From the editor: Building community - Introducing Member Spotlight

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Happy New Year, everyone! In early December, I attended the 2022 AGA Women’s Leadership Collaboration Conference to discuss strategies to promote gender equity in our profession. It was an inspiring weekend and reminded me how many talented individuals we have in the field of gastroenterology, all with fascinating personal and professional stories and much to contribute. I think I speak for all attendees in saying that it was a privilege to have the opportunity to interact with this amazing group of women leaders, reflect on our shared experiences and visions for the future of GI, and expand our networks.

Dr. Megan A. Adams

This month we are excited to launch a new recurring feature in the newspaper and online – the Member Spotlight column. AGA has more than16,000 members from varied backgrounds. Yet the reality is that each of our individual networks is much smaller, and we would all benefit from learning more about one other and building a greater sense of community. To that end, starting with this issue, we will feature a different AGA member each month in our Member Spotlight column. The goal of this new feature is to recognize AGA members’ accomplishments across all career stages and practice settings, to highlight the diversity of our membership, and to help AGA members feel more connected by learning more about each other. Our inaugural Member Spotlight column highlights Patricia Jones, MD, associate professor at the University of Miami and an accomplished hepatologist. We thank Dr. Jones for sharing her story with us.

This will be a recurring monthly feature, so please consider nominating your colleagues (including trainees, practicing GIs in academics and community practice, those with non-traditional careers or unique pursuits outside of medicine, and others) to be featured in future Member Spotlight columns! It’s a great way for the nominee’s accomplishments to be recognized and to build a sense of community among the broader AGA membership. To submit a nomination, please send the nominee’s name, email, and a brief description of why you are nominating them to: GINews@gastro.org. We look forward to reviewing your submissions and hope you will use these Member Spotlights as an opportunity to strike up a conversation with someone new and expand your networks.

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

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Happy New Year, everyone! In early December, I attended the 2022 AGA Women’s Leadership Collaboration Conference to discuss strategies to promote gender equity in our profession. It was an inspiring weekend and reminded me how many talented individuals we have in the field of gastroenterology, all with fascinating personal and professional stories and much to contribute. I think I speak for all attendees in saying that it was a privilege to have the opportunity to interact with this amazing group of women leaders, reflect on our shared experiences and visions for the future of GI, and expand our networks.

Dr. Megan A. Adams

This month we are excited to launch a new recurring feature in the newspaper and online – the Member Spotlight column. AGA has more than16,000 members from varied backgrounds. Yet the reality is that each of our individual networks is much smaller, and we would all benefit from learning more about one other and building a greater sense of community. To that end, starting with this issue, we will feature a different AGA member each month in our Member Spotlight column. The goal of this new feature is to recognize AGA members’ accomplishments across all career stages and practice settings, to highlight the diversity of our membership, and to help AGA members feel more connected by learning more about each other. Our inaugural Member Spotlight column highlights Patricia Jones, MD, associate professor at the University of Miami and an accomplished hepatologist. We thank Dr. Jones for sharing her story with us.

This will be a recurring monthly feature, so please consider nominating your colleagues (including trainees, practicing GIs in academics and community practice, those with non-traditional careers or unique pursuits outside of medicine, and others) to be featured in future Member Spotlight columns! It’s a great way for the nominee’s accomplishments to be recognized and to build a sense of community among the broader AGA membership. To submit a nomination, please send the nominee’s name, email, and a brief description of why you are nominating them to: GINews@gastro.org. We look forward to reviewing your submissions and hope you will use these Member Spotlights as an opportunity to strike up a conversation with someone new and expand your networks.

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

Happy New Year, everyone! In early December, I attended the 2022 AGA Women’s Leadership Collaboration Conference to discuss strategies to promote gender equity in our profession. It was an inspiring weekend and reminded me how many talented individuals we have in the field of gastroenterology, all with fascinating personal and professional stories and much to contribute. I think I speak for all attendees in saying that it was a privilege to have the opportunity to interact with this amazing group of women leaders, reflect on our shared experiences and visions for the future of GI, and expand our networks.

Dr. Megan A. Adams

This month we are excited to launch a new recurring feature in the newspaper and online – the Member Spotlight column. AGA has more than16,000 members from varied backgrounds. Yet the reality is that each of our individual networks is much smaller, and we would all benefit from learning more about one other and building a greater sense of community. To that end, starting with this issue, we will feature a different AGA member each month in our Member Spotlight column. The goal of this new feature is to recognize AGA members’ accomplishments across all career stages and practice settings, to highlight the diversity of our membership, and to help AGA members feel more connected by learning more about each other. Our inaugural Member Spotlight column highlights Patricia Jones, MD, associate professor at the University of Miami and an accomplished hepatologist. We thank Dr. Jones for sharing her story with us.

This will be a recurring monthly feature, so please consider nominating your colleagues (including trainees, practicing GIs in academics and community practice, those with non-traditional careers or unique pursuits outside of medicine, and others) to be featured in future Member Spotlight columns! It’s a great way for the nominee’s accomplishments to be recognized and to build a sense of community among the broader AGA membership. To submit a nomination, please send the nominee’s name, email, and a brief description of why you are nominating them to: GINews@gastro.org. We look forward to reviewing your submissions and hope you will use these Member Spotlights as an opportunity to strike up a conversation with someone new and expand your networks.

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

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Miami hepatologist leverages Golden Rule to balance work, family, address health equities

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Hepatologist Patricia Denise Jones, MD, recollects the balancing act of going through medical training while caring for her four children.

“I had them at every stage: my first one as a medical student; twins when I was a resident, and my last one at the end of fellowship. It was challenging, trying to put their needs first while trying to be a great doctor, learning how to do research,” said Dr. Jones, an associate professor at the University of Miami Health system.

She has no regrets. “I think I’m a better doctor and colleague because I have children. Showing my kids how important it is to help and serve others is one of the best legacies I can leave them.”

University of Miami Miller School of Medicine Sylvester Comprehensive Cancer Center
Dr. Patricia Jones

If there’s anything she’d like to fix, it’s the healthcare delivery system for patients disproportionately affected by liver disease.

Dr. Jones was selected as 1 of 10 scholars in the inaugural cohort of the National Institutes of Health–funded program Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) where she participated in a 2-year program of leadership development, mentorship, and research skills development.

In an interview, Dr. Jones discussed her life’s work to address and research disparities in liver disease and cancer – and the motto that gets her through every day.

Q: Describe your current practice. What gives you the most joy in your day-to-day practice?

Dr. Jones: Being able to make a difference in the lives of patients. A lot of the patients that I take care of have difficulty navigating the health system. That’s the population I feel most inclined to serve. It’s always rewarding to help someone make a connection that they couldn’t make on their own or help them understand something that wasn’t clear. Knowing that you’re helping someone to live a healthier life is deeply gratifying.



Q: Tell me about your patient population.

Dr. Jones: My focus is patients with liver cancer, hepatocellular carcinoma specifically, and cirrhosis patients. They tend to be sick relative to most Americans. I also take care of people who have other forms of liver disease like fatty liver and viral hepatitis. I live in Miami, so most of the patients that I take care of are going to be Hispanic. A good percentage are immigrants with limited health literacy.

Q: What is your biggest practice-related challenge? What are you doing to address it?

Dr. Jones: Lack of insurance and underinsurance. One patient of mine with Medicare and Humana has a carve out: She can see me and some of my colleagues but not the oncologist or a radiation oncologist. For her to be seen in our center, she would have to get a referral from a doctor in a different county. This makes no sense. It’s a hard problem to solve. To me, that’s the most challenging thing – not being able to help when something is beyond my control, beyond what I understand, and translating it into action. 

 

 

Q: What general principles guide you in your professional and personal life?

Dr. Jones: I try to think of the Golden Rule in every encounter with a person, either in clinic or in real life, as if they were my mother or sister. If I’m frustrated or having a bad day, what would I want that person’s experience to be with their doctor? I also try to assume the best possible intent with people.

Latosha Y. Flowers, MD
Dr. Patricia Jones in Tanzania.

Q: What teacher, mentor, or other influences had the greatest impact on you?

Dr. Jones: My father. He started out as a salesman, worked in legislation, and then retired early to focus on and build up our community, making sure that we were better off than we were before. In terms of my professional life, Robert Sandler, MD is one of my greatest mentors. He is at the University of North Carolina and was the division chief of gastroenterology. He saw potential in me and supports me to this day. If you need something, he’s there. If you need him to comment on your draft, he’s very reliable and gives you great, critical feedback.
 

Q: In 10 years, what do you hope you are doing or what do you hope you have accomplished?

Dr. Jones: In 10 years, I hope that my efforts will have revolutionized our approach to delivering care to vulnerable populations. Much of the work that has been done thus far in the field of disparities and liver disease has focused on describing the inequities. However, I have just started working in health equity. This will require partnering with patients and caregivers to get a better understanding of their needs and collaborating with legislators to increase funding directed towards building the infrastructure necessary to deliver health care to those who have been forgotten.

Lightning round questions

Favorite movie, show, or book
Forrest Gump, Blackish, anything by Toni Morrison

Favorite music genre
Hip Hop

Favorite food
Seafood

Favorite travel destination
Tanzania

Your ideal type of pet
Dog

Optimist or pessimist?
Optimist!

Dr. Jones is on Twitter @DrLiverPatty.

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Hepatologist Patricia Denise Jones, MD, recollects the balancing act of going through medical training while caring for her four children.

“I had them at every stage: my first one as a medical student; twins when I was a resident, and my last one at the end of fellowship. It was challenging, trying to put their needs first while trying to be a great doctor, learning how to do research,” said Dr. Jones, an associate professor at the University of Miami Health system.

She has no regrets. “I think I’m a better doctor and colleague because I have children. Showing my kids how important it is to help and serve others is one of the best legacies I can leave them.”

University of Miami Miller School of Medicine Sylvester Comprehensive Cancer Center
Dr. Patricia Jones

If there’s anything she’d like to fix, it’s the healthcare delivery system for patients disproportionately affected by liver disease.

Dr. Jones was selected as 1 of 10 scholars in the inaugural cohort of the National Institutes of Health–funded program Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) where she participated in a 2-year program of leadership development, mentorship, and research skills development.

In an interview, Dr. Jones discussed her life’s work to address and research disparities in liver disease and cancer – and the motto that gets her through every day.

Q: Describe your current practice. What gives you the most joy in your day-to-day practice?

Dr. Jones: Being able to make a difference in the lives of patients. A lot of the patients that I take care of have difficulty navigating the health system. That’s the population I feel most inclined to serve. It’s always rewarding to help someone make a connection that they couldn’t make on their own or help them understand something that wasn’t clear. Knowing that you’re helping someone to live a healthier life is deeply gratifying.



Q: Tell me about your patient population.

Dr. Jones: My focus is patients with liver cancer, hepatocellular carcinoma specifically, and cirrhosis patients. They tend to be sick relative to most Americans. I also take care of people who have other forms of liver disease like fatty liver and viral hepatitis. I live in Miami, so most of the patients that I take care of are going to be Hispanic. A good percentage are immigrants with limited health literacy.

Q: What is your biggest practice-related challenge? What are you doing to address it?

