Mutations linked to higher risk of SNs in CCSs

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Mutations linked to higher risk of SNs in CCSs

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Pediatric cancer patient with St. Jude doctors Photo from Seth Dixon, St. Jude Children’s

New research has shown that childhood cancer survivors (CCSs) with certain germline mutations have higher relative rates (RRs) of secondary neoplasms (SNs) later in life.

Mutation carriers had significantly higher rates of breast cancer and sarcoma if they had received radiation to treat their initial cancer.

Among CCSs who did not receive radiation, the mutations were associated with increased rates of any SN, breast cancer, nonmelanoma skin cancer, and 2 or more histologically distinct SNs.

These findings were reported in the Journal of Clinical Oncology.

Researchers sequenced samples from 3006 CCSs who were at least 5 years from their initial cancer diagnosis as well as 341 samples from cancer-free control subjects.

All subjects were participants in the St. Jude Lifetime Cohort Study, a retrospective study with prospective clinical follow-up.

Thirty-five percent of the CCSs had survived leukemia, and 19% had survived lymphoma.

The CCS’s median age at childhood cancer diagnosis was 7.1 years, and the median follow-up was 28 years. The controls had a median age of 36.4 at follow-up.

Results

There were 1120 SNs diagnosed in 439 CCSs (14.6%). Ninety-one CCSs developed 2 or more histologically distinct SNs. The median time to SN diagnosis was 25.6 years

Non-melanoma skin cancer (580 in 159 CCSs), meningiomas (233 in 102 CCSs), thyroid cancer (67 in 67 CCSs), and breast cancer (60 in 53 CCSs) were among the SNs reported.

There were 15 neoplasms recorded in the control group—14 cases of non-melanoma skin cancer and 1 meningioma.

Pathogenic or likely pathogenic (P/LP) mutations in 32 genes were reported in 175 CCSs. The prevalence in CCSs (5.8%) was nearly 10-fold higher than in controls (0.6%).

The most commonly mutated genes in CCSs were RB1 (n=43), NF1 (n=22), BRCA2 (n=14), BRCA1 (n=12), and TP53 (n=10).

In a multivariable analysis adjusted for sex, age at primary cancer diagnosis, and treatment, P/LP mutation carriers had a significantly higher rate of any SN (RR=1.8).

The rate of subsequent breast cancer was significantly increased among females with a P/LP mutation (RR= 9.4), recipients of chest radiation (RR=7.9), and those with higher anthracycline exposure (RR=2.4).

The rate of subsequent sarcoma was significantly increased for mutation carriers (RR=10.9) and CCSs with greater exposure to alkylating agents (RR=3.8).

Among irradiated CCSs, P/LP mutations were associated with significantly increased rates of breast cancer (RR=13.9) and sarcoma (RR=10.6)

Among non-irradiated CCSs, P/LP mutations were associated with significantly increased rates of any SN (RR=4.7), breast cancer (RR=7.7), nonmelanoma skin cancer (RR=11.0), and 2 or more histologically distinct SNs (RR=18.6).

The researchers said the higher risk of SNs in CCSs with P/LP mutations suggests all CCSs should be referred for genetic counseling.

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Research Hospital
Pediatric cancer patient with St. Jude doctors Photo from Seth Dixon, St. Jude Children’s

New research has shown that childhood cancer survivors (CCSs) with certain germline mutations have higher relative rates (RRs) of secondary neoplasms (SNs) later in life.

Mutation carriers had significantly higher rates of breast cancer and sarcoma if they had received radiation to treat their initial cancer.

Among CCSs who did not receive radiation, the mutations were associated with increased rates of any SN, breast cancer, nonmelanoma skin cancer, and 2 or more histologically distinct SNs.

These findings were reported in the Journal of Clinical Oncology.

Researchers sequenced samples from 3006 CCSs who were at least 5 years from their initial cancer diagnosis as well as 341 samples from cancer-free control subjects.

All subjects were participants in the St. Jude Lifetime Cohort Study, a retrospective study with prospective clinical follow-up.

Thirty-five percent of the CCSs had survived leukemia, and 19% had survived lymphoma.

The CCS’s median age at childhood cancer diagnosis was 7.1 years, and the median follow-up was 28 years. The controls had a median age of 36.4 at follow-up.

Results

There were 1120 SNs diagnosed in 439 CCSs (14.6%). Ninety-one CCSs developed 2 or more histologically distinct SNs. The median time to SN diagnosis was 25.6 years

Non-melanoma skin cancer (580 in 159 CCSs), meningiomas (233 in 102 CCSs), thyroid cancer (67 in 67 CCSs), and breast cancer (60 in 53 CCSs) were among the SNs reported.

There were 15 neoplasms recorded in the control group—14 cases of non-melanoma skin cancer and 1 meningioma.

Pathogenic or likely pathogenic (P/LP) mutations in 32 genes were reported in 175 CCSs. The prevalence in CCSs (5.8%) was nearly 10-fold higher than in controls (0.6%).

The most commonly mutated genes in CCSs were RB1 (n=43), NF1 (n=22), BRCA2 (n=14), BRCA1 (n=12), and TP53 (n=10).

In a multivariable analysis adjusted for sex, age at primary cancer diagnosis, and treatment, P/LP mutation carriers had a significantly higher rate of any SN (RR=1.8).

The rate of subsequent breast cancer was significantly increased among females with a P/LP mutation (RR= 9.4), recipients of chest radiation (RR=7.9), and those with higher anthracycline exposure (RR=2.4).

The rate of subsequent sarcoma was significantly increased for mutation carriers (RR=10.9) and CCSs with greater exposure to alkylating agents (RR=3.8).

Among irradiated CCSs, P/LP mutations were associated with significantly increased rates of breast cancer (RR=13.9) and sarcoma (RR=10.6)

Among non-irradiated CCSs, P/LP mutations were associated with significantly increased rates of any SN (RR=4.7), breast cancer (RR=7.7), nonmelanoma skin cancer (RR=11.0), and 2 or more histologically distinct SNs (RR=18.6).

The researchers said the higher risk of SNs in CCSs with P/LP mutations suggests all CCSs should be referred for genetic counseling.

Research Hospital
Pediatric cancer patient with St. Jude doctors Photo from Seth Dixon, St. Jude Children’s

New research has shown that childhood cancer survivors (CCSs) with certain germline mutations have higher relative rates (RRs) of secondary neoplasms (SNs) later in life.

Mutation carriers had significantly higher rates of breast cancer and sarcoma if they had received radiation to treat their initial cancer.

Among CCSs who did not receive radiation, the mutations were associated with increased rates of any SN, breast cancer, nonmelanoma skin cancer, and 2 or more histologically distinct SNs.

These findings were reported in the Journal of Clinical Oncology.

Researchers sequenced samples from 3006 CCSs who were at least 5 years from their initial cancer diagnosis as well as 341 samples from cancer-free control subjects.

All subjects were participants in the St. Jude Lifetime Cohort Study, a retrospective study with prospective clinical follow-up.

Thirty-five percent of the CCSs had survived leukemia, and 19% had survived lymphoma.

The CCS’s median age at childhood cancer diagnosis was 7.1 years, and the median follow-up was 28 years. The controls had a median age of 36.4 at follow-up.

Results

There were 1120 SNs diagnosed in 439 CCSs (14.6%). Ninety-one CCSs developed 2 or more histologically distinct SNs. The median time to SN diagnosis was 25.6 years

Non-melanoma skin cancer (580 in 159 CCSs), meningiomas (233 in 102 CCSs), thyroid cancer (67 in 67 CCSs), and breast cancer (60 in 53 CCSs) were among the SNs reported.

There were 15 neoplasms recorded in the control group—14 cases of non-melanoma skin cancer and 1 meningioma.

Pathogenic or likely pathogenic (P/LP) mutations in 32 genes were reported in 175 CCSs. The prevalence in CCSs (5.8%) was nearly 10-fold higher than in controls (0.6%).

The most commonly mutated genes in CCSs were RB1 (n=43), NF1 (n=22), BRCA2 (n=14), BRCA1 (n=12), and TP53 (n=10).

In a multivariable analysis adjusted for sex, age at primary cancer diagnosis, and treatment, P/LP mutation carriers had a significantly higher rate of any SN (RR=1.8).

The rate of subsequent breast cancer was significantly increased among females with a P/LP mutation (RR= 9.4), recipients of chest radiation (RR=7.9), and those with higher anthracycline exposure (RR=2.4).

The rate of subsequent sarcoma was significantly increased for mutation carriers (RR=10.9) and CCSs with greater exposure to alkylating agents (RR=3.8).

Among irradiated CCSs, P/LP mutations were associated with significantly increased rates of breast cancer (RR=13.9) and sarcoma (RR=10.6)

Among non-irradiated CCSs, P/LP mutations were associated with significantly increased rates of any SN (RR=4.7), breast cancer (RR=7.7), nonmelanoma skin cancer (RR=11.0), and 2 or more histologically distinct SNs (RR=18.6).

The researchers said the higher risk of SNs in CCSs with P/LP mutations suggests all CCSs should be referred for genetic counseling.

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From the Editors: The Value of Community

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I was recently reminded of the importance of face-to-face meetings to gain understanding and to learn from the experiences of others. In this case, the lesson was delivered in the idyllic setting of Sunriver, Oregon, where the Oregon and Washington chapters of the American College of Surgeons held their annual meeting. I always come away from this meeting energized and inspired by the shared experiences of young and old, urban and rural. This meeting exceeded all expectations in the quality of the presentations but also, more importantly, in the quality of the exchange of ideas and viewpoints among surgeons across the full spectrum of practice types, geographical locations, and generations.

Community and rural surgeons were both well represented at this meeting, perhaps because our Oregon chapter president, Keith Thomas, is a rural surgeon; he had invited rural surgeon extraordinaire Tyler Hughes to be the keynote speaker; and the overarching theme of the meeting was “The Right Care in the Right Place.” The program featured controversial topics that were presented in a way that respected all views and shed more light than heat on the subject: a debate about whether (and which) cancers needed to be referred to tertiary centers, an exploration of how surgical care for all might be improved by regionalization in a matrix that could allow all patients to access timely and appropriate care, and even a discussion of a strategy through which we might build consensus for the prevention of firearm injuries and deaths while avoiding the “demonization of the enemy” that currently occurs whenever the subject is mentioned.

Dr. Karen E. Deveney

The residents’ and fellows’ presentations have evolved over the past few decades to include a broader range of research topics than those in prior meetings. This year, trainees gave papers not only on the treatment of specific surgical conditions or basic science studies but also on quality improvement, patient safety, ethics, end-of-life care, and cutting-edge technologies. Those who presented their research displayed the very best attributes of the millennial generation: creativity, altruism, and a commitment to make our shared future world a better, safer, more humane place. They fielded questions from the audience like “old pros,” demonstrating an impressive understanding of their subjects as well as a passion for their work.

