Introduction: For patients with recurrent SCLC, topotecan remains the only approved second‐line treatment, and the outcomes are poor. CheckMate 032 is a phase 1/2, multicenter, open‐label study of nivolumab or nivolumab plus ipilimumab in SCLC or other advanced/metastatic solid tumors previously treated with one or more platinum‐based chemotherapies. We report results of third‐ or later‐line nivolumab monotherapy treatment in SCLC. Methods: In this analysis, patients with limited‐stage or extensive‐stage SCLC and disease progression after two or more chemotherapy regimens received nivolumab monotherapy, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The primary end point was objective response rate. Secondary end points included duration of response, progression‐free survival, overall survival, and safety. Results: Between December 4, 2013, and November 30, 2016, 109 patients began receiving third‐ or later‐line nivolumab monotherapy. At a median follow‐up of 28.3 months (from first dose to database lock), the objective response rate was 11.9% (95% confidence interval: 6.5–19.5) with a median duration of response of 17.9 months (range 3.0–42.1). At 6 months, 17.2% of patients were progression‐free. The 12‐month and 18‐month overall survival rates were 28.3% and 20.0%, respectively. Grade 3 to 4 treatment‐related adverse events occurred in 11.9% of patients. Three patients (2.8%) discontinued because of treatment‐related adverse events. Conclusions: Nivolumab monotherapy provided durable responses and was well tolerated as a third‐ or later‐line treatment for recurrent SCLC. These results suggest that nivolumab monotherapy is an effective third‐ or later‐line treatment for this patient population.

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复发性小细胞肺癌的三线纳武单抗单药治疗：CheckMate 032

引言：对于复发性小细胞肺癌患者，拓扑替康仍是唯一获批的二线治疗药物，疗效较差。CheckMate 032 是一项 1/2 期、多中心、开放标签研究，针对先前接受过一种或多种铂类化学疗法治疗的 SCLC 或其他晚期/转移性实体瘤中的纳武单抗或纳武单抗加伊匹单抗。我们报告了 SCLC 中三线或后线纳武单抗单药治疗的结果。方法：在这项分析中，局限期或广泛期 SCLC 和在两种或多种化疗方案后疾病进展的患者接受纳武单抗单药治疗，每 2 周 3 mg/kg，直至疾病进展或出现不可接受的毒性。主要终点是客观反应率。次要终点包括反应持续时间、无进展生存期、总生存期和安全性。结果：2013 年 12 月 4 日至 2016 年 11 月 30 日期间，109 名患者开始接受三线或后线纳武单抗单药治疗。中位随访 28.3 个月（从第一剂到数据库锁定），客观缓解率为 11.9%（95% 置信区间：6.5-19.5），中位缓解持续时间为 17.9 个月（范围 3.0-42.1） . 6 个月时，17.2% 的患者无进展。12 个月和 18 个月的总生存率分别为 28.3% 和 20.0%。11.9% 的患者发生 3 至 4 级治疗相关不良事件。三名患者 (2.8%) 由于治疗相关的不良事件而停药。结论：纳武单抗单药治疗提供了持久的反应，并且作为复发性 SCLC 的三线或后线治疗具有良好的耐受性。