Dr. Jones: Lack of insurance and underinsurance. One patient of mine with Medicare and Humana has a carve out: She can see me and some of my colleagues but not the oncologist or a radiation oncologist. For her to be seen in our center, she would have to get a referral from a doctor in a different county. This makes no sense. It’s a hard problem to solve. To me, that’s the most challenging thing – not being able to help when something is beyond my control, beyond what I understand, and translating it into action. 

 

 

Q: What general principles guide you in your professional and personal life?

Dr. Jones: I try to think of the Golden Rule in every encounter with a person, either in clinic or in real life, as if they were my mother or sister. If I’m frustrated or having a bad day, what would I want that person’s experience to be with their doctor? I also try to assume the best possible intent with people.

Latosha Y. Flowers, MD
Dr. Patricia Jones in Tanzania.

Q: What teacher, mentor, or other influences had the greatest impact on you?

Dr. Jones: My father. He started out as a salesman, worked in legislation, and then retired early to focus on and build up our community, making sure that we were better off than we were before. In terms of my professional life, Robert Sandler, MD is one of my greatest mentors. He is at the University of North Carolina and was the division chief of gastroenterology. He saw potential in me and supports me to this day. If you need something, he’s there. If you need him to comment on your draft, he’s very reliable and gives you great, critical feedback.
 

Q: In 10 years, what do you hope you are doing or what do you hope you have accomplished?

Dr. Jones: In 10 years, I hope that my efforts will have revolutionized our approach to delivering care to vulnerable populations. Much of the work that has been done thus far in the field of disparities and liver disease has focused on describing the inequities. However, I have just started working in health equity. This will require partnering with patients and caregivers to get a better understanding of their needs and collaborating with legislators to increase funding directed towards building the infrastructure necessary to deliver health care to those who have been forgotten.

Lightning round questions

Favorite movie, show, or book
Forrest Gump, Blackish, anything by Toni Morrison

Favorite music genre
Hip Hop

Favorite food
Seafood

Favorite travel destination
Tanzania

Your ideal type of pet
Dog

Optimist or pessimist?
Optimist!

Dr. Jones is on Twitter @DrLiverPatty.

Hepatologist Patricia Denise Jones, MD, recollects the balancing act of going through medical training while caring for her four children.

“I had them at every stage: my first one as a medical student; twins when I was a resident, and my last one at the end of fellowship. It was challenging, trying to put their needs first while trying to be a great doctor, learning how to do research,” said Dr. Jones, an associate professor at the University of Miami Health system.

She has no regrets. “I think I’m a better doctor and colleague because I have children. Showing my kids how important it is to help and serve others is one of the best legacies I can leave them.”

University of Miami Miller School of Medicine Sylvester Comprehensive Cancer Center
Dr. Patricia Jones

If there’s anything she’d like to fix, it’s the healthcare delivery system for patients disproportionately affected by liver disease.

Dr. Jones was selected as 1 of 10 scholars in the inaugural cohort of the National Institutes of Health–funded program Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) where she participated in a 2-year program of leadership development, mentorship, and research skills development.

In an interview, Dr. Jones discussed her life’s work to address and research disparities in liver disease and cancer – and the motto that gets her through every day.

Q: Describe your current practice. What gives you the most joy in your day-to-day practice?

Dr. Jones: Being able to make a difference in the lives of patients. A lot of the patients that I take care of have difficulty navigating the health system. That’s the population I feel most inclined to serve. It’s always rewarding to help someone make a connection that they couldn’t make on their own or help them understand something that wasn’t clear. Knowing that you’re helping someone to live a healthier life is deeply gratifying.



Q: Tell me about your patient population.

Dr. Jones: My focus is patients with liver cancer, hepatocellular carcinoma specifically, and cirrhosis patients. They tend to be sick relative to most Americans. I also take care of people who have other forms of liver disease like fatty liver and viral hepatitis. I live in Miami, so most of the patients that I take care of are going to be Hispanic. A good percentage are immigrants with limited health literacy.

Q: What is your biggest practice-related challenge? What are you doing to address it?

Dr. Jones: Lack of insurance and underinsurance. One patient of mine with Medicare and Humana has a carve out: She can see me and some of my colleagues but not the oncologist or a radiation oncologist. For her to be seen in our center, she would have to get a referral from a doctor in a different county. This makes no sense. It’s a hard problem to solve. To me, that’s the most challenging thing – not being able to help when something is beyond my control, beyond what I understand, and translating it into action. 

 

 

Q: What general principles guide you in your professional and personal life?

Dr. Jones: I try to think of the Golden Rule in every encounter with a person, either in clinic or in real life, as if they were my mother or sister. If I’m frustrated or having a bad day, what would I want that person’s experience to be with their doctor? I also try to assume the best possible intent with people.

Latosha Y. Flowers, MD
Dr. Patricia Jones in Tanzania.

Q: What teacher, mentor, or other influences had the greatest impact on you?

Dr. Jones: My father. He started out as a salesman, worked in legislation, and then retired early to focus on and build up our community, making sure that we were better off than we were before. In terms of my professional life, Robert Sandler, MD is one of my greatest mentors. He is at the University of North Carolina and was the division chief of gastroenterology. He saw potential in me and supports me to this day. If you need something, he’s there. If you need him to comment on your draft, he’s very reliable and gives you great, critical feedback.
 

Q: In 10 years, what do you hope you are doing or what do you hope you have accomplished?

Dr. Jones: In 10 years, I hope that my efforts will have revolutionized our approach to delivering care to vulnerable populations. Much of the work that has been done thus far in the field of disparities and liver disease has focused on describing the inequities. However, I have just started working in health equity. This will require partnering with patients and caregivers to get a better understanding of their needs and collaborating with legislators to increase funding directed towards building the infrastructure necessary to deliver health care to those who have been forgotten.

Lightning round questions

Favorite movie, show, or book
Forrest Gump, Blackish, anything by Toni Morrison

Favorite music genre
Hip Hop

Favorite food
Seafood

Favorite travel destination
Tanzania

Your ideal type of pet
Dog

Optimist or pessimist?
Optimist!

Dr. Jones is on Twitter @DrLiverPatty.

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Genetic test identifies parental source of cancer variant

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A new hereditary test can determine whether a cancer-disposing gene was inherited from a patient’s father or mother without the need for parental DNA, potentially improving disease screening and management.

“The presence of parental imprints in regions of the genome has been known for a long time,” study author Peter Lansdorp, MD, PhD, of the BC Cancer Research Centre in Vancouver, said in an interview. In addition, the ability of a specific sequencing technology (Strand-seq) to generate a set of DNA variants that tend to be inherited together from a single parent has been documented in several studies.

“That these two pieces can be put together to assign alleles in a patient to one of the parents without studying the DNA of the parents is a major advance,” said Dr. Lansdorp.

Principal author Steven J.M. Jones, PhD, associate director of bioinformatics at BC Cancer Research Centre, explained, “for directing cascade genetic testing, the test could be used almost immediately, even as a research test. It just guides which side of the family to focus familial genetic testing efforts on and is internally validated by the patient’s variant and later confirmed by clinical testing in the family.”

Directing cascade genetic testing to one side of the family over the other could speed time to diagnosis of more carriers and allow for more efficient use of genetic counseling resources, Dr. Jones added, especially when parents are deceased or unavailable.

The study was published online in Cell Genomics.
 

Low error rate

Determining a parent of origin for hereditary variants “is essential to evaluate disease risk when a pathogenic variant has PofO effects, that is, when a patient’s risk of disease depends on from which parent it is inherited,” the authors wrote. An example is hereditary paraganglioma-pheochromocytoma syndrome as a result of pathogenic variants in SDHD or SDHAF2 genes. Individuals with the variants are at high risk of developing certain cancers, but only if a defective gene is inherited from their father. If inherited from their mother, there is no increased risk.

The new method relies on a technique called “phased DNA methylation” at maternally and paternally imprinted gene loci, as well as chromosome length phasing of DNA sequences.

The team used five human genome “trios” – two parents and the proband (the first person in a family to receive genetic testing or counseling for a suspected hereditary risk) – to pilot the approach. They showed that the method can correctly identify the PofO with an average mismatch error rate of 0.31% for single nucleotide variants and 1.89% for insertions or deletions (indels).

“We will need to validate this technology for different genes in real-world samples from individuals of diverse backgrounds,” said Dr. Jones. The first step is to validate the technology in scenarios with immediate clinical utility, like with SDHD, where lifelong medical management is affected by knowledge of whether the variant was inherited from the mother or father.

“We would also like to quickly validate this for common hereditary cancer genes, like BRCA1, BRCA2, and Lynch syndrome–associated genes, where prediction of PofO may improve low rates of genetic testing in family members by providing more accurate estimates of their risk to carry the familial variant.”

Challenges to moving the test to the clinic, Dr. Jones said, include scaling up the technology, demonstrating clinical and economic utility, compared with existing testing approaches, “and familiarizing clinicians with a new type of test that will routinely give this added dimension of information.”
 

 

 

‘Tremendously promising technology’

Pathologist Stephen Yip, MD, PhD, of the Vancouver Coastal Health Research Institute, who was not involved in the study but disclosed that he collaborates with the authors on other grant-funded projects, said in a comment that “this is a tremendously promising technology that has immediate practical implications in the investigation of PofO of a pathogenic locus, particularly when genetic material is available only from the proband.”

However, “rigorous validation against the current gold standard of short-reading, next-generation sequencing of trios is needed prior to clinical deployment,” he said. “This will take time and effort. However, the promise of this technology is worth the effort.

“Also, there is the possibility of uncovering novel genetics during testing, which could present an ethical dilemma,” he noted. “A robust consenting and ethical framework and early involvement of an ethicist would be helpful.”

Research in Dr. Lansdorp’s laboratory is funded by the Terry Fox Research Institute, the Canadian Institutes of Health Research, the Canadian Foundation for Innovation, and the government of British Columbia. Dr. Lansdorp, Dr. Jones, and Dr. Yip reported no relevant financial relationships.

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

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A new hereditary test can determine whether a cancer-disposing gene was inherited from a patient’s father or mother without the need for parental DNA, potentially improving disease screening and management.

“The presence of parental imprints in regions of the genome has been known for a long time,” study author Peter Lansdorp, MD, PhD, of the BC Cancer Research Centre in Vancouver, said in an interview. In addition, the ability of a specific sequencing technology (Strand-seq) to generate a set of DNA variants that tend to be inherited together from a single parent has been documented in several studies.

“That these two pieces can be put together to assign alleles in a patient to one of the parents without studying the DNA of the parents is a major advance,” said Dr. Lansdorp.

Principal author Steven J.M. Jones, PhD, associate director of bioinformatics at BC Cancer Research Centre, explained, “for directing cascade genetic testing, the test could be used almost immediately, even as a research test. It just guides which side of the family to focus familial genetic testing efforts on and is internally validated by the patient’s variant and later confirmed by clinical testing in the family.”

Directing cascade genetic testing to one side of the family over the other could speed time to diagnosis of more carriers and allow for more efficient use of genetic counseling resources, Dr. Jones added, especially when parents are deceased or unavailable.

The study was published online in Cell Genomics.
 

