Late Immune-Related Adverse Events After At Least Two Years of Immune Checkpoint Inhibitor Therapy: Incidence and Association With Survival in Patients With Advanced NSCLC

IF 3.5 Q2 ONCOLOGY

JTO Clinical and Research Reports Pub Date : 2025-05-26 DOI:10.1016/j.jtocrr.2025.100851

Omar Elghawy MD, Adam Barsouk MD, Jonathan H. Sussman BS, Benjamin A. Bleiberg MD, Lauren Reed-Guy MD, Christopher D’Avella MD, Aditi Singh MD, Christine Ciunci MD, MSCE, Kyle Robinson MD, John Kosteva MD, Corey Langer MD, Roger B. Cohen MD, Charu Aggarwal MD, MPH, Melina Marmarelis MD, MSCE, Lova Sun MD, MSCE

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Abstract

Background

Limited data are available on late immune-related adverse events (IRAEs) in patients with metastatic NSCLC receiving immunotherapy (ICI) beyond 2 years.

Methods

A single-institution retrospective analysis including patients who received longer than 2 years of ICI therapy for metastatic NSCLC between 2012 and 2023 was performed. Late IRAEs were defined as those occurring longer than 2 years after initiation of ICI therapy. The association of late IRAE with OS and PFS was assessed using an extended Cox regression with late IRAE modeled as a time-varying covariate.

Results

In a cohort of 76 patients who received longer than 2 years of ICI, the median duration of treatment was 41.9 months, and 44 out of 76 (58%) experienced an early IRAE before 2 years. After 2 years on ICI, 38 out of 76 (50%) of patients experienced a late IRAE, many of whom (39%) had no previous early IRAE. Higher rates of late IRAEs were seen in females (p = 0.032), White patients (p = 0.041), and patients with previous grade 2 or higher IRAE (p = 0.020). Late IRAE occurrence was not associated with median progression-free survival or median overall survival.

Conclusions

In patients receiving extended-duration ICI beyond 2 years, late IRAEs were common and often occurred in patients without previous history of IRAE. These findings support consideration of ICI discontinuation at 2 years.

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至少两年免疫检查点抑制剂治疗后晚期免疫相关不良事件：晚期非小细胞肺癌患者的发病率及其与生存率的关系

在接受免疫治疗（ICI）超过2年的转移性非小细胞肺癌患者中，晚期免疫相关不良事件（IRAEs）的数据有限。方法对2012年至2023年间接受ICI治疗超过2年的转移性NSCLC患者进行单机构回顾性分析。晚期IRAEs被定义为在ICI治疗开始后超过2年发生的IRAEs。使用扩展Cox回归评估晚期IRAE与OS和PFS的关联，将晚期IRAE建模为时变协变量。结果在76例接受2年以上ICI的患者中，中位治疗时间为41.9个月，76例患者中有44例（58%）在2年前经历了早期IRAE。在ICI治疗2年后，76例患者中有38例（50%）经历了晚期IRAE，其中许多患者（39%）之前没有早期IRAE。晚期IRAE发生率较高的患者为女性（p = 0.032）、白人患者（p = 0.041）和既往IRAE为2级或以上的患者（p = 0.020）。晚期IRAE的发生与中位无进展生存期或中位总生存期无关。结论在接受2年以上延长疗程ICI的患者中，晚期IRAE较为常见，且多发生在无IRAE病史的患者中。这些发现支持考虑在2年时停用ICI。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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