15 minute read
Updates From the Society of Surgical Oncology
All articles by KATE O’ROURKE
Nivolumab Shows Promise for Resected Esophageal, GE Junction Cancers
Adjuvant nivolumab is the first therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival in patients with resected esophageal and gastroesophageal junction cancer. This news comes from research presented at the Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care (abstract 94).
“The risk of recurrence after neoadjuvant chemoradiation therapy followed by surgery (trimodality therapy) remains high in esophageal or gastroesophageal junction cancer and there is no established adjuvant treatment,” said Guillaume Piessen, MD, PhD, of the University of Lille, Claude Huriez University Hospital, in Lille, France, who presented the findings. Nivolumab (Opdivo, Bristol Myers Squibb) offers a new standard of care in these patients, Dr. Piessen said.
The findings come from the CheckMate 577 trial, which is the first global, phase 3, randomized, doubleblind study to report the efficacy and safety of a checkpoint inhibitor in the adjuvant setting after trimodality therapy for esophageal or gastroesophageal junction cancer (N Engl J Med 2021;384:1191-1203).
The trial enrolled 794 adults, of whom 532 received nivolumab and 262 were given placebo. Patients who had resected stage II/III esophageal/gastroesophageal junction cancer and received neoadjuvant chemoradiation therapy and had residual pathologic disease were randomized 2:1 to nivolumab 240 mg or placebo every two weeks for 16 weeks, followed by nivolumab 480 mg or placebo every four weeks. Maximum treatment duration was one year. The primary end point was diseasefree survival.
Approximately 70% of patients had adenocarcinoma and almost 60% had a pathologic lymph node status of ypN1 or higher in both groups. Patients receiving nivolumab were predominantly male (84%) and white (81%), with an Eastern Cooperative Oncology Group (or ECOG) performance status of 0 (58%). They also had predominantly stage III disease (66%) and received a diagnosis of adenocarcinoma (71%). The median age was 62 years.
At a prespecified interim analysis, adjuvant nivolumab was significantly associated with improvement in DFS versus placebo (hazard ratio, 0.69; 96.4% CI, 0.560.86; P=0.0003). Median disease-free survival was doubled. Most treatment-related adverse events were grade 1 or 2. The incidence of serious adverse reactions leading to discontinuation was 9% or lower with nivolumab and 3% with placebo. The majority of treatment-related adverse events with an immunologic etiology were low grade, with grade 3/4 events occurring in fewer than 1% of patients in the nivolumab group.
Based on the promising data from the trial, the FDA accepted the supplemental Biologics License Application for nivolumab for the treatment of patients with resected esophageal/gastroesophageal junction cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy. The agency also granted the application priority review.
Medicaid Expansion Associated With Earlier Diagnosis of Gastric Cancer
According to research presented at the Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care, Medicaid expansion caused a decrease in uninsured patients and led to an earlier diagnosis of gastric cancer with an associated increase in oneyear survival (abstract 95).
“Increased health care access may be associated with a shift toward earlier diagnosis with improved outcomes in gastric cancer,” said study author Clara Zhu, MD, of Cooper University Health Care in Camden, N.J., who presented the findings.
According to Dr. Zhu, the 2014 Medicaid expansion was intended to improve patient access to care. Some states elected to expand Medicaid, while others opted not to expand the program. Dr. Zhu and her colleagues hypothesized that Medicaid expansion was associated with earlier diagnosis and improved outcomes in gastric cancer.
To find out, Dr. Zhu’s research team turned to the National Cancer Database to identify patients with a new primary diagnosis of gastric cancer between 2006 and 2016. The researchers compared states that expanded Medicaid in 2014 to those that did not, excluding states that expanded earlier or later than 2014 and patients older than 64 years. Her research compared the pre- and post-expansion intervals 2012-2013 and 2015-2016.
The study cohort included 20,639 patients. Expansion states demonstrated a significant reduction in uninsured patients from 7.0% to 2.7% (P<0.01) compared with non-expansion states (14.2%-10.9%; P=not significant [NS]).
The researchers identified an increase in patients diagnosed with stage 0 to II gastric cancer from 38% to 41.5% (P<0.01) in expansion states, but found no change at 38.9% in nonexpansion states. Patients 50 years of age and older diagnosed with stage 0 to II gastric cancer increased in expansion states from 38.2% to 42.5% (P<0.01), and in non-expansion states from 39.3% to 39.9% (P=NS). Uninsured and Medicaid patients diagnosed with stage 0 to II gastric cancer increased in expansion states from 32.4% to 37.8% (P=0.01), and decreased in nonexpansion states from 29.7% to 27.3% (P=NS).
Patients receiving treatment rose from 91.6% to 92.2% in expansion states (P=0.01) and from 89.6% to 89.7 (P=NS) in non-expansion states. Rates of treatment for uninsured and Medicaid patients rose in 87.0% to 90.3% in expansion states (P=0.01) and from 83.9% to 84.9% in nonexpansion states (P=NS). Twelve-month survival for patients in expansion states rose from 68.1% to 70.6% (P=0.03), but decreased from 65.2% to 65.1% (P=NS) in non-expansion states.