Low error rate

Determining a parent of origin for hereditary variants “is essential to evaluate disease risk when a pathogenic variant has PofO effects, that is, when a patient’s risk of disease depends on from which parent it is inherited,” the authors wrote. An example is hereditary paraganglioma-pheochromocytoma syndrome as a result of pathogenic variants in SDHD or SDHAF2 genes. Individuals with the variants are at high risk of developing certain cancers, but only if a defective gene is inherited from their father. If inherited from their mother, there is no increased risk.

The new method relies on a technique called “phased DNA methylation” at maternally and paternally imprinted gene loci, as well as chromosome length phasing of DNA sequences.

The team used five human genome “trios” – two parents and the proband (the first person in a family to receive genetic testing or counseling for a suspected hereditary risk) – to pilot the approach. They showed that the method can correctly identify the PofO with an average mismatch error rate of 0.31% for single nucleotide variants and 1.89% for insertions or deletions (indels).

“We will need to validate this technology for different genes in real-world samples from individuals of diverse backgrounds,” said Dr. Jones. The first step is to validate the technology in scenarios with immediate clinical utility, like with SDHD, where lifelong medical management is affected by knowledge of whether the variant was inherited from the mother or father.

“We would also like to quickly validate this for common hereditary cancer genes, like BRCA1, BRCA2, and Lynch syndrome–associated genes, where prediction of PofO may improve low rates of genetic testing in family members by providing more accurate estimates of their risk to carry the familial variant.”

Challenges to moving the test to the clinic, Dr. Jones said, include scaling up the technology, demonstrating clinical and economic utility, compared with existing testing approaches, “and familiarizing clinicians with a new type of test that will routinely give this added dimension of information.”
 

 

 

‘Tremendously promising technology’

Pathologist Stephen Yip, MD, PhD, of the Vancouver Coastal Health Research Institute, who was not involved in the study but disclosed that he collaborates with the authors on other grant-funded projects, said in a comment that “this is a tremendously promising technology that has immediate practical implications in the investigation of PofO of a pathogenic locus, particularly when genetic material is available only from the proband.”

However, “rigorous validation against the current gold standard of short-reading, next-generation sequencing of trios is needed prior to clinical deployment,” he said. “This will take time and effort. However, the promise of this technology is worth the effort.

“Also, there is the possibility of uncovering novel genetics during testing, which could present an ethical dilemma,” he noted. “A robust consenting and ethical framework and early involvement of an ethicist would be helpful.”

Research in Dr. Lansdorp’s laboratory is funded by the Terry Fox Research Institute, the Canadian Institutes of Health Research, the Canadian Foundation for Innovation, and the government of British Columbia. Dr. Lansdorp, Dr. Jones, and Dr. Yip reported no relevant financial relationships.

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

A new hereditary test can determine whether a cancer-disposing gene was inherited from a patient’s father or mother without the need for parental DNA, potentially improving disease screening and management.

“The presence of parental imprints in regions of the genome has been known for a long time,” study author Peter Lansdorp, MD, PhD, of the BC Cancer Research Centre in Vancouver, said in an interview. In addition, the ability of a specific sequencing technology (Strand-seq) to generate a set of DNA variants that tend to be inherited together from a single parent has been documented in several studies.

“That these two pieces can be put together to assign alleles in a patient to one of the parents without studying the DNA of the parents is a major advance,” said Dr. Lansdorp.

Principal author Steven J.M. Jones, PhD, associate director of bioinformatics at BC Cancer Research Centre, explained, “for directing cascade genetic testing, the test could be used almost immediately, even as a research test. It just guides which side of the family to focus familial genetic testing efforts on and is internally validated by the patient’s variant and later confirmed by clinical testing in the family.”

Directing cascade genetic testing to one side of the family over the other could speed time to diagnosis of more carriers and allow for more efficient use of genetic counseling resources, Dr. Jones added, especially when parents are deceased or unavailable.

The study was published online in Cell Genomics.
 

Low error rate

Determining a parent of origin for hereditary variants “is essential to evaluate disease risk when a pathogenic variant has PofO effects, that is, when a patient’s risk of disease depends on from which parent it is inherited,” the authors wrote. An example is hereditary paraganglioma-pheochromocytoma syndrome as a result of pathogenic variants in SDHD or SDHAF2 genes. Individuals with the variants are at high risk of developing certain cancers, but only if a defective gene is inherited from their father. If inherited from their mother, there is no increased risk.

The new method relies on a technique called “phased DNA methylation” at maternally and paternally imprinted gene loci, as well as chromosome length phasing of DNA sequences.

The team used five human genome “trios” – two parents and the proband (the first person in a family to receive genetic testing or counseling for a suspected hereditary risk) – to pilot the approach. They showed that the method can correctly identify the PofO with an average mismatch error rate of 0.31% for single nucleotide variants and 1.89% for insertions or deletions (indels).

“We will need to validate this technology for different genes in real-world samples from individuals of diverse backgrounds,” said Dr. Jones. The first step is to validate the technology in scenarios with immediate clinical utility, like with SDHD, where lifelong medical management is affected by knowledge of whether the variant was inherited from the mother or father.

“We would also like to quickly validate this for common hereditary cancer genes, like BRCA1, BRCA2, and Lynch syndrome–associated genes, where prediction of PofO may improve low rates of genetic testing in family members by providing more accurate estimates of their risk to carry the familial variant.”

Challenges to moving the test to the clinic, Dr. Jones said, include scaling up the technology, demonstrating clinical and economic utility, compared with existing testing approaches, “and familiarizing clinicians with a new type of test that will routinely give this added dimension of information.”
 

 

 

‘Tremendously promising technology’

Pathologist Stephen Yip, MD, PhD, of the Vancouver Coastal Health Research Institute, who was not involved in the study but disclosed that he collaborates with the authors on other grant-funded projects, said in a comment that “this is a tremendously promising technology that has immediate practical implications in the investigation of PofO of a pathogenic locus, particularly when genetic material is available only from the proband.”

However, “rigorous validation against the current gold standard of short-reading, next-generation sequencing of trios is needed prior to clinical deployment,” he said. “This will take time and effort. However, the promise of this technology is worth the effort.

“Also, there is the possibility of uncovering novel genetics during testing, which could present an ethical dilemma,” he noted. “A robust consenting and ethical framework and early involvement of an ethicist would be helpful.”

Research in Dr. Lansdorp’s laboratory is funded by the Terry Fox Research Institute, the Canadian Institutes of Health Research, the Canadian Foundation for Innovation, and the government of British Columbia. Dr. Lansdorp, Dr. Jones, and Dr. Yip reported no relevant financial relationships.

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

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ED docs need a clearer path to outpatient primary care

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It was 2 p.m. on a sunny and humid day, 1 hour before my 8-hour shift was over in the emergency department at the community hospital that I was rotating through. It was part of my fourth-year emergency medicine (EM) clerkship. Not that I would have noticed the weather, save for the few seconds the sliding door to the ED would open periodically, as if on its own cadence, with the sounds of stomping boots and a rolling gurney making its way through.

We were busy. At this particular hospital, I was told, EM volume is already up 35% this year compared with the previous year, and bed holds had been hitting new highs each week.

One more hour until my shift is over and a poor soul will take over my computer, seat, and the chaos.

I took a glance at the electronic health record again, seeing whether there was anything I could do to discharge any of the patients to relieve some of the strain. Knee pain, toe pain, headache/migraine, shoulder pain, elevated blood pressure. Although it’s true that any of these listed complaints could have emergent etiologies, the truth was that all of these patients were here owing to exacerbations of chronic issues. And yet most, if not all, of these patients had been here for nearly 8 hours, some even longer, waiting for treatment and exacerbating an already busy ED.

“I don’t understand. Couldn’t these patients have sought care outpatient with their PCP [primary care physician]? It would have been a lot cheaper and faster.” I asked. A seasoned ED physician, bald, graying, and whom I had just met today and hadn’t spoken to much until this very moment, turned to me and said: “We have become the dumping ground for primary care complaints.”

‘Go to the ED’

“PCPs are already too busy,” the physician continued. “It’s just easier to say: ‘Go to the ED. They’ll take care of it.’ ”

He continued: “In my 30 years of practicing, emergency medicine has changed so much. When I first started in the 1980s, I was only seeing emergencies, and it was fun. Now, 80% of my patients are primary care complaints. These days, I am more of a primary care physician than an emergency physician.”

Hmmm, I thought. Was this physician burned out and jaded? Quite possibly. Was this change the physician experienced throughout his career more likely attributed to a capitalist-run, profit-driven health care system and its cohort of underinsured and noninsured citizens? Certainly. I’m only a fourth-year medical student, so my view of the situation is no doubt limited.

But something he said definitely rang my bell: I’m more of a primary care physician than an emergency physician. That is an argument I can consider. Whether it is caused by poorly designed reimbursement schedules or the state of America’s profit-driven health care system, there is no doubt that these days, emergency physicians are in fact seeing a lot of primary care complaints, which effectively makes these physicians double as PCPs on a daily basis.

I let this thought ruminate on my drive home, along with how there’s a such a huge demand for PCPs, resulting in it taking up to 3 months to get an appointment with one. That’s crazy, and I understand the need to come to the ED where you’ll (hopefully) be seen the same day.

I also ruminated on how emergency physicians have the highest rate of burnout among all the specialties, with no career recourse afterward. Either you’re part of the hospital machine complex, or you’re out. Practicing EM for nearly 30 years is apparently a rarity these days. Most emergency physicians last 5 years, 10 years tops, and then are so burned out that they retire to pursue a life outside of medicine (real estate seems to be popular). But this is a shame.

 

 

Emergency docs exiting medicine

Emergency physicians have seen a ton of wildly different pathologies and have treated a variety of different conditions, including conditions usually reserved for primary care. To let knowledgeable, experienced emergency physicians just exit medicine, with no recourse to further contribute to this country’s health system outside of the hospital machine, is a travesty in its own right.

I ruminated further on the 2021 American College of Emergency Physicians 2021 report on the EM physician workforce, which stated that there is projected to be an oversupply of emergency physicians by 2030, leaving thousands of them out of work. No doubt that report has left an impact on the volume of residency applications into EM in 2021. No one wants to go through residency and be unemployed at the end of it.

And finally, I ruminated on the sheer volume of patients visiting EDs across the country. Patient volumes are up, wait times in general are up, wait times in the ED are up, and bed holds to get admitted are hitting highs across the country each week. The deluge of patients visiting the ED is not getting better, and it’s only likely to get worse as the population ages.

It’s time to offer emergency physicians a path to outpatient primary care.

Now before I get hung for this suggestion (“I went into EM precisely not to do outpatient care!”), hear me out: Such a path should be offered via a 1-year accelerated fellowship and will allow emergency physicians to practice outpatient primary care medicine independently. And although working in urgent care centers is already an option, the opportunity to own and operate their own primary care practice should also exist.

In my humble opinion, by offering such a path, the following objectives could be accomplished:

Alleviate the pressure on primary care medicine in the United States. It’s no secret that the United States needs more primary care physicians. Allowing emergency physicians who got burnt out by hospital life an alternative way to serve their community and country via outpatient primary care would greatly alleviate the pressure on the need for PCPs today.

Provide an alternative career path for emergency physicians. We would be doing a disservice if we don’t offer emergency physicians a way to revive their burnout and utilize their skill set in a post-ED life. Outpatient primary care is the perfect way to do this, and it’s a win-win-win on several fronts: We need more outpatient physicians, they need an opportunity to flex their knowledge in an alternative setting.

