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2017 Hidradenitis Suppurativa 4-Part Video Roundtable
- Robert G. Micheletti, MD, Moderator
- Jacob Levitt, MD
- Michelle Lowes, MD
The editorial staff of Dermatology News was not involved in developing the video roundtable.
- Robert G. Micheletti, MD, Moderator
- Jacob Levitt, MD
- Michelle Lowes, MD
The editorial staff of Dermatology News was not involved in developing the video roundtable.
- Robert G. Micheletti, MD, Moderator
- Jacob Levitt, MD
- Michelle Lowes, MD
The editorial staff of Dermatology News was not involved in developing the video roundtable.
VIDEO: Stroke thrombectomy count jumps after 2015 landmark reports
HOUSTON – Use of endovascular mechanical thrombectomy for treating selected patients with acute ischemic stroke surged in U.S. practice following publication of several studies in early 2015 that documented the treatment’s efficacy, in data collected by a large U.S. hospital registry.
During April-June 2016, 3.5% of all acute ischemic stroke patients seen at the nearly 2,000 U.S. hospitals enrolled in the Get With the Guidelines-Stroke program underwent treatment with endovascular thrombectomy, up from the 2% rate at the end of 2014,The new data he reported also showed substantial increases for other measures of thrombectomy use during a roughly 18-month period that followed a flurry of reports in late 2014 and early 2015 that presented clear evidence of the safety and efficacy of thrombectomy for selected ischemic stroke patients. The percentage of hospitals participating in the Get With the Guidelines-Stroke program that performed thrombectomies increased from about a quarter of enrolled hospitals at the end of 2014 to almost a third by mid 2016, and the average quarterly number of endovascular thrombectomy cases at hospitals offering the procedure rose from about 7 during the final 3 months of 2014 to about 12 during July-September 2016, reported Dr. Smith, a neurologist and medical director of the Cognitive Neurosciences Clinic at the University of Calgary (Alta.).
“Before 2015, we saw a slow increase in the use of intra-arterial therapy, but after studies showed it was effective, there was an acceleration in the proportion of hospitals providing this therapy, the number of cases treated at each hospital, and the number of ischemic stroke patients treated,” Dr. Smith said in a video interview. “This shows rapid uptake of endovascular thrombectomy, but we still have a ways to go.”
He estimated that roughly 10%-15% of all U.S. acute ischemic stroke patients are eligible for endovascular thrombectomy based on location of the occluding clot in a large cerebral artery and the time frame when patients appear at a thrombectomy hospital relative to their stroke onset. This suggests that by mid-2016, roughly 20%-33% of U.S. ischemic stroke patients eligible for thrombectomy actually received the treatment.
“I don’t think we should be satisfied until we treat every eligible patient as quickly as we can. We need to move toward 100%,” he said.
The analyses he reported came from data collected on more than 2.4 million ischemic stroke patients treated at more than 2,200 U.S. hospitals participating in the Get With the Guidelines-Stroke program during 2003-2016.
The 2016 data also showed that, while the median thrombectomy annual case volume from mid-2015 to mid-2016 was 32 patients per year at thrombectomy hospitals, about 5% of these centers performed 100 or more cases during this 1-year period, and about 10% performed 10 or fewer thrombectomy cases. “There may be a relationship between case volume and the skill of performing the procedure, and a potential need for a volume minimum for thrombectomy certification to ensure that centers and operators maintain their skills,” Dr. Smith said.
He contrasted the recent pace of thrombectomy uptake with the first few years of routine thrombolytic treatment for the same disease during the mid-1990s, when little uptake occurred. Dr. Smith attributed the more robust penetration of thrombectomy to several factors: the impressive benefit of the treatment, the concurrent reporting of several confirmatory studies, and the stronger acute stroke–care infrastructure now in place, compared with what was available to stroke patients a generation ago.
“It’s encouraging to see such early growth in thrombectomy when thrombolysis lagged for so many years,” Dr. Smith said.
Dr. Smith had no disclosures. Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association using funding provided by several drug companies.
Eric E. Smith, MD, said at the International Stroke Conference, sponsored by the American Heart Association.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
HOUSTON – Use of endovascular mechanical thrombectomy for treating selected patients with acute ischemic stroke surged in U.S. practice following publication of several studies in early 2015 that documented the treatment’s efficacy, in data collected by a large U.S. hospital registry.
During April-June 2016, 3.5% of all acute ischemic stroke patients seen at the nearly 2,000 U.S. hospitals enrolled in the Get With the Guidelines-Stroke program underwent treatment with endovascular thrombectomy, up from the 2% rate at the end of 2014,The new data he reported also showed substantial increases for other measures of thrombectomy use during a roughly 18-month period that followed a flurry of reports in late 2014 and early 2015 that presented clear evidence of the safety and efficacy of thrombectomy for selected ischemic stroke patients. The percentage of hospitals participating in the Get With the Guidelines-Stroke program that performed thrombectomies increased from about a quarter of enrolled hospitals at the end of 2014 to almost a third by mid 2016, and the average quarterly number of endovascular thrombectomy cases at hospitals offering the procedure rose from about 7 during the final 3 months of 2014 to about 12 during July-September 2016, reported Dr. Smith, a neurologist and medical director of the Cognitive Neurosciences Clinic at the University of Calgary (Alta.).
“Before 2015, we saw a slow increase in the use of intra-arterial therapy, but after studies showed it was effective, there was an acceleration in the proportion of hospitals providing this therapy, the number of cases treated at each hospital, and the number of ischemic stroke patients treated,” Dr. Smith said in a video interview. “This shows rapid uptake of endovascular thrombectomy, but we still have a ways to go.”
He estimated that roughly 10%-15% of all U.S. acute ischemic stroke patients are eligible for endovascular thrombectomy based on location of the occluding clot in a large cerebral artery and the time frame when patients appear at a thrombectomy hospital relative to their stroke onset. This suggests that by mid-2016, roughly 20%-33% of U.S. ischemic stroke patients eligible for thrombectomy actually received the treatment.
“I don’t think we should be satisfied until we treat every eligible patient as quickly as we can. We need to move toward 100%,” he said.
The analyses he reported came from data collected on more than 2.4 million ischemic stroke patients treated at more than 2,200 U.S. hospitals participating in the Get With the Guidelines-Stroke program during 2003-2016.
The 2016 data also showed that, while the median thrombectomy annual case volume from mid-2015 to mid-2016 was 32 patients per year at thrombectomy hospitals, about 5% of these centers performed 100 or more cases during this 1-year period, and about 10% performed 10 or fewer thrombectomy cases. “There may be a relationship between case volume and the skill of performing the procedure, and a potential need for a volume minimum for thrombectomy certification to ensure that centers and operators maintain their skills,” Dr. Smith said.
He contrasted the recent pace of thrombectomy uptake with the first few years of routine thrombolytic treatment for the same disease during the mid-1990s, when little uptake occurred. Dr. Smith attributed the more robust penetration of thrombectomy to several factors: the impressive benefit of the treatment, the concurrent reporting of several confirmatory studies, and the stronger acute stroke–care infrastructure now in place, compared with what was available to stroke patients a generation ago.
“It’s encouraging to see such early growth in thrombectomy when thrombolysis lagged for so many years,” Dr. Smith said.
Dr. Smith had no disclosures. Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association using funding provided by several drug companies.
Eric E. Smith, MD, said at the International Stroke Conference, sponsored by the American Heart Association.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
HOUSTON – Use of endovascular mechanical thrombectomy for treating selected patients with acute ischemic stroke surged in U.S. practice following publication of several studies in early 2015 that documented the treatment’s efficacy, in data collected by a large U.S. hospital registry.
During April-June 2016, 3.5% of all acute ischemic stroke patients seen at the nearly 2,000 U.S. hospitals enrolled in the Get With the Guidelines-Stroke program underwent treatment with endovascular thrombectomy, up from the 2% rate at the end of 2014,The new data he reported also showed substantial increases for other measures of thrombectomy use during a roughly 18-month period that followed a flurry of reports in late 2014 and early 2015 that presented clear evidence of the safety and efficacy of thrombectomy for selected ischemic stroke patients. The percentage of hospitals participating in the Get With the Guidelines-Stroke program that performed thrombectomies increased from about a quarter of enrolled hospitals at the end of 2014 to almost a third by mid 2016, and the average quarterly number of endovascular thrombectomy cases at hospitals offering the procedure rose from about 7 during the final 3 months of 2014 to about 12 during July-September 2016, reported Dr. Smith, a neurologist and medical director of the Cognitive Neurosciences Clinic at the University of Calgary (Alta.).
“Before 2015, we saw a slow increase in the use of intra-arterial therapy, but after studies showed it was effective, there was an acceleration in the proportion of hospitals providing this therapy, the number of cases treated at each hospital, and the number of ischemic stroke patients treated,” Dr. Smith said in a video interview. “This shows rapid uptake of endovascular thrombectomy, but we still have a ways to go.”
He estimated that roughly 10%-15% of all U.S. acute ischemic stroke patients are eligible for endovascular thrombectomy based on location of the occluding clot in a large cerebral artery and the time frame when patients appear at a thrombectomy hospital relative to their stroke onset. This suggests that by mid-2016, roughly 20%-33% of U.S. ischemic stroke patients eligible for thrombectomy actually received the treatment.
“I don’t think we should be satisfied until we treat every eligible patient as quickly as we can. We need to move toward 100%,” he said.
