目的:表征转移性非小细胞肺癌(mNSCLC)患者在抗PD-1/抗PD-L1(本文称为抗PD-(L)1)和铂双联化疗中发展的治疗模式和真实世界临床结果。
方法:美国合格的肿瘤学家/肺科医师,欧洲(法国,德国,andUnitedKingdom),和日本完成了mNSCLC患者的电子病例报告表(无EGFR/ALK/ROS1改变的证据)。符合条件的患者在抗PD-(L)1和铂双联化疗(同时或依次接受)后出现疾病进展,在2017年至2021年之间开始了后续的治疗线(LOT),并且在随后的LOT开始时(索引日期),东部肿瘤协作组(ECOG)的表现状态为0-2.总生存期(OS),治疗终止时间(TTD),使用Kaplan-Meier分析评估指数后的真实世界无进展生存期(rwPFS)。
结果:总体而言,160名医生(学术,54.4%;社区,45.6%)提供了487例患者图表中的未识别数据(美国,141;欧洲,218;日本,128;在mNSCLC诊断时:中位年龄66岁,64.7%男性,81.3%非鳞状,86.2%新生mNSCLC;在感兴趣的起始线:86.0%ECOG0-1,39.6%肝转移,18.9%脑转移,79.1%吸烟史)。抗PD-(L)1/铂双联化疗后最常见的治疗方案是非铂化疗(50.5%),非铂类化疗加血管内皮生长因子受体抑制剂(12.9%),和铂二联化疗(6.6%)。中位OS为8.8个月(鳞状,7.8个月;非鳞状,9.5个月)。中位TTD为4.3个月(鳞状,4.1个月;非鳞状,4.3个月)。rwPFS中位数为5.1个月(鳞状,4.6个月;非鳞状,5.4个月)。
结论:在这个多区域中,汇总患者图表数据的真实世界分析,抗PD-(L)1/铂双联化疗后疾病进展的mNSCLC患者在各种治疗方案下的临床结局较差,证明在抗PD-(L)1和铂双重化疗治疗失败后,对有效选择的临床需求未得到满足。
OBJECTIVE: To characterize treatment patterns and real-world clinical outcomes of patients with metastatic non-small cell lung cancer (mNSCLC) who developed progression on an anti-PD-1/anti-PD-L1, herein referred to as anti-PD-(L)1, and platinum-doublet chemotherapy.
METHODS: Eligible oncologists/pulmonologists in the United States, Europe (France, Germany, and United Kingdom), and Japan completed electronic case report forms for patients with mNSCLC (no evidence of EGFR/ALK/ROS1 alterations). Eligible patients had disease progression on/after an anti-PD-(L)1 and platinum-doublet chemotherapy (received concurrently or sequentially), initiated a subsequent line of therapy (LOT) between 2017 and 2021, and had an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 at this subsequent LOT initiation (index date). Overall survival (OS), time to treatment discontinuation (TTD), and real-world progression-free survival (rwPFS) after index were assessed using Kaplan-Meier analysis.
RESULTS: Overall, 160 physicians (academic, 54.4%; community, 45.6%) provided deidentified data from 487 patient charts (United States, 141; Europe, 218; Japan, 128; at mNSCLC diagnosis: median age 66 years, 64.7% male, 81.3% nonsquamous, 86.2% de novo mNSCLC; at line of interest initiation: 86.0% ECOG 0-1, 39.6% liver metastases, 18.9% brain metastases, 79.1% smoking history). The most common treatment regimens upon progression after anti-PD-(L)1/platinum-doublet chemotherapy were nonplatinum chemotherapy (50.5%), nonplatinum chemotherapy plus vascular endothelial growth factor receptor inhibitor (12.9%), and platinum-doublet chemotherapy (6.6%). Median OS was 8.8 months (squamous, 7.8 months; nonsquamous, 9.5 months). Median TTD was 4.3 months (squamous, 4.1 months; nonsquamous, 4.3 months). Median rwPFS was 5.1 months (squamous, 4.6 months; nonsquamous, 5.4 months).
CONCLUSIONS: In this multiregional, real-world analysis of pooled patient chart data, patients with mNSCLC who had disease progression after anti-PD-(L)1/platinum-doublet chemotherapy had poor clinical outcomes with various treatment regimens, demonstrating an unmet clinical need for effective options after failure on anti-PD-(L)1 and platinum-doublet chemotherapy treatments.