Melanoma

A federal advisory panel stressed the need for further research about potential expanded use of devices in detection of skin cancer, with U.S. regulators readying for challenges in determining how well these tools need to work and how to address longstanding issues of racial equity in this field of medicine.

The Food and Drug Administration has scheduled two meetings to gather expert feedback about managing an expected expansion in the use of skin lesion apps and devices. Outside of the United States, there are apps promoted as being able to help spot skin lesions that should trigger a medical visit.

AGA Institute

The general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee began work on this topic on July 28, with a wide-ranging discussion about potential expanded use of computer-aided, skin lesion analyzer (SLA) devices. On Friday, the panel is considering an FDA proposal to shift the designation for an approved device for aiding dermatologists in skin cancer diagnoses from the most stringent regulatory category, class III, to the less restrictive class II.

The FDA called the meeting amid growing interest in using technology to aid in finding cancers, with some of these products already marketed to consumers outside of the United States. There are presently no legally marketed, FDA-cleared or FDA-approved SLA devices indicated for use by clinicians other than dermatologists or the lay public, the agency said in a briefing memo for the meeting. There are two devices with FDA approval, though, for aiding dermatologists. The FDA approved SciBase’s Nevisense in 2017 and Mela Sciences’ MelaFind, which has fallen out of use, in 2012. Both are class III devices.

But some companies intend to offer products for consumers in the United States. The company SkinVision, for example, has developed an app of the same name, which is intended to detect suspicious-looking skin spots via smartphone photos. SkinVision’s website says the product has been offered to consumers in Australia for remote skin checks since 2015. People in the Netherlands and United Kingdom also can use SkinVision, according to the company’s website. SkinVision says the company is working on providing the app for U.S. customers, “but we are not quite there yet.”

During the meeting, FDA panelists repeatedly emphasized the potential risks of these devices in terms of sensitivity (how often a test correctly generates a positive result) and of specificity (how often a test correctly generates a negative result).

New tools intended to aid in detection of skin cancer might produce too many false positives and thus trigger floods of worried patients seeking care and often facing unnecessary biopsies, the FDA panelists said. But more worrisome would be FDA clearance of tools that delivered too many false negative results, leaving people unaware of their cancers.

The standards would have to be set very high for new products, especially those intended for consumers, said FDA panelist Murad Alam, MD, a dermatologist and vice chair of the department of dermatology at Northwestern University, Chicago. Current technologies for analyzing skin lesions are not yet up to that task. Dr. Alam likened the situation to the hopes for self-driving cars.

“It sounds great in principle. If you read the predictions from 20 years ago, it should already have happened,” Dr. Alam said. “But we’re still struggling with that because there are serious points of failure.”

FDA panelist Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York, also argued for well-designed studies to understand how consumers and clinicians would react to new tools.

“We have to define what prospective information, in the intended use setting, we need to feel comfortable saying that these tools could be in a layperson’s hand or a primary care person’s hand,” Dr. Rotemberg said.

The studies would not need to be large, especially in the case of nonmelanoma skin cancer, which is common, she added.

“There’s too much nuance here for us to be able to say: ‘This is what would happen,’ without testing it,” Dr. Rotemberg said. “I do not think these prospective studies would be very burdensome, but they would help us understand what the burden would be and what the costs would be and what the potential harms would be.”

Because of rules against disclosing corporate information, the FDA cannot tell the public about the kinds of inquiries it already may have fielded from companies interested in selling skin cancer detection tools.

But in response to a question during the FDA meeting, Binita Ashar, MD, a top official in the FDA’s Center for Devices and Radiological Health, said there is interest in having these kinds of products sold in the United States as well.

“I can tell you that this a very timely discussion and questions that we’re posing to you are the questions that we’re encountering or that we have been grappling with,” Dr. Ashar said.

FDA panelists noted that many patients cannot get access easily to dermatology visits.

Companies seeking to develop SLA devices likely will market their tools as attempts to fill a gap that now exists in medical care.

But there will be challenges ahead in explaining to patients how to interpret readings from these tools, the FDA panelists said. Consumers should know these tools are meant to assist in diagnosis, and not to make it.

“I’m not sure the layperson will hear that,” said FDA panelist Paula E. Bourelly, MD, a dermatologist from Olney, Md.

As a result, use of SLA tools could create tension between physicians and patients, with consumers demanding biopsies after seeing readings they don’t understand.

“I do have great concerns about the layperson feeling overly confident and reducing the provider to a technician,” she said.

The FDA panelists were not asked to cast formal votes on any issues discussed during the meeting They instead engaged in broad discussions around questions posed by the FDA in three key areas:

• What standards should be used to confirm lesion diagnosis in clinical testing of the accuracy of SLA devices?
• What would be acceptable true false-positive and false-negative results (sensitivity and specificity) for different diagnoses and users?
• How can the FDA address health equity considerations based on variable incidence of skin lesions?

Developing standards

The FDA asked the panel to consider several scenarios for SLA devices and to discuss how standards might vary depending on the user of the device, whether it would be dermatologists, other clinicians, or consumers.

The agency sought comments in particular about using histological diagnosis (core specimen processing with a consensus diagnosis from an expert dermatopathologist panel). In the briefing document for the meeting, the FDA argued that this approach provides the greatest certainty in the diagnosis.

“Device developers, however, cite concerns, both practical and ethical, in requiring biopsy of all lesions, particularly those that appear benign,” the FDA said. “They have proposed alternate means of defining ground truth, including consensus opinion of experts (of visual or dermoscopic examination of the lesion[s]), opinion of one expert (visual or dermoscopic examination), or other methods.”

In summarizing the discussion on this question, the FDA panel chairman, Hobart W. Harris, MD, MPH, a surgeon from the University of California, San Francisco, noted that there was broad support for histological data in clinical trials of SLA devices, with some allowance for cases where more hybrid approaches would be used.

There were also suggestions offered about designing trials and the need for biopsies of lesions that are clearly benign, as this would help gather data to help in developing algorithms.

Dr. Alam said care should be taken in explaining to study participants that they might have to undergo biopsies that they didn’t need, as part of the larger effort to gather data. This should be detailed in the consent form, he said.

“But I also think this is a relatively minor risk,” Dr. Alam said, comparing these biopsies to the blood samples that patients in many clinical studies routinely give.

“Are all of those blood draws necessary to track the change in whatever parameters that are being tracked? Probably not,” Dr. Alam said. “I think it would be possible to explain to a reasonable patient what this entails.”

Dr. Alam noted that companies might face extra hurdles in enrolling study participants and keeping them in the trials if the FDA seeks this kind of biopsy data. “But I don’t think inconvenience to the study sponsor is a good argument” for not seeking this kind of data, he added.

Leaving a loophole where certain kinds of clearly benign lesions don’t require a biopsy would eventually erode the quality of the research done on these devices. “That bar will be moved to accommodate the convenience of the sponsor, to make the study feasible,” Dr. Alam said. “And pretty soon, you’ll be missing a lot of patients that really should have biopsies.”
 

Acceptable rates of false positives, false negatives

The FDA panel chair noted that his colleagues had strongly urged review standards that would require that the devices improve on the rates of successful catches of suspicious lesions and lower false positives. But they did not endorse specific targets regarding the sensitivity and specificity rates.

“No one seems to be comfortable with providing or preordaining” these targets, Dr. Harris said.

Panelist Deneen Hesser, MSHSA, RN, urged a deep recognition of the power of a FDA clearance in the view of consumers.

“We need to be cognizant of what the term ‘FDA approved’ means to the lay individual,” said Ms. Hesser, who served as the patient representative on the panel. “A patient who sees that those tools are FDA approved will assume that each of those is the gold standard” in terms of expectations for delivering accurate results.

Like many of the panelists, Dr. Rotemberg urged the FDA to gather data about how patients would react to different messages encoded in consumer-oriented products.

Memorial Sloan Kettering Cancer Center

“If the device says: ‘You should see a dermatologist for this’ and no other information, that’s very different from [saying]: ‘That lesion is suspicious for melanoma,’ ” Dr. Rotemberg said.

Despite the likely difficulties in conducting trials, the FDA needs to have the data to answer key questions about patient and physician reactions to readings from new tools, Dr. Rotemberg said.

“We don’t know how many additional biopsies we would cause with a specificity of 80%” for a new SLA tool, Dr. Rotemberg said, giving an example. “We don’t know how confident a dermatologist might be to say: ‘Actually, I’m not suspicious about that lesion and we can just fudge it or not biopsy it.’ We don’t know any of that until we study it in real life.”

The panelists also urged the FDA to seek to ensure that new tools used in analyzing skin lesions improve the quality of diagnosis.
 

Addressing equity

The FDA also asked the panel to weigh in on whether the agency should clear SLA tools in cases where the existing study data is drawn heavily from people considered to be at higher risk for skin cancer.

No credit needed per U.S. gov work.

“To ensure generalizability across the entire U.S. population, should FDA require SLAs indicated for use beyond cancerous lesions be tested in a representative U.S. population?” the FDA asked.

The three most common skin cancers – melanoma, basal cell carcinoma, and squamous cell carcinoma – are more prevalent in people with Fitzpatrick I and II skin types, who tend to get sunburns, not tans. But people of color are more likely to develop melanoma in areas that are not sun exposed, such as the sole of the foot or under fingernails or toenails.

“Due in part to lower expected risk and screening, these melanomas are often detected late,” the FDA said in the briefing document.

There was broad consensus among panelists that the FDA should encourage companies to enroll people with all skin types and tones.

But they also looked for ways that the FDA could clear devices based on initial studies conducted largely with people considered to be at higher risk, with the agency then requiring follow-up trials to see how these products would work for the general U.S. population.

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

A federal advisory panel stressed the need for further research about potential expanded use of devices in detection of skin cancer, with U.S. regulators readying for challenges in determining how well these tools need to work and how to address longstanding issues of racial equity in this field of medicine.

The Food and Drug Administration has scheduled two meetings to gather expert feedback about managing an expected expansion in the use of skin lesion apps and devices. Outside of the United States, there are apps promoted as being able to help spot skin lesions that should trigger a medical visit.

AGA Institute

The general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee began work on this topic on July 28, with a wide-ranging discussion about potential expanded use of computer-aided, skin lesion analyzer (SLA) devices. On Friday, the panel is considering an FDA proposal to shift the designation for an approved device for aiding dermatologists in skin cancer diagnoses from the most stringent regulatory category, class III, to the less restrictive class II.

The FDA called the meeting amid growing interest in using technology to aid in finding cancers, with some of these products already marketed to consumers outside of the United States. There are presently no legally marketed, FDA-cleared or FDA-approved SLA devices indicated for use by clinicians other than dermatologists or the lay public, the agency said in a briefing memo for the meeting. There are two devices with FDA approval, though, for aiding dermatologists. The FDA approved SciBase’s Nevisense in 2017 and Mela Sciences’ MelaFind, which has fallen out of use, in 2012. Both are class III devices.

But some companies intend to offer products for consumers in the United States. The company SkinVision, for example, has developed an app of the same name, which is intended to detect suspicious-looking skin spots via smartphone photos. SkinVision’s website says the product has been offered to consumers in Australia for remote skin checks since 2015. People in the Netherlands and United Kingdom also can use SkinVision, according to the company’s website. SkinVision says the company is working on providing the app for U.S. customers, “but we are not quite there yet.”

During the meeting, FDA panelists repeatedly emphasized the potential risks of these devices in terms of sensitivity (how often a test correctly generates a positive result) and of specificity (how often a test correctly generates a negative result).

New tools intended to aid in detection of skin cancer might produce too many false positives and thus trigger floods of worried patients seeking care and often facing unnecessary biopsies, the FDA panelists said. But more worrisome would be FDA clearance of tools that delivered too many false negative results, leaving people unaware of their cancers.

The standards would have to be set very high for new products, especially those intended for consumers, said FDA panelist Murad Alam, MD, a dermatologist and vice chair of the department of dermatology at Northwestern University, Chicago. Current technologies for analyzing skin lesions are not yet up to that task. Dr. Alam likened the situation to the hopes for self-driving cars.

“It sounds great in principle. If you read the predictions from 20 years ago, it should already have happened,” Dr. Alam said. “But we’re still struggling with that because there are serious points of failure.”

FDA panelist Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York, also argued for well-designed studies to understand how consumers and clinicians would react to new tools.

“We have to define what prospective information, in the intended use setting, we need to feel comfortable saying that these tools could be in a layperson’s hand or a primary care person’s hand,” Dr. Rotemberg said.

The studies would not need to be large, especially in the case of nonmelanoma skin cancer, which is common, she added.

“There’s too much nuance here for us to be able to say: ‘This is what would happen,’ without testing it,” Dr. Rotemberg said. “I do not think these prospective studies would be very burdensome, but they would help us understand what the burden would be and what the costs would be and what the potential harms would be.”

Because of rules against disclosing corporate information, the FDA cannot tell the public about the kinds of inquiries it already may have fielded from companies interested in selling skin cancer detection tools.

But in response to a question during the FDA meeting, Binita Ashar, MD, a top official in the FDA’s Center for Devices and Radiological Health, said there is interest in having these kinds of products sold in the United States as well.

“I can tell you that this a very timely discussion and questions that we’re posing to you are the questions that we’re encountering or that we have been grappling with,” Dr. Ashar said.

FDA panelists noted that many patients cannot get access easily to dermatology visits.

Companies seeking to develop SLA devices likely will market their tools as attempts to fill a gap that now exists in medical care.

But there will be challenges ahead in explaining to patients how to interpret readings from these tools, the FDA panelists said. Consumers should know these tools are meant to assist in diagnosis, and not to make it.

“I’m not sure the layperson will hear that,” said FDA panelist Paula E. Bourelly, MD, a dermatologist from Olney, Md.

As a result, use of SLA tools could create tension between physicians and patients, with consumers demanding biopsies after seeing readings they don’t understand.

“I do have great concerns about the layperson feeling overly confident and reducing the provider to a technician,” she said.

The FDA panelists were not asked to cast formal votes on any issues discussed during the meeting They instead engaged in broad discussions around questions posed by the FDA in three key areas:

• What standards should be used to confirm lesion diagnosis in clinical testing of the accuracy of SLA devices?
• What would be acceptable true false-positive and false-negative results (sensitivity and specificity) for different diagnoses and users?
• How can the FDA address health equity considerations based on variable incidence of skin lesions?

Developing standards

The FDA asked the panel to consider several scenarios for SLA devices and to discuss how standards might vary depending on the user of the device, whether it would be dermatologists, other clinicians, or consumers.

The agency sought comments in particular about using histological diagnosis (core specimen processing with a consensus diagnosis from an expert dermatopathologist panel). In the briefing document for the meeting, the FDA argued that this approach provides the greatest certainty in the diagnosis.

“Device developers, however, cite concerns, both practical and ethical, in requiring biopsy of all lesions, particularly those that appear benign,” the FDA said. “They have proposed alternate means of defining ground truth, including consensus opinion of experts (of visual or dermoscopic examination of the lesion[s]), opinion of one expert (visual or dermoscopic examination), or other methods.”

In summarizing the discussion on this question, the FDA panel chairman, Hobart W. Harris, MD, MPH, a surgeon from the University of California, San Francisco, noted that there was broad support for histological data in clinical trials of SLA devices, with some allowance for cases where more hybrid approaches would be used.

There were also suggestions offered about designing trials and the need for biopsies of lesions that are clearly benign, as this would help gather data to help in developing algorithms.

Dr. Alam said care should be taken in explaining to study participants that they might have to undergo biopsies that they didn’t need, as part of the larger effort to gather data. This should be detailed in the consent form, he said.

“But I also think this is a relatively minor risk,” Dr. Alam said, comparing these biopsies to the blood samples that patients in many clinical studies routinely give.

“Are all of those blood draws necessary to track the change in whatever parameters that are being tracked? Probably not,” Dr. Alam said. “I think it would be possible to explain to a reasonable patient what this entails.”

Dr. Alam noted that companies might face extra hurdles in enrolling study participants and keeping them in the trials if the FDA seeks this kind of biopsy data. “But I don’t think inconvenience to the study sponsor is a good argument” for not seeking this kind of data, he added.