The analyses he reported came from data collected on more than 2.4 million ischemic stroke patients treated at more than 2,200 U.S. hospitals participating in the Get With the Guidelines-Stroke program during 2003-2016.
The 2016 data also showed that, while the median thrombectomy annual case volume from mid-2015 to mid-2016 was 32 patients per year at thrombectomy hospitals, about 5% of these centers performed 100 or more cases during this 1-year period, and about 10% performed 10 or fewer thrombectomy cases. “There may be a relationship between case volume and the skill of performing the procedure, and a potential need for a volume minimum for thrombectomy certification to ensure that centers and operators maintain their skills,” Dr. Smith said.
He contrasted the recent pace of thrombectomy uptake with the first few years of routine thrombolytic treatment for the same disease during the mid-1990s, when little uptake occurred. Dr. Smith attributed the more robust penetration of thrombectomy to several factors: the impressive benefit of the treatment, the concurrent reporting of several confirmatory studies, and the stronger acute stroke–care infrastructure now in place, compared with what was available to stroke patients a generation ago.
“It’s encouraging to see such early growth in thrombectomy when thrombolysis lagged for so many years,” Dr. Smith said.
Dr. Smith had no disclosures. Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association using funding provided by several drug companies.
Eric E. Smith, MD, said at the International Stroke Conference, sponsored by the American Heart Association.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
AT THE INTERNATIONAL STROKE CONFERENCE
Key clinical point:
Major finding: U.S. thrombectomy treatment jumped from 2% of all acute ischemic stroke patients in late 2014 to 3.5% in mid-2016.
Data source: Hospitalization records for more than 2.4 million ischemic stroke patients treated at more than 2,200 U.S. hospitals participating in the Get With the Guidelines-Stroke program during 2003-2016.
Disclosures: Dr. Smith had no disclosures. Get With the Guidelines-Stroke is a program of the American Heart Association and American Stroke Association using funding provided by several drug companies.
How to ‘de-label’ penicillin allergies in the hospital
ATLANTA – With the help of a pharmacist and the electronic health records system, Rochester (N.Y.) General Hospital ruled out penicillin allergies in 47 of 50 adult inpatients, and successfully transitioned them from second-line antibiotics to less expensive and more effective beta-lactam options.
The hospital’s EHR system generated a daily list of patients with a history of penicillin allergy who were on second-line options – vancomycin, daptomycin, aztreonam, linezolid, or moxifloxacin – for infections that would be better treated with beta-lactam antibiotics. An infectious disease pharmacist reviewed their history; if reported penicillin reactions were limited to a nonspecific rash more than 5 years earlier or seemed to be IgE mediated, patients were skin-prick tested to see if they really were allergic. Almost all of the 47 patients who had negative tests were switched to either a penicillin-based regimen or a cephalosporin.
Two weeks after discharge on phone follow-up, just one reported a problem: a mild rash that cleared up when he finished his course.
“We are not a major academic center, and have to prioritize what resources we have,” said Dr. Ramsey, who did most of the skin-prick tests. Triaging patients for testing based on antibiotic use is “a good way to start. We are getting this off the ground at our institution. I think it’s a good model for non-academic community hospitals,” like Rochester General, a 528-bed tertiary care center.
It’s no secret that penicillin allergies are extremely overdiagnosed, and that 90% or more of patients who carry the label – both inside and outside of hospitals – really aren’t allergic. Even so, patients are rarely tested to confirm the allergy, and instead end up on expensive second-line options that don’t work as well. They “wind up back in the hospital in a month,” Dr. Ramsey said.
The problem was a frequent topic of discussion at the American Academy of Allergy, Asthma and Immunology annual meeting, where she reported her findings. The Rochester General approach was of great interest to her audience, judging from the number of people who asked for more details after the presentation.
Most of the subjects were on the internal medicine service; the rest were surgery patients. Skin/soft tissue, bloodstream, respiratory, and intra-abdominal infections were the most common.
The investigators excluded patients with a history of severe allergic reactions, such as joint swelling or skin sloughing, as well as patients with a flat, itchy, non-urticarial rash after penicillin less than 5 years earlier. ICU patients were excluded due to consent issues.
Also for safety, the team did a one-time amoxicillin oral challenge before patients were switched to a cephalosporin.
An audience member said he’d heard of pushback on such efforts because patients are being moved to less expensive antibiotics, so hospitals won’t be able to bill as much.
Dr. Ramsey replied that Rochester General has been “extremely supportive of our efforts, because we have a good case for improving clinical outcomes with this program.” Meanwhile, the two infectious disease pharmacists at the hospital “have embraced this fully. It makes their job easier down the road because most of these patients are frequent fliers.”
Dr. Ramsey had no relevant financial disclosures.
ATLANTA – With the help of a pharmacist and the electronic health records system, Rochester (N.Y.) General Hospital ruled out penicillin allergies in 47 of 50 adult inpatients, and successfully transitioned them from second-line antibiotics to less expensive and more effective beta-lactam options.
The hospital’s EHR system generated a daily list of patients with a history of penicillin allergy who were on second-line options – vancomycin, daptomycin, aztreonam, linezolid, or moxifloxacin – for infections that would be better treated with beta-lactam antibiotics. An infectious disease pharmacist reviewed their history; if reported penicillin reactions were limited to a nonspecific rash more than 5 years earlier or seemed to be IgE mediated, patients were skin-prick tested to see if they really were allergic. Almost all of the 47 patients who had negative tests were switched to either a penicillin-based regimen or a cephalosporin.
Two weeks after discharge on phone follow-up, just one reported a problem: a mild rash that cleared up when he finished his course.
“We are not a major academic center, and have to prioritize what resources we have,” said Dr. Ramsey, who did most of the skin-prick tests. Triaging patients for testing based on antibiotic use is “a good way to start. We are getting this off the ground at our institution. I think it’s a good model for non-academic community hospitals,” like Rochester General, a 528-bed tertiary care center.
It’s no secret that penicillin allergies are extremely overdiagnosed, and that 90% or more of patients who carry the label – both inside and outside of hospitals – really aren’t allergic. Even so, patients are rarely tested to confirm the allergy, and instead end up on expensive second-line options that don’t work as well. They “wind up back in the hospital in a month,” Dr. Ramsey said.
The problem was a frequent topic of discussion at the American Academy of Allergy, Asthma and Immunology annual meeting, where she reported her findings. The Rochester General approach was of great interest to her audience, judging from the number of people who asked for more details after the presentation.
Most of the subjects were on the internal medicine service; the rest were surgery patients. Skin/soft tissue, bloodstream, respiratory, and intra-abdominal infections were the most common.
The investigators excluded patients with a history of severe allergic reactions, such as joint swelling or skin sloughing, as well as patients with a flat, itchy, non-urticarial rash after penicillin less than 5 years earlier. ICU patients were excluded due to consent issues.
Also for safety, the team did a one-time amoxicillin oral challenge before patients were switched to a cephalosporin.
An audience member said he’d heard of pushback on such efforts because patients are being moved to less expensive antibiotics, so hospitals won’t be able to bill as much.
Dr. Ramsey replied that Rochester General has been “extremely supportive of our efforts, because we have a good case for improving clinical outcomes with this program.” Meanwhile, the two infectious disease pharmacists at the hospital “have embraced this fully. It makes their job easier down the road because most of these patients are frequent fliers.”
Dr. Ramsey had no relevant financial disclosures.
ATLANTA – With the help of a pharmacist and the electronic health records system, Rochester (N.Y.) General Hospital ruled out penicillin allergies in 47 of 50 adult inpatients, and successfully transitioned them from second-line antibiotics to less expensive and more effective beta-lactam options.
The hospital’s EHR system generated a daily list of patients with a history of penicillin allergy who were on second-line options – vancomycin, daptomycin, aztreonam, linezolid, or moxifloxacin – for infections that would be better treated with beta-lactam antibiotics. An infectious disease pharmacist reviewed their history; if reported penicillin reactions were limited to a nonspecific rash more than 5 years earlier or seemed to be IgE mediated, patients were skin-prick tested to see if they really were allergic. Almost all of the 47 patients who had negative tests were switched to either a penicillin-based regimen or a cephalosporin.
Two weeks after discharge on phone follow-up, just one reported a problem: a mild rash that cleared up when he finished his course.
“We are not a major academic center, and have to prioritize what resources we have,” said Dr. Ramsey, who did most of the skin-prick tests. Triaging patients for testing based on antibiotic use is “a good way to start. We are getting this off the ground at our institution. I think it’s a good model for non-academic community hospitals,” like Rochester General, a 528-bed tertiary care center.
It’s no secret that penicillin allergies are extremely overdiagnosed, and that 90% or more of patients who carry the label – both inside and outside of hospitals – really aren’t allergic. Even so, patients are rarely tested to confirm the allergy, and instead end up on expensive second-line options that don’t work as well. They “wind up back in the hospital in a month,” Dr. Ramsey said.
The problem was a frequent topic of discussion at the American Academy of Allergy, Asthma and Immunology annual meeting, where she reported her findings. The Rochester General approach was of great interest to her audience, judging from the number of people who asked for more details after the presentation.
Most of the subjects were on the internal medicine service; the rest were surgery patients. Skin/soft tissue, bloodstream, respiratory, and intra-abdominal infections were the most common.
The investigators excluded patients with a history of severe allergic reactions, such as joint swelling or skin sloughing, as well as patients with a flat, itchy, non-urticarial rash after penicillin less than 5 years earlier. ICU patients were excluded due to consent issues.
