ES-SCLC:联合免疫化疗既有效又安全

C. Schumann
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引用次数: 0

摘要

背景:免疫疗法联合铂-依托泊苷(EP)化疗已被批准作为广泛期小细胞肺癌(ES-SCLC)的一线治疗方法。然而,有关免疫检查点抑制剂(ICIs)在ES-SCLC中应用的真实世界(RW)数据还很缺乏。我们旨在评估程序性死亡蛋白1(PD-1)抑制剂和程序性死亡配体1(PD-L1)抑制剂与EP化疗联合作为ES-SCLC一线治疗的差异。方法:我们进行了一项真实世界、多中心、回顾性队列对照研究,比较PD-1和PD-L1抑制剂与化疗同时使用时ES-SCLC患者的预后、疗效和安全性。每位患者最多接受六个周期的依托泊苷、卡铂或顺铂联合 ICI 药物治疗,包括 PD-1 和 PD-L1 抑制剂。主要终点是研究者评估的无进展生存期(PFS)和总生存期(OS)。次要终点是根据实体瘤反应评估标准(RECIST,1.1 版)评估的客观反应率(ORR)和疾病控制率(DCR)。研究结果2017年1月至2021年12月期间,我们的研究纳入了来自解放军某综合医院三个临床中心的194例ES-SCLC患者,其中PD-1组93例,PD-L1组101例。数据截止时,PD-1组的无进展生存期(中位PFS,6.8个月;95% CI,5.3-8.1)与PD-L1组(中位PFS,6.4个月;95% CI,5.5-7.5)相似;PFS的分层危险比为1.12(95% CI,0.83-1.53;P = 0.452)。PD-1组和PD-L1组的中位OS相似(15.8 m vs. 17.7 m,P = 0.566);危险比为0.90(95% CI,0.62-1.30,P = 0.566)。两组研究者评估的确诊客观反应率(ORR)相当(76.3% 对 76.2%)。PD-1组有4例(4.3%)患者因不良反应(AE)而停药,PD-L1组有2例(2.0%)患者因不良反应(AE)而停药。PD-1抑制剂组和PD-L1抑制剂组分别有2例(2.2%)和1例(1.0%)患者因任何原因的AE而死亡。
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ES-SCLC: Kombinierte Immunchemotherapie ist effektiv und sicher
Background: Immunotherapy in combination with platinum-etoposide (EP) chemotherapy has been approved as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). However, real-world (RW) data regarding the use of immune checkpoint inhibitors (ICIs) in ES-SCLC are lacking. We aimed to assess the differences between programmed death protein 1 (PD-1) inhibitors and programmed death ligand 1 (PD-L1) inhibitors, both in conjunction with EP chemotherapy, as first-line treatment for ES SCLC. Methods: We conducted a real-world, multicenter, retrospective cohort, controlled study to compare the prognosis, efficacy, and safety of PD-1 and PD-L1 inhibitors in ES-SCLC patients when used along with chemotherapy. Each patient received up to six cycles of etoposide, carboplatin, or cisplatin combined with ICI drugs, including PD-1 and PD-L1 inhibitors. The primary endpoints were investigator-assessed progression-free survival (PFS) and overall survival (OS). The secondary endpoints were the investigator-assessed objective response rate (ORR) and disease control rate (DCR) according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1). Results: Between January 2017 and December 2021, 194 patients with ES-SCLC from three clinical centers in a PLA general hospital were included in our study, including 93 patients in the PD-1 group and 101 patients in the PD-L1 group. At the time of data cutoff, progression-free survival in the PD-1 group (median PFS, 6.8 months; 95% CI, 5.3–8.1 was similar to that in the PD-L1 group (median PFS, 6.4 months; 95% CI, 5.5–7.5); the stratified hazard ratio for PFS was 1.12 (95% CI, 0.83–1.53; P = 0.452). The median OS was similar in the PD-1 and PD-L1 groups (15.8 m vs. 17.7 m, P = 0.566); the hazard ratio was 0.90 (95% CI, 0.62–1.30, P = 0.566). The two groups had comparable investigator-assessed confirmed objective response rates (ORR) (76.3% vs. 76.2%). Adverse effect (AE)-related discontinuation occurred in 4 (4.3%) patients in the PD-1 group and 2 (2.0%) patients in the PD-L1 group. Deaths due to AEs of any cause occurred in 2 (2.2%) patients in the PD-1 inhibitor group and 1 (1.0%) patient in the PD-L1 inhibitor group.
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