Department of Oncology and Haematology, Cantonal Hospital St. Gallen, 9007, St. Gallen, Switzerland.
Lung Unit, Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada.
Cancer Immunol Immunother. 2020 Aug;69(8):1605-1613. doi: 10.1007/s00262-020-02565-0. Epub 2020 Apr 19.
Early clinical trials showed promising outcomes with immune-checkpoint inhibitors (ICI) in a subset of patients with relapsed small-cell lung carcinoma (SCLC). The aim of this retrospective analysis was to assess the efficacy and safety of ICI for relapsed SCLC in a real-world patient population.
Nine cancer centres in Switzerland contributed data to this cohort. Responses were assessed by the local investigators using standard RECIST v1.1 criteria. Progression-free survival (PFS) and overall survival (OS) were analysed by the Kaplan-Meier method. Associations between potential predictive markers and survival endpoints were probed by Cox proportional hazards.
Forty-five patients were included in the analysis. Median age was 63 years, 73% were males and 18% had an ECOG performance status (PS) ≥ 2. ICIs were given as second-line treatment in 60%. Twenty-four patients (53%) received ipilimumab with nivolumab. Twenty-eight patients (62%) had undergone irradiation (RT) prior to or during ICI. Overall response rate (ORR) was 29% and median PFS and OS were 2.3 and 6.5 months, respectively. Median duration of response was 9 months (95% CI 2.8-NA). Five patients maintained their response for > 6 months, all of them receiving combination treatment. There were no new safety signals.
This is the first report of "real-world" data on ICI in relapsed SCLC also including patients with poor PS. Promising durable responses were observed. No biological prognostic marker could be identified.
早期临床试验表明，免疫检查点抑制剂（ICI）在小细胞肺癌（SCLC）复发患者亚组中具有良好的疗效。本回顾性分析旨在评估 ICI 在真实世界 SCLC 复发患者中的疗效和安全性。
瑞士的 9 家癌症中心参与了该队列研究。反应由当地研究者根据标准 RECIST v1.1 标准进行评估。无进展生存期（PFS）和总生存期（OS）采用 Kaplan-Meier 法分析。采用 Cox 比例风险模型探讨潜在预测标志物与生存终点之间的关系。
共纳入 45 例患者。中位年龄为 63 岁，73%为男性，18%的患者 ECOG 体能状态（PS）≥2。ICI 作为二线治疗的占 60%。24 例（53%）患者接受了伊匹单抗联合纳武单抗治疗。28 例（62%）患者在接受 ICI 治疗前或治疗期间接受了放疗（RT）。总体缓解率（ORR）为 29%，中位 PFS 和 OS 分别为 2.3 个月和 6.5 个月。中位缓解持续时间为 9 个月（95%CI 2.8-NE）。5 例患者的缓解时间超过 6 个月，均接受联合治疗。未出现新的安全性信号。
这是首次报告 ICI 在复发 SCLC 中的“真实世界”数据，其中包括 PS 较差的患者。观察到了有前景的持久缓解。没有发现生物学预后标志物。
