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FDA Calls AstraZeneca’s NSCLC Trial Design Into Question
The trial in question, AEGEAN, investigated perioperative durvalumab for resectable NSCLC tumors across 802 patients. Patients without EGFR or ALK mutations were randomly assigned to receive durvalumab before surgery alongside platinum-containing chemotherapy and after surgery for a year as monotherapy or to receive chemotherapy and surgery alone.
Patients receiving durvalumab demonstrated better event-free survival at 1 year (73.4% vs 64.5% without durvalumab) and a better pathologic complete response rate (17.2% vs 4.3% without). Currently, AstraZeneca is seeking to add the indication for durvalumab to those the agent already has.
However, at the July 25 ODAC meeting, the committee explained that the AEGEAN trial design makes it impossible to tell whether patients benefited from durvalumab before surgery, after it, or at both points.
Mounting evidence, including from AstraZeneca’s own studies, suggests that the benefit of immune checkpoint inhibitors, such as durvalumab, comes before surgery. That means prescribing durvalumab after surgery could be exposing patients to serious side effects and financial toxicity, with potentially no clinical benefit, “magnifying the risk of potential overtreatment,” the committee cautioned.
When AEGEAN was being designed in 2018, FDA requested that AstraZeneca address the uncertainty surrounding when to use durvalumab by including separate neoadjuvant and adjuvant arms, or at least an arm where patients were treated with neoadjuvant durvalumab alone to compare with treatment both before and after surgery.
The company didn’t follow through and, during the July 25 meeting, the committee wanted answers. “Why did you not comply with this?” asked ODAC committee acting chair Daniel Spratt, MD, a radiation oncologist at Case Western Reserve University in Cleveland, Ohio.
AstraZeneca personnel explained that doing so would have required many more subjects, made the trial more expensive, and added about 2 years to AEGEAN.
One speaker noted that the company, which makes more than $4 billion a year on durvalumab, would have taken about 2 days to recoup that added cost. Others wondered whether the motive was to sell durvalumab for as long as possible across a patient’s course of treatment.
Perhaps the biggest reason the company ignored the request is that “it wasn’t our understanding at that time that this was a barrier to approval,” an AstraZeneca regulatory affairs specialist said.
To this end, the agency asked its advisory panel to vote on whether it should require — instead of simply request, as it did with AstraZeneca — companies to prove that patients need immunotherapy both before and after surgery in resectable NSCLC.
The 11-member panel voted unanimously that it should make this a requirement, and several members said it should do so in other cancers as well.
However, when the agency asked whether durvalumab’s resectable NSCLC approval should be delayed until AstraZeneca conducts a trial to answer the neoadjuvant vs adjuvant question, the panel members didn’t think so.
The consensus was that because AEGEAN showed a decent benefit, patients and physicians should have it as an option, and approval shouldn’t be delayed. The panel said that the bigger question about the benefit of maintenance therapy should be left to future studies.
FDA usually follows the advice of its advisory panels.
A version of this article appeared on Medscape.com.
The trial in question, AEGEAN, investigated perioperative durvalumab for resectable NSCLC tumors across 802 patients. Patients without EGFR or ALK mutations were randomly assigned to receive durvalumab before surgery alongside platinum-containing chemotherapy and after surgery for a year as monotherapy or to receive chemotherapy and surgery alone.
Patients receiving durvalumab demonstrated better event-free survival at 1 year (73.4% vs 64.5% without durvalumab) and a better pathologic complete response rate (17.2% vs 4.3% without). Currently, AstraZeneca is seeking to add the indication for durvalumab to those the agent already has.
However, at the July 25 ODAC meeting, the committee explained that the AEGEAN trial design makes it impossible to tell whether patients benefited from durvalumab before surgery, after it, or at both points.
Mounting evidence, including from AstraZeneca’s own studies, suggests that the benefit of immune checkpoint inhibitors, such as durvalumab, comes before surgery. That means prescribing durvalumab after surgery could be exposing patients to serious side effects and financial toxicity, with potentially no clinical benefit, “magnifying the risk of potential overtreatment,” the committee cautioned.
When AEGEAN was being designed in 2018, FDA requested that AstraZeneca address the uncertainty surrounding when to use durvalumab by including separate neoadjuvant and adjuvant arms, or at least an arm where patients were treated with neoadjuvant durvalumab alone to compare with treatment both before and after surgery.
The company didn’t follow through and, during the July 25 meeting, the committee wanted answers. “Why did you not comply with this?” asked ODAC committee acting chair Daniel Spratt, MD, a radiation oncologist at Case Western Reserve University in Cleveland, Ohio.
AstraZeneca personnel explained that doing so would have required many more subjects, made the trial more expensive, and added about 2 years to AEGEAN.
One speaker noted that the company, which makes more than $4 billion a year on durvalumab, would have taken about 2 days to recoup that added cost. Others wondered whether the motive was to sell durvalumab for as long as possible across a patient’s course of treatment.
Perhaps the biggest reason the company ignored the request is that “it wasn’t our understanding at that time that this was a barrier to approval,” an AstraZeneca regulatory affairs specialist said.
To this end, the agency asked its advisory panel to vote on whether it should require — instead of simply request, as it did with AstraZeneca — companies to prove that patients need immunotherapy both before and after surgery in resectable NSCLC.
The 11-member panel voted unanimously that it should make this a requirement, and several members said it should do so in other cancers as well.
However, when the agency asked whether durvalumab’s resectable NSCLC approval should be delayed until AstraZeneca conducts a trial to answer the neoadjuvant vs adjuvant question, the panel members didn’t think so.
The consensus was that because AEGEAN showed a decent benefit, patients and physicians should have it as an option, and approval shouldn’t be delayed. The panel said that the bigger question about the benefit of maintenance therapy should be left to future studies.
FDA usually follows the advice of its advisory panels.
A version of this article appeared on Medscape.com.
The trial in question, AEGEAN, investigated perioperative durvalumab for resectable NSCLC tumors across 802 patients. Patients without EGFR or ALK mutations were randomly assigned to receive durvalumab before surgery alongside platinum-containing chemotherapy and after surgery for a year as monotherapy or to receive chemotherapy and surgery alone.
Patients receiving durvalumab demonstrated better event-free survival at 1 year (73.4% vs 64.5% without durvalumab) and a better pathologic complete response rate (17.2% vs 4.3% without). Currently, AstraZeneca is seeking to add the indication for durvalumab to those the agent already has.
However, at the July 25 ODAC meeting, the committee explained that the AEGEAN trial design makes it impossible to tell whether patients benefited from durvalumab before surgery, after it, or at both points.
Mounting evidence, including from AstraZeneca’s own studies, suggests that the benefit of immune checkpoint inhibitors, such as durvalumab, comes before surgery. That means prescribing durvalumab after surgery could be exposing patients to serious side effects and financial toxicity, with potentially no clinical benefit, “magnifying the risk of potential overtreatment,” the committee cautioned.
When AEGEAN was being designed in 2018, FDA requested that AstraZeneca address the uncertainty surrounding when to use durvalumab by including separate neoadjuvant and adjuvant arms, or at least an arm where patients were treated with neoadjuvant durvalumab alone to compare with treatment both before and after surgery.
The company didn’t follow through and, during the July 25 meeting, the committee wanted answers. “Why did you not comply with this?” asked ODAC committee acting chair Daniel Spratt, MD, a radiation oncologist at Case Western Reserve University in Cleveland, Ohio.
AstraZeneca personnel explained that doing so would have required many more subjects, made the trial more expensive, and added about 2 years to AEGEAN.
One speaker noted that the company, which makes more than $4 billion a year on durvalumab, would have taken about 2 days to recoup that added cost. Others wondered whether the motive was to sell durvalumab for as long as possible across a patient’s course of treatment.
Perhaps the biggest reason the company ignored the request is that “it wasn’t our understanding at that time that this was a barrier to approval,” an AstraZeneca regulatory affairs specialist said.
To this end, the agency asked its advisory panel to vote on whether it should require — instead of simply request, as it did with AstraZeneca — companies to prove that patients need immunotherapy both before and after surgery in resectable NSCLC.
The 11-member panel voted unanimously that it should make this a requirement, and several members said it should do so in other cancers as well.
However, when the agency asked whether durvalumab’s resectable NSCLC approval should be delayed until AstraZeneca conducts a trial to answer the neoadjuvant vs adjuvant question, the panel members didn’t think so.
The consensus was that because AEGEAN showed a decent benefit, patients and physicians should have it as an option, and approval shouldn’t be delayed. The panel said that the bigger question about the benefit of maintenance therapy should be left to future studies.
FDA usually follows the advice of its advisory panels.
A version of this article appeared on Medscape.com.
Advantages of a Pediatric Rheumatology/Dermatology Clinic Evaluated
results from a retrospective cohort study showed.
“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”
To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.
In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.
Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).
Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.
The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.
“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”
In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.
“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”
The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.
A version of this article appeared on Medscape.com.
results from a retrospective cohort study showed.
“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”
To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.
In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.
Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).
Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.
The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.
“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”
In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.
“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”
The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.
A version of this article appeared on Medscape.com.
results from a retrospective cohort study showed.
“This finding highlights the complexity of patients referred to this clinic,” the study’s first author, Jessica Crockett, a fourth-year medical student at UCSF, told this news organization following the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “Integrated care models such as rheumatology/dermatology clinics (RDCs) have been shown to facilitate complete clinical evaluations, establish new or revised diagnoses, and streamline care for adult patients with complex autoimmune skin diseases. However, few pediatric RDCs exist nationwide, and data therefore is quite limited.”
To advance the understanding of pediatric RDC practice patterns, the influence of the care model on patient care, and professional development for trainees and clinicians, Ms. Crockett collaborated with senior author Kelly Cordoro, MD, professor of dermatology and pediatrics at UCSF, and colleagues to evaluate a cohort of 71 patients who received care at the UCSF pediatric RDC. The clinic, which was launched in 2017, includes two dermatologists, two rheumatologists, trainees, a social worker, and a nurse. Team members participate in a preclinic conference to review patient data and images, discuss relevant literature, and develop an approach to each patient.
In a separate part of the study, the researchers distributed a survey to 17 pediatric dermatologists who participate in unique RDCs in North America. Respondents were asked to describe the variability of clinical operations, participants, administrative/clinical support, and educational value for participating physicians and trainees.
Of the 71 patients cared for at the UCSF pediatric RDC, 69% were female, 44% were White, 51% were aged 13-21 years, 42% were aged 3-12 years, and 7% were aged 0-11 years at their first clinic visit. The top four primary RDC diagnoses were linear morphea (33%), lupus (23%), psoriasis (13%), and juvenile dermatomyositis (10%).
Nearly one in four patients (17, or 24%) presented to the RDC without a confirmed diagnosis. A diagnosis was established at the first RDC visit for 7 of these 17 patients (41%). Among 54 patients who presented with an established diagnosis, the first RDC visit confirmed the diagnosis for 52 (96%) and revised it for 2 (4%). “Initial pediatric RDC evaluation significantly influenced patient care by confirming or revising preexisting diagnoses, rendering new diagnoses, and streamlining additional laboratory and imaging recommendations,” the researchers wrote in their poster.
The evaluation also resulted in modified disease management in the form of systemic medication changes or dosage adjustments as well as the initiation of novel therapies. For example, systemic medication changes were made during the first RDC visit in 34 of the 46 patients (74%) who were on systemic medication at presentation.
“Seeing complex patients together in real time allows specialists and other team members (social work, nursing, PT/OT, for example) to share ideas, communicate clearly to families, and efficiently develop recommendations,” Ms. Crockett said of the UCSF pediatric RDC. “Exposure to other specialists while caring for patients enhances medical knowledge, communication skills, and professional competency of faculty and trainees alike.”
In the survey portion of the study, each of the 17 dermatologists reported that the pediatric RDC is valuable for patient care, and 88% believed the RDC was a valuable use of their time. However, only 59% of respondents reported having administrative support, and only 29% had a dedicated clinic coordinator or navigator.
“We were surprised to find that only a quarter of pediatric RDCs incorporate an educational conference,” Dr. Cordoro told this news organization. “We have found that assembling the care team prior to seeing patients to review clinical data, discuss relevant literature, and define the clinical questions for each patient is an integral part of the clinical operation. The trainees are involved in these conference presentations, and it really enhances their understanding of the complex diagnoses we manage in this clinic and the issues faced by affected children and families. The preclinical conference increases efficiency, positively influences patient care, and supports professional development for all participants.”
The study was indirectly supported by a fellowship grant awarded to Ms. Crockett from the Pediatric Dermatology Research Alliance. The researchers reported having no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM SPD 2024
Underserved Families Share Ways to Improve Access to Pediatric Dermatologists
, a theme emerged that surprised lead study author Lucinda L. Kohn, MD, MHS.
“Most families said that racial concordance didn’t matter that much, but they did place high value on being heard,” Dr. Kohn, of the Department of Dermatology at the University of Colorado, Aurora, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “Being heard means that their experience was respected; that their questions and worries were anticipated, addressed, and answered; and that their feelings were acknowledged.”
