer. They were randomized to receive either pembrolizumab at 200 mg every 3 weeks for up to 35 cycles (n = 153) or to the investigators’ choice of chemotherapy (n = 154).

Chemotherapy regimens were modified FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) used alone or in combination with either bevacizumab or cetuximab, or FOLFIRI (leucovorin, fluorouracil, irinotecan) alone or in combination with either bevacizumab or cetuximab.

Crossover from the chemotherapy arm to immunotherapy was permitted for up to 35 cycles if the patient experienced disease progression confirmed by central review.

The primary endpoints were PFS and overall survival, and the trial would be considered successful if either primary endpoint was met.

Treatment with pembrolizumab monotherapy significantly reduced the risk of disease progression or death by 40% (HR, 0.60; 95% CI, 0.45 - 0.80; P = .0004), with a median PFS of 16.5 months versus 8.2 months for chemotherapy. At the time of the PFS analysis, overall survival data were not yet mature (66% of the required number of events for final analysis).

The overall response rate with pembrolizumab was 44%, with a complete response achieved in 11% of patients and a partial response rate of 33%. For the chemotherapy arm, the overall response rate was 33%, with a complete response rate of 4% and a partial response rate of 29%.

The median duration of response was not reached in the pembrolizumab arm versus 10.6 months with chemotherapy.

“In the past, no medical treatment has shown such difference in terms of improvement of PFS in metastatic colorectal cancer,” said study investigator Thierry André, MD, of Hôpital Saint Antoine in Paris, France, at a press briefing held prior to the presentation at the ASCO meeting.

At that time, Michael J. Overman, MD, of the University of Texas MD Anderson Cancer Center in Houston, told Medscape Medical News that “I think this is setting a new standard of care.”

Grade 3 or greater treatment-related adverse events occurred in 22% of patients on pembrolizumab and 66% on chemotherapy.

Immune-mediated adverse events and infusion reactions were more common with pembrolizumab than chemotherapy (31% and 13%, respectively). Adverse events that were common with chemotherapy included gastrointestinal events, fatigue, neutropenia, and peripheral sensory neuropathy.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda, Merck) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer.

This is the first time that an immunotherapy agent has been approved in this setting and as monotherapy, without added chemotherapy.

“Metastatic colorectal cancer is a serious and life-threatening disease with a poor prognosis,” said Richard Pazdur, MD, director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases at the FDA Center for Drug Evaluation and Research, in a statement. “Available current therapy with chemotherapy combinations and other biologics are associated with substantial toxicity.”

“Having a nonchemotherapy option available for selected patients is a noteworthy paradigm shift in treatment,” he commented.

Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and has demonstrated robust antitumor activity and a favorable safety profile in multiple tumor types.

The current approval is based on data from the multicenter, randomized KEYNOTE-177 trial, which found that pembrolizumab more than doubled median progression-free survival (PFS) compared with chemotherapy, the current standard of care. The study results were presented earlier this year at the American Society of Clinical Oncology (ASCO) virtual scientific program, as reported by Medscape Medical News. In a commentary about that study, David Kerr, MD, professor of cancer medicine at the Oxford Cancer Centre, UK, said: “We know that MSI-H/dMMR tumors occur in only 4% or 5% of all patients in the advanced setting. Nevertheless, for that small but important subgroup, we now have a well-tolerated new treatment.”

New standard of care

The KEYNOTE-177 trial involved 307 patients with previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer. They were randomized to receive either pembrolizumab at 200 mg every 3 weeks for up to 35 cycles (n = 153) or to the investigators’ choice of chemotherapy (n = 154).

Chemotherapy regimens were modified FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) used alone or in combination with either bevacizumab or cetuximab, or FOLFIRI (leucovorin, fluorouracil, irinotecan) alone or in combination with either bevacizumab or cetuximab.

Crossover from the chemotherapy arm to immunotherapy was permitted for up to 35 cycles if the patient experienced disease progression confirmed by central review.

The primary endpoints were PFS and overall survival, and the trial would be considered successful if either primary endpoint was met.

Treatment with pembrolizumab monotherapy significantly reduced the risk of disease progression or death by 40% (HR, 0.60; 95% CI, 0.45 - 0.80; P = .0004), with a median PFS of 16.5 months versus 8.2 months for chemotherapy. At the time of the PFS analysis, overall survival data were not yet mature (66% of the required number of events for final analysis).

The overall response rate with pembrolizumab was 44%, with a complete response achieved in 11% of patients and a partial response rate of 33%. For the chemotherapy arm, the overall response rate was 33%, with a complete response rate of 4% and a partial response rate of 29%.

The median duration of response was not reached in the pembrolizumab arm versus 10.6 months with chemotherapy.

“In the past, no medical treatment has shown such difference in terms of improvement of PFS in metastatic colorectal cancer,” said study investigator Thierry André, MD, of Hôpital Saint Antoine in Paris, France, at a press briefing held prior to the presentation at the ASCO meeting.

At that time, Michael J. Overman, MD, of the University of Texas MD Anderson Cancer Center in Houston, told Medscape Medical News that “I think this is setting a new standard of care.”

Grade 3 or greater treatment-related adverse events occurred in 22% of patients on pembrolizumab and 66% on chemotherapy.

Immune-mediated adverse events and infusion reactions were more common with pembrolizumab than chemotherapy (31% and 13%, respectively). Adverse events that were common with chemotherapy included gastrointestinal events, fatigue, neutropenia, and peripheral sensory neuropathy.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda, Merck) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer.

This is the first time that an immunotherapy agent has been approved in this setting and as monotherapy, without added chemotherapy.

“Metastatic colorectal cancer is a serious and life-threatening disease with a poor prognosis,” said Richard Pazdur, MD, director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases at the FDA Center for Drug Evaluation and Research, in a statement. “Available current therapy with chemotherapy combinations and other biologics are associated with substantial toxicity.”

“Having a nonchemotherapy option available for selected patients is a noteworthy paradigm shift in treatment,” he commented.

Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and has demonstrated robust antitumor activity and a favorable safety profile in multiple tumor types.

The current approval is based on data from the multicenter, randomized KEYNOTE-177 trial, which found that pembrolizumab more than doubled median progression-free survival (PFS) compared with chemotherapy, the current standard of care. The study results were presented earlier this year at the American Society of Clinical Oncology (ASCO) virtual scientific program, as reported by Medscape Medical News. In a commentary about that study, David Kerr, MD, professor of cancer medicine at the Oxford Cancer Centre, UK, said: “We know that MSI-H/dMMR tumors occur in only 4% or 5% of all patients in the advanced setting. Nevertheless, for that small but important subgroup, we now have a well-tolerated new treatment.”

New standard of care

The KEYNOTE-177 trial involved 307 patients with previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer. They were randomized to receive either pembrolizumab at 200 mg every 3 weeks for up to 35 cycles (n = 153) or to the investigators’ choice of chemotherapy (n = 154).

Chemotherapy regimens were modified FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) used alone or in combination with either bevacizumab or cetuximab, or FOLFIRI (leucovorin, fluorouracil, irinotecan) alone or in combination with either bevacizumab or cetuximab.

Crossover from the chemotherapy arm to immunotherapy was permitted for up to 35 cycles if the patient experienced disease progression confirmed by central review.

The primary endpoints were PFS and overall survival, and the trial would be considered successful if either primary endpoint was met.

Treatment with pembrolizumab monotherapy significantly reduced the risk of disease progression or death by 40% (HR, 0.60; 95% CI, 0.45 - 0.80; P = .0004), with a median PFS of 16.5 months versus 8.2 months for chemotherapy. At the time of the PFS analysis, overall survival data were not yet mature (66% of the required number of events for final analysis).

The overall response rate with pembrolizumab was 44%, with a complete response achieved in 11% of patients and a partial response rate of 33%. For the chemotherapy arm, the overall response rate was 33%, with a complete response rate of 4% and a partial response rate of 29%.

The median duration of response was not reached in the pembrolizumab arm versus 10.6 months with chemotherapy.

“In the past, no medical treatment has shown such difference in terms of improvement of PFS in metastatic colorectal cancer,” said study investigator Thierry André, MD, of Hôpital Saint Antoine in Paris, France, at a press briefing held prior to the presentation at the ASCO meeting.

At that time, Michael J. Overman, MD, of the University of Texas MD Anderson Cancer Center in Houston, told Medscape Medical News that “I think this is setting a new standard of care.”

Grade 3 or greater treatment-related adverse events occurred in 22% of patients on pembrolizumab and 66% on chemotherapy.

Immune-mediated adverse events and infusion reactions were more common with pembrolizumab than chemotherapy (31% and 13%, respectively). Adverse events that were common with chemotherapy included gastrointestinal events, fatigue, neutropenia, and peripheral sensory neuropathy.

This article first appeared on Medscape.com.

A model created by the National Cancer Institute predicts that tens of thousands of excess cancer deaths will occur over the next decade as a result of missed screenings, delays in diagnosis, and reductions in oncology care caused by the COVID-19 pandemic.

“As director of NCI, I am deeply concerned about the potential impacts of delayed diagnoses and deferred or modified treatment plans on cancer incidence and mortality,” said Norman “Ned” Sharpless, MD.

“In the past 3 decades, we have seen steady and strong progress against death and suffering from cancer, thanks to improvements in prevention, screening, diagnosis, and treatment. I worry that the SARS-CoV-2 pandemic has put those decades of steady progress at risk and may precipitate reversals of these trends.”

In an editorial published June 19 in Science, Dr. Sharpless highlighted modeling performed by the NCI that predicts an excess of 10,000 deaths from breast and colorectal cancer over the next 10 years.

The number of excess deaths per year would peak in the next year or 2, likely sooner for colorectal than for breast cancer, but “for both cancer types, we believe the pandemic will influence cancer deaths for at least a decade.”

In an interview, Dr. Sharpless pointed out that this analysis is conservative because the researchers only evaluated two types of cancer. They chose breast and colorectal cancer because these are common cancers (accounting for about one-sixth of all cancers) with relatively high screening rates.

“We didn’t model other cancer types, but we have no reason to think that we’re not going to see the same thing with other types of malignancies,” he said. “That is a significant amount of excess mortality.”
 

Delayed diagnosis, modified therapy

One of the effects of the pandemic has been to cause delays in cancer diagnosis. “Routine screening has plummeted and is running at less than 90% in some systems,” Dr. Sharpless said.

“Most cancers are diagnosed when people experience symptoms and go see their doctors, and those symptomatic screening events are also not happening,” he continued. “Fear of contracting the coronavirus in health care settings has dissuaded people from visits.”

In some cases, a delay in diagnosis will allow the cancer to progress to a more advanced stage. “The earlier the diagnosis, the better, and if the stages are more advanced, patients will not do as well for virtually every kind of cancer,” he said.

In addition to delays in diagnosis, treatments are being postponed or modified for patients recently diagnosed with cancer. Because of delays and reductions in curative therapies, patients may be receiving less than optimal care.

“We are seeing a lot of nonstandard care,” said Dr. Sharpless. “All of these things add up to increased cancer morbidity and mortality.”

He also pointed out that the term “elective” is confusing and problematic. “It doesn’t mean that it’s not needed, just that it’s not an emergency and doesn’t need to be done today,” said Dr. Sharpless. “But if we’re talking about chemotherapy and surgery, we don’t think they can be delayed for too long – maybe a week, but not for several months.”

Dr. Sharpless feels that overall it is time for cancer care to resume as much as possible, because “ignoring cancer for too long is an untenable choice and may turn one public health crisis into another.”

“If we act now, we can make up for lost time,” he wrote in the editorial. “Clearly, postponing procedures and deferring care due to the pandemic was prudent at one time, but now that we have made it through the initial shock of the pandemic, I believe it is time to resume robust cancer care.”