Although the accelerating demands on our lives have led some to question whether the time required to attend a chapter meeting is worth the money and effort, I would argue that it is crucial to our future to do so. As surgical practice becomes more specialized and “siloed,” it is critical that we reaffirm what unites us rather than focus on what separates us. It is easy to attribute ill motives and malevolent characteristics to someone who sees things differently than you do. Is much more difficult to do so when you spend time with that person and learn about him or her as an individual. Local ACS chapter meetings accomplish that and more. Older surgeons nearing retirement and worried about the future of their communities can meet and mingle with residents and fellows who might become future partners. Former colleagues from medical school or residency who have pursued different practice paths can reacquaint themselves with one another, relive the good (and perhaps bad) old times, and share a chuckle or two. Surgeons who practice in the “ivory tower” can gain appreciation for the challenges of practicing in a resource-limited facility. Those from competing institutions or practices can learn that the “other” is facing the same issues and that common strategies for success might be found. We can all gain a greater understanding that the other person’s problems aren’t that different or less complex than ours.

In addition to providing a stimulating program, a successful chapter meeting requires skillful planning and execution by an experienced chapter manager. Our Oregon chapter is fortunate to have Harvey Gail, an outstanding manager who takes care of those essential tasks that make the meeting run smoothly so that we can focus on the substance of the meeting itself.

Attending a chapter meeting requires a relatively short time commitment of three days away from home – including a weekend – and a tank of gas. Some have suggested that holding the meeting in the largest city in the region would lessen travel time demands for many, but doing so would mean losing the low-key setting that creates the perfect atmosphere for developing professional and personal relationships and building a true community. The future survival of our profession depends on finding better, novel solutions to our common problems; we can accomplish that only by sharing our diverse perspectives and identifying solutions that meet all of our needs and those of our patients.

To those of you who rarely (or never) have attended a chapter meeting, you need to go. You’ll be surprised at how much you can learn from your fellow surgeons, who, I guarantee, are more like you than they are different.
 

 

Dr. Deveney is a professor of surgery and the vice chair of education in the department of surgery at Oregon Health & Science University, Portland. She is the coeditor of ACS Surgery News.

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I was recently reminded of the importance of face-to-face meetings to gain understanding and to learn from the experiences of others. In this case, the lesson was delivered in the idyllic setting of Sunriver, Oregon, where the Oregon and Washington chapters of the American College of Surgeons held their annual meeting. I always come away from this meeting energized and inspired by the shared experiences of young and old, urban and rural. This meeting exceeded all expectations in the quality of the presentations but also, more importantly, in the quality of the exchange of ideas and viewpoints among surgeons across the full spectrum of practice types, geographical locations, and generations.

Community and rural surgeons were both well represented at this meeting, perhaps because our Oregon chapter president, Keith Thomas, is a rural surgeon; he had invited rural surgeon extraordinaire Tyler Hughes to be the keynote speaker; and the overarching theme of the meeting was “The Right Care in the Right Place.” The program featured controversial topics that were presented in a way that respected all views and shed more light than heat on the subject: a debate about whether (and which) cancers needed to be referred to tertiary centers, an exploration of how surgical care for all might be improved by regionalization in a matrix that could allow all patients to access timely and appropriate care, and even a discussion of a strategy through which we might build consensus for the prevention of firearm injuries and deaths while avoiding the “demonization of the enemy” that currently occurs whenever the subject is mentioned.

Dr. Karen E. Deveney

The residents’ and fellows’ presentations have evolved over the past few decades to include a broader range of research topics than those in prior meetings. This year, trainees gave papers not only on the treatment of specific surgical conditions or basic science studies but also on quality improvement, patient safety, ethics, end-of-life care, and cutting-edge technologies. Those who presented their research displayed the very best attributes of the millennial generation: creativity, altruism, and a commitment to make our shared future world a better, safer, more humane place. They fielded questions from the audience like “old pros,” demonstrating an impressive understanding of their subjects as well as a passion for their work.

Although the accelerating demands on our lives have led some to question whether the time required to attend a chapter meeting is worth the money and effort, I would argue that it is crucial to our future to do so. As surgical practice becomes more specialized and “siloed,” it is critical that we reaffirm what unites us rather than focus on what separates us. It is easy to attribute ill motives and malevolent characteristics to someone who sees things differently than you do. Is much more difficult to do so when you spend time with that person and learn about him or her as an individual. Local ACS chapter meetings accomplish that and more. Older surgeons nearing retirement and worried about the future of their communities can meet and mingle with residents and fellows who might become future partners. Former colleagues from medical school or residency who have pursued different practice paths can reacquaint themselves with one another, relive the good (and perhaps bad) old times, and share a chuckle or two. Surgeons who practice in the “ivory tower” can gain appreciation for the challenges of practicing in a resource-limited facility. Those from competing institutions or practices can learn that the “other” is facing the same issues and that common strategies for success might be found. We can all gain a greater understanding that the other person’s problems aren’t that different or less complex than ours.

In addition to providing a stimulating program, a successful chapter meeting requires skillful planning and execution by an experienced chapter manager. Our Oregon chapter is fortunate to have Harvey Gail, an outstanding manager who takes care of those essential tasks that make the meeting run smoothly so that we can focus on the substance of the meeting itself.

Attending a chapter meeting requires a relatively short time commitment of three days away from home – including a weekend – and a tank of gas. Some have suggested that holding the meeting in the largest city in the region would lessen travel time demands for many, but doing so would mean losing the low-key setting that creates the perfect atmosphere for developing professional and personal relationships and building a true community. The future survival of our profession depends on finding better, novel solutions to our common problems; we can accomplish that only by sharing our diverse perspectives and identifying solutions that meet all of our needs and those of our patients.

To those of you who rarely (or never) have attended a chapter meeting, you need to go. You’ll be surprised at how much you can learn from your fellow surgeons, who, I guarantee, are more like you than they are different.
 

 

Dr. Deveney is a professor of surgery and the vice chair of education in the department of surgery at Oregon Health & Science University, Portland. She is the coeditor of ACS Surgery News.

 

I was recently reminded of the importance of face-to-face meetings to gain understanding and to learn from the experiences of others. In this case, the lesson was delivered in the idyllic setting of Sunriver, Oregon, where the Oregon and Washington chapters of the American College of Surgeons held their annual meeting. I always come away from this meeting energized and inspired by the shared experiences of young and old, urban and rural. This meeting exceeded all expectations in the quality of the presentations but also, more importantly, in the quality of the exchange of ideas and viewpoints among surgeons across the full spectrum of practice types, geographical locations, and generations.

Community and rural surgeons were both well represented at this meeting, perhaps because our Oregon chapter president, Keith Thomas, is a rural surgeon; he had invited rural surgeon extraordinaire Tyler Hughes to be the keynote speaker; and the overarching theme of the meeting was “The Right Care in the Right Place.” The program featured controversial topics that were presented in a way that respected all views and shed more light than heat on the subject: a debate about whether (and which) cancers needed to be referred to tertiary centers, an exploration of how surgical care for all might be improved by regionalization in a matrix that could allow all patients to access timely and appropriate care, and even a discussion of a strategy through which we might build consensus for the prevention of firearm injuries and deaths while avoiding the “demonization of the enemy” that currently occurs whenever the subject is mentioned.

Dr. Karen E. Deveney

The residents’ and fellows’ presentations have evolved over the past few decades to include a broader range of research topics than those in prior meetings. This year, trainees gave papers not only on the treatment of specific surgical conditions or basic science studies but also on quality improvement, patient safety, ethics, end-of-life care, and cutting-edge technologies. Those who presented their research displayed the very best attributes of the millennial generation: creativity, altruism, and a commitment to make our shared future world a better, safer, more humane place. They fielded questions from the audience like “old pros,” demonstrating an impressive understanding of their subjects as well as a passion for their work.

Although the accelerating demands on our lives have led some to question whether the time required to attend a chapter meeting is worth the money and effort, I would argue that it is crucial to our future to do so. As surgical practice becomes more specialized and “siloed,” it is critical that we reaffirm what unites us rather than focus on what separates us. It is easy to attribute ill motives and malevolent characteristics to someone who sees things differently than you do. Is much more difficult to do so when you spend time with that person and learn about him or her as an individual. Local ACS chapter meetings accomplish that and more. Older surgeons nearing retirement and worried about the future of their communities can meet and mingle with residents and fellows who might become future partners. Former colleagues from medical school or residency who have pursued different practice paths can reacquaint themselves with one another, relive the good (and perhaps bad) old times, and share a chuckle or two. Surgeons who practice in the “ivory tower” can gain appreciation for the challenges of practicing in a resource-limited facility. Those from competing institutions or practices can learn that the “other” is facing the same issues and that common strategies for success might be found. We can all gain a greater understanding that the other person’s problems aren’t that different or less complex than ours.

In addition to providing a stimulating program, a successful chapter meeting requires skillful planning and execution by an experienced chapter manager. Our Oregon chapter is fortunate to have Harvey Gail, an outstanding manager who takes care of those essential tasks that make the meeting run smoothly so that we can focus on the substance of the meeting itself.

Attending a chapter meeting requires a relatively short time commitment of three days away from home – including a weekend – and a tank of gas. Some have suggested that holding the meeting in the largest city in the region would lessen travel time demands for many, but doing so would mean losing the low-key setting that creates the perfect atmosphere for developing professional and personal relationships and building a true community. The future survival of our profession depends on finding better, novel solutions to our common problems; we can accomplish that only by sharing our diverse perspectives and identifying solutions that meet all of our needs and those of our patients.

To those of you who rarely (or never) have attended a chapter meeting, you need to go. You’ll be surprised at how much you can learn from your fellow surgeons, who, I guarantee, are more like you than they are different.
 

 

Dr. Deveney is a professor of surgery and the vice chair of education in the department of surgery at Oregon Health & Science University, Portland. She is the coeditor of ACS Surgery News.

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Members in the news

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Stephanie J. Drew, DMD, FACS, was elected president of the American College of Oral and Maxillofacial Surgeons (ACOMS) at its Annual Scientific Conference in April. She is the 26th president of ACOMS and the first woman elected to the position.


Dr. Drew, associate professor of surgery, division of oral and maxillofacial surgery, department of surgery, Emory University School of Medicine, Atlanta, GA, has been at the forefront of using computer planning technology to help treat patients, as well as to teach residents and practicing physicians. Her goal as ACOMS president is to bring the latest technological advances in surgical education to the members of the organization. Dr. Drew has been actively involved in the committees of ACOMS and served as the chairperson of their Committee on Continuing Education for two years. She also co-chaired the organization’s Annual Scientific Conference in 2016.

ACOMS immediate past-president R. Bryan Bell, MD, DDS, FACS, said that in selecting Dr. Drew, “We have chosen a proven leader who exemplifies the surgical excellence, academic citizenship, and collegiality ACOMS emphasizes.”

Read more about Dr. Drew at bit.ly/2KBppvK.

The board of directors of the Oregon Health & Science University (OHSU), Portland, has unanimously elected Danny Jacobs, MD, MPH, FACS, as the next president of the university. Dr. Jacobs, presently executive vice-president, provost, and dean of the University of Texas Medical Branch (UTMB) School of Medicine, Galveston, will begin his presidency at OHSU August 1. He will be OHSU’s fifth president.

