Less than half of older adults with attention-deficit/hyperactivity disorder are diagnosed with the condition, and many never receive treatment.

Negative consequences can develop from not treating ADHD, including job loss, suppressed income levels, low educational attainment, and difficulty maintaining relationships. Perhaps as many as 5% of adults have ADHD, which is highly hereditary. 

Primary care physicians or family medicine clinicians are often best placed to diagnose ADHD in older adults, according to experts interviewed for this article. But first these providers need to tease out whether a patient has ADHD or another condition that is causing difficulties for these older adults.

However, clinicians may have a hard time discerning the symptoms of ADHD from that of other conditions of aging, such as mild cognitive impairment. Literature is lacking on best practices for screening and treating the condition in this population, according to a recent review published in the Expert Review of Neurotherapeutics, and a 2020 study by the same authors, epidemiologists, and psychiatrists based in Europe.

“If you don’t manage it, who will? It can be very hard to get psychiatric consults, almost impossible in some cases,” said Brendan Montano, MD, an internist in Cromwell, Conn., who specializes in treating ADHD. 
 

A critical role for primary care and family medicine

Although no formal U.S. guidelines exist on diagnosis of adult ADHD, Dr. Montano stressed that adults usually present with symptoms such as chronic forgetfulness, distractibility, or procrastination. Hyperactivity is more internalized as a feeling of internal restlessness in this age group, Dr. Montano said, rather than the more visible hyper behavior seen in children.

“The two big ways that people present are thinking they have it or [being] in chaos of some sort,” perhaps because they have been fired or their spouse has asked for a divorce, Dr. Montano explained.

To assess the possibility of ADHD, a clinician could give a patient a six-item screening test that asks questions such as how often over the previous 6 months have they had trouble completing assignments or remembering appointments. If they report difficulty in four or more of the six areas in the brief screener, clinicians can move on to a longer 18-item screening tool developed by the World Health Organization, Dr. Montano said.

To make an ADHD diagnosis definitively, however, a patient needs to report sustained difficulties in at least two aspects of life: work, home, or social situations. And they have to indicate to a clinician that these troubles began before age 12.

“You have to really sit down and paint the picture with the patient: There are no shortcuts here,” said Lenard Adler, MD, a psychiatrist who directs the Adult ADHD program at New York University. Dr. Adler helped develop the six-item screener and is currently on a committee developing formal screening guidelines for adult ADHD in the United States.

He said that often, “ADHD cotravels with other mental health disorders like depression, bipolar disorders, anxiety disorders, and substance use disorders at least half the time.”

To tease out if a patient really has ADHD, clinicians can start with a more general screening for anxiety and hone in on the possibility of the condition if the anxiety screening reveals challenges with distractibility and forgetfulness, according to Karen Smith, MD, a family physician in Raeford, N.C.

“We can’t expect patients to walk through the door with the diagnosis stamped on their foreheads,” said Dr. Smith, who is a member of the board of directors for the American Academy of Family Physicians.

But a patient’s apparent signs of ADHD could be due to another condition such as hyperthyroidism or diabetes, Dr. Smith said. The driving principle is to take enough time to figure out exactly what is going on, she said, and then to treat accordingly. “If you ask the right questions, patients will give you good answers.”

Medications are often prescribed to help manage ADHD symptoms. These can include stimulants, controlled substances that include methylphenidate or amphetamine, or nonstimulants, such as atomoxetine and bupropion. Dr. Montano starts his patients on a lower dose and titrates them up rapidly until they reach the optimum dose that allows them to sustain focus and feel more productive. Patients complete frequent self-reports during this process.

“Any diversion is inappropriate,” said Dr. Montano, who writes a contract with his patients saying that stimulant medications will not be refilled if they are used more quickly than prescribed.

For older adults, physicians should make sure that stimulants do not exacerbate any underlying cardiovascular conditions, Dr. Montano said, and consult a cardiologist when needed.

The benefits of proper ADHD treatment can be profound, Dr. Adler noted, no matter when it begins.

“Older adults have lived their lives feeling they’ve been disorganized and a burden to their significant others, and only when they’ve taken medication have they really been able to organize their days and feel effective in their social interactions and with their families,” Dr. Adler said.

Dr. Montano has reported relationships with AbbVie, Axsome, Corium, Idorsia, Intracellular, Otsuka, Supernus, Sage/Biogen, Biohaven, Boehringer Ingelheim, Cassava, Eli Lilly, Intracellular, Janssen, Jazz, Sage, Supernus, Otsuka, and Tonix. Dr. Adler has reported relationships with Shire/Takeda Pharmaceuticals, National Football League, Major League Baseball, Corium, Otsuka, Neurocentria, Bracket/Signant, and SUNY; and is receiving royalty payments for developing adult ADHD assessments. Dr. Smith has reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Less than half of older adults with attention-deficit/hyperactivity disorder are diagnosed with the condition, and many never receive treatment.

Negative consequences can develop from not treating ADHD, including job loss, suppressed income levels, low educational attainment, and difficulty maintaining relationships. Perhaps as many as 5% of adults have ADHD, which is highly hereditary. 

Primary care physicians or family medicine clinicians are often best placed to diagnose ADHD in older adults, according to experts interviewed for this article. But first these providers need to tease out whether a patient has ADHD or another condition that is causing difficulties for these older adults.

However, clinicians may have a hard time discerning the symptoms of ADHD from that of other conditions of aging, such as mild cognitive impairment. Literature is lacking on best practices for screening and treating the condition in this population, according to a recent review published in the Expert Review of Neurotherapeutics, and a 2020 study by the same authors, epidemiologists, and psychiatrists based in Europe.

“If you don’t manage it, who will? It can be very hard to get psychiatric consults, almost impossible in some cases,” said Brendan Montano, MD, an internist in Cromwell, Conn., who specializes in treating ADHD. 
 

A critical role for primary care and family medicine

Although no formal U.S. guidelines exist on diagnosis of adult ADHD, Dr. Montano stressed that adults usually present with symptoms such as chronic forgetfulness, distractibility, or procrastination. Hyperactivity is more internalized as a feeling of internal restlessness in this age group, Dr. Montano said, rather than the more visible hyper behavior seen in children.

“The two big ways that people present are thinking they have it or [being] in chaos of some sort,” perhaps because they have been fired or their spouse has asked for a divorce, Dr. Montano explained.

To assess the possibility of ADHD, a clinician could give a patient a six-item screening test that asks questions such as how often over the previous 6 months have they had trouble completing assignments or remembering appointments. If they report difficulty in four or more of the six areas in the brief screener, clinicians can move on to a longer 18-item screening tool developed by the World Health Organization, Dr. Montano said.

To make an ADHD diagnosis definitively, however, a patient needs to report sustained difficulties in at least two aspects of life: work, home, or social situations. And they have to indicate to a clinician that these troubles began before age 12.

“You have to really sit down and paint the picture with the patient: There are no shortcuts here,” said Lenard Adler, MD, a psychiatrist who directs the Adult ADHD program at New York University. Dr. Adler helped develop the six-item screener and is currently on a committee developing formal screening guidelines for adult ADHD in the United States.

He said that often, “ADHD cotravels with other mental health disorders like depression, bipolar disorders, anxiety disorders, and substance use disorders at least half the time.”

To tease out if a patient really has ADHD, clinicians can start with a more general screening for anxiety and hone in on the possibility of the condition if the anxiety screening reveals challenges with distractibility and forgetfulness, according to Karen Smith, MD, a family physician in Raeford, N.C.

“We can’t expect patients to walk through the door with the diagnosis stamped on their foreheads,” said Dr. Smith, who is a member of the board of directors for the American Academy of Family Physicians.

But a patient’s apparent signs of ADHD could be due to another condition such as hyperthyroidism or diabetes, Dr. Smith said. The driving principle is to take enough time to figure out exactly what is going on, she said, and then to treat accordingly. “If you ask the right questions, patients will give you good answers.”

Medications are often prescribed to help manage ADHD symptoms. These can include stimulants, controlled substances that include methylphenidate or amphetamine, or nonstimulants, such as atomoxetine and bupropion. Dr. Montano starts his patients on a lower dose and titrates them up rapidly until they reach the optimum dose that allows them to sustain focus and feel more productive. Patients complete frequent self-reports during this process.

“Any diversion is inappropriate,” said Dr. Montano, who writes a contract with his patients saying that stimulant medications will not be refilled if they are used more quickly than prescribed.

For older adults, physicians should make sure that stimulants do not exacerbate any underlying cardiovascular conditions, Dr. Montano said, and consult a cardiologist when needed.

The benefits of proper ADHD treatment can be profound, Dr. Adler noted, no matter when it begins.

“Older adults have lived their lives feeling they’ve been disorganized and a burden to their significant others, and only when they’ve taken medication have they really been able to organize their days and feel effective in their social interactions and with their families,” Dr. Adler said.

Dr. Montano has reported relationships with AbbVie, Axsome, Corium, Idorsia, Intracellular, Otsuka, Supernus, Sage/Biogen, Biohaven, Boehringer Ingelheim, Cassava, Eli Lilly, Intracellular, Janssen, Jazz, Sage, Supernus, Otsuka, and Tonix. Dr. Adler has reported relationships with Shire/Takeda Pharmaceuticals, National Football League, Major League Baseball, Corium, Otsuka, Neurocentria, Bracket/Signant, and SUNY; and is receiving royalty payments for developing adult ADHD assessments. Dr. Smith has reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Less than half of older adults with attention-deficit/hyperactivity disorder are diagnosed with the condition, and many never receive treatment.

Negative consequences can develop from not treating ADHD, including job loss, suppressed income levels, low educational attainment, and difficulty maintaining relationships. Perhaps as many as 5% of adults have ADHD, which is highly hereditary. 

Primary care physicians or family medicine clinicians are often best placed to diagnose ADHD in older adults, according to experts interviewed for this article. But first these providers need to tease out whether a patient has ADHD or another condition that is causing difficulties for these older adults.

However, clinicians may have a hard time discerning the symptoms of ADHD from that of other conditions of aging, such as mild cognitive impairment. Literature is lacking on best practices for screening and treating the condition in this population, according to a recent review published in the Expert Review of Neurotherapeutics, and a 2020 study by the same authors, epidemiologists, and psychiatrists based in Europe.

“If you don’t manage it, who will? It can be very hard to get psychiatric consults, almost impossible in some cases,” said Brendan Montano, MD, an internist in Cromwell, Conn., who specializes in treating ADHD. 
 

A critical role for primary care and family medicine

Although no formal U.S. guidelines exist on diagnosis of adult ADHD, Dr. Montano stressed that adults usually present with symptoms such as chronic forgetfulness, distractibility, or procrastination. Hyperactivity is more internalized as a feeling of internal restlessness in this age group, Dr. Montano said, rather than the more visible hyper behavior seen in children.

“The two big ways that people present are thinking they have it or [being] in chaos of some sort,” perhaps because they have been fired or their spouse has asked for a divorce, Dr. Montano explained.

To assess the possibility of ADHD, a clinician could give a patient a six-item screening test that asks questions such as how often over the previous 6 months have they had trouble completing assignments or remembering appointments. If they report difficulty in four or more of the six areas in the brief screener, clinicians can move on to a longer 18-item screening tool developed by the World Health Organization, Dr. Montano said.

To make an ADHD diagnosis definitively, however, a patient needs to report sustained difficulties in at least two aspects of life: work, home, or social situations. And they have to indicate to a clinician that these troubles began before age 12.