DCIS Biological Risk Signature Predicts Recurrence, Radiation Benefit
Women with ductal carcinoma in situ and elevated commercial DCISion scores (DS) had a significantly higher risk for ipsilateral breast events and a greater relative benefit from radiation therapy than women with lower scores. These findings come from research recently presented at the Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care (abstract 5).
Radiation therapy after breast-conserving surgery for DCIS is known to reduce the risk for ipsilateral breast events without altering survival, but its use varies widely due to differing assessments of the risk–benefit ratio. Precise assessment of postsurgical radiation therapy benefit would allow individualized treatment decisions.
In the new study, Bruce Mann, MBBS, PhD, FRACS, of Royal Melbourne Hospital, in Victoria, Australia, and his colleagues conducted a validation of a commercially available biological risk signature, DCISionRT (PreludeDx), to assess ipsilateral breast events risk after breast-conserving surgery and the benefit of radiation therapy.
Using a retrospective Australian cohort, Dr. Mann identified 183 women with DCIS who met eligibility criteria. Medical records were reviewed to collect data on treatment and outcomes, and tissue specimens were provided to the PreludeDx CLIA lab for blinded testing of a panel of biomarkers (HER2, PR, Ki-67, COX2, p16/INK4, FOXA1 and SIAH2) scored by board-certified pathologists, and determination of the patented DS.
The researchers used a multivariate Cox proportional hazards analysis to assess the prognostic effect of DS for ipsilateral breast events risk. They adjusted for adjuvant treatments. The predictive effect of DS for radiation therapy benefit on ipsilateral breast events was assessed by the multivariate analysis, including the radiation therapy‒DS interaction.
Of the 183 women in the study, 72 received radiation therapy and 66 received endocrine therapy. The total cohort had a five-year ipsilateral breast events risk of 10%. By treatment group, women given radiation therapy had a 4% risk and those treated without radiation therapy had a 14% risk. Among patients treated without radiation therapy, those with a low DS had a 7% rate of ipsilateral events, while those with elevated DS had a 23% rate.
After breast-conserving surgery without endocrine therapy, patients with low DS had a nonsignificant difference of 2% with and without radiation therapy, while those with elevated DS had a highly significant 27% difference, indicating tumor radiation sensitivity. Findings were similar when all patients were included—2% and 20% absolute differences with radiation therapy.
“This validation in a contemporary cohort supports previous findings that DCISionRT provides prognostic and predictive information to allow personalized treatment decisions,” Dr. Mann said. ■
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Create Training and Educational Videos
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Use Professional Video Effects
ATEM Mini is really a professional broadcast switcher used by television stations. This means it has professional effects such as a DVE for picture in picture effects commonly used for commentating over a computer slide show. There are titles for presenter names, wipe effects for transitioning between sources and a green screen keyer for replacing backgrounds with graphics! Live Stream Training and Conferences
The ATEM Mini Pro model has a built in hardware streaming engine for live streaming via its ethernet connection. This means you can live stream to YouTube, Facebook and Twitch in much better quality and with perfectly smooth motion. You can even connect a hard disk or flash storage to the USB connection and record your stream for upload later!
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GSN Welcomes New Board Member, Melissa Red Hoffman, MD
Melissa Red Hoffman, MD, NP, FACS initially trained and worked as a naturopathic physician and yoga teacher. She then attended medical school at Oregon Health & Science University, in Portland; completed a residency in general surgery at Maricopa Medical Center, in Phoenix; and completed a fellowship in surgical critical care at the University of North Carolina at Chapel Hill, and a second fellowship in hospice and palliative medicine through Mountain Area Health and Education Center, in Asheville, N.C. She now practices as an acute care surgeon at Mission Hospital and as an inpatient hospice physician at the John C. Keever Solace Center, both in Asheville.
Dr. Hoffman is an adjunct assistant professor in the Department of Surgery at UNC and serves as the surgery clerkship director for UNC School of Medicine Asheville campus. Her clinical interests are in surgical palliative care, the care of surgical patients with substance use disorder and medical education. She is the founder and host of The Surgical Palliative Care Podcast, and has been a guest on multiple podcasts, including Behind the Knife, the GeriPal Podcast and the EAST Traumacast, discussing the integration of palliative medicine into the care of surgical patients.
Dr. Hoffman authors a bimonthly column in General Surgery News, The Surgical Pause, which focuses on surgical palliative care, and her writing has also appeared in JAMA, KevinMD and Doximity. She is happy to chat with or mentor anyone who is interested in palliative care. You can learn more about her on her website www.redhoffmanmd.com and follow her on Twitter @redMDND and @surgpallcare.
Public Perceptions on Resident Participation
LETTER TO THE EDITOR
To the Editor:
[Re: “Public Perceptions,” March 2021, page 3]
I very much enjoyed this most important and insightful editorial by Dr. Frederick Greene on the perceptions of the American public concerning resident participation in surgical care. The well-described wide spectrum of tolerance of trainee participation by patients in their surgical care is an age-old issue, but deserves fresh discussion, particularly in light of the new paradigms in surgical training.