As a way to understand these families’ knowledge, attitudes, and beliefs about access to pediatric dermatology care and how the hospital system and medical team could better support them, Dr. Kohn and colleagues conducted in-depth, semi-structured interviews with 32 English-speaking parents and/or guardians of children who received care at the Children’s Hospital Colorado Anschutz Medical Campus pediatric dermatology clinic. The researchers conducted and recorded the 30- to 60-minute interviews via Zoom or phone call from October 17, 2023, to January 23, 2024. Domains of interest included participant background and experiences, communication preferences, and experience accessing pediatric dermatology care. Next, Dr. Kohn and colleagues used a reflexive, team-based inductive approach to carry out a thematic analysis from the interviews.
The mean age of the 32 study participants was 38.9 years; 14 (43.75%) identified as Hispanic, 11 (34.38%) as Black, and 12 (37.50%) as American Indian/Alaska Native (response categories were not mutually exclusive). Several themes emerged from analysis of the interviews. Barriers to receiving pediatric dermatology care included distrust of the healthcare system, generational and community lack of awareness about dermatology, distance to the hospital, and household income.
“One family mentioned that they needed to save up for 3 months to be able to afford the drive, hotel, and food needed for their child to attend their pediatric dermatology visit,” Dr. Kohn said. “As we know, most pediatric dermatology visits are 10-15 minutes long, so that they needed to cut groceries for 3 months to be able to see a pediatric dermatologist for 10-15 minutes is just heart wrenching. Families also didn’t understand the large teams that we have in medicine: The medical students, residents, nurses, medical assistants, attendings, and physician extenders.”
One key facilitator to receiving pediatric dermatology care was the family’s perception that the provider shares their minoritized experience because of similarities in skin tone. “When it’s your own race, whether it’s Black, Hispanic, or you know, we feel like when it’s someone like me, they will look out for me more,” one study participant said. Other facilitators expressed by the study participants included increased representation from the family’s community at all levels of healthcare (“the more you see providers and people in a space that look like you, I think the more welcoming it will feel,” one said) and normalizing dermatology care (“letting it be known that going to the dermatologist is just like going to a regular doctor,” another said).
Dr. Kohn acknowledged certain limitations of the study, including its single-center qualitative design. “Qualitative studies are not generalizable, but they do dive into the lived experiences of a few,” she said. “There aren’t a lot of qualitative studies in derm, so even though this was a very simple study, we hope the findings will help us to support our most diverse and underserved families access the pediatric dermatology care that they need.”
The researchers reported having no relevant financial disclosures. The study was recognized as an award-winning poster at the meeting.
A version of this article appeared on Medscape.com.
, a theme emerged that surprised lead study author Lucinda L. Kohn, MD, MHS.
“Most families said that racial concordance didn’t matter that much, but they did place high value on being heard,” Dr. Kohn, of the Department of Dermatology at the University of Colorado, Aurora, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “Being heard means that their experience was respected; that their questions and worries were anticipated, addressed, and answered; and that their feelings were acknowledged.”
As a way to understand these families’ knowledge, attitudes, and beliefs about access to pediatric dermatology care and how the hospital system and medical team could better support them, Dr. Kohn and colleagues conducted in-depth, semi-structured interviews with 32 English-speaking parents and/or guardians of children who received care at the Children’s Hospital Colorado Anschutz Medical Campus pediatric dermatology clinic. The researchers conducted and recorded the 30- to 60-minute interviews via Zoom or phone call from October 17, 2023, to January 23, 2024. Domains of interest included participant background and experiences, communication preferences, and experience accessing pediatric dermatology care. Next, Dr. Kohn and colleagues used a reflexive, team-based inductive approach to carry out a thematic analysis from the interviews.
The mean age of the 32 study participants was 38.9 years; 14 (43.75%) identified as Hispanic, 11 (34.38%) as Black, and 12 (37.50%) as American Indian/Alaska Native (response categories were not mutually exclusive). Several themes emerged from analysis of the interviews. Barriers to receiving pediatric dermatology care included distrust of the healthcare system, generational and community lack of awareness about dermatology, distance to the hospital, and household income.
“One family mentioned that they needed to save up for 3 months to be able to afford the drive, hotel, and food needed for their child to attend their pediatric dermatology visit,” Dr. Kohn said. “As we know, most pediatric dermatology visits are 10-15 minutes long, so that they needed to cut groceries for 3 months to be able to see a pediatric dermatologist for 10-15 minutes is just heart wrenching. Families also didn’t understand the large teams that we have in medicine: The medical students, residents, nurses, medical assistants, attendings, and physician extenders.”
One key facilitator to receiving pediatric dermatology care was the family’s perception that the provider shares their minoritized experience because of similarities in skin tone. “When it’s your own race, whether it’s Black, Hispanic, or you know, we feel like when it’s someone like me, they will look out for me more,” one study participant said. Other facilitators expressed by the study participants included increased representation from the family’s community at all levels of healthcare (“the more you see providers and people in a space that look like you, I think the more welcoming it will feel,” one said) and normalizing dermatology care (“letting it be known that going to the dermatologist is just like going to a regular doctor,” another said).
Dr. Kohn acknowledged certain limitations of the study, including its single-center qualitative design. “Qualitative studies are not generalizable, but they do dive into the lived experiences of a few,” she said. “There aren’t a lot of qualitative studies in derm, so even though this was a very simple study, we hope the findings will help us to support our most diverse and underserved families access the pediatric dermatology care that they need.”
The researchers reported having no relevant financial disclosures. The study was recognized as an award-winning poster at the meeting.
A version of this article appeared on Medscape.com.
, a theme emerged that surprised lead study author Lucinda L. Kohn, MD, MHS.
“Most families said that racial concordance didn’t matter that much, but they did place high value on being heard,” Dr. Kohn, of the Department of Dermatology at the University of Colorado, Aurora, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “Being heard means that their experience was respected; that their questions and worries were anticipated, addressed, and answered; and that their feelings were acknowledged.”
As a way to understand these families’ knowledge, attitudes, and beliefs about access to pediatric dermatology care and how the hospital system and medical team could better support them, Dr. Kohn and colleagues conducted in-depth, semi-structured interviews with 32 English-speaking parents and/or guardians of children who received care at the Children’s Hospital Colorado Anschutz Medical Campus pediatric dermatology clinic. The researchers conducted and recorded the 30- to 60-minute interviews via Zoom or phone call from October 17, 2023, to January 23, 2024. Domains of interest included participant background and experiences, communication preferences, and experience accessing pediatric dermatology care. Next, Dr. Kohn and colleagues used a reflexive, team-based inductive approach to carry out a thematic analysis from the interviews.
The mean age of the 32 study participants was 38.9 years; 14 (43.75%) identified as Hispanic, 11 (34.38%) as Black, and 12 (37.50%) as American Indian/Alaska Native (response categories were not mutually exclusive). Several themes emerged from analysis of the interviews. Barriers to receiving pediatric dermatology care included distrust of the healthcare system, generational and community lack of awareness about dermatology, distance to the hospital, and household income.
“One family mentioned that they needed to save up for 3 months to be able to afford the drive, hotel, and food needed for their child to attend their pediatric dermatology visit,” Dr. Kohn said. “As we know, most pediatric dermatology visits are 10-15 minutes long, so that they needed to cut groceries for 3 months to be able to see a pediatric dermatologist for 10-15 minutes is just heart wrenching. Families also didn’t understand the large teams that we have in medicine: The medical students, residents, nurses, medical assistants, attendings, and physician extenders.”
One key facilitator to receiving pediatric dermatology care was the family’s perception that the provider shares their minoritized experience because of similarities in skin tone. “When it’s your own race, whether it’s Black, Hispanic, or you know, we feel like when it’s someone like me, they will look out for me more,” one study participant said. Other facilitators expressed by the study participants included increased representation from the family’s community at all levels of healthcare (“the more you see providers and people in a space that look like you, I think the more welcoming it will feel,” one said) and normalizing dermatology care (“letting it be known that going to the dermatologist is just like going to a regular doctor,” another said).
Dr. Kohn acknowledged certain limitations of the study, including its single-center qualitative design. “Qualitative studies are not generalizable, but they do dive into the lived experiences of a few,” she said. “There aren’t a lot of qualitative studies in derm, so even though this was a very simple study, we hope the findings will help us to support our most diverse and underserved families access the pediatric dermatology care that they need.”
The researchers reported having no relevant financial disclosures. The study was recognized as an award-winning poster at the meeting.
A version of this article appeared on Medscape.com.
FROM SPD 2024
Study Finds Gout Drug Effective for Aphthous Ulcers in Children
“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”
Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.
Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”
The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.
“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.
The researchers reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”
Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.
Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”
The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.
“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.
The researchers reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
“Complex aphthous stomatitis in children is typically treated with topical supportive care, which is often not effective,” one of the study investigators, Ananya Shah, a third-year medical student at the University of Rochester School of Medicine & Dentistry, Rochester, New York, told this news organization following the Society for Pediatric Dermatology annual meeting, where the study was presented during a poster session. “There is limited research on CAS and its treatment in children. Colchicine is often used for treatment of CAS in adults, but its use in children has not been studied.”
Ms. Shah, in collaboration with Hilary Kunkel, MD, Nessa Aghazadeh, MD, and Megha Tollefson, MD, of the Department of Dermatology, Mayo Clinic, Rochester, Minnesota, retrospectively reviewed the charts of 20 children diagnosed with CAS who were treated with colchicine, an anti-inflammatory drug often used to treat gout, at the clinic between 2000 and 2023. Treatment responses were defined as no response, partial response, and complete response. Half of the patients were girls, and their median age at presentation was 5 years.
Ulcers were most commonly located in the buccal mucosa (80%), followed by the gingiva (50%), the mucosal lip (50%), and the palate (40%). Nearly all patients (95%) reported that the CAS caused difficulties with eating or drinking. Other effects on their quality of life included weight loss (35%), bleeding (30%), and difficulty brushing teeth (25%). “I was surprised by how much CAS impacts pediatric patients’ quality of life,” Ms. Shah said. “Almost all of the patients experienced trouble with basic activities of daily living, including eating and drinking. In addition, CAS negatively impacted mental health and led to missed school for patients.”
The researchers had follow-up data on responses to colchicine for 14 of the 20 patients. Of these, 12 (86%) had symptom improvement, 5 (36%) had a complete response, 8 (57%) had a partial response, and 1 (7%) did not respond. Nine patients (64%) experienced side effects. Of these, six had diarrhea, two had nausea, and one had constipation.
“Colchicine should be considered as a treatment in pediatric patients who have refractory complex aphthous stomatitis as it is generally well tolerated with minimal side effects,” Ms. Shah said. She acknowledged certain limitations of the study, including its single-center, retrospective design.
The researchers reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM SPD 2024
Safety Standards a Top Priority for ASLMS President
Arisa E. Ortiz, MD, began her term as president of the American Society for Laser Medicine and Surgery (ASLMS) during the organization’s annual meeting in April 2024.
After earning her medical degree from Albany Medical College, Albany, New York, Dr. Ortiz, a native of Los Angeles, completed her dermatology residency training at the University of California, Irvine, and the university’s Beckman Laser Institute. Next, she completed a laser and cosmetic dermatology fellowship at Massachusetts General Hospital, Harvard Medical School, and the Wellman Center for Photomedicine, all in Boston, and acquired additional fellowship training in Mohs micrographic surgery at the University of California, San Diego (UCSD). Dr. Ortiz is currently director of laser and cosmetic dermatology and a clinical professor of dermatology at UCSD.
She has authored more than 60 publications on new innovations in cutaneous surgery and is a frequent speaker at meetings of the American Academy of Dermatology, the American Society for Dermatologic Surgery (ASDS), and ASLMS, and she cochairs the annual Masters of Aesthetics Symposium in San Diego. Dr. Ortiz has received several awards, including the 2024 Castle Connolly Top Doctor Award and the Exceptional Women in Medicine Award; Newsweek America’s Best Dermatologists; the ASLMS Dr. Horace Furumoto Young Investigator Award, the ASLMS Best of Session Award for Cutaneous Applications, and the ASDS President’s Outstanding Service Award. Her primary research focuses on the laser treatment of nonmelanoma skin cancer.
In an interview, Dr. Ortiz spoke about her goals as ASLMS president and other topics related to dermatology.
Who inspired you most to become a doctor?
I’ve wanted to become a doctor for as long as I can remember. My fascination with science and the idea of helping people improve their health were driving forces. However, my biggest influence early on was my uncle, who was a pediatrician. His dedication and passion for medicine deeply inspired me and solidified my desire to pursue a career in healthcare.
I understand that a bout with chickenpox as a teenager influenced your decision to specialize in dermatology.