Leaving a loophole where certain kinds of clearly benign lesions don’t require a biopsy would eventually erode the quality of the research done on these devices. “That bar will be moved to accommodate the convenience of the sponsor, to make the study feasible,” Dr. Alam said. “And pretty soon, you’ll be missing a lot of patients that really should have biopsies.”
 

Acceptable rates of false positives, false negatives

The FDA panel chair noted that his colleagues had strongly urged review standards that would require that the devices improve on the rates of successful catches of suspicious lesions and lower false positives. But they did not endorse specific targets regarding the sensitivity and specificity rates.

“No one seems to be comfortable with providing or preordaining” these targets, Dr. Harris said.

Panelist Deneen Hesser, MSHSA, RN, urged a deep recognition of the power of a FDA clearance in the view of consumers.

“We need to be cognizant of what the term ‘FDA approved’ means to the lay individual,” said Ms. Hesser, who served as the patient representative on the panel. “A patient who sees that those tools are FDA approved will assume that each of those is the gold standard” in terms of expectations for delivering accurate results.

Like many of the panelists, Dr. Rotemberg urged the FDA to gather data about how patients would react to different messages encoded in consumer-oriented products.

Memorial Sloan Kettering Cancer Center

“If the device says: ‘You should see a dermatologist for this’ and no other information, that’s very different from [saying]: ‘That lesion is suspicious for melanoma,’ ” Dr. Rotemberg said.

Despite the likely difficulties in conducting trials, the FDA needs to have the data to answer key questions about patient and physician reactions to readings from new tools, Dr. Rotemberg said.

“We don’t know how many additional biopsies we would cause with a specificity of 80%” for a new SLA tool, Dr. Rotemberg said, giving an example. “We don’t know how confident a dermatologist might be to say: ‘Actually, I’m not suspicious about that lesion and we can just fudge it or not biopsy it.’ We don’t know any of that until we study it in real life.”

The panelists also urged the FDA to seek to ensure that new tools used in analyzing skin lesions improve the quality of diagnosis.
 

Addressing equity

The FDA also asked the panel to weigh in on whether the agency should clear SLA tools in cases where the existing study data is drawn heavily from people considered to be at higher risk for skin cancer.

No credit needed per U.S. gov work.

“To ensure generalizability across the entire U.S. population, should FDA require SLAs indicated for use beyond cancerous lesions be tested in a representative U.S. population?” the FDA asked.

The three most common skin cancers – melanoma, basal cell carcinoma, and squamous cell carcinoma – are more prevalent in people with Fitzpatrick I and II skin types, who tend to get sunburns, not tans. But people of color are more likely to develop melanoma in areas that are not sun exposed, such as the sole of the foot or under fingernails or toenails.

“Due in part to lower expected risk and screening, these melanomas are often detected late,” the FDA said in the briefing document.

There was broad consensus among panelists that the FDA should encourage companies to enroll people with all skin types and tones.

But they also looked for ways that the FDA could clear devices based on initial studies conducted largely with people considered to be at higher risk, with the agency then requiring follow-up trials to see how these products would work for the general U.S. population.

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

A federal advisory panel stressed the need for further research about potential expanded use of devices in detection of skin cancer, with U.S. regulators readying for challenges in determining how well these tools need to work and how to address longstanding issues of racial equity in this field of medicine.

The Food and Drug Administration has scheduled two meetings to gather expert feedback about managing an expected expansion in the use of skin lesion apps and devices. Outside of the United States, there are apps promoted as being able to help spot skin lesions that should trigger a medical visit.

AGA Institute

The general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee began work on this topic on July 28, with a wide-ranging discussion about potential expanded use of computer-aided, skin lesion analyzer (SLA) devices. On Friday, the panel is considering an FDA proposal to shift the designation for an approved device for aiding dermatologists in skin cancer diagnoses from the most stringent regulatory category, class III, to the less restrictive class II.

The FDA called the meeting amid growing interest in using technology to aid in finding cancers, with some of these products already marketed to consumers outside of the United States. There are presently no legally marketed, FDA-cleared or FDA-approved SLA devices indicated for use by clinicians other than dermatologists or the lay public, the agency said in a briefing memo for the meeting. There are two devices with FDA approval, though, for aiding dermatologists. The FDA approved SciBase’s Nevisense in 2017 and Mela Sciences’ MelaFind, which has fallen out of use, in 2012. Both are class III devices.

But some companies intend to offer products for consumers in the United States. The company SkinVision, for example, has developed an app of the same name, which is intended to detect suspicious-looking skin spots via smartphone photos. SkinVision’s website says the product has been offered to consumers in Australia for remote skin checks since 2015. People in the Netherlands and United Kingdom also can use SkinVision, according to the company’s website. SkinVision says the company is working on providing the app for U.S. customers, “but we are not quite there yet.”

During the meeting, FDA panelists repeatedly emphasized the potential risks of these devices in terms of sensitivity (how often a test correctly generates a positive result) and of specificity (how often a test correctly generates a negative result).

New tools intended to aid in detection of skin cancer might produce too many false positives and thus trigger floods of worried patients seeking care and often facing unnecessary biopsies, the FDA panelists said. But more worrisome would be FDA clearance of tools that delivered too many false negative results, leaving people unaware of their cancers.

The standards would have to be set very high for new products, especially those intended for consumers, said FDA panelist Murad Alam, MD, a dermatologist and vice chair of the department of dermatology at Northwestern University, Chicago. Current technologies for analyzing skin lesions are not yet up to that task. Dr. Alam likened the situation to the hopes for self-driving cars.

“It sounds great in principle. If you read the predictions from 20 years ago, it should already have happened,” Dr. Alam said. “But we’re still struggling with that because there are serious points of failure.”

FDA panelist Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York, also argued for well-designed studies to understand how consumers and clinicians would react to new tools.

“We have to define what prospective information, in the intended use setting, we need to feel comfortable saying that these tools could be in a layperson’s hand or a primary care person’s hand,” Dr. Rotemberg said.

The studies would not need to be large, especially in the case of nonmelanoma skin cancer, which is common, she added.

“There’s too much nuance here for us to be able to say: ‘This is what would happen,’ without testing it,” Dr. Rotemberg said. “I do not think these prospective studies would be very burdensome, but they would help us understand what the burden would be and what the costs would be and what the potential harms would be.”

Because of rules against disclosing corporate information, the FDA cannot tell the public about the kinds of inquiries it already may have fielded from companies interested in selling skin cancer detection tools.

But in response to a question during the FDA meeting, Binita Ashar, MD, a top official in the FDA’s Center for Devices and Radiological Health, said there is interest in having these kinds of products sold in the United States as well.

“I can tell you that this a very timely discussion and questions that we’re posing to you are the questions that we’re encountering or that we have been grappling with,” Dr. Ashar said.

FDA panelists noted that many patients cannot get access easily to dermatology visits.

Companies seeking to develop SLA devices likely will market their tools as attempts to fill a gap that now exists in medical care.

But there will be challenges ahead in explaining to patients how to interpret readings from these tools, the FDA panelists said. Consumers should know these tools are meant to assist in diagnosis, and not to make it.

“I’m not sure the layperson will hear that,” said FDA panelist Paula E. Bourelly, MD, a dermatologist from Olney, Md.

As a result, use of SLA tools could create tension between physicians and patients, with consumers demanding biopsies after seeing readings they don’t understand.

“I do have great concerns about the layperson feeling overly confident and reducing the provider to a technician,” she said.

The FDA panelists were not asked to cast formal votes on any issues discussed during the meeting They instead engaged in broad discussions around questions posed by the FDA in three key areas:

• What standards should be used to confirm lesion diagnosis in clinical testing of the accuracy of SLA devices?
• What would be acceptable true false-positive and false-negative results (sensitivity and specificity) for different diagnoses and users?
• How can the FDA address health equity considerations based on variable incidence of skin lesions?

Developing standards

The FDA asked the panel to consider several scenarios for SLA devices and to discuss how standards might vary depending on the user of the device, whether it would be dermatologists, other clinicians, or consumers.

The agency sought comments in particular about using histological diagnosis (core specimen processing with a consensus diagnosis from an expert dermatopathologist panel). In the briefing document for the meeting, the FDA argued that this approach provides the greatest certainty in the diagnosis.

“Device developers, however, cite concerns, both practical and ethical, in requiring biopsy of all lesions, particularly those that appear benign,” the FDA said. “They have proposed alternate means of defining ground truth, including consensus opinion of experts (of visual or dermoscopic examination of the lesion[s]), opinion of one expert (visual or dermoscopic examination), or other methods.”

In summarizing the discussion on this question, the FDA panel chairman, Hobart W. Harris, MD, MPH, a surgeon from the University of California, San Francisco, noted that there was broad support for histological data in clinical trials of SLA devices, with some allowance for cases where more hybrid approaches would be used.

There were also suggestions offered about designing trials and the need for biopsies of lesions that are clearly benign, as this would help gather data to help in developing algorithms.

Dr. Alam said care should be taken in explaining to study participants that they might have to undergo biopsies that they didn’t need, as part of the larger effort to gather data. This should be detailed in the consent form, he said.

“But I also think this is a relatively minor risk,” Dr. Alam said, comparing these biopsies to the blood samples that patients in many clinical studies routinely give.

“Are all of those blood draws necessary to track the change in whatever parameters that are being tracked? Probably not,” Dr. Alam said. “I think it would be possible to explain to a reasonable patient what this entails.”

Dr. Alam noted that companies might face extra hurdles in enrolling study participants and keeping them in the trials if the FDA seeks this kind of biopsy data. “But I don’t think inconvenience to the study sponsor is a good argument” for not seeking this kind of data, he added.

Leaving a loophole where certain kinds of clearly benign lesions don’t require a biopsy would eventually erode the quality of the research done on these devices. “That bar will be moved to accommodate the convenience of the sponsor, to make the study feasible,” Dr. Alam said. “And pretty soon, you’ll be missing a lot of patients that really should have biopsies.”
 

Acceptable rates of false positives, false negatives

The FDA panel chair noted that his colleagues had strongly urged review standards that would require that the devices improve on the rates of successful catches of suspicious lesions and lower false positives. But they did not endorse specific targets regarding the sensitivity and specificity rates.

“No one seems to be comfortable with providing or preordaining” these targets, Dr. Harris said.

Panelist Deneen Hesser, MSHSA, RN, urged a deep recognition of the power of a FDA clearance in the view of consumers.

“We need to be cognizant of what the term ‘FDA approved’ means to the lay individual,” said Ms. Hesser, who served as the patient representative on the panel. “A patient who sees that those tools are FDA approved will assume that each of those is the gold standard” in terms of expectations for delivering accurate results.

Like many of the panelists, Dr. Rotemberg urged the FDA to gather data about how patients would react to different messages encoded in consumer-oriented products.

Memorial Sloan Kettering Cancer Center

“If the device says: ‘You should see a dermatologist for this’ and no other information, that’s very different from [saying]: ‘That lesion is suspicious for melanoma,’ ” Dr. Rotemberg said.

Despite the likely difficulties in conducting trials, the FDA needs to have the data to answer key questions about patient and physician reactions to readings from new tools, Dr. Rotemberg said.

“We don’t know how many additional biopsies we would cause with a specificity of 80%” for a new SLA tool, Dr. Rotemberg said, giving an example. “We don’t know how confident a dermatologist might be to say: ‘Actually, I’m not suspicious about that lesion and we can just fudge it or not biopsy it.’ We don’t know any of that until we study it in real life.”

The panelists also urged the FDA to seek to ensure that new tools used in analyzing skin lesions improve the quality of diagnosis.
 

Addressing equity

The FDA also asked the panel to weigh in on whether the agency should clear SLA tools in cases where the existing study data is drawn heavily from people considered to be at higher risk for skin cancer.

No credit needed per U.S. gov work.

“To ensure generalizability across the entire U.S. population, should FDA require SLAs indicated for use beyond cancerous lesions be tested in a representative U.S. population?” the FDA asked.

The three most common skin cancers – melanoma, basal cell carcinoma, and squamous cell carcinoma – are more prevalent in people with Fitzpatrick I and II skin types, who tend to get sunburns, not tans. But people of color are more likely to develop melanoma in areas that are not sun exposed, such as the sole of the foot or under fingernails or toenails.

“Due in part to lower expected risk and screening, these melanomas are often detected late,” the FDA said in the briefing document.

There was broad consensus among panelists that the FDA should encourage companies to enroll people with all skin types and tones.

But they also looked for ways that the FDA could clear devices based on initial studies conducted largely with people considered to be at higher risk, with the agency then requiring follow-up trials to see how these products would work for the general U.S. population.

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

Amazon is working with the Fred Hutchinson Cancer Research Center to develop cancer vaccines in a new clinical trial.

The trial is aimed at finding “personalized vaccines” to treat breast cancer and melanoma. The phase 1 trial is recruiting 20 people over the age of 18 to study the safety of the vaccines, according to CNBC.

The Fred Hutchinson Cancer Research Center and University of Washington Cancer Consortium are listed as the researchers of the clinical trial, and Amazon is listed as a collaborator, according to a filing on the ClinicalTrials.gov database.

“Amazon is contributing scientific and machine learning expertise to a partnership with Fred Hutch to explore the development of a personalized treatment for certain forms of cancer,” an Amazon spokesperson told CNBC.

“It’s very early, but Fred Hutch recently received permission from the U.S. Food and Drug Administration to proceed with a phase 1 clinical trial, and it’s unclear whether it will be successful,” the spokesperson said. “This will be a long, multiyear process – should it progress, we would be open to working with other organizations in health care and life sciences that might also be interested in similar efforts.”

In recent years, Amazon has grown its presence in the health care industry, CNBC reported. The company launched an online pharmacy in 2020, developed a telehealth service called Amazon Care, and released its own COVID-19 test during the pandemic.

A research and development group inside Amazon, known as Grand Challenge, oversaw the company’s early cancer vaccine effort, according to Business Insider. It’s now under the purview of a cancer research team that reports to Robert Williams, the company’s vice president of devices.

The study was first posted on ClinicalTrials.gov in October 2021 and began recruiting patients on June 9, according to the filing. The phase 1 trial is expected to run through November 2023.

The phase 1 trial will study the safety of personalized vaccines to treat patients with late-stage melanoma or hormone receptor-positive HER2-negative breast cancer which has either spread to other parts of the body or doesn’t respond to treatment.

More information about the study can be found on ClinicalTrials.gov under the identifier NCT05098210.

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

Amazon is working with the Fred Hutchinson Cancer Research Center to develop cancer vaccines in a new clinical trial.

The trial is aimed at finding “personalized vaccines” to treat breast cancer and melanoma. The phase 1 trial is recruiting 20 people over the age of 18 to study the safety of the vaccines, according to CNBC.

The Fred Hutchinson Cancer Research Center and University of Washington Cancer Consortium are listed as the researchers of the clinical trial, and Amazon is listed as a collaborator, according to a filing on the ClinicalTrials.gov database.

“Amazon is contributing scientific and machine learning expertise to a partnership with Fred Hutch to explore the development of a personalized treatment for certain forms of cancer,” an Amazon spokesperson told CNBC.

“It’s very early, but Fred Hutch recently received permission from the U.S. Food and Drug Administration to proceed with a phase 1 clinical trial, and it’s unclear whether it will be successful,” the spokesperson said. “This will be a long, multiyear process – should it progress, we would be open to working with other organizations in health care and life sciences that might also be interested in similar efforts.”

In recent years, Amazon has grown its presence in the health care industry, CNBC reported. The company launched an online pharmacy in 2020, developed a telehealth service called Amazon Care, and released its own COVID-19 test during the pandemic.

A research and development group inside Amazon, known as Grand Challenge, oversaw the company’s early cancer vaccine effort, according to Business Insider. It’s now under the purview of a cancer research team that reports to Robert Williams, the company’s vice president of devices.

The study was first posted on ClinicalTrials.gov in October 2021 and began recruiting patients on June 9, according to the filing. The phase 1 trial is expected to run through November 2023.

