Clinical Topics & News

For over a decade, the influential National Comprehensive Cancer Network (NCCN) has been recommending that men with low-risk prostate cancer be offered active surveillance as the lone “preferred” initial treatment option.

But the NCCN has now reversed this long-standing recommendation in the latest revision of its prostate cancer guideline.

The organization now recommends that low-risk disease be managed with either active surveillance or radiation therapy or surgery, with equal weight given to all three of these initial options.

The change is seen by some as a retreat to the past and was harshly criticized by many experts on Twitter. The complaints were voiced in unusually blunt and strong language for physicians.

“This is a terrible step back that impacts every urologist,” commented John Griffith, MD, of Hartford Healthcare, who practices in New Britain, Conn.

Dr. Griffith explained that he prints out the NCCN guidance with “every patient newly diagnosed” and that the preferred designation is a “huge help” in reassuring them about not treating low-risk disease initially.

In a Twitter thread, Benjamin Davies, MD, of the University of Pittsburgh, facetiously wondered if a time warp was at play: “To suggest for a millisecond that active surveillance isn’t the preferred method for low-risk men is bizarre thinking ... Is this 1980?”

“I’m baffled,” said Brian Chapin, MD, of MD Anderson Cancer Center, Houston, in another Twitter thread.

“This is ludicrous,” said Andrew Vickers, PhD, of Memorial Sloan Kettering Cancer Center in New York City in a tweet.

Alexander Kutikov, MD, of Fox Chase Cancer Center in Philadelphia, commented on Twitter that the change “seems off the rails…a bit stunned by this.”

Matthew Cooperberg, MD, of the University of California San Francisco, and Minhaj Siddiqui, MD, of the University of Maryland in Baltimore both called the move a “step backward.”

Many others also expressed disappointment in the NCCN, whose guidelines are hugely influential because of the role they play clinically as well as with payors and the legal system.

“A huge setback & frankly a disgrace for @NCCN and its processes,” commented Fox Chase’s Dr. Kutikov.

Stacy Loeb, MD, of NYU Langone Health in New York City, suggested the new guidance may stunt use of active surveillance in the United States. She tweeted: “The updated NCCN guideline certainly won’t help the lagging and heterogenous uptake of active surveillance in the U.S. We should be carefully expanding the pool for active surveillance, not narrowing it.”

The purpose of active surveillance is to avoid adverse events from treatment, which can be life-changing as they include incontinence and erectile dysfunction.

The rationale is that many men with low-risk prostate cancer may not need treatment for their disease, as the disease may be slow-growing and may never threaten their life. With active surveillance, men are instead monitored with blood tests, scans, and biopsies to watch for worsening disease, and treated only when there are signs of disease progression.

This active surveillance approach has grown in acceptance among American patients since 2010.

The concern now is that the change in guidance from the NCCN will lead to a reduction in active surveillance, and an increase in initial treatment with surgery and radiotherapy for low-risk disease, which is considered by many to be “overtreatment’ of this disease and may not be medically necessary.  

For example, UCSF’s Dr. Cooperberg said he feared that the changed guidance “will be used by urologists and radiation oncologists to justify overtreatment of low-risk disease.”

Dr. Kutikov agreed but described that possibility differently, citing the risk of lawsuits. He observed that without the NCCN’s “medico-legal buffer” of active surveillance as the preferred initial treatment, there are “further incentives” for overtreatment.

The new NCCN guidance also conflicts with the American Urological Association’s guidelines and dissolves what was once a mostly united front from the two major organizations on active surveillance and low-risk disease.

The AUA Guideline reads: “Clinicians should recommend active surveillance as the preferable care option for most low-risk localized prostate cancer patients (Moderate Recommendation; Evidence Level: Grade B)
 

Patients protest change in wording

Not surprisingly, the revised NCCN guidance was criticized by multiple patient advocacy groups, including Active Surveillance Patients International (ASPI), which wrote a letter to the NCCN protesting the change.

In that letter, the ASPI writes that active surveillance is now chosen as the initial approach for low-risk prostate cancer in about 90% of cases in some European nations, and in about 50% of cases in the United States. It also warns that eliminating the word “preferred” from the NCCN guidelines represents a retreat, and “will have repercussions far beyond what we may first conceive.” 

“Active surveillance should be the preferred choice to preserve quality of life for men with low-risk cancer,” the advocacy group states. “The PIVOT trials indicate for low-risk disease there is basically no advantage to intervention. Why would one risk the side effects if they knew that?”
 

Why now?

The NCCN’s move to alter its low-risk prostate cancer guidance is especially striking because, 11 years ago, the NCCN broke new ground in recommending active surveillance as the sole initial treatment option for low-risk men. (It was also the first guidelines group to recommend the same for very low-risk men.)

So why the change now? This news organization requested, but did not receive,  comment from the NCCN and its chair of the prostate cancer panel, Edward Schaeffer, MD, of Northwestern University in Chicago.  

However, on Twitter, Dr. Schaeffer hinted at what had turned the tables for the NCCN panel – the risk that, over time, some men with low-risk disease who are on active surveillance are reclassified on biopsy as having a higher risk.

He highlighted a 2020 study on that very subject from the University of California, San Francisco, published in the Journal of Urology. Those authors concluded that: “Given the heterogeneity of the disease, some tumors characterized as low risk may merit early treatment while others may be followed much less intensely over some time interval.”

Dr. Schaeffer tweeted: “I think this nicely sums up the low-risk space ...”

Experts reacting to Dr. Schaeffer’s tweet were not swayed.

Looking at additional measures such as genomic scores and PSA density, as advocated by Dr. Schaeffer via the posted 2020 study, is good for assessing individual risk, “but still, active surveillance is the preferred option for low risk,” said MD Anderson’s Dr. Chapin.

UCSF’s Dr. Cooperberg, who was a co-author on that 2020 Journal of Urology paper,  commented that the university’s urology department had “spent the past quarter century arguing active surveillance is ‘preferred’ for almost all low risk [disease]!”

“Many on active surveillance need treatment someday, but that does not justify immediate overtreatment,” he concluded.

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

For over a decade, the influential National Comprehensive Cancer Network (NCCN) has been recommending that men with low-risk prostate cancer be offered active surveillance as the lone “preferred” initial treatment option.

But the NCCN has now reversed this long-standing recommendation in the latest revision of its prostate cancer guideline.

The organization now recommends that low-risk disease be managed with either active surveillance or radiation therapy or surgery, with equal weight given to all three of these initial options.

The change is seen by some as a retreat to the past and was harshly criticized by many experts on Twitter. The complaints were voiced in unusually blunt and strong language for physicians.

“This is a terrible step back that impacts every urologist,” commented John Griffith, MD, of Hartford Healthcare, who practices in New Britain, Conn.

Dr. Griffith explained that he prints out the NCCN guidance with “every patient newly diagnosed” and that the preferred designation is a “huge help” in reassuring them about not treating low-risk disease initially.

In a Twitter thread, Benjamin Davies, MD, of the University of Pittsburgh, facetiously wondered if a time warp was at play: “To suggest for a millisecond that active surveillance isn’t the preferred method for low-risk men is bizarre thinking ... Is this 1980?”

“I’m baffled,” said Brian Chapin, MD, of MD Anderson Cancer Center, Houston, in another Twitter thread.

“This is ludicrous,” said Andrew Vickers, PhD, of Memorial Sloan Kettering Cancer Center in New York City in a tweet.

Alexander Kutikov, MD, of Fox Chase Cancer Center in Philadelphia, commented on Twitter that the change “seems off the rails…a bit stunned by this.”

Matthew Cooperberg, MD, of the University of California San Francisco, and Minhaj Siddiqui, MD, of the University of Maryland in Baltimore both called the move a “step backward.”

Many others also expressed disappointment in the NCCN, whose guidelines are hugely influential because of the role they play clinically as well as with payors and the legal system.

“A huge setback & frankly a disgrace for @NCCN and its processes,” commented Fox Chase’s Dr. Kutikov.

Stacy Loeb, MD, of NYU Langone Health in New York City, suggested the new guidance may stunt use of active surveillance in the United States. She tweeted: “The updated NCCN guideline certainly won’t help the lagging and heterogenous uptake of active surveillance in the U.S. We should be carefully expanding the pool for active surveillance, not narrowing it.”

The purpose of active surveillance is to avoid adverse events from treatment, which can be life-changing as they include incontinence and erectile dysfunction.

The rationale is that many men with low-risk prostate cancer may not need treatment for their disease, as the disease may be slow-growing and may never threaten their life. With active surveillance, men are instead monitored with blood tests, scans, and biopsies to watch for worsening disease, and treated only when there are signs of disease progression.

This active surveillance approach has grown in acceptance among American patients since 2010.

The concern now is that the change in guidance from the NCCN will lead to a reduction in active surveillance, and an increase in initial treatment with surgery and radiotherapy for low-risk disease, which is considered by many to be “overtreatment’ of this disease and may not be medically necessary.  

For example, UCSF’s Dr. Cooperberg said he feared that the changed guidance “will be used by urologists and radiation oncologists to justify overtreatment of low-risk disease.”

Dr. Kutikov agreed but described that possibility differently, citing the risk of lawsuits. He observed that without the NCCN’s “medico-legal buffer” of active surveillance as the preferred initial treatment, there are “further incentives” for overtreatment.

The new NCCN guidance also conflicts with the American Urological Association’s guidelines and dissolves what was once a mostly united front from the two major organizations on active surveillance and low-risk disease.

The AUA Guideline reads: “Clinicians should recommend active surveillance as the preferable care option for most low-risk localized prostate cancer patients (Moderate Recommendation; Evidence Level: Grade B)
 

Patients protest change in wording

Not surprisingly, the revised NCCN guidance was criticized by multiple patient advocacy groups, including Active Surveillance Patients International (ASPI), which wrote a letter to the NCCN protesting the change.

In that letter, the ASPI writes that active surveillance is now chosen as the initial approach for low-risk prostate cancer in about 90% of cases in some European nations, and in about 50% of cases in the United States. It also warns that eliminating the word “preferred” from the NCCN guidelines represents a retreat, and “will have repercussions far beyond what we may first conceive.” 

“Active surveillance should be the preferred choice to preserve quality of life for men with low-risk cancer,” the advocacy group states. “The PIVOT trials indicate for low-risk disease there is basically no advantage to intervention. Why would one risk the side effects if they knew that?”
 

Why now?

The NCCN’s move to alter its low-risk prostate cancer guidance is especially striking because, 11 years ago, the NCCN broke new ground in recommending active surveillance as the sole initial treatment option for low-risk men. (It was also the first guidelines group to recommend the same for very low-risk men.)

So why the change now? This news organization requested, but did not receive,  comment from the NCCN and its chair of the prostate cancer panel, Edward Schaeffer, MD, of Northwestern University in Chicago.  

However, on Twitter, Dr. Schaeffer hinted at what had turned the tables for the NCCN panel – the risk that, over time, some men with low-risk disease who are on active surveillance are reclassified on biopsy as having a higher risk.

He highlighted a 2020 study on that very subject from the University of California, San Francisco, published in the Journal of Urology. Those authors concluded that: “Given the heterogeneity of the disease, some tumors characterized as low risk may merit early treatment while others may be followed much less intensely over some time interval.”

Dr. Schaeffer tweeted: “I think this nicely sums up the low-risk space ...”

Experts reacting to Dr. Schaeffer’s tweet were not swayed.

Looking at additional measures such as genomic scores and PSA density, as advocated by Dr. Schaeffer via the posted 2020 study, is good for assessing individual risk, “but still, active surveillance is the preferred option for low risk,” said MD Anderson’s Dr. Chapin.

UCSF’s Dr. Cooperberg, who was a co-author on that 2020 Journal of Urology paper,  commented that the university’s urology department had “spent the past quarter century arguing active surveillance is ‘preferred’ for almost all low risk [disease]!”

“Many on active surveillance need treatment someday, but that does not justify immediate overtreatment,” he concluded.

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

For over a decade, the influential National Comprehensive Cancer Network (NCCN) has been recommending that men with low-risk prostate cancer be offered active surveillance as the lone “preferred” initial treatment option.

But the NCCN has now reversed this long-standing recommendation in the latest revision of its prostate cancer guideline.

The organization now recommends that low-risk disease be managed with either active surveillance or radiation therapy or surgery, with equal weight given to all three of these initial options.