“You have to really sit down and paint the picture with the patient: There are no shortcuts here,” said Lenard Adler, MD, a psychiatrist who directs the Adult ADHD program at New York University. Dr. Adler helped develop the six-item screener and is currently on a committee developing formal screening guidelines for adult ADHD in the United States.

He said that often, “ADHD cotravels with other mental health disorders like depression, bipolar disorders, anxiety disorders, and substance use disorders at least half the time.”

To tease out if a patient really has ADHD, clinicians can start with a more general screening for anxiety and hone in on the possibility of the condition if the anxiety screening reveals challenges with distractibility and forgetfulness, according to Karen Smith, MD, a family physician in Raeford, N.C.

“We can’t expect patients to walk through the door with the diagnosis stamped on their foreheads,” said Dr. Smith, who is a member of the board of directors for the American Academy of Family Physicians.

But a patient’s apparent signs of ADHD could be due to another condition such as hyperthyroidism or diabetes, Dr. Smith said. The driving principle is to take enough time to figure out exactly what is going on, she said, and then to treat accordingly. “If you ask the right questions, patients will give you good answers.”

Medications are often prescribed to help manage ADHD symptoms. These can include stimulants, controlled substances that include methylphenidate or amphetamine, or nonstimulants, such as atomoxetine and bupropion. Dr. Montano starts his patients on a lower dose and titrates them up rapidly until they reach the optimum dose that allows them to sustain focus and feel more productive. Patients complete frequent self-reports during this process.

“Any diversion is inappropriate,” said Dr. Montano, who writes a contract with his patients saying that stimulant medications will not be refilled if they are used more quickly than prescribed.

For older adults, physicians should make sure that stimulants do not exacerbate any underlying cardiovascular conditions, Dr. Montano said, and consult a cardiologist when needed.

The benefits of proper ADHD treatment can be profound, Dr. Adler noted, no matter when it begins.

“Older adults have lived their lives feeling they’ve been disorganized and a burden to their significant others, and only when they’ve taken medication have they really been able to organize their days and feel effective in their social interactions and with their families,” Dr. Adler said.

Dr. Montano has reported relationships with AbbVie, Axsome, Corium, Idorsia, Intracellular, Otsuka, Supernus, Sage/Biogen, Biohaven, Boehringer Ingelheim, Cassava, Eli Lilly, Intracellular, Janssen, Jazz, Sage, Supernus, Otsuka, and Tonix. Dr. Adler has reported relationships with Shire/Takeda Pharmaceuticals, National Football League, Major League Baseball, Corium, Otsuka, Neurocentria, Bracket/Signant, and SUNY; and is receiving royalty payments for developing adult ADHD assessments. Dr. Smith has reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Traumatic brain injury (TBI) that occurs in early adulthood is associated with cognitive decline in later life, results from a study of identical twins who served in World War II show.

The research, which included almost 9,000 individuals, showed that twins who had experienced a TBI were more likely to have lower cognitive function at age 70 versus their twin who did not experience a TBI, especially if they had lost consciousness or were older than age 24 at the time of injury. In addition, their cognitive decline occurred at a more rapid rate.

“We know that TBI increases the risk of developing Alzheimer’s disease and other dementias in later life, but we haven’t known about TBI’s effect on cognitive decline that does not quite meet the threshold for dementia,” study investigator Marianne Chanti-Ketterl, PhD, Duke University, Durham, N.C., said in an interview.

“We know that TBI increases the risk of dementia in later life, but we haven’t known if TBI affects cognitive function, causes cognitive decline that has not progressed to the point of severity with Alzheimer’s or dementia,” she added.

Being able to study the impact of TBI in monozygotic twins gives this study a unique strength, she noted.

“The important thing about this is that they are monozygotic twins, and we know they shared a lot of early life exposure, and almost 100% genetics,” Dr. Chanti-Ketterl said.

The study was published online in Neurology.

For the study, the investigators assessed 8,662 participants born between 1917 and 1927 who were part of the National Academy of Sciences National Research Council’s Twin Registry. The registry is composed of male veterans of World War II with a history of TBI, as reported by themselves or a caregiver.

The men were followed up for many years as part of the registry, but cognitive assessment only began in the 1990s. They were followed up at four different time points, at which time the Telephone Interview for Cognitive Status (TICS-m), an alternative to the Mini-Mental State Examination that must be given in person, was administered.

A total of 25% of participants had experienced concussion in their lifetime. Of this cohort, there were 589 pairs of monozygotic twins who were discordant (one twin had TBI and the other had not).

Among the monozygotic twin cohort, a history of any TBI and being older than age 24 at the time of TBI were associated with lower TICS-m scores.

A twin who experienced TBI after age 24 scored 0.59 points lower on the TICS-m at age 70 than his twin with no TBI, and cognitive function declined faster, by 0.05 points per year.
 

First study of its kind

Holly Elser, MD, PhD, MPH, an epidemiologist and resident physician in neurology at the University of Pennsylvania, Philadelphia, and coauthor of an accompanying editorial, said in an interview that the study’s twin design was a definite strength.

“There are lots of papers that have remarked on the apparent association between head injury and subsequent dementia or cognitive decline, but to my knowledge, this is one of the first, if not the first, to use a twin study design, which has the unique advantage of having better control over early life and genetic factors than would ever typically be possible in a dataset of unrelated adults,” said Dr. Elser.

She added that the study findings “strengthen our understanding of the relationship between TBI and later cognitive decline, so I think there is an etiologic value to the study.”

However, Dr. Elser noted that the composition of the study population may limit the extent to which the results apply to contemporary populations.

“This was a population of White male twins born between 1917 and 1927,” she noted. “However, does the experience of people who were in the military generalize to civilian populations? Are twins representative of the general population or are they unique in terms of their risk factors?”

It is always important to emphasize inclusivity in clinical research, and in dementia research in particular, Dr. Elser added.

“There are many examples of instances where racialized and otherwise economically marginalized groups have been excluded from analysis, which is problematic because there are already economically and socially marginalized groups who disproportionately bear the brunt of dementia.

“This is not a criticism of the authors’ work, that their data didn’t include a more diverse patient base, but I think it is an important reminder that we should always interpret study findings within the limitations of the data. It’s a reminder to be thoughtful about taking explicit steps to include more diverse groups in future research,” she said.

The study was funded by the National Institute on Aging/National Institutes of Health and the Department of Defense. Dr. Chanti-Ketterl and Dr. Elser have reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Traumatic brain injury (TBI) that occurs in early adulthood is associated with cognitive decline in later life, results from a study of identical twins who served in World War II show.

The research, which included almost 9,000 individuals, showed that twins who had experienced a TBI were more likely to have lower cognitive function at age 70 versus their twin who did not experience a TBI, especially if they had lost consciousness or were older than age 24 at the time of injury. In addition, their cognitive decline occurred at a more rapid rate.

“We know that TBI increases the risk of developing Alzheimer’s disease and other dementias in later life, but we haven’t known about TBI’s effect on cognitive decline that does not quite meet the threshold for dementia,” study investigator Marianne Chanti-Ketterl, PhD, Duke University, Durham, N.C., said in an interview.

“We know that TBI increases the risk of dementia in later life, but we haven’t known if TBI affects cognitive function, causes cognitive decline that has not progressed to the point of severity with Alzheimer’s or dementia,” she added.

Being able to study the impact of TBI in monozygotic twins gives this study a unique strength, she noted.

“The important thing about this is that they are monozygotic twins, and we know they shared a lot of early life exposure, and almost 100% genetics,” Dr. Chanti-Ketterl said.

The study was published online in Neurology.

For the study, the investigators assessed 8,662 participants born between 1917 and 1927 who were part of the National Academy of Sciences National Research Council’s Twin Registry. The registry is composed of male veterans of World War II with a history of TBI, as reported by themselves or a caregiver.

The men were followed up for many years as part of the registry, but cognitive assessment only began in the 1990s. They were followed up at four different time points, at which time the Telephone Interview for Cognitive Status (TICS-m), an alternative to the Mini-Mental State Examination that must be given in person, was administered.

A total of 25% of participants had experienced concussion in their lifetime. Of this cohort, there were 589 pairs of monozygotic twins who were discordant (one twin had TBI and the other had not).

Among the monozygotic twin cohort, a history of any TBI and being older than age 24 at the time of TBI were associated with lower TICS-m scores.

A twin who experienced TBI after age 24 scored 0.59 points lower on the TICS-m at age 70 than his twin with no TBI, and cognitive function declined faster, by 0.05 points per year.
 

First study of its kind

Holly Elser, MD, PhD, MPH, an epidemiologist and resident physician in neurology at the University of Pennsylvania, Philadelphia, and coauthor of an accompanying editorial, said in an interview that the study’s twin design was a definite strength.

“There are lots of papers that have remarked on the apparent association between head injury and subsequent dementia or cognitive decline, but to my knowledge, this is one of the first, if not the first, to use a twin study design, which has the unique advantage of having better control over early life and genetic factors than would ever typically be possible in a dataset of unrelated adults,” said Dr. Elser.

She added that the study findings “strengthen our understanding of the relationship between TBI and later cognitive decline, so I think there is an etiologic value to the study.”

However, Dr. Elser noted that the composition of the study population may limit the extent to which the results apply to contemporary populations.

“This was a population of White male twins born between 1917 and 1927,” she noted. “However, does the experience of people who were in the military generalize to civilian populations? Are twins representative of the general population or are they unique in terms of their risk factors?”

It is always important to emphasize inclusivity in clinical research, and in dementia research in particular, Dr. Elser added.

“There are many examples of instances where racialized and otherwise economically marginalized groups have been excluded from analysis, which is problematic because there are already economically and socially marginalized groups who disproportionately bear the brunt of dementia.

“This is not a criticism of the authors’ work, that their data didn’t include a more diverse patient base, but I think it is an important reminder that we should always interpret study findings within the limitations of the data. It’s a reminder to be thoughtful about taking explicit steps to include more diverse groups in future research,” she said.

The study was funded by the National Institute on Aging/National Institutes of Health and the Department of Defense. Dr. Chanti-Ketterl and Dr. Elser have reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Traumatic brain injury (TBI) that occurs in early adulthood is associated with cognitive decline in later life, results from a study of identical twins who served in World War II show.

The research, which included almost 9,000 individuals, showed that twins who had experienced a TBI were more likely to have lower cognitive function at age 70 versus their twin who did not experience a TBI, especially if they had lost consciousness or were older than age 24 at the time of injury. In addition, their cognitive decline occurred at a more rapid rate.

“We know that TBI increases the risk of developing Alzheimer’s disease and other dementias in later life, but we haven’t known about TBI’s effect on cognitive decline that does not quite meet the threshold for dementia,” study investigator Marianne Chanti-Ketterl, PhD, Duke University, Durham, N.C., said in an interview.

“We know that TBI increases the risk of dementia in later life, but we haven’t known if TBI affects cognitive function, causes cognitive decline that has not progressed to the point of severity with Alzheimer’s or dementia,” she added.

Being able to study the impact of TBI in monozygotic twins gives this study a unique strength, she noted.

“The important thing about this is that they are monozygotic twins, and we know they shared a lot of early life exposure, and almost 100% genetics,” Dr. Chanti-Ketterl said.

The study was published online in Neurology.

For the study, the investigators assessed 8,662 participants born between 1917 and 1927 who were part of the National Academy of Sciences National Research Council’s Twin Registry. The registry is composed of male veterans of World War II with a history of TBI, as reported by themselves or a caregiver.

