LayerRx Mapping ID
285
Slot System
Featured Buckets
Featured Buckets Admin

Surveillance for 21 Possible Effects of Endocrine Disruptors

Article Type
Changed
Wed, 01/31/2024 - 13:42

Santé Publique France (SPF), the French national public health agency, has released the findings of the PEPS’PE study, which was launched in 2021. The study aims to prioritize, following extensive consultation, the health effects to be monitored for their potential link to endocrine disruptors (EDs). Out of 59 health effects suspected to be associated with exposure to EDs, 21 have been considered a priority for surveillance. Based on these results and others, SPF will expand the scope of the Agency’s surveillance by incorporating new pathologies.

As part of its environmental health program and the National Strategy on EDs, SPF has been conducting surveillance related to EDs targeting reproductive health since 2015. To incorporate new scientific knowledge, the PEPS’PE project aims to prioritize health effects related to EDs and identify health events to integrate into the agency’s current surveillance. The 59 health effects suspected to be associated with exposure to EDs were to be evaluated based on two criteria: The weight of evidence and the epidemiological and societal impact of the health effect. A diverse panel of international experts and French stakeholders in the field of EDs classified 21 health effects as a priority for surveillance.

Among these effects, six reproductive health effects are already monitored in the surveillance program: Cryptorchidismhypospadias, early puberty, testicular cancer, alteration of sperm quality, and endometriosis. In addition, infertility and decreased fertility (which are not currently monitored for their link to EDs) have been included.

Metabolic effects (including overweight and obesity, cardiovascular diseases, type 2 diabetes, and metabolic syndrome), child neurodevelopmental disorders (including behavioral disorders, intellectual deficits, and attention-deficit disorders), cancers (including breast cancer, prostate cancer, lymphomas, and leukemias in children), and asthma have also been highlighted.

Furthermore, 22 effects were considered low priorities or deemed nonpriorities when, for example, they presented weak or moderate evidence with varying levels of interest in implementing surveillance. Finally, 16 health effects could not be prioritized because of a lack of scientific experts on these topics and a failure to achieve consensus (eg, bone disorders, adrenal disorders, and skin and eye disorders). Consensus was sought during this consultation using a Delphi method.

“These results indicate the need to expand the scope of the Agency’s surveillance beyond reproductive health, incorporating new pathologies when surveillance data are available,” SPF declared in a press release.

“With the initial decision elements obtained through this study, Santé Publique France will analyze the feasibility of implementing surveillance for effects classified as priorities.”
 

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

Publications
Topics
Sections

Santé Publique France (SPF), the French national public health agency, has released the findings of the PEPS’PE study, which was launched in 2021. The study aims to prioritize, following extensive consultation, the health effects to be monitored for their potential link to endocrine disruptors (EDs). Out of 59 health effects suspected to be associated with exposure to EDs, 21 have been considered a priority for surveillance. Based on these results and others, SPF will expand the scope of the Agency’s surveillance by incorporating new pathologies.

As part of its environmental health program and the National Strategy on EDs, SPF has been conducting surveillance related to EDs targeting reproductive health since 2015. To incorporate new scientific knowledge, the PEPS’PE project aims to prioritize health effects related to EDs and identify health events to integrate into the agency’s current surveillance. The 59 health effects suspected to be associated with exposure to EDs were to be evaluated based on two criteria: The weight of evidence and the epidemiological and societal impact of the health effect. A diverse panel of international experts and French stakeholders in the field of EDs classified 21 health effects as a priority for surveillance.

Among these effects, six reproductive health effects are already monitored in the surveillance program: Cryptorchidismhypospadias, early puberty, testicular cancer, alteration of sperm quality, and endometriosis. In addition, infertility and decreased fertility (which are not currently monitored for their link to EDs) have been included.

Metabolic effects (including overweight and obesity, cardiovascular diseases, type 2 diabetes, and metabolic syndrome), child neurodevelopmental disorders (including behavioral disorders, intellectual deficits, and attention-deficit disorders), cancers (including breast cancer, prostate cancer, lymphomas, and leukemias in children), and asthma have also been highlighted.

Furthermore, 22 effects were considered low priorities or deemed nonpriorities when, for example, they presented weak or moderate evidence with varying levels of interest in implementing surveillance. Finally, 16 health effects could not be prioritized because of a lack of scientific experts on these topics and a failure to achieve consensus (eg, bone disorders, adrenal disorders, and skin and eye disorders). Consensus was sought during this consultation using a Delphi method.

“These results indicate the need to expand the scope of the Agency’s surveillance beyond reproductive health, incorporating new pathologies when surveillance data are available,” SPF declared in a press release.

“With the initial decision elements obtained through this study, Santé Publique France will analyze the feasibility of implementing surveillance for effects classified as priorities.”
 

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

Santé Publique France (SPF), the French national public health agency, has released the findings of the PEPS’PE study, which was launched in 2021. The study aims to prioritize, following extensive consultation, the health effects to be monitored for their potential link to endocrine disruptors (EDs). Out of 59 health effects suspected to be associated with exposure to EDs, 21 have been considered a priority for surveillance. Based on these results and others, SPF will expand the scope of the Agency’s surveillance by incorporating new pathologies.

As part of its environmental health program and the National Strategy on EDs, SPF has been conducting surveillance related to EDs targeting reproductive health since 2015. To incorporate new scientific knowledge, the PEPS’PE project aims to prioritize health effects related to EDs and identify health events to integrate into the agency’s current surveillance. The 59 health effects suspected to be associated with exposure to EDs were to be evaluated based on two criteria: The weight of evidence and the epidemiological and societal impact of the health effect. A diverse panel of international experts and French stakeholders in the field of EDs classified 21 health effects as a priority for surveillance.

Among these effects, six reproductive health effects are already monitored in the surveillance program: Cryptorchidismhypospadias, early puberty, testicular cancer, alteration of sperm quality, and endometriosis. In addition, infertility and decreased fertility (which are not currently monitored for their link to EDs) have been included.

Metabolic effects (including overweight and obesity, cardiovascular diseases, type 2 diabetes, and metabolic syndrome), child neurodevelopmental disorders (including behavioral disorders, intellectual deficits, and attention-deficit disorders), cancers (including breast cancer, prostate cancer, lymphomas, and leukemias in children), and asthma have also been highlighted.

Furthermore, 22 effects were considered low priorities or deemed nonpriorities when, for example, they presented weak or moderate evidence with varying levels of interest in implementing surveillance. Finally, 16 health effects could not be prioritized because of a lack of scientific experts on these topics and a failure to achieve consensus (eg, bone disorders, adrenal disorders, and skin and eye disorders). Consensus was sought during this consultation using a Delphi method.

“These results indicate the need to expand the scope of the Agency’s surveillance beyond reproductive health, incorporating new pathologies when surveillance data are available,” SPF declared in a press release.

“With the initial decision elements obtained through this study, Santé Publique France will analyze the feasibility of implementing surveillance for effects classified as priorities.”
 

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Liraglutide fixes learning limit tied to insulin resistance

Article Type
Changed
Fri, 09/01/2023 - 17:26

A single injection of the GLP-1 receptor agonist liraglutide led to short-term normalization of associative learning in people with obesity and insulin resistance, a finding that suggests dopamine-driven learning processes are modified by metabolic signaling and that this effect “may contribute to the weight-reducing effects of liraglutide in obesity,” say the authors of a recent report in Nature Metabolism.
 

“We demonstrated that dopamine-driven associative learning about external sensory cues crucially depends on metabolic signaling,” said Marc Tittgemeyer, PhD, professor at the Max Planck Institute for Metabolism Research in Cologne, Germany, and senior author of the study. Study participants with impaired insulin sensitivity “exhibited a reduced amplitude of behavioral updating that was normalized” by a single subcutaneous injection of 0.6 mg of liraglutide (the starting daily dose for liraglutide for weight loss, available as Saxenda, Novo Nordisk) given the evening before testing.

The findings, from 30 adults with normal insulin sensitivity and normal weight and 24 adults with impaired insulin sensitivity and obesity, suggest that metabolic signals, particularly ones that promote energy restoration in a setting of energy deprivation caused by insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist, “profoundly influence neuronal processing,” said Dr. Tittgemeyer. The findings suggest that impaired metabolic signaling such as occurs with insulin resistance in people with obesity can cause deficiencies in associative learning.
 

‘Liraglutide can normalize learning of associations’

“We show that in people with obesity, disrupted circuit mechanisms lead to impaired learning about sensory associations,” Dr. Tittgemeyer said in an interview. “The information provided by sensory systems that the brain must interpret to select a behavioral response are ‘off tune’ ” in these individuals.

“This is rather consequential for understanding food-intake behaviors. Modern obesity treatments, such as liraglutide, can normalize learning of associations and thereby render people susceptible again for sensory signals and make them more prone to react to subliminal interactions, such as weight-normalizing diets and conscious eating,” he added.

The normalization in associative learning that one dose of liraglutide produced in people with obesity “fits with studies showing that these drugs restore a normal feeling of satiety, causing people to eat less and therefore lose weight,” he explained.