It’s an interesting and somewhat humorous story. When I was 18, I contracted chickenpox and ended up with scars on my face. It was a tough experience as a teenager, but it’s fascinating how such events can shape your life. In my quest for help, I opened the Yellow Pages and randomly chose a dermatologist nearby, who turned out to be Gary Lask, MD, director of lasers at UCLA [University of California, Los Angeles]. During our visit, I mentioned that I was premed, and he encouraged me to consider dermatology. About 6 years later, as a second-year medical student, I realized my passion for dermatology. I reached out to Dr. Lask and told him: “You were right. I want to be a dermatologist. Now, you have to help me get in!” Today, he remains my mentor, and I am deeply grateful for his guidance and support on this journey.
One of the initiatives for your term as ASLMS president includes a focus on safety standards for lasers and energy-based devices. Why is this important now?
Working at the university, I frequently encounter severe complications arising from the improper use of lasers and energy-based devices. As these procedures gain popularity, more providers are offering them, yet often without adequate training. As the world’s premier laser society, it is our duty to ensure patient safety. In the ever-evolving field of laser medicine, it is crucial that we continually strive to enhance the regulation of laser usage, ensuring that patients receive the highest standard of care with minimal risk.
One of the suggestions you have for the safety initiative is to offer a rigorous laser safety certification course with continuing education opportunities as a way foster a culture of heightened safety standards. Please explain what would be included in such a course and how it would align with current efforts to report adverse events such as the ASDS-Northwestern University Cutaneous Procedures Adverse Events Reporting (CAPER) registry and the Food and Drug Administration’s MedWatch Program.
A laser safety certification task force has been established to determine the best approach for developing a comprehensive course. The task force aims to assess the necessity of a formal safety certification in our industry, identify the resources needed to support such a certification, establish general safety protocols to form the content foundation, address potential legal concerns, and outline the process for formal certification program recognition. This exploratory work is expected to conclude by the end of the year. The proposed course may include modules on the fundamentals of laser physics, safe operation techniques, patient selection and management, and emergency protocols. Continuing education opportunities would be considered to keep practitioners updated on the latest advancements and safety protocols in laser medicine, thereby fostering a culture of heightened safety standards.
Another initiative for your term is the rollout of a tattoo removal program for former gang members based on the UCSD Clean Slate Tattoo Removal Program. Please tell us more about your vision for this national program.
UCSD Dermatology, in collaboration with UCSD Global Health, has been involved in the Clean Slate Tattoo Removal Program for the past decade. This initiative supports and rehabilitates former gang members by offering laser tattoo removal, helping them reintegrate into society. My vision is to equip our members with the necessary protocols to implement this outreach initiative in their own communities. By providing opportunities for reform and growth, we aim to foster safer and more inclusive communities nationwide.
You were one of the first clinicians to use a laser to treat basal cell carcinoma (BCC). Who are the ideal candidates for this procedure? Is the technique ready for wide clinical adoption? If not, what kind of studies are needed to make it so?
My research passion lies in optimizing laser treatments for BCC. During my fellowship with R. Rox Anderson, MD, and Mathew Avram, MD, at the MGH Wellman Center for Photomedicine, we conducted a pilot study using the 1064-nm Nd:YAG laser, achieving a 92% clearance rate after one treatment. Inspired by these results, we conducted a larger multicenter study, which demonstrated a 90% clearance rate after a single treatment. I now incorporate this technique into my daily practice. The ideal candidates for this procedure are patients with BCC that do not meet the Mohs Appropriate Use Criteria, such as those with nodular or superficial BCC subtypes on the body, individuals who are poor surgical candidates, or those who are surgically exhausted. However, I do not recommend this treatment for patients who are primarily concerned about facial scarring, particularly younger individuals; in such cases, Mohs surgery still remains the preferred option. While I believe this technique is ready for broader clinical adoption, it requires an understanding of laser endpoints. We are also exploring antibody-targeted gold nanorods to enhance the selectivity and standardization of the treatment.
Who inspires you most in your work today?
My patients are my greatest inspiration. Their trust and dedication motivate me to stay at the forefront of dermatologic advancements, ensuring I provide the most cutting-edge and safe treatments possible. Their commitment drives my relentless pursuit of continuous learning and innovation in the field.
What’s the best advice you can give to female dermatologists seeking leadership positions at the local, state, or national level?
My best advice is to have the courage to ask for what you seek. Societies are always looking for members who are eager to participate and contribute. If you express your interest in becoming more involved, there is likely a position available for you. The more you are willing to contribute to a society, the more likely you will be noticed and excel into higher leadership positions. Take initiative, show your commitment, and don’t hesitate to step forward when opportunities arise.
What’s the one tried-and-true laser- or energy-based procedure that you consider a “must” for your dermatology practice? And why?
Determining a single “must-have” laser- or energy-based procedure is a challenging question as it greatly depends on the specific needs of your patient population. However, one of the most common concerns among patients involves issues like redness and pigmentation. Therefore, having a versatile laser or an intense pulsed light device that effectively targets both red and brown pigmentation is indispensable for most practices.
In your view, what are the top three trends in aesthetic dermatology?
Over the years, I have observed several key trends in aesthetic dermatology:
- Minimally invasive procedures. There is a growing preference for less invasive treatments. Patients increasingly desire minimal downtime while still achieving significant results.
- Advancements in laser and energy-based devices for darker skin. There have been substantial advancements in technologies that are safer and more effective for darker skin tones. These developments play a crucial role in addressing diverse patient needs and providing inclusive dermatologic care.
- Natural aesthetic. I am hopeful that the trend toward an overdone appearance is fading. There seems to be a shift back towards a more natural and conservative aesthetic, emphasizing subtle enhancements over dramatic changes.
What development in dermatology are you most excited about in the next 5 years?
I am most excited to see how artificial intelligence and robotics play a role in energy-based devices.
Dr. Ortiz disclosed having financial relationships with several pharmaceutical and device companies. She is also cochair of the MOAS.
Arisa E. Ortiz, MD, began her term as president of the American Society for Laser Medicine and Surgery (ASLMS) during the organization’s annual meeting in April 2024.
After earning her medical degree from Albany Medical College, Albany, New York, Dr. Ortiz, a native of Los Angeles, completed her dermatology residency training at the University of California, Irvine, and the university’s Beckman Laser Institute. Next, she completed a laser and cosmetic dermatology fellowship at Massachusetts General Hospital, Harvard Medical School, and the Wellman Center for Photomedicine, all in Boston, and acquired additional fellowship training in Mohs micrographic surgery at the University of California, San Diego (UCSD). Dr. Ortiz is currently director of laser and cosmetic dermatology and a clinical professor of dermatology at UCSD.
She has authored more than 60 publications on new innovations in cutaneous surgery and is a frequent speaker at meetings of the American Academy of Dermatology, the American Society for Dermatologic Surgery (ASDS), and ASLMS, and she cochairs the annual Masters of Aesthetics Symposium in San Diego. Dr. Ortiz has received several awards, including the 2024 Castle Connolly Top Doctor Award and the Exceptional Women in Medicine Award; Newsweek America’s Best Dermatologists; the ASLMS Dr. Horace Furumoto Young Investigator Award, the ASLMS Best of Session Award for Cutaneous Applications, and the ASDS President’s Outstanding Service Award. Her primary research focuses on the laser treatment of nonmelanoma skin cancer.
In an interview, Dr. Ortiz spoke about her goals as ASLMS president and other topics related to dermatology.
Who inspired you most to become a doctor?
I’ve wanted to become a doctor for as long as I can remember. My fascination with science and the idea of helping people improve their health were driving forces. However, my biggest influence early on was my uncle, who was a pediatrician. His dedication and passion for medicine deeply inspired me and solidified my desire to pursue a career in healthcare.
I understand that a bout with chickenpox as a teenager influenced your decision to specialize in dermatology.
It’s an interesting and somewhat humorous story. When I was 18, I contracted chickenpox and ended up with scars on my face. It was a tough experience as a teenager, but it’s fascinating how such events can shape your life. In my quest for help, I opened the Yellow Pages and randomly chose a dermatologist nearby, who turned out to be Gary Lask, MD, director of lasers at UCLA [University of California, Los Angeles]. During our visit, I mentioned that I was premed, and he encouraged me to consider dermatology. About 6 years later, as a second-year medical student, I realized my passion for dermatology. I reached out to Dr. Lask and told him: “You were right. I want to be a dermatologist. Now, you have to help me get in!” Today, he remains my mentor, and I am deeply grateful for his guidance and support on this journey.
One of the initiatives for your term as ASLMS president includes a focus on safety standards for lasers and energy-based devices. Why is this important now?
Working at the university, I frequently encounter severe complications arising from the improper use of lasers and energy-based devices. As these procedures gain popularity, more providers are offering them, yet often without adequate training. As the world’s premier laser society, it is our duty to ensure patient safety. In the ever-evolving field of laser medicine, it is crucial that we continually strive to enhance the regulation of laser usage, ensuring that patients receive the highest standard of care with minimal risk.
One of the suggestions you have for the safety initiative is to offer a rigorous laser safety certification course with continuing education opportunities as a way foster a culture of heightened safety standards. Please explain what would be included in such a course and how it would align with current efforts to report adverse events such as the ASDS-Northwestern University Cutaneous Procedures Adverse Events Reporting (CAPER) registry and the Food and Drug Administration’s MedWatch Program.
A laser safety certification task force has been established to determine the best approach for developing a comprehensive course. The task force aims to assess the necessity of a formal safety certification in our industry, identify the resources needed to support such a certification, establish general safety protocols to form the content foundation, address potential legal concerns, and outline the process for formal certification program recognition. This exploratory work is expected to conclude by the end of the year. The proposed course may include modules on the fundamentals of laser physics, safe operation techniques, patient selection and management, and emergency protocols. Continuing education opportunities would be considered to keep practitioners updated on the latest advancements and safety protocols in laser medicine, thereby fostering a culture of heightened safety standards.
Another initiative for your term is the rollout of a tattoo removal program for former gang members based on the UCSD Clean Slate Tattoo Removal Program. Please tell us more about your vision for this national program.
UCSD Dermatology, in collaboration with UCSD Global Health, has been involved in the Clean Slate Tattoo Removal Program for the past decade. This initiative supports and rehabilitates former gang members by offering laser tattoo removal, helping them reintegrate into society. My vision is to equip our members with the necessary protocols to implement this outreach initiative in their own communities. By providing opportunities for reform and growth, we aim to foster safer and more inclusive communities nationwide.
You were one of the first clinicians to use a laser to treat basal cell carcinoma (BCC). Who are the ideal candidates for this procedure? Is the technique ready for wide clinical adoption? If not, what kind of studies are needed to make it so?
My research passion lies in optimizing laser treatments for BCC. During my fellowship with R. Rox Anderson, MD, and Mathew Avram, MD, at the MGH Wellman Center for Photomedicine, we conducted a pilot study using the 1064-nm Nd:YAG laser, achieving a 92% clearance rate after one treatment. Inspired by these results, we conducted a larger multicenter study, which demonstrated a 90% clearance rate after a single treatment. I now incorporate this technique into my daily practice. The ideal candidates for this procedure are patients with BCC that do not meet the Mohs Appropriate Use Criteria, such as those with nodular or superficial BCC subtypes on the body, individuals who are poor surgical candidates, or those who are surgically exhausted. However, I do not recommend this treatment for patients who are primarily concerned about facial scarring, particularly younger individuals; in such cases, Mohs surgery still remains the preferred option. While I believe this technique is ready for broader clinical adoption, it requires an understanding of laser endpoints. We are also exploring antibody-targeted gold nanorods to enhance the selectivity and standardization of the treatment.
Who inspires you most in your work today?
My patients are my greatest inspiration. Their trust and dedication motivate me to stay at the forefront of dermatologic advancements, ensuring I provide the most cutting-edge and safe treatments possible. Their commitment drives my relentless pursuit of continuous learning and innovation in the field.
What’s the best advice you can give to female dermatologists seeking leadership positions at the local, state, or national level?
My best advice is to have the courage to ask for what you seek. Societies are always looking for members who are eager to participate and contribute. If you express your interest in becoming more involved, there is likely a position available for you. The more you are willing to contribute to a society, the more likely you will be noticed and excel into higher leadership positions. Take initiative, show your commitment, and don’t hesitate to step forward when opportunities arise.
What’s the one tried-and-true laser- or energy-based procedure that you consider a “must” for your dermatology practice? And why?
Determining a single “must-have” laser- or energy-based procedure is a challenging question as it greatly depends on the specific needs of your patient population. However, one of the most common concerns among patients involves issues like redness and pigmentation. Therefore, having a versatile laser or an intense pulsed light device that effectively targets both red and brown pigmentation is indispensable for most practices.
In your view, what are the top three trends in aesthetic dermatology?
Over the years, I have observed several key trends in aesthetic dermatology:
- Minimally invasive procedures. There is a growing preference for less invasive treatments. Patients increasingly desire minimal downtime while still achieving significant results.