The men were followed up for many years as part of the registry, but cognitive assessment only began in the 1990s. They were followed up at four different time points, at which time the Telephone Interview for Cognitive Status (TICS-m), an alternative to the Mini-Mental State Examination that must be given in person, was administered.

A total of 25% of participants had experienced concussion in their lifetime. Of this cohort, there were 589 pairs of monozygotic twins who were discordant (one twin had TBI and the other had not).

Among the monozygotic twin cohort, a history of any TBI and being older than age 24 at the time of TBI were associated with lower TICS-m scores.

A twin who experienced TBI after age 24 scored 0.59 points lower on the TICS-m at age 70 than his twin with no TBI, and cognitive function declined faster, by 0.05 points per year.
 

First study of its kind

Holly Elser, MD, PhD, MPH, an epidemiologist and resident physician in neurology at the University of Pennsylvania, Philadelphia, and coauthor of an accompanying editorial, said in an interview that the study’s twin design was a definite strength.

“There are lots of papers that have remarked on the apparent association between head injury and subsequent dementia or cognitive decline, but to my knowledge, this is one of the first, if not the first, to use a twin study design, which has the unique advantage of having better control over early life and genetic factors than would ever typically be possible in a dataset of unrelated adults,” said Dr. Elser.

She added that the study findings “strengthen our understanding of the relationship between TBI and later cognitive decline, so I think there is an etiologic value to the study.”

However, Dr. Elser noted that the composition of the study population may limit the extent to which the results apply to contemporary populations.

“This was a population of White male twins born between 1917 and 1927,” she noted. “However, does the experience of people who were in the military generalize to civilian populations? Are twins representative of the general population or are they unique in terms of their risk factors?”

It is always important to emphasize inclusivity in clinical research, and in dementia research in particular, Dr. Elser added.

“There are many examples of instances where racialized and otherwise economically marginalized groups have been excluded from analysis, which is problematic because there are already economically and socially marginalized groups who disproportionately bear the brunt of dementia.

“This is not a criticism of the authors’ work, that their data didn’t include a more diverse patient base, but I think it is an important reminder that we should always interpret study findings within the limitations of the data. It’s a reminder to be thoughtful about taking explicit steps to include more diverse groups in future research,” she said.

The study was funded by the National Institute on Aging/National Institutes of Health and the Department of Defense. Dr. Chanti-Ketterl and Dr. Elser have reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

The second patient to be transplanted with a genetically modified pig heart at the University of Maryland Medical Center (UMMC), Baltimore, is said to be stable and doing well after the Sept. 22 operation. The organ passed an early test by avoiding hyperacute rejection.

Physicians for the patient, a 58-year-old former lab tech repeatedly turned down for standard allograft transplantation, say they are making good use of lessons from last year’s case of David Bennett, who survived in hospital with difficulty for 2 months after receiving the first such heart at the center in January 2022.

Mr. Bennett’s clinical course had been promising at first but grew turbulent with repeated bouts of infection followed by adjustments to his aggressive immunosuppressant regimen and other complications.

It was also learned weeks after the xenotransplant operation that the heart from the genetically modified donor pig had carried a porcine cytomegalovirus to Mr. Bennett’s body, although there was never evidence that the virus infected other organs or played a major role in his death.

The new xenotransplant recipient, Lawrence Faucette of Frederick, Md., is benefiting from that experience, which was documented in journal reports.

Mr. Faucette had been turned down by UMMC “and several other leading transplant hospitals due to his pre-existing peripheral vascular disease and complications with internal bleeding,” notes a UMMC press release describing his procedure.

The patient “is currently breathing on his own, and his heart is functioning well without any assistance from supportive devices,” says the statement.

Despite a few setbacks, Mr. Faucette is “on the right track,” said Muhammad M. Mohiuddin, MBBS, surgeon and xenotransplantation program director at the University of Maryland, Baltimore, in an interview.

“We’re taking one day at a time. His immune system is still intact, despite the heavy immune suppression,” he told this news organization. His heart didn’t carry a virus and “has not shown any signs of rejection so far.”

The University of Maryland team, Dr. Mohiuddin said, “is very hopeful that we will be able to at least mobilize the patient, and he can be discharged. But it’s a little too early to call.”

Mr. Faucette, as part of his immunosuppressant regimen, is receiving tegoprubart (Eledon Pharmaceuticals), an investigational antibody that blocks CD40 ligand. His predecessor Mr. Bennett, in contrast, had received a blocker of the CD40 receptor (Kiniksa Pharmaceuticals) along with other more familiar immunosuppressants.

The new anti–CD40-ligand blocker, Eledon said, is in phase 1 studies looking at efficacy in patients with conventional kidney transplants.

A version of this article appeared on Medscape.com.

The second patient to be transplanted with a genetically modified pig heart at the University of Maryland Medical Center (UMMC), Baltimore, is said to be stable and doing well after the Sept. 22 operation. The organ passed an early test by avoiding hyperacute rejection.

Physicians for the patient, a 58-year-old former lab tech repeatedly turned down for standard allograft transplantation, say they are making good use of lessons from last year’s case of David Bennett, who survived in hospital with difficulty for 2 months after receiving the first such heart at the center in January 2022.

Mr. Bennett’s clinical course had been promising at first but grew turbulent with repeated bouts of infection followed by adjustments to his aggressive immunosuppressant regimen and other complications.

It was also learned weeks after the xenotransplant operation that the heart from the genetically modified donor pig had carried a porcine cytomegalovirus to Mr. Bennett’s body, although there was never evidence that the virus infected other organs or played a major role in his death.

The new xenotransplant recipient, Lawrence Faucette of Frederick, Md., is benefiting from that experience, which was documented in journal reports.

Mr. Faucette had been turned down by UMMC “and several other leading transplant hospitals due to his pre-existing peripheral vascular disease and complications with internal bleeding,” notes a UMMC press release describing his procedure.

The patient “is currently breathing on his own, and his heart is functioning well without any assistance from supportive devices,” says the statement.

Despite a few setbacks, Mr. Faucette is “on the right track,” said Muhammad M. Mohiuddin, MBBS, surgeon and xenotransplantation program director at the University of Maryland, Baltimore, in an interview.

“We’re taking one day at a time. His immune system is still intact, despite the heavy immune suppression,” he told this news organization. His heart didn’t carry a virus and “has not shown any signs of rejection so far.”

The University of Maryland team, Dr. Mohiuddin said, “is very hopeful that we will be able to at least mobilize the patient, and he can be discharged. But it’s a little too early to call.”

Mr. Faucette, as part of his immunosuppressant regimen, is receiving tegoprubart (Eledon Pharmaceuticals), an investigational antibody that blocks CD40 ligand. His predecessor Mr. Bennett, in contrast, had received a blocker of the CD40 receptor (Kiniksa Pharmaceuticals) along with other more familiar immunosuppressants.

The new anti–CD40-ligand blocker, Eledon said, is in phase 1 studies looking at efficacy in patients with conventional kidney transplants.

A version of this article appeared on Medscape.com.

The second patient to be transplanted with a genetically modified pig heart at the University of Maryland Medical Center (UMMC), Baltimore, is said to be stable and doing well after the Sept. 22 operation. The organ passed an early test by avoiding hyperacute rejection.

Physicians for the patient, a 58-year-old former lab tech repeatedly turned down for standard allograft transplantation, say they are making good use of lessons from last year’s case of David Bennett, who survived in hospital with difficulty for 2 months after receiving the first such heart at the center in January 2022.

Mr. Bennett’s clinical course had been promising at first but grew turbulent with repeated bouts of infection followed by adjustments to his aggressive immunosuppressant regimen and other complications.

It was also learned weeks after the xenotransplant operation that the heart from the genetically modified donor pig had carried a porcine cytomegalovirus to Mr. Bennett’s body, although there was never evidence that the virus infected other organs or played a major role in his death.

The new xenotransplant recipient, Lawrence Faucette of Frederick, Md., is benefiting from that experience, which was documented in journal reports.

Mr. Faucette had been turned down by UMMC “and several other leading transplant hospitals due to his pre-existing peripheral vascular disease and complications with internal bleeding,” notes a UMMC press release describing his procedure.

The patient “is currently breathing on his own, and his heart is functioning well without any assistance from supportive devices,” says the statement.

Despite a few setbacks, Mr. Faucette is “on the right track,” said Muhammad M. Mohiuddin, MBBS, surgeon and xenotransplantation program director at the University of Maryland, Baltimore, in an interview.

“We’re taking one day at a time. His immune system is still intact, despite the heavy immune suppression,” he told this news organization. His heart didn’t carry a virus and “has not shown any signs of rejection so far.”

The University of Maryland team, Dr. Mohiuddin said, “is very hopeful that we will be able to at least mobilize the patient, and he can be discharged. But it’s a little too early to call.”

Mr. Faucette, as part of his immunosuppressant regimen, is receiving tegoprubart (Eledon Pharmaceuticals), an investigational antibody that blocks CD40 ligand. His predecessor Mr. Bennett, in contrast, had received a blocker of the CD40 receptor (Kiniksa Pharmaceuticals) along with other more familiar immunosuppressants.

The new anti–CD40-ligand blocker, Eledon said, is in phase 1 studies looking at efficacy in patients with conventional kidney transplants.

A version of this article appeared on Medscape.com.

TOPLINE:

In insulin-naive people with type 2 diabetes, once-weekly icodec titrated with a dosing guide app was both noninferior and superior to daily basal analogs in reducing A1c levels, with improved treatment satisfaction and compliance scores and similarly low hypoglycemia rates.

METHODOLOGY:

• A 52-week, randomized, open-label, parallel-group, phase 3a trial with real-world elements was conducted at 176 sites in seven countries.
• A total of 1,085 insulin-naive patients with type 2 diabetes were randomly assigned to receive icodec with a dosing guide app or daily analogs (U100 glargine, U300 glargine, or icodec).

TAKEAWAY:

• A1c levels dropped from 8.96% at baseline to 7.24% at week 52 with icodec and from 8.88% to 7.61% with the daily analog, a treatment difference of 0.37 percentage point (P < .001 for noninferiority and P = .009 for superiority in favor of icodec plus the app).
• Patient-reported outcomes were more favorable with icodec plus the app vs. daily analogs, with estimated treatment differences that were significant for the Treatment Related Impact Measure for Diabetes (3.04) but not the Diabetes Treatment Satisfaction Questionnaire (0.78).
• Observed rates of combined clinically significant or severe hypoglycemia were low (0.19 event per patient-year of exposure for icodec plus the app vs. 0.14 for daily analogs; estimated rate ratio, 1.17).

IN PRACTICE:

“Once-weekly icodec with a dosing guide app could conceivably address several challenges seen in everyday practice, including inadequate dose titration and nonadherence to prescribed treatment regimens.”

SOURCE:

The study was conducted by Harpreet S. Bajaj, MD, MPH, of LMC Diabetes and Endocrinology, Brampton, Ontario, and colleagues. It was published online in Annals of Internal Medicine.

LIMITATIONS:

The research could not differentiate between the effects of icodec and those of the dosing guide app. The study had an open-label design. A 1-year duration is insufficient to assess long-term diabetes- and cardiovascular-related outcomes.

DISCLOSURES:

The study was funded by Novo Nordisk A/S.
 

A version of this article appeared on Medscape.com.