Through their network of cancer centers, researchers with the NCI can develop innovative solutions that allow screening and treatment to move forward while maintaining safety. “We need to make patients feel safe, and we have to answer important questions quickly,” he said.
 

Impact of COVID-19 on cancer care

The COVID-19 pandemic has overwhelmed health care systems worldwide and has created major challenges for clinicians who are caring for patients with cancer.

As previously reported, hospitals reprioritized resources for an impending onslaught of COVID-19 patients. Services and procedures deemed to be nonessential were canceled or delayed, including surgeries and imaging.

In a survey conducted by the American Cancer Society Cancer Action Network, half of the 1219 respondents reported changes, delays, or disruptions to the care they were receiving. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

In the United Kingdom, Cancer Research UK estimated that because of the disruption to cancer services, 2.4 million people did not undergo cancer screening or further testing or did not receive cancer treatment and that tens of thousands of cases have gone undiagnosed.

Similarly, a survey by Macmillan Cancer Support showed that almost half (45%) of cancer patients have experienced delays or cancellations of cancer treatments, or their treatments have been altered as a result of coronavirus, leaving many living in fear. Calling cancer “the forgotten C” of the pandemic, it warned of a potential cancer “time bomb” when, as the number of deaths from COVID-19 falls, cancer returns as the leading cause of death in the United Kingdom.

Last month, a report also predicted that there will be an excess of cancer deaths in both the United States and United Kingdom because of patients not accessing health care services.

The authors calculated that there will be 6270 excess deaths among cancer patients 1 year from now in England and 33,890 excess deaths among cancer patients older than 40 years in the United States.

This article first appeared on Medscape.com.

A model created by the National Cancer Institute predicts that tens of thousands of excess cancer deaths will occur over the next decade as a result of missed screenings, delays in diagnosis, and reductions in oncology care caused by the COVID-19 pandemic.

“As director of NCI, I am deeply concerned about the potential impacts of delayed diagnoses and deferred or modified treatment plans on cancer incidence and mortality,” said Norman “Ned” Sharpless, MD.

“In the past 3 decades, we have seen steady and strong progress against death and suffering from cancer, thanks to improvements in prevention, screening, diagnosis, and treatment. I worry that the SARS-CoV-2 pandemic has put those decades of steady progress at risk and may precipitate reversals of these trends.”

In an editorial published June 19 in Science, Dr. Sharpless highlighted modeling performed by the NCI that predicts an excess of 10,000 deaths from breast and colorectal cancer over the next 10 years.

The number of excess deaths per year would peak in the next year or 2, likely sooner for colorectal than for breast cancer, but “for both cancer types, we believe the pandemic will influence cancer deaths for at least a decade.”

In an interview, Dr. Sharpless pointed out that this analysis is conservative because the researchers only evaluated two types of cancer. They chose breast and colorectal cancer because these are common cancers (accounting for about one-sixth of all cancers) with relatively high screening rates.

“We didn’t model other cancer types, but we have no reason to think that we’re not going to see the same thing with other types of malignancies,” he said. “That is a significant amount of excess mortality.”
 

Delayed diagnosis, modified therapy

One of the effects of the pandemic has been to cause delays in cancer diagnosis. “Routine screening has plummeted and is running at less than 90% in some systems,” Dr. Sharpless said.

“Most cancers are diagnosed when people experience symptoms and go see their doctors, and those symptomatic screening events are also not happening,” he continued. “Fear of contracting the coronavirus in health care settings has dissuaded people from visits.”

In some cases, a delay in diagnosis will allow the cancer to progress to a more advanced stage. “The earlier the diagnosis, the better, and if the stages are more advanced, patients will not do as well for virtually every kind of cancer,” he said.

In addition to delays in diagnosis, treatments are being postponed or modified for patients recently diagnosed with cancer. Because of delays and reductions in curative therapies, patients may be receiving less than optimal care.

“We are seeing a lot of nonstandard care,” said Dr. Sharpless. “All of these things add up to increased cancer morbidity and mortality.”

He also pointed out that the term “elective” is confusing and problematic. “It doesn’t mean that it’s not needed, just that it’s not an emergency and doesn’t need to be done today,” said Dr. Sharpless. “But if we’re talking about chemotherapy and surgery, we don’t think they can be delayed for too long – maybe a week, but not for several months.”

Dr. Sharpless feels that overall it is time for cancer care to resume as much as possible, because “ignoring cancer for too long is an untenable choice and may turn one public health crisis into another.”

“If we act now, we can make up for lost time,” he wrote in the editorial. “Clearly, postponing procedures and deferring care due to the pandemic was prudent at one time, but now that we have made it through the initial shock of the pandemic, I believe it is time to resume robust cancer care.”

Through their network of cancer centers, researchers with the NCI can develop innovative solutions that allow screening and treatment to move forward while maintaining safety. “We need to make patients feel safe, and we have to answer important questions quickly,” he said.
 

Impact of COVID-19 on cancer care

The COVID-19 pandemic has overwhelmed health care systems worldwide and has created major challenges for clinicians who are caring for patients with cancer.

As previously reported, hospitals reprioritized resources for an impending onslaught of COVID-19 patients. Services and procedures deemed to be nonessential were canceled or delayed, including surgeries and imaging.

In a survey conducted by the American Cancer Society Cancer Action Network, half of the 1219 respondents reported changes, delays, or disruptions to the care they were receiving. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

In the United Kingdom, Cancer Research UK estimated that because of the disruption to cancer services, 2.4 million people did not undergo cancer screening or further testing or did not receive cancer treatment and that tens of thousands of cases have gone undiagnosed.

Similarly, a survey by Macmillan Cancer Support showed that almost half (45%) of cancer patients have experienced delays or cancellations of cancer treatments, or their treatments have been altered as a result of coronavirus, leaving many living in fear. Calling cancer “the forgotten C” of the pandemic, it warned of a potential cancer “time bomb” when, as the number of deaths from COVID-19 falls, cancer returns as the leading cause of death in the United Kingdom.

Last month, a report also predicted that there will be an excess of cancer deaths in both the United States and United Kingdom because of patients not accessing health care services.

The authors calculated that there will be 6270 excess deaths among cancer patients 1 year from now in England and 33,890 excess deaths among cancer patients older than 40 years in the United States.

This article first appeared on Medscape.com.

A model created by the National Cancer Institute predicts that tens of thousands of excess cancer deaths will occur over the next decade as a result of missed screenings, delays in diagnosis, and reductions in oncology care caused by the COVID-19 pandemic.

“As director of NCI, I am deeply concerned about the potential impacts of delayed diagnoses and deferred or modified treatment plans on cancer incidence and mortality,” said Norman “Ned” Sharpless, MD.

“In the past 3 decades, we have seen steady and strong progress against death and suffering from cancer, thanks to improvements in prevention, screening, diagnosis, and treatment. I worry that the SARS-CoV-2 pandemic has put those decades of steady progress at risk and may precipitate reversals of these trends.”

In an editorial published June 19 in Science, Dr. Sharpless highlighted modeling performed by the NCI that predicts an excess of 10,000 deaths from breast and colorectal cancer over the next 10 years.

The number of excess deaths per year would peak in the next year or 2, likely sooner for colorectal than for breast cancer, but “for both cancer types, we believe the pandemic will influence cancer deaths for at least a decade.”

In an interview, Dr. Sharpless pointed out that this analysis is conservative because the researchers only evaluated two types of cancer. They chose breast and colorectal cancer because these are common cancers (accounting for about one-sixth of all cancers) with relatively high screening rates.

“We didn’t model other cancer types, but we have no reason to think that we’re not going to see the same thing with other types of malignancies,” he said. “That is a significant amount of excess mortality.”
 

Delayed diagnosis, modified therapy

One of the effects of the pandemic has been to cause delays in cancer diagnosis. “Routine screening has plummeted and is running at less than 90% in some systems,” Dr. Sharpless said.

“Most cancers are diagnosed when people experience symptoms and go see their doctors, and those symptomatic screening events are also not happening,” he continued. “Fear of contracting the coronavirus in health care settings has dissuaded people from visits.”

In some cases, a delay in diagnosis will allow the cancer to progress to a more advanced stage. “The earlier the diagnosis, the better, and if the stages are more advanced, patients will not do as well for virtually every kind of cancer,” he said.

In addition to delays in diagnosis, treatments are being postponed or modified for patients recently diagnosed with cancer. Because of delays and reductions in curative therapies, patients may be receiving less than optimal care.

“We are seeing a lot of nonstandard care,” said Dr. Sharpless. “All of these things add up to increased cancer morbidity and mortality.”

He also pointed out that the term “elective” is confusing and problematic. “It doesn’t mean that it’s not needed, just that it’s not an emergency and doesn’t need to be done today,” said Dr. Sharpless. “But if we’re talking about chemotherapy and surgery, we don’t think they can be delayed for too long – maybe a week, but not for several months.”

Dr. Sharpless feels that overall it is time for cancer care to resume as much as possible, because “ignoring cancer for too long is an untenable choice and may turn one public health crisis into another.”

“If we act now, we can make up for lost time,” he wrote in the editorial. “Clearly, postponing procedures and deferring care due to the pandemic was prudent at one time, but now that we have made it through the initial shock of the pandemic, I believe it is time to resume robust cancer care.”

Through their network of cancer centers, researchers with the NCI can develop innovative solutions that allow screening and treatment to move forward while maintaining safety. “We need to make patients feel safe, and we have to answer important questions quickly,” he said.
 

Impact of COVID-19 on cancer care

The COVID-19 pandemic has overwhelmed health care systems worldwide and has created major challenges for clinicians who are caring for patients with cancer.

As previously reported, hospitals reprioritized resources for an impending onslaught of COVID-19 patients. Services and procedures deemed to be nonessential were canceled or delayed, including surgeries and imaging.

In a survey conducted by the American Cancer Society Cancer Action Network, half of the 1219 respondents reported changes, delays, or disruptions to the care they were receiving. The services most frequently affected included in-person provider visits (50%), supportive services (20%), and imaging procedures to monitor tumor growth (20%).

In addition, 8% reported that their treatment, including chemotherapy and immunotherapy, had been affected by the COVID-19 pandemic.

In the United Kingdom, Cancer Research UK estimated that because of the disruption to cancer services, 2.4 million people did not undergo cancer screening or further testing or did not receive cancer treatment and that tens of thousands of cases have gone undiagnosed.

Similarly, a survey by Macmillan Cancer Support showed that almost half (45%) of cancer patients have experienced delays or cancellations of cancer treatments, or their treatments have been altered as a result of coronavirus, leaving many living in fear. Calling cancer “the forgotten C” of the pandemic, it warned of a potential cancer “time bomb” when, as the number of deaths from COVID-19 falls, cancer returns as the leading cause of death in the United Kingdom.

Last month, a report also predicted that there will be an excess of cancer deaths in both the United States and United Kingdom because of patients not accessing health care services.

The authors calculated that there will be 6270 excess deaths among cancer patients 1 year from now in England and 33,890 excess deaths among cancer patients older than 40 years in the United States.

This article first appeared on Medscape.com.

Minimally invasive surgery (MIS) is associated with a higher risk for death in comparison to open surgery for patients with gynecologic cancers, according to two new reports.

In the first study, use of MIS for patients with early-stage ovarian cancer was associated with an increased risk for capsule rupture, which, in turn, led to an increase in mortality.

“There was a striking association between an increased risk of capsule rupture with use of minimally invasive surgery,” said Jason D. Wright, MD, chief, division of gynecologic oncology, Columbia University Herbert Irving Cancer Comprehensive Center, New York, who was a coauthor for both studies.

“This is certainly worrisome, as there are limited data describing the safety of minimally invasive surgery for ovarian cancer, and we noted that the use of minimally invasive procedures increased substantially,” he added.