The phase 1 trial will study the safety of personalized vaccines to treat patients with late-stage melanoma or hormone receptor-positive HER2-negative breast cancer which has either spread to other parts of the body or doesn’t respond to treatment.

More information about the study can be found on ClinicalTrials.gov under the identifier NCT05098210.

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

Amazon is working with the Fred Hutchinson Cancer Research Center to develop cancer vaccines in a new clinical trial.

The trial is aimed at finding “personalized vaccines” to treat breast cancer and melanoma. The phase 1 trial is recruiting 20 people over the age of 18 to study the safety of the vaccines, according to CNBC.

The Fred Hutchinson Cancer Research Center and University of Washington Cancer Consortium are listed as the researchers of the clinical trial, and Amazon is listed as a collaborator, according to a filing on the ClinicalTrials.gov database.

“Amazon is contributing scientific and machine learning expertise to a partnership with Fred Hutch to explore the development of a personalized treatment for certain forms of cancer,” an Amazon spokesperson told CNBC.

“It’s very early, but Fred Hutch recently received permission from the U.S. Food and Drug Administration to proceed with a phase 1 clinical trial, and it’s unclear whether it will be successful,” the spokesperson said. “This will be a long, multiyear process – should it progress, we would be open to working with other organizations in health care and life sciences that might also be interested in similar efforts.”

In recent years, Amazon has grown its presence in the health care industry, CNBC reported. The company launched an online pharmacy in 2020, developed a telehealth service called Amazon Care, and released its own COVID-19 test during the pandemic.

A research and development group inside Amazon, known as Grand Challenge, oversaw the company’s early cancer vaccine effort, according to Business Insider. It’s now under the purview of a cancer research team that reports to Robert Williams, the company’s vice president of devices.

The study was first posted on ClinicalTrials.gov in October 2021 and began recruiting patients on June 9, according to the filing. The phase 1 trial is expected to run through November 2023.

The phase 1 trial will study the safety of personalized vaccines to treat patients with late-stage melanoma or hormone receptor-positive HER2-negative breast cancer which has either spread to other parts of the body or doesn’t respond to treatment.

More information about the study can be found on ClinicalTrials.gov under the identifier NCT05098210.

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

CHICAGO – Pembrolizumab has shown promise as adjuvant therapy for stage IIB and IIC melanoma, shows the first interim analysis of the phase 3 KEYNOTE-716 study recently published in The Lancet.

The findings meet an unmet need as the recurrence risk in stage IIB and IIC melanoma is “underrecognized,” said author Georgina Long, MD, comedical director of the Melanoma Institute Australia, University of Sydney.

In fact, their risk of recurrence is similar to patients with stage IIIB disease, wrote David Killock, PhD, in a related commentary published in Nature Reviews.

The adjuvant treatment resulted in an 89% recurrence-free survival in patients who received pembrolizumab, compared with 83% of patients in the placebo group (hazard ratio, 0.65; P = .0066). These findings were used as the basis for Food and Drug Administration approval of pembrolizumab (Keytruda, Merck) for this patient population in December 2021.

Despite the positive findings, Dr. Killock called for more research on distant metastasis-free survival, overall survival, and quality of life data to “establish the true clinical benefit of adjuvant pembrolizumab.”

At the annual meeting of the American Society of Clinical Oncology, Dr. Long presented the third interim analysis which showed pembrolizumab reduced recurrence and distant metastases at 24 months, although the clinical benefit was relatively small at an approximately 8% improvement in recurrence-free survival and about a 6% improvement in distant metastasis-free survival. About 83% in the pembrolizumab group had treatment-related toxicities versus 64% in the placebo group. There were no deaths caused by treatment. About 90% of pembrolizumab-related endocrinopathies led to long-term hormone replacement.

In a discussion that followed the presentation at ASCO, Charlotte Eielson Ariyan, MD, PhD, said the results are bittersweet. Higher-risk stage IIC patients have a risk of recurrence of about 40%. “It’s high, but the absolute risk reduction is about 8%. This is a very personalized discussion with the patient and the physician in understanding their risk of toxicity is about 17% and higher than their absolute risk reduction with the treatment. For me, this is a bitter pill to swallow because you’re treating people longer and you’re not sure if you’re really helping them. Until we can further define who the highest-risk patients are, I think it’s hard to give it to everyone,” said Dr. Ariyan, who is a surgeon with Memorial Sloan Kettering Cancer Center, New York.

In addition to weighing short-term benefits and toxicity, there are longer-term concerns. Toxicity experienced from PD-1 inhibitors in the adjuvant setting could impact future treatment decisions. “We’re very lucky here in melanoma to know that systemic therapies are effective and we can cure people who recur. I would argue this is why we probably will never really see a difference in the survival benefit in this group because people who cross over will probably do well,” Dr. Ariyan said.

During the Q&A session, Vernon Sondek, MD, Moffitt Cancer Center, Tampa, encouraged physician colleagues to have an open mind about treatments. “Beware of dogma. We thought that adjuvant immunotherapy works much better in patients with ulcerated primary tumors. That’s a dogma in some parts of the world. Yet the T4a patients in KEYNOTE-716 dramatically outperformed the ulcerated T3b and T4b [patients]. We still don’t know what we don’t know.”
 

The study details

KEYNOTE-716 included 976 patients 12 years or older with newly diagnosed completely resected stage IIB or IIC melanoma with a negative sentinel lymph node. Patients were randomized to placebo or 200 mg pembrolizumab every 3 weeks, or 2 mg/kg in pediatric patients, over 17 cycles. Almost 40% of patients were age 65 or older. T3b and T4b were the most common melanoma subcategories at 41% and 35%, respectively.

The planned third interim analysis occurred after the occurrence of 146 distant metastases. After a median follow-up of 27.4 months, distant metastasis-free survival favored the pembrolizumab group (HR, 0.64; P = .0029). At 24 months, the pembrolizumab group had a higher distant metastasis-free survival at 88.1% versus 82.2% and a lower recurrence rate at 81.2% versus 72.8% (HR, 0.64; 95% confidence interval, 0.50-0.84).

At 24 months, only the T4a patients had a statistically significant reduction in distant metastases at 58% (HR, 0.42; 95% CI, 0.19-0.96), although there were numerical reductions in T3a (HR, 0.71; 95% CI, 0.41-1.22) and T4b (HR, 0.70; 95% CI, 0.44-1.33) patients. Of patients experiencing a distant metastasis, 73% of the placebo group had a first distant metastasis to the lung compared with 49% of the pembrolizumab group.

Dr. Long has held consulting or advisory roles for Merck Sharpe & Dohme, which funded this study.

CHICAGO – Pembrolizumab has shown promise as adjuvant therapy for stage IIB and IIC melanoma, shows the first interim analysis of the phase 3 KEYNOTE-716 study recently published in The Lancet.

The findings meet an unmet need as the recurrence risk in stage IIB and IIC melanoma is “underrecognized,” said author Georgina Long, MD, comedical director of the Melanoma Institute Australia, University of Sydney.

In fact, their risk of recurrence is similar to patients with stage IIIB disease, wrote David Killock, PhD, in a related commentary published in Nature Reviews.

The adjuvant treatment resulted in an 89% recurrence-free survival in patients who received pembrolizumab, compared with 83% of patients in the placebo group (hazard ratio, 0.65; P = .0066). These findings were used as the basis for Food and Drug Administration approval of pembrolizumab (Keytruda, Merck) for this patient population in December 2021.

Despite the positive findings, Dr. Killock called for more research on distant metastasis-free survival, overall survival, and quality of life data to “establish the true clinical benefit of adjuvant pembrolizumab.”

At the annual meeting of the American Society of Clinical Oncology, Dr. Long presented the third interim analysis which showed pembrolizumab reduced recurrence and distant metastases at 24 months, although the clinical benefit was relatively small at an approximately 8% improvement in recurrence-free survival and about a 6% improvement in distant metastasis-free survival. About 83% in the pembrolizumab group had treatment-related toxicities versus 64% in the placebo group. There were no deaths caused by treatment. About 90% of pembrolizumab-related endocrinopathies led to long-term hormone replacement.

In a discussion that followed the presentation at ASCO, Charlotte Eielson Ariyan, MD, PhD, said the results are bittersweet. Higher-risk stage IIC patients have a risk of recurrence of about 40%. “It’s high, but the absolute risk reduction is about 8%. This is a very personalized discussion with the patient and the physician in understanding their risk of toxicity is about 17% and higher than their absolute risk reduction with the treatment. For me, this is a bitter pill to swallow because you’re treating people longer and you’re not sure if you’re really helping them. Until we can further define who the highest-risk patients are, I think it’s hard to give it to everyone,” said Dr. Ariyan, who is a surgeon with Memorial Sloan Kettering Cancer Center, New York.

In addition to weighing short-term benefits and toxicity, there are longer-term concerns. Toxicity experienced from PD-1 inhibitors in the adjuvant setting could impact future treatment decisions. “We’re very lucky here in melanoma to know that systemic therapies are effective and we can cure people who recur. I would argue this is why we probably will never really see a difference in the survival benefit in this group because people who cross over will probably do well,” Dr. Ariyan said.

During the Q&A session, Vernon Sondek, MD, Moffitt Cancer Center, Tampa, encouraged physician colleagues to have an open mind about treatments. “Beware of dogma. We thought that adjuvant immunotherapy works much better in patients with ulcerated primary tumors. That’s a dogma in some parts of the world. Yet the T4a patients in KEYNOTE-716 dramatically outperformed the ulcerated T3b and T4b [patients]. We still don’t know what we don’t know.”
 

The study details

KEYNOTE-716 included 976 patients 12 years or older with newly diagnosed completely resected stage IIB or IIC melanoma with a negative sentinel lymph node. Patients were randomized to placebo or 200 mg pembrolizumab every 3 weeks, or 2 mg/kg in pediatric patients, over 17 cycles. Almost 40% of patients were age 65 or older. T3b and T4b were the most common melanoma subcategories at 41% and 35%, respectively.

The planned third interim analysis occurred after the occurrence of 146 distant metastases. After a median follow-up of 27.4 months, distant metastasis-free survival favored the pembrolizumab group (HR, 0.64; P = .0029). At 24 months, the pembrolizumab group had a higher distant metastasis-free survival at 88.1% versus 82.2% and a lower recurrence rate at 81.2% versus 72.8% (HR, 0.64; 95% confidence interval, 0.50-0.84).

At 24 months, only the T4a patients had a statistically significant reduction in distant metastases at 58% (HR, 0.42; 95% CI, 0.19-0.96), although there were numerical reductions in T3a (HR, 0.71; 95% CI, 0.41-1.22) and T4b (HR, 0.70; 95% CI, 0.44-1.33) patients. Of patients experiencing a distant metastasis, 73% of the placebo group had a first distant metastasis to the lung compared with 49% of the pembrolizumab group.

Dr. Long has held consulting or advisory roles for Merck Sharpe & Dohme, which funded this study.

CHICAGO – Pembrolizumab has shown promise as adjuvant therapy for stage IIB and IIC melanoma, shows the first interim analysis of the phase 3 KEYNOTE-716 study recently published in The Lancet.

The findings meet an unmet need as the recurrence risk in stage IIB and IIC melanoma is “underrecognized,” said author Georgina Long, MD, comedical director of the Melanoma Institute Australia, University of Sydney.

In fact, their risk of recurrence is similar to patients with stage IIIB disease, wrote David Killock, PhD, in a related commentary published in Nature Reviews.

The adjuvant treatment resulted in an 89% recurrence-free survival in patients who received pembrolizumab, compared with 83% of patients in the placebo group (hazard ratio, 0.65; P = .0066). These findings were used as the basis for Food and Drug Administration approval of pembrolizumab (Keytruda, Merck) for this patient population in December 2021.

Despite the positive findings, Dr. Killock called for more research on distant metastasis-free survival, overall survival, and quality of life data to “establish the true clinical benefit of adjuvant pembrolizumab.”

At the annual meeting of the American Society of Clinical Oncology, Dr. Long presented the third interim analysis which showed pembrolizumab reduced recurrence and distant metastases at 24 months, although the clinical benefit was relatively small at an approximately 8% improvement in recurrence-free survival and about a 6% improvement in distant metastasis-free survival. About 83% in the pembrolizumab group had treatment-related toxicities versus 64% in the placebo group. There were no deaths caused by treatment. About 90% of pembrolizumab-related endocrinopathies led to long-term hormone replacement.

In a discussion that followed the presentation at ASCO, Charlotte Eielson Ariyan, MD, PhD, said the results are bittersweet. Higher-risk stage IIC patients have a risk of recurrence of about 40%. “It’s high, but the absolute risk reduction is about 8%. This is a very personalized discussion with the patient and the physician in understanding their risk of toxicity is about 17% and higher than their absolute risk reduction with the treatment. For me, this is a bitter pill to swallow because you’re treating people longer and you’re not sure if you’re really helping them. Until we can further define who the highest-risk patients are, I think it’s hard to give it to everyone,” said Dr. Ariyan, who is a surgeon with Memorial Sloan Kettering Cancer Center, New York.

In addition to weighing short-term benefits and toxicity, there are longer-term concerns. Toxicity experienced from PD-1 inhibitors in the adjuvant setting could impact future treatment decisions. “We’re very lucky here in melanoma to know that systemic therapies are effective and we can cure people who recur. I would argue this is why we probably will never really see a difference in the survival benefit in this group because people who cross over will probably do well,” Dr. Ariyan said.

During the Q&A session, Vernon Sondek, MD, Moffitt Cancer Center, Tampa, encouraged physician colleagues to have an open mind about treatments. “Beware of dogma. We thought that adjuvant immunotherapy works much better in patients with ulcerated primary tumors. That’s a dogma in some parts of the world. Yet the T4a patients in KEYNOTE-716 dramatically outperformed the ulcerated T3b and T4b [patients]. We still don’t know what we don’t know.”
 

The study details

KEYNOTE-716 included 976 patients 12 years or older with newly diagnosed completely resected stage IIB or IIC melanoma with a negative sentinel lymph node. Patients were randomized to placebo or 200 mg pembrolizumab every 3 weeks, or 2 mg/kg in pediatric patients, over 17 cycles. Almost 40% of patients were age 65 or older. T3b and T4b were the most common melanoma subcategories at 41% and 35%, respectively.

The planned third interim analysis occurred after the occurrence of 146 distant metastases. After a median follow-up of 27.4 months, distant metastasis-free survival favored the pembrolizumab group (HR, 0.64; P = .0029). At 24 months, the pembrolizumab group had a higher distant metastasis-free survival at 88.1% versus 82.2% and a lower recurrence rate at 81.2% versus 72.8% (HR, 0.64; 95% confidence interval, 0.50-0.84).

At 24 months, only the T4a patients had a statistically significant reduction in distant metastases at 58% (HR, 0.42; 95% CI, 0.19-0.96), although there were numerical reductions in T3a (HR, 0.71; 95% CI, 0.41-1.22) and T4b (HR, 0.70; 95% CI, 0.44-1.33) patients. Of patients experiencing a distant metastasis, 73% of the placebo group had a first distant metastasis to the lung compared with 49% of the pembrolizumab group.

Dr. Long has held consulting or advisory roles for Merck Sharpe & Dohme, which funded this study.

INDIANAPOLIS – Among children and adolescents diagnosed with melanoma, females had higher rates of superficial spreading disease, while males were more frequently affected by nodular melanoma.

In addition, male gender was independently associated with increased mortality, but age was not.

Those are key findings from a retrospective cohort analysis of nearly 5,000 records from the National Cancer Database.

“There are multiple studies from primarily adult populations showing females with melanoma have a different presentation and better outcomes than males,” co-first author Rebecca M. Thiede, MD, a dermatologist at the University of Arizona, Tucson, said in an interview with this news organization in advance of the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session. “However, because melanoma is so rare in younger patients, little is known about gender differences in presentation and survival in pediatric and adolescent patients. To our knowledge, this is one of the largest studies to date in this population, and the first to explore gender differences in detail in pediatric and adolescent patients with melanoma.”