TOPLINE:

In insulin-naive people with type 2 diabetes, once-weekly icodec titrated with a dosing guide app was both noninferior and superior to daily basal analogs in reducing A1c levels, with improved treatment satisfaction and compliance scores and similarly low hypoglycemia rates.

METHODOLOGY:

• A 52-week, randomized, open-label, parallel-group, phase 3a trial with real-world elements was conducted at 176 sites in seven countries.
• A total of 1,085 insulin-naive patients with type 2 diabetes were randomly assigned to receive icodec with a dosing guide app or daily analogs (U100 glargine, U300 glargine, or icodec).

TAKEAWAY:

• A1c levels dropped from 8.96% at baseline to 7.24% at week 52 with icodec and from 8.88% to 7.61% with the daily analog, a treatment difference of 0.37 percentage point (P < .001 for noninferiority and P = .009 for superiority in favor of icodec plus the app).
• Patient-reported outcomes were more favorable with icodec plus the app vs. daily analogs, with estimated treatment differences that were significant for the Treatment Related Impact Measure for Diabetes (3.04) but not the Diabetes Treatment Satisfaction Questionnaire (0.78).
• Observed rates of combined clinically significant or severe hypoglycemia were low (0.19 event per patient-year of exposure for icodec plus the app vs. 0.14 for daily analogs; estimated rate ratio, 1.17).

IN PRACTICE:

“Once-weekly icodec with a dosing guide app could conceivably address several challenges seen in everyday practice, including inadequate dose titration and nonadherence to prescribed treatment regimens.”

SOURCE:

The study was conducted by Harpreet S. Bajaj, MD, MPH, of LMC Diabetes and Endocrinology, Brampton, Ontario, and colleagues. It was published online in Annals of Internal Medicine.

LIMITATIONS:

The research could not differentiate between the effects of icodec and those of the dosing guide app. The study had an open-label design. A 1-year duration is insufficient to assess long-term diabetes- and cardiovascular-related outcomes.

DISCLOSURES:

The study was funded by Novo Nordisk A/S.
 

A version of this article appeared on Medscape.com.

TOPLINE:

In insulin-naive people with type 2 diabetes, once-weekly icodec titrated with a dosing guide app was both noninferior and superior to daily basal analogs in reducing A1c levels, with improved treatment satisfaction and compliance scores and similarly low hypoglycemia rates.

METHODOLOGY:

• A 52-week, randomized, open-label, parallel-group, phase 3a trial with real-world elements was conducted at 176 sites in seven countries.
• A total of 1,085 insulin-naive patients with type 2 diabetes were randomly assigned to receive icodec with a dosing guide app or daily analogs (U100 glargine, U300 glargine, or icodec).

TAKEAWAY:

• A1c levels dropped from 8.96% at baseline to 7.24% at week 52 with icodec and from 8.88% to 7.61% with the daily analog, a treatment difference of 0.37 percentage point (P < .001 for noninferiority and P = .009 for superiority in favor of icodec plus the app).
• Patient-reported outcomes were more favorable with icodec plus the app vs. daily analogs, with estimated treatment differences that were significant for the Treatment Related Impact Measure for Diabetes (3.04) but not the Diabetes Treatment Satisfaction Questionnaire (0.78).
• Observed rates of combined clinically significant or severe hypoglycemia were low (0.19 event per patient-year of exposure for icodec plus the app vs. 0.14 for daily analogs; estimated rate ratio, 1.17).

IN PRACTICE:

“Once-weekly icodec with a dosing guide app could conceivably address several challenges seen in everyday practice, including inadequate dose titration and nonadherence to prescribed treatment regimens.”

SOURCE:

The study was conducted by Harpreet S. Bajaj, MD, MPH, of LMC Diabetes and Endocrinology, Brampton, Ontario, and colleagues. It was published online in Annals of Internal Medicine.

LIMITATIONS:

The research could not differentiate between the effects of icodec and those of the dosing guide app. The study had an open-label design. A 1-year duration is insufficient to assess long-term diabetes- and cardiovascular-related outcomes.

DISCLOSURES:

The study was funded by Novo Nordisk A/S.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Women who use cocaine, cannabis, or other substances during pregnancy have increased risks of acute cardiovascular (CV) events while in the hospital for delivery, including more than double the risk of maternal mortality, a new study shows.

METHODOLOGY:

• Using the National Inpatient Sample database to identify hospital deliveries between 2004 and 2018 and diagnostic codes to identify maternal substance use, researchers compared 955,531 pregnancies with accompanying substance use – the most common substances being cannabis and opioids, followed by stimulants – to over 60 million pregnancies in which there was no substance use.
• The primary outcome was any CV event, including acute myocardial infarction, stroke, arrhythmia, endocarditis, any acute cardiomyopathy or heart failure, or cardiac arrest; other outcomes included maternal mortality and major adverse cardiac events (MACE).

TAKEAWAY:

• Deliveries complicated by substance use increased from 1,126 per 100,000 deliveries in 2004 to 1,547 per 100,000 in 2018, peaking at 2,187 per 100,000 in 2014.
• After the researchers controlled for patient demographics and CVD risk factors, results showed that pregnant women who used any substance (cannabis, opioids, methamphetamine, alcohol, tobacco, or cocaine) were more likely to experience a CVD event (adjusted odds ratio [aOR], 1.61; 95% confidence interval [CI], 1.53-1.70; P < .001), MACE (aOR, 1.53; 95% CI, 1.46-1.61; P < .001), or maternal mortality (aOR, 2.65; 95% CI, 2.15-3.25; P < .001) during hospitalization for delivery.
• Those using amphetamine/methamphetamine had ninefold higher odds of cardiomyopathy or heart failure and more than sevenfold higher odds of cardiac arrest.

IN PRACTICE:

“For the wellbeing of pregnant women and their children, substance use needs to be considered an independent risk factor for CV events in pregnancy,” the authors wrote. They called for prenatal assessments by a multidisciplinary cardio-obstetrics team to try to decrease cardiac complications.

In an accompanying editorial by Abha Khandelwal, MD, department of medicine, Stanford (Calif.) University, and others, the authors said the findings “highlight the critical support required during pregnancy and postpartum” for substance users, which should include comprehensive medical care and social services as well as access to addiction medicine and treatment of co-occurring mental health disorders.

SOURCE:

The study was carried out by Kari Evans, MD, division of maternal fetal medicine, department of obstetrics and gynecology, University of Arizona, Phoenix. It was published online in the Journal of the American College of Cardiology: Advances.

LIMITATIONS:

Use of administrative databases may have resulted in underreporting of diagnoses. The researchers could not assess the association of dose, duration, method, or timing of use for any substance with CV events. They also could not examine the effect of vaping on maternal CV events or differentiate hospitalizations for delivery that were complicated by CV events from hospitalizations for CV events that prompted delivery. The data did not reflect the postpartum period, during which a high rate of adverse CV events occurs.

DISCLOSURES:

The authors and editorial writers have no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Women who use cocaine, cannabis, or other substances during pregnancy have increased risks of acute cardiovascular (CV) events while in the hospital for delivery, including more than double the risk of maternal mortality, a new study shows.

METHODOLOGY:

• Using the National Inpatient Sample database to identify hospital deliveries between 2004 and 2018 and diagnostic codes to identify maternal substance use, researchers compared 955,531 pregnancies with accompanying substance use – the most common substances being cannabis and opioids, followed by stimulants – to over 60 million pregnancies in which there was no substance use.
• The primary outcome was any CV event, including acute myocardial infarction, stroke, arrhythmia, endocarditis, any acute cardiomyopathy or heart failure, or cardiac arrest; other outcomes included maternal mortality and major adverse cardiac events (MACE).

TAKEAWAY:

• Deliveries complicated by substance use increased from 1,126 per 100,000 deliveries in 2004 to 1,547 per 100,000 in 2018, peaking at 2,187 per 100,000 in 2014.
• After the researchers controlled for patient demographics and CVD risk factors, results showed that pregnant women who used any substance (cannabis, opioids, methamphetamine, alcohol, tobacco, or cocaine) were more likely to experience a CVD event (adjusted odds ratio [aOR], 1.61; 95% confidence interval [CI], 1.53-1.70; P < .001), MACE (aOR, 1.53; 95% CI, 1.46-1.61; P < .001), or maternal mortality (aOR, 2.65; 95% CI, 2.15-3.25; P < .001) during hospitalization for delivery.
• Those using amphetamine/methamphetamine had ninefold higher odds of cardiomyopathy or heart failure and more than sevenfold higher odds of cardiac arrest.

IN PRACTICE:

“For the wellbeing of pregnant women and their children, substance use needs to be considered an independent risk factor for CV events in pregnancy,” the authors wrote. They called for prenatal assessments by a multidisciplinary cardio-obstetrics team to try to decrease cardiac complications.

In an accompanying editorial by Abha Khandelwal, MD, department of medicine, Stanford (Calif.) University, and others, the authors said the findings “highlight the critical support required during pregnancy and postpartum” for substance users, which should include comprehensive medical care and social services as well as access to addiction medicine and treatment of co-occurring mental health disorders.

SOURCE:

The study was carried out by Kari Evans, MD, division of maternal fetal medicine, department of obstetrics and gynecology, University of Arizona, Phoenix. It was published online in the Journal of the American College of Cardiology: Advances.

LIMITATIONS:

Use of administrative databases may have resulted in underreporting of diagnoses. The researchers could not assess the association of dose, duration, method, or timing of use for any substance with CV events. They also could not examine the effect of vaping on maternal CV events or differentiate hospitalizations for delivery that were complicated by CV events from hospitalizations for CV events that prompted delivery. The data did not reflect the postpartum period, during which a high rate of adverse CV events occurs.

DISCLOSURES:

The authors and editorial writers have no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Women who use cocaine, cannabis, or other substances during pregnancy have increased risks of acute cardiovascular (CV) events while in the hospital for delivery, including more than double the risk of maternal mortality, a new study shows.

METHODOLOGY:

• Using the National Inpatient Sample database to identify hospital deliveries between 2004 and 2018 and diagnostic codes to identify maternal substance use, researchers compared 955,531 pregnancies with accompanying substance use – the most common substances being cannabis and opioids, followed by stimulants – to over 60 million pregnancies in which there was no substance use.
• The primary outcome was any CV event, including acute myocardial infarction, stroke, arrhythmia, endocarditis, any acute cardiomyopathy or heart failure, or cardiac arrest; other outcomes included maternal mortality and major adverse cardiac events (MACE).

TAKEAWAY:

• Deliveries complicated by substance use increased from 1,126 per 100,000 deliveries in 2004 to 1,547 per 100,000 in 2018, peaking at 2,187 per 100,000 in 2014.
• After the researchers controlled for patient demographics and CVD risk factors, results showed that pregnant women who used any substance (cannabis, opioids, methamphetamine, alcohol, tobacco, or cocaine) were more likely to experience a CVD event (adjusted odds ratio [aOR], 1.61; 95% confidence interval [CI], 1.53-1.70; P < .001), MACE (aOR, 1.53; 95% CI, 1.46-1.61; P < .001), or maternal mortality (aOR, 2.65; 95% CI, 2.15-3.25; P < .001) during hospitalization for delivery.
• Those using amphetamine/methamphetamine had ninefold higher odds of cardiomyopathy or heart failure and more than sevenfold higher odds of cardiac arrest.

