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首页> 外文期刊>Investigational new drugs. >Efficacy and safety of pembrolizumab as first-line therapy in advanced non-small cell lung cancer with at least 50% PD-L1 positivity: a multicenter retrospective cohort study (HOPE-001)
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Efficacy and safety of pembrolizumab as first-line therapy in advanced non-small cell lung cancer with at least 50% PD-L1 positivity: a multicenter retrospective cohort study (HOPE-001)

机译:Pembrolizumab作为先进非小细胞肺癌的一线治疗的疗效和安全性,具有至少50%PD-L1积极性:多中心回顾性队列研究(Hope-001)

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摘要

Objectives As first line therapy, pembrolizumab provides longer progression free survival (PFS) and overall survival (OS) than platinum doublets in programmed death ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC) with tumor propensity scores (TPS) >50%. However, clinical trials do not represent real-world patients. Materials and Methods This multicenter retrospective study conducted across 11 medical centers in Japan analyzed clinical data from patients receiving first-line pembrolizumab for NSCLC between February 1, 2017 and April 30, 2018. The efficacy, safety, and suitability of pembrolizumab monotherapy were evaluated. Results The median age of the 213 enrolled patients was 71 (range: 39-91) years. Among them, 176 (82.6%) were male, 20 (9.4%) were never smokers (median Brinkman index: 900), 172 (80.8%) had an ECOG PS of 0-1, 55 (25.8%) had squamous-cell carcinoma (SQ). PD-L1 TPS were 50-74%, 75-89%, and 90-100% in 97 (45.5%), 47 (22.1%), and 69 (32.4%) patients, respectively. Adverse events (AEs) of grades >=3 were observed in 39 (18.3%) patients. Pneumonitis was the most common severe AE, occurring in 10 patients (4.7%) including 1 with grade 4 toxicity; no severe AE-related deaths occurred. The overall response rate, median PFS, and median OS was 51.2%, 8.3 months, and 17.8 months, respectively. On multivariate analysis, ECOG PS (0-1 vs. >=2: HR: 1.69, 95.0% CI: 1.05-2.72;p = 0.03138), CRP/Alb (< 0.3 vs. >=0.3: HR: 1.92,95.0% CI: 1.28-2.87;p = 0.00153), steroid usage (not usage vs. usage: HR: 2.94, 95.0% CI: 1.45-5.95;p = 0.00267), and PD-L1 TPS (50-89% vs. 90-100%: HR: 0.65, 95.0% CI: 0.43-1.00;p = 0.04984) were significantly and independently correlated with PFS of pembrolizumab. Conclusion The results confirm the efficacy and safety of pembrolizumab in real-world patients. Poor PS and steroid usage at the time of commencing pembrolizumab treatment indicate poor outcomes. First-line pembrolizumab particularly benefits patients with PD-L1 TPS >=90% or low inflammatory states (CRP/ALB< 0.3).
机译:作为第一线疗法的目标,Pembrozumab提供更长的进展免费存活(PFS)和总存活(OS),而不是编程死亡配体1(PD-L1) - 阳性非小细胞肺癌(NSCLC)的铂双胞胎,具有肿瘤倾向分数( TPS)> 50%。然而,临床试验不代表现实世界患者。材料和方法在日本的11名医疗中心进行了本多中心回顾性研究,分析了2017年2月1日至2018年4月30日之间接受第一线Pembrolizumab的患者的临床资料。评估彭尔洛丽普单疗法的疗效,安全性和适合性。结果213名患者的中位年龄为71(范围:39-91)年。其中,176名(82.6%)是男性,20(9.4%)从未吸烟(中位数Brinkman指数:900),172(80.8%)有0-1,55(25.8%)的ECOG PS有鳞状细胞癌(SQ)。 PD-L1 TPS分别为50-74%,75-89%,97(45.5%),47(22.1%)和69名(32.4%)患者分别为90-100%。在39例(18.3%)患者中观察到阶段> = 3的不良事件(AES)。肺炎是最常见的严重AE,在10名患者(4.7%)中发生,其中包括4级毒性;没有发生严重的AE相关的死亡。整体响应率,中位数PFS和中位OS分别为51.2%,8.3个月和17.8个月。在多变量分析中,ECOG PS(0-1与> = 2:HR:1.69,95.0%CI:1.05-2.72; P = 0.03138),CRP / ALB(<0.3 Vs.> = 0.3:HR:1.92,95.0 %CI:1.28-2.87; p = 0.00153),类固醇用法(不是使用与用途:HR:2.94,95.0%CI:1.45-5.95; p = 0.00267)和PD-L1 TPS(50-89%Vs. 90-100%:HR:0.65,95.0%CI:0.43-1.00; p = 0.04984)与Pembrolizumab的PFS显着和独立相关。结论结果证实了Pembrolizumab在现实世界患者中的疗效和安全性。开始PEMBROLIZUMAB治疗时的PS和类固醇用法表明了差的结果。第一线Pembrolizumab特别有益于PD-L1 TPS> = 90%或低炎症状态(CRP / ALB <0.3)。

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