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Half of Family Physicians Feel Their Payment Matches Their Workload
More than half of family physicians think that physicians in general are underpaid, but 50% said that in their own situations, they felt fairly paid given their work demands, based on data from Medscape’s annual Family Physician Compensation Report.
The report, based on data from 7,000 physicians across the United States, showed similarly that 50% of family physicians were happy with their pay, which put them about midway on a list of 29 specialties ranking happiness with pay, above some of the higher paid specialties including orthopedics and plastic surgery.
The report cited data from the Mercer consulting firm showing an increase of 3% in 2023 over 2022 earnings among physicians in the United States overall. The average annual earnings for family medicine physicians were near the bottom of a list of 29 specialties included in the report, but 90% said that potential pay was not a factor or a minor factor in choosing the specialty.
According to the report, 61% of family physicians reported taking no additional work to boost income, but 20% reported taking on additional medical-related work, and 6% reported non-medical-related work.
For most family physicians compensation for patient care remained approximately the same as previous years, and a majority said that neither competing physician practices nor other medical businesses (such as retail clinics or nonphysician practitioners) had an effect on their incomes (70% and 62%, respectively).
Although 54% of family practice physicians reported opportunities for incentive bonuses, these bonuses are generally based on a combination of clinical, economic, and experience factors, and are lower for primary care physicians than for specialists. The average bonus for a primary care physician in 2023 was $27,000 compared with an average bonus of $51,000 for a specialist, according to the report.
Overall, 32% of the family physicians reported gratitude from and relationships with patients as the most satisfying part of their jobs, followed by being good at their jobs by finding answers to medical questions and making diagnoses (24%), and making the world a better place (19%).
Why Money Still Matters
The relatively minor increase in earnings is “the minimum necessary to continue to attract talented individuals into family medicine,” Susan Kuchera, MD, associate director of the Family Medicine Residency Program at Jefferson Health, Abington, Pennsylvania, said in an interview.
The current report referenced a 2023 report of interviews with medical residents, and approximately half of residents overall said that potential earnings were influential in their decisions.
However, the current Medscape report does not reflect the debt burden held by most new physicians, said Dr. Kuchera, who was not involved in the report. “The educational debt and long years of training can be a deterrent for some to choose a lower paying specialty like primary care; if we want to continue to provide our communities with primary care specialists, we need to keep pace with other areas of medicine,” she said.
“It takes a minimum of 7 years to train a primary care physician, we can’t lose sight over time of the factors that impact a person’s choice to pursue primary care,” Dr. Kuchera said.
More Support Needed for Community-Based Care
The data from the report were not surprising, given that the work of primary care physicians is hard, but “historically undervalued” compared with procedural medicine, Dr. Kuchera said. With more emphasis on the value of healthy communities, “we will realize that the relationship family physicians have with their communities is paramount to creating a healthy society,” she added.
The fact that patient care accounts for more than 75% of what family doctors feel to be most rewarding in their profession reflects that most do this work because longitudinal care of patients and communities is rewarding, Dr. Kuchera said in an interview.
“Employers need to value the special training of family doctors to take care of communities,” Dr. Kuchera said. This includes finding ways to incentivize value-based care and to provide the necessary resources to care for communities with poor social determinants of health, she added.
Dr. Kuchera had no financial conflicts to disclose.
More than half of family physicians think that physicians in general are underpaid, but 50% said that in their own situations, they felt fairly paid given their work demands, based on data from Medscape’s annual Family Physician Compensation Report.
The report, based on data from 7,000 physicians across the United States, showed similarly that 50% of family physicians were happy with their pay, which put them about midway on a list of 29 specialties ranking happiness with pay, above some of the higher paid specialties including orthopedics and plastic surgery.
The report cited data from the Mercer consulting firm showing an increase of 3% in 2023 over 2022 earnings among physicians in the United States overall. The average annual earnings for family medicine physicians were near the bottom of a list of 29 specialties included in the report, but 90% said that potential pay was not a factor or a minor factor in choosing the specialty.
According to the report, 61% of family physicians reported taking no additional work to boost income, but 20% reported taking on additional medical-related work, and 6% reported non-medical-related work.
For most family physicians compensation for patient care remained approximately the same as previous years, and a majority said that neither competing physician practices nor other medical businesses (such as retail clinics or nonphysician practitioners) had an effect on their incomes (70% and 62%, respectively).
Although 54% of family practice physicians reported opportunities for incentive bonuses, these bonuses are generally based on a combination of clinical, economic, and experience factors, and are lower for primary care physicians than for specialists. The average bonus for a primary care physician in 2023 was $27,000 compared with an average bonus of $51,000 for a specialist, according to the report.
Overall, 32% of the family physicians reported gratitude from and relationships with patients as the most satisfying part of their jobs, followed by being good at their jobs by finding answers to medical questions and making diagnoses (24%), and making the world a better place (19%).
Why Money Still Matters
The relatively minor increase in earnings is “the minimum necessary to continue to attract talented individuals into family medicine,” Susan Kuchera, MD, associate director of the Family Medicine Residency Program at Jefferson Health, Abington, Pennsylvania, said in an interview.
The current report referenced a 2023 report of interviews with medical residents, and approximately half of residents overall said that potential earnings were influential in their decisions.
However, the current Medscape report does not reflect the debt burden held by most new physicians, said Dr. Kuchera, who was not involved in the report. “The educational debt and long years of training can be a deterrent for some to choose a lower paying specialty like primary care; if we want to continue to provide our communities with primary care specialists, we need to keep pace with other areas of medicine,” she said.
“It takes a minimum of 7 years to train a primary care physician, we can’t lose sight over time of the factors that impact a person’s choice to pursue primary care,” Dr. Kuchera said.
More Support Needed for Community-Based Care
The data from the report were not surprising, given that the work of primary care physicians is hard, but “historically undervalued” compared with procedural medicine, Dr. Kuchera said. With more emphasis on the value of healthy communities, “we will realize that the relationship family physicians have with their communities is paramount to creating a healthy society,” she added.
The fact that patient care accounts for more than 75% of what family doctors feel to be most rewarding in their profession reflects that most do this work because longitudinal care of patients and communities is rewarding, Dr. Kuchera said in an interview.
“Employers need to value the special training of family doctors to take care of communities,” Dr. Kuchera said. This includes finding ways to incentivize value-based care and to provide the necessary resources to care for communities with poor social determinants of health, she added.
Dr. Kuchera had no financial conflicts to disclose.
More than half of family physicians think that physicians in general are underpaid, but 50% said that in their own situations, they felt fairly paid given their work demands, based on data from Medscape’s annual Family Physician Compensation Report.
The report, based on data from 7,000 physicians across the United States, showed similarly that 50% of family physicians were happy with their pay, which put them about midway on a list of 29 specialties ranking happiness with pay, above some of the higher paid specialties including orthopedics and plastic surgery.
The report cited data from the Mercer consulting firm showing an increase of 3% in 2023 over 2022 earnings among physicians in the United States overall. The average annual earnings for family medicine physicians were near the bottom of a list of 29 specialties included in the report, but 90% said that potential pay was not a factor or a minor factor in choosing the specialty.
According to the report, 61% of family physicians reported taking no additional work to boost income, but 20% reported taking on additional medical-related work, and 6% reported non-medical-related work.
For most family physicians compensation for patient care remained approximately the same as previous years, and a majority said that neither competing physician practices nor other medical businesses (such as retail clinics or nonphysician practitioners) had an effect on their incomes (70% and 62%, respectively).
Although 54% of family practice physicians reported opportunities for incentive bonuses, these bonuses are generally based on a combination of clinical, economic, and experience factors, and are lower for primary care physicians than for specialists. The average bonus for a primary care physician in 2023 was $27,000 compared with an average bonus of $51,000 for a specialist, according to the report.
Overall, 32% of the family physicians reported gratitude from and relationships with patients as the most satisfying part of their jobs, followed by being good at their jobs by finding answers to medical questions and making diagnoses (24%), and making the world a better place (19%).
Why Money Still Matters
The relatively minor increase in earnings is “the minimum necessary to continue to attract talented individuals into family medicine,” Susan Kuchera, MD, associate director of the Family Medicine Residency Program at Jefferson Health, Abington, Pennsylvania, said in an interview.
The current report referenced a 2023 report of interviews with medical residents, and approximately half of residents overall said that potential earnings were influential in their decisions.
However, the current Medscape report does not reflect the debt burden held by most new physicians, said Dr. Kuchera, who was not involved in the report. “The educational debt and long years of training can be a deterrent for some to choose a lower paying specialty like primary care; if we want to continue to provide our communities with primary care specialists, we need to keep pace with other areas of medicine,” she said.
“It takes a minimum of 7 years to train a primary care physician, we can’t lose sight over time of the factors that impact a person’s choice to pursue primary care,” Dr. Kuchera said.
More Support Needed for Community-Based Care
The data from the report were not surprising, given that the work of primary care physicians is hard, but “historically undervalued” compared with procedural medicine, Dr. Kuchera said. With more emphasis on the value of healthy communities, “we will realize that the relationship family physicians have with their communities is paramount to creating a healthy society,” she added.
The fact that patient care accounts for more than 75% of what family doctors feel to be most rewarding in their profession reflects that most do this work because longitudinal care of patients and communities is rewarding, Dr. Kuchera said in an interview.
“Employers need to value the special training of family doctors to take care of communities,” Dr. Kuchera said. This includes finding ways to incentivize value-based care and to provide the necessary resources to care for communities with poor social determinants of health, she added.
Dr. Kuchera had no financial conflicts to disclose.
Mailed Outreach for CRC Screening Appeals Across Races and Ethnicities
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
In a comparison of four outreach approaches, sending a FIT kit to people between the ages of 45 and 49 via mail garnered better response rates than opt-in strategies to participate in FIT, inviting them to undergo colonoscopy, or asking them to choose between FIT or colonoscopy. At the same time, when given a choice between colonoscopy and FIT, colonoscopy was preferred across all racial and ethnic groups.
“It is well known that colorectal cancer is the second-leading cause of cancer-related deaths in the United States. The good news is that for the past several decades, we’ve seen a decline in colorectal cancer incidence and mortality in ages 50 and above. However, there has been a recent rise in incidence and mortality in people younger than 50,” said lead author Rebecca Ekeanyanwu, a third-year medical student at Meharry Medical College School of Medicine in Nashville, Tennessee. She was awarded the 2024 AGA Institute Council Healthcare Disparities Research Award for the top oral presentation for research in racial and ethnic health care disparities.
CRC incidence, screening rates, and mortality also vary by race and ethnicity, with higher incidence and mortality rates seen among non-Hispanic Black patients, more late-stage diagnoses among Hispanic patients, and lower screening rates among Asian patients.
“There’s no formal guidance on how to screen the population under age 50,” she said. “With the disparities in race and ethnicity, it remains unclear what would be the best population health strategy to optimize colorectal screening participation in young minorities.”
Ms. Ekeanyanwu and colleagues conducted a subanalysis of a 2022 randomized controlled trial at the University of California, Los Angeles, that looked at screening strategies for average-risk patients between ages 45 and 49. The study population included patients who were assigned to a primary care provider in the UCLA Health system and had active electronic portal use and excluded those with a personal or family history of adenoma or CRC, history of IBD or gastrointestinal cancer, and a prior FIT or colonoscopy.
In this study, the research team focused on the completion of any CRC screening at 26 weeks, stratified by race and ethnicity. They included four outreach scenarios: FIT invitation, colonoscopy invitation, a choice between FIT or colonoscopy invitation, or a default mailed FIT kit, which served as the control and typically is sent to UCLA patients overdue for screening among ages 50 and older. The researchers sent letters via US Postal Service and the online patient portal, as well as two texts about CRC screening.
Among 20,509 patients, 8918 were White (43.5%), 2757 were Hispanic (13.4%), 2613 were Asian (12.7%), and 797 were Black (3.9%).
The overall screening participation rate was 18.6%, with the lowest percentage among Black participants at 16.7% and the highest among Asian participants at 23.8%. These numbers varied significantly from the 20% seen among both White and Hispanic participants.
The default mailed outreach approach had the highest uptake with higher screening rates, at 26.2% overall, and had the highest participation in each racial and ethnic group. The rates were 28.7% among White patients, 20.1% among Black patients, 27.5% among Hispanic patients, and 31% among Asian patients.
Participation was lowest among the colonoscopy invitation group — as well as for White (14.8%), Hispanic (16%), and Asian (19.3%) patients. Among Black patients, participation was lowest in the FIT invitation group (12.8%).
Notably, in the choice group, more participants chose colonoscopy above FIT — across all racial and ethnic groups — at 12.1% versus 5.6% overall. In addition, among both FIT groups, there was significant crossover to colonoscopy, with about 7%-14% among the racial and ethnic groups preferring colonoscopy.
Ms. Ekeanyanwu noted the study may be limited by variations in sample size by race and ethnicity, as well as the socioeconomic status of typical patients at UCLA, who tend to fall in middle class and affluent groups. Demographic and socioeconomic factors may play a part in patients’ decision to get screened, she noted.
Patient participation in the digital portal may affect response rates as well, said Benjamin Lebwohl, MD, AGAF, an associate professor of medicine and epidemiology at Columbia University Medical Center, New York, who moderated the DDW session titled Reducing the Burden of GI Cancers Through Early Interventions.
“At least at my institution, we have a large number of such patients [not on the digital portal] who tend to be of lower socioeconomic status and tend to be at higher risk of not getting screened,” Dr. Lebwohl said. It would be important to consider “those who might need this intervention the most.”
Ms. Ekeanyanwu declared no relevant disclosures.
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
In a comparison of four outreach approaches, sending a FIT kit to people between the ages of 45 and 49 via mail garnered better response rates than opt-in strategies to participate in FIT, inviting them to undergo colonoscopy, or asking them to choose between FIT or colonoscopy. At the same time, when given a choice between colonoscopy and FIT, colonoscopy was preferred across all racial and ethnic groups.
“It is well known that colorectal cancer is the second-leading cause of cancer-related deaths in the United States. The good news is that for the past several decades, we’ve seen a decline in colorectal cancer incidence and mortality in ages 50 and above. However, there has been a recent rise in incidence and mortality in people younger than 50,” said lead author Rebecca Ekeanyanwu, a third-year medical student at Meharry Medical College School of Medicine in Nashville, Tennessee. She was awarded the 2024 AGA Institute Council Healthcare Disparities Research Award for the top oral presentation for research in racial and ethnic health care disparities.
CRC incidence, screening rates, and mortality also vary by race and ethnicity, with higher incidence and mortality rates seen among non-Hispanic Black patients, more late-stage diagnoses among Hispanic patients, and lower screening rates among Asian patients.
“There’s no formal guidance on how to screen the population under age 50,” she said. “With the disparities in race and ethnicity, it remains unclear what would be the best population health strategy to optimize colorectal screening participation in young minorities.”
Ms. Ekeanyanwu and colleagues conducted a subanalysis of a 2022 randomized controlled trial at the University of California, Los Angeles, that looked at screening strategies for average-risk patients between ages 45 and 49. The study population included patients who were assigned to a primary care provider in the UCLA Health system and had active electronic portal use and excluded those with a personal or family history of adenoma or CRC, history of IBD or gastrointestinal cancer, and a prior FIT or colonoscopy.
In this study, the research team focused on the completion of any CRC screening at 26 weeks, stratified by race and ethnicity. They included four outreach scenarios: FIT invitation, colonoscopy invitation, a choice between FIT or colonoscopy invitation, or a default mailed FIT kit, which served as the control and typically is sent to UCLA patients overdue for screening among ages 50 and older. The researchers sent letters via US Postal Service and the online patient portal, as well as two texts about CRC screening.
Among 20,509 patients, 8918 were White (43.5%), 2757 were Hispanic (13.4%), 2613 were Asian (12.7%), and 797 were Black (3.9%).
The overall screening participation rate was 18.6%, with the lowest percentage among Black participants at 16.7% and the highest among Asian participants at 23.8%. These numbers varied significantly from the 20% seen among both White and Hispanic participants.
The default mailed outreach approach had the highest uptake with higher screening rates, at 26.2% overall, and had the highest participation in each racial and ethnic group. The rates were 28.7% among White patients, 20.1% among Black patients, 27.5% among Hispanic patients, and 31% among Asian patients.
Participation was lowest among the colonoscopy invitation group — as well as for White (14.8%), Hispanic (16%), and Asian (19.3%) patients. Among Black patients, participation was lowest in the FIT invitation group (12.8%).
Notably, in the choice group, more participants chose colonoscopy above FIT — across all racial and ethnic groups — at 12.1% versus 5.6% overall. In addition, among both FIT groups, there was significant crossover to colonoscopy, with about 7%-14% among the racial and ethnic groups preferring colonoscopy.
Ms. Ekeanyanwu noted the study may be limited by variations in sample size by race and ethnicity, as well as the socioeconomic status of typical patients at UCLA, who tend to fall in middle class and affluent groups. Demographic and socioeconomic factors may play a part in patients’ decision to get screened, she noted.
Patient participation in the digital portal may affect response rates as well, said Benjamin Lebwohl, MD, AGAF, an associate professor of medicine and epidemiology at Columbia University Medical Center, New York, who moderated the DDW session titled Reducing the Burden of GI Cancers Through Early Interventions.
“At least at my institution, we have a large number of such patients [not on the digital portal] who tend to be of lower socioeconomic status and tend to be at higher risk of not getting screened,” Dr. Lebwohl said. It would be important to consider “those who might need this intervention the most.”
Ms. Ekeanyanwu declared no relevant disclosures.
WASHINGTON — , according to a study presented at the annual Digestive Disease Week® (DDW).
In a comparison of four outreach approaches, sending a FIT kit to people between the ages of 45 and 49 via mail garnered better response rates than opt-in strategies to participate in FIT, inviting them to undergo colonoscopy, or asking them to choose between FIT or colonoscopy. At the same time, when given a choice between colonoscopy and FIT, colonoscopy was preferred across all racial and ethnic groups.
“It is well known that colorectal cancer is the second-leading cause of cancer-related deaths in the United States. The good news is that for the past several decades, we’ve seen a decline in colorectal cancer incidence and mortality in ages 50 and above. However, there has been a recent rise in incidence and mortality in people younger than 50,” said lead author Rebecca Ekeanyanwu, a third-year medical student at Meharry Medical College School of Medicine in Nashville, Tennessee. She was awarded the 2024 AGA Institute Council Healthcare Disparities Research Award for the top oral presentation for research in racial and ethnic health care disparities.
CRC incidence, screening rates, and mortality also vary by race and ethnicity, with higher incidence and mortality rates seen among non-Hispanic Black patients, more late-stage diagnoses among Hispanic patients, and lower screening rates among Asian patients.
“There’s no formal guidance on how to screen the population under age 50,” she said. “With the disparities in race and ethnicity, it remains unclear what would be the best population health strategy to optimize colorectal screening participation in young minorities.”
Ms. Ekeanyanwu and colleagues conducted a subanalysis of a 2022 randomized controlled trial at the University of California, Los Angeles, that looked at screening strategies for average-risk patients between ages 45 and 49. The study population included patients who were assigned to a primary care provider in the UCLA Health system and had active electronic portal use and excluded those with a personal or family history of adenoma or CRC, history of IBD or gastrointestinal cancer, and a prior FIT or colonoscopy.
In this study, the research team focused on the completion of any CRC screening at 26 weeks, stratified by race and ethnicity. They included four outreach scenarios: FIT invitation, colonoscopy invitation, a choice between FIT or colonoscopy invitation, or a default mailed FIT kit, which served as the control and typically is sent to UCLA patients overdue for screening among ages 50 and older. The researchers sent letters via US Postal Service and the online patient portal, as well as two texts about CRC screening.
Among 20,509 patients, 8918 were White (43.5%), 2757 were Hispanic (13.4%), 2613 were Asian (12.7%), and 797 were Black (3.9%).
The overall screening participation rate was 18.6%, with the lowest percentage among Black participants at 16.7% and the highest among Asian participants at 23.8%. These numbers varied significantly from the 20% seen among both White and Hispanic participants.
The default mailed outreach approach had the highest uptake with higher screening rates, at 26.2% overall, and had the highest participation in each racial and ethnic group. The rates were 28.7% among White patients, 20.1% among Black patients, 27.5% among Hispanic patients, and 31% among Asian patients.
