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Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer

贝伐单抗 医学 卡铂 卵巢癌 内科学 危险系数 肿瘤科 化疗 人口 胃肠病学 外科 癌症 顺铂 置信区间 环境卫生
作者
Krishnansu S. Tewari,Robert A. Burger,Danielle Enserro,Barbara M. Norquist,Elizabeth M. Swisher,Mark F. Brady,Michael A. Bookman,Gini F. Fleming,Helen Q. Huang,Howard D. Homesley,Jeffrey M. Fowler,Benjamin E. Greer,Matthew Boente,Sharon X. Liang,Kevin Lin,Carlos Bais,Leslie M. Randall,John K. Chan,J. Stuart Ferriss,Robert L. Coleman,Carol Aghajanian,Thomas J. Herzog,Philip J. DiSaia,Larry J. Copeland,Robert S. Mannel,Michael J. Birrer,Bradley J. Monk
出处
期刊:Journal of Clinical Oncology [American Society of Clinical Oncology]
卷期号:37 (26): 2317-2328 被引量:340
标识
DOI:10.1200/jco.19.01009
摘要

PURPOSE We report the final, protocol-specified analysis of overall survival (OS) in GOG-0218, a phase III, randomized trial of bevacizumab in women with newly diagnosed ovarian, fallopian tube, or primary peritoneal carcinoma. METHODS A total of 1,873 women with incompletely resected stage III to IV disease were randomly assigned 1:1:1 to six 21-day cycles of intravenous carboplatin (area under the concentration v time curve 6) and paclitaxel (175 mg/m 2 ) versus chemotherapy plus concurrent bevacizumab (15 mg/kg, cycles 2 to 6) versus chemotherapy plus concurrent and maintenance bevacizumab (cycles 2 to 22). Inclusion criteria included a Gynecologic Oncology Group performance status of 0 to 2 and no history of clinically significant vascular events or evidence of intestinal obstruction. OS was analyzed in the intention-to-treat population. A total of 1,195 serum and/or tumor specimens were sequenced for BRCA1/2 and damaging mutations in homologous recombination repair (HRR) genes. Intratumoral microvessel density was studied using CD31 immunohistochemistry. RESULTS Median follow-up was 102.9 months. Relative to control (n = 625), for patients receiving bevacizumab-concurrent (n = 625), the hazard ratio (HR) of death was 1.06 (95% CI, 0.94 to 1.20); for bevacizumab-concurrent plus maintenance (n = 623), the HR was 0.96 (95% CI, 0.85 to 1.09). Disease-specific survival was not improved in any arm. No survival advantage was observed after censoring patients who received bevacizumab at crossover or as second line. Median OS for stage IV bevacizumab-concurrent plus maintenance was 42.8 v 32.6 months for stage IV control (HR, 0.75; 95% CI, 0.59 to 0.95). Relative to wild type, the HR for death for BRCA1/2 mutated carcinomas was 0.62 (95% CI, 0.52 to 0.73), and for non- BRCA1/2 HRR, the HR was 0.65 (95% CI, 0.51 to 0.85). BRCA1/2, HRR, and CD31 were not predictive of bevacizumab activity. CONCLUSION 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.
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