IN PRACTICE:

“For the wellbeing of pregnant women and their children, substance use needs to be considered an independent risk factor for CV events in pregnancy,” the authors wrote. They called for prenatal assessments by a multidisciplinary cardio-obstetrics team to try to decrease cardiac complications.

In an accompanying editorial by Abha Khandelwal, MD, department of medicine, Stanford (Calif.) University, and others, the authors said the findings “highlight the critical support required during pregnancy and postpartum” for substance users, which should include comprehensive medical care and social services as well as access to addiction medicine and treatment of co-occurring mental health disorders.

SOURCE:

The study was carried out by Kari Evans, MD, division of maternal fetal medicine, department of obstetrics and gynecology, University of Arizona, Phoenix. It was published online in the Journal of the American College of Cardiology: Advances.

LIMITATIONS:

Use of administrative databases may have resulted in underreporting of diagnoses. The researchers could not assess the association of dose, duration, method, or timing of use for any substance with CV events. They also could not examine the effect of vaping on maternal CV events or differentiate hospitalizations for delivery that were complicated by CV events from hospitalizations for CV events that prompted delivery. The data did not reflect the postpartum period, during which a high rate of adverse CV events occurs.

DISCLOSURES:

The authors and editorial writers have no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Women with node-negative breast cancers 2 cm or smaller and negative preoperative axillary ultrasound results may be safely spared sentinel lymph node (SLN) biopsy, new research suggests.

METHODOLOGY:

• SLN biopsy is standard for axillary staging in early breast cancer, but whether this biopsy is necessary and whether imaging could replace it remain uncertain.
• In the prospective SOUND trial, researchers randomized 1,405 women with node-negative breast cancers up to 2 cm and negative preoperative axillary ultrasound 1:1 to SLN biopsy or no axillary surgery.
• The primary outcome was 5-year distant disease-free survival (DFS), analyzed as intention-to-treat in 708 women randomized to SLN biopsy and 697 to no axillary surgery.
• Most patients (87.8%) had ER-positive ERBB2-negative disease, were postmenopausal (78%), and had T1 tumors (95%). In the biopsy group, 13.7% of patients had positive axillary nodes.
• Secondary end points were the cumulative incidence of distant recurrences and axillary recurrences, disease-free survival (DFS), and overall survival.

TAKEAWAY:

• Overall, omitting SLN biopsy did not appear to affect outcomes, with patients demonstrating similar 5-year locoregional relapse rates with and without SLN biopsy (1.7% vs. 1.6%), 5-year distant metastases (1.8% with vs. 2.0% without), and 5-year distant DFS (97.7% with vs. 98.0% without).
• Five-year overall survival was also similar between the two groups: 98.2% among those who received SLN biopsy and 98.4% among those who did not.
• Overall, 21 (3.0%) deaths were observed in the SLNB group and 18 (2.6%) deaths in the no axillary surgery group.
• The authors reported no significant differences in adjuvant treatment recommendations between the two groups.

IN PRACTICE:

“The results of this trial support the safety of omitting axillary surgery in older postmenopausal women with ER-positive ERBB2-negative [breast cancer] who met the SOUND eligibility criteria,” the study authors concluded.

In an accompanying editorial, Seema A. Khan, MD, agreed that the outcome data support “the argument that sentinel node positivity is not, in and of itself, a critical parameter that determines therapeutic plans and outcomes in patients with stage I breast cancer.”

SOURCE:

The study, led by Oreste Davide Gentilini, MD, San Raffaele Scientific and Research Hospital, Milan, was published online in JAMA Oncology, with an editorial by Seema Khan, MD, Northwestern University, Chicago.

LIMITATIONS:

The study enrolled patients who could be considered low risk for recurrence in the short-term (median tumor size of 1.1 cm and 87.8% of patients had hormone-receptor positive, ERBB2-negative disease). The authors noted that differences in outcomes might appear over a longer follow-up period.

DISCLOSURES:

The SOUND trial was funded by the European Institute of Oncology Foundation. Some authors report personal fees from pharmaceutical companies.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with node-negative breast cancers 2 cm or smaller and negative preoperative axillary ultrasound results may be safely spared sentinel lymph node (SLN) biopsy, new research suggests.

METHODOLOGY:

• SLN biopsy is standard for axillary staging in early breast cancer, but whether this biopsy is necessary and whether imaging could replace it remain uncertain.
• In the prospective SOUND trial, researchers randomized 1,405 women with node-negative breast cancers up to 2 cm and negative preoperative axillary ultrasound 1:1 to SLN biopsy or no axillary surgery.
• The primary outcome was 5-year distant disease-free survival (DFS), analyzed as intention-to-treat in 708 women randomized to SLN biopsy and 697 to no axillary surgery.
• Most patients (87.8%) had ER-positive ERBB2-negative disease, were postmenopausal (78%), and had T1 tumors (95%). In the biopsy group, 13.7% of patients had positive axillary nodes.
• Secondary end points were the cumulative incidence of distant recurrences and axillary recurrences, disease-free survival (DFS), and overall survival.

TAKEAWAY:

• Overall, omitting SLN biopsy did not appear to affect outcomes, with patients demonstrating similar 5-year locoregional relapse rates with and without SLN biopsy (1.7% vs. 1.6%), 5-year distant metastases (1.8% with vs. 2.0% without), and 5-year distant DFS (97.7% with vs. 98.0% without).
• Five-year overall survival was also similar between the two groups: 98.2% among those who received SLN biopsy and 98.4% among those who did not.
• Overall, 21 (3.0%) deaths were observed in the SLNB group and 18 (2.6%) deaths in the no axillary surgery group.
• The authors reported no significant differences in adjuvant treatment recommendations between the two groups.

IN PRACTICE:

“The results of this trial support the safety of omitting axillary surgery in older postmenopausal women with ER-positive ERBB2-negative [breast cancer] who met the SOUND eligibility criteria,” the study authors concluded.

In an accompanying editorial, Seema A. Khan, MD, agreed that the outcome data support “the argument that sentinel node positivity is not, in and of itself, a critical parameter that determines therapeutic plans and outcomes in patients with stage I breast cancer.”

SOURCE:

The study, led by Oreste Davide Gentilini, MD, San Raffaele Scientific and Research Hospital, Milan, was published online in JAMA Oncology, with an editorial by Seema Khan, MD, Northwestern University, Chicago.

LIMITATIONS:

The study enrolled patients who could be considered low risk for recurrence in the short-term (median tumor size of 1.1 cm and 87.8% of patients had hormone-receptor positive, ERBB2-negative disease). The authors noted that differences in outcomes might appear over a longer follow-up period.

DISCLOSURES:

The SOUND trial was funded by the European Institute of Oncology Foundation. Some authors report personal fees from pharmaceutical companies.

A version of this article appeared on Medscape.com.

TOPLINE:

Women with node-negative breast cancers 2 cm or smaller and negative preoperative axillary ultrasound results may be safely spared sentinel lymph node (SLN) biopsy, new research suggests.

METHODOLOGY:

• SLN biopsy is standard for axillary staging in early breast cancer, but whether this biopsy is necessary and whether imaging could replace it remain uncertain.
• In the prospective SOUND trial, researchers randomized 1,405 women with node-negative breast cancers up to 2 cm and negative preoperative axillary ultrasound 1:1 to SLN biopsy or no axillary surgery.
• The primary outcome was 5-year distant disease-free survival (DFS), analyzed as intention-to-treat in 708 women randomized to SLN biopsy and 697 to no axillary surgery.
• Most patients (87.8%) had ER-positive ERBB2-negative disease, were postmenopausal (78%), and had T1 tumors (95%). In the biopsy group, 13.7% of patients had positive axillary nodes.
• Secondary end points were the cumulative incidence of distant recurrences and axillary recurrences, disease-free survival (DFS), and overall survival.

TAKEAWAY:

• Overall, omitting SLN biopsy did not appear to affect outcomes, with patients demonstrating similar 5-year locoregional relapse rates with and without SLN biopsy (1.7% vs. 1.6%), 5-year distant metastases (1.8% with vs. 2.0% without), and 5-year distant DFS (97.7% with vs. 98.0% without).
• Five-year overall survival was also similar between the two groups: 98.2% among those who received SLN biopsy and 98.4% among those who did not.
• Overall, 21 (3.0%) deaths were observed in the SLNB group and 18 (2.6%) deaths in the no axillary surgery group.
• The authors reported no significant differences in adjuvant treatment recommendations between the two groups.

IN PRACTICE:

“The results of this trial support the safety of omitting axillary surgery in older postmenopausal women with ER-positive ERBB2-negative [breast cancer] who met the SOUND eligibility criteria,” the study authors concluded.

In an accompanying editorial, Seema A. Khan, MD, agreed that the outcome data support “the argument that sentinel node positivity is not, in and of itself, a critical parameter that determines therapeutic plans and outcomes in patients with stage I breast cancer.”

SOURCE:

The study, led by Oreste Davide Gentilini, MD, San Raffaele Scientific and Research Hospital, Milan, was published online in JAMA Oncology, with an editorial by Seema Khan, MD, Northwestern University, Chicago.

LIMITATIONS:

The study enrolled patients who could be considered low risk for recurrence in the short-term (median tumor size of 1.1 cm and 87.8% of patients had hormone-receptor positive, ERBB2-negative disease). The authors noted that differences in outcomes might appear over a longer follow-up period.

DISCLOSURES:

The SOUND trial was funded by the European Institute of Oncology Foundation. Some authors report personal fees from pharmaceutical companies.

A version of this article appeared on Medscape.com.

Patients with breast cancer often stay on endocrine therapy for 5-10 years.

For many, however, long-term use is a challenge. Studies show about half of breast cancer patients don’t take their hormone therapy as prescribed, and as many as 40% discontinue treatment early.

Stopping adjuvant endocrine therapy prematurely can have major consequences. These patients are more likely to experience cancer recurrence and to die earlier, research shows.

“Given that suboptimal adjuvant endocrine therapy adherence is common and is associated with breast cancer recurrence and mortality, there is a vital need for effective interventions to promote adherence,” Joanna J. Arch, PhD, from the University of Colorado Boulder, and colleagues write in a recent meta-analysis.

Experts discuss why it’s so challenging for patients to adhere to adjuvant endocrine therapy as well as which strategies may help boost long-term use and which likely will not.
 

The adherence problem

To improve adherence to adjuvant endocrine therapy, clinicians first need to understand the barriers patients face.

Studies indicate that a host of issues play into long-term adherence. Medication side effects, such as insomnia, fatigue, anxiety, depression, joint pain, and hot flashes, can deter patients from continuing endocrine therapy.

Tamoxifen, in particular, is known for its severe adverse events. Research suggests it may even increase patients’ risk for endometrial cancer and other uterine diseases.

Recent approvals of aromatase inhibitors – such as anastrozole, exemestane, and letrozole – have provided patients a tamoxifen alterative, but these agents come with their own issues, which include bone loss and vaginal dryness.

Common and severe side effects that affect adherence “should absolutely be addressed sooner, more frequently, and by any provider, not just the medical oncologist,” said Anna Weiss, MD, a breast cancer surgeon with the Wilmot Cancer Center, University of Rochester Medical Center, N.Y.

Other barriers to long-term use include the burden of managing comorbidities and drug costs as well as patients’ uncertainty about the value of long-term cancer therapy.

The issues that take center stage for individual patients may also vary by age. For older patients, comorbidities, cognitive function, and lack of social support may be key barriers to adherence, while for younger patients, fertility and sexual health issues are more pressing.