Dr. Tittgemeyer noted that this effect is likely shared by other agents in the GLP-1 receptor agonist class, such as semaglutide (Ozempic, Wegovy, Novo Nordisk) but is likely not an effect when agents agonize receptors to other nutrient-stimulated hormones such as glucagon and the glucose-dependent insulinotropic polypeptide.

The findings “show that liraglutide restores associative learning in participants with greater insulin resistance,” a “highly relevant” discovery, commented Nils B. Kroemer, PhD, head of the section of medical psychology at the University of Bonn, Germany, who was not involved with this research, in a written statement.

The study run by Dr. Tittgemeyer and his associates included 54 healthy adult volunteers whom they assessed for insulin sensitivity with their homeostasis model assessment of insulin resistance. The researchers divided the cohort into groups; one group included 24 people with impaired insulin sensitivity, and one included 30 with normal insulin sensitivity. The average body mass index (BMI) of the normal sensitivity group was about 24 kg/m2; in the insulin-resistant subgroup, BMI averaged about 33 kg/m2.

The associative learning task tested the ability of participants to learn associations between auditory cues (a high or low tone) and a subsequent visual outcome (a picture of a face or a house). During each associative learning session, participants also underwent functional MRI of the brain.
 

 

 

Liraglutide treatment leveled learning

The results showed that the learning rate was significantly lower in the subgroup with impaired insulin sensitivity, compared with those with normal insulin sensitivity following treatment with a placebo injection. This indicates a decreased adaptation of learning to predictability variations in individuals with impaired insulin sensitivity.

In contrast, treatment with a single dose of liraglutide significantly enhanced the learning rate in the group with impaired insulin sensitivity but significantly reduced the learning rate in the group with normal insulin sensitivity. Liraglutide’s effect was twice as large in the group with impaired insulin sensitivity than in the group with normal insulin sensitivity, and these opposing effects of liraglutide resulted in a convergence of the two groups’ adaptive learning rates so that there wasn’t any significant between-group difference following liraglutide treatment.

After analyzing the functional MRI data along with the learning results, the researchers concluded that liraglutide normalized learning in individuals with impaired insulin sensitivity by enhancing adaptive prediction error encoding in the brain’s ventral striatum and mesocortical projection sites.

This apparent ability of GLP-1 analogues to correct this learning deficit in people with impaired insulin sensitivity and obesity has implications regarding potential benefit for people with other pathologies characterized by impaired dopaminergic function and associated with metabolic impairments, such as psychosis, Parkinson’s disease, and depression, the researchers say.

“The fascinating thing about GLP-1 receptor agonists is that they have an additional mechanism that relates to anti-inflammatory effects, especially for alleviating cell stress,” said Dr. Tittgemeyer. “Many ongoing clinical trials are assessing their effects in neuropsychiatric diseases,” he noted.

The study received no commercial funding. Dr. Tittgemyer and most of his coauthors had no disclosures. One coauthor had several disclosures, which are detailed in the report. Dr. Kroemer had no disclosures.

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

Publications
Topics
Sections

A single injection of the GLP-1 receptor agonist liraglutide led to short-term normalization of associative learning in people with obesity and insulin resistance, a finding that suggests dopamine-driven learning processes are modified by metabolic signaling and that this effect “may contribute to the weight-reducing effects of liraglutide in obesity,” say the authors of a recent report in Nature Metabolism.
 

“We demonstrated that dopamine-driven associative learning about external sensory cues crucially depends on metabolic signaling,” said Marc Tittgemeyer, PhD, professor at the Max Planck Institute for Metabolism Research in Cologne, Germany, and senior author of the study. Study participants with impaired insulin sensitivity “exhibited a reduced amplitude of behavioral updating that was normalized” by a single subcutaneous injection of 0.6 mg of liraglutide (the starting daily dose for liraglutide for weight loss, available as Saxenda, Novo Nordisk) given the evening before testing.

The findings, from 30 adults with normal insulin sensitivity and normal weight and 24 adults with impaired insulin sensitivity and obesity, suggest that metabolic signals, particularly ones that promote energy restoration in a setting of energy deprivation caused by insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist, “profoundly influence neuronal processing,” said Dr. Tittgemeyer. The findings suggest that impaired metabolic signaling such as occurs with insulin resistance in people with obesity can cause deficiencies in associative learning.
 

‘Liraglutide can normalize learning of associations’

“We show that in people with obesity, disrupted circuit mechanisms lead to impaired learning about sensory associations,” Dr. Tittgemeyer said in an interview. “The information provided by sensory systems that the brain must interpret to select a behavioral response are ‘off tune’ ” in these individuals.

“This is rather consequential for understanding food-intake behaviors. Modern obesity treatments, such as liraglutide, can normalize learning of associations and thereby render people susceptible again for sensory signals and make them more prone to react to subliminal interactions, such as weight-normalizing diets and conscious eating,” he added.

The normalization in associative learning that one dose of liraglutide produced in people with obesity “fits with studies showing that these drugs restore a normal feeling of satiety, causing people to eat less and therefore lose weight,” he explained.

Dr. Tittgemeyer noted that this effect is likely shared by other agents in the GLP-1 receptor agonist class, such as semaglutide (Ozempic, Wegovy, Novo Nordisk) but is likely not an effect when agents agonize receptors to other nutrient-stimulated hormones such as glucagon and the glucose-dependent insulinotropic polypeptide.

The findings “show that liraglutide restores associative learning in participants with greater insulin resistance,” a “highly relevant” discovery, commented Nils B. Kroemer, PhD, head of the section of medical psychology at the University of Bonn, Germany, who was not involved with this research, in a written statement.

The study run by Dr. Tittgemeyer and his associates included 54 healthy adult volunteers whom they assessed for insulin sensitivity with their homeostasis model assessment of insulin resistance. The researchers divided the cohort into groups; one group included 24 people with impaired insulin sensitivity, and one included 30 with normal insulin sensitivity. The average body mass index (BMI) of the normal sensitivity group was about 24 kg/m2; in the insulin-resistant subgroup, BMI averaged about 33 kg/m2.

The associative learning task tested the ability of participants to learn associations between auditory cues (a high or low tone) and a subsequent visual outcome (a picture of a face or a house). During each associative learning session, participants also underwent functional MRI of the brain.
 

 

 

Liraglutide treatment leveled learning

The results showed that the learning rate was significantly lower in the subgroup with impaired insulin sensitivity, compared with those with normal insulin sensitivity following treatment with a placebo injection. This indicates a decreased adaptation of learning to predictability variations in individuals with impaired insulin sensitivity.

In contrast, treatment with a single dose of liraglutide significantly enhanced the learning rate in the group with impaired insulin sensitivity but significantly reduced the learning rate in the group with normal insulin sensitivity. Liraglutide’s effect was twice as large in the group with impaired insulin sensitivity than in the group with normal insulin sensitivity, and these opposing effects of liraglutide resulted in a convergence of the two groups’ adaptive learning rates so that there wasn’t any significant between-group difference following liraglutide treatment.

After analyzing the functional MRI data along with the learning results, the researchers concluded that liraglutide normalized learning in individuals with impaired insulin sensitivity by enhancing adaptive prediction error encoding in the brain’s ventral striatum and mesocortical projection sites.

This apparent ability of GLP-1 analogues to correct this learning deficit in people with impaired insulin sensitivity and obesity has implications regarding potential benefit for people with other pathologies characterized by impaired dopaminergic function and associated with metabolic impairments, such as psychosis, Parkinson’s disease, and depression, the researchers say.

“The fascinating thing about GLP-1 receptor agonists is that they have an additional mechanism that relates to anti-inflammatory effects, especially for alleviating cell stress,” said Dr. Tittgemeyer. “Many ongoing clinical trials are assessing their effects in neuropsychiatric diseases,” he noted.

The study received no commercial funding. Dr. Tittgemyer and most of his coauthors had no disclosures. One coauthor had several disclosures, which are detailed in the report. Dr. Kroemer had no disclosures.

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

A single injection of the GLP-1 receptor agonist liraglutide led to short-term normalization of associative learning in people with obesity and insulin resistance, a finding that suggests dopamine-driven learning processes are modified by metabolic signaling and that this effect “may contribute to the weight-reducing effects of liraglutide in obesity,” say the authors of a recent report in Nature Metabolism.
 

“We demonstrated that dopamine-driven associative learning about external sensory cues crucially depends on metabolic signaling,” said Marc Tittgemeyer, PhD, professor at the Max Planck Institute for Metabolism Research in Cologne, Germany, and senior author of the study. Study participants with impaired insulin sensitivity “exhibited a reduced amplitude of behavioral updating that was normalized” by a single subcutaneous injection of 0.6 mg of liraglutide (the starting daily dose for liraglutide for weight loss, available as Saxenda, Novo Nordisk) given the evening before testing.

The findings, from 30 adults with normal insulin sensitivity and normal weight and 24 adults with impaired insulin sensitivity and obesity, suggest that metabolic signals, particularly ones that promote energy restoration in a setting of energy deprivation caused by insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist, “profoundly influence neuronal processing,” said Dr. Tittgemeyer. The findings suggest that impaired metabolic signaling such as occurs with insulin resistance in people with obesity can cause deficiencies in associative learning.
 