“I believe strongly in the values rooted in public academic health centers like OHSU. I believe in OHSU’s mission to serve all Oregonians and its strong commitment to innovation and adaptation to meet the needs of the community,” Dr. Jacobs said.

At UTMB, Dr. Jacobs is the chief academic officer, responsible for approximately 3,800 employees and trainees for its schools of Medicine, Nursing, Health Professions, and Biomedical Sciences. Dr. Jacobs’ faculty appointments at UTMB include professorships in the Institute for Translational Sciences, as well as the department of surgery and the department of preventive medicine and community health. He also oversees the institution’s research programs.

Read more about Dr. Jacobs at bit.ly/2rxGqyX.

Giuliano Testa, MD, FACS, was recently recognized on the annual TIME 100 list, which honors the most influential people of 2018, for his role in a groundbreaking uterine transplant clinical trial. A woman receiving the transplant gave birth to the first baby born via uterus transplant in the U.S.

Dr. Testa is the surgical director of living donor liver transplantation at Baylor University Medical Center, Dallas, TX, where he specializes in living donor liver transplantation for both adult and pediatric patients. In 2016, Dr. Testa and a team of experts at Baylor successfully performed the uterus transplant, which has only been attempted by a handful of teams in the world.

The patient, who was born without a uterus, gave birth to a baby boy in November 2017. Hers was the first functioning transplanted uterus in the U.S. Although she chose to remain anonymous, the woman wrote on TIME’s website (ti.me/2LcZBXE) that Dr. Testa was “a pillar of strength and assurance” during her experience. “It has been the honor of my life to be a small part of his miracle.” 

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Stephanie J. Drew, DMD, FACS, was elected president of the American College of Oral and Maxillofacial Surgeons (ACOMS) at its Annual Scientific Conference in April. She is the 26th president of ACOMS and the first woman elected to the position.


Dr. Drew, associate professor of surgery, division of oral and maxillofacial surgery, department of surgery, Emory University School of Medicine, Atlanta, GA, has been at the forefront of using computer planning technology to help treat patients, as well as to teach residents and practicing physicians. Her goal as ACOMS president is to bring the latest technological advances in surgical education to the members of the organization. Dr. Drew has been actively involved in the committees of ACOMS and served as the chairperson of their Committee on Continuing Education for two years. She also co-chaired the organization’s Annual Scientific Conference in 2016.

ACOMS immediate past-president R. Bryan Bell, MD, DDS, FACS, said that in selecting Dr. Drew, “We have chosen a proven leader who exemplifies the surgical excellence, academic citizenship, and collegiality ACOMS emphasizes.”

Read more about Dr. Drew at bit.ly/2KBppvK.

The board of directors of the Oregon Health & Science University (OHSU), Portland, has unanimously elected Danny Jacobs, MD, MPH, FACS, as the next president of the university. Dr. Jacobs, presently executive vice-president, provost, and dean of the University of Texas Medical Branch (UTMB) School of Medicine, Galveston, will begin his presidency at OHSU August 1. He will be OHSU’s fifth president.

“I believe strongly in the values rooted in public academic health centers like OHSU. I believe in OHSU’s mission to serve all Oregonians and its strong commitment to innovation and adaptation to meet the needs of the community,” Dr. Jacobs said.

At UTMB, Dr. Jacobs is the chief academic officer, responsible for approximately 3,800 employees and trainees for its schools of Medicine, Nursing, Health Professions, and Biomedical Sciences. Dr. Jacobs’ faculty appointments at UTMB include professorships in the Institute for Translational Sciences, as well as the department of surgery and the department of preventive medicine and community health. He also oversees the institution’s research programs.

Read more about Dr. Jacobs at bit.ly/2rxGqyX.

Giuliano Testa, MD, FACS, was recently recognized on the annual TIME 100 list, which honors the most influential people of 2018, for his role in a groundbreaking uterine transplant clinical trial. A woman receiving the transplant gave birth to the first baby born via uterus transplant in the U.S.

Dr. Testa is the surgical director of living donor liver transplantation at Baylor University Medical Center, Dallas, TX, where he specializes in living donor liver transplantation for both adult and pediatric patients. In 2016, Dr. Testa and a team of experts at Baylor successfully performed the uterus transplant, which has only been attempted by a handful of teams in the world.

The patient, who was born without a uterus, gave birth to a baby boy in November 2017. Hers was the first functioning transplanted uterus in the U.S. Although she chose to remain anonymous, the woman wrote on TIME’s website (ti.me/2LcZBXE) that Dr. Testa was “a pillar of strength and assurance” during her experience. “It has been the honor of my life to be a small part of his miracle.” 

 

Stephanie J. Drew, DMD, FACS, was elected president of the American College of Oral and Maxillofacial Surgeons (ACOMS) at its Annual Scientific Conference in April. She is the 26th president of ACOMS and the first woman elected to the position.


Dr. Drew, associate professor of surgery, division of oral and maxillofacial surgery, department of surgery, Emory University School of Medicine, Atlanta, GA, has been at the forefront of using computer planning technology to help treat patients, as well as to teach residents and practicing physicians. Her goal as ACOMS president is to bring the latest technological advances in surgical education to the members of the organization. Dr. Drew has been actively involved in the committees of ACOMS and served as the chairperson of their Committee on Continuing Education for two years. She also co-chaired the organization’s Annual Scientific Conference in 2016.

ACOMS immediate past-president R. Bryan Bell, MD, DDS, FACS, said that in selecting Dr. Drew, “We have chosen a proven leader who exemplifies the surgical excellence, academic citizenship, and collegiality ACOMS emphasizes.”

Read more about Dr. Drew at bit.ly/2KBppvK.

The board of directors of the Oregon Health & Science University (OHSU), Portland, has unanimously elected Danny Jacobs, MD, MPH, FACS, as the next president of the university. Dr. Jacobs, presently executive vice-president, provost, and dean of the University of Texas Medical Branch (UTMB) School of Medicine, Galveston, will begin his presidency at OHSU August 1. He will be OHSU’s fifth president.

“I believe strongly in the values rooted in public academic health centers like OHSU. I believe in OHSU’s mission to serve all Oregonians and its strong commitment to innovation and adaptation to meet the needs of the community,” Dr. Jacobs said.

At UTMB, Dr. Jacobs is the chief academic officer, responsible for approximately 3,800 employees and trainees for its schools of Medicine, Nursing, Health Professions, and Biomedical Sciences. Dr. Jacobs’ faculty appointments at UTMB include professorships in the Institute for Translational Sciences, as well as the department of surgery and the department of preventive medicine and community health. He also oversees the institution’s research programs.

Read more about Dr. Jacobs at bit.ly/2rxGqyX.

Giuliano Testa, MD, FACS, was recently recognized on the annual TIME 100 list, which honors the most influential people of 2018, for his role in a groundbreaking uterine transplant clinical trial. A woman receiving the transplant gave birth to the first baby born via uterus transplant in the U.S.

Dr. Testa is the surgical director of living donor liver transplantation at Baylor University Medical Center, Dallas, TX, where he specializes in living donor liver transplantation for both adult and pediatric patients. In 2016, Dr. Testa and a team of experts at Baylor successfully performed the uterus transplant, which has only been attempted by a handful of teams in the world.

The patient, who was born without a uterus, gave birth to a baby boy in November 2017. Hers was the first functioning transplanted uterus in the U.S. Although she chose to remain anonymous, the woman wrote on TIME’s website (ti.me/2LcZBXE) that Dr. Testa was “a pillar of strength and assurance” during her experience. “It has been the honor of my life to be a small part of his miracle.” 

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Information every surgeon should know about the ACSPA-SurgeonsPAC

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Measuring success when it comes to political action, particularly in the current climate, can be challenging. Just as the American College of Surgeons (ACS) strives to represent all of surgery and focuses on an extensive list of priorities, the American College of Surgeons Professional Association Political Action Committee (ACSPA-SurgeonsPAC) works to maintain relationships with numerous lawmakers to ensure the College’s advocacy and health policy agenda remains at the forefront.

Leading up to the November midterm elections, every surgeon should be familiar with some basic facts about ACSPA-SurgeonsPAC fundraising and disbursement efforts.
 

Fundraising and disbursements

Fundraising is on par with the 2016 election cycle, a record year for “hard” dollars, or personal funds used to support candidates. SurgeonsPAC supports both Democrat and Republican candidates running in U.S. House and Senate races across the nation. SurgeonsPAC has a track record of balanced giving, contributing to candidates and incumbents of both parties who are willing to champion issues of importance to surgeons and surgical patients. All 2017‒2018 election cycle disbursements can be viewed at www.surgeonspac.org/disbursements. Legally, SurgeonsPAC cannot earmark contributions for a particular candidate or based on a single issue.


From January 1, 2017, through May 31, 2018, the ACSPA-SurgeonsPAC reported more than $805,000 in receipts from more than 1,500 College members and staff, and disbursed more than $558,900 to more than 115 congressional candidates, leadership PACs, and political campaign committees. Of the amount given, in line with congressional party ratios, 59 percent was given to Republicans and 41 percent to Democrats.

In addition to raising funds to elect and reelect congressional candidates, SurgeonsPAC hosted several health care industry events in the ACS Washington Office for key members of Congress and political campaign committees, collaborated with other medical community PACs to host fundraising events and physician candidate meet and greets, participated in party committee briefings and additional engagement opportunities, and increased in-district check deliveries and targeted donor events.

To learn more about SurgeonsPAC fundraising or disbursements, visit SurgeonsPAC.org (login required using facs.org username and password) or contact Katie Oehmen, Manager, ACSPA-SurgeonsPAC and Grassroots at 202-672-1503 or [email protected]. For more information about the College’s legislative priorities, visit SurgeonsVoice.org.

Contributions to ACSPA-SurgeonsPAC are not deductible as charitable contributions for federal income tax purposes. Contributions are voluntary, and all members of ACSPA have the right to refuse to contribute without reprisal. Federal law prohibits ACSPA-SurgeonsPAC from accepting contributions from foreign nations. By law, if your contributions are made using a personal check or credit card, ACSPA-SurgeonsPAC may only use your contribution to support candidates in federal elections. All corporate contributions to ACSPA-SurgeonsPAC will be used for educational and administrative fees of ACSPA and other activities permissible under federal law. Federal law requires ACSPA-SurgeonsPAC to use its best efforts to collect and report the name, mailing address, occupation, and the name of the employer of individuals whose contributions exceed $200 in a calendar year. ACSPA-SurgeonsPAC is a program of the ACSPA, which is exempt from federal income tax under section 501c (6) of the Internal Revenue Code.

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Measuring success when it comes to political action, particularly in the current climate, can be challenging. Just as the American College of Surgeons (ACS) strives to represent all of surgery and focuses on an extensive list of priorities, the American College of Surgeons Professional Association Political Action Committee (ACSPA-SurgeonsPAC) works to maintain relationships with numerous lawmakers to ensure the College’s advocacy and health policy agenda remains at the forefront.