The change is seen by some as a retreat to the past and was harshly criticized by many experts on Twitter. The complaints were voiced in unusually blunt and strong language for physicians.

“This is a terrible step back that impacts every urologist,” commented John Griffith, MD, of Hartford Healthcare, who practices in New Britain, Conn.

Dr. Griffith explained that he prints out the NCCN guidance with “every patient newly diagnosed” and that the preferred designation is a “huge help” in reassuring them about not treating low-risk disease initially.

In a Twitter thread, Benjamin Davies, MD, of the University of Pittsburgh, facetiously wondered if a time warp was at play: “To suggest for a millisecond that active surveillance isn’t the preferred method for low-risk men is bizarre thinking ... Is this 1980?”

“I’m baffled,” said Brian Chapin, MD, of MD Anderson Cancer Center, Houston, in another Twitter thread.

“This is ludicrous,” said Andrew Vickers, PhD, of Memorial Sloan Kettering Cancer Center in New York City in a tweet.

Alexander Kutikov, MD, of Fox Chase Cancer Center in Philadelphia, commented on Twitter that the change “seems off the rails…a bit stunned by this.”

Matthew Cooperberg, MD, of the University of California San Francisco, and Minhaj Siddiqui, MD, of the University of Maryland in Baltimore both called the move a “step backward.”

Many others also expressed disappointment in the NCCN, whose guidelines are hugely influential because of the role they play clinically as well as with payors and the legal system.

“A huge setback & frankly a disgrace for @NCCN and its processes,” commented Fox Chase’s Dr. Kutikov.

Stacy Loeb, MD, of NYU Langone Health in New York City, suggested the new guidance may stunt use of active surveillance in the United States. She tweeted: “The updated NCCN guideline certainly won’t help the lagging and heterogenous uptake of active surveillance in the U.S. We should be carefully expanding the pool for active surveillance, not narrowing it.”

The purpose of active surveillance is to avoid adverse events from treatment, which can be life-changing as they include incontinence and erectile dysfunction.

The rationale is that many men with low-risk prostate cancer may not need treatment for their disease, as the disease may be slow-growing and may never threaten their life. With active surveillance, men are instead monitored with blood tests, scans, and biopsies to watch for worsening disease, and treated only when there are signs of disease progression.

This active surveillance approach has grown in acceptance among American patients since 2010.

The concern now is that the change in guidance from the NCCN will lead to a reduction in active surveillance, and an increase in initial treatment with surgery and radiotherapy for low-risk disease, which is considered by many to be “overtreatment’ of this disease and may not be medically necessary.  

For example, UCSF’s Dr. Cooperberg said he feared that the changed guidance “will be used by urologists and radiation oncologists to justify overtreatment of low-risk disease.”

Dr. Kutikov agreed but described that possibility differently, citing the risk of lawsuits. He observed that without the NCCN’s “medico-legal buffer” of active surveillance as the preferred initial treatment, there are “further incentives” for overtreatment.

The new NCCN guidance also conflicts with the American Urological Association’s guidelines and dissolves what was once a mostly united front from the two major organizations on active surveillance and low-risk disease.

The AUA Guideline reads: “Clinicians should recommend active surveillance as the preferable care option for most low-risk localized prostate cancer patients (Moderate Recommendation; Evidence Level: Grade B)
 

Patients protest change in wording

Not surprisingly, the revised NCCN guidance was criticized by multiple patient advocacy groups, including Active Surveillance Patients International (ASPI), which wrote a letter to the NCCN protesting the change.

In that letter, the ASPI writes that active surveillance is now chosen as the initial approach for low-risk prostate cancer in about 90% of cases in some European nations, and in about 50% of cases in the United States. It also warns that eliminating the word “preferred” from the NCCN guidelines represents a retreat, and “will have repercussions far beyond what we may first conceive.” 

“Active surveillance should be the preferred choice to preserve quality of life for men with low-risk cancer,” the advocacy group states. “The PIVOT trials indicate for low-risk disease there is basically no advantage to intervention. Why would one risk the side effects if they knew that?”
 

Why now?

The NCCN’s move to alter its low-risk prostate cancer guidance is especially striking because, 11 years ago, the NCCN broke new ground in recommending active surveillance as the sole initial treatment option for low-risk men. (It was also the first guidelines group to recommend the same for very low-risk men.)

So why the change now? This news organization requested, but did not receive,  comment from the NCCN and its chair of the prostate cancer panel, Edward Schaeffer, MD, of Northwestern University in Chicago.  

However, on Twitter, Dr. Schaeffer hinted at what had turned the tables for the NCCN panel – the risk that, over time, some men with low-risk disease who are on active surveillance are reclassified on biopsy as having a higher risk.

He highlighted a 2020 study on that very subject from the University of California, San Francisco, published in the Journal of Urology. Those authors concluded that: “Given the heterogeneity of the disease, some tumors characterized as low risk may merit early treatment while others may be followed much less intensely over some time interval.”

Dr. Schaeffer tweeted: “I think this nicely sums up the low-risk space ...”

Experts reacting to Dr. Schaeffer’s tweet were not swayed.

Looking at additional measures such as genomic scores and PSA density, as advocated by Dr. Schaeffer via the posted 2020 study, is good for assessing individual risk, “but still, active surveillance is the preferred option for low risk,” said MD Anderson’s Dr. Chapin.

UCSF’s Dr. Cooperberg, who was a co-author on that 2020 Journal of Urology paper,  commented that the university’s urology department had “spent the past quarter century arguing active surveillance is ‘preferred’ for almost all low risk [disease]!”

“Many on active surveillance need treatment someday, but that does not justify immediate overtreatment,” he concluded.

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

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

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

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

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

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

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

Mortality from cancer has dropped substantially in the United States over the past 5 decades, according to a new analysis.

Researchers found that rates for all cancers combined declined by 27% overall between 1971 and 2019 and decreased significantly for 12 of the 15 top cancer sites analyzed.

The data revealed even greater mortality declines for certain cancers in particular years. For example, mortality from lung cancer was 44% lower in 2019, compared with its peak rate in 1993, whereas it was only 13% lower, compared with morality rates in 1971.

“The cancer mortality rate has reduced considerably since 1971 overall and for most cancer sites because of improvements in prevention, early detection, and treatment,” lead author Ahmedin Jemal, DVM, PhD, American Cancer Society, Kennesaw, Ga., and colleagues wrote.

Advances in surgery, radiotherapy, chemotherapy, precision medicine, and combinations therapies over the past 5 decades have contributed to these significant declines in mortality, Dr. Jemal and colleagues explained. The researchers also credit the “expanded investment” in the National Cancer Institute’s annual budget following the 1971 National Cancer Act, which increased the budget 25-fold from $227 million in 1971 to $6 billion in 2019.

The report, published online Nov. 11, 2021, in JAMA Oncology, analyzed mortality rates for all cancers as well as the top 15 sites using the National Center for Health Statistics.

The researchers found that, overall, deaths declined significantly for all cancers over the study period. Some of the biggest headway since 1971 occurred for stomach and cervical cancers – with 72% and 69% lower mortality rates, respectively – as well as colorectal cancer (56%), oral cavity and pharynx cancer (43%), and ovarian cancer (41%). Mortality rates of female breast cancer and prostate cancer also dropped considerably – both by 39%.

“The decline in mortality for female breast, cervical, colorectal, and prostate cancer in part reflects increased detection (and removal) of premalignant lesions and early-stage cancers,” Dr. Jemal and colleagues noted.

Data suggest that screening likely explains about half of the observed decline in mortality from colorectal cancer between 1975 and 2002. A 2018 study also found that the use of adjuvant chemotherapy was responsible for 63% of the decline in mortality from female breast cancer between 2000 and 2012.

In addition, the authors noted, “the decline in lung, oral cavity and bladder cancers largely reflects reductions in smoking because of enhanced public awareness of the health consequences, implementation of increased cigarette excise taxes, and comprehensive smoke-free laws.”

However, mortality did increase in a few categories. For instance, the mortality rate from pancreatic cancer increased by 3% between 1971 and 2019, and by 8% for both esophageal and brain cancers. Mortality rates from cancer were also greater for 29% of the U.S. counties included in the analysis, mostly those in the South.

The increase in mortality from pancreatic cancer likely reflects the growing rates of obesity in the United States, along with no real advances in pancreatic cancer prevention, early detection, or treatment, the authors suggested. In addition, lack of progress in regions of the south may be related to unequal access to improvements in treatment compared with other parts of the country.

“Improving equity through investment in the social determinants of health and implementation research is critical to furthering the national cancer-control agenda,” the authors concluded.

The authors disclosed no relevant financial relationships.

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

Mortality from cancer has dropped substantially in the United States over the past 5 decades, according to a new analysis.

Researchers found that rates for all cancers combined declined by 27% overall between 1971 and 2019 and decreased significantly for 12 of the 15 top cancer sites analyzed.

The data revealed even greater mortality declines for certain cancers in particular years. For example, mortality from lung cancer was 44% lower in 2019, compared with its peak rate in 1993, whereas it was only 13% lower, compared with morality rates in 1971.

“The cancer mortality rate has reduced considerably since 1971 overall and for most cancer sites because of improvements in prevention, early detection, and treatment,” lead author Ahmedin Jemal, DVM, PhD, American Cancer Society, Kennesaw, Ga., and colleagues wrote.

Advances in surgery, radiotherapy, chemotherapy, precision medicine, and combinations therapies over the past 5 decades have contributed to these significant declines in mortality, Dr. Jemal and colleagues explained. The researchers also credit the “expanded investment” in the National Cancer Institute’s annual budget following the 1971 National Cancer Act, which increased the budget 25-fold from $227 million in 1971 to $6 billion in 2019.

The report, published online Nov. 11, 2021, in JAMA Oncology, analyzed mortality rates for all cancers as well as the top 15 sites using the National Center for Health Statistics.

The researchers found that, overall, deaths declined significantly for all cancers over the study period. Some of the biggest headway since 1971 occurred for stomach and cervical cancers – with 72% and 69% lower mortality rates, respectively – as well as colorectal cancer (56%), oral cavity and pharynx cancer (43%), and ovarian cancer (41%). Mortality rates of female breast cancer and prostate cancer also dropped considerably – both by 39%.

“The decline in mortality for female breast, cervical, colorectal, and prostate cancer in part reflects increased detection (and removal) of premalignant lesions and early-stage cancers,” Dr. Jemal and colleagues noted.

Data suggest that screening likely explains about half of the observed decline in mortality from colorectal cancer between 1975 and 2002. A 2018 study also found that the use of adjuvant chemotherapy was responsible for 63% of the decline in mortality from female breast cancer between 2000 and 2012.

In addition, the authors noted, “the decline in lung, oral cavity and bladder cancers largely reflects reductions in smoking because of enhanced public awareness of the health consequences, implementation of increased cigarette excise taxes, and comprehensive smoke-free laws.”

However, mortality did increase in a few categories. For instance, the mortality rate from pancreatic cancer increased by 3% between 1971 and 2019, and by 8% for both esophageal and brain cancers. Mortality rates from cancer were also greater for 29% of the U.S. counties included in the analysis, mostly those in the South.

The increase in mortality from pancreatic cancer likely reflects the growing rates of obesity in the United States, along with no real advances in pancreatic cancer prevention, early detection, or treatment, the authors suggested. In addition, lack of progress in regions of the south may be related to unequal access to improvements in treatment compared with other parts of the country.

“Improving equity through investment in the social determinants of health and implementation research is critical to furthering the national cancer-control agenda,” the authors concluded.

The authors disclosed no relevant financial relationships.

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

Mortality from cancer has dropped substantially in the United States over the past 5 decades, according to a new analysis.

Researchers found that rates for all cancers combined declined by 27% overall between 1971 and 2019 and decreased significantly for 12 of the 15 top cancer sites analyzed.

The data revealed even greater mortality declines for certain cancers in particular years. For example, mortality from lung cancer was 44% lower in 2019, compared with its peak rate in 1993, whereas it was only 13% lower, compared with morality rates in 1971.

“The cancer mortality rate has reduced considerably since 1971 overall and for most cancer sites because of improvements in prevention, early detection, and treatment,” lead author Ahmedin Jemal, DVM, PhD, American Cancer Society, Kennesaw, Ga., and colleagues wrote.