‘Liraglutide can normalize learning of associations’

“We show that in people with obesity, disrupted circuit mechanisms lead to impaired learning about sensory associations,” Dr. Tittgemeyer said in an interview. “The information provided by sensory systems that the brain must interpret to select a behavioral response are ‘off tune’ ” in these individuals.

“This is rather consequential for understanding food-intake behaviors. Modern obesity treatments, such as liraglutide, can normalize learning of associations and thereby render people susceptible again for sensory signals and make them more prone to react to subliminal interactions, such as weight-normalizing diets and conscious eating,” he added.

The normalization in associative learning that one dose of liraglutide produced in people with obesity “fits with studies showing that these drugs restore a normal feeling of satiety, causing people to eat less and therefore lose weight,” he explained.

Dr. Tittgemeyer noted that this effect is likely shared by other agents in the GLP-1 receptor agonist class, such as semaglutide (Ozempic, Wegovy, Novo Nordisk) but is likely not an effect when agents agonize receptors to other nutrient-stimulated hormones such as glucagon and the glucose-dependent insulinotropic polypeptide.

The findings “show that liraglutide restores associative learning in participants with greater insulin resistance,” a “highly relevant” discovery, commented Nils B. Kroemer, PhD, head of the section of medical psychology at the University of Bonn, Germany, who was not involved with this research, in a written statement.

The study run by Dr. Tittgemeyer and his associates included 54 healthy adult volunteers whom they assessed for insulin sensitivity with their homeostasis model assessment of insulin resistance. The researchers divided the cohort into groups; one group included 24 people with impaired insulin sensitivity, and one included 30 with normal insulin sensitivity. The average body mass index (BMI) of the normal sensitivity group was about 24 kg/m2; in the insulin-resistant subgroup, BMI averaged about 33 kg/m2.

The associative learning task tested the ability of participants to learn associations between auditory cues (a high or low tone) and a subsequent visual outcome (a picture of a face or a house). During each associative learning session, participants also underwent functional MRI of the brain.
 

 

 

Liraglutide treatment leveled learning

The results showed that the learning rate was significantly lower in the subgroup with impaired insulin sensitivity, compared with those with normal insulin sensitivity following treatment with a placebo injection. This indicates a decreased adaptation of learning to predictability variations in individuals with impaired insulin sensitivity.

In contrast, treatment with a single dose of liraglutide significantly enhanced the learning rate in the group with impaired insulin sensitivity but significantly reduced the learning rate in the group with normal insulin sensitivity. Liraglutide’s effect was twice as large in the group with impaired insulin sensitivity than in the group with normal insulin sensitivity, and these opposing effects of liraglutide resulted in a convergence of the two groups’ adaptive learning rates so that there wasn’t any significant between-group difference following liraglutide treatment.

After analyzing the functional MRI data along with the learning results, the researchers concluded that liraglutide normalized learning in individuals with impaired insulin sensitivity by enhancing adaptive prediction error encoding in the brain’s ventral striatum and mesocortical projection sites.

This apparent ability of GLP-1 analogues to correct this learning deficit in people with impaired insulin sensitivity and obesity has implications regarding potential benefit for people with other pathologies characterized by impaired dopaminergic function and associated with metabolic impairments, such as psychosis, Parkinson’s disease, and depression, the researchers say.

“The fascinating thing about GLP-1 receptor agonists is that they have an additional mechanism that relates to anti-inflammatory effects, especially for alleviating cell stress,” said Dr. Tittgemeyer. “Many ongoing clinical trials are assessing their effects in neuropsychiatric diseases,” he noted.

The study received no commercial funding. Dr. Tittgemyer and most of his coauthors had no disclosures. One coauthor had several disclosures, which are detailed in the report. Dr. Kroemer had no disclosures.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM NATURE METABOLISM

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Multiprong strategy makes clinical trials less White

Article Type
Changed
Tue, 06/27/2023 - 09:31

– Clinical trials are so White. Only a small percentage of eligible patients participate in clinical trials in the first place, and very few come from racial and ethnic minority groups.

For example, according to the Food and Drug Administration, in trials that resulted in drug approvals from 2017 to 2020, only 2%-5% of participants were Black patients.

When clinical trials lack diverse patient populations, those who are left out have fewer opportunities to get new therapies. Moreover, the scope of the research is limited by smaller phenotypic and genotypic samples, and the trial results are applicable only to more homogeneous patient groups.

There has been a push to include more underrepresented patients in clinical trials. One group reported its success in doing so here at the annual meeting of the American Society of Clinical Oncology.

Researchers from the Alliance for Clinical Trials in Oncology explained how a multifaceted approach resulted in a 75% relative improvement in trial enrollment from 2014 to 2022, a period that included a pandemic-induced hiatus in clinical trials in general.

Alliance member Electra D. Paskett, PhD, from the College of Public Health at the Ohio State University in Columbus, presented accrual data from 117 trials led by the Alliance from 2014 to 2022.

During this period, accrual of racial and ethnic minority patients increased from 13.6% to 25.3% for cancer treatment trials and from 13% to 21.5% for cancer control trials.

Overall, the recruitment program resulted in an absolute increase from 13.5 % to 23.6% of underrepresented populations, which translated into a relative 74.8% improvement.

“We’re focusing now on monitoring accrual of women, rural populations, younger AYAs [adolescents and young adults] and older patients, and we’ll see what strategies we need to implement,” Dr. Packett told this news organization.

The Alliance has implemented a real-time accrual dashboard on its website that allows individual sites to review accrual by trial and overall for all of the identified underrepresented populations, she noted.
 

Program to increase underrepresented patient accrual

The impetus for the program to increase enrollment of underrepresented patients came from the goal set by Monica M. Bertagnolli, MD, group chair of the Alliance from 2011 to 2022 and currently the director of the U.S. National Cancer Institute.

“Our leader, Dr. Bertagnolli, set out a group-wide goal for accrual of underrepresented minorities to our trials of 20%, and that gave us permission to implement a whole host of new strategies,” Dr. Paskett said in an interview.

“These strategies follow the Accrual of Clinical Trials framework, which essentially says that the interaction between the patient and the provider for going on a clinical trial is not just an interaction between the patient and provider but recognizes, for example, that the provider has coworkers and they have norms and beliefs and attitudes, and the patient comes from a family with their own values. And then there are system-level barriers, and there are community barriers that all relate to this interaction about going on a trial,” Dr. Packett said.
 

What works?

The study was presented as a poster at the meeting. During the poster discussion session, comoderator Victoria S. Blinder, MD, from Memorial Sloan Kettering Cancer Center in New York, asked Dr. Paskett, “If you had a certain amount of money and you really wanted to use that resource to focus on one area, where would you put that resource?”

“I’m going to violate the rules of your question,” Dr. Paskett replied.

“You cannot change this problem by focusing on one thing, and that’s what we showed in our Alliance poster, and what I’ve said is based on over 30 years of work in this area,” she said.

She cited what she considered as the two most important components for improving accrual of underrepresented populations: a commitment by leadership to a recruitment goal, and the development of protocols with specific accrual goals for minority populations.

Still, those are only two components of a comprehensive program that includes the aforementioned accrual goal set by Dr. Bertagnolli, as well as the following:

  • Funding of minority junior investigators and research that focuses on issues of concern to underrepresented populations.
  • Establishment of work groups that focus on specific populations with the Alliance health disparities committee.
  • Translation of informational materials for patients.
  • Opening studies at National Cancer Institute Community. Oncology Research Program–designated minority underserved sites.
  • Real-time monitoring of accrual demographics by the Alliance and at the trial site.
  • Closing protocol enrollment to majority populations.
  • Increasing the study sample sizes to enroll additional minority participants and to allow for subgroup analyses.

The study was funded by the National Institutes of Health. Dr. Packett and Dr. Blinder reported no relevant financial relationships.

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

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

– Clinical trials are so White. Only a small percentage of eligible patients participate in clinical trials in the first place, and very few come from racial and ethnic minority groups.

For example, according to the Food and Drug Administration, in trials that resulted in drug approvals from 2017 to 2020, only 2%-5% of participants were Black patients.

When clinical trials lack diverse patient populations, those who are left out have fewer opportunities to get new therapies. Moreover, the scope of the research is limited by smaller phenotypic and genotypic samples, and the trial results are applicable only to more homogeneous patient groups.

There has been a push to include more underrepresented patients in clinical trials. One group reported its success in doing so here at the annual meeting of the American Society of Clinical Oncology.

Researchers from the Alliance for Clinical Trials in Oncology explained how a multifaceted approach resulted in a 75% relative improvement in trial enrollment from 2014 to 2022, a period that included a pandemic-induced hiatus in clinical trials in general.

Alliance member Electra D. Paskett, PhD, from the College of Public Health at the Ohio State University in Columbus, presented accrual data from 117 trials led by the Alliance from 2014 to 2022.

During this period, accrual of racial and ethnic minority patients increased from 13.6% to 25.3% for cancer treatment trials and from 13% to 21.5% for cancer control trials.

Overall, the recruitment program resulted in an absolute increase from 13.5 % to 23.6% of underrepresented populations, which translated into a relative 74.8% improvement.