Also for safety, the team did a one-time amoxicillin oral challenge before patients were switched to a cephalosporin.
An audience member said he’d heard of pushback on such efforts because patients are being moved to less expensive antibiotics, so hospitals won’t be able to bill as much.
Dr. Ramsey replied that Rochester General has been “extremely supportive of our efforts, because we have a good case for improving clinical outcomes with this program.” Meanwhile, the two infectious disease pharmacists at the hospital “have embraced this fully. It makes their job easier down the road because most of these patients are frequent fliers.”
Dr. Ramsey had no relevant financial disclosures.
AT THE 2017 AAAAI ANNUAL MEETING
Key clinical point:
Major finding: Forty-seven of 50 inpatients turned out not to have a penicillin allergy on skin testing, and were switched to beta-lactam antibiotics. Two weeks after discharge, just one reported a problem, a mild rash. The hospital saved close to $40,000.
Data source: Pilot project at non-academic hospital.
Disclosures: Dr. Ramsey had no relevant financial disclosures.
Expanding the role of the Vascular Surgery Board-ABS
Despite increasing financial and regulatory pressures, mainstream vascular surgery must continue to uphold high standards and excellence in clinical care. Achieving this benchmark can only be done by providing rigorous postgraduate training followed by a comprehensive evaluation and certification process.
To receive accreditation, new training programs, working with the support of their local graduate medical education committee and Designated Institutional Official, need to complete the formal application process of the Accreditation Council for Graduate Medical Education (ACGME). Those completed applications, following screening by ACGME staff, are forwarded to the ACGME’s Review Committee for Surgery for evaluation and accreditation determination. For some programs, the application process may require a site visit by ACGME field staff.
Vascular surgery residents and fellows who have successfully completed an ACGME-accredited program may then apply for board certification in vascular surgery, a process by which the individual applies to the Vascular Surgery Board of the American Board of Surgery (VSB-ABS) to take a written qualifying exam and then an oral certifying exam. It is only by maintaining this process that vascular surgery, the medical community, and the public at large can be assured that a board-certified vascular surgeon has met the rigorous requirements of both the ACGME and VSB-ABS for knowledge and training in vascular surgery.
It has been shown time and again that patients value board certification. In fact, in a 2003 Gallup poll,95% of the respondents felt that physicians should be board certified and 95% felt that maintenance of this certification was important (JAMA. 2004;292:1038-43).
The VSB-ABS has undergone many changes since its inception. Initially, the American Board of Surgery issued a certificate of added qualifications to vascular surgeons who met its criteria and passed the proper exams. The first certificate was issued to E. Jack Wylie, MD, on June 30, 1982.
In 2015, the VSB-ABS eliminated this requirement and incorporated core surgical management into the Vascular Surgery Qualifying Examination. This strategic change again affirmed the independence of vascular surgery as a specialty. The total number of board-certified vascular surgeons and number of training programs are summarized in Table 1.
The mission of the VSB-ABS is to serve the public and the specialty of surgery by providing leadership in surgical education and practice, by promoting excellence through rigorous evaluation and examination, and by promoting the highest standards for professionalism, lifelong learning, and the continuous certification of surgeons in practice. The VSB-ABS is responsible for setting the requirements for board certification in vascular surgery, including the creation and administration of the Vascular Surgery Qualifying (written) and Certifying (oral) Examinations. In addition, the VSB-ABS is responsible for the Vascular Surgery In-Training Examination and Maintenance of Certification (MOC) Examination. With the increasing number of graduates from vascular surgery training programs and the changing needs of our dynamic specialty, the VSB-ABS also is working on the following important initiatives.
Expansion of the VSB-ABS
The VSB-ABS currently consists of eight board members elected from the following four national vascular societies: the Society for Vascular Surgery, the Association of Program Directors in Vascular Surgery, the Society for Clinical Vascular Surgery, and the Vascular and Endovascular Surgery Society.
Maintenance of Certification
The American Board of Medical Specialties, the umbrella organization for all 24 medical specialty boards, established in 2003 that all of its member boards must adopt a continuous process of MOC.
In addition, each board was charged with developing requirements addressing each of these four areas: professional standing, lifelong learning and self-assessment, cognitive examination, and evaluation of performance in practice. While the ABS and VSB-ABS have sought to make MOC requirements as flexible as possible, we recognize that MOC needs improvement. Thousands of ABS diplomates were sent a survey this past fall regarding MOC so we could better understand the concerns of surgeons with the current process. The VSB-ABS recognizes these concerns and is currently considering various options to make MOC more relevant and convenient for vascular surgeons. Later this year, we anticipate sending a survey to better gain meaningful input specifically from vascular surgery diplomates regarding the need and options for change.
SCORE for Vascular Surgery
The VSB-ABS has also been hard at work in collaboration with the APDVS to produce SCORE for Vascular Surgery (“V-SCORE”), a structured curriculum for vascular surgery trainees using the SCORE Portal. SCORE for Vascular Surgery is being designed to emphasize the important topics that every vascular trainee should know and expect to be tested on. The curriculum outline is available at www.surgicalcore.org as a PDF document. The curriculum materials are available to vascular surgery training programs from the same website with a subscription and will be continuously updated to remain current.
Creation of a Certifying Examination Committee
This calendar year, a Certifying Examination Committee to write case scenarios and maintain updated images for the oral examination will be formed. This committee will be selected from a pool of qualified diplomates. The request for volunteers to be considered will be released shortly.
In summary, many changes are occurring in the structure and the activities of the VSB-ABS in order to have broader representation from the vascular community and be responsive to diplomate concerns, all the while maintaining a high standard for certification and recertification/MOC. Future regular updates from the VSB-ABS are planned to keep our diplomates informed.
Despite increasing financial and regulatory pressures, mainstream vascular surgery must continue to uphold high standards and excellence in clinical care. Achieving this benchmark can only be done by providing rigorous postgraduate training followed by a comprehensive evaluation and certification process.
To receive accreditation, new training programs, working with the support of their local graduate medical education committee and Designated Institutional Official, need to complete the formal application process of the Accreditation Council for Graduate Medical Education (ACGME). Those completed applications, following screening by ACGME staff, are forwarded to the ACGME’s Review Committee for Surgery for evaluation and accreditation determination. For some programs, the application process may require a site visit by ACGME field staff.
Vascular surgery residents and fellows who have successfully completed an ACGME-accredited program may then apply for board certification in vascular surgery, a process by which the individual applies to the Vascular Surgery Board of the American Board of Surgery (VSB-ABS) to take a written qualifying exam and then an oral certifying exam. It is only by maintaining this process that vascular surgery, the medical community, and the public at large can be assured that a board-certified vascular surgeon has met the rigorous requirements of both the ACGME and VSB-ABS for knowledge and training in vascular surgery.
It has been shown time and again that patients value board certification. In fact, in a 2003 Gallup poll,95% of the respondents felt that physicians should be board certified and 95% felt that maintenance of this certification was important (JAMA. 2004;292:1038-43).
The VSB-ABS has undergone many changes since its inception. Initially, the American Board of Surgery issued a certificate of added qualifications to vascular surgeons who met its criteria and passed the proper exams. The first certificate was issued to E. Jack Wylie, MD, on June 30, 1982.
In 2015, the VSB-ABS eliminated this requirement and incorporated core surgical management into the Vascular Surgery Qualifying Examination. This strategic change again affirmed the independence of vascular surgery as a specialty. The total number of board-certified vascular surgeons and number of training programs are summarized in Table 1.
The mission of the VSB-ABS is to serve the public and the specialty of surgery by providing leadership in surgical education and practice, by promoting excellence through rigorous evaluation and examination, and by promoting the highest standards for professionalism, lifelong learning, and the continuous certification of surgeons in practice. The VSB-ABS is responsible for setting the requirements for board certification in vascular surgery, including the creation and administration of the Vascular Surgery Qualifying (written) and Certifying (oral) Examinations. In addition, the VSB-ABS is responsible for the Vascular Surgery In-Training Examination and Maintenance of Certification (MOC) Examination. With the increasing number of graduates from vascular surgery training programs and the changing needs of our dynamic specialty, the VSB-ABS also is working on the following important initiatives.
Expansion of the VSB-ABS
The VSB-ABS currently consists of eight board members elected from the following four national vascular societies: the Society for Vascular Surgery, the Association of Program Directors in Vascular Surgery, the Society for Clinical Vascular Surgery, and the Vascular and Endovascular Surgery Society.
Maintenance of Certification
The American Board of Medical Specialties, the umbrella organization for all 24 medical specialty boards, established in 2003 that all of its member boards must adopt a continuous process of MOC.
In addition, each board was charged with developing requirements addressing each of these four areas: professional standing, lifelong learning and self-assessment, cognitive examination, and evaluation of performance in practice. While the ABS and VSB-ABS have sought to make MOC requirements as flexible as possible, we recognize that MOC needs improvement. Thousands of ABS diplomates were sent a survey this past fall regarding MOC so we could better understand the concerns of surgeons with the current process. The VSB-ABS recognizes these concerns and is currently considering various options to make MOC more relevant and convenient for vascular surgeons. Later this year, we anticipate sending a survey to better gain meaningful input specifically from vascular surgery diplomates regarding the need and options for change.
SCORE for Vascular Surgery
The VSB-ABS has also been hard at work in collaboration with the APDVS to produce SCORE for Vascular Surgery (“V-SCORE”), a structured curriculum for vascular surgery trainees using the SCORE Portal. SCORE for Vascular Surgery is being designed to emphasize the important topics that every vascular trainee should know and expect to be tested on. The curriculum outline is available at www.surgicalcore.org as a PDF document. The curriculum materials are available to vascular surgery training programs from the same website with a subscription and will be continuously updated to remain current.