- Advancements in laser and energy-based devices for darker skin. There have been substantial advancements in technologies that are safer and more effective for darker skin tones. These developments play a crucial role in addressing diverse patient needs and providing inclusive dermatologic care.
- Natural aesthetic. I am hopeful that the trend toward an overdone appearance is fading. There seems to be a shift back towards a more natural and conservative aesthetic, emphasizing subtle enhancements over dramatic changes.
What development in dermatology are you most excited about in the next 5 years?
I am most excited to see how artificial intelligence and robotics play a role in energy-based devices.
Dr. Ortiz disclosed having financial relationships with several pharmaceutical and device companies. She is also cochair of the MOAS.
Arisa E. Ortiz, MD, began her term as president of the American Society for Laser Medicine and Surgery (ASLMS) during the organization’s annual meeting in April 2024.
After earning her medical degree from Albany Medical College, Albany, New York, Dr. Ortiz, a native of Los Angeles, completed her dermatology residency training at the University of California, Irvine, and the university’s Beckman Laser Institute. Next, she completed a laser and cosmetic dermatology fellowship at Massachusetts General Hospital, Harvard Medical School, and the Wellman Center for Photomedicine, all in Boston, and acquired additional fellowship training in Mohs micrographic surgery at the University of California, San Diego (UCSD). Dr. Ortiz is currently director of laser and cosmetic dermatology and a clinical professor of dermatology at UCSD.
She has authored more than 60 publications on new innovations in cutaneous surgery and is a frequent speaker at meetings of the American Academy of Dermatology, the American Society for Dermatologic Surgery (ASDS), and ASLMS, and she cochairs the annual Masters of Aesthetics Symposium in San Diego. Dr. Ortiz has received several awards, including the 2024 Castle Connolly Top Doctor Award and the Exceptional Women in Medicine Award; Newsweek America’s Best Dermatologists; the ASLMS Dr. Horace Furumoto Young Investigator Award, the ASLMS Best of Session Award for Cutaneous Applications, and the ASDS President’s Outstanding Service Award. Her primary research focuses on the laser treatment of nonmelanoma skin cancer.
In an interview, Dr. Ortiz spoke about her goals as ASLMS president and other topics related to dermatology.
Who inspired you most to become a doctor?
I’ve wanted to become a doctor for as long as I can remember. My fascination with science and the idea of helping people improve their health were driving forces. However, my biggest influence early on was my uncle, who was a pediatrician. His dedication and passion for medicine deeply inspired me and solidified my desire to pursue a career in healthcare.
I understand that a bout with chickenpox as a teenager influenced your decision to specialize in dermatology.
It’s an interesting and somewhat humorous story. When I was 18, I contracted chickenpox and ended up with scars on my face. It was a tough experience as a teenager, but it’s fascinating how such events can shape your life. In my quest for help, I opened the Yellow Pages and randomly chose a dermatologist nearby, who turned out to be Gary Lask, MD, director of lasers at UCLA [University of California, Los Angeles]. During our visit, I mentioned that I was premed, and he encouraged me to consider dermatology. About 6 years later, as a second-year medical student, I realized my passion for dermatology. I reached out to Dr. Lask and told him: “You were right. I want to be a dermatologist. Now, you have to help me get in!” Today, he remains my mentor, and I am deeply grateful for his guidance and support on this journey.
One of the initiatives for your term as ASLMS president includes a focus on safety standards for lasers and energy-based devices. Why is this important now?
Working at the university, I frequently encounter severe complications arising from the improper use of lasers and energy-based devices. As these procedures gain popularity, more providers are offering them, yet often without adequate training. As the world’s premier laser society, it is our duty to ensure patient safety. In the ever-evolving field of laser medicine, it is crucial that we continually strive to enhance the regulation of laser usage, ensuring that patients receive the highest standard of care with minimal risk.
One of the suggestions you have for the safety initiative is to offer a rigorous laser safety certification course with continuing education opportunities as a way foster a culture of heightened safety standards. Please explain what would be included in such a course and how it would align with current efforts to report adverse events such as the ASDS-Northwestern University Cutaneous Procedures Adverse Events Reporting (CAPER) registry and the Food and Drug Administration’s MedWatch Program.
A laser safety certification task force has been established to determine the best approach for developing a comprehensive course. The task force aims to assess the necessity of a formal safety certification in our industry, identify the resources needed to support such a certification, establish general safety protocols to form the content foundation, address potential legal concerns, and outline the process for formal certification program recognition. This exploratory work is expected to conclude by the end of the year. The proposed course may include modules on the fundamentals of laser physics, safe operation techniques, patient selection and management, and emergency protocols. Continuing education opportunities would be considered to keep practitioners updated on the latest advancements and safety protocols in laser medicine, thereby fostering a culture of heightened safety standards.
Another initiative for your term is the rollout of a tattoo removal program for former gang members based on the UCSD Clean Slate Tattoo Removal Program. Please tell us more about your vision for this national program.
UCSD Dermatology, in collaboration with UCSD Global Health, has been involved in the Clean Slate Tattoo Removal Program for the past decade. This initiative supports and rehabilitates former gang members by offering laser tattoo removal, helping them reintegrate into society. My vision is to equip our members with the necessary protocols to implement this outreach initiative in their own communities. By providing opportunities for reform and growth, we aim to foster safer and more inclusive communities nationwide.
You were one of the first clinicians to use a laser to treat basal cell carcinoma (BCC). Who are the ideal candidates for this procedure? Is the technique ready for wide clinical adoption? If not, what kind of studies are needed to make it so?
My research passion lies in optimizing laser treatments for BCC. During my fellowship with R. Rox Anderson, MD, and Mathew Avram, MD, at the MGH Wellman Center for Photomedicine, we conducted a pilot study using the 1064-nm Nd:YAG laser, achieving a 92% clearance rate after one treatment. Inspired by these results, we conducted a larger multicenter study, which demonstrated a 90% clearance rate after a single treatment. I now incorporate this technique into my daily practice. The ideal candidates for this procedure are patients with BCC that do not meet the Mohs Appropriate Use Criteria, such as those with nodular or superficial BCC subtypes on the body, individuals who are poor surgical candidates, or those who are surgically exhausted. However, I do not recommend this treatment for patients who are primarily concerned about facial scarring, particularly younger individuals; in such cases, Mohs surgery still remains the preferred option. While I believe this technique is ready for broader clinical adoption, it requires an understanding of laser endpoints. We are also exploring antibody-targeted gold nanorods to enhance the selectivity and standardization of the treatment.
Who inspires you most in your work today?
My patients are my greatest inspiration. Their trust and dedication motivate me to stay at the forefront of dermatologic advancements, ensuring I provide the most cutting-edge and safe treatments possible. Their commitment drives my relentless pursuit of continuous learning and innovation in the field.
What’s the best advice you can give to female dermatologists seeking leadership positions at the local, state, or national level?
My best advice is to have the courage to ask for what you seek. Societies are always looking for members who are eager to participate and contribute. If you express your interest in becoming more involved, there is likely a position available for you. The more you are willing to contribute to a society, the more likely you will be noticed and excel into higher leadership positions. Take initiative, show your commitment, and don’t hesitate to step forward when opportunities arise.
What’s the one tried-and-true laser- or energy-based procedure that you consider a “must” for your dermatology practice? And why?
Determining a single “must-have” laser- or energy-based procedure is a challenging question as it greatly depends on the specific needs of your patient population. However, one of the most common concerns among patients involves issues like redness and pigmentation. Therefore, having a versatile laser or an intense pulsed light device that effectively targets both red and brown pigmentation is indispensable for most practices.
In your view, what are the top three trends in aesthetic dermatology?
Over the years, I have observed several key trends in aesthetic dermatology:
- Minimally invasive procedures. There is a growing preference for less invasive treatments. Patients increasingly desire minimal downtime while still achieving significant results.
- Advancements in laser and energy-based devices for darker skin. There have been substantial advancements in technologies that are safer and more effective for darker skin tones. These developments play a crucial role in addressing diverse patient needs and providing inclusive dermatologic care.
- Natural aesthetic. I am hopeful that the trend toward an overdone appearance is fading. There seems to be a shift back towards a more natural and conservative aesthetic, emphasizing subtle enhancements over dramatic changes.
What development in dermatology are you most excited about in the next 5 years?
I am most excited to see how artificial intelligence and robotics play a role in energy-based devices.
Dr. Ortiz disclosed having financial relationships with several pharmaceutical and device companies. She is also cochair of the MOAS.
Retirement Planning for Gastroenterologists
Retirement planning starts the day we start our careers. Whenever we start any project, it is always worthwhile to learn how the project works, what we want to pursue and achieve with the project, how to exit the project, and when is the right time to exit.
As physicians, gastroenterologists go through several years of vigorous training, years spent studying, researching, practicing, and juggling between work and life, trying to lead a well-balanced life. With all the years of medical training, we do not get the same level of education in financial planning in order to attain financial stability, financial empowerment, or resources that we need to put in place for a successful retirement.
Many physicians like to work and provide services as long as they can, provided the physical and mental capacity permits. Retirement planning should start as early as possible — at your first job, with the first paycheck. Having a strategic plan and understanding several personal factors can help one make this journey successful.
Financial Planning
Financial planning starts with investments in 401k, IRA, defined benefit, and defined contribution plans, as early as possible and to the maximum extent possible. It is beneficial to contribute at the first opportunity and contribute enough to the employer retirement plan to earn the full employer match. Also consider capital investment opportunities that match your risk appetite and returns, as these compound and grow over time. This can be done by adjusting personal expenses and lifestyle, giving priority to savings and future wealth management, and auto-escalation of permitted retirement contributions annually.
Assessing your financial situation periodically to determine retirement needs based on how long you intend to work and preferred lifestyle post retirement (travel, leisurely activities, etc.) is important. It is also pertinent to align revenue earned, expenses made, and wealth saved to support post-retirement life. Consider hiring a financial advisor who has the best interests in your personal wealth management. These are usually found with reputable institutions at a fixed percentage cost. Finding a trustworthy knowledgeable advisor is the key. Learning from your colleagues, networking, and learning from friends in and out of healthcare are good resources to find the right financial advisor.
Healthcare expenses should be planned as well as part of financial planning. Short-term and long-term disability and long-term care expenses should be investigated when planning for healthcare needs.
Transition Planning
Timing of retirement is based on factors such as age, financial status, personal health and preferences. The transition can be facilitated by better communication with colleagues, partners, employer, staff, and patients. Identifying a successor and planning for continuity of care of the patients, such as transitioning patients to another provider, is important as well. This may involve hiring a new associate, merging with another practice, or selling the practice.
Healthcare Coverage
One of the biggest expenses with retirement is healthcare coverage. Healthcare coverage options need to be analyzed which may include Medicare eligibility, enrollment, potential needs after retirement, including preventative care, treatment of chronic conditions, long term care services, and unexpected health outcomes and consequences.
Lifestyle and Travel Planning
Reflect on the retirement lifestyle, hobbies, and passions to be explored. Some activities like volunteer work, continuing educational opportunities, and advisory work, will help maintain physical and mental health. Consider downsizing living arrangements to align with retirement lifestyle goals which may include relocating to a different area as it fits your needs.
Legal and Estate Planning
Review and update legal documents including power of attorney, healthcare directives, will, trusts, and periodically ensure that these documents reflect your wishes.
Professional Development
Retirement may not mean quitting work completely. Some may look at this as an opportunity for professional development and pivoting to a different career that suits their lifestyle and needs. Gastroenterologists may contribute to the field and stay connected by being mentors, advisors, or, industry partners; being involved in national organizations; leading purposeful projects; or teaching part-time or on a volunteer basis.
Emotional and Social Support
Being a physician and a leader on treatment teams after so many years, some may feel lonely and unproductive with a lack of purpose in retirement; while others are excited about the free time they gained to pursue other activities and projects.
The process can be emotionally challenging even for well-prepared individuals. Finding friends, family, and professionals who can support you through this process will be helpful as you go through the uncertainties, anxiety, and fear during this phase of life. Think of developing hobbies and interests and nurturing networks outside of work environment that will keep you engaged and content during this transition.
Gastroenterologists can plan for a financially secure, emotionally fulfilling, and professionally satisfying transition tailored to their needs and preferences. Seeking help from financial advisors, legal experts, mentors, and other professionals who can provide valuable advice, support, and guidance is crucial during this process.
Do what you love and love what you do.
Dr. Appalaneni is a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio, and a clinical assistant professor at Boonshoft School of Medicine, Wright State University in Dayton, Ohio. This article is not a financial planning document, nor legal advice; these are the author’s learnings, experiences, and opinions and are not considered financial advice.
Retirement planning starts the day we start our careers. Whenever we start any project, it is always worthwhile to learn how the project works, what we want to pursue and achieve with the project, how to exit the project, and when is the right time to exit.
As physicians, gastroenterologists go through several years of vigorous training, years spent studying, researching, practicing, and juggling between work and life, trying to lead a well-balanced life. With all the years of medical training, we do not get the same level of education in financial planning in order to attain financial stability, financial empowerment, or resources that we need to put in place for a successful retirement.