“We’re focusing now on monitoring accrual of women, rural populations, younger AYAs [adolescents and young adults] and older patients, and we’ll see what strategies we need to implement,” Dr. Packett told this news organization.

The Alliance has implemented a real-time accrual dashboard on its website that allows individual sites to review accrual by trial and overall for all of the identified underrepresented populations, she noted.
 

Program to increase underrepresented patient accrual

The impetus for the program to increase enrollment of underrepresented patients came from the goal set by Monica M. Bertagnolli, MD, group chair of the Alliance from 2011 to 2022 and currently the director of the U.S. National Cancer Institute.

“Our leader, Dr. Bertagnolli, set out a group-wide goal for accrual of underrepresented minorities to our trials of 20%, and that gave us permission to implement a whole host of new strategies,” Dr. Paskett said in an interview.

“These strategies follow the Accrual of Clinical Trials framework, which essentially says that the interaction between the patient and the provider for going on a clinical trial is not just an interaction between the patient and provider but recognizes, for example, that the provider has coworkers and they have norms and beliefs and attitudes, and the patient comes from a family with their own values. And then there are system-level barriers, and there are community barriers that all relate to this interaction about going on a trial,” Dr. Packett said.
 

What works?

The study was presented as a poster at the meeting. During the poster discussion session, comoderator Victoria S. Blinder, MD, from Memorial Sloan Kettering Cancer Center in New York, asked Dr. Paskett, “If you had a certain amount of money and you really wanted to use that resource to focus on one area, where would you put that resource?”

“I’m going to violate the rules of your question,” Dr. Paskett replied.

“You cannot change this problem by focusing on one thing, and that’s what we showed in our Alliance poster, and what I’ve said is based on over 30 years of work in this area,” she said.

She cited what she considered as the two most important components for improving accrual of underrepresented populations: a commitment by leadership to a recruitment goal, and the development of protocols with specific accrual goals for minority populations.

Still, those are only two components of a comprehensive program that includes the aforementioned accrual goal set by Dr. Bertagnolli, as well as the following:

  • Funding of minority junior investigators and research that focuses on issues of concern to underrepresented populations.
  • Establishment of work groups that focus on specific populations with the Alliance health disparities committee.
  • Translation of informational materials for patients.
  • Opening studies at National Cancer Institute Community. Oncology Research Program–designated minority underserved sites.
  • Real-time monitoring of accrual demographics by the Alliance and at the trial site.
  • Closing protocol enrollment to majority populations.
  • Increasing the study sample sizes to enroll additional minority participants and to allow for subgroup analyses.

The study was funded by the National Institutes of Health. Dr. Packett and Dr. Blinder reported no relevant financial relationships.

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

– Clinical trials are so White. Only a small percentage of eligible patients participate in clinical trials in the first place, and very few come from racial and ethnic minority groups.

For example, according to the Food and Drug Administration, in trials that resulted in drug approvals from 2017 to 2020, only 2%-5% of participants were Black patients.

When clinical trials lack diverse patient populations, those who are left out have fewer opportunities to get new therapies. Moreover, the scope of the research is limited by smaller phenotypic and genotypic samples, and the trial results are applicable only to more homogeneous patient groups.

There has been a push to include more underrepresented patients in clinical trials. One group reported its success in doing so here at the annual meeting of the American Society of Clinical Oncology.

Researchers from the Alliance for Clinical Trials in Oncology explained how a multifaceted approach resulted in a 75% relative improvement in trial enrollment from 2014 to 2022, a period that included a pandemic-induced hiatus in clinical trials in general.

Alliance member Electra D. Paskett, PhD, from the College of Public Health at the Ohio State University in Columbus, presented accrual data from 117 trials led by the Alliance from 2014 to 2022.

During this period, accrual of racial and ethnic minority patients increased from 13.6% to 25.3% for cancer treatment trials and from 13% to 21.5% for cancer control trials.

Overall, the recruitment program resulted in an absolute increase from 13.5 % to 23.6% of underrepresented populations, which translated into a relative 74.8% improvement.

“We’re focusing now on monitoring accrual of women, rural populations, younger AYAs [adolescents and young adults] and older patients, and we’ll see what strategies we need to implement,” Dr. Packett told this news organization.

The Alliance has implemented a real-time accrual dashboard on its website that allows individual sites to review accrual by trial and overall for all of the identified underrepresented populations, she noted.
 

Program to increase underrepresented patient accrual

The impetus for the program to increase enrollment of underrepresented patients came from the goal set by Monica M. Bertagnolli, MD, group chair of the Alliance from 2011 to 2022 and currently the director of the U.S. National Cancer Institute.

“Our leader, Dr. Bertagnolli, set out a group-wide goal for accrual of underrepresented minorities to our trials of 20%, and that gave us permission to implement a whole host of new strategies,” Dr. Paskett said in an interview.

“These strategies follow the Accrual of Clinical Trials framework, which essentially says that the interaction between the patient and the provider for going on a clinical trial is not just an interaction between the patient and provider but recognizes, for example, that the provider has coworkers and they have norms and beliefs and attitudes, and the patient comes from a family with their own values. And then there are system-level barriers, and there are community barriers that all relate to this interaction about going on a trial,” Dr. Packett said.
 

What works?

The study was presented as a poster at the meeting. During the poster discussion session, comoderator Victoria S. Blinder, MD, from Memorial Sloan Kettering Cancer Center in New York, asked Dr. Paskett, “If you had a certain amount of money and you really wanted to use that resource to focus on one area, where would you put that resource?”

“I’m going to violate the rules of your question,” Dr. Paskett replied.

“You cannot change this problem by focusing on one thing, and that’s what we showed in our Alliance poster, and what I’ve said is based on over 30 years of work in this area,” she said.

She cited what she considered as the two most important components for improving accrual of underrepresented populations: a commitment by leadership to a recruitment goal, and the development of protocols with specific accrual goals for minority populations.

Still, those are only two components of a comprehensive program that includes the aforementioned accrual goal set by Dr. Bertagnolli, as well as the following:

  • Funding of minority junior investigators and research that focuses on issues of concern to underrepresented populations.
  • Establishment of work groups that focus on specific populations with the Alliance health disparities committee.
  • Translation of informational materials for patients.
  • Opening studies at National Cancer Institute Community. Oncology Research Program–designated minority underserved sites.
  • Real-time monitoring of accrual demographics by the Alliance and at the trial site.
  • Closing protocol enrollment to majority populations.
  • Increasing the study sample sizes to enroll additional minority participants and to allow for subgroup analyses.

The study was funded by the National Institutes of Health. Dr. Packett and Dr. Blinder reported no relevant financial relationships.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

AT ASCO 2023

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Phone support helps weight loss in patients with breast cancer

Article Type
Changed
Mon, 06/05/2023 - 22:24

 

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m2, and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.

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

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m2, and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.

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

 

A telephone-based weight loss intervention resulted in clinically meaningful weight loss in patients with breast cancer who were overweight and obese.

The finding comes from a case-control study of 3,136 women who had been diagnosed with stage II or III breast cancer. The average body mass index of participants was 34.5 kg/m2, and mean age was 53.4 years.

After 6 months, patients who received telephone coaching as well as health education lost 4.4 kg (9.7 lb), which was 4.8% of their baseline body weight.

In contrast, patients in the control group, who received only health education, gained 0.2 kg (0.3% of their baseline body weight) over the same period.

At the 1-year mark, the telephone weight loss intervention group had maintained the weight they lost at 6 months, whereas the control group gained even more weight and ended with a 0.9% weight gain.

“This equated to a 5.56% weight differential in the two arms demonstrating significant weight loss, which was also clinically significant given that a 3% weight loss is sufficient to improve diabetes and other chronic diseases,” commented lead author Jennifer Ligibel, MD, associate professor of medicine at the Dana-Farber Cancer Institute in Boston. 

She spoke at a press briefing ahead of the annual meeting of the American Society of Clinical Oncology, where the study was presented.

“Our study provides compelling evidence that weight loss interventions can successfully reduce weight in a diverse population of patients with breast cancer,” she said in a statement. At the time of diagnosis, 57% of patients were postmenopausal, 80.3% were White, 12.8% were Black, and 7.3% were Hispanic. 

Patients in the intervention group received a health education program plus a 2-year telephone-based weight loss program that focused on lowering calorie intake and increasing physical activity.

Those in the control group only received the health education program that included nontailored diet and exercise materials, a quarterly newsletter, twice-yearly webinars, and a subscription to a health magazine of the participant’s choosing

“This study was delivered completely remotely and it was done so purposefully because we wanted to develop a program that could work for somebody who lived in a rural area in the middle of the country, as well as it could for somebody who lived close to a cancer center,” Dr. Ligibel commented.

“The next step will be to determine whether this weight loss translates into lower rates of cancer recurrence and mortality. If our trial is successful in improving cancer outcomes, it will have far-reaching implications, demonstrating that weight loss should be incorporated into the standard of care for survivors of breast cancer,” she added.

Commenting on the new findings, ASCO expert Elizabeth Anne Comen, MD, Memorial Sloan Kettering Cancer Center, New York, said: “This study demonstrates that consistent health coaching by telephone – a more accessible, cost-effective approach compared to in-person programs – can significantly help patients with breast cancer lose weight over 1 year and is effective across diverse groups of patients.