Advances in surgery, radiotherapy, chemotherapy, precision medicine, and combinations therapies over the past 5 decades have contributed to these significant declines in mortality, Dr. Jemal and colleagues explained. The researchers also credit the “expanded investment” in the National Cancer Institute’s annual budget following the 1971 National Cancer Act, which increased the budget 25-fold from $227 million in 1971 to $6 billion in 2019.

The report, published online Nov. 11, 2021, in JAMA Oncology, analyzed mortality rates for all cancers as well as the top 15 sites using the National Center for Health Statistics.

The researchers found that, overall, deaths declined significantly for all cancers over the study period. Some of the biggest headway since 1971 occurred for stomach and cervical cancers – with 72% and 69% lower mortality rates, respectively – as well as colorectal cancer (56%), oral cavity and pharynx cancer (43%), and ovarian cancer (41%). Mortality rates of female breast cancer and prostate cancer also dropped considerably – both by 39%.

“The decline in mortality for female breast, cervical, colorectal, and prostate cancer in part reflects increased detection (and removal) of premalignant lesions and early-stage cancers,” Dr. Jemal and colleagues noted.

Data suggest that screening likely explains about half of the observed decline in mortality from colorectal cancer between 1975 and 2002. A 2018 study also found that the use of adjuvant chemotherapy was responsible for 63% of the decline in mortality from female breast cancer between 2000 and 2012.

In addition, the authors noted, “the decline in lung, oral cavity and bladder cancers largely reflects reductions in smoking because of enhanced public awareness of the health consequences, implementation of increased cigarette excise taxes, and comprehensive smoke-free laws.”

However, mortality did increase in a few categories. For instance, the mortality rate from pancreatic cancer increased by 3% between 1971 and 2019, and by 8% for both esophageal and brain cancers. Mortality rates from cancer were also greater for 29% of the U.S. counties included in the analysis, mostly those in the South.

The increase in mortality from pancreatic cancer likely reflects the growing rates of obesity in the United States, along with no real advances in pancreatic cancer prevention, early detection, or treatment, the authors suggested. In addition, lack of progress in regions of the south may be related to unequal access to improvements in treatment compared with other parts of the country.

“Improving equity through investment in the social determinants of health and implementation research is critical to furthering the national cancer-control agenda,” the authors concluded.

The authors disclosed no relevant financial relationships.

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

A New Mexico oncologist has once again found himself at odds with the law.    

Mohamed Aswad, MD, was still under probation for a past misdemeanor involving misbranded cancer drugs when he allegedly underdosed chemotherapy in a patient with colon cancer. The patient later died.

In a wrongful death case, a jury has awarded $2.3 million in damages to the patient’s wife. The patient, James Hoag, was diagnosed with stage IIIB colon cancer in 2015. He underwent surgery and then went for chemotherapy to Dr. Aswad, who was the only oncologist in the area.

Mr. Hoag’s attorneys alleged that Dr. Aswad “recklessly administered” abnormally low doses of chemotherapy, and dragged out the normal 6-month regimen to 14 months, in an attempt to “unduly profit.”

“It was statistically likely that James would beat his cancer with proper treatment,” said his lawyers during the trial, according to a report in the Albuquerque Journal.

The jury deliberated for only 4 hours, and found that negligence by Dr. Aswad was a proximate cause of the patient’s “lost chance to avoid the loss of his life and resulting damages,” and the jury further described Dr. Aswad’s actions as “wanton,” according to a verdict form filed in the case.

The form also shows that the jury decided Dr. Aswad had obtained Mr. Hoag’s informed consent as to the treatment, but still felt that negligence was a cause of Mr. Hoag’s injury and damages. The original judgment of $2.9 million in damages was subsequently reduced to $2.3 million as the jury found Mr. Hoag was 30% responsible for his injuries.

Dr. Aswad could not be reached for comment. The Albuquerque Journal reports that he plans to appeal the verdict.
 

Only oncologist in the county

The patient had lived in the rural community of Deming, N.M. following his retirement from a career in law enforcement in Michigan. He was diagnosed with colon cancer in 2015, underwent surgical resection, and then went to Dr. Aswad for follow-up chemotherapy.

Dr. Aswad was the only oncologist in the area. Like many other rural communities throughout the United States, this region has a severe shortage of medical specialists.

Sheila Hoag, the patient’s widow, testified during the trial that following her husband’s surgery in August 2015, which removed the tumor, his “prognosis was very good because they had caught it before it spread.” He had an estimated 5-year survival of about 69%.

However, even though Dr. Aswad followed the National Comprehensive Cancer Network (NCCN) guidelines for adjuvant chemotherapy, he did not use the proper dosing. According to trial testimony, he administered “woefully lower doses” than are recommended, and also exceeded the recommended 6-month duration of chemotherapy by more than double. In addition, Dr. Aswad also failed to adequately monitor the disease during treatment, said Hoag’s lawyers.

Aswad has denied the charges and says that he prescribed a modified regimen spread out over a longer period of time because his patient had requested it. He said that Mr. Hoag did not want to undergo chemotherapy that could cause significant side effects, and this was the reason for the altered treatment plan.

However, the chemotherapy failed to slow the cancer’s progression, and Mr. Hoag never returned to see him after November 2016.

By December 2017, Mr. Hoag had been hospitalized and was being treated by another oncologist, located in Las Cruces, 62 miles away from his home. The new oncologist administered the standard treatment, but by then his cancer had metastasized. Mr. Hoag died in 2020 at age 59.
 

Previous misdemeanor with misbranded drugs

At the time he was treating Mr. Hoag, Dr. Aswad was on federal probation after pleading guilty in 2014 to one misdemeanor count of the unlawful introduction of misbranded drugs into interstate commerce.

Dr. Aswad had treated cancer patients with a “misbranded” drug imported from abroad and not approved by the U.S. Food and Drug Administration (FDA). Altuzan is a form of bevacizumab that is approved for use in Turkey but not the United States. Between July 2010 and April 2012, Dr. Aswad ordered prescription cancer drugs, including Altuzan, from a Canadian company and then administered the “misbranded” drugs to his patients.

A prescription drug is considered to be “misbranded” if it is manufactured in a facility that has not been registered with the FDA for commercial distribution within the United States.

According to various media reports, Dr. Aswad paid significantly less for these drugs than he would have if had he purchased the U.S.-approved product bearing the same brand or generic name, and then billed federal programs such as Medicare for the full price. He has admitted to making just under $1.3 million in profits.

Under the terms of the plea agreement, he was sentenced to three years of probation, required to pay just under $1.3 million in restitution to Medicare and Tricare, the victims of his criminal conduct, and also to forfeit $750,000, which represented part of his net criminal proceeds, to the United States.

At the trial, Dr. Aswad denied that there was any profit motive in extending Mr. Hoag’s treatment, and in a 2019 deposition, he also denied he was under financial pressure to increase his billings because of the $2 million debt that he owed because of the misbranded drugs fine.
 

Allowed to resume practice

In late 2015, Dr. Aswad was essentially barred by the federal government from accepting any reimbursement from Medicaid or Medicare for a minimum of 13 years. But because of the urgent need for medical specialists, the New Mexico Human Services Department requested a waiver that would permit him to continuing treating cancer patients since he is the only oncologist in Luna County.

He is currently allowed to treat Medicaid and Medicare patients in four other medically underserved New Mexico counties.

Dr. Aswad, a graduate of the University of Aleppo, in Syria, had an internal medicine residency at Our Lady of Mercy Hospital in New York City, where he also had a fellowship in oncology and hematology. He then settled in Deming and has been licensed in New Mexico since 2003.

With the onset of the COVID-19 pandemic, which caused major disruption to healthcare services, Medicare & Medicaid Services officials requested that Dr. Aswad also be allowed to provide internal medicine services for Medicare patients in Catron and Hildalgo counties for the “duration of the Coronavirus Disease 2019 public health emergency declared by the federal government in January 2020.”

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

A New Mexico oncologist has once again found himself at odds with the law.    

Mohamed Aswad, MD, was still under probation for a past misdemeanor involving misbranded cancer drugs when he allegedly underdosed chemotherapy in a patient with colon cancer. The patient later died.

In a wrongful death case, a jury has awarded $2.3 million in damages to the patient’s wife. The patient, James Hoag, was diagnosed with stage IIIB colon cancer in 2015. He underwent surgery and then went for chemotherapy to Dr. Aswad, who was the only oncologist in the area.

Mr. Hoag’s attorneys alleged that Dr. Aswad “recklessly administered” abnormally low doses of chemotherapy, and dragged out the normal 6-month regimen to 14 months, in an attempt to “unduly profit.”

“It was statistically likely that James would beat his cancer with proper treatment,” said his lawyers during the trial, according to a report in the Albuquerque Journal.

The jury deliberated for only 4 hours, and found that negligence by Dr. Aswad was a proximate cause of the patient’s “lost chance to avoid the loss of his life and resulting damages,” and the jury further described Dr. Aswad’s actions as “wanton,” according to a verdict form filed in the case.

The form also shows that the jury decided Dr. Aswad had obtained Mr. Hoag’s informed consent as to the treatment, but still felt that negligence was a cause of Mr. Hoag’s injury and damages. The original judgment of $2.9 million in damages was subsequently reduced to $2.3 million as the jury found Mr. Hoag was 30% responsible for his injuries.

Dr. Aswad could not be reached for comment. The Albuquerque Journal reports that he plans to appeal the verdict.
 

Only oncologist in the county

The patient had lived in the rural community of Deming, N.M. following his retirement from a career in law enforcement in Michigan. He was diagnosed with colon cancer in 2015, underwent surgical resection, and then went to Dr. Aswad for follow-up chemotherapy.

Dr. Aswad was the only oncologist in the area. Like many other rural communities throughout the United States, this region has a severe shortage of medical specialists.

Sheila Hoag, the patient’s widow, testified during the trial that following her husband’s surgery in August 2015, which removed the tumor, his “prognosis was very good because they had caught it before it spread.” He had an estimated 5-year survival of about 69%.

However, even though Dr. Aswad followed the National Comprehensive Cancer Network (NCCN) guidelines for adjuvant chemotherapy, he did not use the proper dosing. According to trial testimony, he administered “woefully lower doses” than are recommended, and also exceeded the recommended 6-month duration of chemotherapy by more than double. In addition, Dr. Aswad also failed to adequately monitor the disease during treatment, said Hoag’s lawyers.

Aswad has denied the charges and says that he prescribed a modified regimen spread out over a longer period of time because his patient had requested it. He said that Mr. Hoag did not want to undergo chemotherapy that could cause significant side effects, and this was the reason for the altered treatment plan.

However, the chemotherapy failed to slow the cancer’s progression, and Mr. Hoag never returned to see him after November 2016.

By December 2017, Mr. Hoag had been hospitalized and was being treated by another oncologist, located in Las Cruces, 62 miles away from his home. The new oncologist administered the standard treatment, but by then his cancer had metastasized. Mr. Hoag died in 2020 at age 59.
 

Previous misdemeanor with misbranded drugs

At the time he was treating Mr. Hoag, Dr. Aswad was on federal probation after pleading guilty in 2014 to one misdemeanor count of the unlawful introduction of misbranded drugs into interstate commerce.

Dr. Aswad had treated cancer patients with a “misbranded” drug imported from abroad and not approved by the U.S. Food and Drug Administration (FDA). Altuzan is a form of bevacizumab that is approved for use in Turkey but not the United States. Between July 2010 and April 2012, Dr. Aswad ordered prescription cancer drugs, including Altuzan, from a Canadian company and then administered the “misbranded” drugs to his patients.

A prescription drug is considered to be “misbranded” if it is manufactured in a facility that has not been registered with the FDA for commercial distribution within the United States.

According to various media reports, Dr. Aswad paid significantly less for these drugs than he would have if had he purchased the U.S.-approved product bearing the same brand or generic name, and then billed federal programs such as Medicare for the full price. He has admitted to making just under $1.3 million in profits.

Under the terms of the plea agreement, he was sentenced to three years of probation, required to pay just under $1.3 million in restitution to Medicare and Tricare, the victims of his criminal conduct, and also to forfeit $750,000, which represented part of his net criminal proceeds, to the United States.

At the trial, Dr. Aswad denied that there was any profit motive in extending Mr. Hoag’s treatment, and in a 2019 deposition, he also denied he was under financial pressure to increase his billings because of the $2 million debt that he owed because of the misbranded drugs fine.
 

