接受免疫检查点抑制剂的晚期非小细胞肺癌患者停药后生存率：前瞻性队列研究的汇总分析

IF 3.5 Q2 ONCOLOGY

JTO Clinical and Research Reports Pub Date : 2025-05-15 DOI:10.1016/j.jtocrr.2025.100847

Yusuke Inoue MD, PhD , Yoshihiro Kitahara MD , Masato Karayama MD, PhD , Kazuhiro Asada MD, PhD , Koji Nishimoto MD, PhD , Shun Matsuura MD, PhD , Dai Hashimoto MD, PhD , Masato Fujii MD, PhD , Takashi Matsui MD, PhD , Nao Inami MD , Mikio Toyoshima MD, PhD , Hiroyuki Matsuda MD, PhD , Masaki Ikeda MD, PhD , Mitsuru Niwa MD, PhD , Yusuke Kaida MD, PhD , Masaki Sato MD, PhD , Yasuhiro Ito MD , Hideki Yasui MD, PhD , Yuzo Suzuki MD, PhD , Hironao Hozumi MD, PhD , Takafumi Suda MD, PhD

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引用次数: 0

摘要

在晚期NSCLC患者中，由于持续反应而停用免疫检查点抑制剂（ICIs）的安全性仍不确定，基于停药原因的停药后生存结局也没有很好的定义。方法采用四项前瞻性队列研究的数据进行汇总分析，涉及835例停止使用ICIs的晚期NSCLC患者。根据停药原因对患者进行分类：持续反应；免疫相关不良事件（irAEs）（按停药时肿瘤反应分类）；非irae不良事件；疾病进展;还有其他原因。结果疾病进展是ICI停药最常见的原因（N = 528[63.2%]），其次是irAEs （N = 187[22.4%]）和肿瘤反应（N = 23[2.8%]）。关于因irAEs而停药的缓解状态，完全缓解/部分缓解（CR/PR）最为常见（N = 85），其次是疾病稳定/不可评估（SD/NE, N = 69）和疾病进展（N = 33）。在中位停药后随访15.8个月（四分位数范围为6.9-23.2）后，因缓解而停药的患者有很好的结局，没有死亡，只有3个无进展生存事件。虽然irAE-CR/PR组和irAE-SD/NE组停药后总生存期相当，但irAE-CR/PR组ICI治疗≥12个月与ICI停药后生存期改善相关。结论：由于持久的肿瘤反应而停用ICIs在现实环境中是罕见的，但对于晚期NSCLC患者来说是一种可行的策略。如果接受持续≥12个月的ICI治疗，irAE-CR/PR组患者的ICI停药后生存率较高。

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Post-discontinuation Survival in Patients With Advanced NSCLC Receiving Immune Checkpoint Inhibitors: A Pooled Analysis of Prospective Cohort Studies

Introduction

The safety of discontinuing immune checkpoint inhibitors (ICIs) because of a durable response in patients with advanced NSCLC remains uncertain, and post-discontinuation survival outcomes based on the reason for cessation are not well defined.

Methods

A pooled analysis was conducted using data from four prospective cohort studies involving 835 patients with advanced NSCLC who discontinued ICIs. Patients were categorized based on discontinuation reasons: durable response; immune-related adverse events (irAEs) (subcategorized by tumor response at discontinuation); non-irAE adverse events; disease progression; and other causes.

Results

Disease progression was the most common reason for ICI discontinuation (N = 528 [63.2%]), followed by irAEs (N = 187 [22.4%]) and tumor response (N = 23 [2.8%]). Regarding response status at ICI discontinuation due to irAEs, complete/partial response (CR/PR) was the most frequent (N = 85), followed by stable disease/not evaluable (SD/NE, N = 69) and disease progression (N = 33). After a median post-discontinuation follow-up of 15.8 months (interquartile range, 6.9–23.2), patients who discontinued because of a response had excellent outcomes, with no deaths and only three progression-free survival events. While post-discontinuation overall survival was comparable between the irAE-CR/PR and irAE-SD/NE groups, ICI therapy ≥12 months was associated with improved post-ICI discontinuation survival in the irAE-CR/PR group.

Conclusions

Discontinuation of ICIs because of a durable tumor response is rare in real-world settings but represents a feasible strategy for patients with advanced NSCLC. Patients in the irAE-CR/PR group had favorable post-ICI discontinuation survival if they received ICI therapy lasting ≥12 months.

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