Solve the “ACEP” problem. The ACEP report scared medical students away from applying to residency in EM. Who wants to go through 3 years of residency only to be unemployed at the end of it? By offering a path to outpatient primary care, we can offer an important and viable path for those emergency physicians who would be unemployed to continue to practice medicine and serve the community, thereby alleviating concern about an oversupply.

For better or for worse, because of the state of health care today, ED physicians have been exposed to a myriad of primary care concerns, all of which have prepared them for a career as an outpatient PCP. By offering such a path, we can provide more flexibility for an emergency physician’s career, help alleviate the primary care shortage affecting the United States, and serve our community and country in new and helpful ways.

Dr. Gogna is a fourth-year medical student at Philadelphia College of Osteopathic Medicine Georgia, Suwanee. He reported no relevant conflicts of interest.

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

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It was 2 p.m. on a sunny and humid day, 1 hour before my 8-hour shift was over in the emergency department at the community hospital that I was rotating through. It was part of my fourth-year emergency medicine (EM) clerkship. Not that I would have noticed the weather, save for the few seconds the sliding door to the ED would open periodically, as if on its own cadence, with the sounds of stomping boots and a rolling gurney making its way through.

We were busy. At this particular hospital, I was told, EM volume is already up 35% this year compared with the previous year, and bed holds had been hitting new highs each week.

One more hour until my shift is over and a poor soul will take over my computer, seat, and the chaos.

I took a glance at the electronic health record again, seeing whether there was anything I could do to discharge any of the patients to relieve some of the strain. Knee pain, toe pain, headache/migraine, shoulder pain, elevated blood pressure. Although it’s true that any of these listed complaints could have emergent etiologies, the truth was that all of these patients were here owing to exacerbations of chronic issues. And yet most, if not all, of these patients had been here for nearly 8 hours, some even longer, waiting for treatment and exacerbating an already busy ED.

“I don’t understand. Couldn’t these patients have sought care outpatient with their PCP [primary care physician]? It would have been a lot cheaper and faster.” I asked. A seasoned ED physician, bald, graying, and whom I had just met today and hadn’t spoken to much until this very moment, turned to me and said: “We have become the dumping ground for primary care complaints.”

‘Go to the ED’

“PCPs are already too busy,” the physician continued. “It’s just easier to say: ‘Go to the ED. They’ll take care of it.’ ”

He continued: “In my 30 years of practicing, emergency medicine has changed so much. When I first started in the 1980s, I was only seeing emergencies, and it was fun. Now, 80% of my patients are primary care complaints. These days, I am more of a primary care physician than an emergency physician.”

Hmmm, I thought. Was this physician burned out and jaded? Quite possibly. Was this change the physician experienced throughout his career more likely attributed to a capitalist-run, profit-driven health care system and its cohort of underinsured and noninsured citizens? Certainly. I’m only a fourth-year medical student, so my view of the situation is no doubt limited.

But something he said definitely rang my bell: I’m more of a primary care physician than an emergency physician. That is an argument I can consider. Whether it is caused by poorly designed reimbursement schedules or the state of America’s profit-driven health care system, there is no doubt that these days, emergency physicians are in fact seeing a lot of primary care complaints, which effectively makes these physicians double as PCPs on a daily basis.

I let this thought ruminate on my drive home, along with how there’s a such a huge demand for PCPs, resulting in it taking up to 3 months to get an appointment with one. That’s crazy, and I understand the need to come to the ED where you’ll (hopefully) be seen the same day.

I also ruminated on how emergency physicians have the highest rate of burnout among all the specialties, with no career recourse afterward. Either you’re part of the hospital machine complex, or you’re out. Practicing EM for nearly 30 years is apparently a rarity these days. Most emergency physicians last 5 years, 10 years tops, and then are so burned out that they retire to pursue a life outside of medicine (real estate seems to be popular). But this is a shame.

 

 

Emergency docs exiting medicine

Emergency physicians have seen a ton of wildly different pathologies and have treated a variety of different conditions, including conditions usually reserved for primary care. To let knowledgeable, experienced emergency physicians just exit medicine, with no recourse to further contribute to this country’s health system outside of the hospital machine, is a travesty in its own right.

I ruminated further on the 2021 American College of Emergency Physicians 2021 report on the EM physician workforce, which stated that there is projected to be an oversupply of emergency physicians by 2030, leaving thousands of them out of work. No doubt that report has left an impact on the volume of residency applications into EM in 2021. No one wants to go through residency and be unemployed at the end of it.

And finally, I ruminated on the sheer volume of patients visiting EDs across the country. Patient volumes are up, wait times in general are up, wait times in the ED are up, and bed holds to get admitted are hitting highs across the country each week. The deluge of patients visiting the ED is not getting better, and it’s only likely to get worse as the population ages.

It’s time to offer emergency physicians a path to outpatient primary care.

Now before I get hung for this suggestion (“I went into EM precisely not to do outpatient care!”), hear me out: Such a path should be offered via a 1-year accelerated fellowship and will allow emergency physicians to practice outpatient primary care medicine independently. And although working in urgent care centers is already an option, the opportunity to own and operate their own primary care practice should also exist.

In my humble opinion, by offering such a path, the following objectives could be accomplished:

Alleviate the pressure on primary care medicine in the United States. It’s no secret that the United States needs more primary care physicians. Allowing emergency physicians who got burnt out by hospital life an alternative way to serve their community and country via outpatient primary care would greatly alleviate the pressure on the need for PCPs today.

Provide an alternative career path for emergency physicians. We would be doing a disservice if we don’t offer emergency physicians a way to revive their burnout and utilize their skill set in a post-ED life. Outpatient primary care is the perfect way to do this, and it’s a win-win-win on several fronts: We need more outpatient physicians, they need an opportunity to flex their knowledge in an alternative setting.

Solve the “ACEP” problem. The ACEP report scared medical students away from applying to residency in EM. Who wants to go through 3 years of residency only to be unemployed at the end of it? By offering a path to outpatient primary care, we can offer an important and viable path for those emergency physicians who would be unemployed to continue to practice medicine and serve the community, thereby alleviating concern about an oversupply.

For better or for worse, because of the state of health care today, ED physicians have been exposed to a myriad of primary care concerns, all of which have prepared them for a career as an outpatient PCP. By offering such a path, we can provide more flexibility for an emergency physician’s career, help alleviate the primary care shortage affecting the United States, and serve our community and country in new and helpful ways.

Dr. Gogna is a fourth-year medical student at Philadelphia College of Osteopathic Medicine Georgia, Suwanee. He reported no relevant conflicts of interest.

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

 

It was 2 p.m. on a sunny and humid day, 1 hour before my 8-hour shift was over in the emergency department at the community hospital that I was rotating through. It was part of my fourth-year emergency medicine (EM) clerkship. Not that I would have noticed the weather, save for the few seconds the sliding door to the ED would open periodically, as if on its own cadence, with the sounds of stomping boots and a rolling gurney making its way through.

We were busy. At this particular hospital, I was told, EM volume is already up 35% this year compared with the previous year, and bed holds had been hitting new highs each week.

One more hour until my shift is over and a poor soul will take over my computer, seat, and the chaos.

I took a glance at the electronic health record again, seeing whether there was anything I could do to discharge any of the patients to relieve some of the strain. Knee pain, toe pain, headache/migraine, shoulder pain, elevated blood pressure. Although it’s true that any of these listed complaints could have emergent etiologies, the truth was that all of these patients were here owing to exacerbations of chronic issues. And yet most, if not all, of these patients had been here for nearly 8 hours, some even longer, waiting for treatment and exacerbating an already busy ED.

“I don’t understand. Couldn’t these patients have sought care outpatient with their PCP [primary care physician]? It would have been a lot cheaper and faster.” I asked. A seasoned ED physician, bald, graying, and whom I had just met today and hadn’t spoken to much until this very moment, turned to me and said: “We have become the dumping ground for primary care complaints.”

‘Go to the ED’

“PCPs are already too busy,” the physician continued. “It’s just easier to say: ‘Go to the ED. They’ll take care of it.’ ”

He continued: “In my 30 years of practicing, emergency medicine has changed so much. When I first started in the 1980s, I was only seeing emergencies, and it was fun. Now, 80% of my patients are primary care complaints. These days, I am more of a primary care physician than an emergency physician.”

Hmmm, I thought. Was this physician burned out and jaded? Quite possibly. Was this change the physician experienced throughout his career more likely attributed to a capitalist-run, profit-driven health care system and its cohort of underinsured and noninsured citizens? Certainly. I’m only a fourth-year medical student, so my view of the situation is no doubt limited.

But something he said definitely rang my bell: I’m more of a primary care physician than an emergency physician. That is an argument I can consider. Whether it is caused by poorly designed reimbursement schedules or the state of America’s profit-driven health care system, there is no doubt that these days, emergency physicians are in fact seeing a lot of primary care complaints, which effectively makes these physicians double as PCPs on a daily basis.

I let this thought ruminate on my drive home, along with how there’s a such a huge demand for PCPs, resulting in it taking up to 3 months to get an appointment with one. That’s crazy, and I understand the need to come to the ED where you’ll (hopefully) be seen the same day.

I also ruminated on how emergency physicians have the highest rate of burnout among all the specialties, with no career recourse afterward. Either you’re part of the hospital machine complex, or you’re out. Practicing EM for nearly 30 years is apparently a rarity these days. Most emergency physicians last 5 years, 10 years tops, and then are so burned out that they retire to pursue a life outside of medicine (real estate seems to be popular). But this is a shame.

 

 

Emergency docs exiting medicine

Emergency physicians have seen a ton of wildly different pathologies and have treated a variety of different conditions, including conditions usually reserved for primary care. To let knowledgeable, experienced emergency physicians just exit medicine, with no recourse to further contribute to this country’s health system outside of the hospital machine, is a travesty in its own right.

I ruminated further on the 2021 American College of Emergency Physicians 2021 report on the EM physician workforce, which stated that there is projected to be an oversupply of emergency physicians by 2030, leaving thousands of them out of work. No doubt that report has left an impact on the volume of residency applications into EM in 2021. No one wants to go through residency and be unemployed at the end of it.

And finally, I ruminated on the sheer volume of patients visiting EDs across the country. Patient volumes are up, wait times in general are up, wait times in the ED are up, and bed holds to get admitted are hitting highs across the country each week. The deluge of patients visiting the ED is not getting better, and it’s only likely to get worse as the population ages.

It’s time to offer emergency physicians a path to outpatient primary care.

Now before I get hung for this suggestion (“I went into EM precisely not to do outpatient care!”), hear me out: Such a path should be offered via a 1-year accelerated fellowship and will allow emergency physicians to practice outpatient primary care medicine independently. And although working in urgent care centers is already an option, the opportunity to own and operate their own primary care practice should also exist.

In my humble opinion, by offering such a path, the following objectives could be accomplished:

Alleviate the pressure on primary care medicine in the United States. It’s no secret that the United States needs more primary care physicians. Allowing emergency physicians who got burnt out by hospital life an alternative way to serve their community and country via outpatient primary care would greatly alleviate the pressure on the need for PCPs today.

