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晚期非小细胞肺癌双重免疫疗法的真实世界单中心数据分析:疗效、生存率及不良事件

Real-world single-center data analysis of dual immunotherapy in advanced NSCLC: Efficacy, survival, and adverse events.

作者信息

Luan Tao, Hao Jianqing, Xie Xiaohong, Lin Xinqing, Wang Shuaiying, Yu Baodan, Yang Qingqing, Wang Changchun, Luan Yang, Yang Gang, Lu Hanxiu, Sun Ping, Zhang Yunhui, Zhong Nanshan, Zhou Chengzhi

机构信息

Faculty of Life science and Technology, Kunming University of Science and Technology, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, China.

National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, P.R.China.

出版信息

Hum Vaccin Immunother. 2025 Dec;21(1):2542068. doi: 10.1080/21645515.2025.2542068. Epub 2025 Aug 4.

Abstract

We collected 96 patients who received dual immunotherapy between January 2019 and June 2024, in a 1:1:1 ratio based on PD-L1 expression levels of negative (<1%), medium (1% ≤ PD-L1 ≤ 49%), and high (PD-L1 ≥ 50%). This study evaluates the efficacy and safety of dual immunotherapy in patients with advanced NSCLC, stratified by PD-L1 expression levels. Among the 96 patients, the objective response rate (ORR) was 37.5%, disease control rate (DCR) was 67.8%. In the multivariate analysis of PFS, PD-L1 ≥ 50% (HR = 0.40, 95% CI: 0.22-0.74) was identified as a protective factor for PFS, while PS Score ≥ 2 (HR = 2.74, 95% CI: 1.11-6.77) and stage IV tumors (HR = 2.05, 95% CI: 1.02-4.12) were risk factors. In the multivariate analysis of OS, PD-L1 between 1% and 49% (HR = 0.51, 95% CI: 0.28-0.90) and PD-L1 ≥ 50% (HR = 0.31, 95% CI: 0.17-0.57) were protective factors, with no risk factors detected. The incidence of adverse events was 77.1%, with a 34.3% incidence of grade 3-4 immune-related adverse events. And PD-L1 ≥ 50% group adverse events incidence more common, with an overall incidence of 87.5% and a grade 3-4 incidence of 40.6%. Patients with high PD-L1 expression (≥50%) demonstrated improved progression-free survival (PFS, HR = 0.40) and overall survival (OS, HR = 0.31) but experienced a higher incidence of severe adverse events (40.6%).

摘要

我们收集了2019年1月至2024年6月期间接受双免疫疗法的96例患者,根据程序性死亡受体配体1(PD-L1)表达水平阴性(<1%)、中等(1%≤PD-L1≤49%)和高(PD-L1≥50%)按1:1:1的比例分组。本研究评估了双免疫疗法在晚期非小细胞肺癌(NSCLC)患者中的疗效和安全性,并根据PD-L1表达水平进行分层。在这96例患者中,客观缓解率(ORR)为37.5%,疾病控制率(DCR)为67.8%。在无进展生存期(PFS)的多因素分析中,PD-L1≥50%(风险比[HR]=0.40,95%置信区间[CI]:0.22-0.74)被确定为PFS的保护因素,而体能状态(PS)评分≥2(HR=2.74,95%CI:1.11-6.77)和IV期肿瘤(HR=2.05,95%CI:1.02-4.12)是危险因素。在总生存期(OS)的多因素分析中,PD-L1在1%至49%之间(HR=0.51,95%CI:0.28-0.90)和PD-L1≥50%(HR=0.31,95%CI:0.17-0.57)是保护因素,未检测到危险因素。不良事件发生率为77.1%,3-4级免疫相关不良事件发生率为34.3%。且PD-L1≥50%组不良事件发生率更高,总发生率为87.5%,3-4级发生率为40.6%。PD-L1高表达(≥50%)的患者无进展生存期(PFS,HR=0.40)和总生存期(OS,HR=0.31)得到改善,但严重不良事件发生率更高(40.6%)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/83d7/12323414/fd2269dce48e/KHVI_A_2542068_F0001_OC.jpg

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