Leading up to the November midterm elections, every surgeon should be familiar with some basic facts about ACSPA-SurgeonsPAC fundraising and disbursement efforts.
 

Fundraising and disbursements

Fundraising is on par with the 2016 election cycle, a record year for “hard” dollars, or personal funds used to support candidates. SurgeonsPAC supports both Democrat and Republican candidates running in U.S. House and Senate races across the nation. SurgeonsPAC has a track record of balanced giving, contributing to candidates and incumbents of both parties who are willing to champion issues of importance to surgeons and surgical patients. All 2017‒2018 election cycle disbursements can be viewed at www.surgeonspac.org/disbursements. Legally, SurgeonsPAC cannot earmark contributions for a particular candidate or based on a single issue.


From January 1, 2017, through May 31, 2018, the ACSPA-SurgeonsPAC reported more than $805,000 in receipts from more than 1,500 College members and staff, and disbursed more than $558,900 to more than 115 congressional candidates, leadership PACs, and political campaign committees. Of the amount given, in line with congressional party ratios, 59 percent was given to Republicans and 41 percent to Democrats.

In addition to raising funds to elect and reelect congressional candidates, SurgeonsPAC hosted several health care industry events in the ACS Washington Office for key members of Congress and political campaign committees, collaborated with other medical community PACs to host fundraising events and physician candidate meet and greets, participated in party committee briefings and additional engagement opportunities, and increased in-district check deliveries and targeted donor events.

To learn more about SurgeonsPAC fundraising or disbursements, visit SurgeonsPAC.org (login required using facs.org username and password) or contact Katie Oehmen, Manager, ACSPA-SurgeonsPAC and Grassroots at 202-672-1503 or [email protected]. For more information about the College’s legislative priorities, visit SurgeonsVoice.org.

Contributions to ACSPA-SurgeonsPAC are not deductible as charitable contributions for federal income tax purposes. Contributions are voluntary, and all members of ACSPA have the right to refuse to contribute without reprisal. Federal law prohibits ACSPA-SurgeonsPAC from accepting contributions from foreign nations. By law, if your contributions are made using a personal check or credit card, ACSPA-SurgeonsPAC may only use your contribution to support candidates in federal elections. All corporate contributions to ACSPA-SurgeonsPAC will be used for educational and administrative fees of ACSPA and other activities permissible under federal law. Federal law requires ACSPA-SurgeonsPAC to use its best efforts to collect and report the name, mailing address, occupation, and the name of the employer of individuals whose contributions exceed $200 in a calendar year. ACSPA-SurgeonsPAC is a program of the ACSPA, which is exempt from federal income tax under section 501c (6) of the Internal Revenue Code.

 

Measuring success when it comes to political action, particularly in the current climate, can be challenging. Just as the American College of Surgeons (ACS) strives to represent all of surgery and focuses on an extensive list of priorities, the American College of Surgeons Professional Association Political Action Committee (ACSPA-SurgeonsPAC) works to maintain relationships with numerous lawmakers to ensure the College’s advocacy and health policy agenda remains at the forefront.

Leading up to the November midterm elections, every surgeon should be familiar with some basic facts about ACSPA-SurgeonsPAC fundraising and disbursement efforts.
 

Fundraising and disbursements

Fundraising is on par with the 2016 election cycle, a record year for “hard” dollars, or personal funds used to support candidates. SurgeonsPAC supports both Democrat and Republican candidates running in U.S. House and Senate races across the nation. SurgeonsPAC has a track record of balanced giving, contributing to candidates and incumbents of both parties who are willing to champion issues of importance to surgeons and surgical patients. All 2017‒2018 election cycle disbursements can be viewed at www.surgeonspac.org/disbursements. Legally, SurgeonsPAC cannot earmark contributions for a particular candidate or based on a single issue.


From January 1, 2017, through May 31, 2018, the ACSPA-SurgeonsPAC reported more than $805,000 in receipts from more than 1,500 College members and staff, and disbursed more than $558,900 to more than 115 congressional candidates, leadership PACs, and political campaign committees. Of the amount given, in line with congressional party ratios, 59 percent was given to Republicans and 41 percent to Democrats.

In addition to raising funds to elect and reelect congressional candidates, SurgeonsPAC hosted several health care industry events in the ACS Washington Office for key members of Congress and political campaign committees, collaborated with other medical community PACs to host fundraising events and physician candidate meet and greets, participated in party committee briefings and additional engagement opportunities, and increased in-district check deliveries and targeted donor events.

To learn more about SurgeonsPAC fundraising or disbursements, visit SurgeonsPAC.org (login required using facs.org username and password) or contact Katie Oehmen, Manager, ACSPA-SurgeonsPAC and Grassroots at 202-672-1503 or [email protected]. For more information about the College’s legislative priorities, visit SurgeonsVoice.org.

Contributions to ACSPA-SurgeonsPAC are not deductible as charitable contributions for federal income tax purposes. Contributions are voluntary, and all members of ACSPA have the right to refuse to contribute without reprisal. Federal law prohibits ACSPA-SurgeonsPAC from accepting contributions from foreign nations. By law, if your contributions are made using a personal check or credit card, ACSPA-SurgeonsPAC may only use your contribution to support candidates in federal elections. All corporate contributions to ACSPA-SurgeonsPAC will be used for educational and administrative fees of ACSPA and other activities permissible under federal law. Federal law requires ACSPA-SurgeonsPAC to use its best efforts to collect and report the name, mailing address, occupation, and the name of the employer of individuals whose contributions exceed $200 in a calendar year. ACSPA-SurgeonsPAC is a program of the ACSPA, which is exempt from federal income tax under section 501c (6) of the Internal Revenue Code.

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Register for ACS Comprehensive General Surgery Review Course, July 26–29

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The 2018 American College of Surgeons (ACS) Comprehensive General Surgery Review Course, July 26–29 in Chicago, IL, is an intensive three-and-a-half-day review course that will cover essential content areas in general surgery, including alimentary tract, endocrine and soft tissue, oncology, skin and breast, surgical critical care, trauma, and vascular operations, as well as perioperative care.

Course Chair John A. Weigelt, MD, DVM, MMA, FACS, and a distinguished faculty will use didactic and case-based formats to present a comprehensive and practical review. Dr. Weigelt recently retired from the Medical College of Wisconsin, where he was the Milt & Lidy Lunda/Charles Aprahamian Professor of Trauma Surgery, as well as professor and chief, division of trauma and critical care. He is joining the University of South Dakota and the Sanford Health System, Sioux Falls, this summer as professor of surgery. Dr. Weigelt is Medical Director of the ACS Surgical Education and Self-Assessment Program (also known as SESAP®).

The course offers a pragmatic review designed to focus on practice issues and will offer several special features, such as self-assessment materials, including pre- and posttests. It may be helpful in preparing for examinations. Self-assessment credit will be available.

The ACS is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide Continuing Medical Education for physicians.

The ACS designates this live activity for a maximum of 28 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Register today at bit.ly/2s19VtX. Space is limited and registration will be accepted on a first-come, first-served basis. For more information and registration, visit the Comprehensive General Surgery Review Course web page at facs.org/gsreviewcourse or e-mail [email protected] or [email protected]. 

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The 2018 American College of Surgeons (ACS) Comprehensive General Surgery Review Course, July 26–29 in Chicago, IL, is an intensive three-and-a-half-day review course that will cover essential content areas in general surgery, including alimentary tract, endocrine and soft tissue, oncology, skin and breast, surgical critical care, trauma, and vascular operations, as well as perioperative care.

Course Chair John A. Weigelt, MD, DVM, MMA, FACS, and a distinguished faculty will use didactic and case-based formats to present a comprehensive and practical review. Dr. Weigelt recently retired from the Medical College of Wisconsin, where he was the Milt & Lidy Lunda/Charles Aprahamian Professor of Trauma Surgery, as well as professor and chief, division of trauma and critical care. He is joining the University of South Dakota and the Sanford Health System, Sioux Falls, this summer as professor of surgery. Dr. Weigelt is Medical Director of the ACS Surgical Education and Self-Assessment Program (also known as SESAP®).

The course offers a pragmatic review designed to focus on practice issues and will offer several special features, such as self-assessment materials, including pre- and posttests. It may be helpful in preparing for examinations. Self-assessment credit will be available.

The ACS is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide Continuing Medical Education for physicians.

The ACS designates this live activity for a maximum of 28 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Register today at bit.ly/2s19VtX. Space is limited and registration will be accepted on a first-come, first-served basis. For more information and registration, visit the Comprehensive General Surgery Review Course web page at facs.org/gsreviewcourse or e-mail [email protected] or [email protected]. 

The 2018 American College of Surgeons (ACS) Comprehensive General Surgery Review Course, July 26–29 in Chicago, IL, is an intensive three-and-a-half-day review course that will cover essential content areas in general surgery, including alimentary tract, endocrine and soft tissue, oncology, skin and breast, surgical critical care, trauma, and vascular operations, as well as perioperative care.

Course Chair John A. Weigelt, MD, DVM, MMA, FACS, and a distinguished faculty will use didactic and case-based formats to present a comprehensive and practical review. Dr. Weigelt recently retired from the Medical College of Wisconsin, where he was the Milt & Lidy Lunda/Charles Aprahamian Professor of Trauma Surgery, as well as professor and chief, division of trauma and critical care. He is joining the University of South Dakota and the Sanford Health System, Sioux Falls, this summer as professor of surgery. Dr. Weigelt is Medical Director of the ACS Surgical Education and Self-Assessment Program (also known as SESAP®).

The course offers a pragmatic review designed to focus on practice issues and will offer several special features, such as self-assessment materials, including pre- and posttests. It may be helpful in preparing for examinations. Self-assessment credit will be available.

The ACS is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide Continuing Medical Education for physicians.

The ACS designates this live activity for a maximum of 28 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Register today at bit.ly/2s19VtX. Space is limited and registration will be accepted on a first-come, first-served basis. For more information and registration, visit the Comprehensive General Surgery Review Course web page at facs.org/gsreviewcourse or e-mail [email protected] or [email protected]. 

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NAPRC awards first accreditation to John Muir Health Rectal Cancer Program

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The National Accreditation Program for Rectal Cancer (NAPRC), which the American College of Surgeons (ACS) launched in 2017, has awarded its first accreditation to the John Muir Health Rectal Cancer Program, Walnut Creek and Concord, CA. To earn the voluntary accreditation, the John Muir Health Rectal Cancer Program met 19 standards, including the establishment of a rectal cancer multidisciplinary team (RC-MDT) with clinical representatives from surgery, pathology, radiology, radiation oncology, and medical oncology.

Thirteen of those standards address clinical services that the program was required to provide, including carcinoembryonic antigen testing, magnetic resonance imagining, and computed tomography imaging for cancer staging, and ensuring a process whereby the patient starts treatment within a defined time frame. One of the most important clinical standards requires all rectal cancer patients to be present at both pre- and post-treatment RC-MDT meetings.