Allowed to resume practice

In late 2015, Dr. Aswad was essentially barred by the federal government from accepting any reimbursement from Medicaid or Medicare for a minimum of 13 years. But because of the urgent need for medical specialists, the New Mexico Human Services Department requested a waiver that would permit him to continuing treating cancer patients since he is the only oncologist in Luna County.

He is currently allowed to treat Medicaid and Medicare patients in four other medically underserved New Mexico counties.

Dr. Aswad, a graduate of the University of Aleppo, in Syria, had an internal medicine residency at Our Lady of Mercy Hospital in New York City, where he also had a fellowship in oncology and hematology. He then settled in Deming and has been licensed in New Mexico since 2003.

With the onset of the COVID-19 pandemic, which caused major disruption to healthcare services, Medicare & Medicaid Services officials requested that Dr. Aswad also be allowed to provide internal medicine services for Medicare patients in Catron and Hildalgo counties for the “duration of the Coronavirus Disease 2019 public health emergency declared by the federal government in January 2020.”

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

A New Mexico oncologist has once again found himself at odds with the law.    

Mohamed Aswad, MD, was still under probation for a past misdemeanor involving misbranded cancer drugs when he allegedly underdosed chemotherapy in a patient with colon cancer. The patient later died.

In a wrongful death case, a jury has awarded $2.3 million in damages to the patient’s wife. The patient, James Hoag, was diagnosed with stage IIIB colon cancer in 2015. He underwent surgery and then went for chemotherapy to Dr. Aswad, who was the only oncologist in the area.

Mr. Hoag’s attorneys alleged that Dr. Aswad “recklessly administered” abnormally low doses of chemotherapy, and dragged out the normal 6-month regimen to 14 months, in an attempt to “unduly profit.”

“It was statistically likely that James would beat his cancer with proper treatment,” said his lawyers during the trial, according to a report in the Albuquerque Journal.

The jury deliberated for only 4 hours, and found that negligence by Dr. Aswad was a proximate cause of the patient’s “lost chance to avoid the loss of his life and resulting damages,” and the jury further described Dr. Aswad’s actions as “wanton,” according to a verdict form filed in the case.

The form also shows that the jury decided Dr. Aswad had obtained Mr. Hoag’s informed consent as to the treatment, but still felt that negligence was a cause of Mr. Hoag’s injury and damages. The original judgment of $2.9 million in damages was subsequently reduced to $2.3 million as the jury found Mr. Hoag was 30% responsible for his injuries.

Dr. Aswad could not be reached for comment. The Albuquerque Journal reports that he plans to appeal the verdict.
 

Only oncologist in the county

The patient had lived in the rural community of Deming, N.M. following his retirement from a career in law enforcement in Michigan. He was diagnosed with colon cancer in 2015, underwent surgical resection, and then went to Dr. Aswad for follow-up chemotherapy.

Dr. Aswad was the only oncologist in the area. Like many other rural communities throughout the United States, this region has a severe shortage of medical specialists.

Sheila Hoag, the patient’s widow, testified during the trial that following her husband’s surgery in August 2015, which removed the tumor, his “prognosis was very good because they had caught it before it spread.” He had an estimated 5-year survival of about 69%.

However, even though Dr. Aswad followed the National Comprehensive Cancer Network (NCCN) guidelines for adjuvant chemotherapy, he did not use the proper dosing. According to trial testimony, he administered “woefully lower doses” than are recommended, and also exceeded the recommended 6-month duration of chemotherapy by more than double. In addition, Dr. Aswad also failed to adequately monitor the disease during treatment, said Hoag’s lawyers.

Aswad has denied the charges and says that he prescribed a modified regimen spread out over a longer period of time because his patient had requested it. He said that Mr. Hoag did not want to undergo chemotherapy that could cause significant side effects, and this was the reason for the altered treatment plan.

However, the chemotherapy failed to slow the cancer’s progression, and Mr. Hoag never returned to see him after November 2016.

By December 2017, Mr. Hoag had been hospitalized and was being treated by another oncologist, located in Las Cruces, 62 miles away from his home. The new oncologist administered the standard treatment, but by then his cancer had metastasized. Mr. Hoag died in 2020 at age 59.
 

Previous misdemeanor with misbranded drugs

At the time he was treating Mr. Hoag, Dr. Aswad was on federal probation after pleading guilty in 2014 to one misdemeanor count of the unlawful introduction of misbranded drugs into interstate commerce.

Dr. Aswad had treated cancer patients with a “misbranded” drug imported from abroad and not approved by the U.S. Food and Drug Administration (FDA). Altuzan is a form of bevacizumab that is approved for use in Turkey but not the United States. Between July 2010 and April 2012, Dr. Aswad ordered prescription cancer drugs, including Altuzan, from a Canadian company and then administered the “misbranded” drugs to his patients.

A prescription drug is considered to be “misbranded” if it is manufactured in a facility that has not been registered with the FDA for commercial distribution within the United States.

According to various media reports, Dr. Aswad paid significantly less for these drugs than he would have if had he purchased the U.S.-approved product bearing the same brand or generic name, and then billed federal programs such as Medicare for the full price. He has admitted to making just under $1.3 million in profits.

Under the terms of the plea agreement, he was sentenced to three years of probation, required to pay just under $1.3 million in restitution to Medicare and Tricare, the victims of his criminal conduct, and also to forfeit $750,000, which represented part of his net criminal proceeds, to the United States.

At the trial, Dr. Aswad denied that there was any profit motive in extending Mr. Hoag’s treatment, and in a 2019 deposition, he also denied he was under financial pressure to increase his billings because of the $2 million debt that he owed because of the misbranded drugs fine.
 

Allowed to resume practice

In late 2015, Dr. Aswad was essentially barred by the federal government from accepting any reimbursement from Medicaid or Medicare for a minimum of 13 years. But because of the urgent need for medical specialists, the New Mexico Human Services Department requested a waiver that would permit him to continuing treating cancer patients since he is the only oncologist in Luna County.

He is currently allowed to treat Medicaid and Medicare patients in four other medically underserved New Mexico counties.

Dr. Aswad, a graduate of the University of Aleppo, in Syria, had an internal medicine residency at Our Lady of Mercy Hospital in New York City, where he also had a fellowship in oncology and hematology. He then settled in Deming and has been licensed in New Mexico since 2003.

With the onset of the COVID-19 pandemic, which caused major disruption to healthcare services, Medicare & Medicaid Services officials requested that Dr. Aswad also be allowed to provide internal medicine services for Medicare patients in Catron and Hildalgo counties for the “duration of the Coronavirus Disease 2019 public health emergency declared by the federal government in January 2020.”

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

Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.

By comparison, revenues from other types of medications decreased by 18% during the same period.

“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.

To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.

The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.

Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.

Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.

Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.

“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

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

Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.

By comparison, revenues from other types of medications decreased by 18% during the same period.

“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.

To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.

The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.

Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.

Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.

Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.

“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

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

Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.

By comparison, revenues from other types of medications decreased by 18% during the same period.

“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.

To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.

The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.

Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.

Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.

Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.

“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”

No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.

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

It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.

The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.

“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”

Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.

Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.

The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.

Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.

The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.

“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.

“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.

The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.

“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.

Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.

The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.

None of the researchers or commentators had financial disclosures.

It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.

The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.

“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”

Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.

Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.

The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.

Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.

The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.

“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.

“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.

The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.

“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.

Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.

The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.

None of the researchers or commentators had financial disclosures.

It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.

The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.

“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”

Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.

Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.

The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.

Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.

The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.

“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.

“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.

The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.

“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.

Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.

The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.

None of the researchers or commentators had financial disclosures.

LAS VEGAS – People with obesity may be able to reduce their risk of colorectal cancer with weight loss surgery or medication, researchers say.

“We need to have conversations with our patients in the clinic and educate them that they have these resources available,” said Aakash Desai, MD, a hospitalist at MetroHealth Medical Center, Cleveland, in an interview with this news organization.

Dr. Desai and colleagues found that sleeve gastrectomy and four medications were associated with a reduced risk of colorectal cancer but Roux-en-Y gastrojejunostomy and orlistat were not.

Coauthor Zryan Shwani, MD, a gastroenterology fellow at Sibley Memorial Hospital, Washington, D.C., presented the findings here at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting.

Working with an underserved population with high rates of obesity in northeastern Ohio, the researchers wondered how surgery and medication could affect these patients.

They analyzed data from the IBM Explorys clinical database, which compiles and standardizes data from electronic medical records on about 74 million patients from more than 300 U.S. hospitals. Consistent with previous studies, they determined that patients with obesity in the database were 2.5 times more likely than people with a healthy weight to be diagnosed with colorectal cancer (odds ratio, 2.48; 95% CI, 2.45-2.51).

Zeroing in on people who had weight loss interventions, they included adults aged 18-75 years who had undergone either Roux-en-Y gastrojejunostomy or sleeve gastrectomy, or had taken the medications liraglutide, orlistat, phentermine/topiramate, bupropion/naltrexone, or lorcaserin.

They excluded patients with Lynch syndrome, intestinal polyposis syndrome, a family history of gastrointestinal malignancy, inflammatory bowel disease, or tobacco or alcohol abuse. Patients who had taken one of the weight loss medications and also had type 2 diabetes were excluded. They did not include patients who had undergone gastric banding because it has become less popular.

For the weight loss medication group, they found 117,730 patients who met their criteria. For the surgery group, 43,050 patients met the criteria.

In analyzing the colorectal cancer rates, they included only diagnoses of malignant neoplasms made 2 years after the interventions.

They compared these patients to a control group of 52,540 people matched in age, with a body mass index (BMI) greater than 30 kg/m² who did not undergo weight loss surgery or take weight loss medication.

Among the 9,370 patients who underwent Roux-en-Y gastrojejunostomy, 50 were diagnosed with colorectal cancer and 400 had benign polyps. Their rate of colorectal cancer was not statistically different from people who didn’t have surgery (OR, 1.09; 95% CI, 0.82-1.43). The rate of benign polyps after Roux-en-Y gastrojejunostomy was greater (OR, 1.72; 95% CI, 1.55-1.90).

On the other hand, among the 33,680 patients who underwent sleeve gastrectomy, 50 were diagnosed with colorectal cancer, a lower rate than in the population who didn’t have surgery (OR, 0.30; 95% CI, 0.22-0.39). Their risk of benign polyps was also reduced (OR, 0.45; 95% CI, 0.40-0.50).

All of the medications were significantly associated with a lower risk of colorectal cancer, except orlistat (OR, 0.94; 95% CI, 0.72-1.25).

The finding on Roux-en-Y gastrojejunostomy agreed with studies from England and Nordic countries showing double the risk of colorectal cancer in those patients but conflicted with a French study showing decreased risk, Dr. Shwani said.

While the study doesn’t establish a reason why Roux-en-Y gastrojejunostomy was less beneficial, other researchers have associated the procedure with biomarkers of inflammation, Dr. Shwani said. “It’s inconsistent, and I don’t think we have a clear answer why.”

As a retrospective analysis, the study could not establish a cause-and-effect relationship between surgery or medication and cancer, or adjust for such factors as diet, exercise, or genes, he acknowledged.

Colorectal cancer is just one outcome to consider when deciding whether to undergo weight loss surgery or take weight loss drugs, said session moderator Mohammad Yaghoobi, MD, an associate professor of medicine at McMaster University, Hamilton, Ont.

“The most important outcome that should be investigated is the survival of the patients after obesity surgery,” he told this news organization. “The second would be the quality of life of those patients. Colon cancer is preventable if you are having regular colonoscopies.”

Other studies have not shown much difference between patients who have weight loss surgery and those who don’t, he added.

The study was funded by Merck. Dr. Desai and Dr. Shwani have reported receiving grant funding from Merck. Dr. Yaghoobi has reported no relevant financial relationships.

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

LAS VEGAS – People with obesity may be able to reduce their risk of colorectal cancer with weight loss surgery or medication, researchers say.

“We need to have conversations with our patients in the clinic and educate them that they have these resources available,” said Aakash Desai, MD, a hospitalist at MetroHealth Medical Center, Cleveland, in an interview with this news organization.

Dr. Desai and colleagues found that sleeve gastrectomy and four medications were associated with a reduced risk of colorectal cancer but Roux-en-Y gastrojejunostomy and orlistat were not.