Working with co-first author Sabrina Dahak, a fourth-year medical student at the University of Arizona, Phoenix, Dr. Thiede and colleagues retrospectively analyzed the National Cancer Database to identify biopsy-confirmed invasive primary cutaneous melanoma cases diagnosed in patients 0-21 years of age between 2004 and 2018. The search yielded 4,645 cases, and the researchers used American Academy of Pediatrics definitions to categorize the patients by age, from infancy (birth to 2 years), to childhood (3-10 years), early adolescence (11-14 years), middle adolescence (15-17 years), and late adolescence (18-21 years). They used the Kaplan Meier analysis to determine overall survival and multivariate Cox regression to determine independent survival predictors.

Of the 4,645 pediatric melanoma cases, 63.4% were in females and 36.6% were in males, a difference that was significant (P < .001). Dr. Thiede and colleagues also observed a significant relationship between primary site and gender (P < .001). Primary sites included the trunk (34.3% of females vs. 32.9% of males, respectively), head and neck (16.4% vs. 30.9%), upper extremities (19.5% vs. 16%), lower extremities (27.9% vs. 16.5%), and “unspecified” (1.9% vs. 3.7%).

Females had higher rates of superficial spreading melanoma while males were affected by nodular melanoma more often. For example, the median Breslow depth was higher for males (1.05 mm; interquartile range [IQR] 0.50-2.31) than for females (0.80 mm; IQR, 0.40-1.67; P < .001).

Although females accounted for a higher percentage of cases than males overall, from birth to 17 years, a higher percentage of males than females were found to have later stage of melanoma at time of diagnosis: Females were more likely to be diagnosed with stage I disease (67.8%) than were males (53.6%), and males were more likely than were females to be diagnosed with stages II (15.9% vs. 12.3%), III (27.1% vs. 18.3%), and IV disease (3.3% vs. 1.6%; P < .001 for all).

In other findings, the 5- and 10-year overall survival rates were higher for females (95.9% and 93.9%, respectively) than for males (92.0% vs. 86.7%, respectively; P < .001). However, by age group, overall survival rates were similar between females and males among infants, children, and those in early adolescence – but not for those in middle adolescence (96.7% vs. 91.9%; P < .001) or late adolescence (95.7% vs. 90.4%; P < .001).

When the researchers adjusted for confounding variables, male gender was independently associated with an increased risk of death (adjusted hazard ratio 1.37; P < .001), but age was not.

“It was particularly surprising to see that even at such a young age, there is a significant difference in overall survival between males and females, where females have better outcomes than males,” Dr. Thiede said. “When examining pediatric and adolescent patients, it is essential to maintain cutaneous melanoma on the differential,” she advised. “It is important for clinicians to perform a thorough exam at annual visits particularly for those at high risk for melanoma to catch this rare but potentially devastating diagnosis.”

She acknowledged certain limitations of the study, including its reliance on one database, “as comparing multiple databases would strengthen the conclusions,” she said. “There was some missing data present in our dataset, and a large percentage of the histologic subtypes were unspecified, both of which are common issues with cancer registries. An additional limitation is related to the low death rates in adolescent and pediatric patients, which may impact the analysis related to survival and independent predictors of survival.”

Asked to comment on the study results, Carrie C. Coughlin, MD, who directs the section of pediatric dermatology Washington University/St. Louis Children’s Hospital, said that the finding that males were more likely to present with stage II or higher disease compared with females “could be related to their finding that females had more superficial spreading melanomas, whereas males had more nodular melanoma.” Those differences “could influence how providers evaluate melanocytic lesions in children,” she added.

Dr. Coughlin, who directs the pediatric dermatology fellowship at Washington University/St. Louis Children’s Hospital, said it was “interesting” that the authors found no association between older age and an increased risk of death. “It would be helpful to have more data about melanoma subtype, including information about Spitz or Spitzoid melanomas,” she said. “Also, knowing the distribution of melanoma across the age categories could provide more insight into their data.”

Ms. Dahak received an award from the National Cancer Institute to fund travel for presentation of this study at the SPD meeting. No other financial conflicts were reported by the researchers. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance (PeDRA) and the International Immunosuppression and Transplant Skin Cancer Collaborative.

INDIANAPOLIS – Among children and adolescents diagnosed with melanoma, females had higher rates of superficial spreading disease, while males were more frequently affected by nodular melanoma.

In addition, male gender was independently associated with increased mortality, but age was not.

Those are key findings from a retrospective cohort analysis of nearly 5,000 records from the National Cancer Database.

“There are multiple studies from primarily adult populations showing females with melanoma have a different presentation and better outcomes than males,” co-first author Rebecca M. Thiede, MD, a dermatologist at the University of Arizona, Tucson, said in an interview with this news organization in advance of the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session. “However, because melanoma is so rare in younger patients, little is known about gender differences in presentation and survival in pediatric and adolescent patients. To our knowledge, this is one of the largest studies to date in this population, and the first to explore gender differences in detail in pediatric and adolescent patients with melanoma.”

Working with co-first author Sabrina Dahak, a fourth-year medical student at the University of Arizona, Phoenix, Dr. Thiede and colleagues retrospectively analyzed the National Cancer Database to identify biopsy-confirmed invasive primary cutaneous melanoma cases diagnosed in patients 0-21 years of age between 2004 and 2018. The search yielded 4,645 cases, and the researchers used American Academy of Pediatrics definitions to categorize the patients by age, from infancy (birth to 2 years), to childhood (3-10 years), early adolescence (11-14 years), middle adolescence (15-17 years), and late adolescence (18-21 years). They used the Kaplan Meier analysis to determine overall survival and multivariate Cox regression to determine independent survival predictors.

Of the 4,645 pediatric melanoma cases, 63.4% were in females and 36.6% were in males, a difference that was significant (P < .001). Dr. Thiede and colleagues also observed a significant relationship between primary site and gender (P < .001). Primary sites included the trunk (34.3% of females vs. 32.9% of males, respectively), head and neck (16.4% vs. 30.9%), upper extremities (19.5% vs. 16%), lower extremities (27.9% vs. 16.5%), and “unspecified” (1.9% vs. 3.7%).

Females had higher rates of superficial spreading melanoma while males were affected by nodular melanoma more often. For example, the median Breslow depth was higher for males (1.05 mm; interquartile range [IQR] 0.50-2.31) than for females (0.80 mm; IQR, 0.40-1.67; P < .001).

Although females accounted for a higher percentage of cases than males overall, from birth to 17 years, a higher percentage of males than females were found to have later stage of melanoma at time of diagnosis: Females were more likely to be diagnosed with stage I disease (67.8%) than were males (53.6%), and males were more likely than were females to be diagnosed with stages II (15.9% vs. 12.3%), III (27.1% vs. 18.3%), and IV disease (3.3% vs. 1.6%; P < .001 for all).

In other findings, the 5- and 10-year overall survival rates were higher for females (95.9% and 93.9%, respectively) than for males (92.0% vs. 86.7%, respectively; P < .001). However, by age group, overall survival rates were similar between females and males among infants, children, and those in early adolescence – but not for those in middle adolescence (96.7% vs. 91.9%; P < .001) or late adolescence (95.7% vs. 90.4%; P < .001).

When the researchers adjusted for confounding variables, male gender was independently associated with an increased risk of death (adjusted hazard ratio 1.37; P < .001), but age was not.

“It was particularly surprising to see that even at such a young age, there is a significant difference in overall survival between males and females, where females have better outcomes than males,” Dr. Thiede said. “When examining pediatric and adolescent patients, it is essential to maintain cutaneous melanoma on the differential,” she advised. “It is important for clinicians to perform a thorough exam at annual visits particularly for those at high risk for melanoma to catch this rare but potentially devastating diagnosis.”

She acknowledged certain limitations of the study, including its reliance on one database, “as comparing multiple databases would strengthen the conclusions,” she said. “There was some missing data present in our dataset, and a large percentage of the histologic subtypes were unspecified, both of which are common issues with cancer registries. An additional limitation is related to the low death rates in adolescent and pediatric patients, which may impact the analysis related to survival and independent predictors of survival.”

Asked to comment on the study results, Carrie C. Coughlin, MD, who directs the section of pediatric dermatology Washington University/St. Louis Children’s Hospital, said that the finding that males were more likely to present with stage II or higher disease compared with females “could be related to their finding that females had more superficial spreading melanomas, whereas males had more nodular melanoma.” Those differences “could influence how providers evaluate melanocytic lesions in children,” she added.

Dr. Coughlin, who directs the pediatric dermatology fellowship at Washington University/St. Louis Children’s Hospital, said it was “interesting” that the authors found no association between older age and an increased risk of death. “It would be helpful to have more data about melanoma subtype, including information about Spitz or Spitzoid melanomas,” she said. “Also, knowing the distribution of melanoma across the age categories could provide more insight into their data.”

Ms. Dahak received an award from the National Cancer Institute to fund travel for presentation of this study at the SPD meeting. No other financial conflicts were reported by the researchers. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance (PeDRA) and the International Immunosuppression and Transplant Skin Cancer Collaborative.

INDIANAPOLIS – Among children and adolescents diagnosed with melanoma, females had higher rates of superficial spreading disease, while males were more frequently affected by nodular melanoma.

In addition, male gender was independently associated with increased mortality, but age was not.

Those are key findings from a retrospective cohort analysis of nearly 5,000 records from the National Cancer Database.

“There are multiple studies from primarily adult populations showing females with melanoma have a different presentation and better outcomes than males,” co-first author Rebecca M. Thiede, MD, a dermatologist at the University of Arizona, Tucson, said in an interview with this news organization in advance of the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session. “However, because melanoma is so rare in younger patients, little is known about gender differences in presentation and survival in pediatric and adolescent patients. To our knowledge, this is one of the largest studies to date in this population, and the first to explore gender differences in detail in pediatric and adolescent patients with melanoma.”

Working with co-first author Sabrina Dahak, a fourth-year medical student at the University of Arizona, Phoenix, Dr. Thiede and colleagues retrospectively analyzed the National Cancer Database to identify biopsy-confirmed invasive primary cutaneous melanoma cases diagnosed in patients 0-21 years of age between 2004 and 2018. The search yielded 4,645 cases, and the researchers used American Academy of Pediatrics definitions to categorize the patients by age, from infancy (birth to 2 years), to childhood (3-10 years), early adolescence (11-14 years), middle adolescence (15-17 years), and late adolescence (18-21 years). They used the Kaplan Meier analysis to determine overall survival and multivariate Cox regression to determine independent survival predictors.

Of the 4,645 pediatric melanoma cases, 63.4% were in females and 36.6% were in males, a difference that was significant (P < .001). Dr. Thiede and colleagues also observed a significant relationship between primary site and gender (P < .001). Primary sites included the trunk (34.3% of females vs. 32.9% of males, respectively), head and neck (16.4% vs. 30.9%), upper extremities (19.5% vs. 16%), lower extremities (27.9% vs. 16.5%), and “unspecified” (1.9% vs. 3.7%).

Females had higher rates of superficial spreading melanoma while males were affected by nodular melanoma more often. For example, the median Breslow depth was higher for males (1.05 mm; interquartile range [IQR] 0.50-2.31) than for females (0.80 mm; IQR, 0.40-1.67; P < .001).

Although females accounted for a higher percentage of cases than males overall, from birth to 17 years, a higher percentage of males than females were found to have later stage of melanoma at time of diagnosis: Females were more likely to be diagnosed with stage I disease (67.8%) than were males (53.6%), and males were more likely than were females to be diagnosed with stages II (15.9% vs. 12.3%), III (27.1% vs. 18.3%), and IV disease (3.3% vs. 1.6%; P < .001 for all).

In other findings, the 5- and 10-year overall survival rates were higher for females (95.9% and 93.9%, respectively) than for males (92.0% vs. 86.7%, respectively; P < .001). However, by age group, overall survival rates were similar between females and males among infants, children, and those in early adolescence – but not for those in middle adolescence (96.7% vs. 91.9%; P < .001) or late adolescence (95.7% vs. 90.4%; P < .001).

When the researchers adjusted for confounding variables, male gender was independently associated with an increased risk of death (adjusted hazard ratio 1.37; P < .001), but age was not.

“It was particularly surprising to see that even at such a young age, there is a significant difference in overall survival between males and females, where females have better outcomes than males,” Dr. Thiede said. “When examining pediatric and adolescent patients, it is essential to maintain cutaneous melanoma on the differential,” she advised. “It is important for clinicians to perform a thorough exam at annual visits particularly for those at high risk for melanoma to catch this rare but potentially devastating diagnosis.”

She acknowledged certain limitations of the study, including its reliance on one database, “as comparing multiple databases would strengthen the conclusions,” she said. “There was some missing data present in our dataset, and a large percentage of the histologic subtypes were unspecified, both of which are common issues with cancer registries. An additional limitation is related to the low death rates in adolescent and pediatric patients, which may impact the analysis related to survival and independent predictors of survival.”

Asked to comment on the study results, Carrie C. Coughlin, MD, who directs the section of pediatric dermatology Washington University/St. Louis Children’s Hospital, said that the finding that males were more likely to present with stage II or higher disease compared with females “could be related to their finding that females had more superficial spreading melanomas, whereas males had more nodular melanoma.” Those differences “could influence how providers evaluate melanocytic lesions in children,” she added.

Dr. Coughlin, who directs the pediatric dermatology fellowship at Washington University/St. Louis Children’s Hospital, said it was “interesting” that the authors found no association between older age and an increased risk of death. “It would be helpful to have more data about melanoma subtype, including information about Spitz or Spitzoid melanomas,” she said. “Also, knowing the distribution of melanoma across the age categories could provide more insight into their data.”

Ms. Dahak received an award from the National Cancer Institute to fund travel for presentation of this study at the SPD meeting. No other financial conflicts were reported by the researchers. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance (PeDRA) and the International Immunosuppression and Transplant Skin Cancer Collaborative.

Only a small number of research clinical trials for cancer drugs actually show benefit in quality of life, according to a study published in JAMA Oncology.

The study found trials that failed to show improved quality of life often reported their quality of life outcomes more favorably. Non–immunotherapy-targeted drugs were found to lead to worse quality of life outcomes more often than did cytotoxic agents. And, while there is an association between quality of life benefit and overall survival, no such association was found with progression-free survival.

“In this study, we evaluated the outcomes of cancer drug trials with regard to patients’ quality of life and found that only a quarter of phase 3 cancer drug trials in the advanced-disease setting demonstrated improved quality of life,” wrote authors who were led by Bishal Gyawali, MD, PhD, of the Cancer Research Institute, Queen’s University, Kingston, Ont.

“Improved quality of life outcomes were associated with improved overall survival but not with improved progression-free survival. Importantly, almost half of the cancer drugs drug trials that showed improved progression-free survival showed no improved overall survival or quality of life (i.e., PFS-only benefit). Some reports included conclusions regarding quality of life (QOL) findings that were not directly supported by the trial data, particularly for inferior or non–statistically significant QOL outcomes, thereby framing the findings in a favorable light or downplaying detrimental effects of the study intervention on QOL. Furthermore, contrary to common perception, inferior QOL outcomes were more common with targeted drugs than cytotoxic drugs. Taken together, these findings have important policy implications,” the authors wrote.

These findings are based on the results of a cohort study of 45 phase 3 research clinical trials of 24,806 patients. Only a small percentage of patients showed QOL benefits. The study found that industry-funded clinical trial reports often framed QOL findings more favorably than was warranted by the data.

The study found improved QOL with experimental agents in 11 of 45 randomized controlled trials (24.4%). Studies that reported improved QOL were more likely to also show improved overall survival as compared with trials in which quality of life was not improved (7 of 11 [64%] versus 10 of 34 [29%] trials). For improved progression-free survival, however, there was no positive association (6 of 11 [55%] trials versus 17 of 34 [50%] trials without improved QOL). Among six trials reporting worsening QOL, three (50%) were trials of targeted drugs. Among 11 trials reporting improved QOL, 6 (55%) were trials of immunotherapy drugs. Among the 34 trials in which QOL was not improved compared with controls, the findings were framed favorably (versus neutrally or negatively) in the abstract or conclusions in 16 (47%), an observation that was statistically significantly associated with industry funding (chi-squared = 6.35; P = .01).