Clinicians should especially not underestimate the effects of hormonal suppression on adherence, explained Dr. Weiss, who recently published practice pearls on managing side effects of adjunctive endocrine therapy. “I do believe that we have been ignoring the sexual wellness aspect of breast cancer survivorship care for too long,” she said.
 

An array of fixes needed

Given the array of potential obstacles to endocrine therapy adherence, improving long-term use may be equally complex.

In a recent meta-analysis, Dr. Arch and colleagues combed the literature for studies exploring a host of strategies to improve endocrine therapy adherence. The team focused on 25 studies involving 367,873 women with breast cancer who were prescribed tamoxifen or an aromatase inhibitor.

The studies assessed a variety of interventions – disease management and exercise programs to lower side effects, medication reminders via phone or letter to limit missed doses, online educational materials to highlight the importance of adherence, as well as medication changes to reduce drug costs.

Overall, these interventions were of modest benefit in improving adherence. The findings indicate that “a variety of approaches” can be effective, Dr. Arch said.

But, she noted, aside from cost-cutting strategies, “no single approach stood out as more effective than others,” and some studies found minimal or inconsistent benefits to specific interventions.

One analysis, for instance, explored a text message intervention that involved sending patients several texts per week reminding them to take their medication, exercise more, or monitor their side effects. Overall, participants who received text messages missed fewer endocrine therapy doses, compared with those who didn’t – 7.1% versus 17.0% – and for about two-thirds of participants, the text messages motivated lifestyle changes.

Another study included in the meta-analysis, however, found that “twice-weekly text reminders did not improve adherence to aromatase inhibitors.”

Studies in which patients received educational materials about the importance of adherence or how to manage side effects found that effectiveness varied as well. Other analyses indicated that integrating relaxation techniques or other cognitive-behavioral approaches into patient care may have small beneficial effects on adherence.

Dr. Arch’s meta-analysis did, however, find a consistent benefit for cost-cutting interventions. Three large studies reported that medication adherence improved following policy changes that were focused on reducing costs of adjuvant endocrine therapy, either through legislation limiting out-of-pocket costs for oral drugs or by switching to generic formulations.

Xuanzi Qin, PhD, first author on one of the studies, explained that after generic aromatase inhibitor options became available, patients who switched to these options had lower out-of-pocket costs and higher rates of drug adherence.

The take-home message of the study is that “clinicians should know the out-of-pocket costs of the drugs and discuss the costs with patients,” Dr. Qin, of the University of Maryland School of Public Health, College Park, told this news organization.

Dr. Arch pointed out that although the meta-analysis found a consistent benefit to cost-cutting strategies, that does not necessarily translate to a strong benefit.

And overall, the body of research indicates that “we need to develop and test new strategies and hone existing ones,” Dr. Arch said, “so that we can boost adherence even more and help more women benefit fully from these life-extending medications.”

However, Dr. Weiss explained, seemingly small measures may still make important clinical differences for individual patients, even if studies don’t show a statistically significant impact overall on endocrine therapy adherence.

For Dr. Weiss, “even getting one patient to continue their endocrine therapy is a win in my book.”

Dr. Arch reported a consulting or advisory role with AbbVie/Genentech and Bristol-Meyers Squibb and research funding from NCCN/Astrazeneca. Dr. Weiss reports being on the advisory board for Merck and Myriad. Dr. Qin has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Patients with breast cancer often stay on endocrine therapy for 5-10 years.

For many, however, long-term use is a challenge. Studies show about half of breast cancer patients don’t take their hormone therapy as prescribed, and as many as 40% discontinue treatment early.

Stopping adjuvant endocrine therapy prematurely can have major consequences. These patients are more likely to experience cancer recurrence and to die earlier, research shows.

“Given that suboptimal adjuvant endocrine therapy adherence is common and is associated with breast cancer recurrence and mortality, there is a vital need for effective interventions to promote adherence,” Joanna J. Arch, PhD, from the University of Colorado Boulder, and colleagues write in a recent meta-analysis.

Experts discuss why it’s so challenging for patients to adhere to adjuvant endocrine therapy as well as which strategies may help boost long-term use and which likely will not.
 

The adherence problem

To improve adherence to adjuvant endocrine therapy, clinicians first need to understand the barriers patients face.

Studies indicate that a host of issues play into long-term adherence. Medication side effects, such as insomnia, fatigue, anxiety, depression, joint pain, and hot flashes, can deter patients from continuing endocrine therapy.

Tamoxifen, in particular, is known for its severe adverse events. Research suggests it may even increase patients’ risk for endometrial cancer and other uterine diseases.

Recent approvals of aromatase inhibitors – such as anastrozole, exemestane, and letrozole – have provided patients a tamoxifen alterative, but these agents come with their own issues, which include bone loss and vaginal dryness.

Common and severe side effects that affect adherence “should absolutely be addressed sooner, more frequently, and by any provider, not just the medical oncologist,” said Anna Weiss, MD, a breast cancer surgeon with the Wilmot Cancer Center, University of Rochester Medical Center, N.Y.

Other barriers to long-term use include the burden of managing comorbidities and drug costs as well as patients’ uncertainty about the value of long-term cancer therapy.

The issues that take center stage for individual patients may also vary by age. For older patients, comorbidities, cognitive function, and lack of social support may be key barriers to adherence, while for younger patients, fertility and sexual health issues are more pressing.

Clinicians should especially not underestimate the effects of hormonal suppression on adherence, explained Dr. Weiss, who recently published practice pearls on managing side effects of adjunctive endocrine therapy. “I do believe that we have been ignoring the sexual wellness aspect of breast cancer survivorship care for too long,” she said.
 

An array of fixes needed

Given the array of potential obstacles to endocrine therapy adherence, improving long-term use may be equally complex.

In a recent meta-analysis, Dr. Arch and colleagues combed the literature for studies exploring a host of strategies to improve endocrine therapy adherence. The team focused on 25 studies involving 367,873 women with breast cancer who were prescribed tamoxifen or an aromatase inhibitor.

The studies assessed a variety of interventions – disease management and exercise programs to lower side effects, medication reminders via phone or letter to limit missed doses, online educational materials to highlight the importance of adherence, as well as medication changes to reduce drug costs.

Overall, these interventions were of modest benefit in improving adherence. The findings indicate that “a variety of approaches” can be effective, Dr. Arch said.

But, she noted, aside from cost-cutting strategies, “no single approach stood out as more effective than others,” and some studies found minimal or inconsistent benefits to specific interventions.

One analysis, for instance, explored a text message intervention that involved sending patients several texts per week reminding them to take their medication, exercise more, or monitor their side effects. Overall, participants who received text messages missed fewer endocrine therapy doses, compared with those who didn’t – 7.1% versus 17.0% – and for about two-thirds of participants, the text messages motivated lifestyle changes.

Another study included in the meta-analysis, however, found that “twice-weekly text reminders did not improve adherence to aromatase inhibitors.”

Studies in which patients received educational materials about the importance of adherence or how to manage side effects found that effectiveness varied as well. Other analyses indicated that integrating relaxation techniques or other cognitive-behavioral approaches into patient care may have small beneficial effects on adherence.

Dr. Arch’s meta-analysis did, however, find a consistent benefit for cost-cutting interventions. Three large studies reported that medication adherence improved following policy changes that were focused on reducing costs of adjuvant endocrine therapy, either through legislation limiting out-of-pocket costs for oral drugs or by switching to generic formulations.

Xuanzi Qin, PhD, first author on one of the studies, explained that after generic aromatase inhibitor options became available, patients who switched to these options had lower out-of-pocket costs and higher rates of drug adherence.

The take-home message of the study is that “clinicians should know the out-of-pocket costs of the drugs and discuss the costs with patients,” Dr. Qin, of the University of Maryland School of Public Health, College Park, told this news organization.

Dr. Arch pointed out that although the meta-analysis found a consistent benefit to cost-cutting strategies, that does not necessarily translate to a strong benefit.

And overall, the body of research indicates that “we need to develop and test new strategies and hone existing ones,” Dr. Arch said, “so that we can boost adherence even more and help more women benefit fully from these life-extending medications.”

However, Dr. Weiss explained, seemingly small measures may still make important clinical differences for individual patients, even if studies don’t show a statistically significant impact overall on endocrine therapy adherence.

For Dr. Weiss, “even getting one patient to continue their endocrine therapy is a win in my book.”

Dr. Arch reported a consulting or advisory role with AbbVie/Genentech and Bristol-Meyers Squibb and research funding from NCCN/Astrazeneca. Dr. Weiss reports being on the advisory board for Merck and Myriad. Dr. Qin has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Patients with breast cancer often stay on endocrine therapy for 5-10 years.

For many, however, long-term use is a challenge. Studies show about half of breast cancer patients don’t take their hormone therapy as prescribed, and as many as 40% discontinue treatment early.

Stopping adjuvant endocrine therapy prematurely can have major consequences. These patients are more likely to experience cancer recurrence and to die earlier, research shows.

“Given that suboptimal adjuvant endocrine therapy adherence is common and is associated with breast cancer recurrence and mortality, there is a vital need for effective interventions to promote adherence,” Joanna J. Arch, PhD, from the University of Colorado Boulder, and colleagues write in a recent meta-analysis.

Experts discuss why it’s so challenging for patients to adhere to adjuvant endocrine therapy as well as which strategies may help boost long-term use and which likely will not.
 

The adherence problem

To improve adherence to adjuvant endocrine therapy, clinicians first need to understand the barriers patients face.

Studies indicate that a host of issues play into long-term adherence. Medication side effects, such as insomnia, fatigue, anxiety, depression, joint pain, and hot flashes, can deter patients from continuing endocrine therapy.

Tamoxifen, in particular, is known for its severe adverse events. Research suggests it may even increase patients’ risk for endometrial cancer and other uterine diseases.

Recent approvals of aromatase inhibitors – such as anastrozole, exemestane, and letrozole – have provided patients a tamoxifen alterative, but these agents come with their own issues, which include bone loss and vaginal dryness.

Common and severe side effects that affect adherence “should absolutely be addressed sooner, more frequently, and by any provider, not just the medical oncologist,” said Anna Weiss, MD, a breast cancer surgeon with the Wilmot Cancer Center, University of Rochester Medical Center, N.Y.

Other barriers to long-term use include the burden of managing comorbidities and drug costs as well as patients’ uncertainty about the value of long-term cancer therapy.

The issues that take center stage for individual patients may also vary by age. For older patients, comorbidities, cognitive function, and lack of social support may be key barriers to adherence, while for younger patients, fertility and sexual health issues are more pressing.

Clinicians should especially not underestimate the effects of hormonal suppression on adherence, explained Dr. Weiss, who recently published practice pearls on managing side effects of adjunctive endocrine therapy. “I do believe that we have been ignoring the sexual wellness aspect of breast cancer survivorship care for too long,” she said.
 

An array of fixes needed

Given the array of potential obstacles to endocrine therapy adherence, improving long-term use may be equally complex.

In a recent meta-analysis, Dr. Arch and colleagues combed the literature for studies exploring a host of strategies to improve endocrine therapy adherence. The team focused on 25 studies involving 367,873 women with breast cancer who were prescribed tamoxifen or an aromatase inhibitor.

The studies assessed a variety of interventions – disease management and exercise programs to lower side effects, medication reminders via phone or letter to limit missed doses, online educational materials to highlight the importance of adherence, as well as medication changes to reduce drug costs.