Coauthor Zryan Shwani, MD, a gastroenterology fellow at Sibley Memorial Hospital, Washington, D.C., presented the findings here at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting.

Working with an underserved population with high rates of obesity in northeastern Ohio, the researchers wondered how surgery and medication could affect these patients.

They analyzed data from the IBM Explorys clinical database, which compiles and standardizes data from electronic medical records on about 74 million patients from more than 300 U.S. hospitals. Consistent with previous studies, they determined that patients with obesity in the database were 2.5 times more likely than people with a healthy weight to be diagnosed with colorectal cancer (odds ratio, 2.48; 95% CI, 2.45-2.51).

Zeroing in on people who had weight loss interventions, they included adults aged 18-75 years who had undergone either Roux-en-Y gastrojejunostomy or sleeve gastrectomy, or had taken the medications liraglutide, orlistat, phentermine/topiramate, bupropion/naltrexone, or lorcaserin.

They excluded patients with Lynch syndrome, intestinal polyposis syndrome, a family history of gastrointestinal malignancy, inflammatory bowel disease, or tobacco or alcohol abuse. Patients who had taken one of the weight loss medications and also had type 2 diabetes were excluded. They did not include patients who had undergone gastric banding because it has become less popular.

For the weight loss medication group, they found 117,730 patients who met their criteria. For the surgery group, 43,050 patients met the criteria.

In analyzing the colorectal cancer rates, they included only diagnoses of malignant neoplasms made 2 years after the interventions.

They compared these patients to a control group of 52,540 people matched in age, with a body mass index (BMI) greater than 30 kg/m² who did not undergo weight loss surgery or take weight loss medication.

Among the 9,370 patients who underwent Roux-en-Y gastrojejunostomy, 50 were diagnosed with colorectal cancer and 400 had benign polyps. Their rate of colorectal cancer was not statistically different from people who didn’t have surgery (OR, 1.09; 95% CI, 0.82-1.43). The rate of benign polyps after Roux-en-Y gastrojejunostomy was greater (OR, 1.72; 95% CI, 1.55-1.90).

On the other hand, among the 33,680 patients who underwent sleeve gastrectomy, 50 were diagnosed with colorectal cancer, a lower rate than in the population who didn’t have surgery (OR, 0.30; 95% CI, 0.22-0.39). Their risk of benign polyps was also reduced (OR, 0.45; 95% CI, 0.40-0.50).

All of the medications were significantly associated with a lower risk of colorectal cancer, except orlistat (OR, 0.94; 95% CI, 0.72-1.25).

The finding on Roux-en-Y gastrojejunostomy agreed with studies from England and Nordic countries showing double the risk of colorectal cancer in those patients but conflicted with a French study showing decreased risk, Dr. Shwani said.

While the study doesn’t establish a reason why Roux-en-Y gastrojejunostomy was less beneficial, other researchers have associated the procedure with biomarkers of inflammation, Dr. Shwani said. “It’s inconsistent, and I don’t think we have a clear answer why.”

As a retrospective analysis, the study could not establish a cause-and-effect relationship between surgery or medication and cancer, or adjust for such factors as diet, exercise, or genes, he acknowledged.

Colorectal cancer is just one outcome to consider when deciding whether to undergo weight loss surgery or take weight loss drugs, said session moderator Mohammad Yaghoobi, MD, an associate professor of medicine at McMaster University, Hamilton, Ont.

“The most important outcome that should be investigated is the survival of the patients after obesity surgery,” he told this news organization. “The second would be the quality of life of those patients. Colon cancer is preventable if you are having regular colonoscopies.”

Other studies have not shown much difference between patients who have weight loss surgery and those who don’t, he added.

The study was funded by Merck. Dr. Desai and Dr. Shwani have reported receiving grant funding from Merck. Dr. Yaghoobi has reported no relevant financial relationships.

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

LAS VEGAS – People with obesity may be able to reduce their risk of colorectal cancer with weight loss surgery or medication, researchers say.

“We need to have conversations with our patients in the clinic and educate them that they have these resources available,” said Aakash Desai, MD, a hospitalist at MetroHealth Medical Center, Cleveland, in an interview with this news organization.

Dr. Desai and colleagues found that sleeve gastrectomy and four medications were associated with a reduced risk of colorectal cancer but Roux-en-Y gastrojejunostomy and orlistat were not.

Coauthor Zryan Shwani, MD, a gastroenterology fellow at Sibley Memorial Hospital, Washington, D.C., presented the findings here at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting.

Working with an underserved population with high rates of obesity in northeastern Ohio, the researchers wondered how surgery and medication could affect these patients.

They analyzed data from the IBM Explorys clinical database, which compiles and standardizes data from electronic medical records on about 74 million patients from more than 300 U.S. hospitals. Consistent with previous studies, they determined that patients with obesity in the database were 2.5 times more likely than people with a healthy weight to be diagnosed with colorectal cancer (odds ratio, 2.48; 95% CI, 2.45-2.51).

Zeroing in on people who had weight loss interventions, they included adults aged 18-75 years who had undergone either Roux-en-Y gastrojejunostomy or sleeve gastrectomy, or had taken the medications liraglutide, orlistat, phentermine/topiramate, bupropion/naltrexone, or lorcaserin.

They excluded patients with Lynch syndrome, intestinal polyposis syndrome, a family history of gastrointestinal malignancy, inflammatory bowel disease, or tobacco or alcohol abuse. Patients who had taken one of the weight loss medications and also had type 2 diabetes were excluded. They did not include patients who had undergone gastric banding because it has become less popular.

For the weight loss medication group, they found 117,730 patients who met their criteria. For the surgery group, 43,050 patients met the criteria.

In analyzing the colorectal cancer rates, they included only diagnoses of malignant neoplasms made 2 years after the interventions.

They compared these patients to a control group of 52,540 people matched in age, with a body mass index (BMI) greater than 30 kg/m² who did not undergo weight loss surgery or take weight loss medication.

Among the 9,370 patients who underwent Roux-en-Y gastrojejunostomy, 50 were diagnosed with colorectal cancer and 400 had benign polyps. Their rate of colorectal cancer was not statistically different from people who didn’t have surgery (OR, 1.09; 95% CI, 0.82-1.43). The rate of benign polyps after Roux-en-Y gastrojejunostomy was greater (OR, 1.72; 95% CI, 1.55-1.90).

On the other hand, among the 33,680 patients who underwent sleeve gastrectomy, 50 were diagnosed with colorectal cancer, a lower rate than in the population who didn’t have surgery (OR, 0.30; 95% CI, 0.22-0.39). Their risk of benign polyps was also reduced (OR, 0.45; 95% CI, 0.40-0.50).

All of the medications were significantly associated with a lower risk of colorectal cancer, except orlistat (OR, 0.94; 95% CI, 0.72-1.25).

The finding on Roux-en-Y gastrojejunostomy agreed with studies from England and Nordic countries showing double the risk of colorectal cancer in those patients but conflicted with a French study showing decreased risk, Dr. Shwani said.

While the study doesn’t establish a reason why Roux-en-Y gastrojejunostomy was less beneficial, other researchers have associated the procedure with biomarkers of inflammation, Dr. Shwani said. “It’s inconsistent, and I don’t think we have a clear answer why.”

As a retrospective analysis, the study could not establish a cause-and-effect relationship between surgery or medication and cancer, or adjust for such factors as diet, exercise, or genes, he acknowledged.

Colorectal cancer is just one outcome to consider when deciding whether to undergo weight loss surgery or take weight loss drugs, said session moderator Mohammad Yaghoobi, MD, an associate professor of medicine at McMaster University, Hamilton, Ont.

“The most important outcome that should be investigated is the survival of the patients after obesity surgery,” he told this news organization. “The second would be the quality of life of those patients. Colon cancer is preventable if you are having regular colonoscopies.”

Other studies have not shown much difference between patients who have weight loss surgery and those who don’t, he added.

The study was funded by Merck. Dr. Desai and Dr. Shwani have reported receiving grant funding from Merck. Dr. Yaghoobi has reported no relevant financial relationships.

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

Stereotactic body radiation therapy (SBRT) directed at progressive lesions in patients with oligoprogressive metastatic non–small cell lung cancer (NSCLC) was beneficial and significantly improved progression-free survival (PFS), suggest clinical trial results presented this week.

Patients treated with SBRT had a median PFS of 44 weeks, compared with 9 weeks for those who received standard care.

However, no benefit was observed in patients with metastatic breast cancer. There was no significant difference in PFS between the two groups (18 weeks with SBRT vs. 19 weeks with standard care).

“In this preplanned interim analysis, we demonstrated the benefit of SBRT to sites of oligoprogression on overall progression-free survival, which was the primary endpoint,” said lead author C. Jillian Tsai, MD, PhD, a radiation oncologist and director of metastatic disease radiation oncology research at Memorial Sloan Kettering Cancer Center in New York. “The difference was driven by the substantial response in [this] NSCLC cohort.”

There was no benefit of SBRT seen in the breast cohort, she noted, and most breast patients developed new lesions upon further progression.

Dr. Tsai and colleagues are planning to close the trial early, after the interim analysis established the benefit of SBRT. They are now investigating why SBRT was beneficial in NSCLC but not in breast cancer.

The findings were presented at the American Society for Radiation Oncology (ASTRO) annual meeting.

Dr. Tsai explained that the current standard of care for patients with oligoprogressive metastatic NSCLC is to switch to a different targeted therapy or chemotherapy following progression, but options may be limited. Efficacy for second-line therapy can be poor, with PFS ranging from about 4 months to 10 months for NSCLC, “and after second line, efficacy for third and fourth lines is even poorer,” she said.

Similarly, for breast cancer, PFS ranges from about 9 months to 20 months for estrogen-receptor positive patients. “But for triple negative patients, there really is no standard of care and PFS is poor,” Dr. Tsai said.
 

SBRT superior to standard of care

The authors hypothesized that there is an oligoprogressive state in metastatic cancer, in which disease control can be improved by applying local therapy to progressive lesions only.

The cohort included 102 patients with metastatic NSCLC or breast cancer who had received one or more lines of systemic therapy and had oligoprogressive lesions amenable to SBRT. There was no upper limit of nonprogressive lesions.

Oligoprogression was defined as Response Evaluation or Positron Emission Tomography Response Criteria in Solid Tumors documented progression ≤5 individual lesions.

Patients were randomly assigned to receive either SBRT to all progressive sites plus palliative standard of care or systemic SOC only. Systemic therapy was per physician’s discretion.

There were 58 patients with NSCLC (30 in the SBRT group) and 44 patients with breast cancer (22 in each group).

Most patients (75%) had more than one site of oligoprogression and 47% had more than 5 total metastatic lesions. About half of patients (54%) had received immunotherapy and the majority of those with NSCLC (86%) did not harbor an actionable driver mutation. About one-third (32%) of the breast cancer cohort were triple negative.

Patients were followed for a median of 45 weeks (58 weeks for living patients), by which time 78 (74%) had experienced further tumor progression and 39 (37%) had died.

Median progression-free survival for the entire cohort was 31 weeks for SBRT and 11 weeks for palliative SOC (P = .002).

In multivariable analysis that stratified for factors including age, sex, lines of systemic therapy, and change of systemic therapy, the progression-free survival benefit of SBRT continued to remain substantial in the NSCLC cohort (hazard ratio: 0.38; P = .007).

Adverse events were higher in the SBRT group. Grade 2 or higher adverse events occurred in 23 (61%) of SBRT patients, and 15 (40%) of SOC patients (P = .13).
 

Hoped-for results, with a few caveats

Approached for comment on the new findings, Clifford Robinson, MD, professor of radiation oncology, chief of SBRT service, and director of clinical trials and informatics at Washington University, St. Louis, said the results tie in with previous findings.

There are multiple published or presented prospective randomized phase 2 and 3 trials in various disease sites that have explored the role of local therapy, including SBRT, for patients who present with oligometastatic disease.

“These studies have nearly uniformly shown improvements in progression-free and/or overall survival with the inclusion of local therapy,” he told this news organization. Dr. Robinson was not involved with the study.

He explained that relatively few patients present with oligometastatic disease. However, many patients present with more advanced disease, but after an initial course of systemic therapy, develop oligoprogression.