“It is important to clearly understand and communicate the effects of cancer drugs”

To fulfill the obligation to inform patients about proposed treatments, the authors wrote that it is important to clearly understand and communicate the effects of cancer drugs on patient quality of life alongside their effects on overall survival and intermediate end points such as progression-free survival. “Patients with advanced cancer expect treatment to help them live longer or have better lives,” the authors wrote. In that respect, in clinical trials of cancer medicines, overall survival and quality of life are the most important measures. Toxicity profiles and disease progression delays do not reliably predict quality of life, and studies have shown poor correlations between quality of life, overall survival, and progression-free survival. This raises the question of validity of progression-free survival as a surrogate endpoint. “Progression-free survival is meaningless without overall survival or quality of life gains,” Dr. Gyawali said in an interview.

Writing in The Lancet Oncology in March, Dr. Gyawali stated that, because progression free survival “does not directly measure how a patient feels or functions, or how long a patient lives, progression-free survival was not intended to inform clinical practice or establish whether a new therapy provides clinically meaningful benefits for patients. However, over the past 2 decades, it has become the most common primary endpoint in oncology clinical trials. We are deeply worried about how the term survival in this phrase can influence clinical practice and patient choices. We propose replacing the phrase progression-free survival with a less ambiguous term: progression-free interval.”

In JAMA Oncology, Dr. Gyawali aimed to elucidate relationships between QOL, overall survival, and progression-free survival, and to assess, as well, how QOL results are framed, especially in industry-sponsored research. When drug trials they analyzed showed no change in QOL but reported that QOL did not worsen or QOL was maintained rather than stating that QOL did not improve, or if there was downplaying of worse QOL outcomes, the study had favorable interpretation, Dr. Gyawali and associates wrote. The expectation of patients receiving cancer drugs would be improved QOL rather than “not worse” QOL, Dr. Gyawali said.

Regarding the finding that QOL outcomes were described as favorable in 47% of trials with unimproved QOL outcomes, Dr. Gyawali said, “the bias in reporting should be corrected by the reviewers and editors of journals. Also, quality of life reporting should be made mandatory. Without unbiased quality of life information, informed decision making on whether or not to use a certain drug is impossible. Patients and physicians need to know that information. Regulators can demand that this should be mandatory in all trials in noncurative settings.”

He remarked further on the worsening QOL in some targeted drug trials, “People tout chemo-free regimens as automatically having better quality of life, but that doesn’t seem to be the case. Targeted drugs can have a severe impact on quality of life, probably due to prolonged duration of side effects. Quality of life should be measured and reported for all drugs.”

Dr. Gyawali and associates noted the limitation in that several studies with negative QOL results are not published at all or are published after a considerable delay, so the present observations may understate the issues that have been raised.

Dr. Gyawali declared that he received no funding and disclosed no conflicts of interest for this study.

Only a small number of research clinical trials for cancer drugs actually show benefit in quality of life, according to a study published in JAMA Oncology.

The study found trials that failed to show improved quality of life often reported their quality of life outcomes more favorably. Non–immunotherapy-targeted drugs were found to lead to worse quality of life outcomes more often than did cytotoxic agents. And, while there is an association between quality of life benefit and overall survival, no such association was found with progression-free survival.

“In this study, we evaluated the outcomes of cancer drug trials with regard to patients’ quality of life and found that only a quarter of phase 3 cancer drug trials in the advanced-disease setting demonstrated improved quality of life,” wrote authors who were led by Bishal Gyawali, MD, PhD, of the Cancer Research Institute, Queen’s University, Kingston, Ont.

“Improved quality of life outcomes were associated with improved overall survival but not with improved progression-free survival. Importantly, almost half of the cancer drugs drug trials that showed improved progression-free survival showed no improved overall survival or quality of life (i.e., PFS-only benefit). Some reports included conclusions regarding quality of life (QOL) findings that were not directly supported by the trial data, particularly for inferior or non–statistically significant QOL outcomes, thereby framing the findings in a favorable light or downplaying detrimental effects of the study intervention on QOL. Furthermore, contrary to common perception, inferior QOL outcomes were more common with targeted drugs than cytotoxic drugs. Taken together, these findings have important policy implications,” the authors wrote.

These findings are based on the results of a cohort study of 45 phase 3 research clinical trials of 24,806 patients. Only a small percentage of patients showed QOL benefits. The study found that industry-funded clinical trial reports often framed QOL findings more favorably than was warranted by the data.

The study found improved QOL with experimental agents in 11 of 45 randomized controlled trials (24.4%). Studies that reported improved QOL were more likely to also show improved overall survival as compared with trials in which quality of life was not improved (7 of 11 [64%] versus 10 of 34 [29%] trials). For improved progression-free survival, however, there was no positive association (6 of 11 [55%] trials versus 17 of 34 [50%] trials without improved QOL). Among six trials reporting worsening QOL, three (50%) were trials of targeted drugs. Among 11 trials reporting improved QOL, 6 (55%) were trials of immunotherapy drugs. Among the 34 trials in which QOL was not improved compared with controls, the findings were framed favorably (versus neutrally or negatively) in the abstract or conclusions in 16 (47%), an observation that was statistically significantly associated with industry funding (chi-squared = 6.35; P = .01).

“It is important to clearly understand and communicate the effects of cancer drugs”

To fulfill the obligation to inform patients about proposed treatments, the authors wrote that it is important to clearly understand and communicate the effects of cancer drugs on patient quality of life alongside their effects on overall survival and intermediate end points such as progression-free survival. “Patients with advanced cancer expect treatment to help them live longer or have better lives,” the authors wrote. In that respect, in clinical trials of cancer medicines, overall survival and quality of life are the most important measures. Toxicity profiles and disease progression delays do not reliably predict quality of life, and studies have shown poor correlations between quality of life, overall survival, and progression-free survival. This raises the question of validity of progression-free survival as a surrogate endpoint. “Progression-free survival is meaningless without overall survival or quality of life gains,” Dr. Gyawali said in an interview.

Writing in The Lancet Oncology in March, Dr. Gyawali stated that, because progression free survival “does not directly measure how a patient feels or functions, or how long a patient lives, progression-free survival was not intended to inform clinical practice or establish whether a new therapy provides clinically meaningful benefits for patients. However, over the past 2 decades, it has become the most common primary endpoint in oncology clinical trials. We are deeply worried about how the term survival in this phrase can influence clinical practice and patient choices. We propose replacing the phrase progression-free survival with a less ambiguous term: progression-free interval.”

In JAMA Oncology, Dr. Gyawali aimed to elucidate relationships between QOL, overall survival, and progression-free survival, and to assess, as well, how QOL results are framed, especially in industry-sponsored research. When drug trials they analyzed showed no change in QOL but reported that QOL did not worsen or QOL was maintained rather than stating that QOL did not improve, or if there was downplaying of worse QOL outcomes, the study had favorable interpretation, Dr. Gyawali and associates wrote. The expectation of patients receiving cancer drugs would be improved QOL rather than “not worse” QOL, Dr. Gyawali said.

Regarding the finding that QOL outcomes were described as favorable in 47% of trials with unimproved QOL outcomes, Dr. Gyawali said, “the bias in reporting should be corrected by the reviewers and editors of journals. Also, quality of life reporting should be made mandatory. Without unbiased quality of life information, informed decision making on whether or not to use a certain drug is impossible. Patients and physicians need to know that information. Regulators can demand that this should be mandatory in all trials in noncurative settings.”

He remarked further on the worsening QOL in some targeted drug trials, “People tout chemo-free regimens as automatically having better quality of life, but that doesn’t seem to be the case. Targeted drugs can have a severe impact on quality of life, probably due to prolonged duration of side effects. Quality of life should be measured and reported for all drugs.”

Dr. Gyawali and associates noted the limitation in that several studies with negative QOL results are not published at all or are published after a considerable delay, so the present observations may understate the issues that have been raised.

Dr. Gyawali declared that he received no funding and disclosed no conflicts of interest for this study.

Only a small number of research clinical trials for cancer drugs actually show benefit in quality of life, according to a study published in JAMA Oncology.

The study found trials that failed to show improved quality of life often reported their quality of life outcomes more favorably. Non–immunotherapy-targeted drugs were found to lead to worse quality of life outcomes more often than did cytotoxic agents. And, while there is an association between quality of life benefit and overall survival, no such association was found with progression-free survival.

“In this study, we evaluated the outcomes of cancer drug trials with regard to patients’ quality of life and found that only a quarter of phase 3 cancer drug trials in the advanced-disease setting demonstrated improved quality of life,” wrote authors who were led by Bishal Gyawali, MD, PhD, of the Cancer Research Institute, Queen’s University, Kingston, Ont.

“Improved quality of life outcomes were associated with improved overall survival but not with improved progression-free survival. Importantly, almost half of the cancer drugs drug trials that showed improved progression-free survival showed no improved overall survival or quality of life (i.e., PFS-only benefit). Some reports included conclusions regarding quality of life (QOL) findings that were not directly supported by the trial data, particularly for inferior or non–statistically significant QOL outcomes, thereby framing the findings in a favorable light or downplaying detrimental effects of the study intervention on QOL. Furthermore, contrary to common perception, inferior QOL outcomes were more common with targeted drugs than cytotoxic drugs. Taken together, these findings have important policy implications,” the authors wrote.

These findings are based on the results of a cohort study of 45 phase 3 research clinical trials of 24,806 patients. Only a small percentage of patients showed QOL benefits. The study found that industry-funded clinical trial reports often framed QOL findings more favorably than was warranted by the data.

The study found improved QOL with experimental agents in 11 of 45 randomized controlled trials (24.4%). Studies that reported improved QOL were more likely to also show improved overall survival as compared with trials in which quality of life was not improved (7 of 11 [64%] versus 10 of 34 [29%] trials). For improved progression-free survival, however, there was no positive association (6 of 11 [55%] trials versus 17 of 34 [50%] trials without improved QOL). Among six trials reporting worsening QOL, three (50%) were trials of targeted drugs. Among 11 trials reporting improved QOL, 6 (55%) were trials of immunotherapy drugs. Among the 34 trials in which QOL was not improved compared with controls, the findings were framed favorably (versus neutrally or negatively) in the abstract or conclusions in 16 (47%), an observation that was statistically significantly associated with industry funding (chi-squared = 6.35; P = .01).

“It is important to clearly understand and communicate the effects of cancer drugs”

To fulfill the obligation to inform patients about proposed treatments, the authors wrote that it is important to clearly understand and communicate the effects of cancer drugs on patient quality of life alongside their effects on overall survival and intermediate end points such as progression-free survival. “Patients with advanced cancer expect treatment to help them live longer or have better lives,” the authors wrote. In that respect, in clinical trials of cancer medicines, overall survival and quality of life are the most important measures. Toxicity profiles and disease progression delays do not reliably predict quality of life, and studies have shown poor correlations between quality of life, overall survival, and progression-free survival. This raises the question of validity of progression-free survival as a surrogate endpoint. “Progression-free survival is meaningless without overall survival or quality of life gains,” Dr. Gyawali said in an interview.

Writing in The Lancet Oncology in March, Dr. Gyawali stated that, because progression free survival “does not directly measure how a patient feels or functions, or how long a patient lives, progression-free survival was not intended to inform clinical practice or establish whether a new therapy provides clinically meaningful benefits for patients. However, over the past 2 decades, it has become the most common primary endpoint in oncology clinical trials. We are deeply worried about how the term survival in this phrase can influence clinical practice and patient choices. We propose replacing the phrase progression-free survival with a less ambiguous term: progression-free interval.”

In JAMA Oncology, Dr. Gyawali aimed to elucidate relationships between QOL, overall survival, and progression-free survival, and to assess, as well, how QOL results are framed, especially in industry-sponsored research. When drug trials they analyzed showed no change in QOL but reported that QOL did not worsen or QOL was maintained rather than stating that QOL did not improve, or if there was downplaying of worse QOL outcomes, the study had favorable interpretation, Dr. Gyawali and associates wrote. The expectation of patients receiving cancer drugs would be improved QOL rather than “not worse” QOL, Dr. Gyawali said.

Regarding the finding that QOL outcomes were described as favorable in 47% of trials with unimproved QOL outcomes, Dr. Gyawali said, “the bias in reporting should be corrected by the reviewers and editors of journals. Also, quality of life reporting should be made mandatory. Without unbiased quality of life information, informed decision making on whether or not to use a certain drug is impossible. Patients and physicians need to know that information. Regulators can demand that this should be mandatory in all trials in noncurative settings.”

He remarked further on the worsening QOL in some targeted drug trials, “People tout chemo-free regimens as automatically having better quality of life, but that doesn’t seem to be the case. Targeted drugs can have a severe impact on quality of life, probably due to prolonged duration of side effects. Quality of life should be measured and reported for all drugs.”

Dr. Gyawali and associates noted the limitation in that several studies with negative QOL results are not published at all or are published after a considerable delay, so the present observations may understate the issues that have been raised.

Dr. Gyawali declared that he received no funding and disclosed no conflicts of interest for this study.

CHICAGO – Mortality rates from melanoma have fallen in recent years, likely due to the introduction of checkpoint inhibitors, according to a new analysis of the National Cancer Institute SEER database between 1975 and 2019.

“This is very encouraging data and represents the real-world effectiveness of these therapies. The cost of these therapies can be prohibitive for universal treatment access, so the ways to address the accessibility of these treatments and the health care costs need to be supported,” said lead author Navkirat Kaur Kahlon MD, a hematology/oncology fellow at the University of Toledo (Ohio). The study was presented at the annual meeting of the American Society of Clinical Oncology.

According to the American Cancer Society, the 5-year mortality for regional melanoma metastasis is 68%, and 30% for distant metastasis. However, these numbers may underestimate current survival. “People now being diagnosed with melanoma may have a better outlook than these numbers show. Treatments have improved over time, and these numbers are based on people who were diagnosed and treated at least 5 years earlier,” the American Cancer Society wrote.

Other studies have found similar trends. According to Cancer Research UK, 5-year melanoma skin cancer survival approximately doubled, from 46% to 90%, between 1971 and 2010. And, 1-year survival increased from 74% to 96%, but these improvements predated immune checkpoint inhibitors. An analysis of the Canadian Cancer Registry and Canadian Vital Statistics found an increasing incidence of melanoma, but a drop in mortality since 2013. A study of melanoma outcomes in Hungary also found increased incidence, while mortality declined by 16.55% between 2011 and 2019 (P =.013).

“These new drugs, which include immunotherapies and targeted therapies, are effective treatments in the clinical trial data, so the magnitude of drop seen in population mortality was not surprising but very exciting,” Dr. Kahlon said.

The findings are encouraging, but prevention remains the most important strategy. “The utility of sun-protective strategies and policies should be encouraged,” she added.

Cytotoxic chemotherapy has poor efficacy against metastatic melanoma, but novel therapies such as checkpoint inhibitors increased expected survival from months to years. “Given the magnitude of benefit compared to traditional chemotherapy in clinical trials, we decided to see if the real-world population is deriving the same benefit,” Dr. Kahlon said.

The researchers found that the annual percentage change (APC) melanoma mortality rate (MMR) was +1.65% between 1975 and 1988 (P < .01). The APC was 0.01% between 1988 and 2013, which was not statistically significant (P = .85). Between 2013 and 2017, APC was –6.24% (P < .01), and it was –1.56% between 2017 and 2019 (P = .53).

The increase in melanoma mortality between 1975 and 1988 may be due to changes in the way that SEER data was collected. “It is possible that this increase was at least in part due to better capturing of the data. There may also be a contribution of increased mortality due to increased incidence of diagnoses related to increased UV exposure. From the 1920s, increased sun exposure and bronzed skin became fashionable. In the 1940s-1960s, tanning oils and lotions became more popular, and there may have been an increase in UV exposure during that time, which later led to an increase in diagnosis and, without effective therapies, mortality. Further, the use of indoor tanning beds from the 1970s onward may have contributed to increased UV exposure, incidence, and mortality,” she said.

