Cui Shaohua, Ge Xiaoxiao, Li Xiangyang
Department of Respiratory and Critical Care Medicine, Huadong Hospital, Fudan University, Shanghai 200040, China.
Zhongguo Fei Ai Za Zhi. 2023 Apr 20;26(4):257-264. doi: 10.3779/j.issn.1009-3419.2023.101.08.
Immune-related adverse events (irAEs) are commonly occurred in patients treated with immune checkpoint inhibitors. However, evidence of irAEs derived from the Chinese population is relatively lacking. The aim of this study was to investigate the incidence and outcomes of irAEs in Chinese patients with lung cancer after receiving immune checkpoint inhibitors (ICIs).
Clinical and follow-up data from lung cancer patients who received at least one time of ICIs from January 2018 to September 2021 at Huadong Hospital, Fudan University were included. Statistical descriptions and Kaplan-Meier method were used to analyze the overall incidence of irAEs, as well as the incidence and outcomes of each type of irAEs.
135 patients were included in the study. 106 patients (78.5%) presented at least one type of irAEs, and the median time to first irAEs onset was 28 d. Most irAEs occurred at early time after treatment, and most irAEs were mild-moderate and reversible. 57 patients (42.2%) died at the study cutoff. The mortality rate of severe irAEs was 12.6% (n=17), and among them 7 patients (41.2%) died of pneumonitis. The median progression-free survival (PFS) and overall survival (OS) time of the total population was 505 d (95%CI: 352-658) and 625 d (95%CI: 491-759), respectively. Patients who presented any irAEs achieved a longer PFS than those who did not (median PFS: 533 d vs 179 d, P=0.037, HR=0.57), while patients who presented skin toxicities achieved a longer OS than patients who did not (median OS: 797 d vs 469 d, P=0.006, HR=0.70).
In real-world settings, irAEs in lung cancer patients were commonly observed, with pneumonitis as the most common fatal irAEs. In addition, patients who presented any irAEs may tend to achieve a longer PFS.
免疫相关不良事件（irAEs）在接受免疫检查点抑制剂治疗的患者中普遍发生。然而，来自中国人群的irAEs证据相对较少。本研究的目的是调查中国肺癌患者接受免疫检查点抑制剂（ICIs）后irAEs的发生率及转归。
纳入2018年1月至2021年9月在复旦大学附属华东医院接受至少一次ICIs治疗的肺癌患者的临床和随访数据。采用统计描述和Kaplan-Meier法分析irAEs的总体发生率，以及各类型irAEs的发生率和转归。
本研究共纳入135例患者。106例患者（78.5%）出现至少一种类型的irAEs，首次出现irAEs的中位时间为28天。大多数irAEs发生在治疗后的早期，且大多数为轻-中度且可逆转。57例患者（42.2%）在研究截止时死亡。严重irAEs的死亡率为12.6%（n=17），其中7例患者（41.2%）死于肺炎。总体人群的中位无进展生存期（PFS）和总生存期（OS）分别为505天（95%CI：352-658）和625天（95%CI：491-759）。出现任何irAEs的患者的PFS长于未出现者（中位PFS：533天 vs 179天，P=0.037，HR=0.57），而出现皮肤毒性的患者的OS长于未出现者（中位OS：797天 vs 469天，P=0.006，HR=0.70）。
在真实世界中，肺癌患者的irAEs较为常见，肺炎是最常见的致命性irAEs。此外，出现任何irAEs的患者可能倾向于获得更长的PFS。