Creation of a Certifying Examination Committee
This calendar year, a Certifying Examination Committee to write case scenarios and maintain updated images for the oral examination will be formed. This committee will be selected from a pool of qualified diplomates. The request for volunteers to be considered will be released shortly.
In summary, many changes are occurring in the structure and the activities of the VSB-ABS in order to have broader representation from the vascular community and be responsive to diplomate concerns, all the while maintaining a high standard for certification and recertification/MOC. Future regular updates from the VSB-ABS are planned to keep our diplomates informed.
Despite increasing financial and regulatory pressures, mainstream vascular surgery must continue to uphold high standards and excellence in clinical care. Achieving this benchmark can only be done by providing rigorous postgraduate training followed by a comprehensive evaluation and certification process.
To receive accreditation, new training programs, working with the support of their local graduate medical education committee and Designated Institutional Official, need to complete the formal application process of the Accreditation Council for Graduate Medical Education (ACGME). Those completed applications, following screening by ACGME staff, are forwarded to the ACGME’s Review Committee for Surgery for evaluation and accreditation determination. For some programs, the application process may require a site visit by ACGME field staff.
Vascular surgery residents and fellows who have successfully completed an ACGME-accredited program may then apply for board certification in vascular surgery, a process by which the individual applies to the Vascular Surgery Board of the American Board of Surgery (VSB-ABS) to take a written qualifying exam and then an oral certifying exam. It is only by maintaining this process that vascular surgery, the medical community, and the public at large can be assured that a board-certified vascular surgeon has met the rigorous requirements of both the ACGME and VSB-ABS for knowledge and training in vascular surgery.
It has been shown time and again that patients value board certification. In fact, in a 2003 Gallup poll,95% of the respondents felt that physicians should be board certified and 95% felt that maintenance of this certification was important (JAMA. 2004;292:1038-43).
The VSB-ABS has undergone many changes since its inception. Initially, the American Board of Surgery issued a certificate of added qualifications to vascular surgeons who met its criteria and passed the proper exams. The first certificate was issued to E. Jack Wylie, MD, on June 30, 1982.
In 2015, the VSB-ABS eliminated this requirement and incorporated core surgical management into the Vascular Surgery Qualifying Examination. This strategic change again affirmed the independence of vascular surgery as a specialty. The total number of board-certified vascular surgeons and number of training programs are summarized in Table 1.
The mission of the VSB-ABS is to serve the public and the specialty of surgery by providing leadership in surgical education and practice, by promoting excellence through rigorous evaluation and examination, and by promoting the highest standards for professionalism, lifelong learning, and the continuous certification of surgeons in practice. The VSB-ABS is responsible for setting the requirements for board certification in vascular surgery, including the creation and administration of the Vascular Surgery Qualifying (written) and Certifying (oral) Examinations. In addition, the VSB-ABS is responsible for the Vascular Surgery In-Training Examination and Maintenance of Certification (MOC) Examination. With the increasing number of graduates from vascular surgery training programs and the changing needs of our dynamic specialty, the VSB-ABS also is working on the following important initiatives.
Expansion of the VSB-ABS
The VSB-ABS currently consists of eight board members elected from the following four national vascular societies: the Society for Vascular Surgery, the Association of Program Directors in Vascular Surgery, the Society for Clinical Vascular Surgery, and the Vascular and Endovascular Surgery Society.
Maintenance of Certification
The American Board of Medical Specialties, the umbrella organization for all 24 medical specialty boards, established in 2003 that all of its member boards must adopt a continuous process of MOC.
In addition, each board was charged with developing requirements addressing each of these four areas: professional standing, lifelong learning and self-assessment, cognitive examination, and evaluation of performance in practice. While the ABS and VSB-ABS have sought to make MOC requirements as flexible as possible, we recognize that MOC needs improvement. Thousands of ABS diplomates were sent a survey this past fall regarding MOC so we could better understand the concerns of surgeons with the current process. The VSB-ABS recognizes these concerns and is currently considering various options to make MOC more relevant and convenient for vascular surgeons. Later this year, we anticipate sending a survey to better gain meaningful input specifically from vascular surgery diplomates regarding the need and options for change.
SCORE for Vascular Surgery
The VSB-ABS has also been hard at work in collaboration with the APDVS to produce SCORE for Vascular Surgery (“V-SCORE”), a structured curriculum for vascular surgery trainees using the SCORE Portal. SCORE for Vascular Surgery is being designed to emphasize the important topics that every vascular trainee should know and expect to be tested on. The curriculum outline is available at www.surgicalcore.org as a PDF document. The curriculum materials are available to vascular surgery training programs from the same website with a subscription and will be continuously updated to remain current.
Creation of a Certifying Examination Committee
This calendar year, a Certifying Examination Committee to write case scenarios and maintain updated images for the oral examination will be formed. This committee will be selected from a pool of qualified diplomates. The request for volunteers to be considered will be released shortly.
In summary, many changes are occurring in the structure and the activities of the VSB-ABS in order to have broader representation from the vascular community and be responsive to diplomate concerns, all the while maintaining a high standard for certification and recertification/MOC. Future regular updates from the VSB-ABS are planned to keep our diplomates informed.
Monthly lab testing for isotretinoin? No need, expert says
WAILEA, HAWAII – Many physicians perform laboratory monitoring monthly when prescribing isotretinoin for severe acne, but recent evidence indicates that’s excessive, according to Julie C. Harper, MD, president-elect of the American Acne and Rosacea Society.
She pointed to a meta-analysis of isotretinoin studies, which she called “a game changer” in her own dermatology practice in Birmingham, Ala.
The investigators published a meta-analysis of 26 studies including 1,574 isotretinoin-treated acne patients with serial laboratory values available (JAMA Dermatol. 2016 Jan;152[1]:35-44). They were particularly interested in patterns of elevation in triglycerides because that’s the most common lab abnormality associated with the use of isotretinoin. Indeed, the package insert states that, in the original clinical trials, one in four isotretinoin-treated patients developed high triglycerides.
The meta-analysis demonstrated that triglyceride levels rose by a mean of 45.3 mg/dL after 8 weeks on isotretinoin. Notably, however, the mean difference in triglycerides between baseline and 20 weeks was essentially the same at 45.6 mg/dL.
“Therefore, if you’re going to have a change in triglycerides, you’re going to have it early. If it’s good at week 8, it should be good at week 20. And if it’s not good at week 8, you probably ought to keep checking,” Dr. Harper said.
Similarly, there was no substantial late effect of isotretinoin on total cholesterol.
The investigators determined that they had insufficient data to draw conclusions regarding late changes in liver function tests. For guidance on that score, Dr. Harper turned to an earlier study of nearly 14,000 isotretinoin-treated patients led by Lee T. Zane, MD, a dermatologist at University of California, San Francisco, and medical director at Anacor.
Dr. Zane and his coinvestigators found that 1.5% of patients experienced a moderate elevation in transaminase levels, and no one experienced high-risk or grade 2 elevations in transaminases, triglycerides, or total cholesterol. Dr. Zane and his coinvestigators also concluded that monitoring white blood cells, platelets, and hemoglobin was meritless (Arch Dermatol. 2006 Aug;142[8]:1016-22).
“I’m not checking white blood cells, platelets, or hemoglobin. I check only triglycerides, total cholesterol, and hepatic function – and a pregnancy test, of course,” Dr. Harper said.
“I’ve practiced for 17 years,” she continued. “I’ve given a lot of people isotretinoin. And I would agree with Lee Zane – we don’t see elevated liver function tests very often with this drug, and when we do there’s often another explanation for why they’re high.”
In her own practice, when a patient on isotretinoin develops a high triglyceride approaching 300 mg/dL, the first thing she does is recheck it and make sure the patient is fasting. If it’s a true elevation, she pulls the dose back because this is a dose-related side effect. She also recommends that the patient begin taking fish oil supplements at a starting dose of 2 g/day. In a handful of refractory patients, she prescribes fenofibrate.
The exceptions she makes to her policy of no further lab testing if the first 2 months are problem free are patients with polycystic ovary syndrome, central obesity, or outright metabolic syndrome, since they are probably already at increased risk for developing lab abnormalities.
Dr. Harper said her acne patients are pleased with her change in practice regarding laboratory monitoring. Coming in for monthly blood work is inconvenient. And some patients really, really do not want to be stuck with a needle.
“We’re saving money, too,” she noted.
Dr. Harper wasn’t the only dermatologist who found the recent meta-analysis persuasive. The report was accompanied by an editorial by physicians uninvolved in the study entitled, “Isotretinoin Laboratory Test Monitoring – A Call to Decrease Testing in an Era of High-Value, Cost-Conscious Care” (JAMA Dermatol. 2016 Jan;152[1]:17-9).
She reported serving on speakers’ bureaus for Allergan, Bayer, Galderma, LaRoche-Posay, Promius, and Valeant.
SDEF and this news organization are owned by the same parent company.
WAILEA, HAWAII – Many physicians perform laboratory monitoring monthly when prescribing isotretinoin for severe acne, but recent evidence indicates that’s excessive, according to Julie C. Harper, MD, president-elect of the American Acne and Rosacea Society.
She pointed to a meta-analysis of isotretinoin studies, which she called “a game changer” in her own dermatology practice in Birmingham, Ala.