Participation was lowest among the colonoscopy invitation group — as well as for White (14.8%), Hispanic (16%), and Asian (19.3%) patients. Among Black patients, participation was lowest in the FIT invitation group (12.8%).
Notably, in the choice group, more participants chose colonoscopy above FIT — across all racial and ethnic groups — at 12.1% versus 5.6% overall. In addition, among both FIT groups, there was significant crossover to colonoscopy, with about 7%-14% among the racial and ethnic groups preferring colonoscopy.
Ms. Ekeanyanwu noted the study may be limited by variations in sample size by race and ethnicity, as well as the socioeconomic status of typical patients at UCLA, who tend to fall in middle class and affluent groups. Demographic and socioeconomic factors may play a part in patients’ decision to get screened, she noted.
Patient participation in the digital portal may affect response rates as well, said Benjamin Lebwohl, MD, AGAF, an associate professor of medicine and epidemiology at Columbia University Medical Center, New York, who moderated the DDW session titled Reducing the Burden of GI Cancers Through Early Interventions.
“At least at my institution, we have a large number of such patients [not on the digital portal] who tend to be of lower socioeconomic status and tend to be at higher risk of not getting screened,” Dr. Lebwohl said. It would be important to consider “those who might need this intervention the most.”
Ms. Ekeanyanwu declared no relevant disclosures.
FROM DDW 2024
A Simple Stress Intervention for MS
NASHVILLE, TENNESSEE — Stress in patients with multiple sclerosis (MS) can have serious effects on quality of life, but there is some evidence that it could worsen inflammation through activation of pro-inflammatory cytokines, leading to more relapses.
Observational studies have suggested that stress may lead to relapses, according to Amy Sullivan, PsyD, who spoke during a session at the annual meeting of the Consortium of Multiple Sclerosis Centers.
She cited a study conducted during the 34-day war between Israel and Lebanon in 2006, which found more exacerbations among 156 Israeli patients with relapsing-remitting MS patients during the period of hostilities. There were 18 relapses that occurred during the war, and 44% of those who experienced a relapse reported experience intense subjective stress, versus 20% of those who did not experience a relapse, and 67% of relapsers reported high levels of distress linked to rocket attack exposure, versus 42% of those who did not have a relapse (P = .05).
Another study of 216 Lebanese MS patients found 23 relapses during the 2-month war period, compared with a mean of 8.4 during other 2-month periods.
“So we have two observational studies that are showing us that there’s a pretty strong link or correlation between war, a very stressful life event, and MS relapses,” said Dr. Sullivan.
That relationship has prompted development of interventions to reduce stress in MS patients in hopes of improving clinical outcomes. One that “shaped our practice,” according to Dr. Sullivan, was published in 2012. It was the first high-quality randomized controlled trial of such an intervention, she said.
The program was based on cognitive behavioral therapy (CBT) and lasted 24 weeks and 16 psychotherapy sessions. Compared with controls, participants had fewer MRI brain lesions, but there were no differences after week 24. “[That] tells us that when people stopped the stress management techniques, the intervention did not give them protection,” said Dr. Sullivan.
Her group aimed to build on that work by developing a program that would be easier for busy patients to learn and incorporate into their lives. “Being in a psychotherapist office for 24 weeks to me was not feasible. I didn’t think that this was something that individuals would have interest in,” said Dr. Sullivan.
They focused on skills to manage stress, delivered over four sessions and designed to be employed in their private life. “We want them to go into the world for 4 to 6 weeks to do the skills that we taught them in that particular session, and then they come back and they tell us how that worked. We also recognize that each skill is not going to work. It’s not a one-size-fits-all for each person,” said Dr. Sullivan.
In addition to patient self-reports, the team measured physiological indicators of stress like pulse (beats per minute), breath rate (breaths per minute), and saturated oxygen (%SpO2). The measures were taken before and after stress management exercises.
The first session included psychoeducation and diaphragmatic breathing for relaxation. The second reviewed the nervous system and the stress response. The third introduced visualization and guided imagery that was individualized for each patient. The fourth focused on mindfulness and distress tolerance.
The study included 195 individuals (mean age, 44.4 years; 72.0% female, 71.5% White).
In all four sessions, patients achieved significant in-session improvements in breath rate, pulse, and saturated oxygen, as well as improvements from the first to the final session: Among 124 patients who completed at least 2 sessions, Patient Health Questionnaire-9 (PHQ-9) scores improved by 1.61 (P < .001), Generalized Anxiety Disorder (GAD) scores by 1.08 (P = .004), breaths per minute by 3.38 (P = .001), and SpO2 by 1.67 (P = .016). There was no significant change in pulse.
The high dropout rate could be seen as a weakness, but it was actually designed into the program. “We encouraged people to drop out when they were done. Our program is built on feasibility, and it’s built based on wanting our patients to get what they need out of our treatment, and then go live their lives. We don’t want them to feel tied to our offices, so they voluntarily discontinued after they felt they had sufficiently mastered stress management skills,” said Dr. Sullivan.
The results “suggest that short-term treatment with stress management skills can impact physiological and emotional stress in MS. [The] stress management protocol is likely a great adjunctive treatment to bolster skills traditionally taught during psychotherapy sessions,” said Dr. Sullivan.
During the Q&A period, an audience member asked why the group deviated from traditional cognitive behavioral therapy and moved into more right-brain activities. “In our practice, we’re very eclectic. We don’t believe that just CBT helps, or just behavioral therapy helps, or just [dialectical behavior therapy] helps. We want to teach the skills which we believe are the most important skills to train people on,” said Dr. Sullivan.
Dr. Sullivan did not report any relevant disclosures.
NASHVILLE, TENNESSEE — Stress in patients with multiple sclerosis (MS) can have serious effects on quality of life, but there is some evidence that it could worsen inflammation through activation of pro-inflammatory cytokines, leading to more relapses.
Observational studies have suggested that stress may lead to relapses, according to Amy Sullivan, PsyD, who spoke during a session at the annual meeting of the Consortium of Multiple Sclerosis Centers.
She cited a study conducted during the 34-day war between Israel and Lebanon in 2006, which found more exacerbations among 156 Israeli patients with relapsing-remitting MS patients during the period of hostilities. There were 18 relapses that occurred during the war, and 44% of those who experienced a relapse reported experience intense subjective stress, versus 20% of those who did not experience a relapse, and 67% of relapsers reported high levels of distress linked to rocket attack exposure, versus 42% of those who did not have a relapse (P = .05).
Another study of 216 Lebanese MS patients found 23 relapses during the 2-month war period, compared with a mean of 8.4 during other 2-month periods.
“So we have two observational studies that are showing us that there’s a pretty strong link or correlation between war, a very stressful life event, and MS relapses,” said Dr. Sullivan.
That relationship has prompted development of interventions to reduce stress in MS patients in hopes of improving clinical outcomes. One that “shaped our practice,” according to Dr. Sullivan, was published in 2012. It was the first high-quality randomized controlled trial of such an intervention, she said.
The program was based on cognitive behavioral therapy (CBT) and lasted 24 weeks and 16 psychotherapy sessions. Compared with controls, participants had fewer MRI brain lesions, but there were no differences after week 24. “[That] tells us that when people stopped the stress management techniques, the intervention did not give them protection,” said Dr. Sullivan.
Her group aimed to build on that work by developing a program that would be easier for busy patients to learn and incorporate into their lives. “Being in a psychotherapist office for 24 weeks to me was not feasible. I didn’t think that this was something that individuals would have interest in,” said Dr. Sullivan.
They focused on skills to manage stress, delivered over four sessions and designed to be employed in their private life. “We want them to go into the world for 4 to 6 weeks to do the skills that we taught them in that particular session, and then they come back and they tell us how that worked. We also recognize that each skill is not going to work. It’s not a one-size-fits-all for each person,” said Dr. Sullivan.
In addition to patient self-reports, the team measured physiological indicators of stress like pulse (beats per minute), breath rate (breaths per minute), and saturated oxygen (%SpO2). The measures were taken before and after stress management exercises.
The first session included psychoeducation and diaphragmatic breathing for relaxation. The second reviewed the nervous system and the stress response. The third introduced visualization and guided imagery that was individualized for each patient. The fourth focused on mindfulness and distress tolerance.
The study included 195 individuals (mean age, 44.4 years; 72.0% female, 71.5% White).
In all four sessions, patients achieved significant in-session improvements in breath rate, pulse, and saturated oxygen, as well as improvements from the first to the final session: Among 124 patients who completed at least 2 sessions, Patient Health Questionnaire-9 (PHQ-9) scores improved by 1.61 (P < .001), Generalized Anxiety Disorder (GAD) scores by 1.08 (P = .004), breaths per minute by 3.38 (P = .001), and SpO2 by 1.67 (P = .016). There was no significant change in pulse.
The high dropout rate could be seen as a weakness, but it was actually designed into the program. “We encouraged people to drop out when they were done. Our program is built on feasibility, and it’s built based on wanting our patients to get what they need out of our treatment, and then go live their lives. We don’t want them to feel tied to our offices, so they voluntarily discontinued after they felt they had sufficiently mastered stress management skills,” said Dr. Sullivan.
The results “suggest that short-term treatment with stress management skills can impact physiological and emotional stress in MS. [The] stress management protocol is likely a great adjunctive treatment to bolster skills traditionally taught during psychotherapy sessions,” said Dr. Sullivan.
During the Q&A period, an audience member asked why the group deviated from traditional cognitive behavioral therapy and moved into more right-brain activities. “In our practice, we’re very eclectic. We don’t believe that just CBT helps, or just behavioral therapy helps, or just [dialectical behavior therapy] helps. We want to teach the skills which we believe are the most important skills to train people on,” said Dr. Sullivan.
Dr. Sullivan did not report any relevant disclosures.
NASHVILLE, TENNESSEE — Stress in patients with multiple sclerosis (MS) can have serious effects on quality of life, but there is some evidence that it could worsen inflammation through activation of pro-inflammatory cytokines, leading to more relapses.
Observational studies have suggested that stress may lead to relapses, according to Amy Sullivan, PsyD, who spoke during a session at the annual meeting of the Consortium of Multiple Sclerosis Centers.
She cited a study conducted during the 34-day war between Israel and Lebanon in 2006, which found more exacerbations among 156 Israeli patients with relapsing-remitting MS patients during the period of hostilities. There were 18 relapses that occurred during the war, and 44% of those who experienced a relapse reported experience intense subjective stress, versus 20% of those who did not experience a relapse, and 67% of relapsers reported high levels of distress linked to rocket attack exposure, versus 42% of those who did not have a relapse (P = .05).
Another study of 216 Lebanese MS patients found 23 relapses during the 2-month war period, compared with a mean of 8.4 during other 2-month periods.
“So we have two observational studies that are showing us that there’s a pretty strong link or correlation between war, a very stressful life event, and MS relapses,” said Dr. Sullivan.
That relationship has prompted development of interventions to reduce stress in MS patients in hopes of improving clinical outcomes. One that “shaped our practice,” according to Dr. Sullivan, was published in 2012. It was the first high-quality randomized controlled trial of such an intervention, she said.
The program was based on cognitive behavioral therapy (CBT) and lasted 24 weeks and 16 psychotherapy sessions. Compared with controls, participants had fewer MRI brain lesions, but there were no differences after week 24. “[That] tells us that when people stopped the stress management techniques, the intervention did not give them protection,” said Dr. Sullivan.
Her group aimed to build on that work by developing a program that would be easier for busy patients to learn and incorporate into their lives. “Being in a psychotherapist office for 24 weeks to me was not feasible. I didn’t think that this was something that individuals would have interest in,” said Dr. Sullivan.
They focused on skills to manage stress, delivered over four sessions and designed to be employed in their private life. “We want them to go into the world for 4 to 6 weeks to do the skills that we taught them in that particular session, and then they come back and they tell us how that worked. We also recognize that each skill is not going to work. It’s not a one-size-fits-all for each person,” said Dr. Sullivan.
In addition to patient self-reports, the team measured physiological indicators of stress like pulse (beats per minute), breath rate (breaths per minute), and saturated oxygen (%SpO2). The measures were taken before and after stress management exercises.
The first session included psychoeducation and diaphragmatic breathing for relaxation. The second reviewed the nervous system and the stress response. The third introduced visualization and guided imagery that was individualized for each patient. The fourth focused on mindfulness and distress tolerance.
The study included 195 individuals (mean age, 44.4 years; 72.0% female, 71.5% White).
In all four sessions, patients achieved significant in-session improvements in breath rate, pulse, and saturated oxygen, as well as improvements from the first to the final session: Among 124 patients who completed at least 2 sessions, Patient Health Questionnaire-9 (PHQ-9) scores improved by 1.61 (P < .001), Generalized Anxiety Disorder (GAD) scores by 1.08 (P = .004), breaths per minute by 3.38 (P = .001), and SpO2 by 1.67 (P = .016). There was no significant change in pulse.
The high dropout rate could be seen as a weakness, but it was actually designed into the program. “We encouraged people to drop out when they were done. Our program is built on feasibility, and it’s built based on wanting our patients to get what they need out of our treatment, and then go live their lives. We don’t want them to feel tied to our offices, so they voluntarily discontinued after they felt they had sufficiently mastered stress management skills,” said Dr. Sullivan.
The results “suggest that short-term treatment with stress management skills can impact physiological and emotional stress in MS. [The] stress management protocol is likely a great adjunctive treatment to bolster skills traditionally taught during psychotherapy sessions,” said Dr. Sullivan.
During the Q&A period, an audience member asked why the group deviated from traditional cognitive behavioral therapy and moved into more right-brain activities. “In our practice, we’re very eclectic. We don’t believe that just CBT helps, or just behavioral therapy helps, or just [dialectical behavior therapy] helps. We want to teach the skills which we believe are the most important skills to train people on,” said Dr. Sullivan.
Dr. Sullivan did not report any relevant disclosures.
FROM CMSC 2024
Florida Allows Doctors To Perform C-Sections Outside of Hospitals
Florida has become the first state to allow doctors to perform cesarean sections outside of hospitals, siding with a private equity-owned physicians group that says the change will lower costs and give pregnant women the homier birthing atmosphere that many desire.
But the hospital industry and the nation’s leading obstetricians’ association say that even though some Florida hospitals have closed their maternity wards in recent years, performing C-sections in doctor-run clinics will increase the risks for women and babies when complications arise.
“A pregnant patient that is considered low-risk in one moment can suddenly need lifesaving care in the next,” Cole Greves, an Orlando perinatologist who chairs the Florida chapter of the American College of Obstetricians and Gynecologists, said in an email to KFF Health News. The new birth clinics, “even with increased regulation, cannot guarantee the level of safety patients would receive within a hospital.”
This spring, a law was enacted allowing “advanced birth centers,” where physicians can deliver babies vaginally or by C-section to women deemed at low risk of complications. Women would be able to stay overnight at the clinics.
Women’s Care Enterprises, a private equity-owned physicians group with locations mostly in Florida along with California and Kentucky, lobbied the state legislature to make the change. BC Partners, a London-based investment firm, bought Women’s Care in 2020.
“We have patients who don’t want to deliver in a hospital, and that breaks our heart,” said Stephen Snow, who recently retired as an ob.gyn. with Women’s Care and testified before the Florida Legislature advocating for the change in 2018.
Brittany Miller, vice president of strategic initiatives with Women’s Care, said the group would not comment on the issue.
Health experts are leery.
“What this looks like is a poor substitute for quality obstetrical care effectively being billed as something that gives people more choices,” said Alice Abernathy, an assistant professor of obstetrics and gynecology at the University of Pennsylvania Perelman School of Medicine. “This feels like a bad band-aid on a chronic issue that will make outcomes worse rather than better,” Abernathy said.
Nearly one-third of U.S. births occur via C-section, the surgical delivery of a baby through an incision in the mother’s abdomen and uterus. Generally, doctors use the procedure when they believe it is safer than vaginal delivery for the parent, the baby, or both. Such medical decisions can take place months before birth, or in an emergency.
Florida state Sen. Gayle Harrell, the Republican who sponsored the birth center bill, said having a C-section outside of a hospital may seem like a radical change, but so was the opening of outpatient surgery centers in the late 1980s.
Harrell, who managed her husband’s ob.gyn. practice, said birth centers will have to meet the same high standards for staffing, infection control, and other aspects as those at outpatient surgery centers.
“Given where we are with the need, and maternity deserts across the state, this is something that will help us and help moms get the best care,” she said.
Seventeen hospitals in the state have closed their maternity units since 2019, with many citing low insurance reimbursement and high malpractice costs, according to the Florida Hospital Association.
Mary Mayhew, CEO of the Florida Hospital Association, said it is wrong to compare birth centers to ambulatory surgery centers because of the many risks associated with C-sections, such as hemorrhaging.
The Florida law requires advanced birth centers to have a transfer agreement with a hospital, but it does not dictate where the facilities can open nor their proximity to a hospital.
“We have serious concerns about the impact this model has on our collective efforts to improve maternal and infant health,” Mayhew said. “Our hospitals do not see this in the best interest of providing quality and safety in labor and delivery.”
Despite its opposition to the new birth centers, the Florida Hospital Association did not fight passage of the overall bill because it also included a major increase in the amount Medicaid pays hospitals for maternity care.
Mayhew said it is unlikely that the birth centers would help address care shortages. Hospitals are already struggling with a shortage of ob.gyns., she said, and it is unrealistic to expect advanced birth centers to open in rural areas with a large proportion of people on Medicaid, which pays the lowest reimbursement for labor and delivery care.
It is unclear whether insurers will cover the advanced birth centers, though most insurers and Medicaid cover care at midwife-run birth centers. The advanced birth centers will not accept emergency walk-ins and will treat only patients whose insurance contracts with the facilities, making them in-network.
Snow, the retired ob.gyn. with Women’s Care, said the group plans to open an advanced birth center in the Tampa or Orlando area.
The advanced birth center concept is an improvement on midwife care that enables deliveries outside of hospitals, he said, as the centers allow women to stay overnight and, if necessary, offer anesthesia and C-sections.
Snow acknowledged that, with a private equity firm invested in Women’s Care, the birth center idea is also about making money. But he said hospitals have the same profit incentive and, like midwives, likely oppose the idea of centers that can provide C-sections because they could cut into hospital revenue.
“We are trying to reduce the cost of medicine, and this would be more cost-effective and more pleasant for patients,” he said.
Kate Bauer, executive director of the American Association of Birth Centers, said patients could confuse advanced birth centers with the existing, free-standing birth centers for low-risk births that have been run by midwives for decades. There are currently 31 licensed birth centers in Florida and 411 free-standing birth centers in the United States, she said.
“This is a radical departure from the standard of care,” Bauer said. “It’s a bad idea,” she said, because it could increase risks to mom and baby.
No other state allows C-sections outside of hospitals. The only facility that offers similar care is a birth clinic in Wichita, Kansas, which is connected by a short walkway to a hospital, Wesley Medical Center.
The clinic provides “hotel-like” maternity suites where staffers deliver about 100 babies a month, compared with 500 per month in the hospital itself.
Morgan Tracy, a maternity nurse navigator at the center, said the concept works largely because the hospital and birthing suites can share staff and pharmacy access, plus patients can be quickly transferred to the main hospital if complications arise.
“The beauty is there are team members on both sides of the street,” Tracy said.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Florida has become the first state to allow doctors to perform cesarean sections outside of hospitals, siding with a private equity-owned physicians group that says the change will lower costs and give pregnant women the homier birthing atmosphere that many desire.
But the hospital industry and the nation’s leading obstetricians’ association say that even though some Florida hospitals have closed their maternity wards in recent years, performing C-sections in doctor-run clinics will increase the risks for women and babies when complications arise.
“A pregnant patient that is considered low-risk in one moment can suddenly need lifesaving care in the next,” Cole Greves, an Orlando perinatologist who chairs the Florida chapter of the American College of Obstetricians and Gynecologists, said in an email to KFF Health News. The new birth clinics, “even with increased regulation, cannot guarantee the level of safety patients would receive within a hospital.”
This spring, a law was enacted allowing “advanced birth centers,” where physicians can deliver babies vaginally or by C-section to women deemed at low risk of complications. Women would be able to stay overnight at the clinics.
Women’s Care Enterprises, a private equity-owned physicians group with locations mostly in Florida along with California and Kentucky, lobbied the state legislature to make the change. BC Partners, a London-based investment firm, bought Women’s Care in 2020.
