12 Jun Platinum-Sensitive, Recurrent Ovarian Cancer: Trial of Surgery + Chemo With and Without Bevacizumab
MedicalResearch.com Interview with:
Dr. Coleman
Robert L. Coleman, MD, FACOG, FACS
Chief Scientific Officer
US Oncology Research
MedicalResearch.com: What is the background for this study?
Response: For years, there has been general support for surgery in patients with recurrent ovarian cancer supported by reams of retrospective studies that suggest patients live longer if they have surgery preceding chemotherapy. Suggested hypotheses from these trials were that patients most likely to benefit from the procedure were those with good performance status (could tolerate the procedure), had long platinum-free interval (surrogate for potential for chemotherapy response) and those in whom all disease could be resected. Each of these are also characteristics that would portend a good prognostic cohort in general and would likely do better than other patients without these characteristics. So there was a strong selection bias in these retrospective surveys. Thus, the call for randomized trials.
GOG-213 was launched in 2007 with 2 primary endpoints:
1. Determine the impact of adding bevacizumab to paclitaxel/carboplatin in patients with platinum-sensitive recurrent ovarian cancer, and
2. Determine if surgery increases overall survival.
MedicalResearch.com: What are the main findings?
Response: We found first that bevacizumab added to chemotherapy in these patients increased both PFS and OS. We published those data in 2017. In 2019, we published the second objective where we did not demonstrate a survival impact from performing surgery. Even when we restricted the surgical population to those with no gross residual disease after surgery, there was no difference than all patients getting surgery only.
MedicalResearch.com: What should readers take away from your report?
Response: Somewhat conflicting are DESKTOP3 data reported at ASCO 2020 which suggested there was a difference in OS by performing surgery. These two trials differ primarily in the adjuvant therapy choice, with GOG-213 represented by 84% of patients getting bevacizumab (previously shown to increase OS) which was about 4 times higher than used in DESKTOP3.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: More work needs to be done to understand which patients, if any, are benefitted by surgery given the increasingly effective non-surgical options as well as biomarker-informed treatment. These highly effective options combined with the negative impact on overall survival in women undergoing sub-optimal surgery, place a premium on patient selection if it is to be undertaken.
Any disclosures? I was the PI for GOG213 and have research funding in the past 3 years from Roche Genentech – maker of bevacizumab.
Citation: ASCO 2020
A phase III randomized controlled trial of secondary surgical cytoreduction (SSC) followed by platinum-based combination chemotherapy (PBC), with or without bevacizumab (B) in platinum-sensitive, recurrent ovarian cancer (PSOC): A NRG Oncology/Gynecologic Oncology Group (GOG) study.
Robert L. Coleman, Danielle Enserro, Nick Spirtos, Thomas J. Herzog, Paul Sabbatini, Deborah Kay Armstrong, Byoung Kim, Keiichi Fujiwara, Joan L. Walker, Patrick J. Flynn, Angeles Alvarez Secord, David E. Cohn, Mark F. Brady, and Robert S. Mannel
Journal of Clinical Oncology 2018 36:15_suppl, 5501-5501
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Last Updated on June 12, 2020 by Marie Benz MD FAAD