“When a cancer center achieves this type of specialized accreditation, it means that their rectal cancer patients will receive streamlined, modern evaluation and treatment for the disease. Compliance with our standards will assure optimal care for these patients,” said David P. Winchester, MD, FACS, Medical Director, ACS Cancer Programs.

“We have come a long way in the treatment of rectal cancer, but it remains a very complex disease that can be challenging to treat,” said Samuel Oommen, MD, FACS, a colorectal surgeon and medical director of the gastrointestinal oncology program at John Muir Health.

“This accreditation demonstrates to patients that we have an innovative program that is at the forefront of rectal cancer care by following rigorous standards and best practices. Achieving this designation is a recognition of the work done by a dedicated multidisciplinary team providing high quality, patient-centered care to provide superior oncological outcomes while preserving quality of life,” Dr. Oommen said.

The NAPRC was developed through a collaboration between the Optimizing the Surgical Treatment of Rectal Cancer Consortium and the ACS Commission on Cancer. It is based on successful international models that emphasize program structure, patient care processes, performance improvement, and performance measures. Its goal is to ensure that rectal cancer patients receive appropriate care using a multidisciplinary approach.

For more information about the program and instructions on how to apply for accreditation, visit the NAPRC website at facs.org/naprc, or contact [email protected]. 

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The National Accreditation Program for Rectal Cancer (NAPRC), which the American College of Surgeons (ACS) launched in 2017, has awarded its first accreditation to the John Muir Health Rectal Cancer Program, Walnut Creek and Concord, CA. To earn the voluntary accreditation, the John Muir Health Rectal Cancer Program met 19 standards, including the establishment of a rectal cancer multidisciplinary team (RC-MDT) with clinical representatives from surgery, pathology, radiology, radiation oncology, and medical oncology.

Thirteen of those standards address clinical services that the program was required to provide, including carcinoembryonic antigen testing, magnetic resonance imagining, and computed tomography imaging for cancer staging, and ensuring a process whereby the patient starts treatment within a defined time frame. One of the most important clinical standards requires all rectal cancer patients to be present at both pre- and post-treatment RC-MDT meetings.


“When a cancer center achieves this type of specialized accreditation, it means that their rectal cancer patients will receive streamlined, modern evaluation and treatment for the disease. Compliance with our standards will assure optimal care for these patients,” said David P. Winchester, MD, FACS, Medical Director, ACS Cancer Programs.

“We have come a long way in the treatment of rectal cancer, but it remains a very complex disease that can be challenging to treat,” said Samuel Oommen, MD, FACS, a colorectal surgeon and medical director of the gastrointestinal oncology program at John Muir Health.

“This accreditation demonstrates to patients that we have an innovative program that is at the forefront of rectal cancer care by following rigorous standards and best practices. Achieving this designation is a recognition of the work done by a dedicated multidisciplinary team providing high quality, patient-centered care to provide superior oncological outcomes while preserving quality of life,” Dr. Oommen said.

The NAPRC was developed through a collaboration between the Optimizing the Surgical Treatment of Rectal Cancer Consortium and the ACS Commission on Cancer. It is based on successful international models that emphasize program structure, patient care processes, performance improvement, and performance measures. Its goal is to ensure that rectal cancer patients receive appropriate care using a multidisciplinary approach.

For more information about the program and instructions on how to apply for accreditation, visit the NAPRC website at facs.org/naprc, or contact [email protected]. 

 

The National Accreditation Program for Rectal Cancer (NAPRC), which the American College of Surgeons (ACS) launched in 2017, has awarded its first accreditation to the John Muir Health Rectal Cancer Program, Walnut Creek and Concord, CA. To earn the voluntary accreditation, the John Muir Health Rectal Cancer Program met 19 standards, including the establishment of a rectal cancer multidisciplinary team (RC-MDT) with clinical representatives from surgery, pathology, radiology, radiation oncology, and medical oncology.

Thirteen of those standards address clinical services that the program was required to provide, including carcinoembryonic antigen testing, magnetic resonance imagining, and computed tomography imaging for cancer staging, and ensuring a process whereby the patient starts treatment within a defined time frame. One of the most important clinical standards requires all rectal cancer patients to be present at both pre- and post-treatment RC-MDT meetings.


“When a cancer center achieves this type of specialized accreditation, it means that their rectal cancer patients will receive streamlined, modern evaluation and treatment for the disease. Compliance with our standards will assure optimal care for these patients,” said David P. Winchester, MD, FACS, Medical Director, ACS Cancer Programs.

“We have come a long way in the treatment of rectal cancer, but it remains a very complex disease that can be challenging to treat,” said Samuel Oommen, MD, FACS, a colorectal surgeon and medical director of the gastrointestinal oncology program at John Muir Health.

“This accreditation demonstrates to patients that we have an innovative program that is at the forefront of rectal cancer care by following rigorous standards and best practices. Achieving this designation is a recognition of the work done by a dedicated multidisciplinary team providing high quality, patient-centered care to provide superior oncological outcomes while preserving quality of life,” Dr. Oommen said.

The NAPRC was developed through a collaboration between the Optimizing the Surgical Treatment of Rectal Cancer Consortium and the ACS Commission on Cancer. It is based on successful international models that emphasize program structure, patient care processes, performance improvement, and performance measures. Its goal is to ensure that rectal cancer patients receive appropriate care using a multidisciplinary approach.

For more information about the program and instructions on how to apply for accreditation, visit the NAPRC website at facs.org/naprc, or contact [email protected]. 

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Registration for Clinical Congress 2018 now open

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Registration is now open for the American College of Surgeons Clinical Congress 2018, October 21–25 in Boston, MA. The Clinical Congress is one of the largest educational meetings of surgeons in the world and offers outstanding educational opportunities for every stage of your career. The theme of this year’s conference is the Joy and Privilege of a Surgical Career. The scientific program, online registration, travel and hotel reservation links, and previews of other planned events for the conference are available on the Clinical Congress 2018 website at facs.org/clincon2018.

The Clinical Congress 2018 program addresses essential clinical and nonclinical topics. It includes a series of Named Lectures to be delivered by world-renowned experts in their fields, Didactic/Experiential and Surgical Skills Courses, and Video-Based Education Sessions to showcase surgical procedures. The Scientific Forum will include surgical research presentations and posters. This year, all posters will be e-posters, available online for viewing throughout the entire Clinical Congress.

Register now at facs.org/clincon2018/register.

Registration is open to all physicians and individuals in the health care field. To receive the early bird registration fees, be sure to register by 11:59 pm (Central time) Monday, August 27.

 

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Registration is now open for the American College of Surgeons Clinical Congress 2018, October 21–25 in Boston, MA. The Clinical Congress is one of the largest educational meetings of surgeons in the world and offers outstanding educational opportunities for every stage of your career. The theme of this year’s conference is the Joy and Privilege of a Surgical Career. The scientific program, online registration, travel and hotel reservation links, and previews of other planned events for the conference are available on the Clinical Congress 2018 website at facs.org/clincon2018.

The Clinical Congress 2018 program addresses essential clinical and nonclinical topics. It includes a series of Named Lectures to be delivered by world-renowned experts in their fields, Didactic/Experiential and Surgical Skills Courses, and Video-Based Education Sessions to showcase surgical procedures. The Scientific Forum will include surgical research presentations and posters. This year, all posters will be e-posters, available online for viewing throughout the entire Clinical Congress.

Register now at facs.org/clincon2018/register.

Registration is open to all physicians and individuals in the health care field. To receive the early bird registration fees, be sure to register by 11:59 pm (Central time) Monday, August 27.

 

Registration is now open for the American College of Surgeons Clinical Congress 2018, October 21–25 in Boston, MA. The Clinical Congress is one of the largest educational meetings of surgeons in the world and offers outstanding educational opportunities for every stage of your career. The theme of this year’s conference is the Joy and Privilege of a Surgical Career. The scientific program, online registration, travel and hotel reservation links, and previews of other planned events for the conference are available on the Clinical Congress 2018 website at facs.org/clincon2018.

The Clinical Congress 2018 program addresses essential clinical and nonclinical topics. It includes a series of Named Lectures to be delivered by world-renowned experts in their fields, Didactic/Experiential and Surgical Skills Courses, and Video-Based Education Sessions to showcase surgical procedures. The Scientific Forum will include surgical research presentations and posters. This year, all posters will be e-posters, available online for viewing throughout the entire Clinical Congress.

Register now at facs.org/clincon2018/register.

Registration is open to all physicians and individuals in the health care field. To receive the early bird registration fees, be sure to register by 11:59 pm (Central time) Monday, August 27.

 

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CAR T Therapy: From Bench to Bedside and Back

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Release Date: July 15, 2018
Expiration Date: July 14, 2019

Note: This activity is no longer available for credit

 

Introductory Comments: (Duration: 9 minutes)

Aaron P. Rapoport, MD
Bone Marrow Transplant Program
University of Maryland School of Medicine
Baltimore, MD

Presentation: (Duration: 39 minutes)

Carl H. June, MD
Richard W. Vague Professor in Immunotherapy
Perelman School of Medicine
University of Pennsylvania
Philadelphia, PA

Provided by:

Learning Objectives

• Review clinical data and individual case studies to determine where CAR T-cell therapy might be appropriate in the treatment of adult and pediatric patients with leukemia, lymphoma, and multiple myeloma.

• Discuss the management of cytotoxicity of CAR T-cell therapy.

Target Audience

Hematologists, oncologists, and other members of the healthcare team who treat or manage patients with hematologic malignancies.

Statement of Need

It is critical that clinicians managing patients with acute leukemia and other hematologic malignancies are cognizant of exciting breakthroughs and are also able to integrate recent progress into practice. However, given the overwhelming influx of data, it is no surprise that many hematology professionals face difficulties in identifying the most relevant findings for clinical practice. Hematologists are unable to stay abreast of the latest evidence on investigational agents. Educational programs are thus crucial to address this important professional practice gap.

Faculty

Carl H. June, MD
Richard W. Vague Professor in Immunotherapy
Perelman School of Medicine
University of Pennsylvania
Philadelphia, PA
Disclosures: Consultant: Novartis; Grant/Research support and royalties/IPR: Novartis
Stockholder: Tmunity Therapeutics, Inc.