Provide an alternative career path for emergency physicians. We would be doing a disservice if we don’t offer emergency physicians a way to revive their burnout and utilize their skill set in a post-ED life. Outpatient primary care is the perfect way to do this, and it’s a win-win-win on several fronts: We need more outpatient physicians, they need an opportunity to flex their knowledge in an alternative setting.

Solve the “ACEP” problem. The ACEP report scared medical students away from applying to residency in EM. Who wants to go through 3 years of residency only to be unemployed at the end of it? By offering a path to outpatient primary care, we can offer an important and viable path for those emergency physicians who would be unemployed to continue to practice medicine and serve the community, thereby alleviating concern about an oversupply.

For better or for worse, because of the state of health care today, ED physicians have been exposed to a myriad of primary care concerns, all of which have prepared them for a career as an outpatient PCP. By offering such a path, we can provide more flexibility for an emergency physician’s career, help alleviate the primary care shortage affecting the United States, and serve our community and country in new and helpful ways.

Dr. Gogna is a fourth-year medical student at Philadelphia College of Osteopathic Medicine Georgia, Suwanee. He reported no relevant conflicts of interest.

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

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Vonoprazan triple therapy most cost-effective for H. pylori: Study

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Vonoprazan triple therapy most cost-effective for H. pylori: Study

A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.

Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.

The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.

The findings “strongly” suggest that vonoprazan triple therapy would provide the greatest net health benefit and monetary benefit for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.

The study was published online in the American Journal of Gastroenterology.

It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.

Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.

The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.

Among their key findings and conclusions:

  • Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
  • Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
  • Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY. 
  • Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
  • Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
  • Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
  • Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
  • Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
  • Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.

The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.

They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.

The study did not receive any funding. The authors have declared no relevant financial relationships.

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

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A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.

Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.

The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.

The findings “strongly” suggest that vonoprazan triple therapy would provide the greatest net health benefit and monetary benefit for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.

The study was published online in the American Journal of Gastroenterology.

It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.

Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.

The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.

Among their key findings and conclusions:

  • Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
  • Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
  • Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY. 
  • Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
  • Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
  • Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
  • Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
  • Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
  • Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.

The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.

They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.

The study did not receive any funding. The authors have declared no relevant financial relationships.

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

A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.

Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.

The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.

The findings “strongly” suggest that vonoprazan triple therapy would provide the greatest net health benefit and monetary benefit for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.

The study was published online in the American Journal of Gastroenterology.

It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.

Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.

The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.

Among their key findings and conclusions:

  • Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
  • Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
  • Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY. 
  • Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
  • Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
  • Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
  • Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
  • Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
  • Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.

The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.

They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.

The study did not receive any funding. The authors have declared no relevant financial relationships.

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

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Q2. Correct answer: A. Enteric infection 

Rationale 

Despite the numerous side effects associated with long-term PPI use, the quality of evidence and risk of confounding from these studies limits the ability to ascribe sufficient cause and effect between PPI use and these outcomes. However, a recent large randomized controlled trial that evaluated the use of pantoprazole versus placebo demonstrated a statistically significant difference between the pantoprazole and placebo groups only in enteric infections (1.4% vs 1.0%; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). Despite a nearly double increased risk of Clostridioides difficile infection in the PPI group, compared with the placebo group, the number of events was low, and the difference did not reach statistical significance. In the context of these data, and more recent studies suggesting an increased risk of COVID-19 in patients who take PPIs, compared with those who do not, the risk of enteric infections is likely small but significantly increased among long-term PPI users. 

References 

  • Freedberg DE et al. Gastroenterology. 2017;152(4):706-15. doi: 10.1053/j.gastro.2017.01.031. 
  • Moayyedi P et al. Gastroenterology. 2019;157(3):682-91.e2. doi: 10.1053/j.gastro.2019.05.056.
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Q2. Correct answer: A. Enteric infection 

Rationale 

Despite the numerous side effects associated with long-term PPI use, the quality of evidence and risk of confounding from these studies limits the ability to ascribe sufficient cause and effect between PPI use and these outcomes. However, a recent large randomized controlled trial that evaluated the use of pantoprazole versus placebo demonstrated a statistically significant difference between the pantoprazole and placebo groups only in enteric infections (1.4% vs 1.0%; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). Despite a nearly double increased risk of Clostridioides difficile infection in the PPI group, compared with the placebo group, the number of events was low, and the difference did not reach statistical significance. In the context of these data, and more recent studies suggesting an increased risk of COVID-19 in patients who take PPIs, compared with those who do not, the risk of enteric infections is likely small but significantly increased among long-term PPI users. 

References 

  • Freedberg DE et al. Gastroenterology. 2017;152(4):706-15. doi: 10.1053/j.gastro.2017.01.031. 
  • Moayyedi P et al. Gastroenterology. 2019;157(3):682-91.e2. doi: 10.1053/j.gastro.2019.05.056.

Q2. Correct answer: A. Enteric infection 

Rationale 

Despite the numerous side effects associated with long-term PPI use, the quality of evidence and risk of confounding from these studies limits the ability to ascribe sufficient cause and effect between PPI use and these outcomes. However, a recent large randomized controlled trial that evaluated the use of pantoprazole versus placebo demonstrated a statistically significant difference between the pantoprazole and placebo groups only in enteric infections (1.4% vs 1.0%; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). Despite a nearly double increased risk of Clostridioides difficile infection in the PPI group, compared with the placebo group, the number of events was low, and the difference did not reach statistical significance. In the context of these data, and more recent studies suggesting an increased risk of COVID-19 in patients who take PPIs, compared with those who do not, the risk of enteric infections is likely small but significantly increased among long-term PPI users. 

References 

  • Freedberg DE et al. Gastroenterology. 2017;152(4):706-15. doi: 10.1053/j.gastro.2017.01.031. 
  • Moayyedi P et al. Gastroenterology. 2019;157(3):682-91.e2. doi: 10.1053/j.gastro.2019.05.056.
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Quick Quiz Question 1

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Q1. Correct answer: D. Rabeprazole 

Rationale 

Within-class switching of proton pump inhibitors (PPIs) for patients with incomplete control of symptoms is frequently done in clinical practice. For the management of gastroesophageal reflux disease, this practice can be "considered" according to guidelines. More recent data suggest varying potencies of PPIs might be responsible for some patient's incomplete response. When measured as omeprazole equivalents, the relative potencies of standard-dose pantoprazole, lansoprazole, omeprazole, esomeprazole, and rabeprazole have been estimated at 0.23, 0.90, 1.00, 1.60, and 1.82 OEs, respectively. 

References 

  • Graham DY and Tansel A. Clin Gastroenterol Hepatol. 2018;16(6):800-8.e7. doi: 10.1016/j.cgh.2017.09.033 
  • Katz PO et al. Am J Gastroenterol. 2022;117(1):27-56. doi: 10.14309/ ajg.0000000000001538 
  • Kirchheiner J et al. Eur J Clin Pharmacol. 2009;65(1):19-31. doi: 10.1007/s00228-008-0576-5
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Q1. Correct answer: D. Rabeprazole 

Rationale 

Within-class switching of proton pump inhibitors (PPIs) for patients with incomplete control of symptoms is frequently done in clinical practice. For the management of gastroesophageal reflux disease, this practice can be "considered" according to guidelines. More recent data suggest varying potencies of PPIs might be responsible for some patient's incomplete response. When measured as omeprazole equivalents, the relative potencies of standard-dose pantoprazole, lansoprazole, omeprazole, esomeprazole, and rabeprazole have been estimated at 0.23, 0.90, 1.00, 1.60, and 1.82 OEs, respectively. 

References 

  • Graham DY and Tansel A. Clin Gastroenterol Hepatol. 2018;16(6):800-8.e7. doi: 10.1016/j.cgh.2017.09.033 
  • Katz PO et al. Am J Gastroenterol. 2022;117(1):27-56. doi: 10.14309/ ajg.0000000000001538 
  • Kirchheiner J et al. Eur J Clin Pharmacol. 2009;65(1):19-31. doi: 10.1007/s00228-008-0576-5

Q1. Correct answer: D. Rabeprazole 

Rationale 

Within-class switching of proton pump inhibitors (PPIs) for patients with incomplete control of symptoms is frequently done in clinical practice. For the management of gastroesophageal reflux disease, this practice can be "considered" according to guidelines. More recent data suggest varying potencies of PPIs might be responsible for some patient's incomplete response. When measured as omeprazole equivalents, the relative potencies of standard-dose pantoprazole, lansoprazole, omeprazole, esomeprazole, and rabeprazole have been estimated at 0.23, 0.90, 1.00, 1.60, and 1.82 OEs, respectively. 

References 

  • Graham DY and Tansel A. Clin Gastroenterol Hepatol. 2018;16(6):800-8.e7. doi: 10.1016/j.cgh.2017.09.033 
  • Katz PO et al. Am J Gastroenterol. 2022;117(1):27-56. doi: 10.14309/ ajg.0000000000001538 
  • Kirchheiner J et al. Eur J Clin Pharmacol. 2009;65(1):19-31. doi: 10.1007/s00228-008-0576-5
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Oral minoxidil improves anticancer treatment–induced alopecia in women with breast cancer

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Topical minoxidil is widely used to treat hair loss, but new findings suggest that a combination of oral and topical minoxidil could be effective for women with breast cancer who have experienced alopecia from anticancer treatment.

In a retrospective cohort study of women with breast cancer and anticancer therapy–induced alopecia, researchers found that combining low-dose oral minoxidil (LDOM) and topical minoxidil achieved better results than topical minoxidil alone and that the treatment was well tolerated. A total of 5 of the 37 patients (13.5%) in the combination therapy group achieved a complete response, defined as an improvement of alopecia severity from grade 2 to grade 1, compared with none of the 19 patients in the topical therapy–only group.

In contrast, none of the patients in the combination group experienced worsening of alopecia, compared with two (10.5%) in the topical monotherapy group.

The study was published online in the Journal of the American Academy of Dermatology. Topical minoxidil is approved by the Food and Drug Administration to treat androgenetic alopecia. Oral minoxidil is not approved for treating hair loss but has been receiving increased attention as an adjunctive therapy for hair loss, particularly for women. Oral minoxidil is approved for treating hypertension but at much higher doses.

An increasing number of studies have been conducted on the use of oral minoxidil for the treatment of female pattern hair loss, dating back to a pilot study in 2017, with promising results. The findings suggest that LDOM might be more effective than topical therapy, well tolerated, and more convenient for individuals to take.

Hypothesis generating

In a comment, Kai Johnson, MD, a medical oncologist who specializes in treating patients with breast cancer at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, noted that the study, like most small-scale retrospective studies, is hypothesis generating. However, “I’d be hesitant to broadly recommend this practice of dual therapy – oral and topical minoxidil together – until we see a placebo-controlled prospective study performed demonstrating clinically meaningful benefits for patients.”

Another factor is the study endpoints. “While there was a statistically significant benefit documented with dual therapy in this study, it’s important to have study endpoints that are more patient oriented,” Dr. Johnson said. The most important endpoint for patients would be improvements “in the actual alopecia grade, which did occur in 5 of the 37 of dual-therapy patients, versus 0 topical minoxidil patients.”

George Cotsarelis, MD, chair of the department of dermatology and professor of dermatology at the University of Pennsylvania, Philadelphia, also weighed in. He questioned whether adding the topical therapy to oral minoxidil actually improved the results. “What was missing was a study arm that used the oral alone,” he said in an interview. “So we don’t know how effective the oral therapy would be by itself and if combining it with the topical is really adding anything.”

