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瑞士队列中小细胞肺癌复发患者使用免疫检查点抑制剂的结果。

Outcomes with immune checkpoint inhibitors for relapsed small-cell lung cancer in a Swiss cohort.

机构信息

Department of Oncology and Haematology, Cantonal Hospital St. Gallen, 9007, St. Gallen, Switzerland.

Lung Unit, Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada.

出版信息

Cancer Immunol Immunother. 2020 Aug;69(8):1605-1613. doi: 10.1007/s00262-020-02565-0. Epub 2020 Apr 19.

Abstract

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

目的

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。

方法

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。

结果

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。

结论

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。

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