在亚洲人群中缺乏真实世界的数据以调查免疫检查点抑制剂（ICI）单药治疗和联合治疗在非小细胞肺癌（NSCLC）患者中的差异是否基于吸烟状况。在本研究中，我们调查了吸烟状况与ICI治疗NSCLC患者疗效之间的相关性。这项多中心回顾性研究纳入了在2015年12月至2020年7月之间接受ICI治疗的复发性或转移性NSCLC患者。我们使用Fisher's精确检验分析了接受ICI单药治疗或联合治疗的患者的客观缓解率（ORR）以及基于吸烟状况进行的无进展生存期（PFS）和总生存期（OS），并使用Kaplan-Meier方法、log-rank检验和Cox比例风险模型进行分析。共纳入了487名患者。在ICI单药治疗组中，非吸烟者的ORR显著低于吸烟者，PFS和OS显著缩短（10% vs. 26%，p=0.002；中位数：1.8 vs. 3.8个月，p<0.001；中位数：8.0 vs. 15.4个月，p=0.026）。在ICI联合治疗组中，非吸烟者的OS显著长于吸烟者（中位数：未达到vs. 26.3个月，p=0.045），非吸烟者和吸烟者之间的ORR和PFS没有显著差异（63% vs. 51%，p=0.43；中位数：10.2 vs. 9.2个月，p=0.81）。在接受ICI联合治疗的患者的多元分析中，“非吸烟者”状态与PFS（风险比（HR）=1.31；95%置信区间（CI）=0.70-2.45，p=0.40）和OS（HR=0.40；95% CI=0.14-1.13，p=0.083）没有显著关联。采用ICI单药治疗时，非吸烟者的疗效比吸烟者差，但采用ICI联合治疗时两者之间没有显著差异。版权所有 © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios)。

There is no real-world data in an Asian population to investigate the difference between the outcome of immune-checkpoint inhibitor (ICI) monotherapy and combination therapy for non-small cell lung cancer (NSCLC) based on smoking status. In this study, we investigated the correlation between smoking status and the efficacy of ICI therapy for NSCLC patients.This multicentre retrospective study enrolled patients with recurrent or metastatic NSCLC who were treated using ICI therapy between December 2015 and July 2020. We analysed the objective response rate (ORR) of patients who received ICI monotherapy or combination therapy, based on smoking status using Fisher's exact test, and progression-free survival (PFS) and overall survival (OS) based on smoking status using the Kaplan-Meier method, the log-rank test, and Cox proportional hazards model.A total of 487 patients were included in the study. In the ICI monotherapy group, non-smokers showed significantly lower ORR and shorter PFS and OS than smokers (10% vs. 26%, p=0.002; median: 1.8 vs. 3.8 months, p<0.001; median: 8.0 vs. 15.4 months, p=0.026). In the ICI combination therapy group, non-smokers showed significantly longer OS than smokers (median: not reached vs. 26.3 months, p=0.045), and there was no significant difference in ORR and PFS between non-smokers and smokers (63% vs. 51%, p=0.43; median: 10.2 vs. 9.2 months, p=0.81). In the multivariate analysis of patients who received ICI combination therapy, the "non-smoker" status was not significantly associated with PFS [hazard ratio (HR)=1.31; 95% confidence interval (CI)=0.70-2.45, p=0.40] and OS (HR=0.40; 95% CI=0.14-1.13, p=0.083).Non-smokers showed worse outcomes than smokers with ICI monotherapy, but not with ICI combination therapy.Copyright © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.