On the other hand, the researchers noted a slowing of mortality reduction between 2017 and 2019. This was not a surprise, Dr. Kahlon said, since by that time most novel therapies were being introduced in the adjuvant setting. “The mortality benefit, if any, from adjuvant treatments is seen over a longer period and may not yet be captured in SEER data. Even the clinical trial data for most of these treatments have not shown an overall survival advantage and require more time for the data to mature. It will be interesting to see how these trends change in the near future,” Dr. Kahlon said.

The study was limited by its retrospective nature. Dr. Kahlon has no relevant financial disclosures.

CHICAGO – Mortality rates from melanoma have fallen in recent years, likely due to the introduction of checkpoint inhibitors, according to a new analysis of the National Cancer Institute SEER database between 1975 and 2019.

“This is very encouraging data and represents the real-world effectiveness of these therapies. The cost of these therapies can be prohibitive for universal treatment access, so the ways to address the accessibility of these treatments and the health care costs need to be supported,” said lead author Navkirat Kaur Kahlon MD, a hematology/oncology fellow at the University of Toledo (Ohio). The study was presented at the annual meeting of the American Society of Clinical Oncology.

According to the American Cancer Society, the 5-year mortality for regional melanoma metastasis is 68%, and 30% for distant metastasis. However, these numbers may underestimate current survival. “People now being diagnosed with melanoma may have a better outlook than these numbers show. Treatments have improved over time, and these numbers are based on people who were diagnosed and treated at least 5 years earlier,” the American Cancer Society wrote.

Other studies have found similar trends. According to Cancer Research UK, 5-year melanoma skin cancer survival approximately doubled, from 46% to 90%, between 1971 and 2010. And, 1-year survival increased from 74% to 96%, but these improvements predated immune checkpoint inhibitors. An analysis of the Canadian Cancer Registry and Canadian Vital Statistics found an increasing incidence of melanoma, but a drop in mortality since 2013. A study of melanoma outcomes in Hungary also found increased incidence, while mortality declined by 16.55% between 2011 and 2019 (P =.013).

“These new drugs, which include immunotherapies and targeted therapies, are effective treatments in the clinical trial data, so the magnitude of drop seen in population mortality was not surprising but very exciting,” Dr. Kahlon said.

The findings are encouraging, but prevention remains the most important strategy. “The utility of sun-protective strategies and policies should be encouraged,” she added.

Cytotoxic chemotherapy has poor efficacy against metastatic melanoma, but novel therapies such as checkpoint inhibitors increased expected survival from months to years. “Given the magnitude of benefit compared to traditional chemotherapy in clinical trials, we decided to see if the real-world population is deriving the same benefit,” Dr. Kahlon said.

The researchers found that the annual percentage change (APC) melanoma mortality rate (MMR) was +1.65% between 1975 and 1988 (P < .01). The APC was 0.01% between 1988 and 2013, which was not statistically significant (P = .85). Between 2013 and 2017, APC was –6.24% (P < .01), and it was –1.56% between 2017 and 2019 (P = .53).

The increase in melanoma mortality between 1975 and 1988 may be due to changes in the way that SEER data was collected. “It is possible that this increase was at least in part due to better capturing of the data. There may also be a contribution of increased mortality due to increased incidence of diagnoses related to increased UV exposure. From the 1920s, increased sun exposure and bronzed skin became fashionable. In the 1940s-1960s, tanning oils and lotions became more popular, and there may have been an increase in UV exposure during that time, which later led to an increase in diagnosis and, without effective therapies, mortality. Further, the use of indoor tanning beds from the 1970s onward may have contributed to increased UV exposure, incidence, and mortality,” she said.

On the other hand, the researchers noted a slowing of mortality reduction between 2017 and 2019. This was not a surprise, Dr. Kahlon said, since by that time most novel therapies were being introduced in the adjuvant setting. “The mortality benefit, if any, from adjuvant treatments is seen over a longer period and may not yet be captured in SEER data. Even the clinical trial data for most of these treatments have not shown an overall survival advantage and require more time for the data to mature. It will be interesting to see how these trends change in the near future,” Dr. Kahlon said.

The study was limited by its retrospective nature. Dr. Kahlon has no relevant financial disclosures.

CHICAGO – Mortality rates from melanoma have fallen in recent years, likely due to the introduction of checkpoint inhibitors, according to a new analysis of the National Cancer Institute SEER database between 1975 and 2019.

“This is very encouraging data and represents the real-world effectiveness of these therapies. The cost of these therapies can be prohibitive for universal treatment access, so the ways to address the accessibility of these treatments and the health care costs need to be supported,” said lead author Navkirat Kaur Kahlon MD, a hematology/oncology fellow at the University of Toledo (Ohio). The study was presented at the annual meeting of the American Society of Clinical Oncology.

According to the American Cancer Society, the 5-year mortality for regional melanoma metastasis is 68%, and 30% for distant metastasis. However, these numbers may underestimate current survival. “People now being diagnosed with melanoma may have a better outlook than these numbers show. Treatments have improved over time, and these numbers are based on people who were diagnosed and treated at least 5 years earlier,” the American Cancer Society wrote.

Other studies have found similar trends. According to Cancer Research UK, 5-year melanoma skin cancer survival approximately doubled, from 46% to 90%, between 1971 and 2010. And, 1-year survival increased from 74% to 96%, but these improvements predated immune checkpoint inhibitors. An analysis of the Canadian Cancer Registry and Canadian Vital Statistics found an increasing incidence of melanoma, but a drop in mortality since 2013. A study of melanoma outcomes in Hungary also found increased incidence, while mortality declined by 16.55% between 2011 and 2019 (P =.013).

“These new drugs, which include immunotherapies and targeted therapies, are effective treatments in the clinical trial data, so the magnitude of drop seen in population mortality was not surprising but very exciting,” Dr. Kahlon said.

The findings are encouraging, but prevention remains the most important strategy. “The utility of sun-protective strategies and policies should be encouraged,” she added.

Cytotoxic chemotherapy has poor efficacy against metastatic melanoma, but novel therapies such as checkpoint inhibitors increased expected survival from months to years. “Given the magnitude of benefit compared to traditional chemotherapy in clinical trials, we decided to see if the real-world population is deriving the same benefit,” Dr. Kahlon said.

The researchers found that the annual percentage change (APC) melanoma mortality rate (MMR) was +1.65% between 1975 and 1988 (P < .01). The APC was 0.01% between 1988 and 2013, which was not statistically significant (P = .85). Between 2013 and 2017, APC was –6.24% (P < .01), and it was –1.56% between 2017 and 2019 (P = .53).

The increase in melanoma mortality between 1975 and 1988 may be due to changes in the way that SEER data was collected. “It is possible that this increase was at least in part due to better capturing of the data. There may also be a contribution of increased mortality due to increased incidence of diagnoses related to increased UV exposure. From the 1920s, increased sun exposure and bronzed skin became fashionable. In the 1940s-1960s, tanning oils and lotions became more popular, and there may have been an increase in UV exposure during that time, which later led to an increase in diagnosis and, without effective therapies, mortality. Further, the use of indoor tanning beds from the 1970s onward may have contributed to increased UV exposure, incidence, and mortality,” she said.

On the other hand, the researchers noted a slowing of mortality reduction between 2017 and 2019. This was not a surprise, Dr. Kahlon said, since by that time most novel therapies were being introduced in the adjuvant setting. “The mortality benefit, if any, from adjuvant treatments is seen over a longer period and may not yet be captured in SEER data. Even the clinical trial data for most of these treatments have not shown an overall survival advantage and require more time for the data to mature. It will be interesting to see how these trends change in the near future,” Dr. Kahlon said.

The study was limited by its retrospective nature. Dr. Kahlon has no relevant financial disclosures.

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

sodapix/thinkstockphotos.com

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

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

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

sodapix/thinkstockphotos.com

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

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

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

sodapix/thinkstockphotos.com

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

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

A recent study linking the consumption of fish to melanoma had sushi eaters looking up the number of the nearest dermatologist. But experts said the findings had several important limitations and that no one should change their diet based on the results.

© oleksajewicz/Thinkstock

“It wouldn’t impact my fish consumption at all,” said Sancy Leachman, MD, PhD, who directs the melanoma program at Oregon Health & Science University’s Knight Cancer Institute in Portland. “Fish are part of a healthy diet,” particularly if it replaces less healthy proteins such as beef.

Even the authors of the study advised caution when interpreting the findings.

“I wouldn’t encourage anyone to change their fish consumption habits just because of this paper,” said study leader Eunyoung Cho, ScD, an epidemiologist at Brown University, Providence, R.I. “Fish is cardioprotective and is related to reduced risk of developing certain cancers too.”
 

Solid findings or fishing expedition?

The study quickly generated headlines and was the most viewed article of the journal Cancer Causes & Control within a day of its publication.

Dr. Cho, who is on the editorial board of the journal, analyzed the results of a study funded by the National Institutes of Health and the Association for the Advancement of Retired Persons that began in the 1990s and explored possible links between fish consumption and developing different forms of cancer.

Previous research from this project had shown eating fish was associated with an increased risk of melanoma – but no other type of cancer.

Dr. Cho speculated that the risk is due to contaminants, such as mercury and arsenic, in fish. But she was curious to see if she could find a connection between the amount of fish consumed and the risk of developing skin cancer.

At the beginning of the study people reported how much fish they had consumed over the previous year, which varied widely by person. Then researchers tracked participants for 15 years, recording who developed cancer and who did not.

Dietary recall can be difficult; people often say they can’t remember what they ate yesterday, much less 1 year ago. Still, dietitian Clare Collins, PhD, of the University of Newcastle (Australia), noted that previous research showed that the dietary recall tool for this study is reliable.

NIH researchers never checked to see how their diet changed over time, as this was a study meant to observe changes in health status starting from a baseline point. The researchers assumed that the level of fish intake recorded at the beginning of the study remained steady.

Of 491,000 people tracked in the study, 5,000 developed malignant melanoma and another 3,300 developed melanoma cells on the skin surface. People who ate the most fish – an average of almost 43 g, or about 1.5 ounces, per day – were 23% more likely to develop melanoma than the lightest fish eaters, who averaged 3 g per day.  

That risk is modest, Dr. Leachman said, especially for people with red hair who, she said, are 400% more likely to get melanoma than others. “A 23% increase, in the whole scheme of things, is not nearly as important as not getting sunburned if you’re a redhead,” Dr. Leachman said.

And what about the sun? Sun exposure is the principal risk factor for developing melanoma, and the researchers didn’t account for that factor. People who developed melanoma during the study may simply have spent more time in tanning beds or on the beach – or perhaps fishing and then eating their catch.

Dr. Cho and colleagues tried to consider the effects of solar radiation by looking at average sun exposure times in the places where the participants in the study were living when the research began. Using that framework, variation in sun exposure made no difference to melanoma risk, but Dr. Leachman said the technique isn’t foolproof.

“They assumed that they were going to get a certain amount of ultraviolet light just based on where they lived. We don’t know how long they lived there or if they really had ultraviolet exposure or not,” Dr. Leachman said. Someone in presumably less sunny Pennsylvania could get more sun than someone in sun-drenched Arizona depending on their lifestyle and habits.

The kind of study Dr. Cho published cannot account for individual behaviors related to sun exposure, a limitation her team readily acknowledges. Nor does it include information about moles or hair color – important considerations for skin cancers. It may be that redheads with moles who barely ate any fish developed melanoma at higher rates than anyone else, but the data don’t allow for that kind of analysis.

Dr. Cho’s group found that canned tuna and any type of fish that wasn’t fried were associated with a higher risk of developing melanoma, as people reported eating more of those products. However, people who said they ate greater quantities of fried fish had a lower risk of melanoma, a counterintuitive finding that she said warrants further research.

Given that the study showed only a modest chance of developing melanoma regardless of fish intake, and left so many questions unanswered, what was the point?

Other journals declined to publish this paper, Dr. Cho acknowledged, but she defended the article as a step toward better understanding the health impact of environmental contaminants in fish.

Dr. Leachman agreed. “These kinds of studies are very important to do. They have large data sets, where you can start to see trends that may be important,” she said. “They can help you identify things that might be related. These experiments are hypothesis generating.”

“I already published an article showing that total mercury level is related to skin cancer, and we know very well that in the U.S. fish consumption is the major source of mercury contamination,” Dr. Cho said. “So, I naturally thought that fish consumption may be associated with increased risk of skin cancer too.” Dr. Cho said she believed the findings confirm that hypothesis.

Dr. Cho said the next step would be to measure blood levels of different contaminants such as mercury and arsenic in people with melanoma, to determine which toxin is the biggest driver of melanoma. She said she plans to seek funding for that research.

Meanwhile, pass the salmon – but go light on the salt.

Dr. Cho and Dr. Leachman reported no relevant financial relationships. Dr. Cho is on the editorial board of Cancer Causes & Control.

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

A recent study linking the consumption of fish to melanoma had sushi eaters looking up the number of the nearest dermatologist. But experts said the findings had several important limitations and that no one should change their diet based on the results.

© oleksajewicz/Thinkstock

“It wouldn’t impact my fish consumption at all,” said Sancy Leachman, MD, PhD, who directs the melanoma program at Oregon Health & Science University’s Knight Cancer Institute in Portland. “Fish are part of a healthy diet,” particularly if it replaces less healthy proteins such as beef.

Even the authors of the study advised caution when interpreting the findings.

“I wouldn’t encourage anyone to change their fish consumption habits just because of this paper,” said study leader Eunyoung Cho, ScD, an epidemiologist at Brown University, Providence, R.I. “Fish is cardioprotective and is related to reduced risk of developing certain cancers too.”
 

Solid findings or fishing expedition?

The study quickly generated headlines and was the most viewed article of the journal Cancer Causes & Control within a day of its publication.

Dr. Cho, who is on the editorial board of the journal, analyzed the results of a study funded by the National Institutes of Health and the Association for the Advancement of Retired Persons that began in the 1990s and explored possible links between fish consumption and developing different forms of cancer.

Previous research from this project had shown eating fish was associated with an increased risk of melanoma – but no other type of cancer.

Dr. Cho speculated that the risk is due to contaminants, such as mercury and arsenic, in fish. But she was curious to see if she could find a connection between the amount of fish consumed and the risk of developing skin cancer.

At the beginning of the study people reported how much fish they had consumed over the previous year, which varied widely by person. Then researchers tracked participants for 15 years, recording who developed cancer and who did not.

Dietary recall can be difficult; people often say they can’t remember what they ate yesterday, much less 1 year ago. Still, dietitian Clare Collins, PhD, of the University of Newcastle (Australia), noted that previous research showed that the dietary recall tool for this study is reliable.

NIH researchers never checked to see how their diet changed over time, as this was a study meant to observe changes in health status starting from a baseline point. The researchers assumed that the level of fish intake recorded at the beginning of the study remained steady.

Of 491,000 people tracked in the study, 5,000 developed malignant melanoma and another 3,300 developed melanoma cells on the skin surface. People who ate the most fish – an average of almost 43 g, or about 1.5 ounces, per day – were 23% more likely to develop melanoma than the lightest fish eaters, who averaged 3 g per day.  

That risk is modest, Dr. Leachman said, especially for people with red hair who, she said, are 400% more likely to get melanoma than others. “A 23% increase, in the whole scheme of things, is not nearly as important as not getting sunburned if you’re a redhead,” Dr. Leachman said.

And what about the sun? Sun exposure is the principal risk factor for developing melanoma, and the researchers didn’t account for that factor. People who developed melanoma during the study may simply have spent more time in tanning beds or on the beach – or perhaps fishing and then eating their catch.

Dr. Cho and colleagues tried to consider the effects of solar radiation by looking at average sun exposure times in the places where the participants in the study were living when the research began. Using that framework, variation in sun exposure made no difference to melanoma risk, but Dr. Leachman said the technique isn’t foolproof.