“We have patients who don’t want to deliver in a hospital, and that breaks our heart,” said Stephen Snow, who recently retired as an ob.gyn. with Women’s Care and testified before the Florida Legislature advocating for the change in 2018.
Brittany Miller, vice president of strategic initiatives with Women’s Care, said the group would not comment on the issue.
Health experts are leery.
“What this looks like is a poor substitute for quality obstetrical care effectively being billed as something that gives people more choices,” said Alice Abernathy, an assistant professor of obstetrics and gynecology at the University of Pennsylvania Perelman School of Medicine. “This feels like a bad band-aid on a chronic issue that will make outcomes worse rather than better,” Abernathy said.
Nearly one-third of U.S. births occur via C-section, the surgical delivery of a baby through an incision in the mother’s abdomen and uterus. Generally, doctors use the procedure when they believe it is safer than vaginal delivery for the parent, the baby, or both. Such medical decisions can take place months before birth, or in an emergency.
Florida state Sen. Gayle Harrell, the Republican who sponsored the birth center bill, said having a C-section outside of a hospital may seem like a radical change, but so was the opening of outpatient surgery centers in the late 1980s.
Harrell, who managed her husband’s ob.gyn. practice, said birth centers will have to meet the same high standards for staffing, infection control, and other aspects as those at outpatient surgery centers.
“Given where we are with the need, and maternity deserts across the state, this is something that will help us and help moms get the best care,” she said.
Seventeen hospitals in the state have closed their maternity units since 2019, with many citing low insurance reimbursement and high malpractice costs, according to the Florida Hospital Association.
Mary Mayhew, CEO of the Florida Hospital Association, said it is wrong to compare birth centers to ambulatory surgery centers because of the many risks associated with C-sections, such as hemorrhaging.
The Florida law requires advanced birth centers to have a transfer agreement with a hospital, but it does not dictate where the facilities can open nor their proximity to a hospital.
“We have serious concerns about the impact this model has on our collective efforts to improve maternal and infant health,” Mayhew said. “Our hospitals do not see this in the best interest of providing quality and safety in labor and delivery.”
Despite its opposition to the new birth centers, the Florida Hospital Association did not fight passage of the overall bill because it also included a major increase in the amount Medicaid pays hospitals for maternity care.
Mayhew said it is unlikely that the birth centers would help address care shortages. Hospitals are already struggling with a shortage of ob.gyns., she said, and it is unrealistic to expect advanced birth centers to open in rural areas with a large proportion of people on Medicaid, which pays the lowest reimbursement for labor and delivery care.
It is unclear whether insurers will cover the advanced birth centers, though most insurers and Medicaid cover care at midwife-run birth centers. The advanced birth centers will not accept emergency walk-ins and will treat only patients whose insurance contracts with the facilities, making them in-network.
Snow, the retired ob.gyn. with Women’s Care, said the group plans to open an advanced birth center in the Tampa or Orlando area.
The advanced birth center concept is an improvement on midwife care that enables deliveries outside of hospitals, he said, as the centers allow women to stay overnight and, if necessary, offer anesthesia and C-sections.
Snow acknowledged that, with a private equity firm invested in Women’s Care, the birth center idea is also about making money. But he said hospitals have the same profit incentive and, like midwives, likely oppose the idea of centers that can provide C-sections because they could cut into hospital revenue.
“We are trying to reduce the cost of medicine, and this would be more cost-effective and more pleasant for patients,” he said.
Kate Bauer, executive director of the American Association of Birth Centers, said patients could confuse advanced birth centers with the existing, free-standing birth centers for low-risk births that have been run by midwives for decades. There are currently 31 licensed birth centers in Florida and 411 free-standing birth centers in the United States, she said.
“This is a radical departure from the standard of care,” Bauer said. “It’s a bad idea,” she said, because it could increase risks to mom and baby.
No other state allows C-sections outside of hospitals. The only facility that offers similar care is a birth clinic in Wichita, Kansas, which is connected by a short walkway to a hospital, Wesley Medical Center.
The clinic provides “hotel-like” maternity suites where staffers deliver about 100 babies a month, compared with 500 per month in the hospital itself.
Morgan Tracy, a maternity nurse navigator at the center, said the concept works largely because the hospital and birthing suites can share staff and pharmacy access, plus patients can be quickly transferred to the main hospital if complications arise.
“The beauty is there are team members on both sides of the street,” Tracy said.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Florida has become the first state to allow doctors to perform cesarean sections outside of hospitals, siding with a private equity-owned physicians group that says the change will lower costs and give pregnant women the homier birthing atmosphere that many desire.
But the hospital industry and the nation’s leading obstetricians’ association say that even though some Florida hospitals have closed their maternity wards in recent years, performing C-sections in doctor-run clinics will increase the risks for women and babies when complications arise.
“A pregnant patient that is considered low-risk in one moment can suddenly need lifesaving care in the next,” Cole Greves, an Orlando perinatologist who chairs the Florida chapter of the American College of Obstetricians and Gynecologists, said in an email to KFF Health News. The new birth clinics, “even with increased regulation, cannot guarantee the level of safety patients would receive within a hospital.”
This spring, a law was enacted allowing “advanced birth centers,” where physicians can deliver babies vaginally or by C-section to women deemed at low risk of complications. Women would be able to stay overnight at the clinics.
Women’s Care Enterprises, a private equity-owned physicians group with locations mostly in Florida along with California and Kentucky, lobbied the state legislature to make the change. BC Partners, a London-based investment firm, bought Women’s Care in 2020.
“We have patients who don’t want to deliver in a hospital, and that breaks our heart,” said Stephen Snow, who recently retired as an ob.gyn. with Women’s Care and testified before the Florida Legislature advocating for the change in 2018.
Brittany Miller, vice president of strategic initiatives with Women’s Care, said the group would not comment on the issue.
Health experts are leery.
“What this looks like is a poor substitute for quality obstetrical care effectively being billed as something that gives people more choices,” said Alice Abernathy, an assistant professor of obstetrics and gynecology at the University of Pennsylvania Perelman School of Medicine. “This feels like a bad band-aid on a chronic issue that will make outcomes worse rather than better,” Abernathy said.
Nearly one-third of U.S. births occur via C-section, the surgical delivery of a baby through an incision in the mother’s abdomen and uterus. Generally, doctors use the procedure when they believe it is safer than vaginal delivery for the parent, the baby, or both. Such medical decisions can take place months before birth, or in an emergency.
Florida state Sen. Gayle Harrell, the Republican who sponsored the birth center bill, said having a C-section outside of a hospital may seem like a radical change, but so was the opening of outpatient surgery centers in the late 1980s.
Harrell, who managed her husband’s ob.gyn. practice, said birth centers will have to meet the same high standards for staffing, infection control, and other aspects as those at outpatient surgery centers.
“Given where we are with the need, and maternity deserts across the state, this is something that will help us and help moms get the best care,” she said.
Seventeen hospitals in the state have closed their maternity units since 2019, with many citing low insurance reimbursement and high malpractice costs, according to the Florida Hospital Association.
Mary Mayhew, CEO of the Florida Hospital Association, said it is wrong to compare birth centers to ambulatory surgery centers because of the many risks associated with C-sections, such as hemorrhaging.
The Florida law requires advanced birth centers to have a transfer agreement with a hospital, but it does not dictate where the facilities can open nor their proximity to a hospital.
“We have serious concerns about the impact this model has on our collective efforts to improve maternal and infant health,” Mayhew said. “Our hospitals do not see this in the best interest of providing quality and safety in labor and delivery.”
Despite its opposition to the new birth centers, the Florida Hospital Association did not fight passage of the overall bill because it also included a major increase in the amount Medicaid pays hospitals for maternity care.
Mayhew said it is unlikely that the birth centers would help address care shortages. Hospitals are already struggling with a shortage of ob.gyns., she said, and it is unrealistic to expect advanced birth centers to open in rural areas with a large proportion of people on Medicaid, which pays the lowest reimbursement for labor and delivery care.
It is unclear whether insurers will cover the advanced birth centers, though most insurers and Medicaid cover care at midwife-run birth centers. The advanced birth centers will not accept emergency walk-ins and will treat only patients whose insurance contracts with the facilities, making them in-network.
Snow, the retired ob.gyn. with Women’s Care, said the group plans to open an advanced birth center in the Tampa or Orlando area.
The advanced birth center concept is an improvement on midwife care that enables deliveries outside of hospitals, he said, as the centers allow women to stay overnight and, if necessary, offer anesthesia and C-sections.
Snow acknowledged that, with a private equity firm invested in Women’s Care, the birth center idea is also about making money. But he said hospitals have the same profit incentive and, like midwives, likely oppose the idea of centers that can provide C-sections because they could cut into hospital revenue.
“We are trying to reduce the cost of medicine, and this would be more cost-effective and more pleasant for patients,” he said.
Kate Bauer, executive director of the American Association of Birth Centers, said patients could confuse advanced birth centers with the existing, free-standing birth centers for low-risk births that have been run by midwives for decades. There are currently 31 licensed birth centers in Florida and 411 free-standing birth centers in the United States, she said.
“This is a radical departure from the standard of care,” Bauer said. “It’s a bad idea,” she said, because it could increase risks to mom and baby.
No other state allows C-sections outside of hospitals. The only facility that offers similar care is a birth clinic in Wichita, Kansas, which is connected by a short walkway to a hospital, Wesley Medical Center.
The clinic provides “hotel-like” maternity suites where staffers deliver about 100 babies a month, compared with 500 per month in the hospital itself.
Morgan Tracy, a maternity nurse navigator at the center, said the concept works largely because the hospital and birthing suites can share staff and pharmacy access, plus patients can be quickly transferred to the main hospital if complications arise.
“The beauty is there are team members on both sides of the street,” Tracy said.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Carefully Designing De-escalation Trials in Breast Cancer
Over the past few years, several new, highly effective treatment strategies have improved survival outcomes in patients with early breast cancer.
“We’ve been very fortunate” to see these advances, Sara M. Tolaney, MD, MPH, chief, Division of Breast Oncology, Dana-Farber Cancer Institute, Boston, told attendees at the European Society of Medical Oncology (ESMO) Breast Cancer annual congress.
However, Dr. Tolaney noted, these new treatment approaches can come with big limitations — namely, potential overtreatment of some patients as well as short- and long-term toxicities, some of which can be life-threatening.
These caveats have prompted trials exploring strategies to de-escalate therapy, which essentially means providing the right amount of treatment to the right patient at the right time, said Dr. Tolaney. The goal is to “right-size” or “optimize therapy” to maintain strong outcomes while mitigating side effects.
she explained.
But, she added, de-escalation trials are “not a very attractive strategy to pharmaceutical companies” and can be challenging for researchers to conduct. These trials may, for instance, lack adequate sample sizes and sufficient statistical power, which can interfere with achieving clinically meaningful findings that may affect practice.
That is why carefully designing de-escalation trials is crucial, Dr. Tolaney said.
In her talk at ESMO Breast, Dr. Tolaney highlighted several strategies for designing these trials.
One strategy is to shorten the duration of therapy, said Dr. Tolaney.
This approach was explored in the PHARE and PERSEPHONE trials, which looked at 6 vs 12 months of trastuzumab in nonmetastatic breast cancer. Other trials, such as GeparNuevo and KEYNOTE-522, explored whether adjuvant checkpoint inhibitor therapy was needed, or could be skipped, following neoadjuvant therapy. This approach requires establishing noninferiority, or similar efficacy, between the standard of care and the shorter duration of therapy.
A second strategy is to remove part of the chemotherapy regimen, typically the most toxic agent, Dr. Tolaney continued.
Conducting a prospective, randomized trial exploring this approach in human epidermal growth factor receptor 2–positive (HER2+) early breast cancer, for example, would be difficult for a range of reasons, such as the need to enroll thousands of patients.
Dr. Tolaney and colleagues, however, designed a nonrandomized prospective study — the APT trial — with just over 400 patients to assess adjuvant paclitaxel plus trastuzumab in patients with node-negative HER2+ disease. The open-label, single-arm, phase 2 APT trial found that adjuvant paclitaxel and trastuzumab led to a 10-year recurrence-free interval of 96.3%, 10-year overall survival of 94.3%, and 10-year breast cancer–specific survival of 98.8%.
Outcomes with this adjuvant regimen were comparable to previous findings in historical controls who received doxorubicin, cyclophosphamide, paclitaxel, and trastuzumab or docetaxel, carboplatin, and trastuzumab.
Dr. Tolaney concluded that given few events, “it’s unlikely we need to escalate therapy to do better for most patients,” and the APT regimen “can be considered a reasonable and appealing approach for the majority of patients” with node-negative HER2+ breast cancer.
“A single-arm design for a de-escalation study can be practice-changing but only if there are very few recurrences,” Dr. Tolaney said.
Substituting chemotherapy with a targeted, potentially less-toxic agent is a third de-escalation approach. The ATEMPT trial compared patients receiving trastuzumab emtansine (T-DM1) with those receiving paclitaxel plus trastuzumab followed by maintenance trastuzumab.
Investigators found that de-escalation with T-DM1 was associated with very few recurrences but similar rates of certain adverse events, including grade 2 or higher neurotoxicity, febrile neutropenia, and grade 4 or higher hematologic toxicity.
However, there are questions about how to define “less toxic,” Dr. Tolaney said. The trial found, for instance, that T-DM1 did have some advantages — patients reported better quality of life and experienced less alopecia and neurotoxicity, as well as a less severe impact on fertility.
Understanding the right endpoint to demonstrate less toxicity is critical, “as we start to think about how to replace standard chemotherapies with better targeted drugs,” she added.
The ATEMPT 2.0 trial, which is currently enrolling, will aim to answer some of these questions about defining and demonstrating less toxicity, she said.
Finally, some researchers are attempting to omit chemotherapy altogether with the help of biomarkers. The TAILORx trial, for instance, aimed to stratify patients with early-stage breast cancer by clinical risk factors combined with a 21-gene expression assay and found that adjuvant chemotherapy was not necessary in a large proportion of these women.
On the biomarker front, oncologists might be able to use ctDNA to guide decision-making and personalize therapy, Tolaney said. The presence of ctDNA is associated with an almost 100% likelihood of having a recurrence, whereas its absence suggests better outcomes, she explained.
Oncologists could use the presence or absence of ctDNA to guide next steps — assign patients to follow-up assessments when ctDNA is not present or to standard or experimental treatment when it is present. It may also be possible to leverage the presence of minimal residual disease to help direct treatment choices.
But ctDNA is currently not as perfect a predictor of outcome as it could be, she cautioned. “We need more sensitive assays [so] I’m not sure we’re quite ready to use lack of ctDNA to de-escalate treatment,” she said.
Dr. Tolaney declared relationships with Novartis, Pfizer, Merck, Lilly, AstraZeneca, Genentech/Roche, Eisai, Sanofi, Bristol Myers Squib, and other companies.
A version of this article appeared on Medscape.com .
Over the past few years, several new, highly effective treatment strategies have improved survival outcomes in patients with early breast cancer.
“We’ve been very fortunate” to see these advances, Sara M. Tolaney, MD, MPH, chief, Division of Breast Oncology, Dana-Farber Cancer Institute, Boston, told attendees at the European Society of Medical Oncology (ESMO) Breast Cancer annual congress.
However, Dr. Tolaney noted, these new treatment approaches can come with big limitations — namely, potential overtreatment of some patients as well as short- and long-term toxicities, some of which can be life-threatening.
These caveats have prompted trials exploring strategies to de-escalate therapy, which essentially means providing the right amount of treatment to the right patient at the right time, said Dr. Tolaney. The goal is to “right-size” or “optimize therapy” to maintain strong outcomes while mitigating side effects.
she explained.
But, she added, de-escalation trials are “not a very attractive strategy to pharmaceutical companies” and can be challenging for researchers to conduct. These trials may, for instance, lack adequate sample sizes and sufficient statistical power, which can interfere with achieving clinically meaningful findings that may affect practice.
That is why carefully designing de-escalation trials is crucial, Dr. Tolaney said.
In her talk at ESMO Breast, Dr. Tolaney highlighted several strategies for designing these trials.
One strategy is to shorten the duration of therapy, said Dr. Tolaney.
This approach was explored in the PHARE and PERSEPHONE trials, which looked at 6 vs 12 months of trastuzumab in nonmetastatic breast cancer. Other trials, such as GeparNuevo and KEYNOTE-522, explored whether adjuvant checkpoint inhibitor therapy was needed, or could be skipped, following neoadjuvant therapy. This approach requires establishing noninferiority, or similar efficacy, between the standard of care and the shorter duration of therapy.
A second strategy is to remove part of the chemotherapy regimen, typically the most toxic agent, Dr. Tolaney continued.
Conducting a prospective, randomized trial exploring this approach in human epidermal growth factor receptor 2–positive (HER2+) early breast cancer, for example, would be difficult for a range of reasons, such as the need to enroll thousands of patients.
Dr. Tolaney and colleagues, however, designed a nonrandomized prospective study — the APT trial — with just over 400 patients to assess adjuvant paclitaxel plus trastuzumab in patients with node-negative HER2+ disease. The open-label, single-arm, phase 2 APT trial found that adjuvant paclitaxel and trastuzumab led to a 10-year recurrence-free interval of 96.3%, 10-year overall survival of 94.3%, and 10-year breast cancer–specific survival of 98.8%.
Outcomes with this adjuvant regimen were comparable to previous findings in historical controls who received doxorubicin, cyclophosphamide, paclitaxel, and trastuzumab or docetaxel, carboplatin, and trastuzumab.
Dr. Tolaney concluded that given few events, “it’s unlikely we need to escalate therapy to do better for most patients,” and the APT regimen “can be considered a reasonable and appealing approach for the majority of patients” with node-negative HER2+ breast cancer.
“A single-arm design for a de-escalation study can be practice-changing but only if there are very few recurrences,” Dr. Tolaney said.
Substituting chemotherapy with a targeted, potentially less-toxic agent is a third de-escalation approach. The ATEMPT trial compared patients receiving trastuzumab emtansine (T-DM1) with those receiving paclitaxel plus trastuzumab followed by maintenance trastuzumab.
Investigators found that de-escalation with T-DM1 was associated with very few recurrences but similar rates of certain adverse events, including grade 2 or higher neurotoxicity, febrile neutropenia, and grade 4 or higher hematologic toxicity.
However, there are questions about how to define “less toxic,” Dr. Tolaney said. The trial found, for instance, that T-DM1 did have some advantages — patients reported better quality of life and experienced less alopecia and neurotoxicity, as well as a less severe impact on fertility.
Understanding the right endpoint to demonstrate less toxicity is critical, “as we start to think about how to replace standard chemotherapies with better targeted drugs,” she added.
The ATEMPT 2.0 trial, which is currently enrolling, will aim to answer some of these questions about defining and demonstrating less toxicity, she said.
Finally, some researchers are attempting to omit chemotherapy altogether with the help of biomarkers. The TAILORx trial, for instance, aimed to stratify patients with early-stage breast cancer by clinical risk factors combined with a 21-gene expression assay and found that adjuvant chemotherapy was not necessary in a large proportion of these women.
On the biomarker front, oncologists might be able to use ctDNA to guide decision-making and personalize therapy, Tolaney said. The presence of ctDNA is associated with an almost 100% likelihood of having a recurrence, whereas its absence suggests better outcomes, she explained.
Oncologists could use the presence or absence of ctDNA to guide next steps — assign patients to follow-up assessments when ctDNA is not present or to standard or experimental treatment when it is present. It may also be possible to leverage the presence of minimal residual disease to help direct treatment choices.
But ctDNA is currently not as perfect a predictor of outcome as it could be, she cautioned. “We need more sensitive assays [so] I’m not sure we’re quite ready to use lack of ctDNA to de-escalate treatment,” she said.
Dr. Tolaney declared relationships with Novartis, Pfizer, Merck, Lilly, AstraZeneca, Genentech/Roche, Eisai, Sanofi, Bristol Myers Squib, and other companies.
A version of this article appeared on Medscape.com .
Over the past few years, several new, highly effective treatment strategies have improved survival outcomes in patients with early breast cancer.
“We’ve been very fortunate” to see these advances, Sara M. Tolaney, MD, MPH, chief, Division of Breast Oncology, Dana-Farber Cancer Institute, Boston, told attendees at the European Society of Medical Oncology (ESMO) Breast Cancer annual congress.
However, Dr. Tolaney noted, these new treatment approaches can come with big limitations — namely, potential overtreatment of some patients as well as short- and long-term toxicities, some of which can be life-threatening.