“There is tremendous appeal to using local therapy at the time of oligoprogression in lieu of switching systemic therapy,” said Dr. Robinson. “It allows patients to stay on systemic therapy that is otherwise effective for the remainder of their disease.”

First-line systemic therapies are the most effective and the most tolerable, he continued, and switching systemic therapy introduces the potential for more toxicity and less efficacy. Therefore, it has become increasingly popular to offer SBRT to one or a few sites of oligoprogressive disease based on the results of oligometastatic disease.

“However, there is no established prospective data to guide this practice,” he said. “This trial is the first to examine this carefully in lung and breast cancer patients, and this trial shows what we hoped to see – that use of SBRT after oligoprogression results in improved progression-free survival as compared with standard of care alone. And this was accomplished with limited toxicity.”

There are a few caveats, though, he pointed out. “Progression-free survival is defined as time to first progression or death,” he said. “Since we don’t know what the overall survival is in this abstract, it’s entirely possible that patients live for the same length of time, but just take longer to progress.”

Another caveat is that this was a planned interim analysis. “Typically, planned interim analyses occur to see if the trial should be stopped or to adjust the study based on results,” he said. “It’s unclear what the investigators will do with this information.”

“But overall, these are very exciting data and lend support to the increasingly common practice of treating oligoprogressive disease,” Dr. Robinson added. “Since most of the serious adverse events of SBRT occur later, longer follow-up is needed, although the median survival of patients may not reach that timepoint.”

“For now, practice should not be altered based on these interim results,” he added.

Dr. Tsai reported acting as a consultant/advisor for Varian and Galera and also receiving research funding from Varian. Dr. Robinson reports stock/ownership in Radialogica, acting as a consultant/advisor for Varian, AstraZeneca, EMD Serono, Quantitative Radiology Solutions, research funding from Varian and Merck, and owning patents on systems for cardiac arrhythmias and ablation.

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

Stereotactic body radiation therapy (SBRT) directed at progressive lesions in patients with oligoprogressive metastatic non–small cell lung cancer (NSCLC) was beneficial and significantly improved progression-free survival (PFS), suggest clinical trial results presented this week.

Patients treated with SBRT had a median PFS of 44 weeks, compared with 9 weeks for those who received standard care.

However, no benefit was observed in patients with metastatic breast cancer. There was no significant difference in PFS between the two groups (18 weeks with SBRT vs. 19 weeks with standard care).

“In this preplanned interim analysis, we demonstrated the benefit of SBRT to sites of oligoprogression on overall progression-free survival, which was the primary endpoint,” said lead author C. Jillian Tsai, MD, PhD, a radiation oncologist and director of metastatic disease radiation oncology research at Memorial Sloan Kettering Cancer Center in New York. “The difference was driven by the substantial response in [this] NSCLC cohort.”

There was no benefit of SBRT seen in the breast cohort, she noted, and most breast patients developed new lesions upon further progression.

Dr. Tsai and colleagues are planning to close the trial early, after the interim analysis established the benefit of SBRT. They are now investigating why SBRT was beneficial in NSCLC but not in breast cancer.

The findings were presented at the American Society for Radiation Oncology (ASTRO) annual meeting.

Dr. Tsai explained that the current standard of care for patients with oligoprogressive metastatic NSCLC is to switch to a different targeted therapy or chemotherapy following progression, but options may be limited. Efficacy for second-line therapy can be poor, with PFS ranging from about 4 months to 10 months for NSCLC, “and after second line, efficacy for third and fourth lines is even poorer,” she said.

Similarly, for breast cancer, PFS ranges from about 9 months to 20 months for estrogen-receptor positive patients. “But for triple negative patients, there really is no standard of care and PFS is poor,” Dr. Tsai said.
 

SBRT superior to standard of care

The authors hypothesized that there is an oligoprogressive state in metastatic cancer, in which disease control can be improved by applying local therapy to progressive lesions only.

The cohort included 102 patients with metastatic NSCLC or breast cancer who had received one or more lines of systemic therapy and had oligoprogressive lesions amenable to SBRT. There was no upper limit of nonprogressive lesions.

Oligoprogression was defined as Response Evaluation or Positron Emission Tomography Response Criteria in Solid Tumors documented progression ≤5 individual lesions.

Patients were randomly assigned to receive either SBRT to all progressive sites plus palliative standard of care or systemic SOC only. Systemic therapy was per physician’s discretion.

There were 58 patients with NSCLC (30 in the SBRT group) and 44 patients with breast cancer (22 in each group).

Most patients (75%) had more than one site of oligoprogression and 47% had more than 5 total metastatic lesions. About half of patients (54%) had received immunotherapy and the majority of those with NSCLC (86%) did not harbor an actionable driver mutation. About one-third (32%) of the breast cancer cohort were triple negative.

Patients were followed for a median of 45 weeks (58 weeks for living patients), by which time 78 (74%) had experienced further tumor progression and 39 (37%) had died.

Median progression-free survival for the entire cohort was 31 weeks for SBRT and 11 weeks for palliative SOC (P = .002).

In multivariable analysis that stratified for factors including age, sex, lines of systemic therapy, and change of systemic therapy, the progression-free survival benefit of SBRT continued to remain substantial in the NSCLC cohort (hazard ratio: 0.38; P = .007).

Adverse events were higher in the SBRT group. Grade 2 or higher adverse events occurred in 23 (61%) of SBRT patients, and 15 (40%) of SOC patients (P = .13).
 

Hoped-for results, with a few caveats

Approached for comment on the new findings, Clifford Robinson, MD, professor of radiation oncology, chief of SBRT service, and director of clinical trials and informatics at Washington University, St. Louis, said the results tie in with previous findings.

There are multiple published or presented prospective randomized phase 2 and 3 trials in various disease sites that have explored the role of local therapy, including SBRT, for patients who present with oligometastatic disease.

“These studies have nearly uniformly shown improvements in progression-free and/or overall survival with the inclusion of local therapy,” he told this news organization. Dr. Robinson was not involved with the study.

He explained that relatively few patients present with oligometastatic disease. However, many patients present with more advanced disease, but after an initial course of systemic therapy, develop oligoprogression.

“There is tremendous appeal to using local therapy at the time of oligoprogression in lieu of switching systemic therapy,” said Dr. Robinson. “It allows patients to stay on systemic therapy that is otherwise effective for the remainder of their disease.”

First-line systemic therapies are the most effective and the most tolerable, he continued, and switching systemic therapy introduces the potential for more toxicity and less efficacy. Therefore, it has become increasingly popular to offer SBRT to one or a few sites of oligoprogressive disease based on the results of oligometastatic disease.

“However, there is no established prospective data to guide this practice,” he said. “This trial is the first to examine this carefully in lung and breast cancer patients, and this trial shows what we hoped to see – that use of SBRT after oligoprogression results in improved progression-free survival as compared with standard of care alone. And this was accomplished with limited toxicity.”

There are a few caveats, though, he pointed out. “Progression-free survival is defined as time to first progression or death,” he said. “Since we don’t know what the overall survival is in this abstract, it’s entirely possible that patients live for the same length of time, but just take longer to progress.”

Another caveat is that this was a planned interim analysis. “Typically, planned interim analyses occur to see if the trial should be stopped or to adjust the study based on results,” he said. “It’s unclear what the investigators will do with this information.”

“But overall, these are very exciting data and lend support to the increasingly common practice of treating oligoprogressive disease,” Dr. Robinson added. “Since most of the serious adverse events of SBRT occur later, longer follow-up is needed, although the median survival of patients may not reach that timepoint.”

“For now, practice should not be altered based on these interim results,” he added.

Dr. Tsai reported acting as a consultant/advisor for Varian and Galera and also receiving research funding from Varian. Dr. Robinson reports stock/ownership in Radialogica, acting as a consultant/advisor for Varian, AstraZeneca, EMD Serono, Quantitative Radiology Solutions, research funding from Varian and Merck, and owning patents on systems for cardiac arrhythmias and ablation.

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

Stereotactic body radiation therapy (SBRT) directed at progressive lesions in patients with oligoprogressive metastatic non–small cell lung cancer (NSCLC) was beneficial and significantly improved progression-free survival (PFS), suggest clinical trial results presented this week.

Patients treated with SBRT had a median PFS of 44 weeks, compared with 9 weeks for those who received standard care.

However, no benefit was observed in patients with metastatic breast cancer. There was no significant difference in PFS between the two groups (18 weeks with SBRT vs. 19 weeks with standard care).

“In this preplanned interim analysis, we demonstrated the benefit of SBRT to sites of oligoprogression on overall progression-free survival, which was the primary endpoint,” said lead author C. Jillian Tsai, MD, PhD, a radiation oncologist and director of metastatic disease radiation oncology research at Memorial Sloan Kettering Cancer Center in New York. “The difference was driven by the substantial response in [this] NSCLC cohort.”

There was no benefit of SBRT seen in the breast cohort, she noted, and most breast patients developed new lesions upon further progression.

Dr. Tsai and colleagues are planning to close the trial early, after the interim analysis established the benefit of SBRT. They are now investigating why SBRT was beneficial in NSCLC but not in breast cancer.

The findings were presented at the American Society for Radiation Oncology (ASTRO) annual meeting.

Dr. Tsai explained that the current standard of care for patients with oligoprogressive metastatic NSCLC is to switch to a different targeted therapy or chemotherapy following progression, but options may be limited. Efficacy for second-line therapy can be poor, with PFS ranging from about 4 months to 10 months for NSCLC, “and after second line, efficacy for third and fourth lines is even poorer,” she said.

Similarly, for breast cancer, PFS ranges from about 9 months to 20 months for estrogen-receptor positive patients. “But for triple negative patients, there really is no standard of care and PFS is poor,” Dr. Tsai said.
 

SBRT superior to standard of care

The authors hypothesized that there is an oligoprogressive state in metastatic cancer, in which disease control can be improved by applying local therapy to progressive lesions only.

The cohort included 102 patients with metastatic NSCLC or breast cancer who had received one or more lines of systemic therapy and had oligoprogressive lesions amenable to SBRT. There was no upper limit of nonprogressive lesions.

Oligoprogression was defined as Response Evaluation or Positron Emission Tomography Response Criteria in Solid Tumors documented progression ≤5 individual lesions.

Patients were randomly assigned to receive either SBRT to all progressive sites plus palliative standard of care or systemic SOC only. Systemic therapy was per physician’s discretion.

There were 58 patients with NSCLC (30 in the SBRT group) and 44 patients with breast cancer (22 in each group).

Most patients (75%) had more than one site of oligoprogression and 47% had more than 5 total metastatic lesions. About half of patients (54%) had received immunotherapy and the majority of those with NSCLC (86%) did not harbor an actionable driver mutation. About one-third (32%) of the breast cancer cohort were triple negative.

Patients were followed for a median of 45 weeks (58 weeks for living patients), by which time 78 (74%) had experienced further tumor progression and 39 (37%) had died.

Median progression-free survival for the entire cohort was 31 weeks for SBRT and 11 weeks for palliative SOC (P = .002).

In multivariable analysis that stratified for factors including age, sex, lines of systemic therapy, and change of systemic therapy, the progression-free survival benefit of SBRT continued to remain substantial in the NSCLC cohort (hazard ratio: 0.38; P = .007).

Adverse events were higher in the SBRT group. Grade 2 or higher adverse events occurred in 23 (61%) of SBRT patients, and 15 (40%) of SOC patients (P = .13).
 

Hoped-for results, with a few caveats

Approached for comment on the new findings, Clifford Robinson, MD, professor of radiation oncology, chief of SBRT service, and director of clinical trials and informatics at Washington University, St. Louis, said the results tie in with previous findings.

There are multiple published or presented prospective randomized phase 2 and 3 trials in various disease sites that have explored the role of local therapy, including SBRT, for patients who present with oligometastatic disease.

“These studies have nearly uniformly shown improvements in progression-free and/or overall survival with the inclusion of local therapy,” he told this news organization. Dr. Robinson was not involved with the study.

He explained that relatively few patients present with oligometastatic disease. However, many patients present with more advanced disease, but after an initial course of systemic therapy, develop oligoprogression.

“There is tremendous appeal to using local therapy at the time of oligoprogression in lieu of switching systemic therapy,” said Dr. Robinson. “It allows patients to stay on systemic therapy that is otherwise effective for the remainder of their disease.”