“They assumed that they were going to get a certain amount of ultraviolet light just based on where they lived. We don’t know how long they lived there or if they really had ultraviolet exposure or not,” Dr. Leachman said. Someone in presumably less sunny Pennsylvania could get more sun than someone in sun-drenched Arizona depending on their lifestyle and habits.

The kind of study Dr. Cho published cannot account for individual behaviors related to sun exposure, a limitation her team readily acknowledges. Nor does it include information about moles or hair color – important considerations for skin cancers. It may be that redheads with moles who barely ate any fish developed melanoma at higher rates than anyone else, but the data don’t allow for that kind of analysis.

Dr. Cho’s group found that canned tuna and any type of fish that wasn’t fried were associated with a higher risk of developing melanoma, as people reported eating more of those products. However, people who said they ate greater quantities of fried fish had a lower risk of melanoma, a counterintuitive finding that she said warrants further research.

Given that the study showed only a modest chance of developing melanoma regardless of fish intake, and left so many questions unanswered, what was the point?

Other journals declined to publish this paper, Dr. Cho acknowledged, but she defended the article as a step toward better understanding the health impact of environmental contaminants in fish.

Dr. Leachman agreed. “These kinds of studies are very important to do. They have large data sets, where you can start to see trends that may be important,” she said. “They can help you identify things that might be related. These experiments are hypothesis generating.”

“I already published an article showing that total mercury level is related to skin cancer, and we know very well that in the U.S. fish consumption is the major source of mercury contamination,” Dr. Cho said. “So, I naturally thought that fish consumption may be associated with increased risk of skin cancer too.” Dr. Cho said she believed the findings confirm that hypothesis.

Dr. Cho said the next step would be to measure blood levels of different contaminants such as mercury and arsenic in people with melanoma, to determine which toxin is the biggest driver of melanoma. She said she plans to seek funding for that research.

Meanwhile, pass the salmon – but go light on the salt.

Dr. Cho and Dr. Leachman reported no relevant financial relationships. Dr. Cho is on the editorial board of Cancer Causes & Control.

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

A recent study linking the consumption of fish to melanoma had sushi eaters looking up the number of the nearest dermatologist. But experts said the findings had several important limitations and that no one should change their diet based on the results.

© oleksajewicz/Thinkstock

“It wouldn’t impact my fish consumption at all,” said Sancy Leachman, MD, PhD, who directs the melanoma program at Oregon Health & Science University’s Knight Cancer Institute in Portland. “Fish are part of a healthy diet,” particularly if it replaces less healthy proteins such as beef.

Even the authors of the study advised caution when interpreting the findings.

“I wouldn’t encourage anyone to change their fish consumption habits just because of this paper,” said study leader Eunyoung Cho, ScD, an epidemiologist at Brown University, Providence, R.I. “Fish is cardioprotective and is related to reduced risk of developing certain cancers too.”
 

Solid findings or fishing expedition?

The study quickly generated headlines and was the most viewed article of the journal Cancer Causes & Control within a day of its publication.

Dr. Cho, who is on the editorial board of the journal, analyzed the results of a study funded by the National Institutes of Health and the Association for the Advancement of Retired Persons that began in the 1990s and explored possible links between fish consumption and developing different forms of cancer.

Previous research from this project had shown eating fish was associated with an increased risk of melanoma – but no other type of cancer.

Dr. Cho speculated that the risk is due to contaminants, such as mercury and arsenic, in fish. But she was curious to see if she could find a connection between the amount of fish consumed and the risk of developing skin cancer.

At the beginning of the study people reported how much fish they had consumed over the previous year, which varied widely by person. Then researchers tracked participants for 15 years, recording who developed cancer and who did not.

Dietary recall can be difficult; people often say they can’t remember what they ate yesterday, much less 1 year ago. Still, dietitian Clare Collins, PhD, of the University of Newcastle (Australia), noted that previous research showed that the dietary recall tool for this study is reliable.

NIH researchers never checked to see how their diet changed over time, as this was a study meant to observe changes in health status starting from a baseline point. The researchers assumed that the level of fish intake recorded at the beginning of the study remained steady.

Of 491,000 people tracked in the study, 5,000 developed malignant melanoma and another 3,300 developed melanoma cells on the skin surface. People who ate the most fish – an average of almost 43 g, or about 1.5 ounces, per day – were 23% more likely to develop melanoma than the lightest fish eaters, who averaged 3 g per day.  

That risk is modest, Dr. Leachman said, especially for people with red hair who, she said, are 400% more likely to get melanoma than others. “A 23% increase, in the whole scheme of things, is not nearly as important as not getting sunburned if you’re a redhead,” Dr. Leachman said.

And what about the sun? Sun exposure is the principal risk factor for developing melanoma, and the researchers didn’t account for that factor. People who developed melanoma during the study may simply have spent more time in tanning beds or on the beach – or perhaps fishing and then eating their catch.

Dr. Cho and colleagues tried to consider the effects of solar radiation by looking at average sun exposure times in the places where the participants in the study were living when the research began. Using that framework, variation in sun exposure made no difference to melanoma risk, but Dr. Leachman said the technique isn’t foolproof.

“They assumed that they were going to get a certain amount of ultraviolet light just based on where they lived. We don’t know how long they lived there or if they really had ultraviolet exposure or not,” Dr. Leachman said. Someone in presumably less sunny Pennsylvania could get more sun than someone in sun-drenched Arizona depending on their lifestyle and habits.

The kind of study Dr. Cho published cannot account for individual behaviors related to sun exposure, a limitation her team readily acknowledges. Nor does it include information about moles or hair color – important considerations for skin cancers. It may be that redheads with moles who barely ate any fish developed melanoma at higher rates than anyone else, but the data don’t allow for that kind of analysis.

Dr. Cho’s group found that canned tuna and any type of fish that wasn’t fried were associated with a higher risk of developing melanoma, as people reported eating more of those products. However, people who said they ate greater quantities of fried fish had a lower risk of melanoma, a counterintuitive finding that she said warrants further research.

Given that the study showed only a modest chance of developing melanoma regardless of fish intake, and left so many questions unanswered, what was the point?

Other journals declined to publish this paper, Dr. Cho acknowledged, but she defended the article as a step toward better understanding the health impact of environmental contaminants in fish.

Dr. Leachman agreed. “These kinds of studies are very important to do. They have large data sets, where you can start to see trends that may be important,” she said. “They can help you identify things that might be related. These experiments are hypothesis generating.”

“I already published an article showing that total mercury level is related to skin cancer, and we know very well that in the U.S. fish consumption is the major source of mercury contamination,” Dr. Cho said. “So, I naturally thought that fish consumption may be associated with increased risk of skin cancer too.” Dr. Cho said she believed the findings confirm that hypothesis.

Dr. Cho said the next step would be to measure blood levels of different contaminants such as mercury and arsenic in people with melanoma, to determine which toxin is the biggest driver of melanoma. She said she plans to seek funding for that research.

Meanwhile, pass the salmon – but go light on the salt.

Dr. Cho and Dr. Leachman reported no relevant financial relationships. Dr. Cho is on the editorial board of Cancer Causes & Control.

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

Patients who are immunocompromised showed no increased risk of surgical site infection when undergoing Mohs micrographic surgery, regardless of whether or not they received antibiotics, suggesting that antibiotic prophylaxis, which is often used for these patients, may not be necessary, according to new research.

The retrospective cohort study found that “immunosuppressed patients had similar infection rates as immunocompetent patients following Mohs micrographic surgery,” first author Tuyet A. Nguyen, MD, of the department of dermatology, Cedars-Sinai Medical Center, Los Angeles, told this news organization.

“Therefore, antibiotic prescribing patterns should not change simply due to immunosuppression. Furthermore, immunosuppressed patients appear to respond well to antibiotics and recover similarly to immunocompetent patients,” she said.

Dr. Nguyen

Overall, postprocedural infections occurred in 1.6% (95) of patients, a rate that mirrors that of the general population, Dr. Nguyen noted. No significant differences in surgical site infection rates were observed between immunocompromised patients (2.1%, n = 15) and those who were immunocompetent (1.6%, n = 80; P = .30).

Importantly, among those who were immunocompromised, the rates of infection were not significantly different between those who did receive antibiotics (3.0%, n = 8) and those who did not receive antibiotics (1.5%, n = 7; P = .19).

The lack of a difference in surgical site infection rates among those who did and those who did not receive antibiotics extended to the entire study population (2.0% vs. 1.4%; P = .12).

The study cohort mainly comprised immunosuppressed transplant patients, notably, heart, lung, and kidney transplant patients. However, “even in this population, we did not see a higher rate of infection,” senior author Nima M. Gharavi, MD, PhD, director of dermatologic surgery and Mohs micrographic surgery and associate professor of medicine and pathology and laboratory medicine at Cedars-Sinai Medical Center, said in an interview.

Dr. Nima M. Gharavi

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

Patients who are immunocompromised showed no increased risk of surgical site infection when undergoing Mohs micrographic surgery, regardless of whether or not they received antibiotics, suggesting that antibiotic prophylaxis, which is often used for these patients, may not be necessary, according to new research.

The retrospective cohort study found that “immunosuppressed patients had similar infection rates as immunocompetent patients following Mohs micrographic surgery,” first author Tuyet A. Nguyen, MD, of the department of dermatology, Cedars-Sinai Medical Center, Los Angeles, told this news organization.

“Therefore, antibiotic prescribing patterns should not change simply due to immunosuppression. Furthermore, immunosuppressed patients appear to respond well to antibiotics and recover similarly to immunocompetent patients,” she said.

Dr. Nguyen

Overall, postprocedural infections occurred in 1.6% (95) of patients, a rate that mirrors that of the general population, Dr. Nguyen noted. No significant differences in surgical site infection rates were observed between immunocompromised patients (2.1%, n = 15) and those who were immunocompetent (1.6%, n = 80; P = .30).

Importantly, among those who were immunocompromised, the rates of infection were not significantly different between those who did receive antibiotics (3.0%, n = 8) and those who did not receive antibiotics (1.5%, n = 7; P = .19).

The lack of a difference in surgical site infection rates among those who did and those who did not receive antibiotics extended to the entire study population (2.0% vs. 1.4%; P = .12).

The study cohort mainly comprised immunosuppressed transplant patients, notably, heart, lung, and kidney transplant patients. However, “even in this population, we did not see a higher rate of infection,” senior author Nima M. Gharavi, MD, PhD, director of dermatologic surgery and Mohs micrographic surgery and associate professor of medicine and pathology and laboratory medicine at Cedars-Sinai Medical Center, said in an interview.

Dr. Nima M. Gharavi

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

Patients who are immunocompromised showed no increased risk of surgical site infection when undergoing Mohs micrographic surgery, regardless of whether or not they received antibiotics, suggesting that antibiotic prophylaxis, which is often used for these patients, may not be necessary, according to new research.

The retrospective cohort study found that “immunosuppressed patients had similar infection rates as immunocompetent patients following Mohs micrographic surgery,” first author Tuyet A. Nguyen, MD, of the department of dermatology, Cedars-Sinai Medical Center, Los Angeles, told this news organization.

“Therefore, antibiotic prescribing patterns should not change simply due to immunosuppression. Furthermore, immunosuppressed patients appear to respond well to antibiotics and recover similarly to immunocompetent patients,” she said.

Dr. Nguyen

Overall, postprocedural infections occurred in 1.6% (95) of patients, a rate that mirrors that of the general population, Dr. Nguyen noted. No significant differences in surgical site infection rates were observed between immunocompromised patients (2.1%, n = 15) and those who were immunocompetent (1.6%, n = 80; P = .30).

Importantly, among those who were immunocompromised, the rates of infection were not significantly different between those who did receive antibiotics (3.0%, n = 8) and those who did not receive antibiotics (1.5%, n = 7; P = .19).

The lack of a difference in surgical site infection rates among those who did and those who did not receive antibiotics extended to the entire study population (2.0% vs. 1.4%; P = .12).

The study cohort mainly comprised immunosuppressed transplant patients, notably, heart, lung, and kidney transplant patients. However, “even in this population, we did not see a higher rate of infection,” senior author Nima M. Gharavi, MD, PhD, director of dermatologic surgery and Mohs micrographic surgery and associate professor of medicine and pathology and laboratory medicine at Cedars-Sinai Medical Center, said in an interview.

Dr. Nima M. Gharavi

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

As increasing numbers of patients in their 80s, 90s, and even 100s present for possible Mohs micrographic surgery, surgeons are confronted with deciding when the risks of treatment may outweigh the benefits.

In one of two presentations at the annual meeting of the American College of Mohs Surgery that addressed this topic, Howard W. Rogers, MD, of Advanced Dermatology in Norwich, Conn., said that the crux of the issue is the concern not to undertreat. He noted that reduced access to dermatologic care during the pandemic has provided a stark lesson in the risks of delaying treatment in all age groups. “Mohs surgeons have all seen the consequences of delayed treatment due to the pandemic with enormous, destructive, and sometimes fatal cancers coming to the office in the last year,” he told this news organization.

“Pandemic-related treatment delay has caused increased suffering and morbidity for countless skin cancer patients across the U.S.,” he said. “In general, not treating skin cancer and hoping it’s not going to grow or having significant delays in treatment are a recipe for disastrous outcomes.”

That said, active monitoring may be appropriate “for select small cancers that tend to grow slowly in the very elderly,” added Dr. Rogers, the incoming ACMS president. Among the key situations where the benefits of active monitoring may outweigh the risks of surgery are small, slowly growing cancers, when frailty is an issue.

Frailty has been equated to compromised functionality, which can increase the risk of an array of complications, including prolonged wound healing and secondary complications stemming from immobility. The toll those issues can take on patients’ quality of life can be considerable, Dr. Rogers said.

When weighing treatment options with elderly patients, he emphasized that careful consideration should be given to whether the “time needed to benefit from a Mohs procedure is longer than the patient’s life expectancy.” Furthermore, a decision not to treat does not have to be the last word. “We need to have an honest dialogue on the consequences of nontreatment, but part of that should be that just because we don’t treat today, doesn’t mean we can’t treat it tomorrow, if necessary.”

Of note, he added, “more than 100,00 patients have surgery for basal cell carcinoma [BCC] in their last year of life.” And that figure will likely rise exponentially if population projections come to fruition, considering that the population of people over the age of 85 is predicted to increase to nearly 18 million in 2050, from 5.8 million in 2012, Dr. Rogers said.

Until more research emerges on how to best treat this age group, Dr. Rogers noted that experts recommend that for elderly patients, “treatment should be individualized with consideration of active monitoring of primary BCC that is not in the H-zone, asymptomatic, smaller than 1 cm, with treatment initiated if there is substantial growth or symptoms.” Ultimately, he urged surgeons to “be sensitive and treat our patients like ourselves or our family members.”
 

When appropriate – Mohs is safe in the very elderly

Taking on the issue in a separate presentation, Deborah MacFarlane, MD, professor of dermatology and head and neck surgery at MD Anderson Cancer Center, Houston, said that for skin cancer cases that warrant treatment, clinicians should not let age alone stand in the way of Mohs surgery.

The evidence of its safety in the elderly dates back to a paper published in 1997 that Dr. MacFarlane coauthored, describing Mohs surgery of BCCs, squamous cell cancers (SCCs), and melanomas among 115 patients aged 90 and older (average, 92.4 years) who had an average of 1.9 comorbid medical conditions, and were taking an average of 2.3 medications. “Overall, we had just one complication among the patients,” she said.

In a subsequent paper, Dr. MacFarlane and her colleagues found that age at the time of Mohs surgery, even in older patients, was unrelated to survival, stage of cancer, or the type of repair. “We have concluded that this rapidly growing segment of the population can undergo Mohs surgery and should not be relegated to less effective treatment out of fear of its affecting their survival,” Dr. MacFarlane said.

She agreed with the concern about frailty and hence functionality, which may need to be factored in when making a decision to perform Mohs surgery. “I think this is something we do intuitively anyway,” she added. “We’re going to offer Mohs to someone who we think will survive and who is in relatively good health,” Dr. MacFarlane noted.

