Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, State Key Laboratory of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, 151# Yanjiang Road, Guangzhou, 510120, China.
Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Clin Drug Investig. 2023 May;43(5):347-357. doi: 10.1007/s40261-023-01267-6. Epub 2023 Apr 25.
Checkpoint inhibitor-related pneumonitis (CIP) is one of the most common serious and fatal adverse events associated with immune checkpoint inhibitors (ICIs). The study sought to identify risk factors of all-grade and severe CIP and to construct a risk-scoring model specifically for severe CIP.
This observational, retrospective case-control study involved 666 lung cancer patients who received ICIs between April 2018 and March 2021. The study analyzed patient demographic, preexisting lung diseases, and the characteristics and treatment of lung cancer to determine the risk factors for all-grade and severe CIP. A risk score for severe CIP was developed and validated in a separate patient cohort of 187 patients.
Among 666 patients, 95 patients were afflicted with CIP, of which 37 were severe cases. Multivariate analysis revealed age ≥ 65 years, current smoking, chronic obstructive pulmonary disease, squamous cell carcinoma, prior thoracic radiotherapy, and extra-thoracic radiotherapy during ICI were independently associated with CIP events. Five factors, emphysema (odds ratio [OR] 2.87), interstitial lung disease (OR 4.76), pleural effusion (OR 3.00), history of radiotherapy during ICI (OR 4.30), and single-agent immunotherapy (OR 2.44) were independently associated with severe CIP and were incorporated into a risk-score model (score ranging 0-17). The area under the model receiver operating characteristic curve for the model was 0.769 in the development cohort and 0.749 in the validation cohort.
The simple risk-scoring model may predict severe CIP in lung cancer patients receiving ICIs. For patients with high scores, clinicians should use ICIs with caution or strengthen the monitoring of these patients.
免疫检查点抑制剂(ICI)相关肺炎(CIP)是与免疫检查点抑制剂相关的最常见的严重和致命的不良事件之一。本研究旨在确定所有级别和严重 CIP 的风险因素,并构建一个专门用于严重 CIP 的风险评分模型。
这是一项观察性、回顾性病例对照研究,共纳入 666 例 2018 年 4 月至 2021 年 3 月期间接受 ICI 治疗的肺癌患者。本研究分析了患者的人口统计学、既往肺部疾病以及肺癌的特征和治疗情况,以确定所有级别和严重 CIP 的风险因素。在另外 187 例患者的患者队列中,开发并验证了严重 CIP 的风险评分。
在 666 例患者中,有 95 例患有 CIP,其中 37 例为严重病例。多变量分析显示,年龄≥65 岁、当前吸烟、慢性阻塞性肺疾病、鳞状细胞癌、ICI 期间的既往胸部放疗和胸部外放疗与 CIP 事件独立相关。5 个因素,肺气肿(优势比 [OR] 2.87)、间质性肺病(OR 4.76)、胸腔积液(OR 3.00)、ICI 期间的放疗史(OR 4.30)和单药免疫治疗(OR 2.44)与严重 CIP 独立相关,并被纳入风险评分模型(评分范围 0-17)。该模型在开发队列中的模型受试者工作特征曲线下面积为 0.769,在验证队列中的面积为 0.749。
该简单的风险评分模型可预测接受 ICI 治疗的肺癌患者中严重 CIP 的发生。对于评分较高的患者,临床医生应谨慎使用 ICI 或加强对这些患者的监测。