First-line systemic therapies are the most effective and the most tolerable, he continued, and switching systemic therapy introduces the potential for more toxicity and less efficacy. Therefore, it has become increasingly popular to offer SBRT to one or a few sites of oligoprogressive disease based on the results of oligometastatic disease.

“However, there is no established prospective data to guide this practice,” he said. “This trial is the first to examine this carefully in lung and breast cancer patients, and this trial shows what we hoped to see – that use of SBRT after oligoprogression results in improved progression-free survival as compared with standard of care alone. And this was accomplished with limited toxicity.”

There are a few caveats, though, he pointed out. “Progression-free survival is defined as time to first progression or death,” he said. “Since we don’t know what the overall survival is in this abstract, it’s entirely possible that patients live for the same length of time, but just take longer to progress.”

Another caveat is that this was a planned interim analysis. “Typically, planned interim analyses occur to see if the trial should be stopped or to adjust the study based on results,” he said. “It’s unclear what the investigators will do with this information.”

“But overall, these are very exciting data and lend support to the increasingly common practice of treating oligoprogressive disease,” Dr. Robinson added. “Since most of the serious adverse events of SBRT occur later, longer follow-up is needed, although the median survival of patients may not reach that timepoint.”

“For now, practice should not be altered based on these interim results,” he added.

Dr. Tsai reported acting as a consultant/advisor for Varian and Galera and also receiving research funding from Varian. Dr. Robinson reports stock/ownership in Radialogica, acting as a consultant/advisor for Varian, AstraZeneca, EMD Serono, Quantitative Radiology Solutions, research funding from Varian and Merck, and owning patents on systems for cardiac arrhythmias and ablation.

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

The largest-ever breast cancer screening trial in the United States, which is federally funded with costs expected to reach $100 million, is a “waste,” says prominent radiologist Daniel Kopans, MD, from Harvard Medical School, Boston. Funding for this trial is largely misspent money, it may produce misleading results, and it should be abandoned, he says.

Dr. Kopans has been an outspoken critic of the trial, describing it as a “huge waste of money” in comments made last year. Now he has set out his criticisms of the trial in an essay published in the October issue of Clinical Imaging, which outlines his objections and concerns for the first time in a peer-reviewed journal.

The Tomosynthesis Mammographic Imaging Screening Trial (TMIST) is comparing digital breast tomosynthesis (DBT), also known as 3-D mammography, with the older 2-D technology or full-field digital mammography (FFDM).

Dr. Kopans coined the term DBT and formerly held a now-expired patent on the first version of this technology.

“It could be argued that the imaging part of TMIST is a waste of valuable resources,” he writes in the essay.

The “imaging part” of the trial refers to the primary outcome measure and driving purpose of the trial, which is designed to learn which technology is better at finding – and reducing the rate of – potentially lethal “advanced” cancers.

These cancers include larger HER2-positive and triple-negative malignancies; those associated with positive nodes; and metastatic disease. These malignancies correlate with breast cancer mortality, TMIST’s principal investigator Etta Pisano, MD, of the American College of Radiology, has said in the past.

However, Dr. Kopans says that this surrogate endpoint is problematic. “TMIST will only investigate whether or not digital breast tomography results in a decline in advanced cancers, ignoring the fact that many women still die from cancers that are not advanced at the time of diagnosis,” he writes.

“Clearly reducing the rate of advanced cancers is not the only way that early detection saves lives. Lives are also saved by finding cancers at a smaller size within stages,” Dr. Kopans writes. He adds that DBT has been proven in observational cohort studies to find more smaller breast cancers than FFDM.

Dr. Kopans’ opinion that TMIST is largely a waste of resources is not shared by the National Cancer Institute. “We feel strongly that TMIST is a critical study,” an NCI spokesperson told this news organization.
 

Study power concerns

Another concern is that TMIST “may be underpowered,” Dr. Kopans writes. That concern arises in part from a recent review of TMIST by an advisory committee (that was prompted by low patient accrual rates), which proposed reducing the size of the trial. Dr. Kopans says this would result in “a reduction of the planned power of the trial.”  

The NCI says that reducing the study size has been discussed but has not yet been implemented. “Any reduction in size would, of course, have appropriate statistical considerations in mind,” according to the NCI spokesperson.

Dr. Kopans’ concern about statistical power extends beyond downsizing the trial. An advanced cancer in TMIST is counted “if it occurs at any time while the participant is on study,” according to the NCI. Dr. Kopans says that is a problem.

“Since DBT cannot have any effect on advanced cancers in the prevalence year (they are already there), data from the first year (prevalence cancers are likely the largest number) will be unusable, and if used will, inappropriately, dilute the results,” he writes.

Dr. Kopans hopes that the investigators address the statistical power issues with the trial because, if not, “its results may be grossly misleading.”
 

American radiology practice

Dr. Kopans praises one aspect of TMIST – the trial’s effort to create a repository of blood and oral swab specimens, along with participant genetic data. The goal, say TMIST investigators, is to individualize or optimize screening strategies by tying molecular data to clinical outcomes in the trial.

However, apart from that one aspect, Dr. Kopans is highly critical of the trial.

It is now too late to compare the two technologies, he suggests, as DBT is already replacing FFDM for breast cancer screening in the U.S.

He notes that 76% of mammography facilities in the United States have 3-D devices (as of April 2021). That percentage has climbed steadily in recent years. “By the time the TMIST study is completed, DBT will, almost certainly, have become the ‘standard of care,’” he asserts, echoing others who have commented on the trial, including some participating physicians.

The money being spent on TMIST “should not be used for looking backwards,” says Dr. Kopans.

The NCI responded to that criticism. “TMIST is looking to clarify the best screening for women based on the science and is not solely about access. We are seeking to determine which technology is better and [are] providing access to the trial across the country in diverse practices and populations,” the NCI said in an email.

In his essay, Dr. Kopans says it is time to stop TMIST and put the money into other pressing breast cancer issues and questions. “... it makes no sense to continue this flawed trial whose results will be obsolete by the time they become available,” he writes.

Dr. Kopans reports consulting with DART Imaging in China, which is developing a digital breast tomosynthesis machine.

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

The largest-ever breast cancer screening trial in the United States, which is federally funded with costs expected to reach $100 million, is a “waste,” says prominent radiologist Daniel Kopans, MD, from Harvard Medical School, Boston. Funding for this trial is largely misspent money, it may produce misleading results, and it should be abandoned, he says.

Dr. Kopans has been an outspoken critic of the trial, describing it as a “huge waste of money” in comments made last year. Now he has set out his criticisms of the trial in an essay published in the October issue of Clinical Imaging, which outlines his objections and concerns for the first time in a peer-reviewed journal.

The Tomosynthesis Mammographic Imaging Screening Trial (TMIST) is comparing digital breast tomosynthesis (DBT), also known as 3-D mammography, with the older 2-D technology or full-field digital mammography (FFDM).

Dr. Kopans coined the term DBT and formerly held a now-expired patent on the first version of this technology.

“It could be argued that the imaging part of TMIST is a waste of valuable resources,” he writes in the essay.

The “imaging part” of the trial refers to the primary outcome measure and driving purpose of the trial, which is designed to learn which technology is better at finding – and reducing the rate of – potentially lethal “advanced” cancers.

These cancers include larger HER2-positive and triple-negative malignancies; those associated with positive nodes; and metastatic disease. These malignancies correlate with breast cancer mortality, TMIST’s principal investigator Etta Pisano, MD, of the American College of Radiology, has said in the past.

However, Dr. Kopans says that this surrogate endpoint is problematic. “TMIST will only investigate whether or not digital breast tomography results in a decline in advanced cancers, ignoring the fact that many women still die from cancers that are not advanced at the time of diagnosis,” he writes.

“Clearly reducing the rate of advanced cancers is not the only way that early detection saves lives. Lives are also saved by finding cancers at a smaller size within stages,” Dr. Kopans writes. He adds that DBT has been proven in observational cohort studies to find more smaller breast cancers than FFDM.

Dr. Kopans’ opinion that TMIST is largely a waste of resources is not shared by the National Cancer Institute. “We feel strongly that TMIST is a critical study,” an NCI spokesperson told this news organization.
 

Study power concerns

Another concern is that TMIST “may be underpowered,” Dr. Kopans writes. That concern arises in part from a recent review of TMIST by an advisory committee (that was prompted by low patient accrual rates), which proposed reducing the size of the trial. Dr. Kopans says this would result in “a reduction of the planned power of the trial.”  

The NCI says that reducing the study size has been discussed but has not yet been implemented. “Any reduction in size would, of course, have appropriate statistical considerations in mind,” according to the NCI spokesperson.

Dr. Kopans’ concern about statistical power extends beyond downsizing the trial. An advanced cancer in TMIST is counted “if it occurs at any time while the participant is on study,” according to the NCI. Dr. Kopans says that is a problem.

“Since DBT cannot have any effect on advanced cancers in the prevalence year (they are already there), data from the first year (prevalence cancers are likely the largest number) will be unusable, and if used will, inappropriately, dilute the results,” he writes.

Dr. Kopans hopes that the investigators address the statistical power issues with the trial because, if not, “its results may be grossly misleading.”
 

American radiology practice

Dr. Kopans praises one aspect of TMIST – the trial’s effort to create a repository of blood and oral swab specimens, along with participant genetic data. The goal, say TMIST investigators, is to individualize or optimize screening strategies by tying molecular data to clinical outcomes in the trial.

However, apart from that one aspect, Dr. Kopans is highly critical of the trial.

It is now too late to compare the two technologies, he suggests, as DBT is already replacing FFDM for breast cancer screening in the U.S.

He notes that 76% of mammography facilities in the United States have 3-D devices (as of April 2021). That percentage has climbed steadily in recent years. “By the time the TMIST study is completed, DBT will, almost certainly, have become the ‘standard of care,’” he asserts, echoing others who have commented on the trial, including some participating physicians.

The money being spent on TMIST “should not be used for looking backwards,” says Dr. Kopans.

The NCI responded to that criticism. “TMIST is looking to clarify the best screening for women based on the science and is not solely about access. We are seeking to determine which technology is better and [are] providing access to the trial across the country in diverse practices and populations,” the NCI said in an email.

In his essay, Dr. Kopans says it is time to stop TMIST and put the money into other pressing breast cancer issues and questions. “... it makes no sense to continue this flawed trial whose results will be obsolete by the time they become available,” he writes.

Dr. Kopans reports consulting with DART Imaging in China, which is developing a digital breast tomosynthesis machine.

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

The largest-ever breast cancer screening trial in the United States, which is federally funded with costs expected to reach $100 million, is a “waste,” says prominent radiologist Daniel Kopans, MD, from Harvard Medical School, Boston. Funding for this trial is largely misspent money, it may produce misleading results, and it should be abandoned, he says.

Dr. Kopans has been an outspoken critic of the trial, describing it as a “huge waste of money” in comments made last year. Now he has set out his criticisms of the trial in an essay published in the October issue of Clinical Imaging, which outlines his objections and concerns for the first time in a peer-reviewed journal.

The Tomosynthesis Mammographic Imaging Screening Trial (TMIST) is comparing digital breast tomosynthesis (DBT), also known as 3-D mammography, with the older 2-D technology or full-field digital mammography (FFDM).

Dr. Kopans coined the term DBT and formerly held a now-expired patent on the first version of this technology.

“It could be argued that the imaging part of TMIST is a waste of valuable resources,” he writes in the essay.

The “imaging part” of the trial refers to the primary outcome measure and driving purpose of the trial, which is designed to learn which technology is better at finding – and reducing the rate of – potentially lethal “advanced” cancers.

These cancers include larger HER2-positive and triple-negative malignancies; those associated with positive nodes; and metastatic disease. These malignancies correlate with breast cancer mortality, TMIST’s principal investigator Etta Pisano, MD, of the American College of Radiology, has said in the past.

However, Dr. Kopans says that this surrogate endpoint is problematic. “TMIST will only investigate whether or not digital breast tomography results in a decline in advanced cancers, ignoring the fact that many women still die from cancers that are not advanced at the time of diagnosis,” he writes.

“Clearly reducing the rate of advanced cancers is not the only way that early detection saves lives. Lives are also saved by finding cancers at a smaller size within stages,” Dr. Kopans writes. He adds that DBT has been proven in observational cohort studies to find more smaller breast cancers than FFDM.