The investigators published a meta-analysis of 26 studies including 1,574 isotretinoin-treated acne patients with serial laboratory values available (JAMA Dermatol. 2016 Jan;152[1]:35-44). They were particularly interested in patterns of elevation in triglycerides because that’s the most common lab abnormality associated with the use of isotretinoin. Indeed, the package insert states that, in the original clinical trials, one in four isotretinoin-treated patients developed high triglycerides.
The meta-analysis demonstrated that triglyceride levels rose by a mean of 45.3 mg/dL after 8 weeks on isotretinoin. Notably, however, the mean difference in triglycerides between baseline and 20 weeks was essentially the same at 45.6 mg/dL.
“Therefore, if you’re going to have a change in triglycerides, you’re going to have it early. If it’s good at week 8, it should be good at week 20. And if it’s not good at week 8, you probably ought to keep checking,” Dr. Harper said.
Similarly, there was no substantial late effect of isotretinoin on total cholesterol.
The investigators determined that they had insufficient data to draw conclusions regarding late changes in liver function tests. For guidance on that score, Dr. Harper turned to an earlier study of nearly 14,000 isotretinoin-treated patients led by Lee T. Zane, MD, a dermatologist at University of California, San Francisco, and medical director at Anacor.
Dr. Zane and his coinvestigators found that 1.5% of patients experienced a moderate elevation in transaminase levels, and no one experienced high-risk or grade 2 elevations in transaminases, triglycerides, or total cholesterol. Dr. Zane and his coinvestigators also concluded that monitoring white blood cells, platelets, and hemoglobin was meritless (Arch Dermatol. 2006 Aug;142[8]:1016-22).
“I’m not checking white blood cells, platelets, or hemoglobin. I check only triglycerides, total cholesterol, and hepatic function – and a pregnancy test, of course,” Dr. Harper said.
“I’ve practiced for 17 years,” she continued. “I’ve given a lot of people isotretinoin. And I would agree with Lee Zane – we don’t see elevated liver function tests very often with this drug, and when we do there’s often another explanation for why they’re high.”
In her own practice, when a patient on isotretinoin develops a high triglyceride approaching 300 mg/dL, the first thing she does is recheck it and make sure the patient is fasting. If it’s a true elevation, she pulls the dose back because this is a dose-related side effect. She also recommends that the patient begin taking fish oil supplements at a starting dose of 2 g/day. In a handful of refractory patients, she prescribes fenofibrate.
The exceptions she makes to her policy of no further lab testing if the first 2 months are problem free are patients with polycystic ovary syndrome, central obesity, or outright metabolic syndrome, since they are probably already at increased risk for developing lab abnormalities.
Dr. Harper said her acne patients are pleased with her change in practice regarding laboratory monitoring. Coming in for monthly blood work is inconvenient. And some patients really, really do not want to be stuck with a needle.
“We’re saving money, too,” she noted.
Dr. Harper wasn’t the only dermatologist who found the recent meta-analysis persuasive. The report was accompanied by an editorial by physicians uninvolved in the study entitled, “Isotretinoin Laboratory Test Monitoring – A Call to Decrease Testing in an Era of High-Value, Cost-Conscious Care” (JAMA Dermatol. 2016 Jan;152[1]:17-9).
She reported serving on speakers’ bureaus for Allergan, Bayer, Galderma, LaRoche-Posay, Promius, and Valeant.
SDEF and this news organization are owned by the same parent company.
WAILEA, HAWAII – Many physicians perform laboratory monitoring monthly when prescribing isotretinoin for severe acne, but recent evidence indicates that’s excessive, according to Julie C. Harper, MD, president-elect of the American Acne and Rosacea Society.
She pointed to a meta-analysis of isotretinoin studies, which she called “a game changer” in her own dermatology practice in Birmingham, Ala.
The investigators published a meta-analysis of 26 studies including 1,574 isotretinoin-treated acne patients with serial laboratory values available (JAMA Dermatol. 2016 Jan;152[1]:35-44). They were particularly interested in patterns of elevation in triglycerides because that’s the most common lab abnormality associated with the use of isotretinoin. Indeed, the package insert states that, in the original clinical trials, one in four isotretinoin-treated patients developed high triglycerides.
The meta-analysis demonstrated that triglyceride levels rose by a mean of 45.3 mg/dL after 8 weeks on isotretinoin. Notably, however, the mean difference in triglycerides between baseline and 20 weeks was essentially the same at 45.6 mg/dL.
“Therefore, if you’re going to have a change in triglycerides, you’re going to have it early. If it’s good at week 8, it should be good at week 20. And if it’s not good at week 8, you probably ought to keep checking,” Dr. Harper said.
Similarly, there was no substantial late effect of isotretinoin on total cholesterol.
The investigators determined that they had insufficient data to draw conclusions regarding late changes in liver function tests. For guidance on that score, Dr. Harper turned to an earlier study of nearly 14,000 isotretinoin-treated patients led by Lee T. Zane, MD, a dermatologist at University of California, San Francisco, and medical director at Anacor.
Dr. Zane and his coinvestigators found that 1.5% of patients experienced a moderate elevation in transaminase levels, and no one experienced high-risk or grade 2 elevations in transaminases, triglycerides, or total cholesterol. Dr. Zane and his coinvestigators also concluded that monitoring white blood cells, platelets, and hemoglobin was meritless (Arch Dermatol. 2006 Aug;142[8]:1016-22).
“I’m not checking white blood cells, platelets, or hemoglobin. I check only triglycerides, total cholesterol, and hepatic function – and a pregnancy test, of course,” Dr. Harper said.
“I’ve practiced for 17 years,” she continued. “I’ve given a lot of people isotretinoin. And I would agree with Lee Zane – we don’t see elevated liver function tests very often with this drug, and when we do there’s often another explanation for why they’re high.”
In her own practice, when a patient on isotretinoin develops a high triglyceride approaching 300 mg/dL, the first thing she does is recheck it and make sure the patient is fasting. If it’s a true elevation, she pulls the dose back because this is a dose-related side effect. She also recommends that the patient begin taking fish oil supplements at a starting dose of 2 g/day. In a handful of refractory patients, she prescribes fenofibrate.
The exceptions she makes to her policy of no further lab testing if the first 2 months are problem free are patients with polycystic ovary syndrome, central obesity, or outright metabolic syndrome, since they are probably already at increased risk for developing lab abnormalities.
Dr. Harper said her acne patients are pleased with her change in practice regarding laboratory monitoring. Coming in for monthly blood work is inconvenient. And some patients really, really do not want to be stuck with a needle.
“We’re saving money, too,” she noted.
Dr. Harper wasn’t the only dermatologist who found the recent meta-analysis persuasive. The report was accompanied by an editorial by physicians uninvolved in the study entitled, “Isotretinoin Laboratory Test Monitoring – A Call to Decrease Testing in an Era of High-Value, Cost-Conscious Care” (JAMA Dermatol. 2016 Jan;152[1]:17-9).
She reported serving on speakers’ bureaus for Allergan, Bayer, Galderma, LaRoche-Posay, Promius, and Valeant.
SDEF and this news organization are owned by the same parent company.
STAS predictive for lung SCC recurrence
First described in 2015, tumor spread through air spaces is a recently recognized form of invasion in lung carcinoma, but it has not been well described in lung squamous cell carcinoma. However, a study out of Memorial Sloan-Kettering Cancer Center reports spread through air spaces (STAS) is one of the most significant histologic findings in lung squamous cell carcinoma (SCC).
In multivariable models for any recurrence and lung cancer–specific death, the researchers found that STAS was a significant independent predictor for both outcomes (P = .034 and .016, respectively).
“We found that STAS in lung SCC was associated with p-stage, lymphatic and vascular invasion, necrosis, larger nuclear diameter, increased mitoses and high Ki-67 labeling index,” wrote lead author Shaohua Lu, MD, and coauthors (J Thorac Oncol. 2017 Feb;12[2]:223-34). Their findings are based on an analysis of 445 patients who had resection for stage I-III SCC over a 10-year period ending in 2009.
The Sloan-Kettering Group previously reported that STAS was a predictor of recurrence in stage I lung adenocarcinoma patients who had a limited resection (J Thorac Oncol. 2015;10[5]:806-14), and others reported STAS was a clinically significant finding in the disease. In the latest study, Dr. Lu and colleagues set out to determine if STAS is associated with tumor aggressiveness in lung SCC by using a large cohort of patients who had lung SCC resection. The lung resections they studied are from the aforementioned 2015 study that used immunohistochemistry to confirm squamous differentiation in otherwise poorly differentiated tumors.
Two pathologists reviewed tumor slides and used Ki-67 staining to confirm squamous differentiation. The study population comprised 98% former smokers and the median age was 71.3; 76% (336) were older than 65.
Dr. Lu and colleagues noted how STAS in lung SCC differs from its presentation in lung adenocarcinoma. “In contrast to lung adenocarcinoma, in which STAS can manifest as micropapillary clusters, solid nests or single cells, all STAS lesions in lung SCCs consist of solid tumor cell nests,” they wrote.
They found that STAS was associated with a higher risk of recurrence in SCC patients who had lobectomy, but not sublobar resection, whereas in patients with lung adenocarcinoma STAS was associated with a high risk of recurrence if they had sublobar resection.