“We anxiously await longer-term follow-up to see whether this weight reduction will ultimately improve outcomes for these patients,” she added.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM ASCO 2023

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Number of cancer survivors with functional limitations doubled in 20 years

Article Type
Changed
Mon, 06/12/2023 - 11:41

The number of cancer survivors who report functional limitation has more than doubled in 20 years, according to a research letter published in JAMA Oncology.

Vishal Patel, BS, a student at the Dell Medical School at The University of Texas at Austin, and colleagues identified 51,258 cancer survivors from the National Health Interview Survey, representing a weighted population of approximately 178.8 million from 1999 to 2018.

Most survivors were women (60.2%) and were at least 65 years old (55.4%). In 1999, 3.6 million weighted survivors reported functional limitation. In 2018, the number increased to 8.2 million, a 2.25-fold increase.

The number of survivors who reported no limitations also increased, but not by as much. That group grew 1.34-fold during the study period.

For context, “the 70% prevalence of functional limitation among survivors in 2018 is nearly twice that of the general population,” the authors wrote.
 

Patients surveyed on function

Functional limitation was defined as “self-reported difficulty performing any of 12 routine physical or social activities without assistance.” Examples of the activities included difficulty sitting for more than 2 hours, difficulty participating in social activities or difficulty pushing or pulling an object the size of a living room chair.

Over the 2 decades analyzed, the adjusted prevalence of functional limitation was highest among survivors of pancreatic cancer (80.3%) and lung cancer (76.5%). Prevalence was lowest for survivors of melanoma (62.2%), breast (61.8%) and prostate (59.5%) cancers.
 

Not just a result of living longer

Mr. Patel told this publication that one assumption people might make when they read these results is that people are just living longer with cancer and losing functional ability accordingly.

“But, in fact, we found that the youngest [– those less than 65 years–] actually contributed to this trend more than the oldest people, which means it’s not just [happening], because people are getting older,” he said.

Hispanic and Black individuals had disproportionately higher increases in functional limitation; percentage point increases over the 2 decades were 19.5 for Black people, 25.1 for Hispanic people and 12.5 for White people. There may be a couple of reasons for that, Mr. Patel noted.

Those who are Black or Hispanic tend to have less access to cancer survivorship care for reasons including insurance status and historic health care inequities, he noted.

“The other potential reason is that they have had less access to cancer care historically. And if, 20 years ago Black and Hispanic individuals didn’t have access to some chemotherapies, and now they do, maybe it’s the increased access to care that’s causing these functional limitations. Because chemotherapy can sometimes be very toxic. It may be sort of a catch-up toxicity,” he said.
 

Quality of life beyond survivorship

Mr. Patel said the results seem to call for building on improved survival rates by tracking and improving function.

“It’s good to celebrate that there are more survivors. But now that we can keep people alive longer, maybe we can shift gears to improving their quality of life,” he said.

The more-than-doubling of functional limitations over 2 decades “is a very sobering trend,” he noted, while pointing out that the functional limitations applied to 8 million people in the United States – people whose needs are not being met.

There’s no sign of the trend stopping, he continued. “We saw no downward trend, only an upward trend.”

Increasingly, including functionality as an endpoint in cancer trials, in addition to improvements in mortality, is one place to start, he added.

“Our findings suggest an urgent need for care teams to understand and address function, for researchers to evaluate function as a core outcome in trials, and for health systems and policy makers to reimagine survivorship care, recognizing the burden of cancer and its treatment on physical, psychosocial, and cognitive function,” the authors wrote in their paper. Limitations of the study include the potential for recall bias, lack of cancer staging or treatment information, and the subjective perception of function.

A coauthor reported personal fees from Astellas, AstraZeneca, AAA, Blue Earth, Janssen, Lantheus, Myovant, Myriad Genetics, Novartis, Telix, and Sanofi, as well as grants from Pfizer and Bayer during the conduct of the study. No other disclosures were reported.

Publications
Topics
Sections

The number of cancer survivors who report functional limitation has more than doubled in 20 years, according to a research letter published in JAMA Oncology.

Vishal Patel, BS, a student at the Dell Medical School at The University of Texas at Austin, and colleagues identified 51,258 cancer survivors from the National Health Interview Survey, representing a weighted population of approximately 178.8 million from 1999 to 2018.

Most survivors were women (60.2%) and were at least 65 years old (55.4%). In 1999, 3.6 million weighted survivors reported functional limitation. In 2018, the number increased to 8.2 million, a 2.25-fold increase.

The number of survivors who reported no limitations also increased, but not by as much. That group grew 1.34-fold during the study period.

For context, “the 70% prevalence of functional limitation among survivors in 2018 is nearly twice that of the general population,” the authors wrote.
 

Patients surveyed on function

Functional limitation was defined as “self-reported difficulty performing any of 12 routine physical or social activities without assistance.” Examples of the activities included difficulty sitting for more than 2 hours, difficulty participating in social activities or difficulty pushing or pulling an object the size of a living room chair.

Over the 2 decades analyzed, the adjusted prevalence of functional limitation was highest among survivors of pancreatic cancer (80.3%) and lung cancer (76.5%). Prevalence was lowest for survivors of melanoma (62.2%), breast (61.8%) and prostate (59.5%) cancers.
 

Not just a result of living longer

Mr. Patel told this publication that one assumption people might make when they read these results is that people are just living longer with cancer and losing functional ability accordingly.

“But, in fact, we found that the youngest [– those less than 65 years–] actually contributed to this trend more than the oldest people, which means it’s not just [happening], because people are getting older,” he said.

Hispanic and Black individuals had disproportionately higher increases in functional limitation; percentage point increases over the 2 decades were 19.5 for Black people, 25.1 for Hispanic people and 12.5 for White people. There may be a couple of reasons for that, Mr. Patel noted.

Those who are Black or Hispanic tend to have less access to cancer survivorship care for reasons including insurance status and historic health care inequities, he noted.

“The other potential reason is that they have had less access to cancer care historically. And if, 20 years ago Black and Hispanic individuals didn’t have access to some chemotherapies, and now they do, maybe it’s the increased access to care that’s causing these functional limitations. Because chemotherapy can sometimes be very toxic. It may be sort of a catch-up toxicity,” he said.
 

Quality of life beyond survivorship

Mr. Patel said the results seem to call for building on improved survival rates by tracking and improving function.

“It’s good to celebrate that there are more survivors. But now that we can keep people alive longer, maybe we can shift gears to improving their quality of life,” he said.

The more-than-doubling of functional limitations over 2 decades “is a very sobering trend,” he noted, while pointing out that the functional limitations applied to 8 million people in the United States – people whose needs are not being met.

There’s no sign of the trend stopping, he continued. “We saw no downward trend, only an upward trend.”

Increasingly, including functionality as an endpoint in cancer trials, in addition to improvements in mortality, is one place to start, he added.

“Our findings suggest an urgent need for care teams to understand and address function, for researchers to evaluate function as a core outcome in trials, and for health systems and policy makers to reimagine survivorship care, recognizing the burden of cancer and its treatment on physical, psychosocial, and cognitive function,” the authors wrote in their paper. Limitations of the study include the potential for recall bias, lack of cancer staging or treatment information, and the subjective perception of function.

A coauthor reported personal fees from Astellas, AstraZeneca, AAA, Blue Earth, Janssen, Lantheus, Myovant, Myriad Genetics, Novartis, Telix, and Sanofi, as well as grants from Pfizer and Bayer during the conduct of the study. No other disclosures were reported.

The number of cancer survivors who report functional limitation has more than doubled in 20 years, according to a research letter published in JAMA Oncology.

Vishal Patel, BS, a student at the Dell Medical School at The University of Texas at Austin, and colleagues identified 51,258 cancer survivors from the National Health Interview Survey, representing a weighted population of approximately 178.8 million from 1999 to 2018.

Most survivors were women (60.2%) and were at least 65 years old (55.4%). In 1999, 3.6 million weighted survivors reported functional limitation. In 2018, the number increased to 8.2 million, a 2.25-fold increase.

The number of survivors who reported no limitations also increased, but not by as much. That group grew 1.34-fold during the study period.

For context, “the 70% prevalence of functional limitation among survivors in 2018 is nearly twice that of the general population,” the authors wrote.
 

Patients surveyed on function

Functional limitation was defined as “self-reported difficulty performing any of 12 routine physical or social activities without assistance.” Examples of the activities included difficulty sitting for more than 2 hours, difficulty participating in social activities or difficulty pushing or pulling an object the size of a living room chair.

Over the 2 decades analyzed, the adjusted prevalence of functional limitation was highest among survivors of pancreatic cancer (80.3%) and lung cancer (76.5%). Prevalence was lowest for survivors of melanoma (62.2%), breast (61.8%) and prostate (59.5%) cancers.
 

Not just a result of living longer

Mr. Patel told this publication that one assumption people might make when they read these results is that people are just living longer with cancer and losing functional ability accordingly.