Many physicians like to work and provide services as long as they can, provided the physical and mental capacity permits. Retirement planning should start as early as possible — at your first job, with the first paycheck. Having a strategic plan and understanding several personal factors can help one make this journey successful.
Financial Planning
Financial planning starts with investments in 401k, IRA, defined benefit, and defined contribution plans, as early as possible and to the maximum extent possible. It is beneficial to contribute at the first opportunity and contribute enough to the employer retirement plan to earn the full employer match. Also consider capital investment opportunities that match your risk appetite and returns, as these compound and grow over time. This can be done by adjusting personal expenses and lifestyle, giving priority to savings and future wealth management, and auto-escalation of permitted retirement contributions annually.
Assessing your financial situation periodically to determine retirement needs based on how long you intend to work and preferred lifestyle post retirement (travel, leisurely activities, etc.) is important. It is also pertinent to align revenue earned, expenses made, and wealth saved to support post-retirement life. Consider hiring a financial advisor who has the best interests in your personal wealth management. These are usually found with reputable institutions at a fixed percentage cost. Finding a trustworthy knowledgeable advisor is the key. Learning from your colleagues, networking, and learning from friends in and out of healthcare are good resources to find the right financial advisor.
Healthcare expenses should be planned as well as part of financial planning. Short-term and long-term disability and long-term care expenses should be investigated when planning for healthcare needs.
Transition Planning
Timing of retirement is based on factors such as age, financial status, personal health and preferences. The transition can be facilitated by better communication with colleagues, partners, employer, staff, and patients. Identifying a successor and planning for continuity of care of the patients, such as transitioning patients to another provider, is important as well. This may involve hiring a new associate, merging with another practice, or selling the practice.
Healthcare Coverage
One of the biggest expenses with retirement is healthcare coverage. Healthcare coverage options need to be analyzed which may include Medicare eligibility, enrollment, potential needs after retirement, including preventative care, treatment of chronic conditions, long term care services, and unexpected health outcomes and consequences.
Lifestyle and Travel Planning
Reflect on the retirement lifestyle, hobbies, and passions to be explored. Some activities like volunteer work, continuing educational opportunities, and advisory work, will help maintain physical and mental health. Consider downsizing living arrangements to align with retirement lifestyle goals which may include relocating to a different area as it fits your needs.
Legal and Estate Planning
Review and update legal documents including power of attorney, healthcare directives, will, trusts, and periodically ensure that these documents reflect your wishes.
Professional Development
Retirement may not mean quitting work completely. Some may look at this as an opportunity for professional development and pivoting to a different career that suits their lifestyle and needs. Gastroenterologists may contribute to the field and stay connected by being mentors, advisors, or, industry partners; being involved in national organizations; leading purposeful projects; or teaching part-time or on a volunteer basis.
Emotional and Social Support
Being a physician and a leader on treatment teams after so many years, some may feel lonely and unproductive with a lack of purpose in retirement; while others are excited about the free time they gained to pursue other activities and projects.
The process can be emotionally challenging even for well-prepared individuals. Finding friends, family, and professionals who can support you through this process will be helpful as you go through the uncertainties, anxiety, and fear during this phase of life. Think of developing hobbies and interests and nurturing networks outside of work environment that will keep you engaged and content during this transition.
Gastroenterologists can plan for a financially secure, emotionally fulfilling, and professionally satisfying transition tailored to their needs and preferences. Seeking help from financial advisors, legal experts, mentors, and other professionals who can provide valuable advice, support, and guidance is crucial during this process.
Do what you love and love what you do.
Dr. Appalaneni is a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio, and a clinical assistant professor at Boonshoft School of Medicine, Wright State University in Dayton, Ohio. This article is not a financial planning document, nor legal advice; these are the author’s learnings, experiences, and opinions and are not considered financial advice.
Retirement planning starts the day we start our careers. Whenever we start any project, it is always worthwhile to learn how the project works, what we want to pursue and achieve with the project, how to exit the project, and when is the right time to exit.
As physicians, gastroenterologists go through several years of vigorous training, years spent studying, researching, practicing, and juggling between work and life, trying to lead a well-balanced life. With all the years of medical training, we do not get the same level of education in financial planning in order to attain financial stability, financial empowerment, or resources that we need to put in place for a successful retirement.
Many physicians like to work and provide services as long as they can, provided the physical and mental capacity permits. Retirement planning should start as early as possible — at your first job, with the first paycheck. Having a strategic plan and understanding several personal factors can help one make this journey successful.
Financial Planning
Financial planning starts with investments in 401k, IRA, defined benefit, and defined contribution plans, as early as possible and to the maximum extent possible. It is beneficial to contribute at the first opportunity and contribute enough to the employer retirement plan to earn the full employer match. Also consider capital investment opportunities that match your risk appetite and returns, as these compound and grow over time. This can be done by adjusting personal expenses and lifestyle, giving priority to savings and future wealth management, and auto-escalation of permitted retirement contributions annually.
Assessing your financial situation periodically to determine retirement needs based on how long you intend to work and preferred lifestyle post retirement (travel, leisurely activities, etc.) is important. It is also pertinent to align revenue earned, expenses made, and wealth saved to support post-retirement life. Consider hiring a financial advisor who has the best interests in your personal wealth management. These are usually found with reputable institutions at a fixed percentage cost. Finding a trustworthy knowledgeable advisor is the key. Learning from your colleagues, networking, and learning from friends in and out of healthcare are good resources to find the right financial advisor.
Healthcare expenses should be planned as well as part of financial planning. Short-term and long-term disability and long-term care expenses should be investigated when planning for healthcare needs.
Transition Planning
Timing of retirement is based on factors such as age, financial status, personal health and preferences. The transition can be facilitated by better communication with colleagues, partners, employer, staff, and patients. Identifying a successor and planning for continuity of care of the patients, such as transitioning patients to another provider, is important as well. This may involve hiring a new associate, merging with another practice, or selling the practice.
Healthcare Coverage
One of the biggest expenses with retirement is healthcare coverage. Healthcare coverage options need to be analyzed which may include Medicare eligibility, enrollment, potential needs after retirement, including preventative care, treatment of chronic conditions, long term care services, and unexpected health outcomes and consequences.
Lifestyle and Travel Planning
Reflect on the retirement lifestyle, hobbies, and passions to be explored. Some activities like volunteer work, continuing educational opportunities, and advisory work, will help maintain physical and mental health. Consider downsizing living arrangements to align with retirement lifestyle goals which may include relocating to a different area as it fits your needs.
Legal and Estate Planning
Review and update legal documents including power of attorney, healthcare directives, will, trusts, and periodically ensure that these documents reflect your wishes.
Professional Development
Retirement may not mean quitting work completely. Some may look at this as an opportunity for professional development and pivoting to a different career that suits their lifestyle and needs. Gastroenterologists may contribute to the field and stay connected by being mentors, advisors, or, industry partners; being involved in national organizations; leading purposeful projects; or teaching part-time or on a volunteer basis.
Emotional and Social Support
Being a physician and a leader on treatment teams after so many years, some may feel lonely and unproductive with a lack of purpose in retirement; while others are excited about the free time they gained to pursue other activities and projects.
The process can be emotionally challenging even for well-prepared individuals. Finding friends, family, and professionals who can support you through this process will be helpful as you go through the uncertainties, anxiety, and fear during this phase of life. Think of developing hobbies and interests and nurturing networks outside of work environment that will keep you engaged and content during this transition.
Gastroenterologists can plan for a financially secure, emotionally fulfilling, and professionally satisfying transition tailored to their needs and preferences. Seeking help from financial advisors, legal experts, mentors, and other professionals who can provide valuable advice, support, and guidance is crucial during this process.
Do what you love and love what you do.
Dr. Appalaneni is a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio, and a clinical assistant professor at Boonshoft School of Medicine, Wright State University in Dayton, Ohio. This article is not a financial planning document, nor legal advice; these are the author’s learnings, experiences, and opinions and are not considered financial advice.
Navigating as a GI Locum: My Path and Guide to This Alternative Practice Model
My successful career in academic gastroenterology makes me a natural proponent of the academic model of practice. However, in my current role as a locum tenens, I have witnessed the versatility that locum assignments offer gastroenterologists, particularly when flexibility in their professional lives is paramount.
The locum tenens industry is a growing feature of the healthcare staffing landscape. My perspective is unique, transitioning from professor of medicine and chief of gastroenterology at an academic medical center to a self-employed locum gastroenterologist.
As chief, I hired locums to offer additional coverage to the faculty staffing as our division, inclusive of GI fellowship and endoscopy volume, expanded. I recruited, supervised, and assigned responsibilities to the locums. Not only were these physicians professional and competent, but they also contributed to my division’s forward evolution. Based on this experience, I was confident that I could successfully perform as a locum gastroenterologist myself.
My work as a locum these past 5 years has been a positive professional transition for me. I have enjoyed meeting and working with new colleagues, including international locums who travel to work in the United States. I have also witnessed how early-career and mid-career gastroenterologists have taken advantage of this flexible and well-remunerated work.
What It Entails to Be a Locum Tenens
I suspect you have been on the receiving end of emails and postcards from locum tenens companies recruiting for potential assignments and have wondered about the specifics. Essentially, a locum physician functions as an independent contractor who accepts a temporary position at a healthcare organization to provide clinical staffing support during periods of staffing disruption.
Assignments vary in geographic location, facility work site (outpatient vs inpatient), hours, required skills, cadence of assignment, and expected length of staffing need. The locum physician has complete control over selecting the assignment location, the intensity of responsibilities, and the time they wish to commit to the position. Temporal flexibility offers locums the opportunity to commit from a few weeks per year to a full-time commitment. Locums can also combine multiple assignments in different regions or states to match the targeted number of weeks they wish to commit to and the financial goal they have set.
I have met physicians working a few weeks a year during time off from their permanent jobs to supplement their incomes, as well as fully employed physicians leveraging locum placements to explore locations or practices that they have an interest in. Gastroenterologists facing planned or unplanned life events may find the role enticing as locum opportunities offer an elevated level of flexibility and autonomy.
The Role of the Locum Tenens Company
Locum tenens companies have arrangements with healthcare facilities to provide temporary staffing. They aim to recruit prospective physicians, establish a collaborative relationship, and align these physicians with a locum assignment that benefits all parties.
Once the physician has completed the company’s credentialing packet, the company facilitates credentialing for new state medical licensures and the specific healthcare facility. The company conducts all negotiations, communications, and financial arrangements between the locum physician and the facility. Locum physicians do not communicate directly with the facility, at least not initially. The company also provides medical malpractice coverage through an established insurance broker. The company arranges travel (flights, car rentals, and hotels) for the assignment, and the healthcare facility reimburses the company.
Lastly, the company arranges a phone interview between the locum physician and the facility’s gastroenterologist or medical director for a more detailed description of expected responsibilities and level of staffing for endoscopy before the locum physician decides whether the job is a “good fit” for their skills and objectives. It is critical at this point that the locum physician does their due diligence, asking thoughtful questions to ensure a comprehensive understanding of the role before committing.
What Does It Mean to Be an Independent Contractor
An independent contractor is contracted to perform work but is not an employee of an organization (ie, self-employed). This is an important distinction when it comes to the IRS, tax obligations, and allowable deductions.
Initially, this may seem confusing, but some websites review the specifics of these significant taxation differences. Because you are an independent contractor, your paycheck depicts your compensation without any deductions taken. At year’s end, you receive form 1099 rather than the more familiar W-2. The most critical difference is that as a W-2 employed person, you and the employer each contribute half of the obligated Social Security and Medicare taxes owed, but as an independent contractor you are required to pay the entire obligated Social Security and Medicare taxes.
Also important to consider is that although the locum tenens company facilitates necessary documentation, travel, and work schedules, you will be responsible for tracking your work-related finances, and maintaining your CME. This is not difficult but requires attention throughout the year and is manageable with a bit of organizing. A simple example is that meals are deductible on your taxes and can be easily tallied by the government’s per diem rate found at www.gsa.gov — so it is not necessary to save receipts. While it is important to become familiar with these financial nuances as they will affect your net income, they are not as intimidating or complex as you may initially believe.
Primary Benefits of Locum Tenens Assignments
In my experience, the benefits of working as a locum gastroenterologist include the opportunity to remain engaged in a gratifying career while having enhanced autonomy and flexibility. You can construct a schedule in a location most pleasing to you that fits your financial needs. You may work just a few weeks per year to full-time. You can uniquely plan for your desired personal time and alternative professional ambitions. If you choose to transition back to traditional full-time employment, the pivot remains feasible because you have demonstrated attractive professional attributes such as adaptability in different settings, maintenance of necessary skill sets, and collaboration with medical staffing of various complexities.
Quick Points to Consider
- Review the tax obligations and deductions before signing on to your first assignment.