The second article, a meta-analysis of 15 studies, found that minimally invasive radical hysterectomy was associated with a higher risk for recurrence and death in comparison to open surgery for women with early-stage cervical cancer. This confirms previous reports of worse outcomes, including a randomized trial (the LACC study) published in 2018. The results of that trial showed an increased risk for death, which was “unexpected and alarming.”

The meta-analysis confirms and “demonstrates the magnitude of this risk on recurrence rates and survival,” Dr. Wright said in an interview.

“Given these data, I think that clinicians should use great caution in performing this procedure and that the majority of women with cervical cancer who undergo radical hysterectomy should likely have an open surgery,” said Dr. Wright.

Both articles were published on June 11 in JAMA Oncology.

These “two important studies add to the growing body of literature that suggest a worse outcome for patients with gynecologic cancers who are treated with MIS,” Amer Karam, MD, and Oliver Dorigo, MD, PhD, both from Stanford (Calif.) University, wrote in an accompanying editorial.
 

Ovarian cancer MIS and capsule rupture

In the study of MIS in ovarian cancer, observational data were collected on 8850 women (mean age, 55.6 years) with stage I epithelial ovarian cancer who were registered in the National Cancer Database and who underwent surgery between 2010 and 2015. Roughly one third (n = 2,600) underwent MIS; the remainder underwent open surgery.

During the 5 years of the study period, there was a 80% increase in the use of MIS, from 19.8% to 34.9% (P < .001).

The data show that 1,994 patients (22.5%) experienced capsule rupture and that the rate of rupture rose from 20.2% in 2010 to 23.9% in 2015. This extrapolates to an 18.3% relative increase (Cochran-Armitage trend test P = 0.02).

Multivariable analysis showed that MIS was independently associated with capsule rupture (adjusted relative risk, 1.17), as was larger tumor size. Additionally, receipt of chemotherapy increased the risk for rupture (unilateral tumors, 67.0% vs. 38.6%; bilateral tumors, 80.0% vs. 58.9%; P < .001).

The 4-year overall survival rate was 91% in 2010 and fell to 86% in 2015.

Among those with ruptured tumors, the 4-year overall survival was 86.8% for those who underwent open surgery and 88.9% for patients who underwent MIS.

Among women with nonruptured tumors, these rates were 90.5% and 91.5%, respectively (log-rank test, P = .001).

An adjusted model showed that the use of MIS with capsule rupture was independently associated with an increase in all-cause mortality in comparison with MIS in which capsule rupture did not occur (adjusted hazard ratio, 1.41). In addition, laparotomy with capsule rupture was also independently associated with a greater risk for all-cause mortality compared with laparotomy without capsule rupture (aHR, 1.43).

“I think clinicians need to carefully weigh the risks and benefits of minimally invasive surgery and the risk of rupture of an ovarian cancer in women, and high-quality studies are clearly needed to address this topic,” said Dr. Wright.
 

Lower survival in cervical cancer

The second study was a meta-analysis of 15 studies involving 9,499 women who underwent radical hysterectomy for stage IA1 to IIA cervical cancer.

Nearly half of the cohort (n = 4,684; 49%) underwent MIS. Of those, 57% (n = 2675) underwent robot-assisted laparoscopy.

A total of 530 recurrences and 451 deaths were reported. The pooled hazard of recurrence or death was 71% higher among patients who underwent MIS in comparison with those who underwent open surgery (HR, 1.71; P < .001). The hazard of death was 56% higher in the MIS group than in the open surgery group (HR, 1.56; P = .004).

“The magnitude of the effect, while lower than that reported in the LACC trial, is still notable and likely reflects real-world outcomes,” the editorialists said.

They also noted that the “results of the LACC trial remain controversial but were followed by a global decrease in the use of MIS for treatment of early-stage cervical cancer.”

However, the editorialists also highlighted the advantages of MIS, saying it has “considerable benefits” in the treatment of gynecologic cancer.

They cited an article from the American College of Surgeons National Quality Improvement Program, which reports an analysis of 2076 endometrial cancer cases that found a much lower complication rate after MIS compared with laparotomy (12% vs. 31%).

“Shorter hospital stays and lower complication rates could result in an estimated cost savings of $534 million if MIS was used in 90% of all patients with endometrial cancer in the U.S.A.,” they wrote.

Nevertheless, they added that “the short-term advantages of MIS for gynecologic cancers should be weighed against the risks of potentially worse long-term outcomes.”

These two latest studies should serve as another call to action, they concluded. “We owe it to patients to study any surgical or medical intervention adhering to the highest standards of clinical investigation.”

The ovarian cancer study was supported by grants from the National Cancer Institute Cancer Center and the National Institutes of Health. The cervical cancer meta-analysis study was funded by the National Cancer Institute, the American Cancer Society, and the Frank McGraw Memorial Chair in Cancer Research and Ensign Endowment for Gynecologic Cancer Research. Dr. Wright has received grants from Merck and consultation fees from Clovis Oncology outside the submitted work; several coauthors from both articles report relationships with industry. Dr. Karam has received personal fees from Clovis Oncology, AstraZeneca, GSK, and UpToDate outside the submitted work. Dr. Dorigo has received fees from many pharmaceutical companies and salary for medical legal expert witness testimony.

This article first appeared on Medscape.com.

Minimally invasive surgery (MIS) is associated with a higher risk for death in comparison to open surgery for patients with gynecologic cancers, according to two new reports.

In the first study, use of MIS for patients with early-stage ovarian cancer was associated with an increased risk for capsule rupture, which, in turn, led to an increase in mortality.

“There was a striking association between an increased risk of capsule rupture with use of minimally invasive surgery,” said Jason D. Wright, MD, chief, division of gynecologic oncology, Columbia University Herbert Irving Cancer Comprehensive Center, New York, who was a coauthor for both studies.

“This is certainly worrisome, as there are limited data describing the safety of minimally invasive surgery for ovarian cancer, and we noted that the use of minimally invasive procedures increased substantially,” he added.

The second article, a meta-analysis of 15 studies, found that minimally invasive radical hysterectomy was associated with a higher risk for recurrence and death in comparison to open surgery for women with early-stage cervical cancer. This confirms previous reports of worse outcomes, including a randomized trial (the LACC study) published in 2018. The results of that trial showed an increased risk for death, which was “unexpected and alarming.”

The meta-analysis confirms and “demonstrates the magnitude of this risk on recurrence rates and survival,” Dr. Wright said in an interview.

“Given these data, I think that clinicians should use great caution in performing this procedure and that the majority of women with cervical cancer who undergo radical hysterectomy should likely have an open surgery,” said Dr. Wright.

Both articles were published on June 11 in JAMA Oncology.

These “two important studies add to the growing body of literature that suggest a worse outcome for patients with gynecologic cancers who are treated with MIS,” Amer Karam, MD, and Oliver Dorigo, MD, PhD, both from Stanford (Calif.) University, wrote in an accompanying editorial.
 

Ovarian cancer MIS and capsule rupture

In the study of MIS in ovarian cancer, observational data were collected on 8850 women (mean age, 55.6 years) with stage I epithelial ovarian cancer who were registered in the National Cancer Database and who underwent surgery between 2010 and 2015. Roughly one third (n = 2,600) underwent MIS; the remainder underwent open surgery.

During the 5 years of the study period, there was a 80% increase in the use of MIS, from 19.8% to 34.9% (P < .001).

The data show that 1,994 patients (22.5%) experienced capsule rupture and that the rate of rupture rose from 20.2% in 2010 to 23.9% in 2015. This extrapolates to an 18.3% relative increase (Cochran-Armitage trend test P = 0.02).

Multivariable analysis showed that MIS was independently associated with capsule rupture (adjusted relative risk, 1.17), as was larger tumor size. Additionally, receipt of chemotherapy increased the risk for rupture (unilateral tumors, 67.0% vs. 38.6%; bilateral tumors, 80.0% vs. 58.9%; P < .001).

The 4-year overall survival rate was 91% in 2010 and fell to 86% in 2015.

Among those with ruptured tumors, the 4-year overall survival was 86.8% for those who underwent open surgery and 88.9% for patients who underwent MIS.

Among women with nonruptured tumors, these rates were 90.5% and 91.5%, respectively (log-rank test, P = .001).

An adjusted model showed that the use of MIS with capsule rupture was independently associated with an increase in all-cause mortality in comparison with MIS in which capsule rupture did not occur (adjusted hazard ratio, 1.41). In addition, laparotomy with capsule rupture was also independently associated with a greater risk for all-cause mortality compared with laparotomy without capsule rupture (aHR, 1.43).

“I think clinicians need to carefully weigh the risks and benefits of minimally invasive surgery and the risk of rupture of an ovarian cancer in women, and high-quality studies are clearly needed to address this topic,” said Dr. Wright.
 

Lower survival in cervical cancer

The second study was a meta-analysis of 15 studies involving 9,499 women who underwent radical hysterectomy for stage IA1 to IIA cervical cancer.

Nearly half of the cohort (n = 4,684; 49%) underwent MIS. Of those, 57% (n = 2675) underwent robot-assisted laparoscopy.

A total of 530 recurrences and 451 deaths were reported. The pooled hazard of recurrence or death was 71% higher among patients who underwent MIS in comparison with those who underwent open surgery (HR, 1.71; P < .001). The hazard of death was 56% higher in the MIS group than in the open surgery group (HR, 1.56; P = .004).

“The magnitude of the effect, while lower than that reported in the LACC trial, is still notable and likely reflects real-world outcomes,” the editorialists said.

They also noted that the “results of the LACC trial remain controversial but were followed by a global decrease in the use of MIS for treatment of early-stage cervical cancer.”

However, the editorialists also highlighted the advantages of MIS, saying it has “considerable benefits” in the treatment of gynecologic cancer.

They cited an article from the American College of Surgeons National Quality Improvement Program, which reports an analysis of 2076 endometrial cancer cases that found a much lower complication rate after MIS compared with laparotomy (12% vs. 31%).

“Shorter hospital stays and lower complication rates could result in an estimated cost savings of $534 million if MIS was used in 90% of all patients with endometrial cancer in the U.S.A.,” they wrote.

Nevertheless, they added that “the short-term advantages of MIS for gynecologic cancers should be weighed against the risks of potentially worse long-term outcomes.”

These two latest studies should serve as another call to action, they concluded. “We owe it to patients to study any surgical or medical intervention adhering to the highest standards of clinical investigation.”

The ovarian cancer study was supported by grants from the National Cancer Institute Cancer Center and the National Institutes of Health. The cervical cancer meta-analysis study was funded by the National Cancer Institute, the American Cancer Society, and the Frank McGraw Memorial Chair in Cancer Research and Ensign Endowment for Gynecologic Cancer Research. Dr. Wright has received grants from Merck and consultation fees from Clovis Oncology outside the submitted work; several coauthors from both articles report relationships with industry. Dr. Karam has received personal fees from Clovis Oncology, AstraZeneca, GSK, and UpToDate outside the submitted work. Dr. Dorigo has received fees from many pharmaceutical companies and salary for medical legal expert witness testimony.

This article first appeared on Medscape.com.

Minimally invasive surgery (MIS) is associated with a higher risk for death in comparison to open surgery for patients with gynecologic cancers, according to two new reports.

In the first study, use of MIS for patients with early-stage ovarian cancer was associated with an increased risk for capsule rupture, which, in turn, led to an increase in mortality.

“There was a striking association between an increased risk of capsule rupture with use of minimally invasive surgery,” said Jason D. Wright, MD, chief, division of gynecologic oncology, Columbia University Herbert Irving Cancer Comprehensive Center, New York, who was a coauthor for both studies.