Oral minoxidil as a treatment for hair loss is gaining traction, and it’s clear that it is effective. However, the risk of side effects is higher, he said. “The risk isn’t that high with the low dose, but it can grow hair on places other than the scalp, and that can be disconcerting.” In this study, two women who took the oral drug reported edema, and one reported headache and dizziness. Hypertrichosis was reported by five patients who received the combination.
 

 

 

Study details

In the study, Jeewoo Kang, MD, and colleagues from the Seoul National University evaluated the efficacy of LDOM in 100 patients with breast cancer who had been diagnosed with persistent chemotherapy-induced alopecia (pCIA) and endocrine therapy–induced alopecia (EIA) at a dermatology clinic.

They conducted an analysis of medical records, standardized clinical photographs, and trichoscopic images to evaluate the alopecia pattern, severity, treatment response, and posttreatment changes in vertex hair density and thickness.

Compared with those with EIA alone, patients with pCIA were significantly more likely to have diffuse alopecia (P < .001), and they were more likely to have more severe alopecia, although this difference was not significant (P = .058). Outcomes were evaluated for 56 patients who were treated with minoxidil (19 with topical minoxidil alone and 37 with both LDOM and topical minoxidil) and for whom clinical and trichoscopic photos were available at baseline and at the last follow-up (all patients were scheduled for follow-up at 3-month intervals).

The results showed that those treated with 1.25-5.0 mg/d of oral minoxidil and 5% topical minoxidil solution once a day had better responses (P = .002) and a higher percentage increase in hair density from baseline (P = .003), compared with those who received topical minoxidil monotherapy.

However, changes in hair thickness after treatment were not significantly different between the two groups (P = .540).

In addition to the five (13.5%) cases of hypertrichosis, two cases of edema (5.4%), and one case of headache/dizziness (2.7%) among those who received the combination, there was also one report of palpitations (2.7%). Palpitations were reported in one patient (5%) who received topical monotherapy, the only adverse event reported in this group.

Dr. Johnson noted that, at his institution, a dermatologist is conducting a clinical trial with oncology patients post chemotherapy and endocrine therapy. “She is looking at a similar question, although she is comparing oral minoxidil to topical minoxidil directly rather than in combination.” There is also an active clinical trial at Northwestern University, Chicago, of LDOM alone for patients with chemotherapy-induced alopecia.

“So there is a lot of momentum surrounding this concept, and I feel we will continue to see it come up as a possible treatment option, but more data are needed at this time before it can become standard of care,” Dr. Johnson added.

No funding for the study was reported. The authors disclosed no relevant financial relationships.

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

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Topical minoxidil is widely used to treat hair loss, but new findings suggest that a combination of oral and topical minoxidil could be effective for women with breast cancer who have experienced alopecia from anticancer treatment.

In a retrospective cohort study of women with breast cancer and anticancer therapy–induced alopecia, researchers found that combining low-dose oral minoxidil (LDOM) and topical minoxidil achieved better results than topical minoxidil alone and that the treatment was well tolerated. A total of 5 of the 37 patients (13.5%) in the combination therapy group achieved a complete response, defined as an improvement of alopecia severity from grade 2 to grade 1, compared with none of the 19 patients in the topical therapy–only group.

In contrast, none of the patients in the combination group experienced worsening of alopecia, compared with two (10.5%) in the topical monotherapy group.

The study was published online in the Journal of the American Academy of Dermatology. Topical minoxidil is approved by the Food and Drug Administration to treat androgenetic alopecia. Oral minoxidil is not approved for treating hair loss but has been receiving increased attention as an adjunctive therapy for hair loss, particularly for women. Oral minoxidil is approved for treating hypertension but at much higher doses.

An increasing number of studies have been conducted on the use of oral minoxidil for the treatment of female pattern hair loss, dating back to a pilot study in 2017, with promising results. The findings suggest that LDOM might be more effective than topical therapy, well tolerated, and more convenient for individuals to take.

Hypothesis generating

In a comment, Kai Johnson, MD, a medical oncologist who specializes in treating patients with breast cancer at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, noted that the study, like most small-scale retrospective studies, is hypothesis generating. However, “I’d be hesitant to broadly recommend this practice of dual therapy – oral and topical minoxidil together – until we see a placebo-controlled prospective study performed demonstrating clinically meaningful benefits for patients.”

Another factor is the study endpoints. “While there was a statistically significant benefit documented with dual therapy in this study, it’s important to have study endpoints that are more patient oriented,” Dr. Johnson said. The most important endpoint for patients would be improvements “in the actual alopecia grade, which did occur in 5 of the 37 of dual-therapy patients, versus 0 topical minoxidil patients.”

George Cotsarelis, MD, chair of the department of dermatology and professor of dermatology at the University of Pennsylvania, Philadelphia, also weighed in. He questioned whether adding the topical therapy to oral minoxidil actually improved the results. “What was missing was a study arm that used the oral alone,” he said in an interview. “So we don’t know how effective the oral therapy would be by itself and if combining it with the topical is really adding anything.”

Oral minoxidil as a treatment for hair loss is gaining traction, and it’s clear that it is effective. However, the risk of side effects is higher, he said. “The risk isn’t that high with the low dose, but it can grow hair on places other than the scalp, and that can be disconcerting.” In this study, two women who took the oral drug reported edema, and one reported headache and dizziness. Hypertrichosis was reported by five patients who received the combination.
 

 

 

Study details

In the study, Jeewoo Kang, MD, and colleagues from the Seoul National University evaluated the efficacy of LDOM in 100 patients with breast cancer who had been diagnosed with persistent chemotherapy-induced alopecia (pCIA) and endocrine therapy–induced alopecia (EIA) at a dermatology clinic.

They conducted an analysis of medical records, standardized clinical photographs, and trichoscopic images to evaluate the alopecia pattern, severity, treatment response, and posttreatment changes in vertex hair density and thickness.

Compared with those with EIA alone, patients with pCIA were significantly more likely to have diffuse alopecia (P < .001), and they were more likely to have more severe alopecia, although this difference was not significant (P = .058). Outcomes were evaluated for 56 patients who were treated with minoxidil (19 with topical minoxidil alone and 37 with both LDOM and topical minoxidil) and for whom clinical and trichoscopic photos were available at baseline and at the last follow-up (all patients were scheduled for follow-up at 3-month intervals).

The results showed that those treated with 1.25-5.0 mg/d of oral minoxidil and 5% topical minoxidil solution once a day had better responses (P = .002) and a higher percentage increase in hair density from baseline (P = .003), compared with those who received topical minoxidil monotherapy.

However, changes in hair thickness after treatment were not significantly different between the two groups (P = .540).

In addition to the five (13.5%) cases of hypertrichosis, two cases of edema (5.4%), and one case of headache/dizziness (2.7%) among those who received the combination, there was also one report of palpitations (2.7%). Palpitations were reported in one patient (5%) who received topical monotherapy, the only adverse event reported in this group.

Dr. Johnson noted that, at his institution, a dermatologist is conducting a clinical trial with oncology patients post chemotherapy and endocrine therapy. “She is looking at a similar question, although she is comparing oral minoxidil to topical minoxidil directly rather than in combination.” There is also an active clinical trial at Northwestern University, Chicago, of LDOM alone for patients with chemotherapy-induced alopecia.

“So there is a lot of momentum surrounding this concept, and I feel we will continue to see it come up as a possible treatment option, but more data are needed at this time before it can become standard of care,” Dr. Johnson added.

No funding for the study was reported. The authors disclosed no relevant financial relationships.

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

Topical minoxidil is widely used to treat hair loss, but new findings suggest that a combination of oral and topical minoxidil could be effective for women with breast cancer who have experienced alopecia from anticancer treatment.

In a retrospective cohort study of women with breast cancer and anticancer therapy–induced alopecia, researchers found that combining low-dose oral minoxidil (LDOM) and topical minoxidil achieved better results than topical minoxidil alone and that the treatment was well tolerated. A total of 5 of the 37 patients (13.5%) in the combination therapy group achieved a complete response, defined as an improvement of alopecia severity from grade 2 to grade 1, compared with none of the 19 patients in the topical therapy–only group.

In contrast, none of the patients in the combination group experienced worsening of alopecia, compared with two (10.5%) in the topical monotherapy group.

The study was published online in the Journal of the American Academy of Dermatology. Topical minoxidil is approved by the Food and Drug Administration to treat androgenetic alopecia. Oral minoxidil is not approved for treating hair loss but has been receiving increased attention as an adjunctive therapy for hair loss, particularly for women. Oral minoxidil is approved for treating hypertension but at much higher doses.

An increasing number of studies have been conducted on the use of oral minoxidil for the treatment of female pattern hair loss, dating back to a pilot study in 2017, with promising results. The findings suggest that LDOM might be more effective than topical therapy, well tolerated, and more convenient for individuals to take.

Hypothesis generating

In a comment, Kai Johnson, MD, a medical oncologist who specializes in treating patients with breast cancer at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, noted that the study, like most small-scale retrospective studies, is hypothesis generating. However, “I’d be hesitant to broadly recommend this practice of dual therapy – oral and topical minoxidil together – until we see a placebo-controlled prospective study performed demonstrating clinically meaningful benefits for patients.”

Another factor is the study endpoints. “While there was a statistically significant benefit documented with dual therapy in this study, it’s important to have study endpoints that are more patient oriented,” Dr. Johnson said. The most important endpoint for patients would be improvements “in the actual alopecia grade, which did occur in 5 of the 37 of dual-therapy patients, versus 0 topical minoxidil patients.”

George Cotsarelis, MD, chair of the department of dermatology and professor of dermatology at the University of Pennsylvania, Philadelphia, also weighed in. He questioned whether adding the topical therapy to oral minoxidil actually improved the results. “What was missing was a study arm that used the oral alone,” he said in an interview. “So we don’t know how effective the oral therapy would be by itself and if combining it with the topical is really adding anything.”

Oral minoxidil as a treatment for hair loss is gaining traction, and it’s clear that it is effective. However, the risk of side effects is higher, he said. “The risk isn’t that high with the low dose, but it can grow hair on places other than the scalp, and that can be disconcerting.” In this study, two women who took the oral drug reported edema, and one reported headache and dizziness. Hypertrichosis was reported by five patients who received the combination.
 

 

 

Study details

In the study, Jeewoo Kang, MD, and colleagues from the Seoul National University evaluated the efficacy of LDOM in 100 patients with breast cancer who had been diagnosed with persistent chemotherapy-induced alopecia (pCIA) and endocrine therapy–induced alopecia (EIA) at a dermatology clinic.

They conducted an analysis of medical records, standardized clinical photographs, and trichoscopic images to evaluate the alopecia pattern, severity, treatment response, and posttreatment changes in vertex hair density and thickness.

Compared with those with EIA alone, patients with pCIA were significantly more likely to have diffuse alopecia (P < .001), and they were more likely to have more severe alopecia, although this difference was not significant (P = .058). Outcomes were evaluated for 56 patients who were treated with minoxidil (19 with topical minoxidil alone and 37 with both LDOM and topical minoxidil) and for whom clinical and trichoscopic photos were available at baseline and at the last follow-up (all patients were scheduled for follow-up at 3-month intervals).

