Santorelli M L, Chrápavá M, Hrabcová K, Bencina G, Blažek J, Bratová M, Fibigr O, Fischer O, Koubková L, Krejčí J, Ryška A, Zemanová P, Burke T
Klin Onkol. 2025;38(3):192-200. doi: 10.48095/ccko2025192.
This study aimed to describe real-world PD-L1 testing and first-line (1L) treatment patterns for advanced non-small cell lung cancer (NSCLC), and clinical outcomes for metastatic NSCLC after 1L pembrolizumab monotherapy became reimbursed in the Czech Republic (February 2019).
This descriptive noninterventional study drew on two Czech lung cancer registries. We examined PD-L1 testing patterns and results in the KELLY registry for samples submitted on/after 1-Feb-2019 from adult patients with advanced NSCLC. Using the TULUNG registry, we summarized 1L targeted therapies initiated on/after 1-Feb-2019 for advanced NSCLC, in addition to characteristics and outcomes for patients treated with 1L pembrolizumab monotherapy for metastatic NSCLC, PD-L1 tumor proportion score (TPS) ≥ 50%, and no known EGFR/ALK alterations. Real-world time on treatment (rwToT) and overall survival (OS) were determined using Kaplan-Meier curves. The data cutoff was 16-Sept-2021.
The percentage of NSCLC samples in the KELLY registry tested for PD-L1 expression increased from 70.5% in 2019 to 84.4% in 2021. Pembrolizumab monotherapy was the most common 1L targeted therapy in 2019-2021 for patients with advanced NSCLC and PD-L1 TPS ≥ 50% (N = 315), administered to 70-80% each year. Of 235 patients with metastatic NSCLC who received 1L pembrolizumab monotherapy, median age was 69 years, 54% were men, 52% were current smokers, and 28% had squamous NSCLC. Median rwToT was 8.5 months (95% CI; 6.7-10.1), with 6- and 12-month on-treatment rates of 59% and 36%, respectively, for 199 patients with ≥ 6 months of follow-up. With added national registry mortality data, estimated median OS was 13.7 months (12.3-17.7); 6- and 12-month OS rates were 70% and 59%, respectively.
The rates of PD-L1 testing increased from 2019 to 2021. Median OS among patients with metastatic NSCLC and PD-L1 TPS ≥ 50% treated with pembrolizumab was lower than in clinical trials, likely due to differences between real-world patients and trial participants in age, smoking status, performance status, and squamous histology.
本研究旨在描述晚期非小细胞肺癌(NSCLC)的真实世界PD-L1检测和一线(1L)治疗模式,以及在捷克共和国(2019年2月)1L帕博利珠单抗单药治疗报销后转移性NSCLC的临床结局。
这项描述性非干预性研究利用了两个捷克肺癌登记处的数据。我们在KELLY登记处检查了2019年2月1日及以后提交的成年晚期NSCLC患者样本的PD-L1检测模式和结果。使用TULUNG登记处,我们总结了2019年2月1日及以后开始的晚期NSCLC的1L靶向治疗,以及接受1L帕博利珠单抗单药治疗的转移性NSCLC患者(PD-L1肿瘤比例评分(TPS)≥50%且无已知EGFR/ALK改变)的特征和结局。使用Kaplan-Meier曲线确定真实世界治疗时间(rwToT)和总生存期(OS)。数据截止日期为2021年9月16日。
KELLY登记处检测PD-L1表达的NSCLC样本百分比从2019年的70.5%增加到2021年的84.4%。帕博利珠单抗单药治疗是2019 - 2021年晚期NSCLC且PD-L1 TPS≥50%患者(N = 315)中最常见的1L靶向治疗,每年给药比例为70 - 80%。在235例接受1L帕博利珠单抗单药治疗的转移性NSCLC患者中,中位年龄为69岁,54%为男性,52%为当前吸烟者,28%患有鳞状NSCLC。中位rwToT为8.5个月(95%CI;6.7 - 10.1),199例随访≥6个月的患者6个月和12个月的治疗率分别为59%和36%。加上国家登记处的死亡率数据,估计中位OS为13.7个月(12.3 - 17.7);6个月和12个月的OS率分别为70%和59%。
2019年至2021年PD-L1检测率有所增加。接受帕博利珠单抗治疗的转移性NSCLC且PD-L1 TPS≥50%患者的中位OS低于临床试验,这可能是由于真实世界患者与试验参与者在年龄、吸烟状态、体能状态和鳞状组织学方面存在差异。