SGO Issues September 28, 2017
2017 SGO Chemo Handbook now available to order
New video helps patients understand clinical trials
SGO white paper: Surrogate endpoints viable for ovarian cancer
Wellness found in a mentor relationship | Leigh Cantrell, MD, MSPH
ASCCP releases SGO-endorsed recommendations for colposcopy
The third edition of Chemotherapy for Gynecologic Cancers: Society of Gynecologic Oncology Handbook is now available for order. Purchase the pocket-sized hard copy through SGO’s online store at the member price of $75 ($105 for nonmembers). The e-book can be purchased on Amazon for mobile devices for $60.
The new content in the third edition includes:
- All drugs and chemotherapy regimens developed since the second edition (2004)
- Therapies and treatments based on the latest clinical trials
- New chapters on targeted therapies, palliative care, and the role of chemotherapy in the major gynecological cancer sites
- Rewritten chapters on chemotherapy premedication and management of toxicities
- Selected reading lists throughout the document
Chemotherapy for Gynecologic Cancers was written and revised by 25 contributors and edited by Christina M. Annunziata, MD, PhD; Christina S. Chu, MD and Stephen C. Rubin, MD.
In recognition of Gynecologic Cancer Awareness Month (GCAM), today the Society of Gynecologic Oncology and the Foundation for Women’s Cancer released a new brochure and a four-minute explainer video, “Understanding Gynecologic Cancer Clinical Trials.” The video is a useful resource for patients who might be considering a clinical trial. It explains the main phases of clinical trials, as well as the possible differences between treatment arms. The brochure, Clinical Trials: Your Guide, is available to download. Print copies may be ordered now, with delivery in four to six weeks.
Considering the challenges of using overall survival in all studies for ovarian cancer, surrogate endpoints such as progression-free survival (PFS) and objective response should be considered for accelerated Food and Drug Administration (FDA) approval, according to conclusions presented in “FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper,” published in the October 2017 issue of Gynecologic Oncology.
Other key points in the white paper:
- Patient classification systems should incorporate multiple descriptive factors.
- New platforms for drug development (e.g., neoadjuvant chemotherapy) warrant study.
- Patient-reported outcomes need to play a more integral role in assessing surrogate endopints.
- Patient advocate collaborators are vital to meeting the many challenges of enrollment.
The white paper is a result of a 2015 Clinical Trial Endpoints in Ovarian Cancer workshop, which brought together representatives of the FDA, SGO, American Association for Cancer Research (AACR), American Society of Clinical Oncology (ASCO), patient advocates and other stakeholders to address clinical trial endpoints in the setting of an expanding knowledge of disease biology and new therapeutic strategies.
Authors are Thomas J. Herzog, MD; Gwynn Ison, MD; Ronald D. Alvarez, MD; Sanjeeve Balasubramaniam, MD, MPH; Deborah K. Armstrong, MD; Julia A. Beaver, MD; Annie Ellis; Shenghui Tang, PhD; Peg Ford; Amy McKee, MD; David M. Gershenson, MD; Geoffrey Kim, MD; Bradley J. Monk, MD; Richard Pazdur, MD; and Robert L. Coleman, MD.
Dr. Herzog described the workshop as a way to “de-mystify the regulatory approval process, as we all want new, effective and safe therapeutics that truly improve the condition of our patients.”
He noted that the FDA wants to best understand how an agent or treatment strategy impacts patients, both from an activity and a side-effect perspective. “Ideally, integration of efficacy and impact on patient well being would provide the strongest measure of clinical benefit”, he said. “Further, the FDA also recognizes that we need to offer new agents that are more effective in a timely manner. To that end I think that there is an acceptance of validated surrogate endpoints that reflect true clinical benefit. These would include response and PFS depending on the nature of the trial and the specific study population.”
Dr. Herzog added that utilization of surrogate endpoints should accelerate conditional approvals as the timelines are shortened to observe an effect. “Nonetheless, further studies will be needed to confirm the efficacy signal and to assess the impact on overall survival,” he said. “Specifically, regulators need to assure that there is no detriment in overall survival.
“The strongest influence of an optimal endpoint is probably the line of therapy and the anticipated post-progression survival,” said Dr. Herzog.