“This is certainly worrisome, as there are limited data describing the safety of minimally invasive surgery for ovarian cancer, and we noted that the use of minimally invasive procedures increased substantially,” he added.

The second article, a meta-analysis of 15 studies, found that minimally invasive radical hysterectomy was associated with a higher risk for recurrence and death in comparison to open surgery for women with early-stage cervical cancer. This confirms previous reports of worse outcomes, including a randomized trial (the LACC study) published in 2018. The results of that trial showed an increased risk for death, which was “unexpected and alarming.”

The meta-analysis confirms and “demonstrates the magnitude of this risk on recurrence rates and survival,” Dr. Wright said in an interview.

“Given these data, I think that clinicians should use great caution in performing this procedure and that the majority of women with cervical cancer who undergo radical hysterectomy should likely have an open surgery,” said Dr. Wright.

Both articles were published on June 11 in JAMA Oncology.

These “two important studies add to the growing body of literature that suggest a worse outcome for patients with gynecologic cancers who are treated with MIS,” Amer Karam, MD, and Oliver Dorigo, MD, PhD, both from Stanford (Calif.) University, wrote in an accompanying editorial.
 

Ovarian cancer MIS and capsule rupture

In the study of MIS in ovarian cancer, observational data were collected on 8850 women (mean age, 55.6 years) with stage I epithelial ovarian cancer who were registered in the National Cancer Database and who underwent surgery between 2010 and 2015. Roughly one third (n = 2,600) underwent MIS; the remainder underwent open surgery.

During the 5 years of the study period, there was a 80% increase in the use of MIS, from 19.8% to 34.9% (P < .001).

The data show that 1,994 patients (22.5%) experienced capsule rupture and that the rate of rupture rose from 20.2% in 2010 to 23.9% in 2015. This extrapolates to an 18.3% relative increase (Cochran-Armitage trend test P = 0.02).

Multivariable analysis showed that MIS was independently associated with capsule rupture (adjusted relative risk, 1.17), as was larger tumor size. Additionally, receipt of chemotherapy increased the risk for rupture (unilateral tumors, 67.0% vs. 38.6%; bilateral tumors, 80.0% vs. 58.9%; P < .001).

The 4-year overall survival rate was 91% in 2010 and fell to 86% in 2015.

Among those with ruptured tumors, the 4-year overall survival was 86.8% for those who underwent open surgery and 88.9% for patients who underwent MIS.

Among women with nonruptured tumors, these rates were 90.5% and 91.5%, respectively (log-rank test, P = .001).

An adjusted model showed that the use of MIS with capsule rupture was independently associated with an increase in all-cause mortality in comparison with MIS in which capsule rupture did not occur (adjusted hazard ratio, 1.41). In addition, laparotomy with capsule rupture was also independently associated with a greater risk for all-cause mortality compared with laparotomy without capsule rupture (aHR, 1.43).

“I think clinicians need to carefully weigh the risks and benefits of minimally invasive surgery and the risk of rupture of an ovarian cancer in women, and high-quality studies are clearly needed to address this topic,” said Dr. Wright.
 

Lower survival in cervical cancer

The second study was a meta-analysis of 15 studies involving 9,499 women who underwent radical hysterectomy for stage IA1 to IIA cervical cancer.

Nearly half of the cohort (n = 4,684; 49%) underwent MIS. Of those, 57% (n = 2675) underwent robot-assisted laparoscopy.

A total of 530 recurrences and 451 deaths were reported. The pooled hazard of recurrence or death was 71% higher among patients who underwent MIS in comparison with those who underwent open surgery (HR, 1.71; P < .001). The hazard of death was 56% higher in the MIS group than in the open surgery group (HR, 1.56; P = .004).

“The magnitude of the effect, while lower than that reported in the LACC trial, is still notable and likely reflects real-world outcomes,” the editorialists said.

They also noted that the “results of the LACC trial remain controversial but were followed by a global decrease in the use of MIS for treatment of early-stage cervical cancer.”

However, the editorialists also highlighted the advantages of MIS, saying it has “considerable benefits” in the treatment of gynecologic cancer.

They cited an article from the American College of Surgeons National Quality Improvement Program, which reports an analysis of 2076 endometrial cancer cases that found a much lower complication rate after MIS compared with laparotomy (12% vs. 31%).

“Shorter hospital stays and lower complication rates could result in an estimated cost savings of $534 million if MIS was used in 90% of all patients with endometrial cancer in the U.S.A.,” they wrote.

Nevertheless, they added that “the short-term advantages of MIS for gynecologic cancers should be weighed against the risks of potentially worse long-term outcomes.”

These two latest studies should serve as another call to action, they concluded. “We owe it to patients to study any surgical or medical intervention adhering to the highest standards of clinical investigation.”

The ovarian cancer study was supported by grants from the National Cancer Institute Cancer Center and the National Institutes of Health. The cervical cancer meta-analysis study was funded by the National Cancer Institute, the American Cancer Society, and the Frank McGraw Memorial Chair in Cancer Research and Ensign Endowment for Gynecologic Cancer Research. Dr. Wright has received grants from Merck and consultation fees from Clovis Oncology outside the submitted work; several coauthors from both articles report relationships with industry. Dr. Karam has received personal fees from Clovis Oncology, AstraZeneca, GSK, and UpToDate outside the submitted work. Dr. Dorigo has received fees from many pharmaceutical companies and salary for medical legal expert witness testimony.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has granted accelerated approval of the EZH2 inhibitor tazemetostat (Tazverik, Epizyme, Inc) for the treatment of relapsed or refractory follicular lymphoma in adult patients with tumors harboring an EZH2 mutation.

Eligible patients must have already received at least two prior systemic therapies and have tumors that are positive for an EZH2 mutation, as detected by an FDA-approved test. The FDA has also approved the cobas EZH2 Mutation Test (Roche Molecular Systems, Inc) as a companion diagnostic test for tazemetostat.

The new indication is also for adult patients with relapsed/refractory follicular lymphoma who have no other satisfactory alternative treatment options.

“In our view, there remains no clear standard of care in the relapsed and/or refractory [follicular lymphoma] population, as not all patients benefit from today’s available therapies,” said Shefali Agarwal, MD, chief medical officer of Epizyme, in a company press release. “Based on this label, physicians will have the ability to use their clinical discretion to prescribe tazemetostat for their relapsed or refractory patients regardless of EZH2 mutational status and without regard to a specific line of treatment where other options are not satisfactory.”

This accelerated approval is based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials, the FDA notes.

Tazemetostat acts as an inhibitor of EZH2 methyltransferase. Earlier this year, the drug was approved for the treatment of metastatic or locally advanced epithelioid sarcoma in cases in which complete resection is not possible. It is the first drug with this mechanism of action and is the first to be indicated for epithelioid sarcoma.

Promising Efficacy in Phase 2 Trial

The new approval for use in follicular lymphoma was based on results from an open-label, single-arm, multicenter phase 2 clinical trial involving patients who had experienced disease progression after being treated with at least two prior systemic regimens. The cohort was divided into two treatment groups: One group consisted of 45 patients with EZH2-activating mutations, the other included 54 patients with wild-type EZH2.

All patients received tazemetostat at 800 mg administered orally twice a day. The primary efficacy outcome measures were overall response rate and duration of response, in accordance with International Working Group Non-Hodgkin Lymphoma criteria.

The median duration of follow-up was 22 months for patients with EZH2-activating mutations and 36 months for those with wild-type tumors.

Among the 45 patients with an EZH2-activating mutation, the median number of lines of prior systemic therapy was 2.0 (range, 1 – 11). In 49% of patients, disease was refractory to rituximab, and in 49%, it was refractory to the patient’s last therapy.

The overall response rate was 69%; 12% of patients achieved a complete response, and 57% achieved a partial response. The median duration of response was 10.9 months and ongoing.

In the cohort of 54 patients with wild-type EZH2, the median number previous therapies was 3.0 (range, 1 – 8); in 59% of patients, disease was refractory to rituximab, and in 41%, it was refractory to the patient’s last therapy.

The overall response rate to tazemetostat treatment was 34%; 4% of patients achieved a complete response, and 30% achieved a partial response. The median duration of response was 13 months.

Serious adverse reactions occurred in 30% of patients. The most common were fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain. Eight patients (8%) discontinued treatment during the trial because of adverse events. There were no reported deaths. No black box warnings have been published, and there are no contraindications.

“The durable responses observed with this drug are notable in the context of the safety profile and route of oral, at-home administration, and will offer an important new option for physicians as we care for patients with relapsed/refractory follicular lymphoma,” said John Leonard, MD, in a company press release. He is associate dean for clinical research and Richard T. Silver Distinguished Professor of Hematology and Medical Oncology, Meyer Cancer Center, Weill Cornell Medicine and New York–Presbyterian Hospital, New York, and an investigator in the ongoing phase 1b/3 confirmatory trial for tazemetostat.

“Follicular lymphoma remains an incurable disease, and even with the availability of new drugs in recent years, there have remained important unmet needs in the treatment of follicular lymphoma,” he commented.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has granted accelerated approval of the EZH2 inhibitor tazemetostat (Tazverik, Epizyme, Inc) for the treatment of relapsed or refractory follicular lymphoma in adult patients with tumors harboring an EZH2 mutation.

Eligible patients must have already received at least two prior systemic therapies and have tumors that are positive for an EZH2 mutation, as detected by an FDA-approved test. The FDA has also approved the cobas EZH2 Mutation Test (Roche Molecular Systems, Inc) as a companion diagnostic test for tazemetostat.

The new indication is also for adult patients with relapsed/refractory follicular lymphoma who have no other satisfactory alternative treatment options.

“In our view, there remains no clear standard of care in the relapsed and/or refractory [follicular lymphoma] population, as not all patients benefit from today’s available therapies,” said Shefali Agarwal, MD, chief medical officer of Epizyme, in a company press release. “Based on this label, physicians will have the ability to use their clinical discretion to prescribe tazemetostat for their relapsed or refractory patients regardless of EZH2 mutational status and without regard to a specific line of treatment where other options are not satisfactory.”

This accelerated approval is based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials, the FDA notes.

Tazemetostat acts as an inhibitor of EZH2 methyltransferase. Earlier this year, the drug was approved for the treatment of metastatic or locally advanced epithelioid sarcoma in cases in which complete resection is not possible. It is the first drug with this mechanism of action and is the first to be indicated for epithelioid sarcoma.

Promising Efficacy in Phase 2 Trial

The new approval for use in follicular lymphoma was based on results from an open-label, single-arm, multicenter phase 2 clinical trial involving patients who had experienced disease progression after being treated with at least two prior systemic regimens. The cohort was divided into two treatment groups: One group consisted of 45 patients with EZH2-activating mutations, the other included 54 patients with wild-type EZH2.

All patients received tazemetostat at 800 mg administered orally twice a day. The primary efficacy outcome measures were overall response rate and duration of response, in accordance with International Working Group Non-Hodgkin Lymphoma criteria.

The median duration of follow-up was 22 months for patients with EZH2-activating mutations and 36 months for those with wild-type tumors.

Among the 45 patients with an EZH2-activating mutation, the median number of lines of prior systemic therapy was 2.0 (range, 1 – 11). In 49% of patients, disease was refractory to rituximab, and in 49%, it was refractory to the patient’s last therapy.

The overall response rate was 69%; 12% of patients achieved a complete response, and 57% achieved a partial response. The median duration of response was 10.9 months and ongoing.

In the cohort of 54 patients with wild-type EZH2, the median number previous therapies was 3.0 (range, 1 – 8); in 59% of patients, disease was refractory to rituximab, and in 41%, it was refractory to the patient’s last therapy.

The overall response rate to tazemetostat treatment was 34%; 4% of patients achieved a complete response, and 30% achieved a partial response. The median duration of response was 13 months.

