GOG-0218: Final Overall Survival Results for Addition of Bevacizumab to Chemotherapy in Ovarian Cancer
The final overall survival analysis of the phase III GOG-0218 trial, reported in the Journal of Clinical Oncology by Tewari et al, showed no benefit of adding bevacizumab to chemotherapy in women with newly diagnosed, incompletely resected, advanced ovarian cancer.
The trial included 1,873 women with incompletely resected stage III to IV ovarian, fallopian tube, or primary peritoneal carcinoma from 336 sites in the United States, Canada, South Korea, and Japan. Patients were randomly assigned 1:1:1 between October 2005 and June 2009 to receive six 21-day cycles of carboplatin at AUC 6 and paclitaxel at 175 mg/m2 (n = 625), chemotherapy plus concurrent bevacizumab at 15 mg/kg during cycles 2 to 6 (n = 625), or chemotherapy plus concurrent and maintenance bevacizumab (cycles 2–22; n = 623).
A total of 1,195 specimens were sequenced for BRCA1 and BRCA2 mutations and deleterious mutations in homologous recombination repair genes. Intratumoral microvessel density was assessed using CD31 immunohistochemistry. Approximately 25% of patients had stage IV disease.
Overall Survival
Median follow-up was 102.9 months. Compared with the chemotherapy group, the hazard ratio (HR) for death was 1.06 (95% confidence interval [CI] = 0.94–1.20) in the concurrent bevacizumab group and 0.96 (95% CI = 0.85–1.09) in the concurrent-plus-maintenance bevacizumab group. No significant differences in disease-specific survival were observed among groups.
No survival benefit in the bevacizumab groups was observed after censoring patients who received bevacizumab at crossover or as second-line treatment. Median overall survival among patients with stage IV disease was improved in the concurrent-plus-maintenance bevacizumab group vs the chemotherapy group (42.8 vs 32.6 months; HR = 0.75, 95% CI = 0.59–0.95).
Compared with wild-type, the hazard ratios for death were 0.62 (95% CI = 0.52–0.73) among patients with BRCA1/2-mutant disease and 0.65 (95% CI = 0.51–0.85) among those with non-BRCA1/2 homologous recombination repair mutations. BRCA1/2, homologous recombination repair, and CD31 were not associated with bevacizumab benefit.
The investigators concluded, “No survival differences were observed for patients who received bevacizumab compared with chemotherapy alone. Testing for BRCA1/2 mutations and homologous recombination deficiency is essential.”
Krishnansu S. Tewari, MD, of the University of California, Irvine Medical Center, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by National Cancer Institute grants, Department of Defense Ovarian Cancer Research Program, and an Ovarian Cancer Research Foundation Alliance Liz Tilberis Award. For full disclosures of the study authors, visit jco.ascopubs.org.
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