“But, in fact, we found that the youngest [– those less than 65 years–] actually contributed to this trend more than the oldest people, which means it’s not just [happening], because people are getting older,” he said.

Hispanic and Black individuals had disproportionately higher increases in functional limitation; percentage point increases over the 2 decades were 19.5 for Black people, 25.1 for Hispanic people and 12.5 for White people. There may be a couple of reasons for that, Mr. Patel noted.

Those who are Black or Hispanic tend to have less access to cancer survivorship care for reasons including insurance status and historic health care inequities, he noted.

“The other potential reason is that they have had less access to cancer care historically. And if, 20 years ago Black and Hispanic individuals didn’t have access to some chemotherapies, and now they do, maybe it’s the increased access to care that’s causing these functional limitations. Because chemotherapy can sometimes be very toxic. It may be sort of a catch-up toxicity,” he said.
 

Quality of life beyond survivorship

Mr. Patel said the results seem to call for building on improved survival rates by tracking and improving function.

“It’s good to celebrate that there are more survivors. But now that we can keep people alive longer, maybe we can shift gears to improving their quality of life,” he said.

The more-than-doubling of functional limitations over 2 decades “is a very sobering trend,” he noted, while pointing out that the functional limitations applied to 8 million people in the United States – people whose needs are not being met.

There’s no sign of the trend stopping, he continued. “We saw no downward trend, only an upward trend.”

Increasingly, including functionality as an endpoint in cancer trials, in addition to improvements in mortality, is one place to start, he added.

“Our findings suggest an urgent need for care teams to understand and address function, for researchers to evaluate function as a core outcome in trials, and for health systems and policy makers to reimagine survivorship care, recognizing the burden of cancer and its treatment on physical, psychosocial, and cognitive function,” the authors wrote in their paper. Limitations of the study include the potential for recall bias, lack of cancer staging or treatment information, and the subjective perception of function.

A coauthor reported personal fees from Astellas, AstraZeneca, AAA, Blue Earth, Janssen, Lantheus, Myovant, Myriad Genetics, Novartis, Telix, and Sanofi, as well as grants from Pfizer and Bayer during the conduct of the study. No other disclosures were reported.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA ONCOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Radiofrequency ablation successful in small thyroid cancers

Article Type
Changed
Mon, 05/08/2023 - 14:58

Radiofrequency ablation (RFA) appears safe and effective for the treatment of low-risk papillary thyroid microcarcinoma (PTMC), new data suggest.

RFA is increasingly gaining favor as a less-invasive alternative to surgery for patients with large, symptomatic, benign thyroid nodules in the United States and elsewhere and for the treatment of thyroid microcarcinomas in other countries, particularly South Korea and China.

Now, new findings from eight patients seen at the Mayo Clinic are the first to be reported for use of RFA for PTMC in the United States, Kharisa Rachmasari, MD, an endocrinology fellow at Mayo, said at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.

Papillary thyroid cancers of 10 mm or less are the most common thyroid cancers, and their incidence is rising. They are commonly discovered incidentally in the setting of increased cross-sectional imaging. These tiny cancers are typically indolent, and they are associated with an excellent prognosis. In the United States, standard management is either surveillance or surgery, whereas RFA has been used in Europe and Asia for more than a decade, Dr. Rachmasari said.

“There has been some hesitancy when it comes to cancer, because there’s no guarantee that we can do it in such a clean way as is done with surgery, where you can actually confirm a negative margin in pathology. And the follow-up is easier as well. With RFA, the PTMC is still there, and you can only follow it with ultrasound, not biochemically with thyroglobulin or certain biomarkers,” she said in an interview.

Nonetheless, for these eight patients who underwent the procedure at Mayo’s ablation clinic, where interventional radiologists team up with endocrinologists, there were no serious adverse events, and no further interventions were required during 24 months of follow-up, she reported.

Asked to comment, session moderator Anupam Kotwal, MD, assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha, said, “It’s very novel. We talk about balancing the comorbidities that come from treatment of thyroid cancer, but at the same time we want to treat it appropriately ... And of course, there are patient factors. Some may prefer to have the cancer completely out, while others are okay with watching and are against any cuts in their neck. This comes as kind of a middle ground.”

But, Dr. Kotwal added, “[Investigators] definitely need to do a bit more work, especially in the population that may be at higher risk of cancer spread, such as those with a family history of thyroid cancer. We still don’t know how autoimmune disease influences cancer progression.”

He said that if RFA is to be used for PTMC, “I think it has to be done at a center that specializes in multidisciplinary care of thyroid cancers where there are not only the experts in doing the RFA procedure but also surgical expertise, in case a complication does happen, like a vocal cord injury. Or if the cancer is growing, they can expedite getting the person that appropriate treatment.”
 

An alternative to waiting vs. surgery?

The eight patients were seen at Mayo Clinic between July 2020 and February 2023. All had papillary thyroid carcinoma that was confirmed cytologically via fine-needle biopsy and single lesions without lymph node metastasis. All patients had been offered RFA as an alternative to either surgery or active surveillance.

Seven patients were female, and one was male (mean age, 53 years). All were euthyroid at baseline, and two were receiving thyroid hormone therapy. The mean diameter of their nodules was 9.5 mm, and the mean volume was 0.3 mL.

For the first six patients, the procedure was conducted under general anesthesia; deep sedation was used for the next patient, and moderate sedation was used for the most recent. “As we learn more and gain more experience, patients nowadays have moderate sedation,” she explained.

The active tip size was 10 mm for five patients and 7 mm with three. The radiofrequency power that was delivered ranged from 25 to 45 watts. The median ablation duration was 6 minutes and ranged from 2 to 14.5. “Patients usually stay in the suite about half an hour, so it’s a quick procedure, and the patient can go home on the same day,” Dr. Rachmasari said.

Following the procedure, the ablated area increased in size during the first 3-6 months because the ablation was applied beyond the cancer margins in an attempt to ensure a negative margin, as is done surgically. By 18 months, the ablated area had shrunk and resolved.

All patients remained euthyroid in 18-24 months’ follow-up, none had any cervical adenopathy, and none required subsequent intervention.

No significant adverse events were observed during or after the RFA procedure. A few patients complained of erythema and soreness around the area of the procedure, but this resolved with over-the-counter analgesia.

Longer follow-up will be necessary to detect any recurrence, Dr. Rachmasari noted.

Dr. Kotwal pointed out that lack of reimbursement for RFA has contributed to the slow adoption of RFA overall for the treatment of thyroid nodules in the United States, but added, “I think that will change quickly, especially with more and more data coming out about large benign nodules ... I think at least from the benign nodule standpoint, with discussions happening at national meetings and societies, it should push the payers to cover.”

Overall, he said, “If you have a complication or it affects quality of life, all of those things add to the cost. So if you can use a procedure early on to prevent increasing size of either the big nodule or reduce the size of a big nodule, or even a small cancer, and give that person months or years, even if they ultimately need surgery, I think that’s still a benefit for their quality of life. But again, we have to take patient factors into account.”

Dr. Rachmasari and Dr. Kotwal have disclosed no relevant financial relationships.
 

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

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

Radiofrequency ablation (RFA) appears safe and effective for the treatment of low-risk papillary thyroid microcarcinoma (PTMC), new data suggest.

RFA is increasingly gaining favor as a less-invasive alternative to surgery for patients with large, symptomatic, benign thyroid nodules in the United States and elsewhere and for the treatment of thyroid microcarcinomas in other countries, particularly South Korea and China.

Now, new findings from eight patients seen at the Mayo Clinic are the first to be reported for use of RFA for PTMC in the United States, Kharisa Rachmasari, MD, an endocrinology fellow at Mayo, said at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.

Papillary thyroid cancers of 10 mm or less are the most common thyroid cancers, and their incidence is rising. They are commonly discovered incidentally in the setting of increased cross-sectional imaging. These tiny cancers are typically indolent, and they are associated with an excellent prognosis. In the United States, standard management is either surveillance or surgery, whereas RFA has been used in Europe and Asia for more than a decade, Dr. Rachmasari said.

“There has been some hesitancy when it comes to cancer, because there’s no guarantee that we can do it in such a clean way as is done with surgery, where you can actually confirm a negative margin in pathology. And the follow-up is easier as well. With RFA, the PTMC is still there, and you can only follow it with ultrasound, not biochemically with thyroglobulin or certain biomarkers,” she said in an interview.

Nonetheless, for these eight patients who underwent the procedure at Mayo’s ablation clinic, where interventional radiologists team up with endocrinologists, there were no serious adverse events, and no further interventions were required during 24 months of follow-up, she reported.

Asked to comment, session moderator Anupam Kotwal, MD, assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha, said, “It’s very novel. We talk about balancing the comorbidities that come from treatment of thyroid cancer, but at the same time we want to treat it appropriately ... And of course, there are patient factors. Some may prefer to have the cancer completely out, while others are okay with watching and are against any cuts in their neck. This comes as kind of a middle ground.”

But, Dr. Kotwal added, “[Investigators] definitely need to do a bit more work, especially in the population that may be at higher risk of cancer spread, such as those with a family history of thyroid cancer. We still don’t know how autoimmune disease influences cancer progression.”