The results showed that those treated with 1.25-5.0 mg/d of oral minoxidil and 5% topical minoxidil solution once a day had better responses (P = .002) and a higher percentage increase in hair density from baseline (P = .003), compared with those who received topical minoxidil monotherapy.

However, changes in hair thickness after treatment were not significantly different between the two groups (P = .540).

In addition to the five (13.5%) cases of hypertrichosis, two cases of edema (5.4%), and one case of headache/dizziness (2.7%) among those who received the combination, there was also one report of palpitations (2.7%). Palpitations were reported in one patient (5%) who received topical monotherapy, the only adverse event reported in this group.

Dr. Johnson noted that, at his institution, a dermatologist is conducting a clinical trial with oncology patients post chemotherapy and endocrine therapy. “She is looking at a similar question, although she is comparing oral minoxidil to topical minoxidil directly rather than in combination.” There is also an active clinical trial at Northwestern University, Chicago, of LDOM alone for patients with chemotherapy-induced alopecia.

“So there is a lot of momentum surrounding this concept, and I feel we will continue to see it come up as a possible treatment option, but more data are needed at this time before it can become standard of care,” Dr. Johnson added.

No funding for the study was reported. The authors disclosed no relevant financial relationships.

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

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FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

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Bad breath? Mouthwash is out. Yogurt is in.

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Leave the mouthwash. Take the yogurt

Most of us have experienced some sort of bad breath. It’s common in the morning right after waking up, but it also may be a sign for underlying medical issues like dental problems or acid reflux. Wherever it comes from, we always want to get rid of it. A recent meta-analysis in BMJ Open may have found the answer in some common foods.

Mladenovic/iStock/Getty Images

For those with halitosis, the basic problem is that the bacteria in their mouths are not happy about where they are. The researchers looked at 130 studies and found seven that suggested fermented food has some effect in combating bad breath.

Now when we say fermented food, we’re not talking about that science project waiting to happen in the back of the refrigerator. Think yogurt, sourdough bread, or miso soup. Anything that contains probiotic bacteria.

Matthew J. Messina, DDS, assistant professor of dentistry at Ohio State University, who was not involved with the study, told Healthline that “the whole idea behind probiotics is [bacteria replacement]. Supplant the ‘bad guys’ with the ‘good guys,’ then we’ll end up with a better result.” Essentially balancing the scales in your mouth.

It may not be a long-term solution, Dr. Messina said, but the short-term data are positive. So if you experience bad breath from time to time, try a little bowl of yogurt instead of chewing gum. If nothing else, the bacteria in your mouth will thank you.

You can talk the silly talk, but can you walk the silly walk?

The Ministry of Silly Walks sketch from Monty Python is an enduring comedy classic, and one of surprising relevance for doctors. After all, this isn’t the first time a study has analyzed the unusual strides of Mr. Putey and Mr. Teabag.

The BMJ Christmas edition truly is the gift that keeps on giving. For this plunge into the Flying Circus, the study authors recruited a small group of fairly average adults and had them walk normally around a track for 5 minutes, monitoring their oxygen intake and energy expenditure. After that, the study participants imitated Mr. Putey’s walk and then Mr. Teabag’s.

Michael Blann/DigitalVision

In the sketch, Mr. Teabag notes that Mr. Putey’s walk is “not particularly silly,” which is borne out in the research. When imitating Mr. Putey’s walk, oxygen intake and energy expenditure were barely higher than a normal walk, not enough to achieve a meaningful difference. Hopefully he’ll get that government grant to further develop his silly walk, because right now Mr. Putey’s walk simply doesn’t cut it.

Mr. Teabag’s walk is a different story and the very image of inefficiency. Oxygen intake was 2.5 times higher than during the normal walk, and energy expenditure was noticeably higher (8 kcal in men and 5.2 kcal in women). In fact, the walk was so inefficient and its effect so drastic it actually reached the level of vigorous exercise. Thanks to this, the study authors noted that just 11 minutes a day of walking like Mr. Teabag would be enough to reach the general goal of 75 minutes of vigorous exercise per week. Boosting that to 12-19 minutes would increase daily energy expenditure by 100 kcal.

The study authors wrote, “Had an initiative to promote inefficient movement been adopted in the early 1970s, we might now be living among a healthier society. Efforts to promote higher energy – and perhaps more joyful – walking should ensure inclusivity and inefficiency for all.” We think they just advocated for a real-life Ministry of Silly Walks. Well, there have been worse ideas. Just look at Twitter.
 

 

 

When efficient gut microbes go bad

With the latest news from the Ministry of Silly Walks, is it time for humans to embrace all things inefficient? Maybe.

ChrisChrisW/Getty Images

Turns out that individuals with more efficient digestive systems – those that extract more energy from the fuel supplied to them by the busy mouths above – tend to gain more weight than those with less efficient guts, even when they eat the same food, according to a recent study published in Microbiome.

The researchers took a look at the composition of gut microbes in a group of 85 volunteers and found that about 40% had microbiomes dominated by Bacteroides bacteria, which are more effective at extracting nutrients from food. That group also weighed 10% more on average, amounting to an extra 9 kg.

In a rather blatant demonstration of efficiency, the investigators also measured the speed of the participants’ digestion, as they had hypothesized that those with the longest digestive travel times would be the ones who harvested the most nutrition from their food. That was not the case.

The study subjects with the most efficient gut bacteria “also have the fastest passage through the gastrointestinal system, which has given us something to think about,” senior author Henrik Roager of the University of Copenhagen said in a written statement.

You know what gives us something to think about? Stool energy density and intestinal transit time and faecal bacterial cell counts, that’s what. Ick. Sometimes science is gross.

Here’s another thought, though: Seeing faecal instead of fecal is kind of funny to our American eyes, but adding that extra letter is also inefficient, which could mean that it’s good. So, in the spirit of embracing the inefficient as a new year begins, we’re resolving to wrap our editorial arms around faecal and the faeces it represents. Well, not literally, of course. More like we’re embracing the spirit of faeces.

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Leave the mouthwash. Take the yogurt

Most of us have experienced some sort of bad breath. It’s common in the morning right after waking up, but it also may be a sign for underlying medical issues like dental problems or acid reflux. Wherever it comes from, we always want to get rid of it. A recent meta-analysis in BMJ Open may have found the answer in some common foods.

Mladenovic/iStock/Getty Images

For those with halitosis, the basic problem is that the bacteria in their mouths are not happy about where they are. The researchers looked at 130 studies and found seven that suggested fermented food has some effect in combating bad breath.

Now when we say fermented food, we’re not talking about that science project waiting to happen in the back of the refrigerator. Think yogurt, sourdough bread, or miso soup. Anything that contains probiotic bacteria.

Matthew J. Messina, DDS, assistant professor of dentistry at Ohio State University, who was not involved with the study, told Healthline that “the whole idea behind probiotics is [bacteria replacement]. Supplant the ‘bad guys’ with the ‘good guys,’ then we’ll end up with a better result.” Essentially balancing the scales in your mouth.

It may not be a long-term solution, Dr. Messina said, but the short-term data are positive. So if you experience bad breath from time to time, try a little bowl of yogurt instead of chewing gum. If nothing else, the bacteria in your mouth will thank you.

You can talk the silly talk, but can you walk the silly walk?

The Ministry of Silly Walks sketch from Monty Python is an enduring comedy classic, and one of surprising relevance for doctors. After all, this isn’t the first time a study has analyzed the unusual strides of Mr. Putey and Mr. Teabag.

The BMJ Christmas edition truly is the gift that keeps on giving. For this plunge into the Flying Circus, the study authors recruited a small group of fairly average adults and had them walk normally around a track for 5 minutes, monitoring their oxygen intake and energy expenditure. After that, the study participants imitated Mr. Putey’s walk and then Mr. Teabag’s.

Michael Blann/DigitalVision

In the sketch, Mr. Teabag notes that Mr. Putey’s walk is “not particularly silly,” which is borne out in the research. When imitating Mr. Putey’s walk, oxygen intake and energy expenditure were barely higher than a normal walk, not enough to achieve a meaningful difference. Hopefully he’ll get that government grant to further develop his silly walk, because right now Mr. Putey’s walk simply doesn’t cut it.

Mr. Teabag’s walk is a different story and the very image of inefficiency. Oxygen intake was 2.5 times higher than during the normal walk, and energy expenditure was noticeably higher (8 kcal in men and 5.2 kcal in women). In fact, the walk was so inefficient and its effect so drastic it actually reached the level of vigorous exercise. Thanks to this, the study authors noted that just 11 minutes a day of walking like Mr. Teabag would be enough to reach the general goal of 75 minutes of vigorous exercise per week. Boosting that to 12-19 minutes would increase daily energy expenditure by 100 kcal.

The study authors wrote, “Had an initiative to promote inefficient movement been adopted in the early 1970s, we might now be living among a healthier society. Efforts to promote higher energy – and perhaps more joyful – walking should ensure inclusivity and inefficiency for all.” We think they just advocated for a real-life Ministry of Silly Walks. Well, there have been worse ideas. Just look at Twitter.
 

 

 

When efficient gut microbes go bad

With the latest news from the Ministry of Silly Walks, is it time for humans to embrace all things inefficient? Maybe.

ChrisChrisW/Getty Images

Turns out that individuals with more efficient digestive systems – those that extract more energy from the fuel supplied to them by the busy mouths above – tend to gain more weight than those with less efficient guts, even when they eat the same food, according to a recent study published in Microbiome.

The researchers took a look at the composition of gut microbes in a group of 85 volunteers and found that about 40% had microbiomes dominated by Bacteroides bacteria, which are more effective at extracting nutrients from food. That group also weighed 10% more on average, amounting to an extra 9 kg.

In a rather blatant demonstration of efficiency, the investigators also measured the speed of the participants’ digestion, as they had hypothesized that those with the longest digestive travel times would be the ones who harvested the most nutrition from their food. That was not the case.

The study subjects with the most efficient gut bacteria “also have the fastest passage through the gastrointestinal system, which has given us something to think about,” senior author Henrik Roager of the University of Copenhagen said in a written statement.

You know what gives us something to think about? Stool energy density and intestinal transit time and faecal bacterial cell counts, that’s what. Ick. Sometimes science is gross.

Here’s another thought, though: Seeing faecal instead of fecal is kind of funny to our American eyes, but adding that extra letter is also inefficient, which could mean that it’s good. So, in the spirit of embracing the inefficient as a new year begins, we’re resolving to wrap our editorial arms around faecal and the faeces it represents. Well, not literally, of course. More like we’re embracing the spirit of faeces.

Leave the mouthwash. Take the yogurt

Most of us have experienced some sort of bad breath. It’s common in the morning right after waking up, but it also may be a sign for underlying medical issues like dental problems or acid reflux. Wherever it comes from, we always want to get rid of it. A recent meta-analysis in BMJ Open may have found the answer in some common foods.

Mladenovic/iStock/Getty Images

For those with halitosis, the basic problem is that the bacteria in their mouths are not happy about where they are. The researchers looked at 130 studies and found seven that suggested fermented food has some effect in combating bad breath.

Now when we say fermented food, we’re not talking about that science project waiting to happen in the back of the refrigerator. Think yogurt, sourdough bread, or miso soup. Anything that contains probiotic bacteria.