Aaron P. Rapoport, MD
Bone Marrow Transplant Program
University of Maryland School of Medicine
Baltimore, Maryland
Disclosures: No relevant financial relationships with a commercial supporter

Permissions

  • Slide 3: Complex tumor, host and environmental factors govern the strength and timing of anti-cancer immune responses
    • Reprinted from Immunity, Vol 39/No 1, Chen DS, Mellman I, Oncology meets immunology: the cancer-immunity cycle, pp 1-10, 2013, with permission from Elsevier
  • Slide 9: Genes differentially expressed in CART19 cellular infusion products from CLL patients
    • From Fraietta JA, Lacey SF, Orlando EJ, . . . June CH, Melenhorst JJ. Determinants of response and resistance to CD19 chimeric antigen receptor (CAR) T cell therapy of chronic lymphocytic leukemia. Nat Med 2018; 24:563-571
  • Slide 10: Characterization of CLL CAR T cells in NSG CLL model
    • Same as slide 9
  • Slide 15: First adult ALL patient
  • Slide 21: Efficient trafficking of CTL019 T Cells to CNS in ALL
    • From N Engl J Med, Grupp SA, Kalos M, Barrett D, . . V. June CH, Chimeric antigen receptor-modified T cells for acute lymphoid leukemia, Volume No 368, pp 1509-1518. Copyright © 2013 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
  • Slide 26: Long-term persistence and expression of CTL019 is associated with durable remission in leukemia: Predictive Biomarker
    • From Porter DL, Hwang WT, Frey NV . . . June CH. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med 2015; 7(303):303ra139. Reprinted with permission from AAAS.
  • Slide 28: Rapid massive expansion of clonal CART cell population in patient #10
    • Initially published in Fraietta JA, Nobles CL, Sammons MA, . . . June CH, Melenhors JJ. Disruption of TET2 promotes the therapeutic efficacy of CD19-targeted T cells. Nature 2018; 558(7709):307-312
  • Slide 29: Mapping CAR integration site in Pt #10
    • Same as slide 28.
  • Slide 31: Long-term stable persistence of TET2-deficient CAR T cells in Pt #10
    • Same as slide 28
  • Slide 32: Epigenetic and genetic changes uncovered by ATAC-seq in Pt #10
    • Same as slide 28.
  • Slide 33: TET2 knock down in healthy donor T cells
    • Same as slide 28.
  • Slide 34: TET2 knock down in healthy donor T cells
    • Same as slide 28.
  • Slide 36: CAR T for myeloma: BCMA
    • From Rickert RC, Jellusova J, Miletic AV. Signaling by the tumor necrosis factor receptor superfamily in B-cell biology and disease. Immunol Rev 2011; 244(1):115-33. Reprinted with permission from John Wiley and Sons.
  • Slide 38: CAR T for myeloma: Patient #1
  • Slide 39: Autoimmunity is the “Achilles’ Heel” of immunotherapy
    • First published in June CH, Warshauer JT, and Bluestone JA. Is autoimmunity the Achilles’ heel of cancer immunotherapy? Nat Med 2017;23(5):540-7
  • Slide 41: Multiplex CRISPR /Cas9 editing: Universal T cells TCR, HLA, PD-1, CTLA-4 and Fas
    • From Ren J, Zhang X, Liu X, Fang C, Jiang S, June CH, Zhao Y. A versatile system for rapid multiplex genome-edited CAR T cell generation. Oncotarget 2017; 8:17002-17011.
  • Slide 45: CAR T-cell trials for cancer are now global
    • From June CH, O’Connor RS, Kawalekar OU, Ghassemi S, Milone MC. CAR T cell immunotherapy for human cancer. Science 2018; 359:1361-1365. Reprinted with permission from AAAS.

Disclaimer

The content and views presented in this educational activity are those of the author and do not necessarily reflect those of Hemedicus or Frontline Medical Communications. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.

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Release Date: July 15, 2018
Expiration Date: July 14, 2019

Note: This activity is no longer available for credit

 

Introductory Comments: (Duration: 9 minutes)

Aaron P. Rapoport, MD
Bone Marrow Transplant Program
University of Maryland School of Medicine
Baltimore, MD

Presentation: (Duration: 39 minutes)

Carl H. June, MD
Richard W. Vague Professor in Immunotherapy
Perelman School of Medicine
University of Pennsylvania
Philadelphia, PA

Provided by:

Learning Objectives

• Review clinical data and individual case studies to determine where CAR T-cell therapy might be appropriate in the treatment of adult and pediatric patients with leukemia, lymphoma, and multiple myeloma.

• Discuss the management of cytotoxicity of CAR T-cell therapy.

Target Audience

Hematologists, oncologists, and other members of the healthcare team who treat or manage patients with hematologic malignancies.

Statement of Need

It is critical that clinicians managing patients with acute leukemia and other hematologic malignancies are cognizant of exciting breakthroughs and are also able to integrate recent progress into practice. However, given the overwhelming influx of data, it is no surprise that many hematology professionals face difficulties in identifying the most relevant findings for clinical practice. Hematologists are unable to stay abreast of the latest evidence on investigational agents. Educational programs are thus crucial to address this important professional practice gap.

Faculty

Carl H. June, MD
Richard W. Vague Professor in Immunotherapy
Perelman School of Medicine
University of Pennsylvania
Philadelphia, PA
Disclosures: Consultant: Novartis; Grant/Research support and royalties/IPR: Novartis
Stockholder: Tmunity Therapeutics, Inc.

Aaron P. Rapoport, MD
Bone Marrow Transplant Program
University of Maryland School of Medicine
Baltimore, Maryland
Disclosures: No relevant financial relationships with a commercial supporter

Permissions

  • Slide 3: Complex tumor, host and environmental factors govern the strength and timing of anti-cancer immune responses
    • Reprinted from Immunity, Vol 39/No 1, Chen DS, Mellman I, Oncology meets immunology: the cancer-immunity cycle, pp 1-10, 2013, with permission from Elsevier
  • Slide 9: Genes differentially expressed in CART19 cellular infusion products from CLL patients
    • From Fraietta JA, Lacey SF, Orlando EJ, . . . June CH, Melenhorst JJ. Determinants of response and resistance to CD19 chimeric antigen receptor (CAR) T cell therapy of chronic lymphocytic leukemia. Nat Med 2018; 24:563-571
  • Slide 10: Characterization of CLL CAR T cells in NSG CLL model
    • Same as slide 9
  • Slide 15: First adult ALL patient
  • Slide 21: Efficient trafficking of CTL019 T Cells to CNS in ALL
    • From N Engl J Med, Grupp SA, Kalos M, Barrett D, . . V. June CH, Chimeric antigen receptor-modified T cells for acute lymphoid leukemia, Volume No 368, pp 1509-1518. Copyright © 2013 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
  • Slide 26: Long-term persistence and expression of CTL019 is associated with durable remission in leukemia: Predictive Biomarker
    • From Porter DL, Hwang WT, Frey NV . . . June CH. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med 2015; 7(303):303ra139. Reprinted with permission from AAAS.
  • Slide 28: Rapid massive expansion of clonal CART cell population in patient #10
    • Initially published in Fraietta JA, Nobles CL, Sammons MA, . . . June CH, Melenhors JJ. Disruption of TET2 promotes the therapeutic efficacy of CD19-targeted T cells. Nature 2018; 558(7709):307-312
  • Slide 29: Mapping CAR integration site in Pt #10
    • Same as slide 28.
  • Slide 31: Long-term stable persistence of TET2-deficient CAR T cells in Pt #10
    • Same as slide 28
  • Slide 32: Epigenetic and genetic changes uncovered by ATAC-seq in Pt #10
    • Same as slide 28.
  • Slide 33: TET2 knock down in healthy donor T cells
    • Same as slide 28.
  • Slide 34: TET2 knock down in healthy donor T cells
    • Same as slide 28.
  • Slide 36: CAR T for myeloma: BCMA
    • From Rickert RC, Jellusova J, Miletic AV. Signaling by the tumor necrosis factor receptor superfamily in B-cell biology and disease. Immunol Rev 2011; 244(1):115-33. Reprinted with permission from John Wiley and Sons.
  • Slide 38: CAR T for myeloma: Patient #1
  • Slide 39: Autoimmunity is the “Achilles’ Heel” of immunotherapy
    • First published in June CH, Warshauer JT, and Bluestone JA. Is autoimmunity the Achilles’ heel of cancer immunotherapy? Nat Med 2017;23(5):540-7
  • Slide 41: Multiplex CRISPR /Cas9 editing: Universal T cells TCR, HLA, PD-1, CTLA-4 and Fas
    • From Ren J, Zhang X, Liu X, Fang C, Jiang S, June CH, Zhao Y. A versatile system for rapid multiplex genome-edited CAR T cell generation. Oncotarget 2017; 8:17002-17011.
  • Slide 45: CAR T-cell trials for cancer are now global
    • From June CH, O’Connor RS, Kawalekar OU, Ghassemi S, Milone MC. CAR T cell immunotherapy for human cancer. Science 2018; 359:1361-1365. Reprinted with permission from AAAS.

Disclaimer

The content and views presented in this educational activity are those of the author and do not necessarily reflect those of Hemedicus or Frontline Medical Communications. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.

Release Date: July 15, 2018
Expiration Date: July 14, 2019

Note: This activity is no longer available for credit

 

Introductory Comments: (Duration: 9 minutes)

Aaron P. Rapoport, MD
Bone Marrow Transplant Program
University of Maryland School of Medicine
Baltimore, MD

Presentation: (Duration: 39 minutes)

Carl H. June, MD
Richard W. Vague Professor in Immunotherapy
Perelman School of Medicine
University of Pennsylvania
Philadelphia, PA

Provided by:

Learning Objectives

• Review clinical data and individual case studies to determine where CAR T-cell therapy might be appropriate in the treatment of adult and pediatric patients with leukemia, lymphoma, and multiple myeloma.

• Discuss the management of cytotoxicity of CAR T-cell therapy.

Target Audience

Hematologists, oncologists, and other members of the healthcare team who treat or manage patients with hematologic malignancies.

Statement of Need

It is critical that clinicians managing patients with acute leukemia and other hematologic malignancies are cognizant of exciting breakthroughs and are also able to integrate recent progress into practice. However, given the overwhelming influx of data, it is no surprise that many hematology professionals face difficulties in identifying the most relevant findings for clinical practice. Hematologists are unable to stay abreast of the latest evidence on investigational agents. Educational programs are thus crucial to address this important professional practice gap.

Faculty

Carl H. June, MD
Richard W. Vague Professor in Immunotherapy
Perelman School of Medicine
University of Pennsylvania
Philadelphia, PA
Disclosures: Consultant: Novartis; Grant/Research support and royalties/IPR: Novartis
Stockholder: Tmunity Therapeutics, Inc.