These caveats have prompted trials exploring strategies to de-escalate therapy, which essentially means providing the right amount of treatment to the right patient at the right time, said Dr. Tolaney. The goal is to “right-size” or “optimize therapy” to maintain strong outcomes while mitigating side effects.
she explained.
But, she added, de-escalation trials are “not a very attractive strategy to pharmaceutical companies” and can be challenging for researchers to conduct. These trials may, for instance, lack adequate sample sizes and sufficient statistical power, which can interfere with achieving clinically meaningful findings that may affect practice.
That is why carefully designing de-escalation trials is crucial, Dr. Tolaney said.
In her talk at ESMO Breast, Dr. Tolaney highlighted several strategies for designing these trials.
One strategy is to shorten the duration of therapy, said Dr. Tolaney.
This approach was explored in the PHARE and PERSEPHONE trials, which looked at 6 vs 12 months of trastuzumab in nonmetastatic breast cancer. Other trials, such as GeparNuevo and KEYNOTE-522, explored whether adjuvant checkpoint inhibitor therapy was needed, or could be skipped, following neoadjuvant therapy. This approach requires establishing noninferiority, or similar efficacy, between the standard of care and the shorter duration of therapy.
A second strategy is to remove part of the chemotherapy regimen, typically the most toxic agent, Dr. Tolaney continued.
Conducting a prospective, randomized trial exploring this approach in human epidermal growth factor receptor 2–positive (HER2+) early breast cancer, for example, would be difficult for a range of reasons, such as the need to enroll thousands of patients.
Dr. Tolaney and colleagues, however, designed a nonrandomized prospective study — the APT trial — with just over 400 patients to assess adjuvant paclitaxel plus trastuzumab in patients with node-negative HER2+ disease. The open-label, single-arm, phase 2 APT trial found that adjuvant paclitaxel and trastuzumab led to a 10-year recurrence-free interval of 96.3%, 10-year overall survival of 94.3%, and 10-year breast cancer–specific survival of 98.8%.
Outcomes with this adjuvant regimen were comparable to previous findings in historical controls who received doxorubicin, cyclophosphamide, paclitaxel, and trastuzumab or docetaxel, carboplatin, and trastuzumab.
Dr. Tolaney concluded that given few events, “it’s unlikely we need to escalate therapy to do better for most patients,” and the APT regimen “can be considered a reasonable and appealing approach for the majority of patients” with node-negative HER2+ breast cancer.
“A single-arm design for a de-escalation study can be practice-changing but only if there are very few recurrences,” Dr. Tolaney said.
Substituting chemotherapy with a targeted, potentially less-toxic agent is a third de-escalation approach. The ATEMPT trial compared patients receiving trastuzumab emtansine (T-DM1) with those receiving paclitaxel plus trastuzumab followed by maintenance trastuzumab.
Investigators found that de-escalation with T-DM1 was associated with very few recurrences but similar rates of certain adverse events, including grade 2 or higher neurotoxicity, febrile neutropenia, and grade 4 or higher hematologic toxicity.
However, there are questions about how to define “less toxic,” Dr. Tolaney said. The trial found, for instance, that T-DM1 did have some advantages — patients reported better quality of life and experienced less alopecia and neurotoxicity, as well as a less severe impact on fertility.
Understanding the right endpoint to demonstrate less toxicity is critical, “as we start to think about how to replace standard chemotherapies with better targeted drugs,” she added.
The ATEMPT 2.0 trial, which is currently enrolling, will aim to answer some of these questions about defining and demonstrating less toxicity, she said.
Finally, some researchers are attempting to omit chemotherapy altogether with the help of biomarkers. The TAILORx trial, for instance, aimed to stratify patients with early-stage breast cancer by clinical risk factors combined with a 21-gene expression assay and found that adjuvant chemotherapy was not necessary in a large proportion of these women.
On the biomarker front, oncologists might be able to use ctDNA to guide decision-making and personalize therapy, Tolaney said. The presence of ctDNA is associated with an almost 100% likelihood of having a recurrence, whereas its absence suggests better outcomes, she explained.
Oncologists could use the presence or absence of ctDNA to guide next steps — assign patients to follow-up assessments when ctDNA is not present or to standard or experimental treatment when it is present. It may also be possible to leverage the presence of minimal residual disease to help direct treatment choices.
But ctDNA is currently not as perfect a predictor of outcome as it could be, she cautioned. “We need more sensitive assays [so] I’m not sure we’re quite ready to use lack of ctDNA to de-escalate treatment,” she said.
Dr. Tolaney declared relationships with Novartis, Pfizer, Merck, Lilly, AstraZeneca, Genentech/Roche, Eisai, Sanofi, Bristol Myers Squib, and other companies.
A version of this article appeared on Medscape.com .
FROM ESMO BREAST CANCER 2024
ADCs for Breast Cancer: Clear Benefits, Manageable Risks
These medications, which are designed to selectively deliver potent cytotoxic drugs to cancer cells expressing specific surface antigens such as human epidermal growth factor receptor 2 (HER2) and trophoblast cell surface antigen 2 (TROP2), can be highly effective but can also come with significant toxicities.
The latest data on several ADCs — their clinical benefit and safety — were the focus of three presentations here at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
TROPION-Breast01
In her presentation, Komal Jhaveri, MD, of Memorial Sloan Kettering Cancer Center in New York City, reported additional safety analyses from the phase 3 TROPION-Breast01 trial looking at datopotamab deruxtecan (Dato-DXd) in patients with metastatic hormone receptor–positive (HR+)/HER2− breast cancer resistant to endocrine therapy.
Dato-DXd is an investigational ADC composed of a monoclonal antibody targeting TROP2, a transmembrane glycoprotein overexpressed in cancer cells, linked to the topoisomerase 1 inhibitor deruxtecan as the toxic payload.
As previously reported by this news organization, median progression-free survival was 6.9 months with Dato-DXd compared with 4.9 months for investigator’s choice of chemotherapy (eribulin mesylate, vinorelbine, gemcitabine, or capecitabine), which translated into a 37% (hazard ratio [HR], 0.63; P < .0001) reduction in risk for disease progression.
In addition, the rate of grade 3 or higher treatment-related adverse events with Dato-DXd was less than half that with standard chemotherapy and led to fewer dose interruptions or reductions, indicating that Dato-DXd is better tolerated.
Dr. Jhaveri focused on three treatment-related adverse events of special interest: Stomatitis/oral mucositis, ocular surface events, and adjudicated drug-related interstitial lung disease.
The rate of any grade oral mucositis with Dato-DXd was 56%, she reported. Most were grade 1 (25%) or grade 2 (23%), with only 7% grade 3. About 13% of patients had a dose reduction for oral mucositis, and only one (0.3%) patient discontinued treatment.
The median time to onset was 22 days, and median time to resolution (for events recovered/resolved at data cutoff) was 36 days.
“The study did provide toxicity management guidelines for patients who experienced stomatitis,” Dr. Jhaveri told attendees. The guidelines highly recommended daily use of a steroid-containing mouthwash as prophylaxis or, if that wasn’t available, an inert, bland mouth rinse.
“Prophylactic cryotherapy — ice chips or ice water held in the mouth throughout the infusion — was also suggested,” she said.
The overall rate of ocular surface events with Dato-DXd was 40%, with most grade 1 (32%) or grade 2 (7%), with only 0.8% grade 3. Rates of dose reduction/interruption (3.3%) and discontinuation (0.3%) were low. Most ocular events were either dry eye (22%) or keratitis (14%).
The incidence of ocular events in the chemotherapy group was 12%, higher than typically seen. The study mandated regular ocular assessments, and Jhaveri noted that it was possible that this contributed to the high rate of low-grade ocular events found in both arms.
Median time to onset of ocular events was 65 days, and median time to resolution was 67 days.
Toxicity management guidelines were also incorporated for ocular events, suggesting daily use of artificial tears and avoidance of contact lenses, Dr. Jhaveri said.
In the Dato-DXd group, there were 12 adjudicated cases (3.3%) of drug-related interstitial lung disease; most were grade 1 (1.4%) and grade 2 (1.1%).
“There was one patient who had a grade 5 event, which was characterized by the investigator as grade 3 pneumonitis, with death attributed to disease progression,” Dr. Jhaveri said. This was subsequently adjudicated to be a grade 5 drug-related death.
The median time to onset of interstitial lung disease was 84.5 days, and median time to resolution was 28 days.
Among other treatment-related adverse events of clinical interest, any grade nausea was the most common event with Dato-DXd, reported by 51% of patients, with only 1.4% grade 3 or higher.
“Prophylactic antiemetic agents are highly recommended prior to infusion of Dato-DXd and on subsequent days as needed,” Dr. Jhaveri said.
Any grade diarrhea was reported in 7.5%, with no grade 3+ diarrhea. Alopecia was reported in 36.4%, of which grade 1 was 21% and grade 2 was 15%.
Summing up, the researcher said the new safety data suggest that Dato-DXd offers “better tolerability” than standard chemotherapy. Coupled with the efficacy data, this further supports “Dato-DXd as a potential new therapeutic option for patients with previously treated, inoperable, or metastatic HR+/HER2− breast cancer.”
DESTINY-Breast02
New data from the phase 3 DESTINY-Breast02 study confirm a long-term survival benefit, as well as a favorable benefit/risk profile of trastuzumab deruxtecan in patients with HER2+ metastatic breast cancer previously treated with trastuzumab emtansine (T-DM1), reported Sung-Bae Kim, MD, PhD, with University of Ulsan College of Medicine, Seoul, Republic of Korea.
In the phase 3 randomized, multicenter, open-label clinical trial, study participants received either trastuzumab deruxtecan or physician’s choice of trastuzumab plus capecitabine or lapatinib or capecitabine. The primary results of the trial were published last year in The Lancet.
As previously reported by this news organization, after median follow-up of 21.5 months in the trastuzumab deruxtecan group and 18.6 months in the treatment of choice group, median progression-free survival was 17.8 months for trastuzumab deruxtecan vs 6.9 months for the physician’s choice group (HR, 0.36; P < .000001).
The latest data show that after a median follow-up of 30.2 months in the trastuzumab deruxtecan group and 20.5 months in the treatment of choice group, median progression-free survival was 16.7 months with trastuzumab deruxtecan vs 5.5 months with the treatment of choice — a 70% reduction in risk for progression (HR, 0.30), Dr. Kim said.
From time of randomization to progression to next line of therapy or death, median progression-free survival was 33.0 months with trastuzumab deruxtecan vs 15.0 with treatment of choice (HR, 0.42).
Median overall survival was 35.7 months with trastuzumab deruxtecan vs 25.0 months with the treatment of choice, with the risk for death reduced by 31% with trastuzumab deruxtecan (HR, 0.69).
The safety profile of trastuzumab deruxtecan continues to be “manageable, with no long-term toxicity observed with longer follow-up,” Dr. Kim told attendees. The most common treatment-emergent adverse events were nausea (73%), fatigue (62%), and vomiting (38%).
There were a total of 46 (11.4%) adjudicated drug-related interstitial lung disease/pneumonitis cases with trastuzumab deruxtecan. Most were grade 1 or 2. This risk did not increase with longer treatment duration; most events occurred within 12 months of starting treatment, Dr. Kim noted.
With longer follow-up, results of DESTINY-Breast02 “reinforce the substantial benefit” of trastuzumab deruxtecan over the treatment of physician’s choice in patients with HER2+ metastatic breast cancer previously treated with T-DM1, he concluded.
Pooled Data from TROPiCS-02 and EVER-132-002
Hope S. Rugo, MD, of the University of California San Francisco, and colleagues reported a meta-analysis of data from the phase 3 TROPiCS-02 and EVER-132-002 trials of the TROP2-directed ADC sacituzumab govitecan vs the treatment of physician’s choice in HR+/HER2− metastatic breast cancer.
In the pooled analysis, median overall survival was significantly longer with sacituzumab govitecan than with the treatment of physician’s choice in the overall population (16.2 vs 12.7 months) and in patients who received prior CDK4/6 inhibitor treatment (15.4 vs 11.5 months). Progression-free survival also favored sacituzumab govitecan.
These results are consistent with trial-level results from TROPICS-02 and EVER-132-002, reinforcing the efficacy benefits of sacituzumab govitecan over the treatment of physician’s choice, the study team said.
Evolving Landscape of ADCs in Breast Cancer
Giuseppe Curigliano, MD, PhD, with the University of Milan, Italy, who served as discussant for the TROPION-Breast01 safety analysis, noted that the clinical landscape of ADCs has “evolved over time.”
He added that despite having a similar target and similar payload, the anti-TROP2 ADCs in development for HR+/HER2− metastatic breast cancer — Dato-DXd, sacituzumab govitecan, and sacituzumab tirumotecan — appear to have different spectrums of toxicity.
Looking ahead, he said it will be important to determine whether toxicity of these agents can be predicted with a pharmacogenomic analysis and whether toxicity is related to the payload or to the linker antibody complex.
“The science and chemistry of ADCs has shown significant promise in terms of clinical activity, but we also need to better understand safety,” Dr. Curigliano told attendees.
“We need to pay attention to signals in the early phase trials of ADCs and be willing to adjust accordingly to maximize therapeutic benefit and minimize toxicity. Team science will be important in the future developmental ADCs,” he added.
TROPION-Breast01 was sponsored by AstraZeneca. DESTINY-Breast-02 was sponsored by Daiichi Sankyo. TROPiCS-02 and EVER-132-002 were supported by Gilead Sciences. Several trial investigators have disclosed various relationships with these and other pharmaceutical companies.
A version of this article appeared on Medscape.com.
These medications, which are designed to selectively deliver potent cytotoxic drugs to cancer cells expressing specific surface antigens such as human epidermal growth factor receptor 2 (HER2) and trophoblast cell surface antigen 2 (TROP2), can be highly effective but can also come with significant toxicities.
The latest data on several ADCs — their clinical benefit and safety — were the focus of three presentations here at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
TROPION-Breast01
In her presentation, Komal Jhaveri, MD, of Memorial Sloan Kettering Cancer Center in New York City, reported additional safety analyses from the phase 3 TROPION-Breast01 trial looking at datopotamab deruxtecan (Dato-DXd) in patients with metastatic hormone receptor–positive (HR+)/HER2− breast cancer resistant to endocrine therapy.
Dato-DXd is an investigational ADC composed of a monoclonal antibody targeting TROP2, a transmembrane glycoprotein overexpressed in cancer cells, linked to the topoisomerase 1 inhibitor deruxtecan as the toxic payload.
As previously reported by this news organization, median progression-free survival was 6.9 months with Dato-DXd compared with 4.9 months for investigator’s choice of chemotherapy (eribulin mesylate, vinorelbine, gemcitabine, or capecitabine), which translated into a 37% (hazard ratio [HR], 0.63; P < .0001) reduction in risk for disease progression.
In addition, the rate of grade 3 or higher treatment-related adverse events with Dato-DXd was less than half that with standard chemotherapy and led to fewer dose interruptions or reductions, indicating that Dato-DXd is better tolerated.
Dr. Jhaveri focused on three treatment-related adverse events of special interest: Stomatitis/oral mucositis, ocular surface events, and adjudicated drug-related interstitial lung disease.
The rate of any grade oral mucositis with Dato-DXd was 56%, she reported. Most were grade 1 (25%) or grade 2 (23%), with only 7% grade 3. About 13% of patients had a dose reduction for oral mucositis, and only one (0.3%) patient discontinued treatment.
The median time to onset was 22 days, and median time to resolution (for events recovered/resolved at data cutoff) was 36 days.
“The study did provide toxicity management guidelines for patients who experienced stomatitis,” Dr. Jhaveri told attendees. The guidelines highly recommended daily use of a steroid-containing mouthwash as prophylaxis or, if that wasn’t available, an inert, bland mouth rinse.
“Prophylactic cryotherapy — ice chips or ice water held in the mouth throughout the infusion — was also suggested,” she said.
The overall rate of ocular surface events with Dato-DXd was 40%, with most grade 1 (32%) or grade 2 (7%), with only 0.8% grade 3. Rates of dose reduction/interruption (3.3%) and discontinuation (0.3%) were low. Most ocular events were either dry eye (22%) or keratitis (14%).
The incidence of ocular events in the chemotherapy group was 12%, higher than typically seen. The study mandated regular ocular assessments, and Jhaveri noted that it was possible that this contributed to the high rate of low-grade ocular events found in both arms.
Median time to onset of ocular events was 65 days, and median time to resolution was 67 days.
Toxicity management guidelines were also incorporated for ocular events, suggesting daily use of artificial tears and avoidance of contact lenses, Dr. Jhaveri said.
In the Dato-DXd group, there were 12 adjudicated cases (3.3%) of drug-related interstitial lung disease; most were grade 1 (1.4%) and grade 2 (1.1%).
“There was one patient who had a grade 5 event, which was characterized by the investigator as grade 3 pneumonitis, with death attributed to disease progression,” Dr. Jhaveri said. This was subsequently adjudicated to be a grade 5 drug-related death.
The median time to onset of interstitial lung disease was 84.5 days, and median time to resolution was 28 days.
Among other treatment-related adverse events of clinical interest, any grade nausea was the most common event with Dato-DXd, reported by 51% of patients, with only 1.4% grade 3 or higher.
“Prophylactic antiemetic agents are highly recommended prior to infusion of Dato-DXd and on subsequent days as needed,” Dr. Jhaveri said.
Any grade diarrhea was reported in 7.5%, with no grade 3+ diarrhea. Alopecia was reported in 36.4%, of which grade 1 was 21% and grade 2 was 15%.
Summing up, the researcher said the new safety data suggest that Dato-DXd offers “better tolerability” than standard chemotherapy. Coupled with the efficacy data, this further supports “Dato-DXd as a potential new therapeutic option for patients with previously treated, inoperable, or metastatic HR+/HER2− breast cancer.”
DESTINY-Breast02
New data from the phase 3 DESTINY-Breast02 study confirm a long-term survival benefit, as well as a favorable benefit/risk profile of trastuzumab deruxtecan in patients with HER2+ metastatic breast cancer previously treated with trastuzumab emtansine (T-DM1), reported Sung-Bae Kim, MD, PhD, with University of Ulsan College of Medicine, Seoul, Republic of Korea.
In the phase 3 randomized, multicenter, open-label clinical trial, study participants received either trastuzumab deruxtecan or physician’s choice of trastuzumab plus capecitabine or lapatinib or capecitabine. The primary results of the trial were published last year in The Lancet.
As previously reported by this news organization, after median follow-up of 21.5 months in the trastuzumab deruxtecan group and 18.6 months in the treatment of choice group, median progression-free survival was 17.8 months for trastuzumab deruxtecan vs 6.9 months for the physician’s choice group (HR, 0.36; P < .000001).
The latest data show that after a median follow-up of 30.2 months in the trastuzumab deruxtecan group and 20.5 months in the treatment of choice group, median progression-free survival was 16.7 months with trastuzumab deruxtecan vs 5.5 months with the treatment of choice — a 70% reduction in risk for progression (HR, 0.30), Dr. Kim said.
From time of randomization to progression to next line of therapy or death, median progression-free survival was 33.0 months with trastuzumab deruxtecan vs 15.0 with treatment of choice (HR, 0.42).
Median overall survival was 35.7 months with trastuzumab deruxtecan vs 25.0 months with the treatment of choice, with the risk for death reduced by 31% with trastuzumab deruxtecan (HR, 0.69).
The safety profile of trastuzumab deruxtecan continues to be “manageable, with no long-term toxicity observed with longer follow-up,” Dr. Kim told attendees. The most common treatment-emergent adverse events were nausea (73%), fatigue (62%), and vomiting (38%).
There were a total of 46 (11.4%) adjudicated drug-related interstitial lung disease/pneumonitis cases with trastuzumab deruxtecan. Most were grade 1 or 2. This risk did not increase with longer treatment duration; most events occurred within 12 months of starting treatment, Dr. Kim noted.
With longer follow-up, results of DESTINY-Breast02 “reinforce the substantial benefit” of trastuzumab deruxtecan over the treatment of physician’s choice in patients with HER2+ metastatic breast cancer previously treated with T-DM1, he concluded.