Overall, these interventions were of modest benefit in improving adherence. The findings indicate that “a variety of approaches” can be effective, Dr. Arch said.

But, she noted, aside from cost-cutting strategies, “no single approach stood out as more effective than others,” and some studies found minimal or inconsistent benefits to specific interventions.

One analysis, for instance, explored a text message intervention that involved sending patients several texts per week reminding them to take their medication, exercise more, or monitor their side effects. Overall, participants who received text messages missed fewer endocrine therapy doses, compared with those who didn’t – 7.1% versus 17.0% – and for about two-thirds of participants, the text messages motivated lifestyle changes.

Another study included in the meta-analysis, however, found that “twice-weekly text reminders did not improve adherence to aromatase inhibitors.”

Studies in which patients received educational materials about the importance of adherence or how to manage side effects found that effectiveness varied as well. Other analyses indicated that integrating relaxation techniques or other cognitive-behavioral approaches into patient care may have small beneficial effects on adherence.

Dr. Arch’s meta-analysis did, however, find a consistent benefit for cost-cutting interventions. Three large studies reported that medication adherence improved following policy changes that were focused on reducing costs of adjuvant endocrine therapy, either through legislation limiting out-of-pocket costs for oral drugs or by switching to generic formulations.

Xuanzi Qin, PhD, first author on one of the studies, explained that after generic aromatase inhibitor options became available, patients who switched to these options had lower out-of-pocket costs and higher rates of drug adherence.

The take-home message of the study is that “clinicians should know the out-of-pocket costs of the drugs and discuss the costs with patients,” Dr. Qin, of the University of Maryland School of Public Health, College Park, told this news organization.

Dr. Arch pointed out that although the meta-analysis found a consistent benefit to cost-cutting strategies, that does not necessarily translate to a strong benefit.

And overall, the body of research indicates that “we need to develop and test new strategies and hone existing ones,” Dr. Arch said, “so that we can boost adherence even more and help more women benefit fully from these life-extending medications.”

However, Dr. Weiss explained, seemingly small measures may still make important clinical differences for individual patients, even if studies don’t show a statistically significant impact overall on endocrine therapy adherence.

For Dr. Weiss, “even getting one patient to continue their endocrine therapy is a win in my book.”

Dr. Arch reported a consulting or advisory role with AbbVie/Genentech and Bristol-Meyers Squibb and research funding from NCCN/Astrazeneca. Dr. Weiss reports being on the advisory board for Merck and Myriad. Dr. Qin has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

New research suggests that the presence of high-risk colon polyps at screening colonoscopy is significantly associated with an increased risk for death from hepatobiliary cancer.

METHODOLOGY:

• Researchers conducted a retrospective analysis of 343,838 screening colonoscopies performed in Austria from 2007 to 2020. National death registry data were used to identify deaths from gastrointestinal cancers among patients in the cohort.
• Risk for hepatobiliary cancer death by colon polyp risk profile was assessed.
• A cause-specific Cox regression model was used to estimate the association of time to death with polyp risk group at screening colonoscopy.

TAKEAWAY:

• Of the screening colonoscopies, 17,678 (5.1%) revealed high-risk polyps: that is, polyps of at least 10 mm, adenomas with high-grade dysplasia, serrated polyps with dysplasia, or five or more adenomas.
• The cumulative incidence of hepatobiliary cancer death was 0.19% at 6 years and 0.44% at 12 years in the high-risk polyp group versus 0.07% and 0.18%, respectively, in the negative colonoscopy group.
• Overall hepatobiliary cancer mortality was more than twice as high in patients with high-risk polyps compared with peers who had negative colonoscopy (cumulative incidence, 0.39% vs 0.17%).
• After adjustment for age and sex, the presence of high-risk polyps at screening colonoscopy was significantly associated with death from any hepatobiliary cancer (hazard ratio [HR], 1.83); the HRs for death from hepatocellular carcinoma (HCC) and non-HCC hepatobiliary cancer were 1.79 and 1.88, respectively.
• There was no significant association of low-risk polyps with hepatobiliary cancer death (HR, 1.23).

IN PRACTICE:

“Hepatobiliary cancers share risk factors with colorectal cancer, but there are no combined screening programs for these conditions,” the researchers write. “Our findings imply that risk stratification at colonoscopy might be helping to identify patients at need for liver cancer surveillance. However, further studies will be needed to address whether a targeted surveillance of these patients will be cost effective.”

SOURCE:

The study, with first author Jasmin Zessner-Spitzenberg, MD, of the Medical University of Vienna, was published online in Digestive and Liver Disease.

LIMITATIONS:

Some liver cancer deaths might have been falsely classified as other hepatic cancers. The authors lacked information on modifiable cancer risk factors. The generalizability of the findings outside of the screening setting is limited.

DISCLOSURES:

Support for data collection was provided by the Main Association of Statutory Insurance Institutions, the Austrian Society for Gastroenterology and Hepatology, and Austrian Cancer Aid. One author reported relationships with various pharmaceutical companies.

A version of this article appeared on Medscape.com.

TOPLINE:

New research suggests that the presence of high-risk colon polyps at screening colonoscopy is significantly associated with an increased risk for death from hepatobiliary cancer.

METHODOLOGY:

• Researchers conducted a retrospective analysis of 343,838 screening colonoscopies performed in Austria from 2007 to 2020. National death registry data were used to identify deaths from gastrointestinal cancers among patients in the cohort.
• Risk for hepatobiliary cancer death by colon polyp risk profile was assessed.
• A cause-specific Cox regression model was used to estimate the association of time to death with polyp risk group at screening colonoscopy.

TAKEAWAY:

• Of the screening colonoscopies, 17,678 (5.1%) revealed high-risk polyps: that is, polyps of at least 10 mm, adenomas with high-grade dysplasia, serrated polyps with dysplasia, or five or more adenomas.
• The cumulative incidence of hepatobiliary cancer death was 0.19% at 6 years and 0.44% at 12 years in the high-risk polyp group versus 0.07% and 0.18%, respectively, in the negative colonoscopy group.
• Overall hepatobiliary cancer mortality was more than twice as high in patients with high-risk polyps compared with peers who had negative colonoscopy (cumulative incidence, 0.39% vs 0.17%).
• After adjustment for age and sex, the presence of high-risk polyps at screening colonoscopy was significantly associated with death from any hepatobiliary cancer (hazard ratio [HR], 1.83); the HRs for death from hepatocellular carcinoma (HCC) and non-HCC hepatobiliary cancer were 1.79 and 1.88, respectively.
• There was no significant association of low-risk polyps with hepatobiliary cancer death (HR, 1.23).

IN PRACTICE:

“Hepatobiliary cancers share risk factors with colorectal cancer, but there are no combined screening programs for these conditions,” the researchers write. “Our findings imply that risk stratification at colonoscopy might be helping to identify patients at need for liver cancer surveillance. However, further studies will be needed to address whether a targeted surveillance of these patients will be cost effective.”

SOURCE:

The study, with first author Jasmin Zessner-Spitzenberg, MD, of the Medical University of Vienna, was published online in Digestive and Liver Disease.

LIMITATIONS:

Some liver cancer deaths might have been falsely classified as other hepatic cancers. The authors lacked information on modifiable cancer risk factors. The generalizability of the findings outside of the screening setting is limited.

DISCLOSURES:

Support for data collection was provided by the Main Association of Statutory Insurance Institutions, the Austrian Society for Gastroenterology and Hepatology, and Austrian Cancer Aid. One author reported relationships with various pharmaceutical companies.

A version of this article appeared on Medscape.com.

TOPLINE:

New research suggests that the presence of high-risk colon polyps at screening colonoscopy is significantly associated with an increased risk for death from hepatobiliary cancer.

METHODOLOGY:

• Researchers conducted a retrospective analysis of 343,838 screening colonoscopies performed in Austria from 2007 to 2020. National death registry data were used to identify deaths from gastrointestinal cancers among patients in the cohort.
• Risk for hepatobiliary cancer death by colon polyp risk profile was assessed.
• A cause-specific Cox regression model was used to estimate the association of time to death with polyp risk group at screening colonoscopy.

TAKEAWAY:

• Of the screening colonoscopies, 17,678 (5.1%) revealed high-risk polyps: that is, polyps of at least 10 mm, adenomas with high-grade dysplasia, serrated polyps with dysplasia, or five or more adenomas.
• The cumulative incidence of hepatobiliary cancer death was 0.19% at 6 years and 0.44% at 12 years in the high-risk polyp group versus 0.07% and 0.18%, respectively, in the negative colonoscopy group.
• Overall hepatobiliary cancer mortality was more than twice as high in patients with high-risk polyps compared with peers who had negative colonoscopy (cumulative incidence, 0.39% vs 0.17%).
• After adjustment for age and sex, the presence of high-risk polyps at screening colonoscopy was significantly associated with death from any hepatobiliary cancer (hazard ratio [HR], 1.83); the HRs for death from hepatocellular carcinoma (HCC) and non-HCC hepatobiliary cancer were 1.79 and 1.88, respectively.
• There was no significant association of low-risk polyps with hepatobiliary cancer death (HR, 1.23).

IN PRACTICE:

“Hepatobiliary cancers share risk factors with colorectal cancer, but there are no combined screening programs for these conditions,” the researchers write. “Our findings imply that risk stratification at colonoscopy might be helping to identify patients at need for liver cancer surveillance. However, further studies will be needed to address whether a targeted surveillance of these patients will be cost effective.”

SOURCE:

The study, with first author Jasmin Zessner-Spitzenberg, MD, of the Medical University of Vienna, was published online in Digestive and Liver Disease.

LIMITATIONS:

Some liver cancer deaths might have been falsely classified as other hepatic cancers. The authors lacked information on modifiable cancer risk factors. The generalizability of the findings outside of the screening setting is limited.

DISCLOSURES:

Support for data collection was provided by the Main Association of Statutory Insurance Institutions, the Austrian Society for Gastroenterology and Hepatology, and Austrian Cancer Aid. One author reported relationships with various pharmaceutical companies.

A version of this article appeared on Medscape.com.

Recent data suggest that the incidence of early-onset cancer, defined as cancer diagnosed in people younger than 50 years, is on the rise in several countries. Two recent studies confirm this trend, including one published in early September in BMJ Oncology that presents worldwide data on the matter.

Early-onset cancer

The article published in BMJ Oncology shows that over the past 30 years (1990 to 2019), new cancer cases in patients younger than 50 years have increased by 79% worldwide, reaching 3.26 million cases. Among them, early-onset breast cancer had the highest incidence (13.7) and mortality (3.5 per 100k) rates in the global population.

Tracheal (nasopharyngeal) and prostate cancer have increased the most rapidly since 1990, with annual percentage changes estimated at 2.28% and 2.23%, respectively. At the other end of the scale, cases of early-onset liver cancer dropped by around 2.88% year on year.
 

Increase in deaths

There were more than a million (1.06) cancer deaths among patients younger than 50 years in 2019, which is an increase of slightly less than 28% compared with the figures from 1990.

The top four early-onset cancers with the highest mortality and disability-adjusted life year rates among young adults in 2019 were early-onset breast; tracheal, bronchus and lung; stomach; and colorectal cancers. The mortality rates of early-onset kidney cancer and ovarian cancer showed the fastest increasing trends.