The study observed STAS in 132 patients (30%). With a median follow-up of 3.4 years, 61% (273) of all patients died in that time. STAS tumors were more aggressive in nature than were non-STAS tumors. Pathologic features strongly associated with STAS were lymphatic invasion (40% for STAS vs. 19% for non-STAS patients); vascular invasion (36% vs. 22%); larger tumor size (median 4 cm vs. 3 cm); higher Ki-67 labeling index (32% vs. 13%); and higher tumor stage (23% with p-stage I, 35% p-stage II, and 43% p-stage III), all significant differences. Patients with STAS also had a higher 5-year cumulative incidence of any recurrence (39% vs. 26%) and lung cancer-specific death (30% vs. 14%), both significant differences.
STAS has an “insidious pattern of tumor invasion” that can be difficult for pathologists to detect and requires the gathering of specimens that include the adjacent lung parenchyma, Dr. Lu and colleagues said. They also dispelled the myth that STAS is an ex vivo artifact. “STAS is morphologically different from tissue floaters and contaminant or extraneous tissues that can lead to diagnostic errors,” they said.
And while the study showed that STAS is an independent predictor of recurrence and cancer-specific death, it was not predictive of overall survival – perhaps because most of the study population was over age 65 and were more likely to die from other causes rather than lung cancer. “We found a strong correlation between STAS and high-grade morphologic patterns such as nuclear size, nuclear atypia, mitotic count and Ki-67 labeling index, suggesting that STAS is associated with tumor proliferation,” Dr. Lu and coauthors said.
“Because we found STAS to show greater prognostic significance than lymphatic vascular, and visceral pleural invasion, all of which are histologic features recommended to be recorded in pathology reports for lung cancer specimens, in the future, STAS may be appropriate to add to this list,” the researchers noted.
Dr. Lu and coauthors had no financial relationships to disclose.
STAS (spread through air spaces) has emerged as a harbinger of poor clinical behavior in adenocarcinoma of the lung. In this new manuscript, a team from Memorial Sloan-Kettering Cancer Center demonstrates that this phenomenon is evident in squamous cell cancer of the lung as well.
While the study needs to be replicated in other datasets, it demonstrates the power of careful pathologic examination in predicting tumor biology. The age old concept deserves renewed emphasis in the current era of ‘Omics’ of various kinds.
Sai Yendamuri, MD, is professor and chair of the department of thoracic surgery at Roswell Park Cancer Institute in Buffalo, N.Y., and is an associate medical editor for Thoracic Surgery News. He has no relevant disclosures.
STAS (spread through air spaces) has emerged as a harbinger of poor clinical behavior in adenocarcinoma of the lung. In this new manuscript, a team from Memorial Sloan-Kettering Cancer Center demonstrates that this phenomenon is evident in squamous cell cancer of the lung as well.
While the study needs to be replicated in other datasets, it demonstrates the power of careful pathologic examination in predicting tumor biology. The age old concept deserves renewed emphasis in the current era of ‘Omics’ of various kinds.
Sai Yendamuri, MD, is professor and chair of the department of thoracic surgery at Roswell Park Cancer Institute in Buffalo, N.Y., and is an associate medical editor for Thoracic Surgery News. He has no relevant disclosures.
STAS (spread through air spaces) has emerged as a harbinger of poor clinical behavior in adenocarcinoma of the lung. In this new manuscript, a team from Memorial Sloan-Kettering Cancer Center demonstrates that this phenomenon is evident in squamous cell cancer of the lung as well.
While the study needs to be replicated in other datasets, it demonstrates the power of careful pathologic examination in predicting tumor biology. The age old concept deserves renewed emphasis in the current era of ‘Omics’ of various kinds.
Sai Yendamuri, MD, is professor and chair of the department of thoracic surgery at Roswell Park Cancer Institute in Buffalo, N.Y., and is an associate medical editor for Thoracic Surgery News. He has no relevant disclosures.
First described in 2015, tumor spread through air spaces is a recently recognized form of invasion in lung carcinoma, but it has not been well described in lung squamous cell carcinoma. However, a study out of Memorial Sloan-Kettering Cancer Center reports spread through air spaces (STAS) is one of the most significant histologic findings in lung squamous cell carcinoma (SCC).
In multivariable models for any recurrence and lung cancer–specific death, the researchers found that STAS was a significant independent predictor for both outcomes (P = .034 and .016, respectively).
“We found that STAS in lung SCC was associated with p-stage, lymphatic and vascular invasion, necrosis, larger nuclear diameter, increased mitoses and high Ki-67 labeling index,” wrote lead author Shaohua Lu, MD, and coauthors (J Thorac Oncol. 2017 Feb;12[2]:223-34). Their findings are based on an analysis of 445 patients who had resection for stage I-III SCC over a 10-year period ending in 2009.
The Sloan-Kettering Group previously reported that STAS was a predictor of recurrence in stage I lung adenocarcinoma patients who had a limited resection (J Thorac Oncol. 2015;10[5]:806-14), and others reported STAS was a clinically significant finding in the disease. In the latest study, Dr. Lu and colleagues set out to determine if STAS is associated with tumor aggressiveness in lung SCC by using a large cohort of patients who had lung SCC resection. The lung resections they studied are from the aforementioned 2015 study that used immunohistochemistry to confirm squamous differentiation in otherwise poorly differentiated tumors.
Two pathologists reviewed tumor slides and used Ki-67 staining to confirm squamous differentiation. The study population comprised 98% former smokers and the median age was 71.3; 76% (336) were older than 65.
Dr. Lu and colleagues noted how STAS in lung SCC differs from its presentation in lung adenocarcinoma. “In contrast to lung adenocarcinoma, in which STAS can manifest as micropapillary clusters, solid nests or single cells, all STAS lesions in lung SCCs consist of solid tumor cell nests,” they wrote.
They found that STAS was associated with a higher risk of recurrence in SCC patients who had lobectomy, but not sublobar resection, whereas in patients with lung adenocarcinoma STAS was associated with a high risk of recurrence if they had sublobar resection.
The study observed STAS in 132 patients (30%). With a median follow-up of 3.4 years, 61% (273) of all patients died in that time. STAS tumors were more aggressive in nature than were non-STAS tumors. Pathologic features strongly associated with STAS were lymphatic invasion (40% for STAS vs. 19% for non-STAS patients); vascular invasion (36% vs. 22%); larger tumor size (median 4 cm vs. 3 cm); higher Ki-67 labeling index (32% vs. 13%); and higher tumor stage (23% with p-stage I, 35% p-stage II, and 43% p-stage III), all significant differences. Patients with STAS also had a higher 5-year cumulative incidence of any recurrence (39% vs. 26%) and lung cancer-specific death (30% vs. 14%), both significant differences.
STAS has an “insidious pattern of tumor invasion” that can be difficult for pathologists to detect and requires the gathering of specimens that include the adjacent lung parenchyma, Dr. Lu and colleagues said. They also dispelled the myth that STAS is an ex vivo artifact. “STAS is morphologically different from tissue floaters and contaminant or extraneous tissues that can lead to diagnostic errors,” they said.
And while the study showed that STAS is an independent predictor of recurrence and cancer-specific death, it was not predictive of overall survival – perhaps because most of the study population was over age 65 and were more likely to die from other causes rather than lung cancer. “We found a strong correlation between STAS and high-grade morphologic patterns such as nuclear size, nuclear atypia, mitotic count and Ki-67 labeling index, suggesting that STAS is associated with tumor proliferation,” Dr. Lu and coauthors said.
“Because we found STAS to show greater prognostic significance than lymphatic vascular, and visceral pleural invasion, all of which are histologic features recommended to be recorded in pathology reports for lung cancer specimens, in the future, STAS may be appropriate to add to this list,” the researchers noted.
Dr. Lu and coauthors had no financial relationships to disclose.
First described in 2015, tumor spread through air spaces is a recently recognized form of invasion in lung carcinoma, but it has not been well described in lung squamous cell carcinoma. However, a study out of Memorial Sloan-Kettering Cancer Center reports spread through air spaces (STAS) is one of the most significant histologic findings in lung squamous cell carcinoma (SCC).
In multivariable models for any recurrence and lung cancer–specific death, the researchers found that STAS was a significant independent predictor for both outcomes (P = .034 and .016, respectively).
“We found that STAS in lung SCC was associated with p-stage, lymphatic and vascular invasion, necrosis, larger nuclear diameter, increased mitoses and high Ki-67 labeling index,” wrote lead author Shaohua Lu, MD, and coauthors (J Thorac Oncol. 2017 Feb;12[2]:223-34). Their findings are based on an analysis of 445 patients who had resection for stage I-III SCC over a 10-year period ending in 2009.
The Sloan-Kettering Group previously reported that STAS was a predictor of recurrence in stage I lung adenocarcinoma patients who had a limited resection (J Thorac Oncol. 2015;10[5]:806-14), and others reported STAS was a clinically significant finding in the disease. In the latest study, Dr. Lu and colleagues set out to determine if STAS is associated with tumor aggressiveness in lung SCC by using a large cohort of patients who had lung SCC resection. The lung resections they studied are from the aforementioned 2015 study that used immunohistochemistry to confirm squamous differentiation in otherwise poorly differentiated tumors.
Two pathologists reviewed tumor slides and used Ki-67 staining to confirm squamous differentiation. The study population comprised 98% former smokers and the median age was 71.3; 76% (336) were older than 65.
Dr. Lu and colleagues noted how STAS in lung SCC differs from its presentation in lung adenocarcinoma. “In contrast to lung adenocarcinoma, in which STAS can manifest as micropapillary clusters, solid nests or single cells, all STAS lesions in lung SCCs consist of solid tumor cell nests,” they wrote.