Dr. Kopans’ opinion that TMIST is largely a waste of resources is not shared by the National Cancer Institute. “We feel strongly that TMIST is a critical study,” an NCI spokesperson told this news organization.
 

Study power concerns

Another concern is that TMIST “may be underpowered,” Dr. Kopans writes. That concern arises in part from a recent review of TMIST by an advisory committee (that was prompted by low patient accrual rates), which proposed reducing the size of the trial. Dr. Kopans says this would result in “a reduction of the planned power of the trial.”  

The NCI says that reducing the study size has been discussed but has not yet been implemented. “Any reduction in size would, of course, have appropriate statistical considerations in mind,” according to the NCI spokesperson.

Dr. Kopans’ concern about statistical power extends beyond downsizing the trial. An advanced cancer in TMIST is counted “if it occurs at any time while the participant is on study,” according to the NCI. Dr. Kopans says that is a problem.

“Since DBT cannot have any effect on advanced cancers in the prevalence year (they are already there), data from the first year (prevalence cancers are likely the largest number) will be unusable, and if used will, inappropriately, dilute the results,” he writes.

Dr. Kopans hopes that the investigators address the statistical power issues with the trial because, if not, “its results may be grossly misleading.”
 

American radiology practice

Dr. Kopans praises one aspect of TMIST – the trial’s effort to create a repository of blood and oral swab specimens, along with participant genetic data. The goal, say TMIST investigators, is to individualize or optimize screening strategies by tying molecular data to clinical outcomes in the trial.

However, apart from that one aspect, Dr. Kopans is highly critical of the trial.

It is now too late to compare the two technologies, he suggests, as DBT is already replacing FFDM for breast cancer screening in the U.S.

He notes that 76% of mammography facilities in the United States have 3-D devices (as of April 2021). That percentage has climbed steadily in recent years. “By the time the TMIST study is completed, DBT will, almost certainly, have become the ‘standard of care,’” he asserts, echoing others who have commented on the trial, including some participating physicians.

The money being spent on TMIST “should not be used for looking backwards,” says Dr. Kopans.

The NCI responded to that criticism. “TMIST is looking to clarify the best screening for women based on the science and is not solely about access. We are seeking to determine which technology is better and [are] providing access to the trial across the country in diverse practices and populations,” the NCI said in an email.

In his essay, Dr. Kopans says it is time to stop TMIST and put the money into other pressing breast cancer issues and questions. “... it makes no sense to continue this flawed trial whose results will be obsolete by the time they become available,” he writes.

Dr. Kopans reports consulting with DART Imaging in China, which is developing a digital breast tomosynthesis machine.

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

A new systematic review and meta-analysis finds that unvaccinated cancer patients who contracted COVID-19 last year, were more than two times more likely – than people without cancer – to develop a case of COVID-19 so severe it required hospitalization in an intensive care unit.

“Our study provides the most precise measure to date of the effect of COVID-19 in cancer patients,” wrote researchers who were led by Paolo Boffetta, MD, MPH, a specialist in population science with the Stony Brook Cancer Center in New York.

Dr. Boffetta and colleagues also found that patients with hematologic neoplasms had a higher mortality rate from COVID-19 comparable to that of all cancers combined.

Cancer patients have long been considered to be among those patients who are at high risk of developing COVID-19, and if they contract the disease, they are at high risk of having poor outcomes. Other high-risk patients include those with hypertension, diabetes, chronic kidney disease, or COPD, or the elderly. But how high the risk of developing severe COVID-19 disease is for cancer patients hasn’t yet been documented on a wide scale.

The study, which was made available as a preprint on medRxiv on Oct. 23, is based on an analysis of COVID-19 cases that were documented in 35 reviews, meta-analyses, case reports, and studies indexed in PubMed from authors in North America, Europe, and Asia.

In this study, the pooled odds ratio for mortality for all patients with any cancer was 2.32 (95% confidence interval, 1.82-2.94; 24 studies). For ICU admission, the odds ratio was 2.39 (95% CI, 1.90-3.02; I2 0.0%; 5 studies). And, for disease severity or hospitalization, it was 2.08 (95% CI, 1.60-2.72; I2 92.1%; 15 studies). The pooled mortality odds ratio for hematologic neoplasms was 2.14 (95% CI, 1.87-2.44; I2 20.8%; 8 studies).

Their findings, which have not yet been peer reviewed, confirmed the results of a similar analysis from China published as a preprint in May 2020. The analysis included 181,323 patients (23,736 cancer patients) from 26 studies reported an odds ratio of 2.54 (95% CI, 1.47-4.42). “Cancer patients with COVID-19 have an increased likelihood of death compared to non-cancer COVID-19 patients,” Venkatesulu et al. wrote. And a systematic review and meta-analysis of five studies of 2,619 patients published in October 2020 in Medicine also found a significantly higher risk of death from COVID-19 among cancer patients (odds ratio, 2.63; 95% confidence interval, 1.14-6.06; P = .023; I2 = 26.4%).

Fakih et al., writing in the journal Hematology/Oncology and Stem Cell Therapy conducted a meta-analysis early last year finding a threefold increase for admission to the intensive care unit, an almost fourfold increase for a severe SARS-CoV-2 infection, and a fivefold increase for being intubated.

The three studies show that mortality rates were higher early in the pandemic “when diagnosis and treatment for SARS-CoV-2 might have been delayed, resulting in higher death rate,” Boffetta et al. wrote, adding that their analysis showed only a twofold increase most likely because it was a year-long analysis.

“Future studies will be able to better analyze this association for the different subtypes of cancer. Furthermore, they will eventually be able to evaluate whether the difference among vaccinated population is reduced,” Boffetta et al. wrote.

The authors noted several limitations for the study, including the fact that many of the studies included in the analysis did not include sex, age, comorbidities, and therapy. Nor were the authors able to analyze specific cancers other than hematologic neoplasms.

The authors declared no conflicts of interest.

A new systematic review and meta-analysis finds that unvaccinated cancer patients who contracted COVID-19 last year, were more than two times more likely – than people without cancer – to develop a case of COVID-19 so severe it required hospitalization in an intensive care unit.

“Our study provides the most precise measure to date of the effect of COVID-19 in cancer patients,” wrote researchers who were led by Paolo Boffetta, MD, MPH, a specialist in population science with the Stony Brook Cancer Center in New York.

Dr. Boffetta and colleagues also found that patients with hematologic neoplasms had a higher mortality rate from COVID-19 comparable to that of all cancers combined.

Cancer patients have long been considered to be among those patients who are at high risk of developing COVID-19, and if they contract the disease, they are at high risk of having poor outcomes. Other high-risk patients include those with hypertension, diabetes, chronic kidney disease, or COPD, or the elderly. But how high the risk of developing severe COVID-19 disease is for cancer patients hasn’t yet been documented on a wide scale.

The study, which was made available as a preprint on medRxiv on Oct. 23, is based on an analysis of COVID-19 cases that were documented in 35 reviews, meta-analyses, case reports, and studies indexed in PubMed from authors in North America, Europe, and Asia.

In this study, the pooled odds ratio for mortality for all patients with any cancer was 2.32 (95% confidence interval, 1.82-2.94; 24 studies). For ICU admission, the odds ratio was 2.39 (95% CI, 1.90-3.02; I2 0.0%; 5 studies). And, for disease severity or hospitalization, it was 2.08 (95% CI, 1.60-2.72; I2 92.1%; 15 studies). The pooled mortality odds ratio for hematologic neoplasms was 2.14 (95% CI, 1.87-2.44; I2 20.8%; 8 studies).

Their findings, which have not yet been peer reviewed, confirmed the results of a similar analysis from China published as a preprint in May 2020. The analysis included 181,323 patients (23,736 cancer patients) from 26 studies reported an odds ratio of 2.54 (95% CI, 1.47-4.42). “Cancer patients with COVID-19 have an increased likelihood of death compared to non-cancer COVID-19 patients,” Venkatesulu et al. wrote. And a systematic review and meta-analysis of five studies of 2,619 patients published in October 2020 in Medicine also found a significantly higher risk of death from COVID-19 among cancer patients (odds ratio, 2.63; 95% confidence interval, 1.14-6.06; P = .023; I2 = 26.4%).

Fakih et al., writing in the journal Hematology/Oncology and Stem Cell Therapy conducted a meta-analysis early last year finding a threefold increase for admission to the intensive care unit, an almost fourfold increase for a severe SARS-CoV-2 infection, and a fivefold increase for being intubated.

The three studies show that mortality rates were higher early in the pandemic “when diagnosis and treatment for SARS-CoV-2 might have been delayed, resulting in higher death rate,” Boffetta et al. wrote, adding that their analysis showed only a twofold increase most likely because it was a year-long analysis.

“Future studies will be able to better analyze this association for the different subtypes of cancer. Furthermore, they will eventually be able to evaluate whether the difference among vaccinated population is reduced,” Boffetta et al. wrote.

The authors noted several limitations for the study, including the fact that many of the studies included in the analysis did not include sex, age, comorbidities, and therapy. Nor were the authors able to analyze specific cancers other than hematologic neoplasms.

The authors declared no conflicts of interest.

A new systematic review and meta-analysis finds that unvaccinated cancer patients who contracted COVID-19 last year, were more than two times more likely – than people without cancer – to develop a case of COVID-19 so severe it required hospitalization in an intensive care unit.

“Our study provides the most precise measure to date of the effect of COVID-19 in cancer patients,” wrote researchers who were led by Paolo Boffetta, MD, MPH, a specialist in population science with the Stony Brook Cancer Center in New York.

Dr. Boffetta and colleagues also found that patients with hematologic neoplasms had a higher mortality rate from COVID-19 comparable to that of all cancers combined.

Cancer patients have long been considered to be among those patients who are at high risk of developing COVID-19, and if they contract the disease, they are at high risk of having poor outcomes. Other high-risk patients include those with hypertension, diabetes, chronic kidney disease, or COPD, or the elderly. But how high the risk of developing severe COVID-19 disease is for cancer patients hasn’t yet been documented on a wide scale.

The study, which was made available as a preprint on medRxiv on Oct. 23, is based on an analysis of COVID-19 cases that were documented in 35 reviews, meta-analyses, case reports, and studies indexed in PubMed from authors in North America, Europe, and Asia.

In this study, the pooled odds ratio for mortality for all patients with any cancer was 2.32 (95% confidence interval, 1.82-2.94; 24 studies). For ICU admission, the odds ratio was 2.39 (95% CI, 1.90-3.02; I2 0.0%; 5 studies). And, for disease severity or hospitalization, it was 2.08 (95% CI, 1.60-2.72; I2 92.1%; 15 studies). The pooled mortality odds ratio for hematologic neoplasms was 2.14 (95% CI, 1.87-2.44; I2 20.8%; 8 studies).

Their findings, which have not yet been peer reviewed, confirmed the results of a similar analysis from China published as a preprint in May 2020. The analysis included 181,323 patients (23,736 cancer patients) from 26 studies reported an odds ratio of 2.54 (95% CI, 1.47-4.42). “Cancer patients with COVID-19 have an increased likelihood of death compared to non-cancer COVID-19 patients,” Venkatesulu et al. wrote. And a systematic review and meta-analysis of five studies of 2,619 patients published in October 2020 in Medicine also found a significantly higher risk of death from COVID-19 among cancer patients (odds ratio, 2.63; 95% confidence interval, 1.14-6.06; P = .023; I2 = 26.4%).

Fakih et al., writing in the journal Hematology/Oncology and Stem Cell Therapy conducted a meta-analysis early last year finding a threefold increase for admission to the intensive care unit, an almost fourfold increase for a severe SARS-CoV-2 infection, and a fivefold increase for being intubated.

The three studies show that mortality rates were higher early in the pandemic “when diagnosis and treatment for SARS-CoV-2 might have been delayed, resulting in higher death rate,” Boffetta et al. wrote, adding that their analysis showed only a twofold increase most likely because it was a year-long analysis.

“Future studies will be able to better analyze this association for the different subtypes of cancer. Furthermore, they will eventually be able to evaluate whether the difference among vaccinated population is reduced,” Boffetta et al. wrote.

The authors noted several limitations for the study, including the fact that many of the studies included in the analysis did not include sex, age, comorbidities, and therapy. Nor were the authors able to analyze specific cancers other than hematologic neoplasms.

The authors declared no conflicts of interest.