Aaron P. Rapoport, MD
Bone Marrow Transplant Program
University of Maryland School of Medicine
Baltimore, Maryland
Disclosures: No relevant financial relationships with a commercial supporter

Permissions

  • Slide 3: Complex tumor, host and environmental factors govern the strength and timing of anti-cancer immune responses
    • Reprinted from Immunity, Vol 39/No 1, Chen DS, Mellman I, Oncology meets immunology: the cancer-immunity cycle, pp 1-10, 2013, with permission from Elsevier
  • Slide 9: Genes differentially expressed in CART19 cellular infusion products from CLL patients
    • From Fraietta JA, Lacey SF, Orlando EJ, . . . June CH, Melenhorst JJ. Determinants of response and resistance to CD19 chimeric antigen receptor (CAR) T cell therapy of chronic lymphocytic leukemia. Nat Med 2018; 24:563-571
  • Slide 10: Characterization of CLL CAR T cells in NSG CLL model
    • Same as slide 9
  • Slide 15: First adult ALL patient
  • Slide 21: Efficient trafficking of CTL019 T Cells to CNS in ALL
    • From N Engl J Med, Grupp SA, Kalos M, Barrett D, . . V. June CH, Chimeric antigen receptor-modified T cells for acute lymphoid leukemia, Volume No 368, pp 1509-1518. Copyright © 2013 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
  • Slide 26: Long-term persistence and expression of CTL019 is associated with durable remission in leukemia: Predictive Biomarker
    • From Porter DL, Hwang WT, Frey NV . . . June CH. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med 2015; 7(303):303ra139. Reprinted with permission from AAAS.
  • Slide 28: Rapid massive expansion of clonal CART cell population in patient #10
    • Initially published in Fraietta JA, Nobles CL, Sammons MA, . . . June CH, Melenhors JJ. Disruption of TET2 promotes the therapeutic efficacy of CD19-targeted T cells. Nature 2018; 558(7709):307-312
  • Slide 29: Mapping CAR integration site in Pt #10
    • Same as slide 28.
  • Slide 31: Long-term stable persistence of TET2-deficient CAR T cells in Pt #10
    • Same as slide 28
  • Slide 32: Epigenetic and genetic changes uncovered by ATAC-seq in Pt #10
    • Same as slide 28.
  • Slide 33: TET2 knock down in healthy donor T cells
    • Same as slide 28.
  • Slide 34: TET2 knock down in healthy donor T cells
    • Same as slide 28.
  • Slide 36: CAR T for myeloma: BCMA
    • From Rickert RC, Jellusova J, Miletic AV. Signaling by the tumor necrosis factor receptor superfamily in B-cell biology and disease. Immunol Rev 2011; 244(1):115-33. Reprinted with permission from John Wiley and Sons.
  • Slide 38: CAR T for myeloma: Patient #1
  • Slide 39: Autoimmunity is the “Achilles’ Heel” of immunotherapy
    • First published in June CH, Warshauer JT, and Bluestone JA. Is autoimmunity the Achilles’ heel of cancer immunotherapy? Nat Med 2017;23(5):540-7
  • Slide 41: Multiplex CRISPR /Cas9 editing: Universal T cells TCR, HLA, PD-1, CTLA-4 and Fas
    • From Ren J, Zhang X, Liu X, Fang C, Jiang S, June CH, Zhao Y. A versatile system for rapid multiplex genome-edited CAR T cell generation. Oncotarget 2017; 8:17002-17011.
  • Slide 45: CAR T-cell trials for cancer are now global
    • From June CH, O’Connor RS, Kawalekar OU, Ghassemi S, Milone MC. CAR T cell immunotherapy for human cancer. Science 2018; 359:1361-1365. Reprinted with permission from AAAS.

Disclaimer

The content and views presented in this educational activity are those of the author and do not necessarily reflect those of Hemedicus or Frontline Medical Communications. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.

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Migraine treatment insights offered for noninvasive vagus nerve stimulation

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– Now that noninvasive vagus nerve stimulation using a small handheld device has earned clearance from the Food and Drug Administration for acute treatment of migraine attacks, investigators are pouring over data from the major clinical trials to gain post hoc insight into how to optimize use of the gammaCore device in routine clinical practice.

The answer is to use it early in the course of an attack and use it often, Eric Liebler said at the annual meeting of the American Headache Society.

Bruce Jancin/MDedge News
Eric Liebler

“Our motto here in the U.S. is to get the device and use it as many times as you want during the month. There are no pharmacologic side effects, no drug-drug interactions, and no risk of overusing it that we are aware of at this point. So if you give it to a patient who’s able to say, ‘Wait a second – I don’t feel good, I have premonitory symptoms,’ if they use it, then they’re likely to feel better, with a clinically relevant reduction of at least 1 point when treating a migraine while it’s mild,” according to Mr. Liebler, senior vice president for neurology at electroCore, of Basking Ridge, N.J., which markets the noninvasive vagus nerve stimulation (nVNS) gammaCore device.

The device received FDA clearance for acute treatment of migraine in January 2018 following regulatory approval in the spring of 2017 for treatment of episodic cluster headache.

Mr. Liebler presented key highlights of the recently published pivotal PRESTO trial (Prospective Study of nVNS for the Acute Treatment of Migraine), a randomized, double-blind, multicenter, sham-controlled study of 243 adults under age 50 years who experienced 3-8 migraine attacks per month (Neurology. 2018 Jun 15. doi: 10.1212/WNL.0000000000005857).

“This study provides Class I evidence that, for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free post stimulation,” Mr. Liebler declared.

During the 4-week, double-blind treatment period, 48% of the active nVNS group met the International Headache Society definition of pain relief, which meant at least a 1-point reduction in migraine severity on a 0-3 point pain scale at 120 minutes in at least 50% of treated migraine episodes without using rescue medications. This was a significantly better result than the 32% rate seen in patients in the control group who were given a sham device that emitted a perceptible but ineffective signal.

Similar results were documented during the subsequent 4-week, open-label treatment period, during which the control group was switched over to a functioning gammaCore.

“You can tell your patients they have a reliable chance of having a response more often than not,” according to Mr. Liebler.

What else can physicians tell their migraine patients to expect regarding efficacy? The pain-free responder rate at 120 minutes in PRESTO and other studies is similar to rates reported in meta-analyses of oral triptan therapy but without any drug side effects or limitations on frequency of use. Furthermore, the need for rescue medication at any time during a migraine attack was significantly lower with nVNS than it was with sham treatment, by a margin of 48%-63%.

“If they use this device, they’re often able to save that triptan for when they wake up in the morning and they’re already at a 3 in migraine severity,” he observed.

Also, nVNS is fast-acting: At 30 minutes from onset of pain in the first treated attack, 27% of the nVNS group had experienced pain relief, compared with 19% of controls.

The tolerability profile of the device therapy was outstanding, with no treatment discontinuations in the active treatment arm and only occasional reports of mild transient application site discomfort.

Asked about insurance coverage, Mr. Liebler said broad coverage is coming, but it’s not here yet.

“Insurers don’t really want to pay for anything, and devices confuse them even more than drugs. But we’re getting there because of the quality of the evidence. They were really having a good time telling us we didn’t have any published papers, and now that we’ve given them a class I study published in Neurology, they’ve said they had to review it. CVS will cover it starting Jan. 1,” he continued.

Planning is underway for additional clinical trials of the gammaCore for prevention of episodic migraine, acute treatment of attacks in adolescents, and for use in pregnancy.

 

 

Using the nVNS device

This nVNS device produces a proprietary, low-voltage electrical signal with a 24-volt peak voltage and a 60-mA peak output current. In the PRESTO study, patients were instructed to self-administer bilateral 120-second stimulations to the right and left sides of their necks within 20 minutes of pain onset. If the pain hadn’t improved within 15 minutes, they were to repeat the stimulations.

In a post hoc analysis of the PREVA (Prevention and Acute treatment of chronic cluster headache) study (Cephalalgia. 2016;36[6]:534-46), investigators determined that the mean reduction in the number of cluster headache attacks was significantly greater in patients who used the device to treat at least 77% of their attacks. That had a bigger preventive effect than did the number of stimulations a patient applied per day.

The PRESTO and PREVA trials were sponsored by electroCore, where Mr. Liebler is employed.

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– Now that noninvasive vagus nerve stimulation using a small handheld device has earned clearance from the Food and Drug Administration for acute treatment of migraine attacks, investigators are pouring over data from the major clinical trials to gain post hoc insight into how to optimize use of the gammaCore device in routine clinical practice.

The answer is to use it early in the course of an attack and use it often, Eric Liebler said at the annual meeting of the American Headache Society.

Bruce Jancin/MDedge News
Eric Liebler

“Our motto here in the U.S. is to get the device and use it as many times as you want during the month. There are no pharmacologic side effects, no drug-drug interactions, and no risk of overusing it that we are aware of at this point. So if you give it to a patient who’s able to say, ‘Wait a second – I don’t feel good, I have premonitory symptoms,’ if they use it, then they’re likely to feel better, with a clinically relevant reduction of at least 1 point when treating a migraine while it’s mild,” according to Mr. Liebler, senior vice president for neurology at electroCore, of Basking Ridge, N.J., which markets the noninvasive vagus nerve stimulation (nVNS) gammaCore device.

The device received FDA clearance for acute treatment of migraine in January 2018 following regulatory approval in the spring of 2017 for treatment of episodic cluster headache.

Mr. Liebler presented key highlights of the recently published pivotal PRESTO trial (Prospective Study of nVNS for the Acute Treatment of Migraine), a randomized, double-blind, multicenter, sham-controlled study of 243 adults under age 50 years who experienced 3-8 migraine attacks per month (Neurology. 2018 Jun 15. doi: 10.1212/WNL.0000000000005857).

“This study provides Class I evidence that, for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free post stimulation,” Mr. Liebler declared.

During the 4-week, double-blind treatment period, 48% of the active nVNS group met the International Headache Society definition of pain relief, which meant at least a 1-point reduction in migraine severity on a 0-3 point pain scale at 120 minutes in at least 50% of treated migraine episodes without using rescue medications. This was a significantly better result than the 32% rate seen in patients in the control group who were given a sham device that emitted a perceptible but ineffective signal.

Similar results were documented during the subsequent 4-week, open-label treatment period, during which the control group was switched over to a functioning gammaCore.

“You can tell your patients they have a reliable chance of having a response more often than not,” according to Mr. Liebler.

What else can physicians tell their migraine patients to expect regarding efficacy? The pain-free responder rate at 120 minutes in PRESTO and other studies is similar to rates reported in meta-analyses of oral triptan therapy but without any drug side effects or limitations on frequency of use. Furthermore, the need for rescue medication at any time during a migraine attack was significantly lower with nVNS than it was with sham treatment, by a margin of 48%-63%.

“If they use this device, they’re often able to save that triptan for when they wake up in the morning and they’re already at a 3 in migraine severity,” he observed.

Also, nVNS is fast-acting: At 30 minutes from onset of pain in the first treated attack, 27% of the nVNS group had experienced pain relief, compared with 19% of controls.

The tolerability profile of the device therapy was outstanding, with no treatment discontinuations in the active treatment arm and only occasional reports of mild transient application site discomfort.

Asked about insurance coverage, Mr. Liebler said broad coverage is coming, but it’s not here yet.

“Insurers don’t really want to pay for anything, and devices confuse them even more than drugs. But we’re getting there because of the quality of the evidence. They were really having a good time telling us we didn’t have any published papers, and now that we’ve given them a class I study published in Neurology, they’ve said they had to review it. CVS will cover it starting Jan. 1,” he continued.

Planning is underway for additional clinical trials of the gammaCore for prevention of episodic migraine, acute treatment of attacks in adolescents, and for use in pregnancy.