- Healthcare benefits are not provided. If you must purchase healthcare, your healthcare premiums are 100% deductible.
- Malpractice insurance is provided through the locum tenens company.
- The points on flights, hotels, and car rentals remain in your accounts and can be used by you for personal travel in the future.
- You may be able to negotiate hourly rates and terms of responsibilities in certain instances. There’s no harm in requesting.
- Before accepting an assignment, review the website and location of the facility, accessibility to airports, frequency of flights, the physician directory, and services available.
- If your plans change and you are unable to complete a scheduled assignment previously confirmed, you must notify the locum tenens company within a specified window from the start date (usually 30 days) to avoid penalty.
Institutions utilizing locum physicians generally are doing so because their staffing is not optimal; for example, there may have been a transition in leadership or the facility may be located in a rural area. Self-awareness is key; recognize that you are essentially a guest who may need to adapt to the prevailing culture and make do with the resources at hand. You are not there to step in, innovate, or institute changes. Most often the office staff, nurses, and other physicians are very grateful that you are present and a part of the team.
Dr. Bartholomew is a gastroenterologist based in Sarasota, Florida. She has no conflicts to declare in relation to this article.
My successful career in academic gastroenterology makes me a natural proponent of the academic model of practice. However, in my current role as a locum tenens, I have witnessed the versatility that locum assignments offer gastroenterologists, particularly when flexibility in their professional lives is paramount.
The locum tenens industry is a growing feature of the healthcare staffing landscape. My perspective is unique, transitioning from professor of medicine and chief of gastroenterology at an academic medical center to a self-employed locum gastroenterologist.
As chief, I hired locums to offer additional coverage to the faculty staffing as our division, inclusive of GI fellowship and endoscopy volume, expanded. I recruited, supervised, and assigned responsibilities to the locums. Not only were these physicians professional and competent, but they also contributed to my division’s forward evolution. Based on this experience, I was confident that I could successfully perform as a locum gastroenterologist myself.
My work as a locum these past 5 years has been a positive professional transition for me. I have enjoyed meeting and working with new colleagues, including international locums who travel to work in the United States. I have also witnessed how early-career and mid-career gastroenterologists have taken advantage of this flexible and well-remunerated work.
What It Entails to Be a Locum Tenens
I suspect you have been on the receiving end of emails and postcards from locum tenens companies recruiting for potential assignments and have wondered about the specifics. Essentially, a locum physician functions as an independent contractor who accepts a temporary position at a healthcare organization to provide clinical staffing support during periods of staffing disruption.
Assignments vary in geographic location, facility work site (outpatient vs inpatient), hours, required skills, cadence of assignment, and expected length of staffing need. The locum physician has complete control over selecting the assignment location, the intensity of responsibilities, and the time they wish to commit to the position. Temporal flexibility offers locums the opportunity to commit from a few weeks per year to a full-time commitment. Locums can also combine multiple assignments in different regions or states to match the targeted number of weeks they wish to commit to and the financial goal they have set.
I have met physicians working a few weeks a year during time off from their permanent jobs to supplement their incomes, as well as fully employed physicians leveraging locum placements to explore locations or practices that they have an interest in. Gastroenterologists facing planned or unplanned life events may find the role enticing as locum opportunities offer an elevated level of flexibility and autonomy.
The Role of the Locum Tenens Company
Locum tenens companies have arrangements with healthcare facilities to provide temporary staffing. They aim to recruit prospective physicians, establish a collaborative relationship, and align these physicians with a locum assignment that benefits all parties.
Once the physician has completed the company’s credentialing packet, the company facilitates credentialing for new state medical licensures and the specific healthcare facility. The company conducts all negotiations, communications, and financial arrangements between the locum physician and the facility. Locum physicians do not communicate directly with the facility, at least not initially. The company also provides medical malpractice coverage through an established insurance broker. The company arranges travel (flights, car rentals, and hotels) for the assignment, and the healthcare facility reimburses the company.
Lastly, the company arranges a phone interview between the locum physician and the facility’s gastroenterologist or medical director for a more detailed description of expected responsibilities and level of staffing for endoscopy before the locum physician decides whether the job is a “good fit” for their skills and objectives. It is critical at this point that the locum physician does their due diligence, asking thoughtful questions to ensure a comprehensive understanding of the role before committing.
What Does It Mean to Be an Independent Contractor
An independent contractor is contracted to perform work but is not an employee of an organization (ie, self-employed). This is an important distinction when it comes to the IRS, tax obligations, and allowable deductions.
Initially, this may seem confusing, but some websites review the specifics of these significant taxation differences. Because you are an independent contractor, your paycheck depicts your compensation without any deductions taken. At year’s end, you receive form 1099 rather than the more familiar W-2. The most critical difference is that as a W-2 employed person, you and the employer each contribute half of the obligated Social Security and Medicare taxes owed, but as an independent contractor you are required to pay the entire obligated Social Security and Medicare taxes.
Also important to consider is that although the locum tenens company facilitates necessary documentation, travel, and work schedules, you will be responsible for tracking your work-related finances, and maintaining your CME. This is not difficult but requires attention throughout the year and is manageable with a bit of organizing. A simple example is that meals are deductible on your taxes and can be easily tallied by the government’s per diem rate found at www.gsa.gov — so it is not necessary to save receipts. While it is important to become familiar with these financial nuances as they will affect your net income, they are not as intimidating or complex as you may initially believe.
Primary Benefits of Locum Tenens Assignments
In my experience, the benefits of working as a locum gastroenterologist include the opportunity to remain engaged in a gratifying career while having enhanced autonomy and flexibility. You can construct a schedule in a location most pleasing to you that fits your financial needs. You may work just a few weeks per year to full-time. You can uniquely plan for your desired personal time and alternative professional ambitions. If you choose to transition back to traditional full-time employment, the pivot remains feasible because you have demonstrated attractive professional attributes such as adaptability in different settings, maintenance of necessary skill sets, and collaboration with medical staffing of various complexities.
Quick Points to Consider
- Review the tax obligations and deductions before signing on to your first assignment.
- Healthcare benefits are not provided. If you must purchase healthcare, your healthcare premiums are 100% deductible.
- Malpractice insurance is provided through the locum tenens company.
- The points on flights, hotels, and car rentals remain in your accounts and can be used by you for personal travel in the future.
- You may be able to negotiate hourly rates and terms of responsibilities in certain instances. There’s no harm in requesting.
- Before accepting an assignment, review the website and location of the facility, accessibility to airports, frequency of flights, the physician directory, and services available.
- If your plans change and you are unable to complete a scheduled assignment previously confirmed, you must notify the locum tenens company within a specified window from the start date (usually 30 days) to avoid penalty.
Institutions utilizing locum physicians generally are doing so because their staffing is not optimal; for example, there may have been a transition in leadership or the facility may be located in a rural area. Self-awareness is key; recognize that you are essentially a guest who may need to adapt to the prevailing culture and make do with the resources at hand. You are not there to step in, innovate, or institute changes. Most often the office staff, nurses, and other physicians are very grateful that you are present and a part of the team.
Dr. Bartholomew is a gastroenterologist based in Sarasota, Florida. She has no conflicts to declare in relation to this article.
My successful career in academic gastroenterology makes me a natural proponent of the academic model of practice. However, in my current role as a locum tenens, I have witnessed the versatility that locum assignments offer gastroenterologists, particularly when flexibility in their professional lives is paramount.
The locum tenens industry is a growing feature of the healthcare staffing landscape. My perspective is unique, transitioning from professor of medicine and chief of gastroenterology at an academic medical center to a self-employed locum gastroenterologist.
As chief, I hired locums to offer additional coverage to the faculty staffing as our division, inclusive of GI fellowship and endoscopy volume, expanded. I recruited, supervised, and assigned responsibilities to the locums. Not only were these physicians professional and competent, but they also contributed to my division’s forward evolution. Based on this experience, I was confident that I could successfully perform as a locum gastroenterologist myself.
My work as a locum these past 5 years has been a positive professional transition for me. I have enjoyed meeting and working with new colleagues, including international locums who travel to work in the United States. I have also witnessed how early-career and mid-career gastroenterologists have taken advantage of this flexible and well-remunerated work.
What It Entails to Be a Locum Tenens
I suspect you have been on the receiving end of emails and postcards from locum tenens companies recruiting for potential assignments and have wondered about the specifics. Essentially, a locum physician functions as an independent contractor who accepts a temporary position at a healthcare organization to provide clinical staffing support during periods of staffing disruption.
Assignments vary in geographic location, facility work site (outpatient vs inpatient), hours, required skills, cadence of assignment, and expected length of staffing need. The locum physician has complete control over selecting the assignment location, the intensity of responsibilities, and the time they wish to commit to the position. Temporal flexibility offers locums the opportunity to commit from a few weeks per year to a full-time commitment. Locums can also combine multiple assignments in different regions or states to match the targeted number of weeks they wish to commit to and the financial goal they have set.
I have met physicians working a few weeks a year during time off from their permanent jobs to supplement their incomes, as well as fully employed physicians leveraging locum placements to explore locations or practices that they have an interest in. Gastroenterologists facing planned or unplanned life events may find the role enticing as locum opportunities offer an elevated level of flexibility and autonomy.
The Role of the Locum Tenens Company
Locum tenens companies have arrangements with healthcare facilities to provide temporary staffing. They aim to recruit prospective physicians, establish a collaborative relationship, and align these physicians with a locum assignment that benefits all parties.
Once the physician has completed the company’s credentialing packet, the company facilitates credentialing for new state medical licensures and the specific healthcare facility. The company conducts all negotiations, communications, and financial arrangements between the locum physician and the facility. Locum physicians do not communicate directly with the facility, at least not initially. The company also provides medical malpractice coverage through an established insurance broker. The company arranges travel (flights, car rentals, and hotels) for the assignment, and the healthcare facility reimburses the company.
Lastly, the company arranges a phone interview between the locum physician and the facility’s gastroenterologist or medical director for a more detailed description of expected responsibilities and level of staffing for endoscopy before the locum physician decides whether the job is a “good fit” for their skills and objectives. It is critical at this point that the locum physician does their due diligence, asking thoughtful questions to ensure a comprehensive understanding of the role before committing.
What Does It Mean to Be an Independent Contractor
An independent contractor is contracted to perform work but is not an employee of an organization (ie, self-employed). This is an important distinction when it comes to the IRS, tax obligations, and allowable deductions.
Initially, this may seem confusing, but some websites review the specifics of these significant taxation differences. Because you are an independent contractor, your paycheck depicts your compensation without any deductions taken. At year’s end, you receive form 1099 rather than the more familiar W-2. The most critical difference is that as a W-2 employed person, you and the employer each contribute half of the obligated Social Security and Medicare taxes owed, but as an independent contractor you are required to pay the entire obligated Social Security and Medicare taxes.
Also important to consider is that although the locum tenens company facilitates necessary documentation, travel, and work schedules, you will be responsible for tracking your work-related finances, and maintaining your CME. This is not difficult but requires attention throughout the year and is manageable with a bit of organizing. A simple example is that meals are deductible on your taxes and can be easily tallied by the government’s per diem rate found at www.gsa.gov — so it is not necessary to save receipts. While it is important to become familiar with these financial nuances as they will affect your net income, they are not as intimidating or complex as you may initially believe.
Primary Benefits of Locum Tenens Assignments
In my experience, the benefits of working as a locum gastroenterologist include the opportunity to remain engaged in a gratifying career while having enhanced autonomy and flexibility. You can construct a schedule in a location most pleasing to you that fits your financial needs. You may work just a few weeks per year to full-time. You can uniquely plan for your desired personal time and alternative professional ambitions. If you choose to transition back to traditional full-time employment, the pivot remains feasible because you have demonstrated attractive professional attributes such as adaptability in different settings, maintenance of necessary skill sets, and collaboration with medical staffing of various complexities.
Quick Points to Consider
- Review the tax obligations and deductions before signing on to your first assignment.
- Healthcare benefits are not provided. If you must purchase healthcare, your healthcare premiums are 100% deductible.
- Malpractice insurance is provided through the locum tenens company.
- The points on flights, hotels, and car rentals remain in your accounts and can be used by you for personal travel in the future.
- You may be able to negotiate hourly rates and terms of responsibilities in certain instances. There’s no harm in requesting.
- Before accepting an assignment, review the website and location of the facility, accessibility to airports, frequency of flights, the physician directory, and services available.
- If your plans change and you are unable to complete a scheduled assignment previously confirmed, you must notify the locum tenens company within a specified window from the start date (usually 30 days) to avoid penalty.
Institutions utilizing locum physicians generally are doing so because their staffing is not optimal; for example, there may have been a transition in leadership or the facility may be located in a rural area. Self-awareness is key; recognize that you are essentially a guest who may need to adapt to the prevailing culture and make do with the resources at hand. You are not there to step in, innovate, or institute changes. Most often the office staff, nurses, and other physicians are very grateful that you are present and a part of the team.