Serious adverse reactions occurred in 30% of patients. The most common were fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain. Eight patients (8%) discontinued treatment during the trial because of adverse events. There were no reported deaths. No black box warnings have been published, and there are no contraindications.

“The durable responses observed with this drug are notable in the context of the safety profile and route of oral, at-home administration, and will offer an important new option for physicians as we care for patients with relapsed/refractory follicular lymphoma,” said John Leonard, MD, in a company press release. He is associate dean for clinical research and Richard T. Silver Distinguished Professor of Hematology and Medical Oncology, Meyer Cancer Center, Weill Cornell Medicine and New York–Presbyterian Hospital, New York, and an investigator in the ongoing phase 1b/3 confirmatory trial for tazemetostat.

“Follicular lymphoma remains an incurable disease, and even with the availability of new drugs in recent years, there have remained important unmet needs in the treatment of follicular lymphoma,” he commented.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has granted accelerated approval of the EZH2 inhibitor tazemetostat (Tazverik, Epizyme, Inc) for the treatment of relapsed or refractory follicular lymphoma in adult patients with tumors harboring an EZH2 mutation.

Eligible patients must have already received at least two prior systemic therapies and have tumors that are positive for an EZH2 mutation, as detected by an FDA-approved test. The FDA has also approved the cobas EZH2 Mutation Test (Roche Molecular Systems, Inc) as a companion diagnostic test for tazemetostat.

The new indication is also for adult patients with relapsed/refractory follicular lymphoma who have no other satisfactory alternative treatment options.

“In our view, there remains no clear standard of care in the relapsed and/or refractory [follicular lymphoma] population, as not all patients benefit from today’s available therapies,” said Shefali Agarwal, MD, chief medical officer of Epizyme, in a company press release. “Based on this label, physicians will have the ability to use their clinical discretion to prescribe tazemetostat for their relapsed or refractory patients regardless of EZH2 mutational status and without regard to a specific line of treatment where other options are not satisfactory.”

This accelerated approval is based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials, the FDA notes.

Tazemetostat acts as an inhibitor of EZH2 methyltransferase. Earlier this year, the drug was approved for the treatment of metastatic or locally advanced epithelioid sarcoma in cases in which complete resection is not possible. It is the first drug with this mechanism of action and is the first to be indicated for epithelioid sarcoma.

Promising Efficacy in Phase 2 Trial

The new approval for use in follicular lymphoma was based on results from an open-label, single-arm, multicenter phase 2 clinical trial involving patients who had experienced disease progression after being treated with at least two prior systemic regimens. The cohort was divided into two treatment groups: One group consisted of 45 patients with EZH2-activating mutations, the other included 54 patients with wild-type EZH2.

All patients received tazemetostat at 800 mg administered orally twice a day. The primary efficacy outcome measures were overall response rate and duration of response, in accordance with International Working Group Non-Hodgkin Lymphoma criteria.

The median duration of follow-up was 22 months for patients with EZH2-activating mutations and 36 months for those with wild-type tumors.

Among the 45 patients with an EZH2-activating mutation, the median number of lines of prior systemic therapy was 2.0 (range, 1 – 11). In 49% of patients, disease was refractory to rituximab, and in 49%, it was refractory to the patient’s last therapy.

The overall response rate was 69%; 12% of patients achieved a complete response, and 57% achieved a partial response. The median duration of response was 10.9 months and ongoing.

In the cohort of 54 patients with wild-type EZH2, the median number previous therapies was 3.0 (range, 1 – 8); in 59% of patients, disease was refractory to rituximab, and in 41%, it was refractory to the patient’s last therapy.

The overall response rate to tazemetostat treatment was 34%; 4% of patients achieved a complete response, and 30% achieved a partial response. The median duration of response was 13 months.

Serious adverse reactions occurred in 30% of patients. The most common were fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain. Eight patients (8%) discontinued treatment during the trial because of adverse events. There were no reported deaths. No black box warnings have been published, and there are no contraindications.

“The durable responses observed with this drug are notable in the context of the safety profile and route of oral, at-home administration, and will offer an important new option for physicians as we care for patients with relapsed/refractory follicular lymphoma,” said John Leonard, MD, in a company press release. He is associate dean for clinical research and Richard T. Silver Distinguished Professor of Hematology and Medical Oncology, Meyer Cancer Center, Weill Cornell Medicine and New York–Presbyterian Hospital, New York, and an investigator in the ongoing phase 1b/3 confirmatory trial for tazemetostat.

“Follicular lymphoma remains an incurable disease, and even with the availability of new drugs in recent years, there have remained important unmet needs in the treatment of follicular lymphoma,” he commented.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has expanded the indication for the Gardasil-9 (Merck) vaccine to include prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.

This new indication is approved under the FDA’s accelerated approval program and is based on the vaccine’s effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial, which is currently underway.

“At Merck, working to help prevent certain HPV-related cancers has been a priority for more than two decades,” Alain Luxembourg, MD, director, clinical research, Merck Research Laboratories, said in a statement. “Today’s approval for the prevention of HPV-related oropharyngeal and other head and neck cancers represents an important step in Merck’s mission to help reduce the number of men and women affected by certain HPV-related cancers.”

This new indication doesn’t affect the current recommendations that are already in place. In 2018, a supplemental application for Gardasil 9 was approved to include women and men aged 27 through 45 years for preventing a variety of cancers including cervical, vulvar, vaginal, and anal cancer as well as genital warts. But cancers of the head and neck were not included.

The original Gardasil vaccine came on the market in 2006, with an indication to prevent certain cancers and diseases caused by HPV types 6, 11, 16, and 18. It is no longer distributed in the United States.

In 2014, the FDA approved Gardasil 9, which extends the vaccine coverage for the initial four HPV types as five additional types (31, 33, 45, 52, and 58), and its initial indication was for use in both men and women between the ages of 9 through 26 years.
 

Head and neck cancers surpass cervical cancer

More than 2 decades ago, researchers first found a connection between HPV and a subset of head and neck cancers (Curr Opin Oncol. 1999;11(3):191-199). The cancers associated with HPV also appeared to have a different biology and disease pattern, as well as a better prognosis, compared with those that were unrelated. HPV is now responsible for the majority of oropharyngeal squamous cell cancers diagnosed in the United States.

A study published last year found that oral HPV infections were occurring with significantly less frequency among sexually active female adolescents who had received the quadrivalent vaccine, as compared with those who were unvaccinated.

These findings provided evidence that HPV vaccination was associated with a reduced frequency of HPV infection in the oral cavity, suggesting that vaccination could decrease the future risk of HPV-associated head and neck cancers.

The omission of head and neck cancers from the initial list of indications for the vaccine is notable because, according to data from the Centers for Disease Control and Prevention (CDC), oropharyngeal cancers are now the most common malignancy caused by HPV, surpassing cervical cancer.
 

Who will benefit?

An estimated 14 million new HPV infections occur every year in the United States, according to the CDC, and about 80% of individuals who are sexually active have been exposed at some point during their lifetime. In most people, however, the virus will clear on its own without causing any illness or symptoms.

In a Medscape videoblog, Sandra Adamson Fryhofer, MD, MACP, FRCP, helped clarify the adult population most likely to benefit from the vaccine. She pointed out that the HPV vaccine doesn’t treat HPV-related disease or help clear infections, and there are currently no clinical antibody tests or titers that can predict immunity.

“Many adults aged 27-45 have already been exposed to HPV early in life,” she said. Those in a long-term mutually monogamous relationship are not likely to get a new HPV infection. Those with multiple prior sex partners are more likely to have already been exposed to vaccine serotypes. For them, the vaccine will be less effective.”

Fryhofer added that individuals who are now at risk for exposure to a new HPV infection from a new sex partner are the ones most likely to benefit from HPV vaccination.
 

Confirmation needed

The FDA’s accelerated approval is contingent on confirmatory data, and Merck opened a clinical trial this past February to evaluate the efficacy, immunogenicity, and safety of the 9-valent HPV vaccine in men 20 to 45 years of age. The phase 3 multicenter randomized trial will have an estimated enrollment of 6000 men.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has expanded the indication for the Gardasil-9 (Merck) vaccine to include prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.

This new indication is approved under the FDA’s accelerated approval program and is based on the vaccine’s effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial, which is currently underway.

“At Merck, working to help prevent certain HPV-related cancers has been a priority for more than two decades,” Alain Luxembourg, MD, director, clinical research, Merck Research Laboratories, said in a statement. “Today’s approval for the prevention of HPV-related oropharyngeal and other head and neck cancers represents an important step in Merck’s mission to help reduce the number of men and women affected by certain HPV-related cancers.”

This new indication doesn’t affect the current recommendations that are already in place. In 2018, a supplemental application for Gardasil 9 was approved to include women and men aged 27 through 45 years for preventing a variety of cancers including cervical, vulvar, vaginal, and anal cancer as well as genital warts. But cancers of the head and neck were not included.

The original Gardasil vaccine came on the market in 2006, with an indication to prevent certain cancers and diseases caused by HPV types 6, 11, 16, and 18. It is no longer distributed in the United States.

In 2014, the FDA approved Gardasil 9, which extends the vaccine coverage for the initial four HPV types as five additional types (31, 33, 45, 52, and 58), and its initial indication was for use in both men and women between the ages of 9 through 26 years.
 

Head and neck cancers surpass cervical cancer

More than 2 decades ago, researchers first found a connection between HPV and a subset of head and neck cancers (Curr Opin Oncol. 1999;11(3):191-199). The cancers associated with HPV also appeared to have a different biology and disease pattern, as well as a better prognosis, compared with those that were unrelated. HPV is now responsible for the majority of oropharyngeal squamous cell cancers diagnosed in the United States.

A study published last year found that oral HPV infections were occurring with significantly less frequency among sexually active female adolescents who had received the quadrivalent vaccine, as compared with those who were unvaccinated.

These findings provided evidence that HPV vaccination was associated with a reduced frequency of HPV infection in the oral cavity, suggesting that vaccination could decrease the future risk of HPV-associated head and neck cancers.

The omission of head and neck cancers from the initial list of indications for the vaccine is notable because, according to data from the Centers for Disease Control and Prevention (CDC), oropharyngeal cancers are now the most common malignancy caused by HPV, surpassing cervical cancer.
 

Who will benefit?

An estimated 14 million new HPV infections occur every year in the United States, according to the CDC, and about 80% of individuals who are sexually active have been exposed at some point during their lifetime. In most people, however, the virus will clear on its own without causing any illness or symptoms.

In a Medscape videoblog, Sandra Adamson Fryhofer, MD, MACP, FRCP, helped clarify the adult population most likely to benefit from the vaccine. She pointed out that the HPV vaccine doesn’t treat HPV-related disease or help clear infections, and there are currently no clinical antibody tests or titers that can predict immunity.

“Many adults aged 27-45 have already been exposed to HPV early in life,” she said. Those in a long-term mutually monogamous relationship are not likely to get a new HPV infection. Those with multiple prior sex partners are more likely to have already been exposed to vaccine serotypes. For them, the vaccine will be less effective.”

Fryhofer added that individuals who are now at risk for exposure to a new HPV infection from a new sex partner are the ones most likely to benefit from HPV vaccination.
 

Confirmation needed

The FDA’s accelerated approval is contingent on confirmatory data, and Merck opened a clinical trial this past February to evaluate the efficacy, immunogenicity, and safety of the 9-valent HPV vaccine in men 20 to 45 years of age. The phase 3 multicenter randomized trial will have an estimated enrollment of 6000 men.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has expanded the indication for the Gardasil-9 (Merck) vaccine to include prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.

This new indication is approved under the FDA’s accelerated approval program and is based on the vaccine’s effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial, which is currently underway.

