Final overall survival (OS) analysis of an international randomized trial evaluating bevacizumab (BEV) in the primary treatment of advanced ovarian cancer: A NRG oncology/Gynecologic Oncology Group (GOG) study.

Authors

Robert Burger

Robert Allen Burger

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

Organizations

Department of Obstetrics & Gynecology, Division of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, NRG Oncology, Buffalo, NY, The Division of Gynecologic Oncology at the University of California, Irvine, Orange, CA, NRG Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY, University of Arizona, Tucson, AZ, The University of Chicago, Chicago, IL, GOG Statistical and Data Center, Rochester, NY, The Brody School of Medcine, Greenville, NC, James Cancer Hosp Ohio State Univ, Columbus, OH, Genentech Inc, San Francisco, CA, University of California, Irvine, Orange, CA, Palo Alto Medical Foundation, San Francisco, CA, University Medical Center - Breckenridge Shivers Center, Austin, TX, University of California Irvine Medical Center, Orange, CA, James Cancer Hosp, Columbus, OH, Stephenson Cancer Center, Oklahoma City, OK, University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL, University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, AZ

Research Funding

NIH

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 Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT00262847

Citation

J Clin Oncol 36, 2018 (suppl; abstr 5517)

DOI

10.1200/JCO.2018.36.15_suppl.5517

Abstract #

5517

Poster Bd #

244

Abstract Disclosures