Dr. Bartholomew is a gastroenterologist based in Sarasota, Florida. She has no conflicts to declare in relation to this article.
FDA Approves Deuruxolitinib for Severe Alopecia Areata in Adults
The
The development, which was announced in a July 25, 2024, news release from the drug’s manufacturer Sun Pharma, is based on data from two pivotal randomized, double-blind, placebo-controlled phase 3 clinical trials: THRIVE-AA1 and THRIVE-AA2, which included 1220 adults with severe alopecia areata enrolled at sites in the United States, Canada, and Europe. Study participants had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than 6 months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.
Deuruxolitinib, which comes in 8-mg tablets, is an oral selective inhibitor of JAK1 and JAK2 and is administered twice a day. According to the company press release, the average patient enrolled in the clinical trials had only 13% of their scalp hair coverage at baseline. At week 24, more than 30% of patients taking deuruxolitinib experiencing 80% or more scalp hair coverage (SALT score ≤ 20). Also, up to 25% of patients had almost all of their scalp hair back at 24 weeks (≥ 90% coverage).
In terms of safety, the data showed that 3.1% of patients who received deuruxolitinib 8 mg twice daily in the phase 2 dose-ranging study and phase 3 randomized placebo-controlled trials discontinued treatment owing to adverse reactions. The three most common adverse events in placebo-controlled trials were headache (12.4% vs 9.4% with placebo), acne (10% vs 4.3% with placebo), and nasopharyngitis (8.1% vs 6.7% with placebo). More than 100 people continued taking deuruxolitinib for more than 3 years.
Deuruxolitinib is the third treatment and third JAK inhibitor approved by the FDA for severe alopecia areata. Baricitinib (Olumiant) was approved in June 2022 for adults with alopecia areata, followed by ritlecitinib (Litfulo) approved in June 2023 for patients aged 12 years and older.
In a statement from the National Alopecia Areata Foundation (NAAF), Nicole Friedland, NAAF’s president and CEO, said that “it is with tremendous excitement that we welcome the FDA’s approval of a third treatment for severe alopecia areata in as many years.”
A version of this article first appeared on Medscape.com.
The
The development, which was announced in a July 25, 2024, news release from the drug’s manufacturer Sun Pharma, is based on data from two pivotal randomized, double-blind, placebo-controlled phase 3 clinical trials: THRIVE-AA1 and THRIVE-AA2, which included 1220 adults with severe alopecia areata enrolled at sites in the United States, Canada, and Europe. Study participants had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than 6 months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.
Deuruxolitinib, which comes in 8-mg tablets, is an oral selective inhibitor of JAK1 and JAK2 and is administered twice a day. According to the company press release, the average patient enrolled in the clinical trials had only 13% of their scalp hair coverage at baseline. At week 24, more than 30% of patients taking deuruxolitinib experiencing 80% or more scalp hair coverage (SALT score ≤ 20). Also, up to 25% of patients had almost all of their scalp hair back at 24 weeks (≥ 90% coverage).
In terms of safety, the data showed that 3.1% of patients who received deuruxolitinib 8 mg twice daily in the phase 2 dose-ranging study and phase 3 randomized placebo-controlled trials discontinued treatment owing to adverse reactions. The three most common adverse events in placebo-controlled trials were headache (12.4% vs 9.4% with placebo), acne (10% vs 4.3% with placebo), and nasopharyngitis (8.1% vs 6.7% with placebo). More than 100 people continued taking deuruxolitinib for more than 3 years.
Deuruxolitinib is the third treatment and third JAK inhibitor approved by the FDA for severe alopecia areata. Baricitinib (Olumiant) was approved in June 2022 for adults with alopecia areata, followed by ritlecitinib (Litfulo) approved in June 2023 for patients aged 12 years and older.
In a statement from the National Alopecia Areata Foundation (NAAF), Nicole Friedland, NAAF’s president and CEO, said that “it is with tremendous excitement that we welcome the FDA’s approval of a third treatment for severe alopecia areata in as many years.”
A version of this article first appeared on Medscape.com.
The
The development, which was announced in a July 25, 2024, news release from the drug’s manufacturer Sun Pharma, is based on data from two pivotal randomized, double-blind, placebo-controlled phase 3 clinical trials: THRIVE-AA1 and THRIVE-AA2, which included 1220 adults with severe alopecia areata enrolled at sites in the United States, Canada, and Europe. Study participants had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than 6 months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.
Deuruxolitinib, which comes in 8-mg tablets, is an oral selective inhibitor of JAK1 and JAK2 and is administered twice a day. According to the company press release, the average patient enrolled in the clinical trials had only 13% of their scalp hair coverage at baseline. At week 24, more than 30% of patients taking deuruxolitinib experiencing 80% or more scalp hair coverage (SALT score ≤ 20). Also, up to 25% of patients had almost all of their scalp hair back at 24 weeks (≥ 90% coverage).
In terms of safety, the data showed that 3.1% of patients who received deuruxolitinib 8 mg twice daily in the phase 2 dose-ranging study and phase 3 randomized placebo-controlled trials discontinued treatment owing to adverse reactions. The three most common adverse events in placebo-controlled trials were headache (12.4% vs 9.4% with placebo), acne (10% vs 4.3% with placebo), and nasopharyngitis (8.1% vs 6.7% with placebo). More than 100 people continued taking deuruxolitinib for more than 3 years.
Deuruxolitinib is the third treatment and third JAK inhibitor approved by the FDA for severe alopecia areata. Baricitinib (Olumiant) was approved in June 2022 for adults with alopecia areata, followed by ritlecitinib (Litfulo) approved in June 2023 for patients aged 12 years and older.
In a statement from the National Alopecia Areata Foundation (NAAF), Nicole Friedland, NAAF’s president and CEO, said that “it is with tremendous excitement that we welcome the FDA’s approval of a third treatment for severe alopecia areata in as many years.”
A version of this article first appeared on Medscape.com.
Pilot Study Finds Experimental CBD Cream Decreases UVA Skin Damage
, results from a small prospective pilot study showed.
“This study hopefully reinvigorates interest in the utilization of whether it be plant-based, human-derived, or synthetic cannabinoids in the management of dermatologic disease,” one of the study investigators, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization. The study was published in the Journal of the American Academy of Dermatology.
For the prospective, single-center, pilot trial, which is believed to be the first of its kind, 19 volunteers aged 22-65 with Fitzpatrick skin types I-III applied either a nano-encapsulated CBD cream or a vehicle cream to blind spots on the skin of the buttocks twice daily for 14 days. Next, researchers applied a minimal erythema dose of UV radiation to the treated skin areas for 30 minutes. After 24 hours, they visually inspected the treated areas to clinically compare the erythema. They also performed five 4-mm punch biopsies from UVA- and non-UVA–exposed treatment sites on each buttock, as well as from an untreated control site that was at least 5 cm away from the treated left buttock.
At 24 hours, 21% of study participants showed less redness on CBD-treated skin compared with control-treated skin, while histology showed that CBD-treated skin demonstrated reduced UVA-induced epidermal hyperplasia compared with control-treated skin (a mean 11.3% change from baseline vs 28.7%, respectively; P = .01). In other findings, application of CBD cream reduced DNA damage and DNA mutations associated with UVA-induced skin aging/damage and ultimately skin cancer.
In addition, the CBD-treated skin samples had a reduction in the UVA-associated increase in the premutagenic marker 8-oxoguanine DNA glycosylase 1 and a reduction of two major UVA-induced mitochondrial DNA deletions associated with skin photoaging.
The research, Dr. Friedman noted, “took a village of collaborators and almost 3 years to pull together,” including collaborating with his long-standing mentor, Brian Berman, MD, PhD, professor emeritus of dermatology and dermatologic surgery at the University of Miami, Coral Gables, Florida, and a study coauthor. The study “demonstrated that purposeful delivery of CBD using an established nanoparticle platform ... can have a quantifiable impact on preventing the expected DNA damage and cellular injury one should see from UVA exposure,” said Dr. Friedman, who codeveloped the nanoparticle platform with his father, Joel M. Friedman, MD, PhD, professor of microbiology and immunology at Albert Einstein College of Medicine, New York City.
“Never before has a dermatologic study on topical cannabinoids dove so deeply into the biological impact of this natural ingredient to highlight its potential, here, as a mitigation strategy for unprotected exposure to prevent the downstream sequelae of UV radiation,” Dr. Friedman said.
In the paper, he and his coauthors acknowledged certain limitations of their study, including its small sample size and the single-center design.
Dr. Friedman disclosed that he coinvented the nanoparticle technology used in the trial. Dr. Berman is a consultant at MINO Labs, which funded the study. The remaining authors had no disclosures. The study was done in collaboration with the Center for Clinical and Cosmetic Research in Aventura, Florida.
A version of this article first appeared on Medscape.com.
, results from a small prospective pilot study showed.
“This study hopefully reinvigorates interest in the utilization of whether it be plant-based, human-derived, or synthetic cannabinoids in the management of dermatologic disease,” one of the study investigators, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization. The study was published in the Journal of the American Academy of Dermatology.
For the prospective, single-center, pilot trial, which is believed to be the first of its kind, 19 volunteers aged 22-65 with Fitzpatrick skin types I-III applied either a nano-encapsulated CBD cream or a vehicle cream to blind spots on the skin of the buttocks twice daily for 14 days. Next, researchers applied a minimal erythema dose of UV radiation to the treated skin areas for 30 minutes. After 24 hours, they visually inspected the treated areas to clinically compare the erythema. They also performed five 4-mm punch biopsies from UVA- and non-UVA–exposed treatment sites on each buttock, as well as from an untreated control site that was at least 5 cm away from the treated left buttock.
At 24 hours, 21% of study participants showed less redness on CBD-treated skin compared with control-treated skin, while histology showed that CBD-treated skin demonstrated reduced UVA-induced epidermal hyperplasia compared with control-treated skin (a mean 11.3% change from baseline vs 28.7%, respectively; P = .01). In other findings, application of CBD cream reduced DNA damage and DNA mutations associated with UVA-induced skin aging/damage and ultimately skin cancer.
In addition, the CBD-treated skin samples had a reduction in the UVA-associated increase in the premutagenic marker 8-oxoguanine DNA glycosylase 1 and a reduction of two major UVA-induced mitochondrial DNA deletions associated with skin photoaging.
The research, Dr. Friedman noted, “took a village of collaborators and almost 3 years to pull together,” including collaborating with his long-standing mentor, Brian Berman, MD, PhD, professor emeritus of dermatology and dermatologic surgery at the University of Miami, Coral Gables, Florida, and a study coauthor. The study “demonstrated that purposeful delivery of CBD using an established nanoparticle platform ... can have a quantifiable impact on preventing the expected DNA damage and cellular injury one should see from UVA exposure,” said Dr. Friedman, who codeveloped the nanoparticle platform with his father, Joel M. Friedman, MD, PhD, professor of microbiology and immunology at Albert Einstein College of Medicine, New York City.
“Never before has a dermatologic study on topical cannabinoids dove so deeply into the biological impact of this natural ingredient to highlight its potential, here, as a mitigation strategy for unprotected exposure to prevent the downstream sequelae of UV radiation,” Dr. Friedman said.
In the paper, he and his coauthors acknowledged certain limitations of their study, including its small sample size and the single-center design.
Dr. Friedman disclosed that he coinvented the nanoparticle technology used in the trial. Dr. Berman is a consultant at MINO Labs, which funded the study. The remaining authors had no disclosures. The study was done in collaboration with the Center for Clinical and Cosmetic Research in Aventura, Florida.
A version of this article first appeared on Medscape.com.
, results from a small prospective pilot study showed.
“This study hopefully reinvigorates interest in the utilization of whether it be plant-based, human-derived, or synthetic cannabinoids in the management of dermatologic disease,” one of the study investigators, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization. The study was published in the Journal of the American Academy of Dermatology.
For the prospective, single-center, pilot trial, which is believed to be the first of its kind, 19 volunteers aged 22-65 with Fitzpatrick skin types I-III applied either a nano-encapsulated CBD cream or a vehicle cream to blind spots on the skin of the buttocks twice daily for 14 days. Next, researchers applied a minimal erythema dose of UV radiation to the treated skin areas for 30 minutes. After 24 hours, they visually inspected the treated areas to clinically compare the erythema. They also performed five 4-mm punch biopsies from UVA- and non-UVA–exposed treatment sites on each buttock, as well as from an untreated control site that was at least 5 cm away from the treated left buttock.
At 24 hours, 21% of study participants showed less redness on CBD-treated skin compared with control-treated skin, while histology showed that CBD-treated skin demonstrated reduced UVA-induced epidermal hyperplasia compared with control-treated skin (a mean 11.3% change from baseline vs 28.7%, respectively; P = .01). In other findings, application of CBD cream reduced DNA damage and DNA mutations associated with UVA-induced skin aging/damage and ultimately skin cancer.