“At Merck, working to help prevent certain HPV-related cancers has been a priority for more than two decades,” Alain Luxembourg, MD, director, clinical research, Merck Research Laboratories, said in a statement. “Today’s approval for the prevention of HPV-related oropharyngeal and other head and neck cancers represents an important step in Merck’s mission to help reduce the number of men and women affected by certain HPV-related cancers.”

This new indication doesn’t affect the current recommendations that are already in place. In 2018, a supplemental application for Gardasil 9 was approved to include women and men aged 27 through 45 years for preventing a variety of cancers including cervical, vulvar, vaginal, and anal cancer as well as genital warts. But cancers of the head and neck were not included.

The original Gardasil vaccine came on the market in 2006, with an indication to prevent certain cancers and diseases caused by HPV types 6, 11, 16, and 18. It is no longer distributed in the United States.

In 2014, the FDA approved Gardasil 9, which extends the vaccine coverage for the initial four HPV types as five additional types (31, 33, 45, 52, and 58), and its initial indication was for use in both men and women between the ages of 9 through 26 years.
 

Head and neck cancers surpass cervical cancer

More than 2 decades ago, researchers first found a connection between HPV and a subset of head and neck cancers (Curr Opin Oncol. 1999;11(3):191-199). The cancers associated with HPV also appeared to have a different biology and disease pattern, as well as a better prognosis, compared with those that were unrelated. HPV is now responsible for the majority of oropharyngeal squamous cell cancers diagnosed in the United States.

A study published last year found that oral HPV infections were occurring with significantly less frequency among sexually active female adolescents who had received the quadrivalent vaccine, as compared with those who were unvaccinated.

These findings provided evidence that HPV vaccination was associated with a reduced frequency of HPV infection in the oral cavity, suggesting that vaccination could decrease the future risk of HPV-associated head and neck cancers.

The omission of head and neck cancers from the initial list of indications for the vaccine is notable because, according to data from the Centers for Disease Control and Prevention (CDC), oropharyngeal cancers are now the most common malignancy caused by HPV, surpassing cervical cancer.
 

Who will benefit?

An estimated 14 million new HPV infections occur every year in the United States, according to the CDC, and about 80% of individuals who are sexually active have been exposed at some point during their lifetime. In most people, however, the virus will clear on its own without causing any illness or symptoms.

In a Medscape videoblog, Sandra Adamson Fryhofer, MD, MACP, FRCP, helped clarify the adult population most likely to benefit from the vaccine. She pointed out that the HPV vaccine doesn’t treat HPV-related disease or help clear infections, and there are currently no clinical antibody tests or titers that can predict immunity.

“Many adults aged 27-45 have already been exposed to HPV early in life,” she said. Those in a long-term mutually monogamous relationship are not likely to get a new HPV infection. Those with multiple prior sex partners are more likely to have already been exposed to vaccine serotypes. For them, the vaccine will be less effective.”

Fryhofer added that individuals who are now at risk for exposure to a new HPV infection from a new sex partner are the ones most likely to benefit from HPV vaccination.
 

Confirmation needed

The FDA’s accelerated approval is contingent on confirmatory data, and Merck opened a clinical trial this past February to evaluate the efficacy, immunogenicity, and safety of the 9-valent HPV vaccine in men 20 to 45 years of age. The phase 3 multicenter randomized trial will have an estimated enrollment of 6000 men.

This article first appeared on Medscape.com.

Visits to the emergency department (ED) and hospitalizations are often frequent occurrences for cancer patients, but what if the “hospital” could be brought into the home instead?

A new American cohort study provides evidence that this can be a workable option for cancer patients. The authors report improved patient outcomes, with 56% lower odds of unplanned hospitalizations (P = .001), 45% lower odds of ED visits (P = .037), and 50% lower cumulative charges (P = .001), as compared with patients who received usual care.

“The oncology hospital-at-home model of care that extends acute-level care to the patient at home offers promise in addressing a long-term gap in cancer care service delivery,” said lead author Kathi Mooney, PhD, RN, interim senior director of population sciences at the Huntsman Cancer Institute and distinguished professor of nursing at the University of Utah, Salt Lake City. “In light of the current global pandemic, we are compelled to consider new ways to provide cancer care, and the oncology hospital-at-home model is on point to address critical elements of an improved cancer care delivery system.”

Mooney presented the findings during the virtual scientific program of the American Society of Clinical Oncology 2020 annual meeting (abstract 7000).

The hospital-at-home model of care provides hospital-level care in the comfort of the patient’s home and is a component of many healthcare systems worldwide. Although it was introduced in the United States more than 2 decades ago, it has not been widely adopted or studied specifically in oncology.

Most cancer treatment is provided on an outpatient basis, which means that patients experience significant adverse events, toxicities, and disease progression while they are at home. Thus, Mooney noted, patients tend to rely heavily on the ED and sometimes experience unplanned hospitalizations and 30-day readmissions.

“These care patterns are distressing to the patients and their families and tax healthcare resources,” she said. “They are even more concerning and salient as we endeavor to protect cancer patients and provide cancer care during a pandemic.”

Currently, strategies to evaluate and support cancer patients and caregivers at home are limited. In 2018, the Huntsman Cancer Institute implemented Huntsman at Home, a demonstration project to evaluate the utility of an oncology hospital-at-home model.
 

Significantly Fewer Unplanned Hospitalizations

Huntsman at Home is run by nurse practitioner and registered nurse teams who deliver acute-level care at home. Physicians provide backup support for both medical oncology and palliative care. Nurse practitioners also work directly with the patient’s oncology team to coordinate care needs, including services such as social work and physical therapy.

To evaluate the hospital-at-home model, Mooney and colleagues compared patients who were enrolled in the program with those who received usual care. The usual-care comparison group was drawn from patients who lived in the Salt Lake City area. These patients would have qualified for enrollment in the Huntsman at Home program, but they lived outside the 20-mile service area.

The cohort included 367 patients (169 Huntsman at Home patients and 198 usual-care patients). Of those patients, 77% had stage IV cancer. A range of cancer types was represented; the most common were colon, gynecologic, prostate, and lung cancers. As compared to the usual-care group, those in the home model were more likely to be women (61% vs 43%).

During the first 30 days after admission, Huntsman at Home patients had significantly fewer unplanned hospitalizations (19.5% vs 35.4%) and a shorter length of stay (1.4 vs 2.6 days). Their care was also less expensive. The estimated charges for the hospital-at-home patients was $10,238, compared with $21,363 for the usual-care patients. There was no real difference in stays in the intensive care unit between the two groups.

Mooney noted that since there have been few studies of the hospital-at-home model for oncology patients, the investigators’ initial focus was on patients at hospital discharge who needed continued acute-level care and those who had acute problems identified through their oncology care clinic. Therefore, patients were not admitted to the program directly from emergency services, and chemotherapy infusions were not provided, although these are “other areas to consider in an oncology hospital-at-home model.”

Other limitations of the study were that it was not a randomized trial, and the evaluation was from a single program located at one comprehensive cancer center.

“These findings provide the oncology community with an opportunity to rethink cancer care as solely hospital- and clinic-based and instead reimagine care delivery that moves with the patient with key components provided at home,” said Mooney. “We plan to continue the development and evaluation of Huntsman at Home and extend care to admission from the emergency department.”

She added that, together with Flatiron Health, they are validating a tool to prospectively predict, on the basis of the likelihood of ED use, which patients may benefit from Huntsman at Home support. They also plan to extend care to patients who live at a distance from the cancer center and in rural communities, and may include chemotherapy infusion services.

Palliative Care Patients Prefer Home-Based Treatment

In a discussion of the paper, Lynne Wagner, PhD, a professor in the Department of Social Sciences and Health Policy with the Wake Forest School of Medicine, Winston-Salem, North Carolina, and a member of the Wake Forest Baptist Comprehensive Cancer Center, explained that some “aspects of healthcare are more translatable to a virtual or alternative delivery model than others. An area of cancer care greatly in need of innovation and quality improvement pertains to the management of oncologic emergencies.”

She pointed out that optimal care for oncologic emergencies requires the “intersection of oncology and emergency medicine specialists,” but there are often no well-defined processes for care coordination in place.

“Emergency department utilization could be reduced through greater precision with regard to risk stratification and early intervention and improved outpatient management, including improved symptom management,” said Wagner.

Wagner suggested that research should incorporate patient-reported outcomes so as to measure patient-centered benefits of home-based care. “Patients who are receiving palliative care services prefer home-based care, and it’s reasonable to anticipate this finding would extrapolate to the investigator’s target population,” she said. “However, there may also be unanticipated consequences, potentially including increased anxiety or increased burden on caretakers.”

In addition, the tangible and intangible costs associated with traveling to receive healthcare services and time away from work can be reduced with home-based care, and this should also be quantified. “The costs associated with COVID infection should be estimated to realize the full economic value of this care model, given significant reductions in cohort exposure afforded by home-based visits,” Wagner added.

The Huntsman at Home program is funded by the Huntsman Cancer Institute. The evaluation was funded by the Cambia Health Foundation. Mooney has a consulting or advisory role with Cognitive Medical System, Inc, and has patents, royalties, and other intellectual property for the development of Symptom Care at Home, a remote symptom-monitoring platform developed through research grants funded by the National Cancer Institute. No royalties have been received to date. Wagner has relationships with Celgene, Eli Lilly, Gilead Sciences, and Johnson & Johnson.
 

This article first appeared on Medscape.com.

Visits to the emergency department (ED) and hospitalizations are often frequent occurrences for cancer patients, but what if the “hospital” could be brought into the home instead?

A new American cohort study provides evidence that this can be a workable option for cancer patients. The authors report improved patient outcomes, with 56% lower odds of unplanned hospitalizations (P = .001), 45% lower odds of ED visits (P = .037), and 50% lower cumulative charges (P = .001), as compared with patients who received usual care.

“The oncology hospital-at-home model of care that extends acute-level care to the patient at home offers promise in addressing a long-term gap in cancer care service delivery,” said lead author Kathi Mooney, PhD, RN, interim senior director of population sciences at the Huntsman Cancer Institute and distinguished professor of nursing at the University of Utah, Salt Lake City. “In light of the current global pandemic, we are compelled to consider new ways to provide cancer care, and the oncology hospital-at-home model is on point to address critical elements of an improved cancer care delivery system.”

Mooney presented the findings during the virtual scientific program of the American Society of Clinical Oncology 2020 annual meeting (abstract 7000).

The hospital-at-home model of care provides hospital-level care in the comfort of the patient’s home and is a component of many healthcare systems worldwide. Although it was introduced in the United States more than 2 decades ago, it has not been widely adopted or studied specifically in oncology.

Most cancer treatment is provided on an outpatient basis, which means that patients experience significant adverse events, toxicities, and disease progression while they are at home. Thus, Mooney noted, patients tend to rely heavily on the ED and sometimes experience unplanned hospitalizations and 30-day readmissions.

“These care patterns are distressing to the patients and their families and tax healthcare resources,” she said. “They are even more concerning and salient as we endeavor to protect cancer patients and provide cancer care during a pandemic.”

Currently, strategies to evaluate and support cancer patients and caregivers at home are limited. In 2018, the Huntsman Cancer Institute implemented Huntsman at Home, a demonstration project to evaluate the utility of an oncology hospital-at-home model.
 

Significantly Fewer Unplanned Hospitalizations

Huntsman at Home is run by nurse practitioner and registered nurse teams who deliver acute-level care at home. Physicians provide backup support for both medical oncology and palliative care. Nurse practitioners also work directly with the patient’s oncology team to coordinate care needs, including services such as social work and physical therapy.

To evaluate the hospital-at-home model, Mooney and colleagues compared patients who were enrolled in the program with those who received usual care. The usual-care comparison group was drawn from patients who lived in the Salt Lake City area. These patients would have qualified for enrollment in the Huntsman at Home program, but they lived outside the 20-mile service area.