Academic training programs have the immense responsibility of producing a competent, safe and dedicated workforce needed to meet the varied and complex needs of our surgical patients. Over the past few decades, socioeconomic, regulatory and generational pressures have made this task increasingly difficult, mainly through reductions in resident operative experience and autonomy. Surgery, not unlike many other professions, such as airline piloting, is a physical discipline that requires repetitive practice, graded responsibility and autonomy to reach the desired goal of competency. Although the current sophistication of simulators and like teaching aides are helpful, there is absolutely no substitute for real operative experience to gain the skills and judgment needed to safely practice this most complex and demanding art. Any further limitations or reductions of this most critical part of training will significantly limit overall competency and the safe delivery of surgical care to our patients.
I have had the immense privilege of working in both private and academic practice, and have participated in residency operative training at all levels of surgical sophistication. Assuming adequate supervision and a procedure tailored to the level of the resident’s skill, I have found that resident participation is safe, and in no way reduces the quality of the conduct of the procedure. Quite honestly, residents often enhance the quality of the experience with their elevated academic thoughts, questions and perspectives. Furthermore, I am aware of no serious study that has found an increase in complications or diminutive outcome rate with resident participation in surgery.
Therefore, I firmly believe that resident participation in surgery is safe, that it frequently elevates the quality of care, and that it is an essential societal requirement for the production of competent surgeons and the future quality of surgical care for all our patients. I agree with Dr. Greene that our profession needs to undertake a vigorous campaign to educate the populous as to the importance, safety and benefits of resident surgical participation in academic surgical training. James K. Elsey, MD, FACS Professor of Surgery, Medical University of South Carolina, Charleston
The Scientific Greats: A Series of Drawings
By MOISES MENENDEZ, MD, FACS
William Thomas Green Morton (1819-1868)
William Thomas Morton was an American dentist who first publicly demonstrated the use of inhaled ether as a surgical anesthetic in 1846. The promotion of his questionable claim to have been the discoverer of anesthesia became an obsession for the rest of his life. Of all milestones and achievements in medicine, conquering pain must be one of the very few that has potentially affected every human being in the world. It was in 1846 when one of mankind’s greatest fears, the pain of surgery, was eliminated.
In the autumn of 1844, Dr. Morton entered Harvard Medical School and attended the chemistry lectures of Charles T. Jackson, who introduced Dr. Morton to the anesthetic properties of ether. Dr. Morton then left Harvard without graduating. On Sept. 30, 1846, he performed a painless tooth extraction after administering ether to a patient. Upon reading a favorable newspaper account of this event, Boston surgeon Henry Jacob Bigelow arranged for a now-famous demonstration of ether on Oct. 16, 1846, in the OR of Massachusetts General Hospital (MGH). At this demonstration, John Collins Warren painlessly removed a tumor from the neck of Edward Gilbert Abbott.
News of this use of ether spread rapidly around the world, and the first recorded use of ether outside the United Sates took place in London, by dentist James Robinson in a tooth extraction at the home of Francis Boote, an American doctor who had heard of Drs. Morton’s and Bigelow’s demonstrations. The MGH OR became known as the Ether Dome, and has been preserved as a monument to this historic event. Following the demonstration, Dr. Morton tried to hide the identity of the substance Mr. Abbott had inhaled, by referring to it as “Letheon,” but it soon was found to be ether.
Dr. Morton had single-handedly proven to the world that ether is a gas that, when inhaled in the proper dose, provided safe and effective anesthesia.
Dr. Morton was in New York City in July 1868. He was riding in a carriage with his wife when he suddenly demanded the carriage to stop, and he ran into the lake in Central Park “to cool off.” This peculiar behavior was attributed to a major stroke (cerebrovascular accident) that he had suffered, which proved fatal soon after.
Dr. Morton was taken to nearby St. Luke’s Hospital. It is reported by his wife that upon recognizing Dr. Morton, the chief surgeon made the following remark to his students: “Young gentlemen, you see lying before you a man who has done more for humanity and for the relief of suffering than any man who has ever lived.”
Sources
Fitzharris L. The Butchering Art: Joseph Lister’s Quest to Transform the Grisly World of Victorian Medicine. Farrar, Straus and Grious; 2018:1-304. Hollingham R. Blood and Guts: A History of Surgery. St. Martin’s Press; 2009:11, 62. Robinson DH, Toledo AH. Historical development of modern anesthesia. J Invest Surg. 2012;25(3):141-149. William T.G. Morton. https://en.wikipedia.org/wiki/ William_T._G._Morton
William Thomas Green Morton (1819-1868)
Work was done on a Canford gray paper, 11×15, using panpastel, charcoal pencils and white chalks.
Artist: Moises Menendez, MD, FACS
—Dr. Menendez is a general surgeon and self-taught portrait artist in Magnolia, Ark. Since 2012, he has completed a series of portraits of historical figures, particularly well-known physicians and surgeons.