They found that STAS was associated with a higher risk of recurrence in SCC patients who had lobectomy, but not sublobar resection, whereas in patients with lung adenocarcinoma STAS was associated with a high risk of recurrence if they had sublobar resection.
The study observed STAS in 132 patients (30%). With a median follow-up of 3.4 years, 61% (273) of all patients died in that time. STAS tumors were more aggressive in nature than were non-STAS tumors. Pathologic features strongly associated with STAS were lymphatic invasion (40% for STAS vs. 19% for non-STAS patients); vascular invasion (36% vs. 22%); larger tumor size (median 4 cm vs. 3 cm); higher Ki-67 labeling index (32% vs. 13%); and higher tumor stage (23% with p-stage I, 35% p-stage II, and 43% p-stage III), all significant differences. Patients with STAS also had a higher 5-year cumulative incidence of any recurrence (39% vs. 26%) and lung cancer-specific death (30% vs. 14%), both significant differences.
STAS has an “insidious pattern of tumor invasion” that can be difficult for pathologists to detect and requires the gathering of specimens that include the adjacent lung parenchyma, Dr. Lu and colleagues said. They also dispelled the myth that STAS is an ex vivo artifact. “STAS is morphologically different from tissue floaters and contaminant or extraneous tissues that can lead to diagnostic errors,” they said.
And while the study showed that STAS is an independent predictor of recurrence and cancer-specific death, it was not predictive of overall survival – perhaps because most of the study population was over age 65 and were more likely to die from other causes rather than lung cancer. “We found a strong correlation between STAS and high-grade morphologic patterns such as nuclear size, nuclear atypia, mitotic count and Ki-67 labeling index, suggesting that STAS is associated with tumor proliferation,” Dr. Lu and coauthors said.
“Because we found STAS to show greater prognostic significance than lymphatic vascular, and visceral pleural invasion, all of which are histologic features recommended to be recorded in pathology reports for lung cancer specimens, in the future, STAS may be appropriate to add to this list,” the researchers noted.
Dr. Lu and coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC ONCOLOGY
Key clinical point: Spread through air spaces (STAS) is a prognostic histologic finding in lung squamous cell carcinoma.
Major finding: STAS was observed in 30% of patients and frequency increased with age.
Data source: Retrospective analysis of 445 resections for solitary stage I-III lung squamous cell carcinoma at Memorial Sloan-Kettering Cancer Center between 1999 and 2009.
Disclosure: Dr. Lu and coauthors reported having no relevant financial disclosures.
Morris Levin, MD
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The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
HCV testing stagnant among baby boomers
Despite the urging of the United States Preventive Services Task Force and other organizations in 2013, the percentage of baby boomers who underwent testing for hepatitis C (HCV) infection had barely changed 2 years later – from 12.3% in 2013 to 13.8% in 2015.
The numbers are particularly troubling because new and improved antiviral drugs offer cures that could forestall liver cancer, cirrhosis, and other potential complications, with shorter regimens and fewer side effects than older regimens.
Other reactions were more forceful. “Kind of pathetic, isn’t it?” said John D. Scott, MD, assistant director of the Hepatitis and Liver Clinic at Harborview Medical Center, and an associate professor of medicine at the University of Washington, Seattle.
The researchers analyzed 2013 and 2015 data from the National Health Interview Survey, which included records for 21,827 baby boomers with HCV testing data.
The slight increase overall of 12.3% to 13.8% was small but also statistically significant (P = .013). Some populations fared better: Compared with the privately insured, those with Medicare plus Medicaid were more likely to have been tested (prevalence ratio, 1.83; 95% confidence interval, 1.32-2.53), as were those only on Medicaid (PR, 1.35; 95% CI, 1.04-1.76), and those with military insurance (PR, 1.62; 95% CI, 1.16-2.26).
The study could be subject to recall bias, since it relied on participants’ self-reports.
The authors speculate that the higher prevalence of testing in those with military insurance may reflect efforts by the Veterans Health Administration to reduce the high prevalence of HCV-associated disease among veterans.
It’s entirely possible to increase testing rates, according to Dr. Scott, who has a grant from the Centers for Disease Control and Prevention to study ways to increase uptake. “Probably the easiest thing to do is just incorporate this information into your electronic medical record and make it part of your alerts and standard preventative practices. Try to automate a lot of this rather than remind a very busy primary care doctor of all the things they have to do,” he said.
For example, one strategy that Seattle’s King County has employed is to automatically notify the testing laboratory if an antibody test is positive. “The lab knows to keep that blood and run a second (nucleic acid) test without the patient having to come back. That has helped to get our confirmatory rates up,” said Dr. Scott.
More broadly, the importance of testing needs to be emphasized, according to Paul J. Thuluvath, MD, medical director at the Institute of Digestive Health and Liver Disease at Mercy Medical Center, Baltimore, and a professor of medicine and surgery at the University of Maryland. “We need everybody to buy into this: the primary care physicians, internists, and gynecologists. If they are not convinced of the importance of this, it’s not going to happen. And I don’t think many primary care physicians and internists are convinced yet,” he said.
AGA Resource
Through the HCV Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c
Despite the urging of the United States Preventive Services Task Force and other organizations in 2013, the percentage of baby boomers who underwent testing for hepatitis C (HCV) infection had barely changed 2 years later – from 12.3% in 2013 to 13.8% in 2015.
The numbers are particularly troubling because new and improved antiviral drugs offer cures that could forestall liver cancer, cirrhosis, and other potential complications, with shorter regimens and fewer side effects than older regimens.
Other reactions were more forceful. “Kind of pathetic, isn’t it?” said John D. Scott, MD, assistant director of the Hepatitis and Liver Clinic at Harborview Medical Center, and an associate professor of medicine at the University of Washington, Seattle.
The researchers analyzed 2013 and 2015 data from the National Health Interview Survey, which included records for 21,827 baby boomers with HCV testing data.
The slight increase overall of 12.3% to 13.8% was small but also statistically significant (P = .013). Some populations fared better: Compared with the privately insured, those with Medicare plus Medicaid were more likely to have been tested (prevalence ratio, 1.83; 95% confidence interval, 1.32-2.53), as were those only on Medicaid (PR, 1.35; 95% CI, 1.04-1.76), and those with military insurance (PR, 1.62; 95% CI, 1.16-2.26).
The study could be subject to recall bias, since it relied on participants’ self-reports.
The authors speculate that the higher prevalence of testing in those with military insurance may reflect efforts by the Veterans Health Administration to reduce the high prevalence of HCV-associated disease among veterans.
It’s entirely possible to increase testing rates, according to Dr. Scott, who has a grant from the Centers for Disease Control and Prevention to study ways to increase uptake. “Probably the easiest thing to do is just incorporate this information into your electronic medical record and make it part of your alerts and standard preventative practices. Try to automate a lot of this rather than remind a very busy primary care doctor of all the things they have to do,” he said.
For example, one strategy that Seattle’s King County has employed is to automatically notify the testing laboratory if an antibody test is positive. “The lab knows to keep that blood and run a second (nucleic acid) test without the patient having to come back. That has helped to get our confirmatory rates up,” said Dr. Scott.
More broadly, the importance of testing needs to be emphasized, according to Paul J. Thuluvath, MD, medical director at the Institute of Digestive Health and Liver Disease at Mercy Medical Center, Baltimore, and a professor of medicine and surgery at the University of Maryland. “We need everybody to buy into this: the primary care physicians, internists, and gynecologists. If they are not convinced of the importance of this, it’s not going to happen. And I don’t think many primary care physicians and internists are convinced yet,” he said.
AGA Resource
Through the HCV Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c
Despite the urging of the United States Preventive Services Task Force and other organizations in 2013, the percentage of baby boomers who underwent testing for hepatitis C (HCV) infection had barely changed 2 years later – from 12.3% in 2013 to 13.8% in 2015.
The numbers are particularly troubling because new and improved antiviral drugs offer cures that could forestall liver cancer, cirrhosis, and other potential complications, with shorter regimens and fewer side effects than older regimens.
Other reactions were more forceful. “Kind of pathetic, isn’t it?” said John D. Scott, MD, assistant director of the Hepatitis and Liver Clinic at Harborview Medical Center, and an associate professor of medicine at the University of Washington, Seattle.
The researchers analyzed 2013 and 2015 data from the National Health Interview Survey, which included records for 21,827 baby boomers with HCV testing data.
The slight increase overall of 12.3% to 13.8% was small but also statistically significant (P = .013). Some populations fared better: Compared with the privately insured, those with Medicare plus Medicaid were more likely to have been tested (prevalence ratio, 1.83; 95% confidence interval, 1.32-2.53), as were those only on Medicaid (PR, 1.35; 95% CI, 1.04-1.76), and those with military insurance (PR, 1.62; 95% CI, 1.16-2.26).
The study could be subject to recall bias, since it relied on participants’ self-reports.
The authors speculate that the higher prevalence of testing in those with military insurance may reflect efforts by the Veterans Health Administration to reduce the high prevalence of HCV-associated disease among veterans.
It’s entirely possible to increase testing rates, according to Dr. Scott, who has a grant from the Centers for Disease Control and Prevention to study ways to increase uptake. “Probably the easiest thing to do is just incorporate this information into your electronic medical record and make it part of your alerts and standard preventative practices. Try to automate a lot of this rather than remind a very busy primary care doctor of all the things they have to do,” he said.
