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携带、或改变的晚期非鳞状非小细胞肺癌患者一线免疫治疗的真实世界治疗模式与结局

Real-World Treatment Patterns and Outcomes of First-Line Immunotherapy Among Patients With Advanced Nonsquamous NSCLC Harboring , , or Alterations.

作者信息

Garassino Marina C, Oskar Sabine, Arunachalam Ashwini, Zu Ke, Kao Yu-Han, Chen Cai, Meng Weilin, Pietanza M Catherine, Zhao Bin, Aggarwal Himani

机构信息

Thoracic Oncology Program, Section of Hematology Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois.

Center for Observational and Real-World Evidence (CORE), Merck & Co., Inc., Rahway, New Jersey.

出版信息

JTO Clin Res Rep. 2023 Aug 23;4(10):100568. doi: 10.1016/j.jtocrr.2023.100568. eCollection 2023 Oct.

Abstract

INTRODUCTION

Data on utilization and clinical outcomes of programmed cell death protein or programmed death-ligand 1 (PD-[L]1) inhibitors in NSCLC with uncommon oncogenic alterations is limited.

METHODS

This retrospective study used a deidentified U.S. nationwide clinicogenomic database to select patients with advanced nonsquamous NSCLC without , , or alterations, diagnosed from January 1, 2016 to September 30, 2020, who initiated first-line therapy. Our objectives were to summarize characteristics and treatment patterns for patients with four little-studied genomic alterations or driver-negative NSCLC. We estimated Kaplan-Meier real-world time on treatment (rwTOT) and time to next treatment for patients receiving PD-(L)1 inhibitors. The data cutoff was September 30, 2021.

RESULTS

Of the 3971 eligible patients, 84 (2%) had NSCLC with V600E mutation, 117 (3%) had exon 14 skipping mutation, 130 (3%) had amplification, 91 (2%) had activation mutation, and 691 patients (17%) had driver-negative NSCLC. Patient characteristics differed among cohorts as expected. The most common first-line regimen in each cohort was a PD-(L)1 inhibitor as monotherapy or in combination with chemotherapy. The median rwTOT with anti-PD-(L)1 monotherapy was 4.6 months in the driver-negative cohort and ranged from 2.9 months ( mutation) to 7.6 months ( V600E mutation). The median rwTOT with anti-PD-(L)1-chemotherapy combination was 5.2 months in the driver-negative cohort and 6 months in all but the V600E cohort (17.5 mo). The patterns of real-world time to next treatment results were similar.

CONCLUSIONS

Substantial use of anti-PD-(L)1 therapy and associated clinical outcomes are consistent with previous real-world findings and suggest no detriment from PD-(L)1 inhibitors for advanced nonsquamous NSCLC harboring one of these four genomic alterations relative to driver-negative NSCLC.

摘要

引言

关于程序性细胞死亡蛋白或程序性死亡配体1(PD-[L]1)抑制剂在具有罕见致癌改变的非小细胞肺癌(NSCLC)中的应用及临床结果的数据有限。

方法

这项回顾性研究使用了一个身份不明的美国全国临床基因组数据库,以选择2016年1月1日至2020年9月30日期间诊断为晚期非鳞状NSCLC且无 、 或 改变并开始一线治疗的患者。我们的目标是总结具有四种研究较少的基因组改变或驱动基因阴性NSCLC患者的特征和治疗模式。我们估计了接受PD-(L)1抑制剂治疗的患者的Kaplan-Meier真实世界治疗时间(rwTOT)和下次治疗时间。数据截止日期为2021年9月30日。

结果

在3971名符合条件的患者中,84名(2%)患有 V600E突变的NSCLC,117名(3%)患有 外显子14跳跃突变,130名(3%)患有 扩增,91名(2%)患有 激活突变,691名患者(17%)患有驱动基因阴性NSCLC。各队列的患者特征如预期的那样有所不同。每个队列中最常见的一线治疗方案是PD-(L)1抑制剂单药治疗或与化疗联合使用。在驱动基因阴性队列中,抗PD-(L)1单药治疗的中位rwTOT为4.6个月,范围从2.9个月( 突变)到7.6个月( V600E突变)。在驱动基因阴性队列中,抗PD-(L)1-化疗联合治疗的中位rwTOT为5.2个月,除 V600E队列(17.5个月)外,其他队列均为6个月。真实世界下次治疗时间结果的模式相似。

结论

抗PD-(L)1疗法的大量使用及相关临床结果与先前的真实世界研究结果一致,表明对于携带这四种基因组改变之一的晚期非鳞状NSCLC,相对于驱动基因阴性NSCLC,PD-(L)1抑制剂并无损害作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc86/10514206/a728e2acd280/gr1.jpg

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