Department of Obstetrics & Gynecology, Division of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA
Robert Allen Burger , Danielle Enserro , Krishnansu Sujata Tewari , Mark F. Brady , Michael A. Bookman , Gini F. Fleming , Helen Q Huang , Howard D. Homesley , Jeffrey Fowler , Matthew Boente , Leslie M. Randall , John K. Chan , James Stuart Ferris , Philip J. DiSaia , Larry J. Copeland , Robert S. Mannel , Michael J. Birrer , Bradley J. Monk
Background: GOG 0218 is a double-blind, placebo-controlled, phase 3 randomized trial studying chemotherapy with and without concurrent BEV, and with concurrent BEV followed by maintenance BEV for advanced stage ovarian carcinoma. In 2010, at a median follow-up of 17.4 months (m), the trial met its primary endpoint demonstrating improvement in progression-free survival (PFS) for patients receiving BEV with and following chemotherapy compared to chemotherapy alone: median PFS 14.1 vs 10.3m, respectively; HR 0.717; 95% CI, 0.625-0.824; p < 0.001 [Burger RA, et al N Engl J Med 2011]. With extended follow-up, we report on the key secondary endpoint, final OS. Methods: 1,873 women with newly diagnosed, incompletely resected stage III or stage IV ovarian cancer received six 21-day cycles of carboplatin (AUC 6) IV and paclitaxel (175 mg/m2 BSA) IV chemotherapy alone (control) vs chemotherapy plus BEV (15 mg/kg body weight) IV cycles 2-6 (BEV-initiation) vs chemotherapy plus BEV cycles 2-22 (BEV-throughout). OS was analyzed in the intention-to-treat (ITT) population. The database was locked on Jan. 17, 2018 at a median follow-up of 102.9m. Results: After 1,491 (79.6%) deaths, 204 patients (10.9%) are alive with a progression event, and 178 (9.5%) are alive without progression. Comparing BEV-throughout to control, the hazard of death (HR) is 0.96; 95% CI, 0.85-1.09; p = 0.53. For BEV-initiation vs control, HR is 1.06; 95% CI, 0.94-1.20; p = 0.34. The relative HR for stage IV patients was reduced for BEV-throughout compared to control (HR 0.774). While the median survival times for stage IV control and stage IV bevacizumab-initiation were 32.6 and 34.5 mos., respectively, the median OS (42.8m) for stage IV BEV-throughout patients was similar to the median OS (control, 44.3m; BEV-initiation, 42.9m; BEV-throughout, 44.2m) of stage III patients. Conclusions: In the ITT analysis, there were no survival differences between patients receiving BEV compared to chemotherapy alone. Patients with FIGO stage IV disease may derive a survival advantage from BEV when administered with and following front-line chemotherapy. Clinical trial information: NCT00262847
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Abstract Disclosures
2023 ASCO Annual Meeting
First Author: Bradley J. Monk
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