Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer.
Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer.
复制标题
DOI：
10.1016/j.ygyno.2015.08.004
复制
发表时间：
2015-10
影响因子：
4.7
通讯作者：
Blank SV
中科院分区：
文献类型：
--
作者：
Aghajanian C;Goff B;Nycum LR;Wang YV;Husain A;Blank SV
OCES是一项随机、安慰剂(PL)对照的3期试验，评估贝伐单抗联合吉西他滨+卡铂(GC)治疗对铂敏感的复发性卵巢癌(ROC)的疗效和安全性。这项研究达到了它的主要终点，证明了与GC+PL相比，GC+贝伐单抗改善了无进展生存率。在此，我们描述最终总存活率(OS)和更新的安全性的结果。对铂敏感的复发(一线铂类药物治疗后6个月复发的≥)和基线可测量疾病的患者随机接受GC+贝伐单抗或GC+PL治疗6-10个周期；然后继续接受PL或贝伐单抗治疗，直到疾病进展。在这项最新的分析中，使用了COX比例风险模型来比较两个治疗组之间的OS。截至数据截止日期(2013年7月19日)，已有353名患者(72.9%)死亡。OS的中位随访期，试验组为58.2个月，对照组为56.4个月。与中期分析一致，ARM之间的中位OS是相似的(GC+贝伐单抗：33.6个月；GC+PL：32.9个月；风险比=0.95；对数等级p=0.65)，并且在所有接受检查的患者亚组中是一致的。不良事件的频率和严重程度与之前的分析一致；没有发现新的安全问题。3期海洋研究的最终OS分析结果显示，接受GC+贝伐单抗治疗的患者的OS与GC+PL相比没有显著差异。
OCEANS is a randomized, placebo (PL)-controlled, phase 3 trial evaluating the efficacy and safety of bevacizumab combined with gemcitabine + carboplatin (GC) for patients with platinum-sensitive recurrent ovarian cancer (ROC). The study met its primary endpoint, demonstrating improved progression-free survival with GC + bevacizumab compared with GC + PL. Herein, we describe results of final overall survival (OS) and updated safety. Patients with recurrent platinum-sensitive ROC (recurring ≥6 months after first-line platinum-based therapy) and measurable disease at baseline were randomized to receive GC + bevacizumab or GC + PL for 6–10 cycles; PL or bevacizumab was then continued until disease progression. In this updated analysis, a Cox proportional hazards model was used to compare OS between the 2 treatment arms. At the data cutoff date (July 19, 2013), 353 patients (72.9%) had died. Median follow-up for OS was 58.2 months in the experimental arm and 56.4 months in the control arm. Consistent with interim analyses, median OS was comparable between arms (GC + bevacizumab: 33.6 months; GC + PL: 32.9 months; hazard ratio = 0.95; log-rank p = 0.65), and was consistent across all examined patient subgroups. The frequency and severity of adverse events were consistent with previous analyses; no new safety concerns were identified. Results from final OS analysis of the phase 3 OCEANS study showed no significant difference in OS for patients treated with GC + bevacizumab compared with GC + PL.