For example, one strategy that Seattle’s King County has employed is to automatically notify the testing laboratory if an antibody test is positive. “The lab knows to keep that blood and run a second (nucleic acid) test without the patient having to come back. That has helped to get our confirmatory rates up,” said Dr. Scott.
More broadly, the importance of testing needs to be emphasized, according to Paul J. Thuluvath, MD, medical director at the Institute of Digestive Health and Liver Disease at Mercy Medical Center, Baltimore, and a professor of medicine and surgery at the University of Maryland. “We need everybody to buy into this: the primary care physicians, internists, and gynecologists. If they are not convinced of the importance of this, it’s not going to happen. And I don’t think many primary care physicians and internists are convinced yet,” he said.
AGA Resource
Through the HCV Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c
FROM AMERICAN JOURNAL OF PREVENTIVE MEDICINE
Immunotherapy boosts OS from metastatic cervical cancer in early trial
NATIONAL HARBOR, MD – An investigational targeted immunotherapy led to a 52% improvement in overall survival, compared with pooled historical data, among patients with previously treated metastatic cervical cancer.
Patients in the phase II trial who received axalimogene filolisbac (AXAL) had a 12-month overall survival (OS) rate of 38%, which significantly exceeded the predicted rate of 25% had they gone untreated (P = .02), Charles Leath, MD, said during a late-breaking presentation at the annual meeting of the Society of Gynecologic Oncology. Investigators are now recruiting for a placebo-controlled phase III trial of AXAL in the adjuvant setting, he said.
In a previous trial in India, therapy with AXAL was associated with a 12-month OS of 34% among patients with persistent or recurrent metastatic cervical cancer. For the current trial, 50 women with persistent or recurrent metastatic cervical cancer despite prior systemic therapy received intravenous AXAL (1 x 109 CFU) every 28 days for up to three doses or until disease progression. Patients had a median age of 46 years, and most had a Gynecologic Oncology Group (GOG) performance status of 0. Most patients had received at least two previous lines of treatment, more than half had received bevacizumab, and 86% had received pelvic radiation, Dr. Leath reported.
Median overall survival time was 6.2 months (95% confidence interval, 4.4-12.3 months), and 44% of patients progressed on therapy, while 30% had stable disease. The only complete response occurred in a patient with squamous cell carcinoma of the cervix who developed pelvic recurrence 7 years after undergoing radical hysterectomy. She received paclitaxel/carboplatin, bevacizumab, and pelvic radiation, and her cancer recurred 1 year later. She subsequently received three intravenous doses of AXAL and has survived 18.5 months so far, Dr. Leath said.
Treatment-related adverse events affected 96% of patients, and usually consisted of grade 1 or 2 fatigue, chills, anemia, nausea, and fever. A total of 36% of patients had grade 3 treatment-related adverse events, of which anemia was the most common. One patient developed grade 4 hypotension that was considered probably related to treatment, and one patient developed grade 4 Klebsiella pneumonia and sepsis deemed possibly related to treatment.
The survival curve dropped off steeply at first and then had a long tail, reflecting the delayed effects of immunotherapy, Dr. Leath commented. For the phase III trial, patients with high-risk cervical cancer will receive at least 3 weeks of cisplatin and external beam radiation therapy before being randomly assigned to either intravenous AXAL (1 x 109 CFU) or placebo for up to 1 year, he added.
The trial was funded by the Gynecologic Oncology Group, Advaxis, and the National Cancer Institute. Dr. Leath disclosed grant funding from Celsion, Novartis, Astra Zeneca, and Plexikkon, and disclosed honoraria or reimbursements from Celsion and Genentech/Roche.
NATIONAL HARBOR, MD – An investigational targeted immunotherapy led to a 52% improvement in overall survival, compared with pooled historical data, among patients with previously treated metastatic cervical cancer.
Patients in the phase II trial who received axalimogene filolisbac (AXAL) had a 12-month overall survival (OS) rate of 38%, which significantly exceeded the predicted rate of 25% had they gone untreated (P = .02), Charles Leath, MD, said during a late-breaking presentation at the annual meeting of the Society of Gynecologic Oncology. Investigators are now recruiting for a placebo-controlled phase III trial of AXAL in the adjuvant setting, he said.
In a previous trial in India, therapy with AXAL was associated with a 12-month OS of 34% among patients with persistent or recurrent metastatic cervical cancer. For the current trial, 50 women with persistent or recurrent metastatic cervical cancer despite prior systemic therapy received intravenous AXAL (1 x 109 CFU) every 28 days for up to three doses or until disease progression. Patients had a median age of 46 years, and most had a Gynecologic Oncology Group (GOG) performance status of 0. Most patients had received at least two previous lines of treatment, more than half had received bevacizumab, and 86% had received pelvic radiation, Dr. Leath reported.
Median overall survival time was 6.2 months (95% confidence interval, 4.4-12.3 months), and 44% of patients progressed on therapy, while 30% had stable disease. The only complete response occurred in a patient with squamous cell carcinoma of the cervix who developed pelvic recurrence 7 years after undergoing radical hysterectomy. She received paclitaxel/carboplatin, bevacizumab, and pelvic radiation, and her cancer recurred 1 year later. She subsequently received three intravenous doses of AXAL and has survived 18.5 months so far, Dr. Leath said.
Treatment-related adverse events affected 96% of patients, and usually consisted of grade 1 or 2 fatigue, chills, anemia, nausea, and fever. A total of 36% of patients had grade 3 treatment-related adverse events, of which anemia was the most common. One patient developed grade 4 hypotension that was considered probably related to treatment, and one patient developed grade 4 Klebsiella pneumonia and sepsis deemed possibly related to treatment.
The survival curve dropped off steeply at first and then had a long tail, reflecting the delayed effects of immunotherapy, Dr. Leath commented. For the phase III trial, patients with high-risk cervical cancer will receive at least 3 weeks of cisplatin and external beam radiation therapy before being randomly assigned to either intravenous AXAL (1 x 109 CFU) or placebo for up to 1 year, he added.
The trial was funded by the Gynecologic Oncology Group, Advaxis, and the National Cancer Institute. Dr. Leath disclosed grant funding from Celsion, Novartis, Astra Zeneca, and Plexikkon, and disclosed honoraria or reimbursements from Celsion and Genentech/Roche.
NATIONAL HARBOR, MD – An investigational targeted immunotherapy led to a 52% improvement in overall survival, compared with pooled historical data, among patients with previously treated metastatic cervical cancer.
Patients in the phase II trial who received axalimogene filolisbac (AXAL) had a 12-month overall survival (OS) rate of 38%, which significantly exceeded the predicted rate of 25% had they gone untreated (P = .02), Charles Leath, MD, said during a late-breaking presentation at the annual meeting of the Society of Gynecologic Oncology. Investigators are now recruiting for a placebo-controlled phase III trial of AXAL in the adjuvant setting, he said.
In a previous trial in India, therapy with AXAL was associated with a 12-month OS of 34% among patients with persistent or recurrent metastatic cervical cancer. For the current trial, 50 women with persistent or recurrent metastatic cervical cancer despite prior systemic therapy received intravenous AXAL (1 x 109 CFU) every 28 days for up to three doses or until disease progression. Patients had a median age of 46 years, and most had a Gynecologic Oncology Group (GOG) performance status of 0. Most patients had received at least two previous lines of treatment, more than half had received bevacizumab, and 86% had received pelvic radiation, Dr. Leath reported.
Median overall survival time was 6.2 months (95% confidence interval, 4.4-12.3 months), and 44% of patients progressed on therapy, while 30% had stable disease. The only complete response occurred in a patient with squamous cell carcinoma of the cervix who developed pelvic recurrence 7 years after undergoing radical hysterectomy. She received paclitaxel/carboplatin, bevacizumab, and pelvic radiation, and her cancer recurred 1 year later. She subsequently received three intravenous doses of AXAL and has survived 18.5 months so far, Dr. Leath said.
Treatment-related adverse events affected 96% of patients, and usually consisted of grade 1 or 2 fatigue, chills, anemia, nausea, and fever. A total of 36% of patients had grade 3 treatment-related adverse events, of which anemia was the most common. One patient developed grade 4 hypotension that was considered probably related to treatment, and one patient developed grade 4 Klebsiella pneumonia and sepsis deemed possibly related to treatment.
The survival curve dropped off steeply at first and then had a long tail, reflecting the delayed effects of immunotherapy, Dr. Leath commented. For the phase III trial, patients with high-risk cervical cancer will receive at least 3 weeks of cisplatin and external beam radiation therapy before being randomly assigned to either intravenous AXAL (1 x 109 CFU) or placebo for up to 1 year, he added.
The trial was funded by the Gynecologic Oncology Group, Advaxis, and the National Cancer Institute. Dr. Leath disclosed grant funding from Celsion, Novartis, Astra Zeneca, and Plexikkon, and disclosed honoraria or reimbursements from Celsion and Genentech/Roche.
Key clinical point. Treatment with axalimogene filolisbac led to a 52% improvement in overall survival, compared with pooled historical data, in previously treated patients with metastatic cervical cancer.
Major finding: Twelve-month overall survival was 38%, significantly greater than the modeled prediction of 25% had patients gone untreated (P = .02).
Data source: A multicenter phase II trial of 50 patients with previously treated metastatic cervical cancer.
Disclosures: The study was supported by the Gynecologic Oncology Group, Advaxis, and the National Cancer Institute. Dr. Leath disclosed grant funding from Celsion, Novartis, Astra Zeneca, and Plexikkon, and honoraria or reimbursements from Celsion and Genentech/Roche.
