PURPOSE Patients with non-small-cell lung cancer (NSCLC) have been shown to benefit from maintenance therapy. COMPASS evaluated the efficacy and safety of bevacizumab with or without pemetrexed as continuation maintenance therapy after carboplatin, pemetrexed, and bevacizumab induction therapy. PATIENTS AND METHODS Patients with untreated advanced nonsquamous NSCLC without confirmed EGFR 19 deletion or L858R mutation received first-line therapy with carboplatin area under the curve 6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg once every 3 weeks for 4 cycles. Patients without disease progression during the induction therapy were randomly assigned 1:1 for maintenance therapy with pemetrexed 500 mg/m2 plus bevacizumab 15 mg/kg or bevacizumab 15 mg/kg once every 3 weeks until disease progression or unacceptable toxicity. The primary end point was overall survival (OS) after random assignment. RESULTS Between September 2010 and September 2015, 907 patients received induction therapy. Of those, 599 were randomly assigned: 298 received pemetrexed plus bevacizumab, and 301 received bevacizumab. The median OS was 23.3 v 19.6 months (hazard ratio [HR], 0.87; 95% CI, 0.73 to 1.05; 1-sided stratified log-rank P = .069). In the wild-type EGFR subset, the OS HR was 0.82 (95% CI, 0.68 to 0.99; 1-sided unstratified log-rank P = .020). The median progression-free survival (PFS) was 5.7 v 4.0 months (HR, 0.67; 95% CI, 0.57 to 0.79; 2-sided log-rank P < .001). The safety data were consistent with previous reports of treatment regimens. CONCLUSION In terms of the primary end point of OS, no statistically significant benefit was observed; however, PFS in the total patient population and OS in patients with wild-type EGFR was prolonged with the addition of pemetrexed to bevacizumab maintenance therapy.

中文翻译：

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贝伐珠单抗联合或不联合培美曲塞治疗晚期非鳞状非小细胞肺癌的随机 III 期研究：COMPASS (WJOG5610L)

目的 非小细胞肺癌 (NSCLC) 患者已显示受益于维持治疗。COMPASS 评估了贝伐单抗联合或不联合培美曲塞作为卡铂、培美曲塞和贝伐珠单抗诱导治疗后继续维持治疗的有效性和安全性。患者和方法 未经治疗的晚期非鳞状 NSCLC 患者未确认 EGFR 19 缺失或 L858R 突变，接受了卡铂曲线 6 下面积、培美曲塞 500 mg/m2 和贝伐单抗 15 mg/kg 的一线治疗，每 3 周一次，共 4 个周期。诱导治疗期间未出现疾病进展的患者按 1:1 随机分配接受培美曲塞 500 mg/m2 加贝伐单抗 15 mg/kg 或贝伐单抗 15 mg/kg 每 3 周一次的维持治疗，直至疾病进展或出现不可接受的毒性。主要终点是随机分配后的总生存期 (OS)。结果 2010 年 9 月至 2015 年 9 月期间，907 名患者接受了诱导治疗。其中，599 人被随机分配：298 人接受培美曲塞加贝伐单抗，301 人接受贝伐单抗。中位 OS 为 23.3 v 19.6 个月（风险比 [HR]，0.87；95% CI，0.73 至 1.05；单侧分层对数秩 P = .069）。在野生型 EGFR 子集中，OS HR 为 0.82（95% CI，0.68 至 0.99；单侧未分层对数秩 P = .020）。中位无进展生存期 (PFS) 为 5.7 个月和 4.0 个月（HR，0.67；95% CI，0.57 至 0.79；双侧对数秩 P < .001）。安全性数据与之前的治疗方案报告一致。结论 就 OS 的主要终点而言，未观察到具有统计学意义的益处；然而，