In a recent article in Journal of Clinical Oncology, Tewari et al¹ provided high-quality data on the final protocol-specified analysis of overall survival (OS) of 1,873 women treated with chemotherapy and/or bevacizumab for incompletely resected stage III or IV ovarian cancer. This randomized, three-arm, double-blind, placebo-controlled phase III trial (GOG-0218) revealed that after a median follow-up of nearly 9 years, there was no OS benefit from bevacizumab. Women receiving carboplatin and paclitaxel had median survival times equivalent to those receiving concurrent carboplatin, paclitaxel, and bevacizumab and those receiving concurrent carboplatin, paclitaxel, and bevacizumab plus bevacizumab maintenance (hazard ratios [HRs], 1.06 and 0.96; P = .34 and .53, respectively). These OS data are congruent with three earlier phase III trials for this indication: ICON7, AURELIA, and OCEANS (HRs, 0.99, 0.85, and 0.95; P = .85, .17, and .65, respectively). All four trials yielded unequivocal outcomes using the gold standard of OS. The high-probability conclusion is that bevacizumab-based targeting of vascular endothelial growth factor (VEGF) in ovarian cancer fails to increase median lifespan. The additional clinical concern is that bevacizumab contributes to many adverse events, including thromboembolism, GI perforation, hypertension, and proteinuria. These data have important implications for other more prevalent and incurable cancer types,^2-4 where the lowered bar of progression-free survival (PFS) has controversially garnered US Food and Drug Administration approval for the use of bevacizumab.

中文翻译：

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贝伐单抗Moonshots：最新卵巢癌任务的重要结果。

Tewari等[ ^1]在最近发表的《临床肿瘤学杂志》上的文章中提供了高质量的数据，用于最终方案指定的1873名接受化疗和/或贝伐单抗治疗的不完全切除的III或IV期卵巢妇女的整体生存（OS）分析癌症。这项随机，三臂，双盲，安慰剂对照的III期临床试验（GOG-0218）显示，在中位随访近9年之后，贝伐单抗没有OS获益。接受卡铂和紫杉醇的妇女的中位生存时间等于同时接受卡铂，紫杉醇和贝伐单抗的妇女以及接受同时卡铂，紫杉醇和贝伐单抗加贝伐单抗维持的妇女的中位生存时间（危险比[HRs]，1.06和0.96；P分别为0.34和.53）。这些OS数据与三个较早的III期临床试验相符，可用于此指征：ICON7，AURELIA和OCEANS（HR分别为0.99、0.85和0.95；P分别为.85，.17和.65）。使用OS的黄金标准，所有四项试验均取得了明确的结果。高可能性的结论是卵巢癌中基于贝伐单抗的血管内皮生长因子（VEGF）靶向不能延长中位寿命。另一个临床关注是贝伐单抗会导致许多不良事件，包括血栓栓塞，胃肠道穿孔，高血压和蛋白尿。这些数据对其他更普遍和无法治愈的癌症类型具有重要意义，^2-4 降低无进展生存期（PFS）的标准引起争议的美国食品药品监督管理局（FDA）批准使用贝伐单抗。