First-line pembrolizumab for non-small cell lung cancer patients with PD-L1 ≥50% in a multicenter real-life cohort: The PEMBREIZH study
First-line pembrolizumab for non-small cell lung cancer patients with PD-L1 ≥50% in a multicenter real-life cohort: The PEMBREIZH study
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DOI：
10.1002/cam4.2806
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发表时间：
2020-02-05
期刊：
影响因子：
4
通讯作者：
Descourt, Renaud
中科院分区：
文献类型：
--
作者：
Amrane, Karim;Geier, Margaux;Descourt, Renaud
KEYNOTE-024试验表明，PD-1抑制剂pembrolizumab可显著改善既往未经治疗的PD-L1肿瘤比例评分（TPS）≥ 50%且无EGFR/ALK畸变的晚期非小细胞肺癌（NSCLC）患者的无进展生存期（PFS）和总生存期（OS）。本研究的主要目的是报告pembrolizumab在现实生活conditions.Method的疗效和安全性，这是一个法国回顾性多中心纵向研究的108例晚期NSCLC患者，PD-L1 TPS >= 50%，没有EGFR/ALK畸变谁是pembrolizumab治疗，在一线。患者数据来自医疗文件。结果队列的主要特征是：中位年龄[范围] 66.7 [37-87]岁，64.8%为男性，23.1%的体力状态（PS）为2，88.9%为当前或既往吸烟者。87%在诊断时患有IV期NSCLC，9.2%在入选时未经治疗的脑转移。中位随访时间为8.2个月，中位PFS为10.1个月（95% CI，8.8-11.4）。客观缓解率为57.3%（完全缓解2.7%，部分缓解54.6%）。疾病控制率71.1%。在6个月时，OS率估计为86.2%。8%的患者发生了3级治疗相关不良事件（AE）。结论在PD-L1 TPS >= 50%的晚期NSCLC患者（包括PS 2和未治疗的脑转移瘤）的真实生活队列中，pembrolizumab显示与关键临床试验相似的PFS。
Background The KEYNOTE-024 trial demonstrated that pembrolizumab, a PD-1 inhibitor, significantly improves progression-free survival (PFS) and overall survival (OS) in selected patients with previously untreated advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score (TPS) >= 50% and without EGFR/ALK aberrations. The main aim of this study was to report the efficacy and safety profile of pembrolizumab in real-life conditions.Method This was a French retrospective multicenter longitudinal study of 108 consecutive patients with advanced NSCLC, a PD-L1 TPS >= 50% and without EGFR/ALK aberrations who were treated by pembrolizumab, in first line. Patient data were obtained from medical files.Results The main characteristics of the cohort were: median age [range] 66.7 [37-87] years, 64.8% male, 23.1% with a performance status (PS) of 2, and 88.9% current or former smokers. Eighty-seven percent had stage IV NSCLC at diagnosis, 9.2% untreated brain metastases at inclusion,. With a median follow-up of 8.2 months, the median PFS was 10.1 months (95% CI, 8.8-11.4). The objective response rate was 57.3% (complete response 2.7%, partial response 54.6%). Disease control rate was 71.1%. At 6 months, the OS rate estimated was 86.2%. Treatment-related adverse events (AE) of grade 3 occurred in 8% of patients. There were no grade 4 or 5 AEs.Conclusion In a real-life cohort of advanced NSCLC patients (including PS 2 and untreated brain metastases), with PD-L1 TPS >= 50%, pembrolizumab demonstrates similar PFS to the pivotal clinical trial.