Pooled Data from TROPiCS-02 and EVER-132-002
Hope S. Rugo, MD, of the University of California San Francisco, and colleagues reported a meta-analysis of data from the phase 3 TROPiCS-02 and EVER-132-002 trials of the TROP2-directed ADC sacituzumab govitecan vs the treatment of physician’s choice in HR+/HER2− metastatic breast cancer.
In the pooled analysis, median overall survival was significantly longer with sacituzumab govitecan than with the treatment of physician’s choice in the overall population (16.2 vs 12.7 months) and in patients who received prior CDK4/6 inhibitor treatment (15.4 vs 11.5 months). Progression-free survival also favored sacituzumab govitecan.
These results are consistent with trial-level results from TROPICS-02 and EVER-132-002, reinforcing the efficacy benefits of sacituzumab govitecan over the treatment of physician’s choice, the study team said.
Evolving Landscape of ADCs in Breast Cancer
Giuseppe Curigliano, MD, PhD, with the University of Milan, Italy, who served as discussant for the TROPION-Breast01 safety analysis, noted that the clinical landscape of ADCs has “evolved over time.”
He added that despite having a similar target and similar payload, the anti-TROP2 ADCs in development for HR+/HER2− metastatic breast cancer — Dato-DXd, sacituzumab govitecan, and sacituzumab tirumotecan — appear to have different spectrums of toxicity.
Looking ahead, he said it will be important to determine whether toxicity of these agents can be predicted with a pharmacogenomic analysis and whether toxicity is related to the payload or to the linker antibody complex.
“The science and chemistry of ADCs has shown significant promise in terms of clinical activity, but we also need to better understand safety,” Dr. Curigliano told attendees.
“We need to pay attention to signals in the early phase trials of ADCs and be willing to adjust accordingly to maximize therapeutic benefit and minimize toxicity. Team science will be important in the future developmental ADCs,” he added.
TROPION-Breast01 was sponsored by AstraZeneca. DESTINY-Breast-02 was sponsored by Daiichi Sankyo. TROPiCS-02 and EVER-132-002 were supported by Gilead Sciences. Several trial investigators have disclosed various relationships with these and other pharmaceutical companies.
A version of this article appeared on Medscape.com.
These medications, which are designed to selectively deliver potent cytotoxic drugs to cancer cells expressing specific surface antigens such as human epidermal growth factor receptor 2 (HER2) and trophoblast cell surface antigen 2 (TROP2), can be highly effective but can also come with significant toxicities.
The latest data on several ADCs — their clinical benefit and safety — were the focus of three presentations here at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
TROPION-Breast01
In her presentation, Komal Jhaveri, MD, of Memorial Sloan Kettering Cancer Center in New York City, reported additional safety analyses from the phase 3 TROPION-Breast01 trial looking at datopotamab deruxtecan (Dato-DXd) in patients with metastatic hormone receptor–positive (HR+)/HER2− breast cancer resistant to endocrine therapy.
Dato-DXd is an investigational ADC composed of a monoclonal antibody targeting TROP2, a transmembrane glycoprotein overexpressed in cancer cells, linked to the topoisomerase 1 inhibitor deruxtecan as the toxic payload.
As previously reported by this news organization, median progression-free survival was 6.9 months with Dato-DXd compared with 4.9 months for investigator’s choice of chemotherapy (eribulin mesylate, vinorelbine, gemcitabine, or capecitabine), which translated into a 37% (hazard ratio [HR], 0.63; P < .0001) reduction in risk for disease progression.
In addition, the rate of grade 3 or higher treatment-related adverse events with Dato-DXd was less than half that with standard chemotherapy and led to fewer dose interruptions or reductions, indicating that Dato-DXd is better tolerated.
Dr. Jhaveri focused on three treatment-related adverse events of special interest: Stomatitis/oral mucositis, ocular surface events, and adjudicated drug-related interstitial lung disease.
The rate of any grade oral mucositis with Dato-DXd was 56%, she reported. Most were grade 1 (25%) or grade 2 (23%), with only 7% grade 3. About 13% of patients had a dose reduction for oral mucositis, and only one (0.3%) patient discontinued treatment.
The median time to onset was 22 days, and median time to resolution (for events recovered/resolved at data cutoff) was 36 days.
“The study did provide toxicity management guidelines for patients who experienced stomatitis,” Dr. Jhaveri told attendees. The guidelines highly recommended daily use of a steroid-containing mouthwash as prophylaxis or, if that wasn’t available, an inert, bland mouth rinse.
“Prophylactic cryotherapy — ice chips or ice water held in the mouth throughout the infusion — was also suggested,” she said.
The overall rate of ocular surface events with Dato-DXd was 40%, with most grade 1 (32%) or grade 2 (7%), with only 0.8% grade 3. Rates of dose reduction/interruption (3.3%) and discontinuation (0.3%) were low. Most ocular events were either dry eye (22%) or keratitis (14%).
The incidence of ocular events in the chemotherapy group was 12%, higher than typically seen. The study mandated regular ocular assessments, and Jhaveri noted that it was possible that this contributed to the high rate of low-grade ocular events found in both arms.
Median time to onset of ocular events was 65 days, and median time to resolution was 67 days.
Toxicity management guidelines were also incorporated for ocular events, suggesting daily use of artificial tears and avoidance of contact lenses, Dr. Jhaveri said.
In the Dato-DXd group, there were 12 adjudicated cases (3.3%) of drug-related interstitial lung disease; most were grade 1 (1.4%) and grade 2 (1.1%).
“There was one patient who had a grade 5 event, which was characterized by the investigator as grade 3 pneumonitis, with death attributed to disease progression,” Dr. Jhaveri said. This was subsequently adjudicated to be a grade 5 drug-related death.
The median time to onset of interstitial lung disease was 84.5 days, and median time to resolution was 28 days.
Among other treatment-related adverse events of clinical interest, any grade nausea was the most common event with Dato-DXd, reported by 51% of patients, with only 1.4% grade 3 or higher.
“Prophylactic antiemetic agents are highly recommended prior to infusion of Dato-DXd and on subsequent days as needed,” Dr. Jhaveri said.
Any grade diarrhea was reported in 7.5%, with no grade 3+ diarrhea. Alopecia was reported in 36.4%, of which grade 1 was 21% and grade 2 was 15%.
Summing up, the researcher said the new safety data suggest that Dato-DXd offers “better tolerability” than standard chemotherapy. Coupled with the efficacy data, this further supports “Dato-DXd as a potential new therapeutic option for patients with previously treated, inoperable, or metastatic HR+/HER2− breast cancer.”
DESTINY-Breast02
New data from the phase 3 DESTINY-Breast02 study confirm a long-term survival benefit, as well as a favorable benefit/risk profile of trastuzumab deruxtecan in patients with HER2+ metastatic breast cancer previously treated with trastuzumab emtansine (T-DM1), reported Sung-Bae Kim, MD, PhD, with University of Ulsan College of Medicine, Seoul, Republic of Korea.
In the phase 3 randomized, multicenter, open-label clinical trial, study participants received either trastuzumab deruxtecan or physician’s choice of trastuzumab plus capecitabine or lapatinib or capecitabine. The primary results of the trial were published last year in The Lancet.
As previously reported by this news organization, after median follow-up of 21.5 months in the trastuzumab deruxtecan group and 18.6 months in the treatment of choice group, median progression-free survival was 17.8 months for trastuzumab deruxtecan vs 6.9 months for the physician’s choice group (HR, 0.36; P < .000001).
The latest data show that after a median follow-up of 30.2 months in the trastuzumab deruxtecan group and 20.5 months in the treatment of choice group, median progression-free survival was 16.7 months with trastuzumab deruxtecan vs 5.5 months with the treatment of choice — a 70% reduction in risk for progression (HR, 0.30), Dr. Kim said.
From time of randomization to progression to next line of therapy or death, median progression-free survival was 33.0 months with trastuzumab deruxtecan vs 15.0 with treatment of choice (HR, 0.42).
Median overall survival was 35.7 months with trastuzumab deruxtecan vs 25.0 months with the treatment of choice, with the risk for death reduced by 31% with trastuzumab deruxtecan (HR, 0.69).
The safety profile of trastuzumab deruxtecan continues to be “manageable, with no long-term toxicity observed with longer follow-up,” Dr. Kim told attendees. The most common treatment-emergent adverse events were nausea (73%), fatigue (62%), and vomiting (38%).
There were a total of 46 (11.4%) adjudicated drug-related interstitial lung disease/pneumonitis cases with trastuzumab deruxtecan. Most were grade 1 or 2. This risk did not increase with longer treatment duration; most events occurred within 12 months of starting treatment, Dr. Kim noted.
With longer follow-up, results of DESTINY-Breast02 “reinforce the substantial benefit” of trastuzumab deruxtecan over the treatment of physician’s choice in patients with HER2+ metastatic breast cancer previously treated with T-DM1, he concluded.
Pooled Data from TROPiCS-02 and EVER-132-002
Hope S. Rugo, MD, of the University of California San Francisco, and colleagues reported a meta-analysis of data from the phase 3 TROPiCS-02 and EVER-132-002 trials of the TROP2-directed ADC sacituzumab govitecan vs the treatment of physician’s choice in HR+/HER2− metastatic breast cancer.
In the pooled analysis, median overall survival was significantly longer with sacituzumab govitecan than with the treatment of physician’s choice in the overall population (16.2 vs 12.7 months) and in patients who received prior CDK4/6 inhibitor treatment (15.4 vs 11.5 months). Progression-free survival also favored sacituzumab govitecan.
These results are consistent with trial-level results from TROPICS-02 and EVER-132-002, reinforcing the efficacy benefits of sacituzumab govitecan over the treatment of physician’s choice, the study team said.
Evolving Landscape of ADCs in Breast Cancer
Giuseppe Curigliano, MD, PhD, with the University of Milan, Italy, who served as discussant for the TROPION-Breast01 safety analysis, noted that the clinical landscape of ADCs has “evolved over time.”
He added that despite having a similar target and similar payload, the anti-TROP2 ADCs in development for HR+/HER2− metastatic breast cancer — Dato-DXd, sacituzumab govitecan, and sacituzumab tirumotecan — appear to have different spectrums of toxicity.
Looking ahead, he said it will be important to determine whether toxicity of these agents can be predicted with a pharmacogenomic analysis and whether toxicity is related to the payload or to the linker antibody complex.
“The science and chemistry of ADCs has shown significant promise in terms of clinical activity, but we also need to better understand safety,” Dr. Curigliano told attendees.
“We need to pay attention to signals in the early phase trials of ADCs and be willing to adjust accordingly to maximize therapeutic benefit and minimize toxicity. Team science will be important in the future developmental ADCs,” he added.
TROPION-Breast01 was sponsored by AstraZeneca. DESTINY-Breast-02 was sponsored by Daiichi Sankyo. TROPiCS-02 and EVER-132-002 were supported by Gilead Sciences. Several trial investigators have disclosed various relationships with these and other pharmaceutical companies.
A version of this article appeared on Medscape.com.
FROM ESMO BREAST CANCER 2024
Beyond the Prescription Pad
The envelope was a small one, with a handwritten address. Of course, there were other things in the mail to sort through: insurance payments, bills, correspondence. So I attended to those while I made coffee and started my computer.
After a few minutes I came back to the small envelope.
Inside was a card from a recently widowed lady, thanking me for my care of her husband and telling me I was very kind.
I’d only seem him once, about a year ago, and then had a follow-up phone call to go over the results.
In medicine you develop, as I’ve previously written, “Spidey Sense.” Things alert you that something bad is going on, even when you can’t quite put your finger on it yet. His story set off several of my alarms, and I sent him off for tests.
A few days later the electromyography and nerve conduction velocity (EMG/NCV) specialist I’d referred him to called to confirm the gentleman had ALS. He’d given him the diagnosis and started him on riluzole.
I called the patient and his wife that night to discuss things in more detail. My colleague, since neuromuscular disease is his field, had already started the process (this isn’t patient poaching, he and I have worked together long enough that he knows I’d rather he take over the case). I explained things further. They didn’t have any questions.
I didn’t hear from them again until the card came. On the flip side was a picture of them and their extended family. I have no idea how they vote, or what their religion is, or how much money they have. None of that matters.
They’re nice people, and a patient, who came to me for help. I was touched by her appreciation for the little I could do, and that she took time to express that to me.
None of us cures anyone in the long run. We can put off the inevitable, do our best to relieve suffering, and try to bring comfort — even when the last is all we can do.
Here in 2024, with all of our medications and computers and tests it’s hard to believe that we still come up short — very short – against so many diseases. Yet we do.
All of us can only do our best, even when the best we can do is to be kind.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
The envelope was a small one, with a handwritten address. Of course, there were other things in the mail to sort through: insurance payments, bills, correspondence. So I attended to those while I made coffee and started my computer.
After a few minutes I came back to the small envelope.
Inside was a card from a recently widowed lady, thanking me for my care of her husband and telling me I was very kind.
I’d only seem him once, about a year ago, and then had a follow-up phone call to go over the results.
In medicine you develop, as I’ve previously written, “Spidey Sense.” Things alert you that something bad is going on, even when you can’t quite put your finger on it yet. His story set off several of my alarms, and I sent him off for tests.
A few days later the electromyography and nerve conduction velocity (EMG/NCV) specialist I’d referred him to called to confirm the gentleman had ALS. He’d given him the diagnosis and started him on riluzole.
I called the patient and his wife that night to discuss things in more detail. My colleague, since neuromuscular disease is his field, had already started the process (this isn’t patient poaching, he and I have worked together long enough that he knows I’d rather he take over the case). I explained things further. They didn’t have any questions.
I didn’t hear from them again until the card came. On the flip side was a picture of them and their extended family. I have no idea how they vote, or what their religion is, or how much money they have. None of that matters.
They’re nice people, and a patient, who came to me for help. I was touched by her appreciation for the little I could do, and that she took time to express that to me.
None of us cures anyone in the long run. We can put off the inevitable, do our best to relieve suffering, and try to bring comfort — even when the last is all we can do.
Here in 2024, with all of our medications and computers and tests it’s hard to believe that we still come up short — very short – against so many diseases. Yet we do.
All of us can only do our best, even when the best we can do is to be kind.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
The envelope was a small one, with a handwritten address. Of course, there were other things in the mail to sort through: insurance payments, bills, correspondence. So I attended to those while I made coffee and started my computer.
After a few minutes I came back to the small envelope.
Inside was a card from a recently widowed lady, thanking me for my care of her husband and telling me I was very kind.
I’d only seem him once, about a year ago, and then had a follow-up phone call to go over the results.
In medicine you develop, as I’ve previously written, “Spidey Sense.” Things alert you that something bad is going on, even when you can’t quite put your finger on it yet. His story set off several of my alarms, and I sent him off for tests.
A few days later the electromyography and nerve conduction velocity (EMG/NCV) specialist I’d referred him to called to confirm the gentleman had ALS. He’d given him the diagnosis and started him on riluzole.
I called the patient and his wife that night to discuss things in more detail. My colleague, since neuromuscular disease is his field, had already started the process (this isn’t patient poaching, he and I have worked together long enough that he knows I’d rather he take over the case). I explained things further. They didn’t have any questions.
I didn’t hear from them again until the card came. On the flip side was a picture of them and their extended family. I have no idea how they vote, or what their religion is, or how much money they have. None of that matters.
They’re nice people, and a patient, who came to me for help. I was touched by her appreciation for the little I could do, and that she took time to express that to me.
None of us cures anyone in the long run. We can put off the inevitable, do our best to relieve suffering, and try to bring comfort — even when the last is all we can do.
Here in 2024, with all of our medications and computers and tests it’s hard to believe that we still come up short — very short – against so many diseases. Yet we do.
All of us can only do our best, even when the best we can do is to be kind.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
The ASCO Annual Meeting Starts This Week
From its origins in 1964, ASCO’s annual event has grown to become the world’s largest clinical oncology meeting, drawing attendees from across the globe.
More than 7000 abstracts were submitted for this year’s meeting a new record — and over 5000 were selected for presentation.
This year’s chair of the Annual Meeting Education Committee, Thomas William LeBlanc, MD, told us he has been attending the meeting since his training days more than a decade ago.
The event is “just incredibly empowering and energizing,” Dr. LeBlanc said, with opportunities to catch up with old colleagues and meet new ones, learn how far oncology has come and where it’s headed, and hear clinical pearls to take back the clinic.
This year’s theme, selected by ASCO President Lynn M. Schuchter, MD, is “The Art and Science of Cancer Care: From Comfort to Cure.”
Dr. LeBlanc, a blood cancer specialist at Duke University, Durham, North Carolina, said the theme has been woven throughout the abstract and educational sessions. Most sessions will have at least one presentation related to how we support people — not only “when we cure them but also when we can’t cure them,” he said.
Topics will include patient well-being, comfort measures, and survivorship. And for the first time the plenary session will include a palliative care abstract that addresses whether or not palliative care can be delivered effectively through telemedicine. The session is on Sunday, June 2.
Other potentially practice changing plenary abstracts tackle immunotherapy combinations for resectable melanoma, perioperative chemotherapy vs neoadjuvant chemoradiation for esophageal cancer, and osimertinib after definitive chemoradiotherapy for unresectable non–small cell lung cancer.
ASCO is piloting a slightly different format for research presentations this year. Instead of starting with context and background, speakers have been asked to present study results upfront as well as repeat them at the end of the talk. The reason behind the tweak is that engagement and retention tend to be better when results are presented upfront, instead of just at the end of a talk.
A popular session — ASCO Voices — has also been given a more central position in the conference: Friday, May 31. In this session, speakers will give short presentations about their personal experiences as providers, researchers, or patients.
ASCO Voices is a relatively recent addition to the meeting that has grown and gotten better. The talks are usually “very powerful narratives” that remind clinicians about “the importance of what they’re doing each day,” Dr. LeBlanc said.
Snippets of the talks will be played while people wait for sessions to begin at the meeting, so attendees who miss the Friday talks can still hear them.
In terms of educational sessions, Dr. LeBlanc highlighted two that might be of general interest to practicing oncologists: A joint ASCO/American Association for Cancer Research session entitled “Drugging the ‘Undruggable’ Target: Successes, Challenges, and the Road Ahead,” on Sunday morning and “Common Sense Oncology: Equity, Value, and Outcomes That Matter” on Monday morning.
As a blood cancer specialist, he said he is particularly interested in the topline results from the ASC4FIRST trial of asciminib, a newer kinase inhibitor, in newly diagnosed chronic myeloid leukemia, presented on Friday.
As in past years, this news organization will be on hand providing coverage with a dedicated team of reporters, editors, and videographers. Stop by our exhibit hall booth — number 26030 — to learn about the tools we offer to support your practice.
A version of this article appeared on Medscape.com .
From its origins in 1964, ASCO’s annual event has grown to become the world’s largest clinical oncology meeting, drawing attendees from across the globe.
More than 7000 abstracts were submitted for this year’s meeting a new record — and over 5000 were selected for presentation.
This year’s chair of the Annual Meeting Education Committee, Thomas William LeBlanc, MD, told us he has been attending the meeting since his training days more than a decade ago.
The event is “just incredibly empowering and energizing,” Dr. LeBlanc said, with opportunities to catch up with old colleagues and meet new ones, learn how far oncology has come and where it’s headed, and hear clinical pearls to take back the clinic.
This year’s theme, selected by ASCO President Lynn M. Schuchter, MD, is “The Art and Science of Cancer Care: From Comfort to Cure.”
Dr. LeBlanc, a blood cancer specialist at Duke University, Durham, North Carolina, said the theme has been woven throughout the abstract and educational sessions. Most sessions will have at least one presentation related to how we support people — not only “when we cure them but also when we can’t cure them,” he said.
Topics will include patient well-being, comfort measures, and survivorship. And for the first time the plenary session will include a palliative care abstract that addresses whether or not palliative care can be delivered effectively through telemedicine. The session is on Sunday, June 2.
Other potentially practice changing plenary abstracts tackle immunotherapy combinations for resectable melanoma, perioperative chemotherapy vs neoadjuvant chemoradiation for esophageal cancer, and osimertinib after definitive chemoradiotherapy for unresectable non–small cell lung cancer.
ASCO is piloting a slightly different format for research presentations this year. Instead of starting with context and background, speakers have been asked to present study results upfront as well as repeat them at the end of the talk. The reason behind the tweak is that engagement and retention tend to be better when results are presented upfront, instead of just at the end of a talk.
A popular session — ASCO Voices — has also been given a more central position in the conference: Friday, May 31. In this session, speakers will give short presentations about their personal experiences as providers, researchers, or patients.