 

 

Using the nVNS device

This nVNS device produces a proprietary, low-voltage electrical signal with a 24-volt peak voltage and a 60-mA peak output current. In the PRESTO study, patients were instructed to self-administer bilateral 120-second stimulations to the right and left sides of their necks within 20 minutes of pain onset. If the pain hadn’t improved within 15 minutes, they were to repeat the stimulations.

In a post hoc analysis of the PREVA (Prevention and Acute treatment of chronic cluster headache) study (Cephalalgia. 2016;36[6]:534-46), investigators determined that the mean reduction in the number of cluster headache attacks was significantly greater in patients who used the device to treat at least 77% of their attacks. That had a bigger preventive effect than did the number of stimulations a patient applied per day.

The PRESTO and PREVA trials were sponsored by electroCore, where Mr. Liebler is employed.

 

– Now that noninvasive vagus nerve stimulation using a small handheld device has earned clearance from the Food and Drug Administration for acute treatment of migraine attacks, investigators are pouring over data from the major clinical trials to gain post hoc insight into how to optimize use of the gammaCore device in routine clinical practice.

The answer is to use it early in the course of an attack and use it often, Eric Liebler said at the annual meeting of the American Headache Society.

Bruce Jancin/MDedge News
Eric Liebler

“Our motto here in the U.S. is to get the device and use it as many times as you want during the month. There are no pharmacologic side effects, no drug-drug interactions, and no risk of overusing it that we are aware of at this point. So if you give it to a patient who’s able to say, ‘Wait a second – I don’t feel good, I have premonitory symptoms,’ if they use it, then they’re likely to feel better, with a clinically relevant reduction of at least 1 point when treating a migraine while it’s mild,” according to Mr. Liebler, senior vice president for neurology at electroCore, of Basking Ridge, N.J., which markets the noninvasive vagus nerve stimulation (nVNS) gammaCore device.

The device received FDA clearance for acute treatment of migraine in January 2018 following regulatory approval in the spring of 2017 for treatment of episodic cluster headache.

Mr. Liebler presented key highlights of the recently published pivotal PRESTO trial (Prospective Study of nVNS for the Acute Treatment of Migraine), a randomized, double-blind, multicenter, sham-controlled study of 243 adults under age 50 years who experienced 3-8 migraine attacks per month (Neurology. 2018 Jun 15. doi: 10.1212/WNL.0000000000005857).

“This study provides Class I evidence that, for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free post stimulation,” Mr. Liebler declared.

During the 4-week, double-blind treatment period, 48% of the active nVNS group met the International Headache Society definition of pain relief, which meant at least a 1-point reduction in migraine severity on a 0-3 point pain scale at 120 minutes in at least 50% of treated migraine episodes without using rescue medications. This was a significantly better result than the 32% rate seen in patients in the control group who were given a sham device that emitted a perceptible but ineffective signal.

Similar results were documented during the subsequent 4-week, open-label treatment period, during which the control group was switched over to a functioning gammaCore.

“You can tell your patients they have a reliable chance of having a response more often than not,” according to Mr. Liebler.

What else can physicians tell their migraine patients to expect regarding efficacy? The pain-free responder rate at 120 minutes in PRESTO and other studies is similar to rates reported in meta-analyses of oral triptan therapy but without any drug side effects or limitations on frequency of use. Furthermore, the need for rescue medication at any time during a migraine attack was significantly lower with nVNS than it was with sham treatment, by a margin of 48%-63%.

“If they use this device, they’re often able to save that triptan for when they wake up in the morning and they’re already at a 3 in migraine severity,” he observed.

Also, nVNS is fast-acting: At 30 minutes from onset of pain in the first treated attack, 27% of the nVNS group had experienced pain relief, compared with 19% of controls.

The tolerability profile of the device therapy was outstanding, with no treatment discontinuations in the active treatment arm and only occasional reports of mild transient application site discomfort.

Asked about insurance coverage, Mr. Liebler said broad coverage is coming, but it’s not here yet.

“Insurers don’t really want to pay for anything, and devices confuse them even more than drugs. But we’re getting there because of the quality of the evidence. They were really having a good time telling us we didn’t have any published papers, and now that we’ve given them a class I study published in Neurology, they’ve said they had to review it. CVS will cover it starting Jan. 1,” he continued.

Planning is underway for additional clinical trials of the gammaCore for prevention of episodic migraine, acute treatment of attacks in adolescents, and for use in pregnancy.

 

 

Using the nVNS device

This nVNS device produces a proprietary, low-voltage electrical signal with a 24-volt peak voltage and a 60-mA peak output current. In the PRESTO study, patients were instructed to self-administer bilateral 120-second stimulations to the right and left sides of their necks within 20 minutes of pain onset. If the pain hadn’t improved within 15 minutes, they were to repeat the stimulations.

In a post hoc analysis of the PREVA (Prevention and Acute treatment of chronic cluster headache) study (Cephalalgia. 2016;36[6]:534-46), investigators determined that the mean reduction in the number of cluster headache attacks was significantly greater in patients who used the device to treat at least 77% of their attacks. That had a bigger preventive effect than did the number of stimulations a patient applied per day.

The PRESTO and PREVA trials were sponsored by electroCore, where Mr. Liebler is employed.

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For smokers, the ends may not justify the ENDS

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Smokers who used e-cigarettes and other electronic nicotine delivery systems (ENDS) were less likely to quit than were those who did not use such products, according to a 2015 survey and a follow-up conducted a year later.

“Under ‘real world’ use and conditions [ENDS] may have suppressed or delayed quitting among some adult smokers,” Scott R. Weaver, PhD, and his associates at Georgia State University, Atlanta, wrote in PLoS One. The original survey, conducted in August and September of 2015, involved 1,284 U.S. adult smokers from the GfK KnowledgePanel, of whom 858 completed the follow-up survey in September 2016.

Smokers who used ENDS at baseline were slightly more likely to attempt to quit (53.7%) than were those who did not (48.6%) but were much less likely to have quit (defined as no smoking for at least 30 days at the time of follow-up): 9.4% vs. 18.9%, for an adjusted odds ratio of 0.30. Those who used ENDS at any time during the study were much more likely than were non-ENDS users to make an attempt (58.5% vs. 44.4%), but they were, again, much less likely to succeed (7.7% vs. 22.2%; AOR, 0.25), the investigators reported.

The results were similar for the subset of respondents who smoked every day: ENDS users were more likely to attempt to quit but less likely to succeed. Odds ratios for quitting were 0.37 for those using ENDS at baseline and 0.36 for those who used ENDS at any time since the first survey, Dr. Weaver and his associates said.

“Use of current ENDS products in real world conditions [does] not seem to improve the chances of quitting for smokers, and, under the current landscape, may not be the disruptive technology that increases the population quit rate and reduces the harm of combustibles,” they wrote.

The study was supported by the National Institute of Drug Abuse and the Food and Drug Administration’s Center for Tobacco Products. One of the investigators has received funding in the form of grant funding from Pfizer and the National Institutes of Health and another has served as a paid consultant to the Centers for Disease Control and Prevention.

SOURCE: Weaver SR et al. PLoS ONE. 2018 Jul 9;13(7): e0198047. doi: 10.1371/journal.pone.0198047.

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Smokers who used e-cigarettes and other electronic nicotine delivery systems (ENDS) were less likely to quit than were those who did not use such products, according to a 2015 survey and a follow-up conducted a year later.

“Under ‘real world’ use and conditions [ENDS] may have suppressed or delayed quitting among some adult smokers,” Scott R. Weaver, PhD, and his associates at Georgia State University, Atlanta, wrote in PLoS One. The original survey, conducted in August and September of 2015, involved 1,284 U.S. adult smokers from the GfK KnowledgePanel, of whom 858 completed the follow-up survey in September 2016.

Smokers who used ENDS at baseline were slightly more likely to attempt to quit (53.7%) than were those who did not (48.6%) but were much less likely to have quit (defined as no smoking for at least 30 days at the time of follow-up): 9.4% vs. 18.9%, for an adjusted odds ratio of 0.30. Those who used ENDS at any time during the study were much more likely than were non-ENDS users to make an attempt (58.5% vs. 44.4%), but they were, again, much less likely to succeed (7.7% vs. 22.2%; AOR, 0.25), the investigators reported.

The results were similar for the subset of respondents who smoked every day: ENDS users were more likely to attempt to quit but less likely to succeed. Odds ratios for quitting were 0.37 for those using ENDS at baseline and 0.36 for those who used ENDS at any time since the first survey, Dr. Weaver and his associates said.

“Use of current ENDS products in real world conditions [does] not seem to improve the chances of quitting for smokers, and, under the current landscape, may not be the disruptive technology that increases the population quit rate and reduces the harm of combustibles,” they wrote.

The study was supported by the National Institute of Drug Abuse and the Food and Drug Administration’s Center for Tobacco Products. One of the investigators has received funding in the form of grant funding from Pfizer and the National Institutes of Health and another has served as a paid consultant to the Centers for Disease Control and Prevention.

SOURCE: Weaver SR et al. PLoS ONE. 2018 Jul 9;13(7): e0198047. doi: 10.1371/journal.pone.0198047.

 

Smokers who used e-cigarettes and other electronic nicotine delivery systems (ENDS) were less likely to quit than were those who did not use such products, according to a 2015 survey and a follow-up conducted a year later.

“Under ‘real world’ use and conditions [ENDS] may have suppressed or delayed quitting among some adult smokers,” Scott R. Weaver, PhD, and his associates at Georgia State University, Atlanta, wrote in PLoS One. The original survey, conducted in August and September of 2015, involved 1,284 U.S. adult smokers from the GfK KnowledgePanel, of whom 858 completed the follow-up survey in September 2016.

Smokers who used ENDS at baseline were slightly more likely to attempt to quit (53.7%) than were those who did not (48.6%) but were much less likely to have quit (defined as no smoking for at least 30 days at the time of follow-up): 9.4% vs. 18.9%, for an adjusted odds ratio of 0.30. Those who used ENDS at any time during the study were much more likely than were non-ENDS users to make an attempt (58.5% vs. 44.4%), but they were, again, much less likely to succeed (7.7% vs. 22.2%; AOR, 0.25), the investigators reported.

The results were similar for the subset of respondents who smoked every day: ENDS users were more likely to attempt to quit but less likely to succeed. Odds ratios for quitting were 0.37 for those using ENDS at baseline and 0.36 for those who used ENDS at any time since the first survey, Dr. Weaver and his associates said.

“Use of current ENDS products in real world conditions [does] not seem to improve the chances of quitting for smokers, and, under the current landscape, may not be the disruptive technology that increases the population quit rate and reduces the harm of combustibles,” they wrote.

The study was supported by the National Institute of Drug Abuse and the Food and Drug Administration’s Center for Tobacco Products. One of the investigators has received funding in the form of grant funding from Pfizer and the National Institutes of Health and another has served as a paid consultant to the Centers for Disease Control and Prevention.

SOURCE: Weaver SR et al. PLoS ONE. 2018 Jul 9;13(7): e0198047. doi: 10.1371/journal.pone.0198047.

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