一线帕博利珠单抗单药治疗程序性死亡配体1表达大于或等于50%的晚期非小细胞肺癌：纳入日本老年患者的真实世界研究
First-Line Pembrolizumab Monotherapy for Advanced NSCLC With Programmed Death-Ligand 1 Expression Greater Than or Equal to 50%: Real-World Study Including Older Patients in Japan.
作者信息
Goto Yasushi, Tamura Atsuhisa, Matsumoto Hirotaka, Isobe Kazutoshi, Ozaki Tomohiro, Santorelli Melissa L, Taniguchi Kazuko, Kamitani Tetsu, Irisawa Masato, Kanda Kingo, Abe Machiko, Burke Thomas, Nokihara Hiroshi
机构信息
Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Center for Pulmonary Diseases, National Hospital Organization Tokyo National Hospital, Tokyo, Japan.
出版信息
JTO Clin Res Rep. 2022 Aug 5;3(9):100397. doi: 10.1016/j.jtocrr.2022.100397. eCollection 2022 Sep.
INTRODUCTION
Pembrolizumab became available in Japan in February 2017 for first-line monotherapy of unresectable advanced and metastatic NSCLC with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) greater than or equal to 50%. This retrospective chart review study aimed to describe real-world clinical outcomes of first-line pembrolizumab monotherapy, including for patients 75 years or older, who are under-represented in clinical trials.
METHODS
We identified patients (≥20 y old) at 23 sites initiating first-line pembrolizumab monotherapy from July 1, 2017, to December 20, 2018, for stages IIIB, IIIC, and IV NSCLC with PD-L1 TPS greater than or equal to 50% and Eastern Cooperative Oncology Group performance status of 0 to 2 or unknown. Patients with actionable genomic alterations (, , , ) and clinical trial participants were excluded. Time-to-event outcomes were estimated using Kaplan-Meier, with data cutoff on September 30, 2019.
RESULTS
Of 441 eligible patients (78% men), 303 (69%) were younger than 75 years and 138 (31%) were 75 years or older; median age was 70 years. With median follow-up of 13.5 months, median overall survival (OS) was not reached (NR); 12- and 24-month OS rates were 72% and 58%, respectively. For ages younger than 75 and 75 years or older, median OS was NR and 23.5 months (95% confidence interval: 16.2-NR), respectively; 12-month OS rates were 74% and 67% and 24-month OS rates were 62% and 48%, respectively. Median real-world progression-free survival was similar in the two age groups (10.1 and 9.5 mo, respectively), as was median real-world time on treatment with pembrolizumab (5.7 and 5.6 mo).
CONCLUSIONS
These findings complement clinical trial results, adding real-world evidence supporting benefits of first-line pembrolizumab monotherapy for advanced NSCLC with PD-L1 TPS greater than or equal to 50%, including for patients 75 years or older.
引言
帕博利珠单抗于2017年2月在日本获批用于一线单药治疗不可切除的晚期和转移性非小细胞肺癌（NSCLC），其程序性死亡配体1（PD-L1）肿瘤比例评分（TPS）大于或等于50%。这项回顾性图表审查研究旨在描述一线帕博利珠单抗单药治疗的真实世界临床结局，包括75岁及以上患者，这类患者在临床试验中的代表性不足。
方法
我们确定了23个研究地点中在2017年7月1日至2018年12月20日开始接受一线帕博利珠单抗单药治疗的患者（年龄≥20岁），这些患者患有ⅢB期、ⅡIC期和IV期NSCLC，PD-L1 TPS大于或等于50%，东部肿瘤协作组体能状态为0至2或未知。有可操作基因组改变（、、、）的患者和临床试验参与者被排除。使用Kaplan-Meier法估计至事件结局，数据截止于2019年9月30日。
结果
在441例符合条件的患者中（78%为男性），303例（69%）年龄小于75岁，138例（31%）年龄为75岁及以上；中位年龄为70岁。中位随访13.5个月，中位总生存期（OS）未达到（NR）；12个月和24个月的OS率分别为72%和58%。年龄小于75岁和75岁及以上患者的中位OS分别为NR和23.5个月（95%置信区间：16.2-NR）；12个月的OS率分别为74%和67%，24个月的OS率分别为62%和48%。两个年龄组的中位真实世界无进展生存期相似（分别为10.1个月和9.5个月），帕博利珠单抗治疗的中位真实世界时间也相似（5.7个月和5.6个月）。
结论
这些发现补充了临床试验结果，增加了真实世界证据，支持一线帕博利珠单抗单药治疗PD-L1 TPS大于或等于50%的晚期NSCLC的获益，包括75岁及以上患者。
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