ASCO Voices is a relatively recent addition to the meeting that has grown and gotten better. The talks are usually “very powerful narratives” that remind clinicians about “the importance of what they’re doing each day,” Dr. LeBlanc said.
Snippets of the talks will be played while people wait for sessions to begin at the meeting, so attendees who miss the Friday talks can still hear them.
In terms of educational sessions, Dr. LeBlanc highlighted two that might be of general interest to practicing oncologists: A joint ASCO/American Association for Cancer Research session entitled “Drugging the ‘Undruggable’ Target: Successes, Challenges, and the Road Ahead,” on Sunday morning and “Common Sense Oncology: Equity, Value, and Outcomes That Matter” on Monday morning.
As a blood cancer specialist, he said he is particularly interested in the topline results from the ASC4FIRST trial of asciminib, a newer kinase inhibitor, in newly diagnosed chronic myeloid leukemia, presented on Friday.
As in past years, this news organization will be on hand providing coverage with a dedicated team of reporters, editors, and videographers. Stop by our exhibit hall booth — number 26030 — to learn about the tools we offer to support your practice.
A version of this article appeared on Medscape.com .
From its origins in 1964, ASCO’s annual event has grown to become the world’s largest clinical oncology meeting, drawing attendees from across the globe.
More than 7000 abstracts were submitted for this year’s meeting a new record — and over 5000 were selected for presentation.
This year’s chair of the Annual Meeting Education Committee, Thomas William LeBlanc, MD, told us he has been attending the meeting since his training days more than a decade ago.
The event is “just incredibly empowering and energizing,” Dr. LeBlanc said, with opportunities to catch up with old colleagues and meet new ones, learn how far oncology has come and where it’s headed, and hear clinical pearls to take back the clinic.
This year’s theme, selected by ASCO President Lynn M. Schuchter, MD, is “The Art and Science of Cancer Care: From Comfort to Cure.”
Dr. LeBlanc, a blood cancer specialist at Duke University, Durham, North Carolina, said the theme has been woven throughout the abstract and educational sessions. Most sessions will have at least one presentation related to how we support people — not only “when we cure them but also when we can’t cure them,” he said.
Topics will include patient well-being, comfort measures, and survivorship. And for the first time the plenary session will include a palliative care abstract that addresses whether or not palliative care can be delivered effectively through telemedicine. The session is on Sunday, June 2.
Other potentially practice changing plenary abstracts tackle immunotherapy combinations for resectable melanoma, perioperative chemotherapy vs neoadjuvant chemoradiation for esophageal cancer, and osimertinib after definitive chemoradiotherapy for unresectable non–small cell lung cancer.
ASCO is piloting a slightly different format for research presentations this year. Instead of starting with context and background, speakers have been asked to present study results upfront as well as repeat them at the end of the talk. The reason behind the tweak is that engagement and retention tend to be better when results are presented upfront, instead of just at the end of a talk.
A popular session — ASCO Voices — has also been given a more central position in the conference: Friday, May 31. In this session, speakers will give short presentations about their personal experiences as providers, researchers, or patients.
ASCO Voices is a relatively recent addition to the meeting that has grown and gotten better. The talks are usually “very powerful narratives” that remind clinicians about “the importance of what they’re doing each day,” Dr. LeBlanc said.
Snippets of the talks will be played while people wait for sessions to begin at the meeting, so attendees who miss the Friday talks can still hear them.
In terms of educational sessions, Dr. LeBlanc highlighted two that might be of general interest to practicing oncologists: A joint ASCO/American Association for Cancer Research session entitled “Drugging the ‘Undruggable’ Target: Successes, Challenges, and the Road Ahead,” on Sunday morning and “Common Sense Oncology: Equity, Value, and Outcomes That Matter” on Monday morning.
As a blood cancer specialist, he said he is particularly interested in the topline results from the ASC4FIRST trial of asciminib, a newer kinase inhibitor, in newly diagnosed chronic myeloid leukemia, presented on Friday.
As in past years, this news organization will be on hand providing coverage with a dedicated team of reporters, editors, and videographers. Stop by our exhibit hall booth — number 26030 — to learn about the tools we offer to support your practice.
A version of this article appeared on Medscape.com .
Semaglutide Aids Weight Loss With or Without Bariatric Surgery
, a first-of-its-kind study reveals.
In addition, insurance coverage/expense was the most common issue for people wishing to start the popular medications, known as GLP-1 receptor agonists. Side effects and drug shortages were among the reasons people stopped taking the medication.
Overall, people lost an average of 6% of their total body weight in almost 1 year of taking semaglutide, the class of drugs that includes Wegovy and Ozempic. When researchers compared people who had weight loss surgery with those who had not, total weight loss was almost identical: 5.8% in those who had surgery, vs 6.0% in those who had not.
People in this study lost a lower percentage of their total body weight, compared with people in clinical trials for the drugs, who tended to lose up to 15%, said lead investigator Pourya Medhati, MD, a postdoctoral research fellow at Brigham and Women’s Hospital in Boston.
These results suggest real-world weight loss results may be different than those in carefully controlled research studies. Dr. Medhati presented the findings at Digestive Disease Week® (DDW) 2024 in Washington.
Total weight loss was not significantly different between men and women in the surgery group. But in the nonsurgery group, women lost 6.4%, compared with 4.8% among men, a significant difference.
Dr. Medhati and Ali Tavakkoli, MD, chief of the Division of General and GI Surgery at Brigham and Women’s Hospital, used electronic health records to study 2491 adults prescribed semaglutide between 2018 and 2023 at Brigham and Women’s Hospital. Average age was 51, 74% were White, and 78% were women. A total of 13% had a history of weight loss surgery.
Costs, Side Effects, and Other Concerns
The investigators looked at issues around starting and staying on semaglutide in a subgroup of 500 patients. A total of 75 people never started the drug, for example. The majority, 72%, of this group said it was because of insurance coverage or the cost of the medication. Another 19% did not give a reason, and 9% said it was because of side effects.
People with higher body mass indexes and diabetes were less likely to start taking semaglutide, Dr. Medhati said.
Another 100 of the 500 patients started and then stopped semaglutide. Again, insurance coverage and cost were reasons, this time cited by 13%. About 36% stopped because of side effects; 21% pointed to a shortage of semaglutide; and 30% stopped for an unspecified reason.
“Our study highlights the importance of addressing insurance to ensure broader access,” Dr. Medhati said.
The 325 people who stayed on semaglutide lost an average of 8.5% of their total body weight at 50 weeks.
Access Remains Unequal
“These medications are incredibly powerful to treat obesity and weight-related disease both for people with a history of bariatric surgery and those without,” said session co-moderator Matthew Kroh, MD, vice chair of innovation and technology in the Department of General Surgery at Cleveland Clinic.
More equitable access to semaglutide and other GLP-1s is needed, he said. “Because the cost is so high and they’re not covered by most insurance plans at this point, people with better financial means have access to these medications,” while others may not.
Dr. Kroh said the findings may only apply to the patients, most of whom were female, White, and middle-aged. But he applauded the researchers for doing the study outside of a clinical trial. “Real-world data will help guide these decisions in the future,” he said.
A version of this article appeared on WebMD.com.
, a first-of-its-kind study reveals.
In addition, insurance coverage/expense was the most common issue for people wishing to start the popular medications, known as GLP-1 receptor agonists. Side effects and drug shortages were among the reasons people stopped taking the medication.
Overall, people lost an average of 6% of their total body weight in almost 1 year of taking semaglutide, the class of drugs that includes Wegovy and Ozempic. When researchers compared people who had weight loss surgery with those who had not, total weight loss was almost identical: 5.8% in those who had surgery, vs 6.0% in those who had not.
People in this study lost a lower percentage of their total body weight, compared with people in clinical trials for the drugs, who tended to lose up to 15%, said lead investigator Pourya Medhati, MD, a postdoctoral research fellow at Brigham and Women’s Hospital in Boston.
These results suggest real-world weight loss results may be different than those in carefully controlled research studies. Dr. Medhati presented the findings at Digestive Disease Week® (DDW) 2024 in Washington.
Total weight loss was not significantly different between men and women in the surgery group. But in the nonsurgery group, women lost 6.4%, compared with 4.8% among men, a significant difference.
Dr. Medhati and Ali Tavakkoli, MD, chief of the Division of General and GI Surgery at Brigham and Women’s Hospital, used electronic health records to study 2491 adults prescribed semaglutide between 2018 and 2023 at Brigham and Women’s Hospital. Average age was 51, 74% were White, and 78% were women. A total of 13% had a history of weight loss surgery.
Costs, Side Effects, and Other Concerns
The investigators looked at issues around starting and staying on semaglutide in a subgroup of 500 patients. A total of 75 people never started the drug, for example. The majority, 72%, of this group said it was because of insurance coverage or the cost of the medication. Another 19% did not give a reason, and 9% said it was because of side effects.
People with higher body mass indexes and diabetes were less likely to start taking semaglutide, Dr. Medhati said.
Another 100 of the 500 patients started and then stopped semaglutide. Again, insurance coverage and cost were reasons, this time cited by 13%. About 36% stopped because of side effects; 21% pointed to a shortage of semaglutide; and 30% stopped for an unspecified reason.
“Our study highlights the importance of addressing insurance to ensure broader access,” Dr. Medhati said.
The 325 people who stayed on semaglutide lost an average of 8.5% of their total body weight at 50 weeks.
Access Remains Unequal
“These medications are incredibly powerful to treat obesity and weight-related disease both for people with a history of bariatric surgery and those without,” said session co-moderator Matthew Kroh, MD, vice chair of innovation and technology in the Department of General Surgery at Cleveland Clinic.
More equitable access to semaglutide and other GLP-1s is needed, he said. “Because the cost is so high and they’re not covered by most insurance plans at this point, people with better financial means have access to these medications,” while others may not.
Dr. Kroh said the findings may only apply to the patients, most of whom were female, White, and middle-aged. But he applauded the researchers for doing the study outside of a clinical trial. “Real-world data will help guide these decisions in the future,” he said.
A version of this article appeared on WebMD.com.
, a first-of-its-kind study reveals.
In addition, insurance coverage/expense was the most common issue for people wishing to start the popular medications, known as GLP-1 receptor agonists. Side effects and drug shortages were among the reasons people stopped taking the medication.
Overall, people lost an average of 6% of their total body weight in almost 1 year of taking semaglutide, the class of drugs that includes Wegovy and Ozempic. When researchers compared people who had weight loss surgery with those who had not, total weight loss was almost identical: 5.8% in those who had surgery, vs 6.0% in those who had not.
People in this study lost a lower percentage of their total body weight, compared with people in clinical trials for the drugs, who tended to lose up to 15%, said lead investigator Pourya Medhati, MD, a postdoctoral research fellow at Brigham and Women’s Hospital in Boston.
These results suggest real-world weight loss results may be different than those in carefully controlled research studies. Dr. Medhati presented the findings at Digestive Disease Week® (DDW) 2024 in Washington.
Total weight loss was not significantly different between men and women in the surgery group. But in the nonsurgery group, women lost 6.4%, compared with 4.8% among men, a significant difference.
Dr. Medhati and Ali Tavakkoli, MD, chief of the Division of General and GI Surgery at Brigham and Women’s Hospital, used electronic health records to study 2491 adults prescribed semaglutide between 2018 and 2023 at Brigham and Women’s Hospital. Average age was 51, 74% were White, and 78% were women. A total of 13% had a history of weight loss surgery.
Costs, Side Effects, and Other Concerns
The investigators looked at issues around starting and staying on semaglutide in a subgroup of 500 patients. A total of 75 people never started the drug, for example. The majority, 72%, of this group said it was because of insurance coverage or the cost of the medication. Another 19% did not give a reason, and 9% said it was because of side effects.
People with higher body mass indexes and diabetes were less likely to start taking semaglutide, Dr. Medhati said.
Another 100 of the 500 patients started and then stopped semaglutide. Again, insurance coverage and cost were reasons, this time cited by 13%. About 36% stopped because of side effects; 21% pointed to a shortage of semaglutide; and 30% stopped for an unspecified reason.
“Our study highlights the importance of addressing insurance to ensure broader access,” Dr. Medhati said.
The 325 people who stayed on semaglutide lost an average of 8.5% of their total body weight at 50 weeks.
Access Remains Unequal
“These medications are incredibly powerful to treat obesity and weight-related disease both for people with a history of bariatric surgery and those without,” said session co-moderator Matthew Kroh, MD, vice chair of innovation and technology in the Department of General Surgery at Cleveland Clinic.
More equitable access to semaglutide and other GLP-1s is needed, he said. “Because the cost is so high and they’re not covered by most insurance plans at this point, people with better financial means have access to these medications,” while others may not.
Dr. Kroh said the findings may only apply to the patients, most of whom were female, White, and middle-aged. But he applauded the researchers for doing the study outside of a clinical trial. “Real-world data will help guide these decisions in the future,” he said.
A version of this article appeared on WebMD.com.
Could a Fungal Infection Cause a Future Pandemic?
The principle of resilience and survival is crucial for medically significant fungi. These microorganisms are far from creating the postapocalyptic scenario depicted in TV series like The Last of Us, and much work is necessary to learn more about them. Accurate statistics on fungal infections, accompanied by clinical histories, simple laboratory tests, new antifungals, and a necessary One Health approach are lacking.
The entomopathogenic fungus Ophiocordyceps unilateralis was made notorious by the TV series, but for now, it only manages to control the brains of some ants at will. Luckily, there are no signs that fungi affecting humans are inclined to create zombies.
What is clear is that the world belongs to the kingdom of fungi and that fungi are everywhere. There are already close to 150,000 described species, but millions remain to be discovered. They abound in decomposing organic matter, soil, or animal excrement, including that of bats and pigeons. Some fungi have even managed to find a home in hospitals. Lastly, we must not forget those that establish themselves in the human microbiome.
Given such diversity, it is legitimate to ask whether any of them could be capable of generating new pandemics. Could the forgotten Cryptococcus neoformans, Aspergillus fumigatus, or Histoplasma species, among others, trigger new health emergencies on the scale of the one generated by SARS-CoV-2?
We cannot forget that a coronavirus has already confirmed that reality can surpass fiction. However, Edith Sánchez Paredes, a biologist, doctor in biomedical sciences, and specialist in medical mycology, provided a reassuring response to Medscape Spanish Edition on this point.
“That would be very difficult to see because the way fungal infections are acquired is not from person to person, in most cases,” said Dr. Sánchez Paredes, from the Mycology Unit of the Faculty of Medicine at the National Autonomous University of Mexico.
Close to 300 species have already been classified as pathogenic in humans. Although the numbers are not precise and are increasing, it is estimated that around 1,500,000 people worldwide die each year of systemic fungal infections.
“However, it is important to emphasize that establishment of an infection depends not only on the causal agent. A crucial factor is the host, in this case, the human. Generally, these types of infections will develop in individuals with some deficiency in their immune system. The more deficient the immune response, the more likely a fungal infection may occur,” stated Dr. Sánchez Paredes.
The possibility of a pandemic like the one experienced with SARS-CoV-2 in the short term is remote, but the threat posed by fungal infections persists.
In 2022, the World Health Organization (WHO) defined a priority list of pathogenic fungi, with the aim of guiding actions to control them. It is mentioned there that invasive fungal diseases are on the rise worldwide, particularly in immunocompromised populations.
“Despite the growing concern, fungal infections receive very little attention and resources, leading to a paucity of quality data on fungal disease distribution and antifungal resistance patterns. Consequently, it is impossible to estimate their exact burden,” as stated in the document.
In line with this, an article published in Mycoses in 2022 concluded that fungal infections are neglected diseases in Latin America. Among other difficulties, deficiencies in access to tests such as polymerase chain reaction or serum detection of beta-1,3-D-glucan have been reported there.
In terms of treatments, most countries encounter problems with access to liposomal amphotericin B and new azoles, such as posaconazole and isavuconazole.
“Unfortunately, in Latin America, we suffer from a poor infrastructure for diagnosing fungal infections; likewise, we have limited access to antifungals available in the global market. What’s more, we lack reliable data on the epidemiology of fungal infections in the region, so many times governments are unaware of the true extent of the problem,” said Rogelio de Jesús Treviño Rangel, PhD, a medical microbiologist and expert in clinical mycology, professor, and researcher at the Faculty of Medicine of the Autonomous University of Nuevo León in Mexico.
Need for More Medical Mycology Training
Dr. Fernando Messina is a medical mycologist with the Mycology Unit of the Francisco Javier Muñiz Infectious Diseases Hospital in Buenos Aires, Argentina. He has noted an increase in the number of cases of cryptococcosis, histoplasmosis, and aspergillosis in his daily practice.
“Particularly, pulmonary aspergillosis is steadily increasing. This is because many patients have structural lung alterations that favor the appearance of this mycosis. This is related to the increase in cases of tuberculosis and the rise in life expectancy of patients with chronic obstructive pulmonary disease or other pulmonary or systemic diseases,” Dr. Messina stated.
For Dr. Messina, the main obstacle in current clinical practice is the low level of awareness among nonspecialist physicians regarding the presence of systemic fungal infections, and because these infections are more common than realized, it is vital to consider fungal etiology before starting empirical antibiotic therapy.
“Health professionals usually do not think about mycoses because mycology occupies a very small space in medical education at universities. As the Venezuelan mycologist Gioconda Cunto de San Blas once said, ‘Mycology is the Cinderella of microbiology.’ To change this, we need to give more space to mycoses in undergraduate and postgraduate studies,” Dr. Messina asserted.
He added, “The main challenge is to train professionals with an emphasis on the clinical interpretation of cases. Current medicine has a strong trend toward molecular biology and the use of rapid diagnostic methods, without considering the clinical symptoms or the patient’s history. Determinations are very useful, but it is necessary to interpret the results.”
Dr. Messina sees it as unlikely in the short term for a pandemic to be caused by fungi, but if it were to occur, he believes it would happen in healthcare systems in regions that are not prepared in terms of infrastructure. However, as seen in the health emergency resulting from SARS-CoV-2, he thinks the impact would be mitigated by the performance of healthcare professionals.
“In general, we have the ability to adapt to any adverse situation or change — although it is clear that we need more doctors, biochemists, and microbiologists trained in mycology,” emphasized Dr. Messina.
More than 40 interns pass through Muñiz Hospital each year. They are doctors and biochemists from Argentina, other countries in the region, or even Europe, seeking to enhance their training in mycology. Regarding fungal infection laboratory work, the interest lies in learning to use traditional techniques and innovative molecular methods.
“Rapid diagnostic methods, especially the detection of circulating antigens, have marked a change in the prognosis of deep mycosis in immunocompromised hosts. The possibility of screening and monitoring in this group of patients is very important and has a great benefit,” said Gabriela Santiso, PhD, a biochemist and head of the Mycology Unit of the Francisco Javier Muñiz Infectious Diseases Hospital.
According to Dr. Santiso, the current landscape includes the ability to identify genus and species, which can help in understanding resistance to antifungals. Furthermore, conducting sensitivity tests to these drugs, using standardized commercial methods, also provides timely information for treatment.
But Dr. Santiso warns that Latin America is a vast region with great disparity in human and technological resources. Although most countries in the region have networks facilitating access to timely diagnosis, resources are generally more available in major urban centers.
This often clashes with the epidemiology of most fungal infections. “Let’s not forget that many fungal pathologies affect low-income people who have difficulties accessing health centers, which sometimes turns them into chronic diseases that are hard to treat,” Dr. Santiso pointed out.
In mycology laboratories, the biggest cost is incurred by new diagnostic tests, such as those allowing molecular identification. Conventional methods are not usually expensive, but they require time and effort to train human resources to handle them.
Because new methodologies are not always available or easily accessible throughout the region, Dr. Santiso recommended not neglecting traditional mycological techniques. “Molecular methods, rapid diagnostic methods, and conventional mycology techniques are complementary and not mutually exclusive tests. Continuous training and updating are needed in this area,” she emphasized.
Why Are Resistant Fungal Infections Becoming Increasingly Common?
The first barrier for fungi to cause infection in humans is body temperature; most of them cannot withstand 37 °C. However, they also struggle to evade the immune response that is activated when they try to enter the body.
“We are normally exposed to many of these fungi, almost all the time, but if our immune system is adequate, it may not go beyond a mild infection, in most cases subclinical, which will resolve quickly,” Dr. Sánchez Paredes stated.