The point is illustrated in a new multicenter study of 1,181 patients at 22 U.S. sites, aged 85 years and older with nonmelanoma skin cancer referred for Mohs surgery. In the study, published in JAMA Dermatology after the ACMS meeting, patients who had Mohs surgery were almost four times more likely to have high functional status (P < .001) and were more likely to have facial tumors (P < .001), compared with those who had an alternate surgery.

The main reasons provided by the surgeons for opting to treat with Mohs included a patient’s desire for treatment with a high cure rate (66%), good/excellent patient functional status for age (57%), and a high risk associated with the tumor based on histology (40%), noted Dr. MacFarlane, one of the authors.

She reiterated the point raised by Dr. Rogers that “this is something we’re going to increasingly face,” noting that people over 85 represent the fastest growing segment of the population. “I have more patients over the age of 100 than I’ve ever had before,” she said.

Nevertheless, her own experience with elderly patients speaks to the safety of Mohs surgery in this population: Dr. MacFarlane reported a review of her practice’s records of 171 patients aged 85 years and older between May 2016 and May 2022, who received 414 separate procedures, without a single complication.

Sharing many of Dr. Rogers’ concerns about using caution in at-risk patients, Dr. MacFarlane offered recommendations for the optimal treatment of elderly patients receiving Mohs, including handling tissue delicately, and “keep undermining to a minimum.” She noted that intermediate closures and full thickness skin grafts are ideal closures for the elderly, while flaps may be performed in selected robust skin. It is also important to involve caretakers from the onset, talk and listen to patients – and play their choice of music during treatment, she said.

Commenting on the debate, comoderator Nahid Y. Vidal, MD, of the department of dermatology, Mayo Clinic, Rochester, Minn., noted that the expanding older population is accompanied by increases in skin cancer, in addition to more immunosenescence that is related to development of infections, autoimmune disease, and malignant tumors.

“In our academic practice, as with both the reference speakers, we do frequently see elderly, and not uncommonly the super-elderly,” she told this news organization. “The take-home point for me is to treat your whole patient, not just the tumor,” considering social factors, frailty/spry factor, and preferences, “and to do the humanistic thing, while also remaining evidence based,” she said.

“Don’t assume that increased age translates to morbidity, worse outcomes, or futility of treatment,” she added. “Chances are, if [a patient] made it to 90 years old with only a few medications and few medical problems, they may make it to 100, so why put the patient at risk for metastasis and death from a treatable/curable skin cancer,” in the case of SCC, she said.

“By the same token, why not perform more conservative treatments such as ED&C [electrodesiccation and curettage] for very low-risk skin cancers in low-risk locations, such as a superficial basal cell carcinoma on the trunk?” Overall, instead of trying to determine how long a super-elderly individual will live, Dr. Vidal said that “it’s better to educate the patient, engage in a discussion about goals of care, and to make few assumptions.”

Dr. Rogers, Dr. MacFarlane, and Dr. Vidal report no disclosures.

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

As increasing numbers of patients in their 80s, 90s, and even 100s present for possible Mohs micrographic surgery, surgeons are confronted with deciding when the risks of treatment may outweigh the benefits.

In one of two presentations at the annual meeting of the American College of Mohs Surgery that addressed this topic, Howard W. Rogers, MD, of Advanced Dermatology in Norwich, Conn., said that the crux of the issue is the concern not to undertreat. He noted that reduced access to dermatologic care during the pandemic has provided a stark lesson in the risks of delaying treatment in all age groups. “Mohs surgeons have all seen the consequences of delayed treatment due to the pandemic with enormous, destructive, and sometimes fatal cancers coming to the office in the last year,” he told this news organization.

“Pandemic-related treatment delay has caused increased suffering and morbidity for countless skin cancer patients across the U.S.,” he said. “In general, not treating skin cancer and hoping it’s not going to grow or having significant delays in treatment are a recipe for disastrous outcomes.”

That said, active monitoring may be appropriate “for select small cancers that tend to grow slowly in the very elderly,” added Dr. Rogers, the incoming ACMS president. Among the key situations where the benefits of active monitoring may outweigh the risks of surgery are small, slowly growing cancers, when frailty is an issue.

Frailty has been equated to compromised functionality, which can increase the risk of an array of complications, including prolonged wound healing and secondary complications stemming from immobility. The toll those issues can take on patients’ quality of life can be considerable, Dr. Rogers said.

When weighing treatment options with elderly patients, he emphasized that careful consideration should be given to whether the “time needed to benefit from a Mohs procedure is longer than the patient’s life expectancy.” Furthermore, a decision not to treat does not have to be the last word. “We need to have an honest dialogue on the consequences of nontreatment, but part of that should be that just because we don’t treat today, doesn’t mean we can’t treat it tomorrow, if necessary.”

Of note, he added, “more than 100,00 patients have surgery for basal cell carcinoma [BCC] in their last year of life.” And that figure will likely rise exponentially if population projections come to fruition, considering that the population of people over the age of 85 is predicted to increase to nearly 18 million in 2050, from 5.8 million in 2012, Dr. Rogers said.

Until more research emerges on how to best treat this age group, Dr. Rogers noted that experts recommend that for elderly patients, “treatment should be individualized with consideration of active monitoring of primary BCC that is not in the H-zone, asymptomatic, smaller than 1 cm, with treatment initiated if there is substantial growth or symptoms.” Ultimately, he urged surgeons to “be sensitive and treat our patients like ourselves or our family members.”
 

When appropriate – Mohs is safe in the very elderly

Taking on the issue in a separate presentation, Deborah MacFarlane, MD, professor of dermatology and head and neck surgery at MD Anderson Cancer Center, Houston, said that for skin cancer cases that warrant treatment, clinicians should not let age alone stand in the way of Mohs surgery.

The evidence of its safety in the elderly dates back to a paper published in 1997 that Dr. MacFarlane coauthored, describing Mohs surgery of BCCs, squamous cell cancers (SCCs), and melanomas among 115 patients aged 90 and older (average, 92.4 years) who had an average of 1.9 comorbid medical conditions, and were taking an average of 2.3 medications. “Overall, we had just one complication among the patients,” she said.

In a subsequent paper, Dr. MacFarlane and her colleagues found that age at the time of Mohs surgery, even in older patients, was unrelated to survival, stage of cancer, or the type of repair. “We have concluded that this rapidly growing segment of the population can undergo Mohs surgery and should not be relegated to less effective treatment out of fear of its affecting their survival,” Dr. MacFarlane said.

She agreed with the concern about frailty and hence functionality, which may need to be factored in when making a decision to perform Mohs surgery. “I think this is something we do intuitively anyway,” she added. “We’re going to offer Mohs to someone who we think will survive and who is in relatively good health,” Dr. MacFarlane noted.

The point is illustrated in a new multicenter study of 1,181 patients at 22 U.S. sites, aged 85 years and older with nonmelanoma skin cancer referred for Mohs surgery. In the study, published in JAMA Dermatology after the ACMS meeting, patients who had Mohs surgery were almost four times more likely to have high functional status (P < .001) and were more likely to have facial tumors (P < .001), compared with those who had an alternate surgery.

The main reasons provided by the surgeons for opting to treat with Mohs included a patient’s desire for treatment with a high cure rate (66%), good/excellent patient functional status for age (57%), and a high risk associated with the tumor based on histology (40%), noted Dr. MacFarlane, one of the authors.

She reiterated the point raised by Dr. Rogers that “this is something we’re going to increasingly face,” noting that people over 85 represent the fastest growing segment of the population. “I have more patients over the age of 100 than I’ve ever had before,” she said.

Nevertheless, her own experience with elderly patients speaks to the safety of Mohs surgery in this population: Dr. MacFarlane reported a review of her practice’s records of 171 patients aged 85 years and older between May 2016 and May 2022, who received 414 separate procedures, without a single complication.

Sharing many of Dr. Rogers’ concerns about using caution in at-risk patients, Dr. MacFarlane offered recommendations for the optimal treatment of elderly patients receiving Mohs, including handling tissue delicately, and “keep undermining to a minimum.” She noted that intermediate closures and full thickness skin grafts are ideal closures for the elderly, while flaps may be performed in selected robust skin. It is also important to involve caretakers from the onset, talk and listen to patients – and play their choice of music during treatment, she said.

Commenting on the debate, comoderator Nahid Y. Vidal, MD, of the department of dermatology, Mayo Clinic, Rochester, Minn., noted that the expanding older population is accompanied by increases in skin cancer, in addition to more immunosenescence that is related to development of infections, autoimmune disease, and malignant tumors.

“In our academic practice, as with both the reference speakers, we do frequently see elderly, and not uncommonly the super-elderly,” she told this news organization. “The take-home point for me is to treat your whole patient, not just the tumor,” considering social factors, frailty/spry factor, and preferences, “and to do the humanistic thing, while also remaining evidence based,” she said.

“Don’t assume that increased age translates to morbidity, worse outcomes, or futility of treatment,” she added. “Chances are, if [a patient] made it to 90 years old with only a few medications and few medical problems, they may make it to 100, so why put the patient at risk for metastasis and death from a treatable/curable skin cancer,” in the case of SCC, she said.

“By the same token, why not perform more conservative treatments such as ED&C [electrodesiccation and curettage] for very low-risk skin cancers in low-risk locations, such as a superficial basal cell carcinoma on the trunk?” Overall, instead of trying to determine how long a super-elderly individual will live, Dr. Vidal said that “it’s better to educate the patient, engage in a discussion about goals of care, and to make few assumptions.”

Dr. Rogers, Dr. MacFarlane, and Dr. Vidal report no disclosures.

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

As increasing numbers of patients in their 80s, 90s, and even 100s present for possible Mohs micrographic surgery, surgeons are confronted with deciding when the risks of treatment may outweigh the benefits.

In one of two presentations at the annual meeting of the American College of Mohs Surgery that addressed this topic, Howard W. Rogers, MD, of Advanced Dermatology in Norwich, Conn., said that the crux of the issue is the concern not to undertreat. He noted that reduced access to dermatologic care during the pandemic has provided a stark lesson in the risks of delaying treatment in all age groups. “Mohs surgeons have all seen the consequences of delayed treatment due to the pandemic with enormous, destructive, and sometimes fatal cancers coming to the office in the last year,” he told this news organization.

“Pandemic-related treatment delay has caused increased suffering and morbidity for countless skin cancer patients across the U.S.,” he said. “In general, not treating skin cancer and hoping it’s not going to grow or having significant delays in treatment are a recipe for disastrous outcomes.”

That said, active monitoring may be appropriate “for select small cancers that tend to grow slowly in the very elderly,” added Dr. Rogers, the incoming ACMS president. Among the key situations where the benefits of active monitoring may outweigh the risks of surgery are small, slowly growing cancers, when frailty is an issue.

Frailty has been equated to compromised functionality, which can increase the risk of an array of complications, including prolonged wound healing and secondary complications stemming from immobility. The toll those issues can take on patients’ quality of life can be considerable, Dr. Rogers said.

When weighing treatment options with elderly patients, he emphasized that careful consideration should be given to whether the “time needed to benefit from a Mohs procedure is longer than the patient’s life expectancy.” Furthermore, a decision not to treat does not have to be the last word. “We need to have an honest dialogue on the consequences of nontreatment, but part of that should be that just because we don’t treat today, doesn’t mean we can’t treat it tomorrow, if necessary.”

Of note, he added, “more than 100,00 patients have surgery for basal cell carcinoma [BCC] in their last year of life.” And that figure will likely rise exponentially if population projections come to fruition, considering that the population of people over the age of 85 is predicted to increase to nearly 18 million in 2050, from 5.8 million in 2012, Dr. Rogers said.

Until more research emerges on how to best treat this age group, Dr. Rogers noted that experts recommend that for elderly patients, “treatment should be individualized with consideration of active monitoring of primary BCC that is not in the H-zone, asymptomatic, smaller than 1 cm, with treatment initiated if there is substantial growth or symptoms.” Ultimately, he urged surgeons to “be sensitive and treat our patients like ourselves or our family members.”
 

When appropriate – Mohs is safe in the very elderly

Taking on the issue in a separate presentation, Deborah MacFarlane, MD, professor of dermatology and head and neck surgery at MD Anderson Cancer Center, Houston, said that for skin cancer cases that warrant treatment, clinicians should not let age alone stand in the way of Mohs surgery.

The evidence of its safety in the elderly dates back to a paper published in 1997 that Dr. MacFarlane coauthored, describing Mohs surgery of BCCs, squamous cell cancers (SCCs), and melanomas among 115 patients aged 90 and older (average, 92.4 years) who had an average of 1.9 comorbid medical conditions, and were taking an average of 2.3 medications. “Overall, we had just one complication among the patients,” she said.

In a subsequent paper, Dr. MacFarlane and her colleagues found that age at the time of Mohs surgery, even in older patients, was unrelated to survival, stage of cancer, or the type of repair. “We have concluded that this rapidly growing segment of the population can undergo Mohs surgery and should not be relegated to less effective treatment out of fear of its affecting their survival,” Dr. MacFarlane said.

She agreed with the concern about frailty and hence functionality, which may need to be factored in when making a decision to perform Mohs surgery. “I think this is something we do intuitively anyway,” she added. “We’re going to offer Mohs to someone who we think will survive and who is in relatively good health,” Dr. MacFarlane noted.

The point is illustrated in a new multicenter study of 1,181 patients at 22 U.S. sites, aged 85 years and older with nonmelanoma skin cancer referred for Mohs surgery. In the study, published in JAMA Dermatology after the ACMS meeting, patients who had Mohs surgery were almost four times more likely to have high functional status (P < .001) and were more likely to have facial tumors (P < .001), compared with those who had an alternate surgery.

The main reasons provided by the surgeons for opting to treat with Mohs included a patient’s desire for treatment with a high cure rate (66%), good/excellent patient functional status for age (57%), and a high risk associated with the tumor based on histology (40%), noted Dr. MacFarlane, one of the authors.

She reiterated the point raised by Dr. Rogers that “this is something we’re going to increasingly face,” noting that people over 85 represent the fastest growing segment of the population. “I have more patients over the age of 100 than I’ve ever had before,” she said.

Nevertheless, her own experience with elderly patients speaks to the safety of Mohs surgery in this population: Dr. MacFarlane reported a review of her practice’s records of 171 patients aged 85 years and older between May 2016 and May 2022, who received 414 separate procedures, without a single complication.

Sharing many of Dr. Rogers’ concerns about using caution in at-risk patients, Dr. MacFarlane offered recommendations for the optimal treatment of elderly patients receiving Mohs, including handling tissue delicately, and “keep undermining to a minimum.” She noted that intermediate closures and full thickness skin grafts are ideal closures for the elderly, while flaps may be performed in selected robust skin. It is also important to involve caretakers from the onset, talk and listen to patients – and play their choice of music during treatment, she said.

Commenting on the debate, comoderator Nahid Y. Vidal, MD, of the department of dermatology, Mayo Clinic, Rochester, Minn., noted that the expanding older population is accompanied by increases in skin cancer, in addition to more immunosenescence that is related to development of infections, autoimmune disease, and malignant tumors.

“In our academic practice, as with both the reference speakers, we do frequently see elderly, and not uncommonly the super-elderly,” she told this news organization. “The take-home point for me is to treat your whole patient, not just the tumor,” considering social factors, frailty/spry factor, and preferences, “and to do the humanistic thing, while also remaining evidence based,” she said.

“Don’t assume that increased age translates to morbidity, worse outcomes, or futility of treatment,” she added. “Chances are, if [a patient] made it to 90 years old with only a few medications and few medical problems, they may make it to 100, so why put the patient at risk for metastasis and death from a treatable/curable skin cancer,” in the case of SCC, she said.

“By the same token, why not perform more conservative treatments such as ED&C [electrodesiccation and curettage] for very low-risk skin cancers in low-risk locations, such as a superficial basal cell carcinoma on the trunk?” Overall, instead of trying to determine how long a super-elderly individual will live, Dr. Vidal said that “it’s better to educate the patient, engage in a discussion about goals of care, and to make few assumptions.”

Dr. Rogers, Dr. MacFarlane, and Dr. Vidal report no disclosures.

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