Matthew J. Messina, DDS, assistant professor of dentistry at Ohio State University, who was not involved with the study, told Healthline that “the whole idea behind probiotics is [bacteria replacement]. Supplant the ‘bad guys’ with the ‘good guys,’ then we’ll end up with a better result.” Essentially balancing the scales in your mouth.

It may not be a long-term solution, Dr. Messina said, but the short-term data are positive. So if you experience bad breath from time to time, try a little bowl of yogurt instead of chewing gum. If nothing else, the bacteria in your mouth will thank you.

You can talk the silly talk, but can you walk the silly walk?

The Ministry of Silly Walks sketch from Monty Python is an enduring comedy classic, and one of surprising relevance for doctors. After all, this isn’t the first time a study has analyzed the unusual strides of Mr. Putey and Mr. Teabag.

The BMJ Christmas edition truly is the gift that keeps on giving. For this plunge into the Flying Circus, the study authors recruited a small group of fairly average adults and had them walk normally around a track for 5 minutes, monitoring their oxygen intake and energy expenditure. After that, the study participants imitated Mr. Putey’s walk and then Mr. Teabag’s.

Michael Blann/DigitalVision

In the sketch, Mr. Teabag notes that Mr. Putey’s walk is “not particularly silly,” which is borne out in the research. When imitating Mr. Putey’s walk, oxygen intake and energy expenditure were barely higher than a normal walk, not enough to achieve a meaningful difference. Hopefully he’ll get that government grant to further develop his silly walk, because right now Mr. Putey’s walk simply doesn’t cut it.

Mr. Teabag’s walk is a different story and the very image of inefficiency. Oxygen intake was 2.5 times higher than during the normal walk, and energy expenditure was noticeably higher (8 kcal in men and 5.2 kcal in women). In fact, the walk was so inefficient and its effect so drastic it actually reached the level of vigorous exercise. Thanks to this, the study authors noted that just 11 minutes a day of walking like Mr. Teabag would be enough to reach the general goal of 75 minutes of vigorous exercise per week. Boosting that to 12-19 minutes would increase daily energy expenditure by 100 kcal.

The study authors wrote, “Had an initiative to promote inefficient movement been adopted in the early 1970s, we might now be living among a healthier society. Efforts to promote higher energy – and perhaps more joyful – walking should ensure inclusivity and inefficiency for all.” We think they just advocated for a real-life Ministry of Silly Walks. Well, there have been worse ideas. Just look at Twitter.
 

 

 

When efficient gut microbes go bad

With the latest news from the Ministry of Silly Walks, is it time for humans to embrace all things inefficient? Maybe.

ChrisChrisW/Getty Images

Turns out that individuals with more efficient digestive systems – those that extract more energy from the fuel supplied to them by the busy mouths above – tend to gain more weight than those with less efficient guts, even when they eat the same food, according to a recent study published in Microbiome.

The researchers took a look at the composition of gut microbes in a group of 85 volunteers and found that about 40% had microbiomes dominated by Bacteroides bacteria, which are more effective at extracting nutrients from food. That group also weighed 10% more on average, amounting to an extra 9 kg.

In a rather blatant demonstration of efficiency, the investigators also measured the speed of the participants’ digestion, as they had hypothesized that those with the longest digestive travel times would be the ones who harvested the most nutrition from their food. That was not the case.

The study subjects with the most efficient gut bacteria “also have the fastest passage through the gastrointestinal system, which has given us something to think about,” senior author Henrik Roager of the University of Copenhagen said in a written statement.

You know what gives us something to think about? Stool energy density and intestinal transit time and faecal bacterial cell counts, that’s what. Ick. Sometimes science is gross.

Here’s another thought, though: Seeing faecal instead of fecal is kind of funny to our American eyes, but adding that extra letter is also inefficient, which could mean that it’s good. So, in the spirit of embracing the inefficient as a new year begins, we’re resolving to wrap our editorial arms around faecal and the faeces it represents. Well, not literally, of course. More like we’re embracing the spirit of faeces.

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FDA approves first-in-class drug for follicular lymphoma

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The U.S. Food and Drug Administration has approved mosunetuzumab-axgb (Lunsumio) for use in patients with relapsed or refractory follicular lymphoma who have received at least two previous systemic therapies.

This product is a first-in-class bispecific antibody that is designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells, according to the manufacturer, Genentech.

Mosunetuzumab-axgb is administered as an intravenous infusion for a fixed duration, which allows for time off therapy, and can be infused in an outpatient setting, the company noted.

The drug was granted an accelerated approval on the basis of response rate data from the phase 2 GO29781 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, the company noted.

The GO29781 study was carried out in individuals with pretreated follicular lymphoma, including those who were at high risk for disease progression or whose disease was refractory to prior therapies.

A complete response was achieved in 60% of patients (54 of 90).

An objective response rate (a combination of complete and partial responses) was seen in 80% of patients who received the drug, with a majority maintaining responses for at least 18 months.

The median duration of response among those who responded was 22.8 months.

Safety data come from 218 patients with hematologic cancers who received mosunetuzumab-axgb at the recommended dose. The most common adverse event was cytokine release syndrome (39%), which can be severe and life-threatening. The median duration of cytokine release syndrome events was 3 days (range, 1-29 days). Other common adverse events (≥ 20%) included fatigue, rash, pyrexia, and headache.

“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, MD, PhD, from the City of Hope, Los Angeles, division of lymphoma, and clinical trial investigator.

Dr. Budde presented data on mosunetuzumab-axgb at the 2021 annual meeting of the American Society of Hematology, as reported by this news organization.

She noted that the 60% complete response rate seen with this new drug contrasts with the 14% that has been seen for historical controls.

“We have seen deep and durable responses in heavily pretreated, high-risk relapsed/refractory follicular lymphoma patients with fixed-duration treatment. We also observed a very favorable tolerability profile, with most cytokine release syndrome confined to cycle 1 and low grade, and treatment administration is without mandatory hospitalization,” she commented at the time.

A lymphoma specialist who was not involved in the study told this news organization at the time that he was favorably impressed by the findings.

“To me, the single-agent data looks really outstanding, with a response rate of 80%, a complete response rate of 60%, and a median duration of response of 23 months, and really very acceptable rates of cytokine release syndrome,” commented Brad S. Kahl, MD, from the Siteman Cancer Center and Washington University in St. Louis.

“I think as a single agent – if it does get approval – it will be a really valuable addition to the armamentarium in follicular lymphoma,” he added.

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

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The U.S. Food and Drug Administration has approved mosunetuzumab-axgb (Lunsumio) for use in patients with relapsed or refractory follicular lymphoma who have received at least two previous systemic therapies.

This product is a first-in-class bispecific antibody that is designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells, according to the manufacturer, Genentech.

Mosunetuzumab-axgb is administered as an intravenous infusion for a fixed duration, which allows for time off therapy, and can be infused in an outpatient setting, the company noted.

The drug was granted an accelerated approval on the basis of response rate data from the phase 2 GO29781 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, the company noted.

The GO29781 study was carried out in individuals with pretreated follicular lymphoma, including those who were at high risk for disease progression or whose disease was refractory to prior therapies.

A complete response was achieved in 60% of patients (54 of 90).

An objective response rate (a combination of complete and partial responses) was seen in 80% of patients who received the drug, with a majority maintaining responses for at least 18 months.

The median duration of response among those who responded was 22.8 months.

Safety data come from 218 patients with hematologic cancers who received mosunetuzumab-axgb at the recommended dose. The most common adverse event was cytokine release syndrome (39%), which can be severe and life-threatening. The median duration of cytokine release syndrome events was 3 days (range, 1-29 days). Other common adverse events (≥ 20%) included fatigue, rash, pyrexia, and headache.

“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, MD, PhD, from the City of Hope, Los Angeles, division of lymphoma, and clinical trial investigator.

Dr. Budde presented data on mosunetuzumab-axgb at the 2021 annual meeting of the American Society of Hematology, as reported by this news organization.

She noted that the 60% complete response rate seen with this new drug contrasts with the 14% that has been seen for historical controls.

“We have seen deep and durable responses in heavily pretreated, high-risk relapsed/refractory follicular lymphoma patients with fixed-duration treatment. We also observed a very favorable tolerability profile, with most cytokine release syndrome confined to cycle 1 and low grade, and treatment administration is without mandatory hospitalization,” she commented at the time.

A lymphoma specialist who was not involved in the study told this news organization at the time that he was favorably impressed by the findings.

“To me, the single-agent data looks really outstanding, with a response rate of 80%, a complete response rate of 60%, and a median duration of response of 23 months, and really very acceptable rates of cytokine release syndrome,” commented Brad S. Kahl, MD, from the Siteman Cancer Center and Washington University in St. Louis.

“I think as a single agent – if it does get approval – it will be a really valuable addition to the armamentarium in follicular lymphoma,” he added.

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

The U.S. Food and Drug Administration has approved mosunetuzumab-axgb (Lunsumio) for use in patients with relapsed or refractory follicular lymphoma who have received at least two previous systemic therapies.

This product is a first-in-class bispecific antibody that is designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells, according to the manufacturer, Genentech.

Mosunetuzumab-axgb is administered as an intravenous infusion for a fixed duration, which allows for time off therapy, and can be infused in an outpatient setting, the company noted.

The drug was granted an accelerated approval on the basis of response rate data from the phase 2 GO29781 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, the company noted.

The GO29781 study was carried out in individuals with pretreated follicular lymphoma, including those who were at high risk for disease progression or whose disease was refractory to prior therapies.

A complete response was achieved in 60% of patients (54 of 90).

An objective response rate (a combination of complete and partial responses) was seen in 80% of patients who received the drug, with a majority maintaining responses for at least 18 months.

The median duration of response among those who responded was 22.8 months.

Safety data come from 218 patients with hematologic cancers who received mosunetuzumab-axgb at the recommended dose. The most common adverse event was cytokine release syndrome (39%), which can be severe and life-threatening. The median duration of cytokine release syndrome events was 3 days (range, 1-29 days). Other common adverse events (≥ 20%) included fatigue, rash, pyrexia, and headache.

“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, MD, PhD, from the City of Hope, Los Angeles, division of lymphoma, and clinical trial investigator.

Dr. Budde presented data on mosunetuzumab-axgb at the 2021 annual meeting of the American Society of Hematology, as reported by this news organization.

She noted that the 60% complete response rate seen with this new drug contrasts with the 14% that has been seen for historical controls.

“We have seen deep and durable responses in heavily pretreated, high-risk relapsed/refractory follicular lymphoma patients with fixed-duration treatment. We also observed a very favorable tolerability profile, with most cytokine release syndrome confined to cycle 1 and low grade, and treatment administration is without mandatory hospitalization,” she commented at the time.

A lymphoma specialist who was not involved in the study told this news organization at the time that he was favorably impressed by the findings.

“To me, the single-agent data looks really outstanding, with a response rate of 80%, a complete response rate of 60%, and a median duration of response of 23 months, and really very acceptable rates of cytokine release syndrome,” commented Brad S. Kahl, MD, from the Siteman Cancer Center and Washington University in St. Louis.

“I think as a single agent – if it does get approval – it will be a really valuable addition to the armamentarium in follicular lymphoma,” he added.

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

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