The cohort included 367 patients (169 Huntsman at Home patients and 198 usual-care patients). Of those patients, 77% had stage IV cancer. A range of cancer types was represented; the most common were colon, gynecologic, prostate, and lung cancers. As compared to the usual-care group, those in the home model were more likely to be women (61% vs 43%).

During the first 30 days after admission, Huntsman at Home patients had significantly fewer unplanned hospitalizations (19.5% vs 35.4%) and a shorter length of stay (1.4 vs 2.6 days). Their care was also less expensive. The estimated charges for the hospital-at-home patients was $10,238, compared with $21,363 for the usual-care patients. There was no real difference in stays in the intensive care unit between the two groups.

Mooney noted that since there have been few studies of the hospital-at-home model for oncology patients, the investigators’ initial focus was on patients at hospital discharge who needed continued acute-level care and those who had acute problems identified through their oncology care clinic. Therefore, patients were not admitted to the program directly from emergency services, and chemotherapy infusions were not provided, although these are “other areas to consider in an oncology hospital-at-home model.”

Other limitations of the study were that it was not a randomized trial, and the evaluation was from a single program located at one comprehensive cancer center.

“These findings provide the oncology community with an opportunity to rethink cancer care as solely hospital- and clinic-based and instead reimagine care delivery that moves with the patient with key components provided at home,” said Mooney. “We plan to continue the development and evaluation of Huntsman at Home and extend care to admission from the emergency department.”

She added that, together with Flatiron Health, they are validating a tool to prospectively predict, on the basis of the likelihood of ED use, which patients may benefit from Huntsman at Home support. They also plan to extend care to patients who live at a distance from the cancer center and in rural communities, and may include chemotherapy infusion services.

Palliative Care Patients Prefer Home-Based Treatment

In a discussion of the paper, Lynne Wagner, PhD, a professor in the Department of Social Sciences and Health Policy with the Wake Forest School of Medicine, Winston-Salem, North Carolina, and a member of the Wake Forest Baptist Comprehensive Cancer Center, explained that some “aspects of healthcare are more translatable to a virtual or alternative delivery model than others. An area of cancer care greatly in need of innovation and quality improvement pertains to the management of oncologic emergencies.”

She pointed out that optimal care for oncologic emergencies requires the “intersection of oncology and emergency medicine specialists,” but there are often no well-defined processes for care coordination in place.

“Emergency department utilization could be reduced through greater precision with regard to risk stratification and early intervention and improved outpatient management, including improved symptom management,” said Wagner.

Wagner suggested that research should incorporate patient-reported outcomes so as to measure patient-centered benefits of home-based care. “Patients who are receiving palliative care services prefer home-based care, and it’s reasonable to anticipate this finding would extrapolate to the investigator’s target population,” she said. “However, there may also be unanticipated consequences, potentially including increased anxiety or increased burden on caretakers.”

In addition, the tangible and intangible costs associated with traveling to receive healthcare services and time away from work can be reduced with home-based care, and this should also be quantified. “The costs associated with COVID infection should be estimated to realize the full economic value of this care model, given significant reductions in cohort exposure afforded by home-based visits,” Wagner added.

The Huntsman at Home program is funded by the Huntsman Cancer Institute. The evaluation was funded by the Cambia Health Foundation. Mooney has a consulting or advisory role with Cognitive Medical System, Inc, and has patents, royalties, and other intellectual property for the development of Symptom Care at Home, a remote symptom-monitoring platform developed through research grants funded by the National Cancer Institute. No royalties have been received to date. Wagner has relationships with Celgene, Eli Lilly, Gilead Sciences, and Johnson & Johnson.
 

This article first appeared on Medscape.com.

Visits to the emergency department (ED) and hospitalizations are often frequent occurrences for cancer patients, but what if the “hospital” could be brought into the home instead?

A new American cohort study provides evidence that this can be a workable option for cancer patients. The authors report improved patient outcomes, with 56% lower odds of unplanned hospitalizations (P = .001), 45% lower odds of ED visits (P = .037), and 50% lower cumulative charges (P = .001), as compared with patients who received usual care.

“The oncology hospital-at-home model of care that extends acute-level care to the patient at home offers promise in addressing a long-term gap in cancer care service delivery,” said lead author Kathi Mooney, PhD, RN, interim senior director of population sciences at the Huntsman Cancer Institute and distinguished professor of nursing at the University of Utah, Salt Lake City. “In light of the current global pandemic, we are compelled to consider new ways to provide cancer care, and the oncology hospital-at-home model is on point to address critical elements of an improved cancer care delivery system.”

Mooney presented the findings during the virtual scientific program of the American Society of Clinical Oncology 2020 annual meeting (abstract 7000).

The hospital-at-home model of care provides hospital-level care in the comfort of the patient’s home and is a component of many healthcare systems worldwide. Although it was introduced in the United States more than 2 decades ago, it has not been widely adopted or studied specifically in oncology.

Most cancer treatment is provided on an outpatient basis, which means that patients experience significant adverse events, toxicities, and disease progression while they are at home. Thus, Mooney noted, patients tend to rely heavily on the ED and sometimes experience unplanned hospitalizations and 30-day readmissions.

“These care patterns are distressing to the patients and their families and tax healthcare resources,” she said. “They are even more concerning and salient as we endeavor to protect cancer patients and provide cancer care during a pandemic.”

Currently, strategies to evaluate and support cancer patients and caregivers at home are limited. In 2018, the Huntsman Cancer Institute implemented Huntsman at Home, a demonstration project to evaluate the utility of an oncology hospital-at-home model.
 

Significantly Fewer Unplanned Hospitalizations

Huntsman at Home is run by nurse practitioner and registered nurse teams who deliver acute-level care at home. Physicians provide backup support for both medical oncology and palliative care. Nurse practitioners also work directly with the patient’s oncology team to coordinate care needs, including services such as social work and physical therapy.

To evaluate the hospital-at-home model, Mooney and colleagues compared patients who were enrolled in the program with those who received usual care. The usual-care comparison group was drawn from patients who lived in the Salt Lake City area. These patients would have qualified for enrollment in the Huntsman at Home program, but they lived outside the 20-mile service area.

The cohort included 367 patients (169 Huntsman at Home patients and 198 usual-care patients). Of those patients, 77% had stage IV cancer. A range of cancer types was represented; the most common were colon, gynecologic, prostate, and lung cancers. As compared to the usual-care group, those in the home model were more likely to be women (61% vs 43%).

During the first 30 days after admission, Huntsman at Home patients had significantly fewer unplanned hospitalizations (19.5% vs 35.4%) and a shorter length of stay (1.4 vs 2.6 days). Their care was also less expensive. The estimated charges for the hospital-at-home patients was $10,238, compared with $21,363 for the usual-care patients. There was no real difference in stays in the intensive care unit between the two groups.

Mooney noted that since there have been few studies of the hospital-at-home model for oncology patients, the investigators’ initial focus was on patients at hospital discharge who needed continued acute-level care and those who had acute problems identified through their oncology care clinic. Therefore, patients were not admitted to the program directly from emergency services, and chemotherapy infusions were not provided, although these are “other areas to consider in an oncology hospital-at-home model.”

Other limitations of the study were that it was not a randomized trial, and the evaluation was from a single program located at one comprehensive cancer center.

“These findings provide the oncology community with an opportunity to rethink cancer care as solely hospital- and clinic-based and instead reimagine care delivery that moves with the patient with key components provided at home,” said Mooney. “We plan to continue the development and evaluation of Huntsman at Home and extend care to admission from the emergency department.”

She added that, together with Flatiron Health, they are validating a tool to prospectively predict, on the basis of the likelihood of ED use, which patients may benefit from Huntsman at Home support. They also plan to extend care to patients who live at a distance from the cancer center and in rural communities, and may include chemotherapy infusion services.

Palliative Care Patients Prefer Home-Based Treatment

In a discussion of the paper, Lynne Wagner, PhD, a professor in the Department of Social Sciences and Health Policy with the Wake Forest School of Medicine, Winston-Salem, North Carolina, and a member of the Wake Forest Baptist Comprehensive Cancer Center, explained that some “aspects of healthcare are more translatable to a virtual or alternative delivery model than others. An area of cancer care greatly in need of innovation and quality improvement pertains to the management of oncologic emergencies.”

She pointed out that optimal care for oncologic emergencies requires the “intersection of oncology and emergency medicine specialists,” but there are often no well-defined processes for care coordination in place.

“Emergency department utilization could be reduced through greater precision with regard to risk stratification and early intervention and improved outpatient management, including improved symptom management,” said Wagner.

Wagner suggested that research should incorporate patient-reported outcomes so as to measure patient-centered benefits of home-based care. “Patients who are receiving palliative care services prefer home-based care, and it’s reasonable to anticipate this finding would extrapolate to the investigator’s target population,” she said. “However, there may also be unanticipated consequences, potentially including increased anxiety or increased burden on caretakers.”

In addition, the tangible and intangible costs associated with traveling to receive healthcare services and time away from work can be reduced with home-based care, and this should also be quantified. “The costs associated with COVID infection should be estimated to realize the full economic value of this care model, given significant reductions in cohort exposure afforded by home-based visits,” Wagner added.

The Huntsman at Home program is funded by the Huntsman Cancer Institute. The evaluation was funded by the Cambia Health Foundation. Mooney has a consulting or advisory role with Cognitive Medical System, Inc, and has patents, royalties, and other intellectual property for the development of Symptom Care at Home, a remote symptom-monitoring platform developed through research grants funded by the National Cancer Institute. No royalties have been received to date. Wagner has relationships with Celgene, Eli Lilly, Gilead Sciences, and Johnson & Johnson.
 

This article first appeared on Medscape.com.

In its updated cancer prevention guidelines, the American Cancer Society now recommends that “it is best not to drink alcohol.”

Previously, ACS suggested that, for those who consume alcoholic beverages, intake should be no more than one drink per day for women or two per day for men. That recommendation is still in place, but is now accompanied by this new, stronger directive.

The revised guidelines also place more emphasis on reducing the consumption of processed and red meat and highly processed foods, and on increasing physical activity.

But importantly, there is also a call for action from public, private, and community organizations to work to together to increase access to affordable, nutritious foods and physical activity.

“Making healthy choices can be challenging for many, and there are strategies included in the guidelines that communities can undertake to help reduce barriers to eating well and physical activity,” said Laura Makaroff, DO, American Cancer Society senior vice president. “Individual choice is an important part of a healthy lifestyle, but having the right policies and environmental factors to break down these barriers is also important, and that is something that clinicians can support.”

The guidelines were published in CA: A Cancer Journal for Clinicians.

The link between cancer and lifestyle factors has long been established, and for the past 4 decades, both government and leading nonprofit health organizations, including the ACS and the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR), have released cancer prevention guidelines and recommendations that focus on managing weight, diet, physical activity, and alcohol consumption.

In 2012, the ACS issued guidelines on diet and physical activity, and their current guideline is largely based on the WCRF/AICR systematic reviews and Continuous Update Project reports, which were last updated in 2018. The ACS guidelines also incorporated systematic reviews conducted by the International Agency on Cancer Research (IARC) and the U.S. Department of Agriculture and the Department of Health and Human Services (USDA/HHS) and other analyses that were published since the WCRF/AICR recommendations were released.
 

Emphasis on three areas

The differences between the old guidelines and the update do not differ dramatically, but Makaroff highlighted a few areas that have increased emphasis.

Time spent being physically active is critical. The recommendation has changed to encourage adults to engage in 150-300 minutes (2.5-5 hours) of moderate-intensity physical activity, or 75-150 minutes (1.25-2.5 hours) of vigorous-intensity physical activity, or an equivalent combination, per week. Achieving or exceeding the upper limit of 300 minutes is optimal.