In addition, the CBD-treated skin samples had a reduction in the UVA-associated increase in the premutagenic marker 8-oxoguanine DNA glycosylase 1 and a reduction of two major UVA-induced mitochondrial DNA deletions associated with skin photoaging.
The research, Dr. Friedman noted, “took a village of collaborators and almost 3 years to pull together,” including collaborating with his long-standing mentor, Brian Berman, MD, PhD, professor emeritus of dermatology and dermatologic surgery at the University of Miami, Coral Gables, Florida, and a study coauthor. The study “demonstrated that purposeful delivery of CBD using an established nanoparticle platform ... can have a quantifiable impact on preventing the expected DNA damage and cellular injury one should see from UVA exposure,” said Dr. Friedman, who codeveloped the nanoparticle platform with his father, Joel M. Friedman, MD, PhD, professor of microbiology and immunology at Albert Einstein College of Medicine, New York City.
“Never before has a dermatologic study on topical cannabinoids dove so deeply into the biological impact of this natural ingredient to highlight its potential, here, as a mitigation strategy for unprotected exposure to prevent the downstream sequelae of UV radiation,” Dr. Friedman said.
In the paper, he and his coauthors acknowledged certain limitations of their study, including its small sample size and the single-center design.
Dr. Friedman disclosed that he coinvented the nanoparticle technology used in the trial. Dr. Berman is a consultant at MINO Labs, which funded the study. The remaining authors had no disclosures. The study was done in collaboration with the Center for Clinical and Cosmetic Research in Aventura, Florida.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Which Patients With Early TNBC Can Avoid Chemotherapy?
TOPLINE:
which suggest that stromal TILs could be a useful biomarker to optimize treatment decisions in this patient population.
METHODOLOGY:
- The absolute benefit of chemotherapy remains unclear among patients with stage I TNBC. High levels of stromal TILs, a promising biomarker, have been linked to better survival in patients with TNBC, but data focused on stage I disease are lacking.
- In the current analysis, researchers identified a cohort of 1041 women (mean age at diagnosis, 64.4 years) from the Netherlands Cancer Registry with stage I TNBC who had an available TIL score and had undergone a lumpectomy or a mastectomy but had not received neoadjuvant or adjuvant chemotherapy.
- Patients’ clinical data were matched to their corresponding pathologic data provided by the Dutch Pathology Registry, and a pathologist blinded to outcomes scored stromal TIL levels according to the International Immuno-Oncology Biomarker Working Group guidelines.
- The primary endpoint was breast cancer–specific survival at prespecified stromal TIL cutoffs of 30%, 50%, and 75%. Secondary outcomes included specific survival by pathologic tumor stage and overall survival.
TAKEAWAY:
- Overall, 8.6% of women had a pT1a tumor, 38.7% had a pT1b tumor, and 52.6% had a pT1c tumor. In the cohort, 25.6% of patients had stromal TIL levels of 30% or higher, 19.5% had levels of 50% or higher, and 13.5% had levels of 75% or higher.
- Over a median follow-up of 11.4 years, 335 patients died, 107 (32%) of whom died from breast cancer. Patients with smaller tumors (pT1abNO) had better survival outcomes than those with larger tumors (pT1cNO) — a 10-year breast cancer–specific survival of 92% vs 86%, respectively.
- In the overall cohort, stromal TIL levels of 30% or higher were associated with better breast cancer–specific survival than those with stromal TIL levels below 30% (96% vs 87%; hazard ratio [HR], 0.45). Stromal TIL levels of 50% or greater were also associated with better 10-year breast cancer–specific survival than those with levels below 50% (92% vs 88%; HR, 0.59). A similar pattern was observed for stromal TIL levels and overall survival.
- In patients with pT1c tumors, the 10-year breast cancer–specific survival among those with stromal TIL levels of 30% or higher was 95% vs 83% for levels below the 30% cutoff (HR, 0.24). Similarly, the 10-year breast cancer–specific survival for those in the 50% or higher group was 95% vs 84% for levels below that cutoff (HR, 0.27). The 10-year breast cancer–specific survival improved to 98% among patients with stromal TIL levels of 75% or higher (HR, 0.09).
IN PRACTICE:
The results supported the establishment of “treatment-optimization clinical trials in patients with stage I TNBC, using [stromal] TIL level as an integral biomarker to prospectively confirm the observed excellent survival when neoadjuvant or adjuvant chemotherapy is not administered,” the authors wrote. Assessing stromal TILs is also “inexpensive,” the authors added.
SOURCE:
The research, conducted by Marleen Kok, MD, PhD, Department of Medical Oncology, the Netherlands Cancer Institute, Amsterdam, and colleagues, was published online in JAMA Oncology.
LIMITATIONS:
The authors noted that the study was limited by its observational nature. The patients were drawn from a larger cohort, about half of whom received adjuvant chemotherapy, and the patients who did not receive chemotherapy may have had favorable tumor characteristics. There were also no data on BRCA1 or BRCA2 germline mutation status and recurrences and/or distant metastases. The database did not include data on patient ethnicity because most Dutch patients were White.
DISCLOSURES:
Research at the Netherlands Cancer Institute was supported by institutional grants from the Dutch Cancer Society and the Dutch Ministry of Health, Welfare and Sport. Dr. Kok declared financial relationships with several organizations including Gilead and Domain Therapeutics, as well as institutional grants from AstraZeneca, BMS, and Roche. Other authors also declared numerous financial relationships for themselves and their institutions with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
which suggest that stromal TILs could be a useful biomarker to optimize treatment decisions in this patient population.
METHODOLOGY:
- The absolute benefit of chemotherapy remains unclear among patients with stage I TNBC. High levels of stromal TILs, a promising biomarker, have been linked to better survival in patients with TNBC, but data focused on stage I disease are lacking.
- In the current analysis, researchers identified a cohort of 1041 women (mean age at diagnosis, 64.4 years) from the Netherlands Cancer Registry with stage I TNBC who had an available TIL score and had undergone a lumpectomy or a mastectomy but had not received neoadjuvant or adjuvant chemotherapy.
- Patients’ clinical data were matched to their corresponding pathologic data provided by the Dutch Pathology Registry, and a pathologist blinded to outcomes scored stromal TIL levels according to the International Immuno-Oncology Biomarker Working Group guidelines.
- The primary endpoint was breast cancer–specific survival at prespecified stromal TIL cutoffs of 30%, 50%, and 75%. Secondary outcomes included specific survival by pathologic tumor stage and overall survival.
TAKEAWAY:
- Overall, 8.6% of women had a pT1a tumor, 38.7% had a pT1b tumor, and 52.6% had a pT1c tumor. In the cohort, 25.6% of patients had stromal TIL levels of 30% or higher, 19.5% had levels of 50% or higher, and 13.5% had levels of 75% or higher.
- Over a median follow-up of 11.4 years, 335 patients died, 107 (32%) of whom died from breast cancer. Patients with smaller tumors (pT1abNO) had better survival outcomes than those with larger tumors (pT1cNO) — a 10-year breast cancer–specific survival of 92% vs 86%, respectively.
- In the overall cohort, stromal TIL levels of 30% or higher were associated with better breast cancer–specific survival than those with stromal TIL levels below 30% (96% vs 87%; hazard ratio [HR], 0.45). Stromal TIL levels of 50% or greater were also associated with better 10-year breast cancer–specific survival than those with levels below 50% (92% vs 88%; HR, 0.59). A similar pattern was observed for stromal TIL levels and overall survival.
- In patients with pT1c tumors, the 10-year breast cancer–specific survival among those with stromal TIL levels of 30% or higher was 95% vs 83% for levels below the 30% cutoff (HR, 0.24). Similarly, the 10-year breast cancer–specific survival for those in the 50% or higher group was 95% vs 84% for levels below that cutoff (HR, 0.27). The 10-year breast cancer–specific survival improved to 98% among patients with stromal TIL levels of 75% or higher (HR, 0.09).
IN PRACTICE:
The results supported the establishment of “treatment-optimization clinical trials in patients with stage I TNBC, using [stromal] TIL level as an integral biomarker to prospectively confirm the observed excellent survival when neoadjuvant or adjuvant chemotherapy is not administered,” the authors wrote. Assessing stromal TILs is also “inexpensive,” the authors added.
SOURCE:
The research, conducted by Marleen Kok, MD, PhD, Department of Medical Oncology, the Netherlands Cancer Institute, Amsterdam, and colleagues, was published online in JAMA Oncology.
LIMITATIONS:
The authors noted that the study was limited by its observational nature. The patients were drawn from a larger cohort, about half of whom received adjuvant chemotherapy, and the patients who did not receive chemotherapy may have had favorable tumor characteristics. There were also no data on BRCA1 or BRCA2 germline mutation status and recurrences and/or distant metastases. The database did not include data on patient ethnicity because most Dutch patients were White.
DISCLOSURES:
Research at the Netherlands Cancer Institute was supported by institutional grants from the Dutch Cancer Society and the Dutch Ministry of Health, Welfare and Sport. Dr. Kok declared financial relationships with several organizations including Gilead and Domain Therapeutics, as well as institutional grants from AstraZeneca, BMS, and Roche. Other authors also declared numerous financial relationships for themselves and their institutions with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
which suggest that stromal TILs could be a useful biomarker to optimize treatment decisions in this patient population.
METHODOLOGY:
- The absolute benefit of chemotherapy remains unclear among patients with stage I TNBC. High levels of stromal TILs, a promising biomarker, have been linked to better survival in patients with TNBC, but data focused on stage I disease are lacking.
- In the current analysis, researchers identified a cohort of 1041 women (mean age at diagnosis, 64.4 years) from the Netherlands Cancer Registry with stage I TNBC who had an available TIL score and had undergone a lumpectomy or a mastectomy but had not received neoadjuvant or adjuvant chemotherapy.
- Patients’ clinical data were matched to their corresponding pathologic data provided by the Dutch Pathology Registry, and a pathologist blinded to outcomes scored stromal TIL levels according to the International Immuno-Oncology Biomarker Working Group guidelines.
- The primary endpoint was breast cancer–specific survival at prespecified stromal TIL cutoffs of 30%, 50%, and 75%. Secondary outcomes included specific survival by pathologic tumor stage and overall survival.
TAKEAWAY:
- Overall, 8.6% of women had a pT1a tumor, 38.7% had a pT1b tumor, and 52.6% had a pT1c tumor. In the cohort, 25.6% of patients had stromal TIL levels of 30% or higher, 19.5% had levels of 50% or higher, and 13.5% had levels of 75% or higher.
- Over a median follow-up of 11.4 years, 335 patients died, 107 (32%) of whom died from breast cancer. Patients with smaller tumors (pT1abNO) had better survival outcomes than those with larger tumors (pT1cNO) — a 10-year breast cancer–specific survival of 92% vs 86%, respectively.
- In the overall cohort, stromal TIL levels of 30% or higher were associated with better breast cancer–specific survival than those with stromal TIL levels below 30% (96% vs 87%; hazard ratio [HR], 0.45). Stromal TIL levels of 50% or greater were also associated with better 10-year breast cancer–specific survival than those with levels below 50% (92% vs 88%; HR, 0.59). A similar pattern was observed for stromal TIL levels and overall survival.
- In patients with pT1c tumors, the 10-year breast cancer–specific survival among those with stromal TIL levels of 30% or higher was 95% vs 83% for levels below the 30% cutoff (HR, 0.24). Similarly, the 10-year breast cancer–specific survival for those in the 50% or higher group was 95% vs 84% for levels below that cutoff (HR, 0.27). The 10-year breast cancer–specific survival improved to 98% among patients with stromal TIL levels of 75% or higher (HR, 0.09).
IN PRACTICE:
The results supported the establishment of “treatment-optimization clinical trials in patients with stage I TNBC, using [stromal] TIL level as an integral biomarker to prospectively confirm the observed excellent survival when neoadjuvant or adjuvant chemotherapy is not administered,” the authors wrote. Assessing stromal TILs is also “inexpensive,” the authors added.
SOURCE:
The research, conducted by Marleen Kok, MD, PhD, Department of Medical Oncology, the Netherlands Cancer Institute, Amsterdam, and colleagues, was published online in JAMA Oncology.
LIMITATIONS:
The authors noted that the study was limited by its observational nature. The patients were drawn from a larger cohort, about half of whom received adjuvant chemotherapy, and the patients who did not receive chemotherapy may have had favorable tumor characteristics. There were also no data on BRCA1 or BRCA2 germline mutation status and recurrences and/or distant metastases. The database did not include data on patient ethnicity because most Dutch patients were White.
DISCLOSURES:
Research at the Netherlands Cancer Institute was supported by institutional grants from the Dutch Cancer Society and the Dutch Ministry of Health, Welfare and Sport. Dr. Kok declared financial relationships with several organizations including Gilead and Domain Therapeutics, as well as institutional grants from AstraZeneca, BMS, and Roche. Other authors also declared numerous financial relationships for themselves and their institutions with pharmaceutical companies.
A version of this article first appeared on Medscape.com.