“These results contrast with a more traditionally held view of ‘typical’ cancers in adults aged under 50 years,” Ashleigh C. Hamilton, MD, an academic clinical lecturer, and Helen G. Coleman, PhD, a professor, both at Queen’s University Belfast’s Centre for Public Health in the United Kingdom, explained in an accompanying editorial. An important aspect of this study is that it tackled the issue of increasing cancer rates among young people on a global scale, they added. Here, the researchers made use of 2019 data from the Global Burden of Disease database for 29 types of cancer in 204 countries and regions.
 

Industrialized countries

The highest rates of early-onset cancer in 2019 were reported in North America, Australasia, and Western Europe. However, the burden of early-onset cancers in low- to middle-income countries is also of major public health concern. The highest death rates among patients younger than 50 years were in Oceania, Eastern Europe, and Central Asia.

In low- or middle-income regions, early-onset cancer had a significantly higher impact on women than on men in terms of mortality and disease burden, the researchers reported.

On the basis of trends observed over the past 30 years, they estimate that the global incidence and deaths of early-onset cancer would increase by 31% and 21% in 2030, respectively, with 40-year-olds being the most affected.
 

Hypotheses and limitations

How can this increase in the incidence of cancer among patients younger than 50 years be explained? For the authors, genetic factors likely play a role. But dietary risk factors (diet high in red meat, low in fruits, high in sodium, and low in milk, etc.), alcohol consumption, and tobacco use are the main risk factors underlying early-onset cancers in patients under age 50 years. Physical inactivity, excess weight, and hyperglycemia were shown to be contributing factors.

The researchers recognized several limitations to their conclusions. First, the accuracy of Global Burden of Disease data was compromised by the quality of cancer registry data in different countries, which may have led to underreporting and underdiagnosis. Also, questions remain about how screening and early exposure to environmental factors can affect the observed trends.

For the authors of the editorial, “Full understanding of the reasons driving the observed trends remains elusive, although lifestyle factors are likely contributing, and novel areas of research such as antibiotic usage, the gut microbiome, outdoor air pollution, and early life exposures are being explored.”

They concluded, “Prevention and early detection measures are urgently required, along with identifying optimal treatment strategies for early-onset cancers, which should include a holistic approach addressing the unique supportive care needs of younger patients.”

The authors added, “It is worth exploring whether early screening and prevention programs for early-onset cancer should be expanded to include individuals aged 40-44 and 45-49, but further systematic studies and randomized trials are necessary to make a definitive determination.”
 

Trend in the United States

Between 2010 and 2019, although the incidence of cancer dropped in people over age 50 years in the United States, a study published in JAMA Network Open in August showed that the standardized incidence rate of early-onset cancer increased overall. More specifically, the rate increased in women but decreased in men.

In 2019, most early-onset cancer cases involved breast cancer. Between 2010 and 2019, gastrointestinal cancers saw the fastest rise. And among gastrointestinal cancers, those whose incidence rate increased the most rapidly were those affecting the appendix, the intrahepatic bile ducts, and the pancreas.
 

This article was translated from the Medscape French Edition. A version of this article appeared on Medscape.com.

Recent data suggest that the incidence of early-onset cancer, defined as cancer diagnosed in people younger than 50 years, is on the rise in several countries. Two recent studies confirm this trend, including one published in early September in BMJ Oncology that presents worldwide data on the matter.

Early-onset cancer

The article published in BMJ Oncology shows that over the past 30 years (1990 to 2019), new cancer cases in patients younger than 50 years have increased by 79% worldwide, reaching 3.26 million cases. Among them, early-onset breast cancer had the highest incidence (13.7) and mortality (3.5 per 100k) rates in the global population.

Tracheal (nasopharyngeal) and prostate cancer have increased the most rapidly since 1990, with annual percentage changes estimated at 2.28% and 2.23%, respectively. At the other end of the scale, cases of early-onset liver cancer dropped by around 2.88% year on year.
 

Increase in deaths

There were more than a million (1.06) cancer deaths among patients younger than 50 years in 2019, which is an increase of slightly less than 28% compared with the figures from 1990.

The top four early-onset cancers with the highest mortality and disability-adjusted life year rates among young adults in 2019 were early-onset breast; tracheal, bronchus and lung; stomach; and colorectal cancers. The mortality rates of early-onset kidney cancer and ovarian cancer showed the fastest increasing trends.

“These results contrast with a more traditionally held view of ‘typical’ cancers in adults aged under 50 years,” Ashleigh C. Hamilton, MD, an academic clinical lecturer, and Helen G. Coleman, PhD, a professor, both at Queen’s University Belfast’s Centre for Public Health in the United Kingdom, explained in an accompanying editorial. An important aspect of this study is that it tackled the issue of increasing cancer rates among young people on a global scale, they added. Here, the researchers made use of 2019 data from the Global Burden of Disease database for 29 types of cancer in 204 countries and regions.
 

Industrialized countries

The highest rates of early-onset cancer in 2019 were reported in North America, Australasia, and Western Europe. However, the burden of early-onset cancers in low- to middle-income countries is also of major public health concern. The highest death rates among patients younger than 50 years were in Oceania, Eastern Europe, and Central Asia.

In low- or middle-income regions, early-onset cancer had a significantly higher impact on women than on men in terms of mortality and disease burden, the researchers reported.

On the basis of trends observed over the past 30 years, they estimate that the global incidence and deaths of early-onset cancer would increase by 31% and 21% in 2030, respectively, with 40-year-olds being the most affected.
 

Hypotheses and limitations

How can this increase in the incidence of cancer among patients younger than 50 years be explained? For the authors, genetic factors likely play a role. But dietary risk factors (diet high in red meat, low in fruits, high in sodium, and low in milk, etc.), alcohol consumption, and tobacco use are the main risk factors underlying early-onset cancers in patients under age 50 years. Physical inactivity, excess weight, and hyperglycemia were shown to be contributing factors.

The researchers recognized several limitations to their conclusions. First, the accuracy of Global Burden of Disease data was compromised by the quality of cancer registry data in different countries, which may have led to underreporting and underdiagnosis. Also, questions remain about how screening and early exposure to environmental factors can affect the observed trends.

For the authors of the editorial, “Full understanding of the reasons driving the observed trends remains elusive, although lifestyle factors are likely contributing, and novel areas of research such as antibiotic usage, the gut microbiome, outdoor air pollution, and early life exposures are being explored.”

They concluded, “Prevention and early detection measures are urgently required, along with identifying optimal treatment strategies for early-onset cancers, which should include a holistic approach addressing the unique supportive care needs of younger patients.”

The authors added, “It is worth exploring whether early screening and prevention programs for early-onset cancer should be expanded to include individuals aged 40-44 and 45-49, but further systematic studies and randomized trials are necessary to make a definitive determination.”
 

Trend in the United States

Between 2010 and 2019, although the incidence of cancer dropped in people over age 50 years in the United States, a study published in JAMA Network Open in August showed that the standardized incidence rate of early-onset cancer increased overall. More specifically, the rate increased in women but decreased in men.

In 2019, most early-onset cancer cases involved breast cancer. Between 2010 and 2019, gastrointestinal cancers saw the fastest rise. And among gastrointestinal cancers, those whose incidence rate increased the most rapidly were those affecting the appendix, the intrahepatic bile ducts, and the pancreas.
 

This article was translated from the Medscape French Edition. A version of this article appeared on Medscape.com.

Recent data suggest that the incidence of early-onset cancer, defined as cancer diagnosed in people younger than 50 years, is on the rise in several countries. Two recent studies confirm this trend, including one published in early September in BMJ Oncology that presents worldwide data on the matter.

Early-onset cancer

The article published in BMJ Oncology shows that over the past 30 years (1990 to 2019), new cancer cases in patients younger than 50 years have increased by 79% worldwide, reaching 3.26 million cases. Among them, early-onset breast cancer had the highest incidence (13.7) and mortality (3.5 per 100k) rates in the global population.

Tracheal (nasopharyngeal) and prostate cancer have increased the most rapidly since 1990, with annual percentage changes estimated at 2.28% and 2.23%, respectively. At the other end of the scale, cases of early-onset liver cancer dropped by around 2.88% year on year.
 

Increase in deaths

There were more than a million (1.06) cancer deaths among patients younger than 50 years in 2019, which is an increase of slightly less than 28% compared with the figures from 1990.

The top four early-onset cancers with the highest mortality and disability-adjusted life year rates among young adults in 2019 were early-onset breast; tracheal, bronchus and lung; stomach; and colorectal cancers. The mortality rates of early-onset kidney cancer and ovarian cancer showed the fastest increasing trends.

“These results contrast with a more traditionally held view of ‘typical’ cancers in adults aged under 50 years,” Ashleigh C. Hamilton, MD, an academic clinical lecturer, and Helen G. Coleman, PhD, a professor, both at Queen’s University Belfast’s Centre for Public Health in the United Kingdom, explained in an accompanying editorial. An important aspect of this study is that it tackled the issue of increasing cancer rates among young people on a global scale, they added. Here, the researchers made use of 2019 data from the Global Burden of Disease database for 29 types of cancer in 204 countries and regions.
 

Industrialized countries

The highest rates of early-onset cancer in 2019 were reported in North America, Australasia, and Western Europe. However, the burden of early-onset cancers in low- to middle-income countries is also of major public health concern. The highest death rates among patients younger than 50 years were in Oceania, Eastern Europe, and Central Asia.

In low- or middle-income regions, early-onset cancer had a significantly higher impact on women than on men in terms of mortality and disease burden, the researchers reported.

On the basis of trends observed over the past 30 years, they estimate that the global incidence and deaths of early-onset cancer would increase by 31% and 21% in 2030, respectively, with 40-year-olds being the most affected.
 

Hypotheses and limitations

How can this increase in the incidence of cancer among patients younger than 50 years be explained? For the authors, genetic factors likely play a role. But dietary risk factors (diet high in red meat, low in fruits, high in sodium, and low in milk, etc.), alcohol consumption, and tobacco use are the main risk factors underlying early-onset cancers in patients under age 50 years. Physical inactivity, excess weight, and hyperglycemia were shown to be contributing factors.

The researchers recognized several limitations to their conclusions. First, the accuracy of Global Burden of Disease data was compromised by the quality of cancer registry data in different countries, which may have led to underreporting and underdiagnosis. Also, questions remain about how screening and early exposure to environmental factors can affect the observed trends.

For the authors of the editorial, “Full understanding of the reasons driving the observed trends remains elusive, although lifestyle factors are likely contributing, and novel areas of research such as antibiotic usage, the gut microbiome, outdoor air pollution, and early life exposures are being explored.”

They concluded, “Prevention and early detection measures are urgently required, along with identifying optimal treatment strategies for early-onset cancers, which should include a holistic approach addressing the unique supportive care needs of younger patients.”

The authors added, “It is worth exploring whether early screening and prevention programs for early-onset cancer should be expanded to include individuals aged 40-44 and 45-49, but further systematic studies and randomized trials are necessary to make a definitive determination.”
 

Trend in the United States

Between 2010 and 2019, although the incidence of cancer dropped in people over age 50 years in the United States, a study published in JAMA Network Open in August showed that the standardized incidence rate of early-onset cancer increased overall. More specifically, the rate increased in women but decreased in men.

In 2019, most early-onset cancer cases involved breast cancer. Between 2010 and 2019, gastrointestinal cancers saw the fastest rise. And among gastrointestinal cancers, those whose incidence rate increased the most rapidly were those affecting the appendix, the intrahepatic bile ducts, and the pancreas.
 

This article was translated from the Medscape French Edition. A version of this article appeared on Medscape.com.