He said that if RFA is to be used for PTMC, “I think it has to be done at a center that specializes in multidisciplinary care of thyroid cancers where there are not only the experts in doing the RFA procedure but also surgical expertise, in case a complication does happen, like a vocal cord injury. Or if the cancer is growing, they can expedite getting the person that appropriate treatment.”
 

An alternative to waiting vs. surgery?

The eight patients were seen at Mayo Clinic between July 2020 and February 2023. All had papillary thyroid carcinoma that was confirmed cytologically via fine-needle biopsy and single lesions without lymph node metastasis. All patients had been offered RFA as an alternative to either surgery or active surveillance.

Seven patients were female, and one was male (mean age, 53 years). All were euthyroid at baseline, and two were receiving thyroid hormone therapy. The mean diameter of their nodules was 9.5 mm, and the mean volume was 0.3 mL.

For the first six patients, the procedure was conducted under general anesthesia; deep sedation was used for the next patient, and moderate sedation was used for the most recent. “As we learn more and gain more experience, patients nowadays have moderate sedation,” she explained.

The active tip size was 10 mm for five patients and 7 mm with three. The radiofrequency power that was delivered ranged from 25 to 45 watts. The median ablation duration was 6 minutes and ranged from 2 to 14.5. “Patients usually stay in the suite about half an hour, so it’s a quick procedure, and the patient can go home on the same day,” Dr. Rachmasari said.

Following the procedure, the ablated area increased in size during the first 3-6 months because the ablation was applied beyond the cancer margins in an attempt to ensure a negative margin, as is done surgically. By 18 months, the ablated area had shrunk and resolved.

All patients remained euthyroid in 18-24 months’ follow-up, none had any cervical adenopathy, and none required subsequent intervention.

No significant adverse events were observed during or after the RFA procedure. A few patients complained of erythema and soreness around the area of the procedure, but this resolved with over-the-counter analgesia.

Longer follow-up will be necessary to detect any recurrence, Dr. Rachmasari noted.

Dr. Kotwal pointed out that lack of reimbursement for RFA has contributed to the slow adoption of RFA overall for the treatment of thyroid nodules in the United States, but added, “I think that will change quickly, especially with more and more data coming out about large benign nodules ... I think at least from the benign nodule standpoint, with discussions happening at national meetings and societies, it should push the payers to cover.”

Overall, he said, “If you have a complication or it affects quality of life, all of those things add to the cost. So if you can use a procedure early on to prevent increasing size of either the big nodule or reduce the size of a big nodule, or even a small cancer, and give that person months or years, even if they ultimately need surgery, I think that’s still a benefit for their quality of life. But again, we have to take patient factors into account.”

Dr. Rachmasari and Dr. Kotwal have disclosed no relevant financial relationships.
 

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

Radiofrequency ablation (RFA) appears safe and effective for the treatment of low-risk papillary thyroid microcarcinoma (PTMC), new data suggest.

RFA is increasingly gaining favor as a less-invasive alternative to surgery for patients with large, symptomatic, benign thyroid nodules in the United States and elsewhere and for the treatment of thyroid microcarcinomas in other countries, particularly South Korea and China.

Now, new findings from eight patients seen at the Mayo Clinic are the first to be reported for use of RFA for PTMC in the United States, Kharisa Rachmasari, MD, an endocrinology fellow at Mayo, said at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.

Papillary thyroid cancers of 10 mm or less are the most common thyroid cancers, and their incidence is rising. They are commonly discovered incidentally in the setting of increased cross-sectional imaging. These tiny cancers are typically indolent, and they are associated with an excellent prognosis. In the United States, standard management is either surveillance or surgery, whereas RFA has been used in Europe and Asia for more than a decade, Dr. Rachmasari said.

“There has been some hesitancy when it comes to cancer, because there’s no guarantee that we can do it in such a clean way as is done with surgery, where you can actually confirm a negative margin in pathology. And the follow-up is easier as well. With RFA, the PTMC is still there, and you can only follow it with ultrasound, not biochemically with thyroglobulin or certain biomarkers,” she said in an interview.

Nonetheless, for these eight patients who underwent the procedure at Mayo’s ablation clinic, where interventional radiologists team up with endocrinologists, there were no serious adverse events, and no further interventions were required during 24 months of follow-up, she reported.

Asked to comment, session moderator Anupam Kotwal, MD, assistant professor in the division of diabetes, endocrinology and metabolism at the University of Nebraska, Omaha, said, “It’s very novel. We talk about balancing the comorbidities that come from treatment of thyroid cancer, but at the same time we want to treat it appropriately ... And of course, there are patient factors. Some may prefer to have the cancer completely out, while others are okay with watching and are against any cuts in their neck. This comes as kind of a middle ground.”

But, Dr. Kotwal added, “[Investigators] definitely need to do a bit more work, especially in the population that may be at higher risk of cancer spread, such as those with a family history of thyroid cancer. We still don’t know how autoimmune disease influences cancer progression.”

He said that if RFA is to be used for PTMC, “I think it has to be done at a center that specializes in multidisciplinary care of thyroid cancers where there are not only the experts in doing the RFA procedure but also surgical expertise, in case a complication does happen, like a vocal cord injury. Or if the cancer is growing, they can expedite getting the person that appropriate treatment.”
 

An alternative to waiting vs. surgery?

The eight patients were seen at Mayo Clinic between July 2020 and February 2023. All had papillary thyroid carcinoma that was confirmed cytologically via fine-needle biopsy and single lesions without lymph node metastasis. All patients had been offered RFA as an alternative to either surgery or active surveillance.

Seven patients were female, and one was male (mean age, 53 years). All were euthyroid at baseline, and two were receiving thyroid hormone therapy. The mean diameter of their nodules was 9.5 mm, and the mean volume was 0.3 mL.

For the first six patients, the procedure was conducted under general anesthesia; deep sedation was used for the next patient, and moderate sedation was used for the most recent. “As we learn more and gain more experience, patients nowadays have moderate sedation,” she explained.

The active tip size was 10 mm for five patients and 7 mm with three. The radiofrequency power that was delivered ranged from 25 to 45 watts. The median ablation duration was 6 minutes and ranged from 2 to 14.5. “Patients usually stay in the suite about half an hour, so it’s a quick procedure, and the patient can go home on the same day,” Dr. Rachmasari said.

Following the procedure, the ablated area increased in size during the first 3-6 months because the ablation was applied beyond the cancer margins in an attempt to ensure a negative margin, as is done surgically. By 18 months, the ablated area had shrunk and resolved.

All patients remained euthyroid in 18-24 months’ follow-up, none had any cervical adenopathy, and none required subsequent intervention.

No significant adverse events were observed during or after the RFA procedure. A few patients complained of erythema and soreness around the area of the procedure, but this resolved with over-the-counter analgesia.

Longer follow-up will be necessary to detect any recurrence, Dr. Rachmasari noted.

Dr. Kotwal pointed out that lack of reimbursement for RFA has contributed to the slow adoption of RFA overall for the treatment of thyroid nodules in the United States, but added, “I think that will change quickly, especially with more and more data coming out about large benign nodules ... I think at least from the benign nodule standpoint, with discussions happening at national meetings and societies, it should push the payers to cover.”

Overall, he said, “If you have a complication or it affects quality of life, all of those things add to the cost. So if you can use a procedure early on to prevent increasing size of either the big nodule or reduce the size of a big nodule, or even a small cancer, and give that person months or years, even if they ultimately need surgery, I think that’s still a benefit for their quality of life. But again, we have to take patient factors into account.”

Dr. Rachmasari and Dr. Kotwal have disclosed no relevant financial relationships.
 

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

Publications
Publications
Topics
Article Type
Sections
Article Source

AT AACE 2023

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Study shows higher obesity-related cancer mortality in areas with more fast food

Article Type
Changed
Sun, 05/07/2023 - 00:56

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

 

 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

Publications
Topics
Sections

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

 

 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

Communities with easy access to fast food were 77% more likely to have high levels of obesity-related cancer mortality, based on data from a new cross-sectional study of more than 3,000 communities.

Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.

In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.

“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.

In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.

Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.

The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).

Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.

A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).

Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.

The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.

The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
 

 

 

Community-level investments can benefit individual health

Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.  

“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said. 

“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.

Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
 

Data provide foundation for multilevel interventions

The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.

The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.

The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.

“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.

The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA ONCOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Prostate cancer drug shortage leaves some with uncertainty

Article Type
Changed
Thu, 03/23/2023 - 10:56

 

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

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

Publications
Topics
Sections

 

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

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

 

A radioligand treatment approved for certain men with metastatic castration-resistant prostate cancer is in short supply because of manufacturing and delivery issues, according to the Food and Drug Administration. 

The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.

In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.

“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”

Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.

Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States. 

The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.

Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.

Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”

Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

COVID can mimic prostate cancer symptoms

Article Type
Changed
Wed, 03/22/2023 - 10:21

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study2 of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies3 have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

Publications
Topics
Sections

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study2 of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies3 have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study2 of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies3 have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Increased cancer in military pilots and ground crew: Pentagon

Article Type
Changed
Mon, 03/20/2023 - 12:56

New data released by the U.S. Department of Defense show that the incidence of many types of cancer is higher among military pilots and aviation support personnel in comparison with the general population.

