Analysis of immune-related adverse events and its correlation with efficacy of anti-PD-1 monotherapy in advanced non-small cell lung cancer

义维丽; 赵文成; 黄东宁; 覃　莉; 吴新天; 周　斐; 吴凤英

doi:10.19401/j.cnki.1007-3639.2021.03.007

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Analysis of immune-related adverse events and its correlation with efficacy of anti-PD-1 monotherapy in advanced non-small cell lung cancer

更新时间：2026-01-27

- Analysis of immune-related adverse events and its correlation with efficacy of anti-PD-1 monotherapy in advanced non-small cell lung cancer
- China Oncology Vol. 31, Issue 3, Pages: 203-211(2021)
- 作者机构：
  
  1. 柳州市工人医院肿瘤科,广西,柳州,545005
  2. 同济大学附属上海市肺科医院肿瘤科,上海,200433
- 作者简介：
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2021.03.007
  CLC： R734.2
- Published Online：01 April 2021，
  
  Published：01 April 2021
- 稿件说明：
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义维丽, 赵文成, 黄东宁, 覃　莉, 吴新天, 周　斐, 吴凤英 . PD-1单抗治疗非小细胞肺癌相关不良反应及其与疗效的相关性分析[J]. 中国癌症杂志, 2021, 31(3): 203-211.

义维丽, 赵文成, 黄东宁, et al. Analysis of immune-related adverse events and its correlation with efficacy of anti-PD-1 monotherapy in advanced non-small cell lung cancer[J]. China Oncology, 2021, 31(3): 203-211.
义维丽, 赵文成, 黄东宁, 覃　莉, 吴新天, 周　斐, 吴凤英 . PD-1单抗治疗非小细胞肺癌相关不良反应及其与疗效的相关性分析[J]. 中国癌症杂志, 2021, 31(3): 203-211. DOI： 10.19401/j.cnki.1007-3639.2021.03.007.

义维丽, 赵文成, 黄东宁, et al. Analysis of immune-related adverse events and its correlation with efficacy of anti-PD-1 monotherapy in advanced non-small cell lung cancer[J]. China Oncology, 2021, 31(3): 203-211. DOI： 10.19401/j.cnki.1007-3639.2021.03.007.

摘要

背景与目的：随着免疫检查点抑制剂在肺癌中的应用增多，免疫相关不良反应（immune-related adverse event，irAE）受到越来越多的重视。分析使用单药免疫治疗肺癌患者的irAE发生情况及其与免疫治疗效果的相关性。方法：回顾性收集同济大学附属上海市肺科医院2015年6月—2019年1月接受抗程序性死亡［蛋白］-1（programmed death-1，PD-1）免疫治疗的晚期非小细胞肺癌患者的基线临床资料、irAE发生的种类、时间、严重程度、处理、转归以及免疫治疗效果［客观缓解率（objective response rate，ORR）、疾病控制率（disease control rate，DCR）、无进展生存期（progression-free survival，PFS）］等资料。使用SPSS 23.0软件，探讨irAE与患者免疫治疗效果的相关性。结果：共109例患者入组，中位年龄64岁（32~82岁），男女比例为89∶20，ECOG体能状态评分0、1、2分者分别为4、103、2例，接受一线、二线、三线及以上治疗的患者分别为15、65、29例。63例（57.8%）患者发生irAE，其中43例出现复合irAE，常见irAE为皮肤反应（28例，25.7%）、免疫性肝炎（18例，16.6%）、疲乏（16例，14.7%）、内分泌系统毒性（15例，13.8%）、免疫性肺炎（12例，11.0%）及胃肠道反应（10例，9.2%）等；irAE常见于6~27周，10例（9.2%）患者发生了3~4级irAE，主要为免疫相关性肺炎。总人群ORR为24.7%，DCR为77.9%，中位PFS为4.6个月（95% CI：3.9~5.2）。irAE组对比非irAE组有着较高的ORR（36.5% vs 8.7%，P=0.001）和中位PFS（8.7个月 vs 3.5个月，HR=0.294，95% CI：0.184~0.469，P0.001)，其中皮肤不良反应与预后最为相关：中位PFS为12.7和4.3个月（HR=2.332，95% CI：1.184~4.595，P=0.014）。结论：肺癌irAE多见于治疗后6~27周，多为1~2级，其中3~4级irAE多为免疫性肺炎，irAE发生与疗效相关。

Abstract

Background and purpose: With the increasing application of immune checkpoint inhibitors in lung cancer

immune-related adverse event (irAE) has attracted more and more attention. This study aimed to analyze the occurrence of irAE in patients receiving single-drug immunotherapy and the correlation between irAE and immunotherapy efficacy. Methods: Data of patients with advanced non-small cell lung cancer (NSCLC) treated with anti-programmed death-1 (PD-1) monotherapy in Shanghai Pulmonary Hospital

Tongji University from June 2015 to Janurary 2019 were collected. Patients’ baseline clinical data

irAE types

occurrence time

severity

management of irAE

the objective response rate (ORR)

disease control rate (DCR) and progression-free survival (PFS) were retrospectively analyzed. And then

we used the SPSS 23.0 software to explore the correlation between irAE and PFS. Results: One hundred and nine advanced NSCLC patients were treated in our hospital. The median age of the patients was 64 years (range 32-82 years). The ratio of male to female was 89∶20. The ECOG performance status scores of 0

1 and 2 were 4

103 and 2 cases respectively. The number of patients who received the first-line

second-line and third-line and above treatment were 15

65 and 29 respectively. At the data cutoff

irAE occurred in 63 patients (57.8%). Among them

43 cases had complex irAE. The most common irAE were skin adverse events (n=28

25.7%). Other irAE were liver dysfunction (n=18

16.6%)

fatigue (n=16

14.7%)

endocrine toxicity (n=15

13.8%)

immune-related pneumonitis (n=12

11.0%) and gastrointestinal toxicity (n=10

9.2%). Most irAE occurred between 6 and 27 weeks. Ten patients (9.2%) had grade 3-4 irAE

mainly immune-related pneumonitis. Among the overall population

ORR was 24.7%

DCR was 77.9%

and median PFS was 4.6 months (95% CI: 3.9-5.2). Patients with irAE had significantly higher ORR compared with patients who did not have irAE (36.5% vs 8.7%

P=0.001). Similarly

the median PFS among patients with irAE was longer than patients without irAE (8.7 months vs 3.5 months

HR=0.294

95% CI: 0.184-0.469

P0.001). Among them

skin adverse events were most correlated with prognosis (median PFS: 12.7 months vs 4.3 months

HR=2.332

95% CI: 1.184-4.595

P=0.014). Conclusion: Most cases of irAE in immunotherapy of lung cancer occurred in 6-27 weeks of treatment

and most of them were grade 1-2. Grade 3-4 irAE were mostly immune-related pneumonitis. Development of irAE was associated with survival outcome.

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