“That is more than what we have recommended in the past, along with the continued message that children and adolescents engage in at least 1 hour of moderate- or vigorous-intensity activity each day,” she told Medscape Medical News.

The ACS has also increased emphasis on reducing the consumption of processed and red meat. “This is part of a healthy eating pattern and making sure that people are eating food that is high in nutrients that help achieve and maintain a healthy body weight,” said Makaroff.

A healthy diet should include a variety of dark green, red, and orange vegetables; fiber-rich legumes; and fruits with a variety of colors and whole grains, according to the guidelines. Sugar-sweetened beverages, highly processed foods, and refined grain products should be limited or avoided.

The revised dietary recommendations reflect a shift from a “reductionist or nutrient-centric” approach to one that is more “holistic” and that focuses on dietary patterns. In contrast to a focus on individual nutrients and bioactive compounds, the new approach is more consistent with what and how people actually eat, ACS points out.

The third area that Makaroff highlighted is alcohol, where the recommendation is to avoid or limit consumption. “The current update says not to drink alcohol, which is in line with the scientific evidence, but for those people who choose to drink alcohol, to limit it to one drink per day for women and two drinks per day for men.”

Thus, the change here is that the previous guideline only recommended limiting alcohol consumption, while the update suggests that, optimally, it should be avoided completely.

The ACS has also called for community involvement to help implement these goals: “Public, private, and community organizations should work collaboratively at national, state, and local levels to develop, advocate for, and implement policy and environmental changes that increase access to affordable, nutritious foods; provide safe, enjoyable, and accessible opportunities for physical activity; and limit alcohol for all individuals.”
 

No smoking guns

Commenting on the guidelines, Steven K. Clinton, MD, PhD, associate director of the Center for Advanced Functional Foods Research and Entrepreneurship at the Ohio State University, Columbus, explained that he didn’t view the change in alcohol as that much of an evolution. “It’s been 8 years since they revised their overall guidelines, and during that time frame, there has been an enormous growth in the evidence that has been used by many organizations,” he said.

Clinton noted that the guidelines are consistent with the whole body of current scientific literature. “It’s very easy to go to the document and look for the ‘smoking gun’ – but the smoking gun is really not one thing,” he said. “It’s a pattern, and what dietitians and nutritionists are telling people is that you need to orchestrate a healthy lifestyle and diet, with a diet that has a foundation of fruits, vegetables, whole grains, and modest intake of refined grains and meat. You are orchestrating an entire pattern to get the maximum benefit.”

Makaroff is an employee of the ACS. Clinton has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

In its updated cancer prevention guidelines, the American Cancer Society now recommends that “it is best not to drink alcohol.”

Previously, ACS suggested that, for those who consume alcoholic beverages, intake should be no more than one drink per day for women or two per day for men. That recommendation is still in place, but is now accompanied by this new, stronger directive.

The revised guidelines also place more emphasis on reducing the consumption of processed and red meat and highly processed foods, and on increasing physical activity.

But importantly, there is also a call for action from public, private, and community organizations to work to together to increase access to affordable, nutritious foods and physical activity.

“Making healthy choices can be challenging for many, and there are strategies included in the guidelines that communities can undertake to help reduce barriers to eating well and physical activity,” said Laura Makaroff, DO, American Cancer Society senior vice president. “Individual choice is an important part of a healthy lifestyle, but having the right policies and environmental factors to break down these barriers is also important, and that is something that clinicians can support.”

The guidelines were published in CA: A Cancer Journal for Clinicians.

The link between cancer and lifestyle factors has long been established, and for the past 4 decades, both government and leading nonprofit health organizations, including the ACS and the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR), have released cancer prevention guidelines and recommendations that focus on managing weight, diet, physical activity, and alcohol consumption.

In 2012, the ACS issued guidelines on diet and physical activity, and their current guideline is largely based on the WCRF/AICR systematic reviews and Continuous Update Project reports, which were last updated in 2018. The ACS guidelines also incorporated systematic reviews conducted by the International Agency on Cancer Research (IARC) and the U.S. Department of Agriculture and the Department of Health and Human Services (USDA/HHS) and other analyses that were published since the WCRF/AICR recommendations were released.
 

Emphasis on three areas

The differences between the old guidelines and the update do not differ dramatically, but Makaroff highlighted a few areas that have increased emphasis.

Time spent being physically active is critical. The recommendation has changed to encourage adults to engage in 150-300 minutes (2.5-5 hours) of moderate-intensity physical activity, or 75-150 minutes (1.25-2.5 hours) of vigorous-intensity physical activity, or an equivalent combination, per week. Achieving or exceeding the upper limit of 300 minutes is optimal.

“That is more than what we have recommended in the past, along with the continued message that children and adolescents engage in at least 1 hour of moderate- or vigorous-intensity activity each day,” she told Medscape Medical News.

The ACS has also increased emphasis on reducing the consumption of processed and red meat. “This is part of a healthy eating pattern and making sure that people are eating food that is high in nutrients that help achieve and maintain a healthy body weight,” said Makaroff.

A healthy diet should include a variety of dark green, red, and orange vegetables; fiber-rich legumes; and fruits with a variety of colors and whole grains, according to the guidelines. Sugar-sweetened beverages, highly processed foods, and refined grain products should be limited or avoided.

The revised dietary recommendations reflect a shift from a “reductionist or nutrient-centric” approach to one that is more “holistic” and that focuses on dietary patterns. In contrast to a focus on individual nutrients and bioactive compounds, the new approach is more consistent with what and how people actually eat, ACS points out.

The third area that Makaroff highlighted is alcohol, where the recommendation is to avoid or limit consumption. “The current update says not to drink alcohol, which is in line with the scientific evidence, but for those people who choose to drink alcohol, to limit it to one drink per day for women and two drinks per day for men.”

Thus, the change here is that the previous guideline only recommended limiting alcohol consumption, while the update suggests that, optimally, it should be avoided completely.

The ACS has also called for community involvement to help implement these goals: “Public, private, and community organizations should work collaboratively at national, state, and local levels to develop, advocate for, and implement policy and environmental changes that increase access to affordable, nutritious foods; provide safe, enjoyable, and accessible opportunities for physical activity; and limit alcohol for all individuals.”
 

No smoking guns

Commenting on the guidelines, Steven K. Clinton, MD, PhD, associate director of the Center for Advanced Functional Foods Research and Entrepreneurship at the Ohio State University, Columbus, explained that he didn’t view the change in alcohol as that much of an evolution. “It’s been 8 years since they revised their overall guidelines, and during that time frame, there has been an enormous growth in the evidence that has been used by many organizations,” he said.

Clinton noted that the guidelines are consistent with the whole body of current scientific literature. “It’s very easy to go to the document and look for the ‘smoking gun’ – but the smoking gun is really not one thing,” he said. “It’s a pattern, and what dietitians and nutritionists are telling people is that you need to orchestrate a healthy lifestyle and diet, with a diet that has a foundation of fruits, vegetables, whole grains, and modest intake of refined grains and meat. You are orchestrating an entire pattern to get the maximum benefit.”

Makaroff is an employee of the ACS. Clinton has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

In its updated cancer prevention guidelines, the American Cancer Society now recommends that “it is best not to drink alcohol.”

Previously, ACS suggested that, for those who consume alcoholic beverages, intake should be no more than one drink per day for women or two per day for men. That recommendation is still in place, but is now accompanied by this new, stronger directive.

The revised guidelines also place more emphasis on reducing the consumption of processed and red meat and highly processed foods, and on increasing physical activity.

But importantly, there is also a call for action from public, private, and community organizations to work to together to increase access to affordable, nutritious foods and physical activity.

“Making healthy choices can be challenging for many, and there are strategies included in the guidelines that communities can undertake to help reduce barriers to eating well and physical activity,” said Laura Makaroff, DO, American Cancer Society senior vice president. “Individual choice is an important part of a healthy lifestyle, but having the right policies and environmental factors to break down these barriers is also important, and that is something that clinicians can support.”

The guidelines were published in CA: A Cancer Journal for Clinicians.

The link between cancer and lifestyle factors has long been established, and for the past 4 decades, both government and leading nonprofit health organizations, including the ACS and the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR), have released cancer prevention guidelines and recommendations that focus on managing weight, diet, physical activity, and alcohol consumption.

In 2012, the ACS issued guidelines on diet and physical activity, and their current guideline is largely based on the WCRF/AICR systematic reviews and Continuous Update Project reports, which were last updated in 2018. The ACS guidelines also incorporated systematic reviews conducted by the International Agency on Cancer Research (IARC) and the U.S. Department of Agriculture and the Department of Health and Human Services (USDA/HHS) and other analyses that were published since the WCRF/AICR recommendations were released.
 

Emphasis on three areas

The differences between the old guidelines and the update do not differ dramatically, but Makaroff highlighted a few areas that have increased emphasis.

Time spent being physically active is critical. The recommendation has changed to encourage adults to engage in 150-300 minutes (2.5-5 hours) of moderate-intensity physical activity, or 75-150 minutes (1.25-2.5 hours) of vigorous-intensity physical activity, or an equivalent combination, per week. Achieving or exceeding the upper limit of 300 minutes is optimal.

“That is more than what we have recommended in the past, along with the continued message that children and adolescents engage in at least 1 hour of moderate- or vigorous-intensity activity each day,” she told Medscape Medical News.

The ACS has also increased emphasis on reducing the consumption of processed and red meat. “This is part of a healthy eating pattern and making sure that people are eating food that is high in nutrients that help achieve and maintain a healthy body weight,” said Makaroff.

A healthy diet should include a variety of dark green, red, and orange vegetables; fiber-rich legumes; and fruits with a variety of colors and whole grains, according to the guidelines. Sugar-sweetened beverages, highly processed foods, and refined grain products should be limited or avoided.

The revised dietary recommendations reflect a shift from a “reductionist or nutrient-centric” approach to one that is more “holistic” and that focuses on dietary patterns. In contrast to a focus on individual nutrients and bioactive compounds, the new approach is more consistent with what and how people actually eat, ACS points out.

The third area that Makaroff highlighted is alcohol, where the recommendation is to avoid or limit consumption. “The current update says not to drink alcohol, which is in line with the scientific evidence, but for those people who choose to drink alcohol, to limit it to one drink per day for women and two drinks per day for men.”

Thus, the change here is that the previous guideline only recommended limiting alcohol consumption, while the update suggests that, optimally, it should be avoided completely.

The ACS has also called for community involvement to help implement these goals: “Public, private, and community organizations should work collaboratively at national, state, and local levels to develop, advocate for, and implement policy and environmental changes that increase access to affordable, nutritious foods; provide safe, enjoyable, and accessible opportunities for physical activity; and limit alcohol for all individuals.”
 

No smoking guns

Commenting on the guidelines, Steven K. Clinton, MD, PhD, associate director of the Center for Advanced Functional Foods Research and Entrepreneurship at the Ohio State University, Columbus, explained that he didn’t view the change in alcohol as that much of an evolution. “It’s been 8 years since they revised their overall guidelines, and during that time frame, there has been an enormous growth in the evidence that has been used by many organizations,” he said.

Clinton noted that the guidelines are consistent with the whole body of current scientific literature. “It’s very easy to go to the document and look for the ‘smoking gun’ – but the smoking gun is really not one thing,” he said. “It’s a pattern, and what dietitians and nutritionists are telling people is that you need to orchestrate a healthy lifestyle and diet, with a diet that has a foundation of fruits, vegetables, whole grains, and modest intake of refined grains and meat. You are orchestrating an entire pattern to get the maximum benefit.”

Makaroff is an employee of the ACS. Clinton has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.