Assessment of Immune-Related Interstitial Lung Disease in Patients With NSCLC Treated with Immune Checkpoint Inhibitors: A Multicenter Prospective Study
Assessment of Immune-Related Interstitial Lung Disease in Patients With NSCLC Treated with Immune Checkpoint Inhibitors: A Multicenter Prospective Study
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DOI：
10.1016/j.jtho.2020.04.002
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发表时间：
2020-08-01
影响因子：
20.4
通讯作者：
Suda, Takafumi
中科院分区：
文献类型：
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作者：
Suzuki, Yuzo;Karayama, Masato;Suda, Takafumi
前言：程序性细胞死亡蛋白1免疫检查点抑制剂(ICIS)已被报道可改善非小细胞肺癌患者的生存。随着各种癌症临床用药的扩大，免疫相关的不良事件通常被认为与ICIS有关，因此，有必要对这些患者进行监测和管理。在免疫相关的不良事件中，免疫相关间质性肺病(ir-ILD)是一种严重的并发症，会中断治疗，有时甚至是致命的。然而，目前尚无前瞻性研究调查IR-ILD的发病率及其在临床环境中发展的相关危险因素。方法：这是一项由接受ICIS治疗的NSCLC患者组成的前瞻性队列研究。结果：在138例接受抗程序性细胞死亡蛋白1单一治疗的非小细胞肺癌患者中，20例(14.5%)患者在中位51.5天(四分位数范围29-147)内发生了IR-ILD。这大约是临床试验中的三倍。共有11名患者(55.0%)在60天内发展为IR-ILD，其中包括所有8名高级别IR-ILD患者(=3级)。肺活量测定受损、1秒用力肺活量和用力呼气量下降以及使用修订的医学研究理事会量表测量的日常呼吸困难症状被确定为发生IR-ILD的危险因素。此外，1秒用力肺活量和用力呼气量的联合评估成功地将IR-ILD患者分为发生IR-ILD的高危人群。ICI治疗前的肺活量测定和日常呼吸困难症状的评估可能有助于监测和处理非小细胞肺癌患者。(C)2020年国际肺癌研究协会。爱思唯尔公司出版，版权所有。
Introduction: Programmed cell death protein 1 immune checkpoint inhibitors (ICIs) have been reported to improve the survival of patients with NSCLC. On the expansion of clinical administration for a variety of cancers, immune-related adverse events have been typically recognized to be associated with ICIs, therefore, necessitating the monitoring and management of these patients. Among immune-related adverse events, immune-related interstitial lung disease (ir-ILD) is a serious complication that interrupts treatment and can occasionally be fatal. However, no prospective studies have investigated the incidence of ir-ILD and associated risk factors for its development in the clinical setting.Methods: This is a prospective cohort study consisting of patients with NSCLC treated with ICIs. Baseline characteristics, including laboratory data, pulmonary function tests, daily symptoms of dyspnea defined by the modified Medical Research Council, and antitumor response were assessed.Results: Among the 138 patients with NSCLC who received anti-programmed cell death protein 1 monotherapy, 20 patients (14.5%) had ir-ILD within median 51.5 days (interquartile range: 29-147). This was approximately three times higher than those in clinical trials. A total of 11 patients (55.0%), including all eight patients with high-grade ir-ILD (>= grade 3), developed ir-ILD within 60 days. Impaired spirometry, decreased forced vital capacity and forced expiratory volume in 1 second, and daily symptoms of dyspnea measured using the modified Medical Research Council scale were identified as risk factors for ir-ILD development. In addition, combination assessment of forced vital capacity and forced expiratory volume in 1 second successfully classified patients at risk for ir-ILD development.Conclusions: The incidence of ir-ILD was substantially higher in the clinical setting. Assessment of spirometry and daily dyspneic symptoms before ICI treatment may be useful in monitoring and managing patients with NSCLC. (C) 2020 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.