However, according to Dr. Sánchez Paredes, if the immune response is weak, “the fungus will have no trouble establishing itself in our organs. Some are even part of our microbiota, such as Candida albicans, which in the face of an imbalance or immunocompromise, can lead to serious infections.”
It is clear that the population at risk for immunosuppression has increased. According to the WHO, this is due to the high prevalence of such diseases as tuberculosis, cancer, and HIV infection, among others.
But the WHO also believes that the increase in fungal infections is related to greater population access to critical care units, invasive procedures, chemotherapy, or immunotherapy treatments.
Furthermore, factors related to the fungus itself and the environment play a role. “These organisms have enzymes, proteins, and other molecules that allow them to survive in the environment in which they normally inhabit. When they face a new and stressful one, they must express other molecules that will allow them to survive. All of this helps them evade elements of the immune system, antifungals, and, of course, body temperature,” according to Dr. Sánchez Paredes.
It is possible that climate change is also behind the noticeable increase in fungal infections and that this crisis may have an even greater impact in the future. The temperature of the environment has increased, and fungi will have to adapt to the planet’s temperature, to the point where body temperature may no longer be a significant barrier for them.
Environmental changes would also be responsible for modifications in the distribution of endemic mycoses, and it is believed that fungi will more frequently find new ecological niches, be able to survive in other environments, and alter distribution zones.
This is what is happening between Mexico and the United States with coccidioidomycosis, or valley fever. “We will begin to see cases of some mycoses where they were not normally seen, so we will have to conduct more studies to confirm that the fungus is inhabiting these new areas or is simply appearing in new sites owing to migration and the great mobility of populations,” Dr. Sánchez Paredes said.
Finally, exposure to environmental factors would partly be responsible for the increasing resistance to first-line antifungals observed in these microorganisms. This seems to be the case with A. fumigatus when exposed to azoles used as fungicides in agriculture.
One Health in Fungal Infections
The increasing resistance to antifungals is a clear testament that human, animal, and environmental health are interconnected. This is why a multidisciplinary approach that adopts the perspective of One Health is necessary for its management.
“The use of fungicides in agriculture, structurally similar to the azoles used in clinics, generates resistance in Aspergillus fumigatus found in the environment. These fungi in humans can be associated with infections that do not respond to first-line treatment,” explained Carlos Arturo Álvarez, an infectious diseases physician and professor at the Faculty of Medicine at the National University of Colombia.
According to Dr. Álvarez, the approach to control them should not only focus on the search for diagnostic methods that allow early detection of antifungal resistance or research on new antifungal treatments. He believes that progress must also be made with strategies that allow for the proper use of antifungals in agriculture.
“Unfortunately, the One Health approach is not yet well implemented in the region, and in my view, there is a lack of articulation in the different sectors. That is, there is a need for true coordination between government offices of agriculture, animal and human health, academia, and international organizations. This is not happening yet, and I believe we are in the initial stage of visibility,” Dr. Álvarez opined.
Veterinary public health is another pillar of the aforementioned approach. For various reasons, animals experience a higher frequency of fungal infections. A few carry and transmit true zoonoses that affect human health, but most often, animals act only as sentinels indicating a potential source of transmission.
Carolina Segundo Zaragoza, PhD, has worked in veterinary mycology for 30 years. She currently heads the veterinary mycology laboratory at the Animal Production Teaching, Research, and Extension Center in Altiplano, under the Faculty of Veterinary Medicine and Animal Husbandry at the National Autonomous University of Mexico. Because she has frequent contact with specialists in human mycology, during her professional career she has received several patient consultations, most of which were for cutaneous mycoses.
“They detect some dermatomycosis and realize that the common factor is owning a companion animal or a production animal with which the patient has contact. Both animals and humans present the same type of lesions, and then comes the question: Who infected whom? I remind them that the main source of infection is the soil and that animals should not be blamed in the first instance,” Dr. Segundo Zaragoza clarified.
She is currently collaborating on a research project analyzing the presence of Coccidioides immitis in the soil. This pathogen is responsible for coccidioidomycosis in dogs and humans, and she sees with satisfaction how these types of initiatives, which include some components of the One Health vision, are becoming more common in Mexico.
“Fortunately, human mycologists are increasingly providing more space for the dissemination of veterinary mycology. So I have had the opportunity to be invited to different forums on medical mycology to present the clinical cases we can have in animals and talk about the research projects we carry out. I have more and more opportunities to conduct joint research with human mycologists and veterinary doctors,” she said.
Dr. Segundo Zaragoza believes that to better implement the One Health vision, standardizing the criteria for detecting, diagnosing, and treating mycoses is necessary. She considers that teamwork will be key to achieving the common goal of safeguarding the well-being and health of humans and animals.
Alarms Sound for Candida auris
The WHO included the yeast Candida auris in its group of pathogens with critical priority, and since 2009, it has raised alarm owing to the ease with which it grows in hospitals. In that setting, C auris is known for its high transmissibility, its ability to cause outbreaks, and the high mortality rate from disseminated infections.
“It has been a concern for the mycological community because it shows resistance to most antifungals used clinically, mainly azoles, but also for causing epidemic outbreaks,” emphasized Dr. Sánchez Paredes.
Its mode of transmission is not very clear, but it has been documented to be present on the skin and persist in hospital materials and furniture. It causes nosocomial infections in critically ill patients, such as those in intensive care, and those with cancer or who have received a transplant.
Risk factors for its development include renal insufficiency, hospital stays of more than 15 days, mechanical ventilation, central lines, use of parenteral nutrition, and presence of sepsis.
As for other mycoses, there are no precise studies reporting global incidence rates, but the trend indicates an increase in the detection of outbreaks in various countries lately — something that began to be visible during the COVID-19 pandemic.
In Mexico, Dr. Treviño Rangel and colleagues from Nuevo León reported the first case of candidemia caused by this agent. It occurred in May 2020 and involved a 58-year-old woman with a history of severe endometriosis and multiple complications in the gastrointestinal tract. The patient’s condition improved favorably thanks to antifungal therapy with caspofungin and liposomal amphotericin B.
However, 3 months after that episode, the group reported an outbreak of C. auris at the same hospital in 12 critically ill patients co-infected with SARS-CoV-2. All were on mechanical ventilation, had peripherally inserted central catheters and urinary catheters, and had a prolonged hospital stay (20-70 days). The mortality in patients with candidemia in this cohort was 83.3%.
Open Ending
As seen in some science fiction series, fungal infections in the region still have an open ending, and Global Action For Fungal Infections (GAFFI) has estimated that with better diagnostics and treatments, deaths caused by fungi could decrease to less than 750,000 per year worldwide.
But if everything continues as is, some aspects of what is to come may resemble the dystopia depicted in The Last of Us. No zombies, but emerging and reemerging fungi in a chaotic distribution, and resistant to all established treatments.
“The risk factors of patients and their immune status, combined with the behavior of mycoses, bring a complicated scenario. But therapeutic failure resulting from multidrug resistance to antifungals could make it catastrophic,” Dr. Sánchez Paredes summarized.
At the moment, there are only four families of drugs capable of counteracting fungal infections — and as mentioned, some are already scarce in Latin America’s hospital pharmacies.
“Historically, fungal infections have been given less importance than those caused by viruses or bacteria. Even in some developed countries, the true extent of morbidity and mortality they present is unknown. This results in less investment in the development of new antifungal molecules because knowledge is lacking about the incidence and prevalence of these diseases,” Dr. Treviño Rangel pointed out.
He added that the main limitation for the development of new drugs is economic. “Unfortunately, not many pharmaceutical companies are willing to invest in the development of new antifungals, and there are no government programs specifically promoting and supporting research into new therapeutic options against these neglected diseases,” he asserted.
Development of vaccines to prevent fungal infections faces the same barriers. Although, according to Dr. Treviño Rangel, the difficulties are compounded by the great similarity between fungal cells and human cells. This makes it possible for harmful cross-reactivity to occur. In addition, because most severe fungal infections occur in individuals with immunosuppression, a vaccine would need to trigger an adequate immune response despite this issue.
Meanwhile, fungi quietly continue to do what they do best: resist and survive. For millions of years, they have mutated and adapted to new environments. Some theories even blame them for the extinction of dinosaurs and the subsequent rise of mammals. They exist on the edge of life and death, decomposing and creating. There is consensus that at the moment, it does not seem feasible for them to generate a pandemic like the one due to SARS-CoV-2, given their transmission mechanism. But who is willing to rule out that this may not happen in the long or medium term?
Dr. Sánchez Paredes, Dr. Treviño Rangel, Dr. Messina, Dr. Santiso, Dr. Álvarez, and Dr. Segundo Zaragoza have declared no relevant financial conflicts of interest.
This story was translated from Medscape Spanish Edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The principle of resilience and survival is crucial for medically significant fungi. These microorganisms are far from creating the postapocalyptic scenario depicted in TV series like The Last of Us, and much work is necessary to learn more about them. Accurate statistics on fungal infections, accompanied by clinical histories, simple laboratory tests, new antifungals, and a necessary One Health approach are lacking.
The entomopathogenic fungus Ophiocordyceps unilateralis was made notorious by the TV series, but for now, it only manages to control the brains of some ants at will. Luckily, there are no signs that fungi affecting humans are inclined to create zombies.
What is clear is that the world belongs to the kingdom of fungi and that fungi are everywhere. There are already close to 150,000 described species, but millions remain to be discovered. They abound in decomposing organic matter, soil, or animal excrement, including that of bats and pigeons. Some fungi have even managed to find a home in hospitals. Lastly, we must not forget those that establish themselves in the human microbiome.
Given such diversity, it is legitimate to ask whether any of them could be capable of generating new pandemics. Could the forgotten Cryptococcus neoformans, Aspergillus fumigatus, or Histoplasma species, among others, trigger new health emergencies on the scale of the one generated by SARS-CoV-2?
We cannot forget that a coronavirus has already confirmed that reality can surpass fiction. However, Edith Sánchez Paredes, a biologist, doctor in biomedical sciences, and specialist in medical mycology, provided a reassuring response to Medscape Spanish Edition on this point.
“That would be very difficult to see because the way fungal infections are acquired is not from person to person, in most cases,” said Dr. Sánchez Paredes, from the Mycology Unit of the Faculty of Medicine at the National Autonomous University of Mexico.
Close to 300 species have already been classified as pathogenic in humans. Although the numbers are not precise and are increasing, it is estimated that around 1,500,000 people worldwide die each year of systemic fungal infections.
“However, it is important to emphasize that establishment of an infection depends not only on the causal agent. A crucial factor is the host, in this case, the human. Generally, these types of infections will develop in individuals with some deficiency in their immune system. The more deficient the immune response, the more likely a fungal infection may occur,” stated Dr. Sánchez Paredes.
The possibility of a pandemic like the one experienced with SARS-CoV-2 in the short term is remote, but the threat posed by fungal infections persists.
In 2022, the World Health Organization (WHO) defined a priority list of pathogenic fungi, with the aim of guiding actions to control them. It is mentioned there that invasive fungal diseases are on the rise worldwide, particularly in immunocompromised populations.
“Despite the growing concern, fungal infections receive very little attention and resources, leading to a paucity of quality data on fungal disease distribution and antifungal resistance patterns. Consequently, it is impossible to estimate their exact burden,” as stated in the document.
In line with this, an article published in Mycoses in 2022 concluded that fungal infections are neglected diseases in Latin America. Among other difficulties, deficiencies in access to tests such as polymerase chain reaction or serum detection of beta-1,3-D-glucan have been reported there.
In terms of treatments, most countries encounter problems with access to liposomal amphotericin B and new azoles, such as posaconazole and isavuconazole.
“Unfortunately, in Latin America, we suffer from a poor infrastructure for diagnosing fungal infections; likewise, we have limited access to antifungals available in the global market. What’s more, we lack reliable data on the epidemiology of fungal infections in the region, so many times governments are unaware of the true extent of the problem,” said Rogelio de Jesús Treviño Rangel, PhD, a medical microbiologist and expert in clinical mycology, professor, and researcher at the Faculty of Medicine of the Autonomous University of Nuevo León in Mexico.
Need for More Medical Mycology Training
Dr. Fernando Messina is a medical mycologist with the Mycology Unit of the Francisco Javier Muñiz Infectious Diseases Hospital in Buenos Aires, Argentina. He has noted an increase in the number of cases of cryptococcosis, histoplasmosis, and aspergillosis in his daily practice.
“Particularly, pulmonary aspergillosis is steadily increasing. This is because many patients have structural lung alterations that favor the appearance of this mycosis. This is related to the increase in cases of tuberculosis and the rise in life expectancy of patients with chronic obstructive pulmonary disease or other pulmonary or systemic diseases,” Dr. Messina stated.
For Dr. Messina, the main obstacle in current clinical practice is the low level of awareness among nonspecialist physicians regarding the presence of systemic fungal infections, and because these infections are more common than realized, it is vital to consider fungal etiology before starting empirical antibiotic therapy.
“Health professionals usually do not think about mycoses because mycology occupies a very small space in medical education at universities. As the Venezuelan mycologist Gioconda Cunto de San Blas once said, ‘Mycology is the Cinderella of microbiology.’ To change this, we need to give more space to mycoses in undergraduate and postgraduate studies,” Dr. Messina asserted.
He added, “The main challenge is to train professionals with an emphasis on the clinical interpretation of cases. Current medicine has a strong trend toward molecular biology and the use of rapid diagnostic methods, without considering the clinical symptoms or the patient’s history. Determinations are very useful, but it is necessary to interpret the results.”
Dr. Messina sees it as unlikely in the short term for a pandemic to be caused by fungi, but if it were to occur, he believes it would happen in healthcare systems in regions that are not prepared in terms of infrastructure. However, as seen in the health emergency resulting from SARS-CoV-2, he thinks the impact would be mitigated by the performance of healthcare professionals.
“In general, we have the ability to adapt to any adverse situation or change — although it is clear that we need more doctors, biochemists, and microbiologists trained in mycology,” emphasized Dr. Messina.
More than 40 interns pass through Muñiz Hospital each year. They are doctors and biochemists from Argentina, other countries in the region, or even Europe, seeking to enhance their training in mycology. Regarding fungal infection laboratory work, the interest lies in learning to use traditional techniques and innovative molecular methods.
“Rapid diagnostic methods, especially the detection of circulating antigens, have marked a change in the prognosis of deep mycosis in immunocompromised hosts. The possibility of screening and monitoring in this group of patients is very important and has a great benefit,” said Gabriela Santiso, PhD, a biochemist and head of the Mycology Unit of the Francisco Javier Muñiz Infectious Diseases Hospital.
According to Dr. Santiso, the current landscape includes the ability to identify genus and species, which can help in understanding resistance to antifungals. Furthermore, conducting sensitivity tests to these drugs, using standardized commercial methods, also provides timely information for treatment.
But Dr. Santiso warns that Latin America is a vast region with great disparity in human and technological resources. Although most countries in the region have networks facilitating access to timely diagnosis, resources are generally more available in major urban centers.
This often clashes with the epidemiology of most fungal infections. “Let’s not forget that many fungal pathologies affect low-income people who have difficulties accessing health centers, which sometimes turns them into chronic diseases that are hard to treat,” Dr. Santiso pointed out.
In mycology laboratories, the biggest cost is incurred by new diagnostic tests, such as those allowing molecular identification. Conventional methods are not usually expensive, but they require time and effort to train human resources to handle them.
Because new methodologies are not always available or easily accessible throughout the region, Dr. Santiso recommended not neglecting traditional mycological techniques. “Molecular methods, rapid diagnostic methods, and conventional mycology techniques are complementary and not mutually exclusive tests. Continuous training and updating are needed in this area,” she emphasized.
Why Are Resistant Fungal Infections Becoming Increasingly Common?
The first barrier for fungi to cause infection in humans is body temperature; most of them cannot withstand 37 °C. However, they also struggle to evade the immune response that is activated when they try to enter the body.
“We are normally exposed to many of these fungi, almost all the time, but if our immune system is adequate, it may not go beyond a mild infection, in most cases subclinical, which will resolve quickly,” Dr. Sánchez Paredes stated.
However, according to Dr. Sánchez Paredes, if the immune response is weak, “the fungus will have no trouble establishing itself in our organs. Some are even part of our microbiota, such as Candida albicans, which in the face of an imbalance or immunocompromise, can lead to serious infections.”
It is clear that the population at risk for immunosuppression has increased. According to the WHO, this is due to the high prevalence of such diseases as tuberculosis, cancer, and HIV infection, among others.
But the WHO also believes that the increase in fungal infections is related to greater population access to critical care units, invasive procedures, chemotherapy, or immunotherapy treatments.
Furthermore, factors related to the fungus itself and the environment play a role. “These organisms have enzymes, proteins, and other molecules that allow them to survive in the environment in which they normally inhabit. When they face a new and stressful one, they must express other molecules that will allow them to survive. All of this helps them evade elements of the immune system, antifungals, and, of course, body temperature,” according to Dr. Sánchez Paredes.
It is possible that climate change is also behind the noticeable increase in fungal infections and that this crisis may have an even greater impact in the future. The temperature of the environment has increased, and fungi will have to adapt to the planet’s temperature, to the point where body temperature may no longer be a significant barrier for them.
Environmental changes would also be responsible for modifications in the distribution of endemic mycoses, and it is believed that fungi will more frequently find new ecological niches, be able to survive in other environments, and alter distribution zones.
This is what is happening between Mexico and the United States with coccidioidomycosis, or valley fever. “We will begin to see cases of some mycoses where they were not normally seen, so we will have to conduct more studies to confirm that the fungus is inhabiting these new areas or is simply appearing in new sites owing to migration and the great mobility of populations,” Dr. Sánchez Paredes said.
Finally, exposure to environmental factors would partly be responsible for the increasing resistance to first-line antifungals observed in these microorganisms. This seems to be the case with A. fumigatus when exposed to azoles used as fungicides in agriculture.
One Health in Fungal Infections
The increasing resistance to antifungals is a clear testament that human, animal, and environmental health are interconnected. This is why a multidisciplinary approach that adopts the perspective of One Health is necessary for its management.
“The use of fungicides in agriculture, structurally similar to the azoles used in clinics, generates resistance in Aspergillus fumigatus found in the environment. These fungi in humans can be associated with infections that do not respond to first-line treatment,” explained Carlos Arturo Álvarez, an infectious diseases physician and professor at the Faculty of Medicine at the National University of Colombia.
According to Dr. Álvarez, the approach to control them should not only focus on the search for diagnostic methods that allow early detection of antifungal resistance or research on new antifungal treatments. He believes that progress must also be made with strategies that allow for the proper use of antifungals in agriculture.
“Unfortunately, the One Health approach is not yet well implemented in the region, and in my view, there is a lack of articulation in the different sectors. That is, there is a need for true coordination between government offices of agriculture, animal and human health, academia, and international organizations. This is not happening yet, and I believe we are in the initial stage of visibility,” Dr. Álvarez opined.
Veterinary public health is another pillar of the aforementioned approach. For various reasons, animals experience a higher frequency of fungal infections. A few carry and transmit true zoonoses that affect human health, but most often, animals act only as sentinels indicating a potential source of transmission.
Carolina Segundo Zaragoza, PhD, has worked in veterinary mycology for 30 years. She currently heads the veterinary mycology laboratory at the Animal Production Teaching, Research, and Extension Center in Altiplano, under the Faculty of Veterinary Medicine and Animal Husbandry at the National Autonomous University of Mexico. Because she has frequent contact with specialists in human mycology, during her professional career she has received several patient consultations, most of which were for cutaneous mycoses.
“They detect some dermatomycosis and realize that the common factor is owning a companion animal or a production animal with which the patient has contact. Both animals and humans present the same type of lesions, and then comes the question: Who infected whom? I remind them that the main source of infection is the soil and that animals should not be blamed in the first instance,” Dr. Segundo Zaragoza clarified.
She is currently collaborating on a research project analyzing the presence of Coccidioides immitis in the soil. This pathogen is responsible for coccidioidomycosis in dogs and humans, and she sees with satisfaction how these types of initiatives, which include some components of the One Health vision, are becoming more common in Mexico.
“Fortunately, human mycologists are increasingly providing more space for the dissemination of veterinary mycology. So I have had the opportunity to be invited to different forums on medical mycology to present the clinical cases we can have in animals and talk about the research projects we carry out. I have more and more opportunities to conduct joint research with human mycologists and veterinary doctors,” she said.