“Military aircrew and ground crew were overall more likely to be diagnosed with cancer, but less likely to die from cancer compared to the U.S. population,” the report concludes.

The study involved 156,050 aircrew and 737,891 ground crew. Participants were followed between 1992 and 2017. Both groups were predominantly male and non-Hispanic.

Data on cancer incidence and mortality for these two groups were compared with data from groups of similar age in the general population through use of the Surveillance, Epidemiology, and End Results (SEER) Database of the National Cancer Institute.

For aircrew, the study found an 87% higher rate of melanoma, a 39% higher rate of thyroid cancer, a 16% higher rate of prostate cancer, and a 24% higher rate of cancer for all sites combined.

A higher rate of melanoma and prostate cancer among aircrew has been reported previously, but the increased rate of thyroid cancer is a new finding, the authors note.

The uptick in melanoma has also been reported in studies of civilian pilots and cabin crew. It has been attributed to exposure to hazardous ultraviolet and cosmic radiation.

For ground crew members, the analysis found a 19% higher rate of cancers of the brain and nervous system, a 15% higher rate of thyroid cancer, a 9% higher rate of melanoma and of kidney and renal pelvis cancers, and a 3% higher rate of cancer for all sites combined.

There is little to compare these findings with: This is the first time that cancer risk has been evaluated in such a large population of military ground crew.
 

Lower rates of cancer mortality

In contrast to the increase in cancer incidence, the report found a decrease in cancer mortality.

When compared with a demographically similar U.S. population, the mortality rate among aircrew was 56% lower for all cancer sites; for ground crew, the mortality rate was 35% lower.

However, the report authors emphasize that “it is important to note that the military study population was relatively young.”

The median age at the end of follow-up for the cancer incidence analysis was 41 years for aircrew and 26 years for ground crew. The median age at the end of follow-up for the cancer mortality analysis was 48 years for aircrew and 41 years for ground crew.

“Results may have differed if additional older former Service members had been included in the study, since cancer risk and mortality rates increase with age,” the authors comment.

Other studies have found an increase in deaths from melanoma as well as an increase in the incidence of melanoma. A meta-analysis published in 2019 in the British Journal of Dermatology found that airline pilots and cabin crew have about twice the risk of melanoma and other skin cancers than the general population. Pilots are also more likely to die from melanoma.
 

Further study underway

The findings on military air and ground crew come from phase 1 of a study that was required by Congress in the 2021 defense bill. Because the investigators found an increase in the incidence of cancer, phase 2 of the study is now necessary.

The report authors explain that phase 2 will consist of identifying the carcinogenic toxicants or hazardous materials associated with military flight operations; identifying operating environments that could be associated with increased amounts of ionizing and nonionizing radiation; identifying specific duties, dates of service, and types of aircraft flown that could have increased the risk for cancer; identifying duty locations associated with a higher incidence of cancers; identifying potential exposures through military service that are not related to aviation; and determining the appropriate age to begin screening military aircrew and ground crew for cancers.

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

Publications
Topics
Sections

New data released by the U.S. Department of Defense show that the incidence of many types of cancer is higher among military pilots and aviation support personnel in comparison with the general population.

“Military aircrew and ground crew were overall more likely to be diagnosed with cancer, but less likely to die from cancer compared to the U.S. population,” the report concludes.

The study involved 156,050 aircrew and 737,891 ground crew. Participants were followed between 1992 and 2017. Both groups were predominantly male and non-Hispanic.

Data on cancer incidence and mortality for these two groups were compared with data from groups of similar age in the general population through use of the Surveillance, Epidemiology, and End Results (SEER) Database of the National Cancer Institute.

For aircrew, the study found an 87% higher rate of melanoma, a 39% higher rate of thyroid cancer, a 16% higher rate of prostate cancer, and a 24% higher rate of cancer for all sites combined.

A higher rate of melanoma and prostate cancer among aircrew has been reported previously, but the increased rate of thyroid cancer is a new finding, the authors note.

The uptick in melanoma has also been reported in studies of civilian pilots and cabin crew. It has been attributed to exposure to hazardous ultraviolet and cosmic radiation.

For ground crew members, the analysis found a 19% higher rate of cancers of the brain and nervous system, a 15% higher rate of thyroid cancer, a 9% higher rate of melanoma and of kidney and renal pelvis cancers, and a 3% higher rate of cancer for all sites combined.

There is little to compare these findings with: This is the first time that cancer risk has been evaluated in such a large population of military ground crew.
 

Lower rates of cancer mortality

In contrast to the increase in cancer incidence, the report found a decrease in cancer mortality.

When compared with a demographically similar U.S. population, the mortality rate among aircrew was 56% lower for all cancer sites; for ground crew, the mortality rate was 35% lower.

However, the report authors emphasize that “it is important to note that the military study population was relatively young.”

The median age at the end of follow-up for the cancer incidence analysis was 41 years for aircrew and 26 years for ground crew. The median age at the end of follow-up for the cancer mortality analysis was 48 years for aircrew and 41 years for ground crew.

“Results may have differed if additional older former Service members had been included in the study, since cancer risk and mortality rates increase with age,” the authors comment.

Other studies have found an increase in deaths from melanoma as well as an increase in the incidence of melanoma. A meta-analysis published in 2019 in the British Journal of Dermatology found that airline pilots and cabin crew have about twice the risk of melanoma and other skin cancers than the general population. Pilots are also more likely to die from melanoma.
 

Further study underway

The findings on military air and ground crew come from phase 1 of a study that was required by Congress in the 2021 defense bill. Because the investigators found an increase in the incidence of cancer, phase 2 of the study is now necessary.

The report authors explain that phase 2 will consist of identifying the carcinogenic toxicants or hazardous materials associated with military flight operations; identifying operating environments that could be associated with increased amounts of ionizing and nonionizing radiation; identifying specific duties, dates of service, and types of aircraft flown that could have increased the risk for cancer; identifying duty locations associated with a higher incidence of cancers; identifying potential exposures through military service that are not related to aviation; and determining the appropriate age to begin screening military aircrew and ground crew for cancers.

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

New data released by the U.S. Department of Defense show that the incidence of many types of cancer is higher among military pilots and aviation support personnel in comparison with the general population.

“Military aircrew and ground crew were overall more likely to be diagnosed with cancer, but less likely to die from cancer compared to the U.S. population,” the report concludes.

The study involved 156,050 aircrew and 737,891 ground crew. Participants were followed between 1992 and 2017. Both groups were predominantly male and non-Hispanic.

Data on cancer incidence and mortality for these two groups were compared with data from groups of similar age in the general population through use of the Surveillance, Epidemiology, and End Results (SEER) Database of the National Cancer Institute.

For aircrew, the study found an 87% higher rate of melanoma, a 39% higher rate of thyroid cancer, a 16% higher rate of prostate cancer, and a 24% higher rate of cancer for all sites combined.

A higher rate of melanoma and prostate cancer among aircrew has been reported previously, but the increased rate of thyroid cancer is a new finding, the authors note.

The uptick in melanoma has also been reported in studies of civilian pilots and cabin crew. It has been attributed to exposure to hazardous ultraviolet and cosmic radiation.

For ground crew members, the analysis found a 19% higher rate of cancers of the brain and nervous system, a 15% higher rate of thyroid cancer, a 9% higher rate of melanoma and of kidney and renal pelvis cancers, and a 3% higher rate of cancer for all sites combined.

There is little to compare these findings with: This is the first time that cancer risk has been evaluated in such a large population of military ground crew.
 

Lower rates of cancer mortality

In contrast to the increase in cancer incidence, the report found a decrease in cancer mortality.

When compared with a demographically similar U.S. population, the mortality rate among aircrew was 56% lower for all cancer sites; for ground crew, the mortality rate was 35% lower.

However, the report authors emphasize that “it is important to note that the military study population was relatively young.”

The median age at the end of follow-up for the cancer incidence analysis was 41 years for aircrew and 26 years for ground crew. The median age at the end of follow-up for the cancer mortality analysis was 48 years for aircrew and 41 years for ground crew.

“Results may have differed if additional older former Service members had been included in the study, since cancer risk and mortality rates increase with age,” the authors comment.

Other studies have found an increase in deaths from melanoma as well as an increase in the incidence of melanoma. A meta-analysis published in 2019 in the British Journal of Dermatology found that airline pilots and cabin crew have about twice the risk of melanoma and other skin cancers than the general population. Pilots are also more likely to die from melanoma.
 

Further study underway

The findings on military air and ground crew come from phase 1 of a study that was required by Congress in the 2021 defense bill. Because the investigators found an increase in the incidence of cancer, phase 2 of the study is now necessary.

The report authors explain that phase 2 will consist of identifying the carcinogenic toxicants or hazardous materials associated with military flight operations; identifying operating environments that could be associated with increased amounts of ionizing and nonionizing radiation; identifying specific duties, dates of service, and types of aircraft flown that could have increased the risk for cancer; identifying duty locations associated with a higher incidence of cancers; identifying potential exposures through military service that are not related to aviation; and determining the appropriate age to begin screening military aircrew and ground crew for cancers.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article