For patients with ovarian cancer, the authors of the white paper assert that these findings can serve as an opportunity for participation in clinical trials, regardless of where they are located. “Patients should be excited that we are gaining specificity in treatment options based upon their individual histologic type and in some cases molecular profile of the tumor,” said Dr. Herzog. “We hope that it makes it easier as everyone wants to expand access to trials and regulators are very interested in ‘real world use’ of these novel agents.”
Seven years ago I joined the faculty of the University of Virginia. Fresh out of fellowship, I was assigned a mentor within my department–someone to help me settle in, learn the ropes and culture and ensure that I worked towards accomplishing all of the tasks needed for promotion. While that mentor was wonderful, it was an artificial relationship. It is the mentor that I gained by chance who has promoted my wellness and helped me deal with burnout. Many colleagues have questioned how a hand surgeon could mentor a gynecologist oncologist and I can’t explain it, but I know it works.
A. Bobby Chhabra, MD, Chair of the Department of Orthopedic Surgery at UVA, and I met during work on an OR Committee and my single request for advice has led to an ongoing mentorship. Little did I know that after several years on faculty the hot topic of burnout would hit a little too close to home and that Dr. Chhabra would offer me the great gift of his experiences. Hearing how he addressed wellness and burnout, the way he balanced work and life (and not always perfectly) was therapeutic.
In my research for this blog, I uncovered data that young faculty (and trainees) benefit from a mentor. A recent article by Wilkes and Feldman in The Lancet on mentoring clinical trainees outlined the four general qualities that make Dr. Chhabra such an excellent mentor:
- The mentee wants to emulate them
- The mentor is approachable and trustworthy
- The mentor can, wants to and will help the mentee
- The mentor makes himself/herself available to the mentee and is responsive
In my own life, I have found mentorship helps combat burnout and promote wellness. While I wish that I could bestow a “Chhabra” mentor to everyone, I realize that I am extremely fortunate to have found, by chance, someone who is both mentor and friend.
As you strategize your wellness, I encourage you to make time for mentorship, both as mentor and mentee. For further information, I highly recommend the articles below. As the Wilkes and Feldman article states:
- “The time constraints that lead to burnout are, ironically, the exact reason you must devote time to create a valuable relationship with your mentor.”
- “Your mentor is not your therapist. However, they are a resource to help you thrive.”
- “Your mentor is your advisor…. mentorship is a ‘replenishing factor’ for the ‘coping reservoir,’ alongside psychological support, social activities, and intellectual stimulation.”
- Wilkes M, Feldman MD. Mentoring clinical trainees: a need for high touch. The Lancet. 2017;389:135-137.
- Dunn LB, Iglewicz A, Moutier C. A conceptual model of medical student well-being: promoting resilience and preventing burnout. Acad Psychiatry. 2008;32:44-53.
- Vaughn V, Saint S, Chopra V. Mentee missteps: tales from the academic trenches. JAMA. 2017;317:475-476.
Leigh Cantrell, MD, MSPH, is an Associate Professor of gynecologic oncology at the University of Virginia in Charlottesville, VA.
Today the ASCCP, the Society of Lower Genital Tract Disorders, released recommendations for colposcopy, which has been published in the October 2017 issue of the Journal of Lower Genital Tract Disorders. SGO endorsed the recommendations.
The ASCCP Colposcopy Standards recommendations address the role of colposcopy and directed biopsy for cervical cancer prevention in the United States. The recommendations were developed by an expert working group appointed by ASCCP’s Board of Directors. An extensive literature review was conducted, supplemented by a systematic review and meta-analysis of unpublished data. Additionally, a survey of practicing colposcopists was conducted to assess current colposcopy practice in the United States. Recommendations were approved by the working group members, and final revisions were made based on comments received from the public. The recommendations cover terminology, risk-based colposcopic biopsy, colposcopy procedures, and colposcopy adjuncts.
According to the official ASCCP announcement, “The ASCCP Colposcopy Standards recommendations are an important step towards raising the standard of colposcopy services delivered to women in the United States. Since cervical cancer screening programs are currently undergoing important changes that may affect colposcopy performance, updates to some of the current recommendations may be necessary in the future.”
The Colposcopy Standards recommendations are endorsed by SGO as well as the American Congress of Obstetricians and Gynecologists (ACOG), American College Health Association (ACHA), American Sexual Health Association (ASHA), American Society for Clinical Pathology (ASCP), Association of Reproductive Health Professionals (ARHP), and Nurse Practitioners in Women’s Health (NPWH).