Dr. Segundo Zaragoza believes that to better implement the One Health vision, standardizing the criteria for detecting, diagnosing, and treating mycoses is necessary. She considers that teamwork will be key to achieving the common goal of safeguarding the well-being and health of humans and animals.
Alarms Sound for Candida auris
The WHO included the yeast Candida auris in its group of pathogens with critical priority, and since 2009, it has raised alarm owing to the ease with which it grows in hospitals. In that setting, C auris is known for its high transmissibility, its ability to cause outbreaks, and the high mortality rate from disseminated infections.
“It has been a concern for the mycological community because it shows resistance to most antifungals used clinically, mainly azoles, but also for causing epidemic outbreaks,” emphasized Dr. Sánchez Paredes.
Its mode of transmission is not very clear, but it has been documented to be present on the skin and persist in hospital materials and furniture. It causes nosocomial infections in critically ill patients, such as those in intensive care, and those with cancer or who have received a transplant.
Risk factors for its development include renal insufficiency, hospital stays of more than 15 days, mechanical ventilation, central lines, use of parenteral nutrition, and presence of sepsis.
As for other mycoses, there are no precise studies reporting global incidence rates, but the trend indicates an increase in the detection of outbreaks in various countries lately — something that began to be visible during the COVID-19 pandemic.
In Mexico, Dr. Treviño Rangel and colleagues from Nuevo León reported the first case of candidemia caused by this agent. It occurred in May 2020 and involved a 58-year-old woman with a history of severe endometriosis and multiple complications in the gastrointestinal tract. The patient’s condition improved favorably thanks to antifungal therapy with caspofungin and liposomal amphotericin B.
However, 3 months after that episode, the group reported an outbreak of C. auris at the same hospital in 12 critically ill patients co-infected with SARS-CoV-2. All were on mechanical ventilation, had peripherally inserted central catheters and urinary catheters, and had a prolonged hospital stay (20-70 days). The mortality in patients with candidemia in this cohort was 83.3%.
Open Ending
As seen in some science fiction series, fungal infections in the region still have an open ending, and Global Action For Fungal Infections (GAFFI) has estimated that with better diagnostics and treatments, deaths caused by fungi could decrease to less than 750,000 per year worldwide.
But if everything continues as is, some aspects of what is to come may resemble the dystopia depicted in The Last of Us. No zombies, but emerging and reemerging fungi in a chaotic distribution, and resistant to all established treatments.
“The risk factors of patients and their immune status, combined with the behavior of mycoses, bring a complicated scenario. But therapeutic failure resulting from multidrug resistance to antifungals could make it catastrophic,” Dr. Sánchez Paredes summarized.
At the moment, there are only four families of drugs capable of counteracting fungal infections — and as mentioned, some are already scarce in Latin America’s hospital pharmacies.
“Historically, fungal infections have been given less importance than those caused by viruses or bacteria. Even in some developed countries, the true extent of morbidity and mortality they present is unknown. This results in less investment in the development of new antifungal molecules because knowledge is lacking about the incidence and prevalence of these diseases,” Dr. Treviño Rangel pointed out.
He added that the main limitation for the development of new drugs is economic. “Unfortunately, not many pharmaceutical companies are willing to invest in the development of new antifungals, and there are no government programs specifically promoting and supporting research into new therapeutic options against these neglected diseases,” he asserted.
Development of vaccines to prevent fungal infections faces the same barriers. Although, according to Dr. Treviño Rangel, the difficulties are compounded by the great similarity between fungal cells and human cells. This makes it possible for harmful cross-reactivity to occur. In addition, because most severe fungal infections occur in individuals with immunosuppression, a vaccine would need to trigger an adequate immune response despite this issue.
Meanwhile, fungi quietly continue to do what they do best: resist and survive. For millions of years, they have mutated and adapted to new environments. Some theories even blame them for the extinction of dinosaurs and the subsequent rise of mammals. They exist on the edge of life and death, decomposing and creating. There is consensus that at the moment, it does not seem feasible for them to generate a pandemic like the one due to SARS-CoV-2, given their transmission mechanism. But who is willing to rule out that this may not happen in the long or medium term?
Dr. Sánchez Paredes, Dr. Treviño Rangel, Dr. Messina, Dr. Santiso, Dr. Álvarez, and Dr. Segundo Zaragoza have declared no relevant financial conflicts of interest.
This story was translated from Medscape Spanish Edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The principle of resilience and survival is crucial for medically significant fungi. These microorganisms are far from creating the postapocalyptic scenario depicted in TV series like The Last of Us, and much work is necessary to learn more about them. Accurate statistics on fungal infections, accompanied by clinical histories, simple laboratory tests, new antifungals, and a necessary One Health approach are lacking.
The entomopathogenic fungus Ophiocordyceps unilateralis was made notorious by the TV series, but for now, it only manages to control the brains of some ants at will. Luckily, there are no signs that fungi affecting humans are inclined to create zombies.
What is clear is that the world belongs to the kingdom of fungi and that fungi are everywhere. There are already close to 150,000 described species, but millions remain to be discovered. They abound in decomposing organic matter, soil, or animal excrement, including that of bats and pigeons. Some fungi have even managed to find a home in hospitals. Lastly, we must not forget those that establish themselves in the human microbiome.
Given such diversity, it is legitimate to ask whether any of them could be capable of generating new pandemics. Could the forgotten Cryptococcus neoformans, Aspergillus fumigatus, or Histoplasma species, among others, trigger new health emergencies on the scale of the one generated by SARS-CoV-2?
We cannot forget that a coronavirus has already confirmed that reality can surpass fiction. However, Edith Sánchez Paredes, a biologist, doctor in biomedical sciences, and specialist in medical mycology, provided a reassuring response to Medscape Spanish Edition on this point.
“That would be very difficult to see because the way fungal infections are acquired is not from person to person, in most cases,” said Dr. Sánchez Paredes, from the Mycology Unit of the Faculty of Medicine at the National Autonomous University of Mexico.
Close to 300 species have already been classified as pathogenic in humans. Although the numbers are not precise and are increasing, it is estimated that around 1,500,000 people worldwide die each year of systemic fungal infections.
“However, it is important to emphasize that establishment of an infection depends not only on the causal agent. A crucial factor is the host, in this case, the human. Generally, these types of infections will develop in individuals with some deficiency in their immune system. The more deficient the immune response, the more likely a fungal infection may occur,” stated Dr. Sánchez Paredes.
The possibility of a pandemic like the one experienced with SARS-CoV-2 in the short term is remote, but the threat posed by fungal infections persists.
In 2022, the World Health Organization (WHO) defined a priority list of pathogenic fungi, with the aim of guiding actions to control them. It is mentioned there that invasive fungal diseases are on the rise worldwide, particularly in immunocompromised populations.
“Despite the growing concern, fungal infections receive very little attention and resources, leading to a paucity of quality data on fungal disease distribution and antifungal resistance patterns. Consequently, it is impossible to estimate their exact burden,” as stated in the document.
In line with this, an article published in Mycoses in 2022 concluded that fungal infections are neglected diseases in Latin America. Among other difficulties, deficiencies in access to tests such as polymerase chain reaction or serum detection of beta-1,3-D-glucan have been reported there.
In terms of treatments, most countries encounter problems with access to liposomal amphotericin B and new azoles, such as posaconazole and isavuconazole.
“Unfortunately, in Latin America, we suffer from a poor infrastructure for diagnosing fungal infections; likewise, we have limited access to antifungals available in the global market. What’s more, we lack reliable data on the epidemiology of fungal infections in the region, so many times governments are unaware of the true extent of the problem,” said Rogelio de Jesús Treviño Rangel, PhD, a medical microbiologist and expert in clinical mycology, professor, and researcher at the Faculty of Medicine of the Autonomous University of Nuevo León in Mexico.
Need for More Medical Mycology Training
Dr. Fernando Messina is a medical mycologist with the Mycology Unit of the Francisco Javier Muñiz Infectious Diseases Hospital in Buenos Aires, Argentina. He has noted an increase in the number of cases of cryptococcosis, histoplasmosis, and aspergillosis in his daily practice.
“Particularly, pulmonary aspergillosis is steadily increasing. This is because many patients have structural lung alterations that favor the appearance of this mycosis. This is related to the increase in cases of tuberculosis and the rise in life expectancy of patients with chronic obstructive pulmonary disease or other pulmonary or systemic diseases,” Dr. Messina stated.
For Dr. Messina, the main obstacle in current clinical practice is the low level of awareness among nonspecialist physicians regarding the presence of systemic fungal infections, and because these infections are more common than realized, it is vital to consider fungal etiology before starting empirical antibiotic therapy.
“Health professionals usually do not think about mycoses because mycology occupies a very small space in medical education at universities. As the Venezuelan mycologist Gioconda Cunto de San Blas once said, ‘Mycology is the Cinderella of microbiology.’ To change this, we need to give more space to mycoses in undergraduate and postgraduate studies,” Dr. Messina asserted.
He added, “The main challenge is to train professionals with an emphasis on the clinical interpretation of cases. Current medicine has a strong trend toward molecular biology and the use of rapid diagnostic methods, without considering the clinical symptoms or the patient’s history. Determinations are very useful, but it is necessary to interpret the results.”
Dr. Messina sees it as unlikely in the short term for a pandemic to be caused by fungi, but if it were to occur, he believes it would happen in healthcare systems in regions that are not prepared in terms of infrastructure. However, as seen in the health emergency resulting from SARS-CoV-2, he thinks the impact would be mitigated by the performance of healthcare professionals.
“In general, we have the ability to adapt to any adverse situation or change — although it is clear that we need more doctors, biochemists, and microbiologists trained in mycology,” emphasized Dr. Messina.
More than 40 interns pass through Muñiz Hospital each year. They are doctors and biochemists from Argentina, other countries in the region, or even Europe, seeking to enhance their training in mycology. Regarding fungal infection laboratory work, the interest lies in learning to use traditional techniques and innovative molecular methods.
“Rapid diagnostic methods, especially the detection of circulating antigens, have marked a change in the prognosis of deep mycosis in immunocompromised hosts. The possibility of screening and monitoring in this group of patients is very important and has a great benefit,” said Gabriela Santiso, PhD, a biochemist and head of the Mycology Unit of the Francisco Javier Muñiz Infectious Diseases Hospital.
According to Dr. Santiso, the current landscape includes the ability to identify genus and species, which can help in understanding resistance to antifungals. Furthermore, conducting sensitivity tests to these drugs, using standardized commercial methods, also provides timely information for treatment.
But Dr. Santiso warns that Latin America is a vast region with great disparity in human and technological resources. Although most countries in the region have networks facilitating access to timely diagnosis, resources are generally more available in major urban centers.
This often clashes with the epidemiology of most fungal infections. “Let’s not forget that many fungal pathologies affect low-income people who have difficulties accessing health centers, which sometimes turns them into chronic diseases that are hard to treat,” Dr. Santiso pointed out.
In mycology laboratories, the biggest cost is incurred by new diagnostic tests, such as those allowing molecular identification. Conventional methods are not usually expensive, but they require time and effort to train human resources to handle them.
Because new methodologies are not always available or easily accessible throughout the region, Dr. Santiso recommended not neglecting traditional mycological techniques. “Molecular methods, rapid diagnostic methods, and conventional mycology techniques are complementary and not mutually exclusive tests. Continuous training and updating are needed in this area,” she emphasized.
Why Are Resistant Fungal Infections Becoming Increasingly Common?
The first barrier for fungi to cause infection in humans is body temperature; most of them cannot withstand 37 °C. However, they also struggle to evade the immune response that is activated when they try to enter the body.
“We are normally exposed to many of these fungi, almost all the time, but if our immune system is adequate, it may not go beyond a mild infection, in most cases subclinical, which will resolve quickly,” Dr. Sánchez Paredes stated.
However, according to Dr. Sánchez Paredes, if the immune response is weak, “the fungus will have no trouble establishing itself in our organs. Some are even part of our microbiota, such as Candida albicans, which in the face of an imbalance or immunocompromise, can lead to serious infections.”
It is clear that the population at risk for immunosuppression has increased. According to the WHO, this is due to the high prevalence of such diseases as tuberculosis, cancer, and HIV infection, among others.
But the WHO also believes that the increase in fungal infections is related to greater population access to critical care units, invasive procedures, chemotherapy, or immunotherapy treatments.
Furthermore, factors related to the fungus itself and the environment play a role. “These organisms have enzymes, proteins, and other molecules that allow them to survive in the environment in which they normally inhabit. When they face a new and stressful one, they must express other molecules that will allow them to survive. All of this helps them evade elements of the immune system, antifungals, and, of course, body temperature,” according to Dr. Sánchez Paredes.
It is possible that climate change is also behind the noticeable increase in fungal infections and that this crisis may have an even greater impact in the future. The temperature of the environment has increased, and fungi will have to adapt to the planet’s temperature, to the point where body temperature may no longer be a significant barrier for them.
Environmental changes would also be responsible for modifications in the distribution of endemic mycoses, and it is believed that fungi will more frequently find new ecological niches, be able to survive in other environments, and alter distribution zones.
This is what is happening between Mexico and the United States with coccidioidomycosis, or valley fever. “We will begin to see cases of some mycoses where they were not normally seen, so we will have to conduct more studies to confirm that the fungus is inhabiting these new areas or is simply appearing in new sites owing to migration and the great mobility of populations,” Dr. Sánchez Paredes said.
Finally, exposure to environmental factors would partly be responsible for the increasing resistance to first-line antifungals observed in these microorganisms. This seems to be the case with A. fumigatus when exposed to azoles used as fungicides in agriculture.
One Health in Fungal Infections
The increasing resistance to antifungals is a clear testament that human, animal, and environmental health are interconnected. This is why a multidisciplinary approach that adopts the perspective of One Health is necessary for its management.
“The use of fungicides in agriculture, structurally similar to the azoles used in clinics, generates resistance in Aspergillus fumigatus found in the environment. These fungi in humans can be associated with infections that do not respond to first-line treatment,” explained Carlos Arturo Álvarez, an infectious diseases physician and professor at the Faculty of Medicine at the National University of Colombia.
According to Dr. Álvarez, the approach to control them should not only focus on the search for diagnostic methods that allow early detection of antifungal resistance or research on new antifungal treatments. He believes that progress must also be made with strategies that allow for the proper use of antifungals in agriculture.
“Unfortunately, the One Health approach is not yet well implemented in the region, and in my view, there is a lack of articulation in the different sectors. That is, there is a need for true coordination between government offices of agriculture, animal and human health, academia, and international organizations. This is not happening yet, and I believe we are in the initial stage of visibility,” Dr. Álvarez opined.
Veterinary public health is another pillar of the aforementioned approach. For various reasons, animals experience a higher frequency of fungal infections. A few carry and transmit true zoonoses that affect human health, but most often, animals act only as sentinels indicating a potential source of transmission.
Carolina Segundo Zaragoza, PhD, has worked in veterinary mycology for 30 years. She currently heads the veterinary mycology laboratory at the Animal Production Teaching, Research, and Extension Center in Altiplano, under the Faculty of Veterinary Medicine and Animal Husbandry at the National Autonomous University of Mexico. Because she has frequent contact with specialists in human mycology, during her professional career she has received several patient consultations, most of which were for cutaneous mycoses.
“They detect some dermatomycosis and realize that the common factor is owning a companion animal or a production animal with which the patient has contact. Both animals and humans present the same type of lesions, and then comes the question: Who infected whom? I remind them that the main source of infection is the soil and that animals should not be blamed in the first instance,” Dr. Segundo Zaragoza clarified.
She is currently collaborating on a research project analyzing the presence of Coccidioides immitis in the soil. This pathogen is responsible for coccidioidomycosis in dogs and humans, and she sees with satisfaction how these types of initiatives, which include some components of the One Health vision, are becoming more common in Mexico.
“Fortunately, human mycologists are increasingly providing more space for the dissemination of veterinary mycology. So I have had the opportunity to be invited to different forums on medical mycology to present the clinical cases we can have in animals and talk about the research projects we carry out. I have more and more opportunities to conduct joint research with human mycologists and veterinary doctors,” she said.
Dr. Segundo Zaragoza believes that to better implement the One Health vision, standardizing the criteria for detecting, diagnosing, and treating mycoses is necessary. She considers that teamwork will be key to achieving the common goal of safeguarding the well-being and health of humans and animals.
Alarms Sound for Candida auris
The WHO included the yeast Candida auris in its group of pathogens with critical priority, and since 2009, it has raised alarm owing to the ease with which it grows in hospitals. In that setting, C auris is known for its high transmissibility, its ability to cause outbreaks, and the high mortality rate from disseminated infections.
“It has been a concern for the mycological community because it shows resistance to most antifungals used clinically, mainly azoles, but also for causing epidemic outbreaks,” emphasized Dr. Sánchez Paredes.
Its mode of transmission is not very clear, but it has been documented to be present on the skin and persist in hospital materials and furniture. It causes nosocomial infections in critically ill patients, such as those in intensive care, and those with cancer or who have received a transplant.
Risk factors for its development include renal insufficiency, hospital stays of more than 15 days, mechanical ventilation, central lines, use of parenteral nutrition, and presence of sepsis.
As for other mycoses, there are no precise studies reporting global incidence rates, but the trend indicates an increase in the detection of outbreaks in various countries lately — something that began to be visible during the COVID-19 pandemic.
In Mexico, Dr. Treviño Rangel and colleagues from Nuevo León reported the first case of candidemia caused by this agent. It occurred in May 2020 and involved a 58-year-old woman with a history of severe endometriosis and multiple complications in the gastrointestinal tract. The patient’s condition improved favorably thanks to antifungal therapy with caspofungin and liposomal amphotericin B.
However, 3 months after that episode, the group reported an outbreak of C. auris at the same hospital in 12 critically ill patients co-infected with SARS-CoV-2. All were on mechanical ventilation, had peripherally inserted central catheters and urinary catheters, and had a prolonged hospital stay (20-70 days). The mortality in patients with candidemia in this cohort was 83.3%.
Open Ending
As seen in some science fiction series, fungal infections in the region still have an open ending, and Global Action For Fungal Infections (GAFFI) has estimated that with better diagnostics and treatments, deaths caused by fungi could decrease to less than 750,000 per year worldwide.
But if everything continues as is, some aspects of what is to come may resemble the dystopia depicted in The Last of Us. No zombies, but emerging and reemerging fungi in a chaotic distribution, and resistant to all established treatments.
“The risk factors of patients and their immune status, combined with the behavior of mycoses, bring a complicated scenario. But therapeutic failure resulting from multidrug resistance to antifungals could make it catastrophic,” Dr. Sánchez Paredes summarized.
At the moment, there are only four families of drugs capable of counteracting fungal infections — and as mentioned, some are already scarce in Latin America’s hospital pharmacies.
“Historically, fungal infections have been given less importance than those caused by viruses or bacteria. Even in some developed countries, the true extent of morbidity and mortality they present is unknown. This results in less investment in the development of new antifungal molecules because knowledge is lacking about the incidence and prevalence of these diseases,” Dr. Treviño Rangel pointed out.
He added that the main limitation for the development of new drugs is economic. “Unfortunately, not many pharmaceutical companies are willing to invest in the development of new antifungals, and there are no government programs specifically promoting and supporting research into new therapeutic options against these neglected diseases,” he asserted.
Development of vaccines to prevent fungal infections faces the same barriers. Although, according to Dr. Treviño Rangel, the difficulties are compounded by the great similarity between fungal cells and human cells. This makes it possible for harmful cross-reactivity to occur. In addition, because most severe fungal infections occur in individuals with immunosuppression, a vaccine would need to trigger an adequate immune response despite this issue.
Meanwhile, fungi quietly continue to do what they do best: resist and survive. For millions of years, they have mutated and adapted to new environments. Some theories even blame them for the extinction of dinosaurs and the subsequent rise of mammals. They exist on the edge of life and death, decomposing and creating. There is consensus that at the moment, it does not seem feasible for them to generate a pandemic like the one due to SARS-CoV-2, given their transmission mechanism. But who is willing to rule out that this may not happen in the long or medium term?
Dr. Sánchez Paredes, Dr. Treviño Rangel, Dr. Messina, Dr. Santiso, Dr. Álvarez, and Dr. Segundo Zaragoza have declared no relevant financial conflicts of interest.
This story was translated from Medscape Spanish Edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.