基于iRECIST标准的晚期NSCLC免疫治疗的真实世界研究

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基于iRECIST标准的晚期NSCLC免疫治疗的真实世界研究

临床医学 | 更新时间：2026-01-09

- 基于iRECIST标准的晚期NSCLC免疫治疗的真实世界研究
- Real-world research of advanced NSCLC immunotherapy based on iRECIST criteria
- 第三军医大学学报 2020年42卷第5期页码：480-486
- 作者机构：
  
  400037 重庆，陆军军医大学(第三军医大学)第二附属医院全军肿瘤研究所
- 作者简介：
  
  [孙建国，E-mail:sunjg09@aliyun.comSUN Jianguo, E-mail: sunjg09@aliyun.com
- 基金信息：
  
  国家自然科学基金面上项目(81972858);国家自然科学基金青年科学基金(81602688);2018年度陆军军医大学临床医学科研人才培养计划(2018XLC1010);重庆市自然科学基金(CSTS2016jcyjA0531)
- DOI：10.16016/j.1000-5404.201910122
  中图分类号： R181.32;R730.51;R734.2
- 收稿：2019-10-19，
  
  修回：2019-12-26，
  
  纸质出版：2020-03-15
- 稿件说明：
移动端阅览
陈明镜, 杨峤, 许子寒, 等. 基于iRECIST标准的晚期NSCLC免疫治疗的真实世界研究[J]. 第三军医大学学报, 2020,42(5):480-486.

Mingjing CHEN, Qiao YANG, Zihan XU, et al. Real-world research of advanced NSCLC immunotherapy based on iRECIST criteria[J]. Journal of Third Military Medical University, 2020, 42(5): 480-486.
陈明镜, 杨峤, 许子寒, 等. 基于iRECIST标准的晚期NSCLC免疫治疗的真实世界研究[J]. 第三军医大学学报, 2020,42(5):480-486. DOI： 10.16016/j.1000-5404.201910122.

Mingjing CHEN, Qiao YANG, Zihan XU, et al. Real-world research of advanced NSCLC immunotherapy based on iRECIST criteria[J]. Journal of Third Military Medical University, 2020, 42(5): 480-486. DOI： 10.16016/j.1000-5404.201910122.

摘要

目的

2

根据iRECIST标准(modified RECIST1.1 for immune based therapeutics)，评估免疫检查点抑制剂(immune checkpoint inhibitors

ICIs)治疗晚期非小细胞肺癌(non-small cell lung cancer

NSCLC)的真实世界数据。

方法

2

按真实世界研究方法，纳入本院2016年8月10日至2019年7月10日接受免疫检查点抑制剂治疗的晚期NSCLC患者，按iRECIST标准评估一线单药、一线联合、二线单药、二线联合的临床疗效，包括最佳应答(best overall response

bOR)、无进展生存时间(progression-free survival

PFS)、缓解持续时间(duration of response

DoR)等，并评价免疫相关不良反应(immue-related adverse events

irAEs)。

结果

2

共纳入61例Ⅳ期NSCLC患者，其中男性54例，女性7例；中位年龄58岁；腺癌31例，鳞癌30例。一线单药bOR为27.3%，中位PFS(mPFS)为11.8个月；一线联合bOR为47.1%，mPFS未达到；一线总体bOR为35.9%，mPFS为11.8个月；二线单药bOR为30%，mPFS为6.0个月；二线联合bOR为41.7%，mPFS未达到；二线总体bOR为36.4%，mPFS为6.3个月。最常见的irAEs为1~2级皮肤毒性(5例

8.20%)。

结论

2

基于iRECIST标准评估免疫检测点抑制剂治疗晚期NSCLC的真实世界研究显示，一线单药、一线联合及二线单药bOR及PFS获益优于既往RCT研究结果，而二线联合的bOR及PFS显著优于单药治疗，irAEs可控。

Abstract

Objective

2

To analyze the real-world data about immune checkpoint inhibitors (ICIs) for advanced non-small cell lung cancer (NSCLC) based on the modified RECIST 1.1 for immune based therapeutics (iRECIST).

Methods

2

According to real-world research methods

all advanced NSCLC patients treated with immune checkpoint inhibitors (ICIs) in our hospital from August 10

2016 to July 10

2019 were enrolled in this study. The efficacy

including best overall response (bOR)

progression-free survival (PFS) and duration of response (DoR) was evaluated in first-line monotherapy

first-line combination

second-line monotherapy and second-line combination based on iRECIST. Also

immune-related adverse events (irAEs) were evaluated.

Results

2

A total of 61 patients (54 males and 7 females) with stage IV NSCLC were included

at a median age of 58 years

and there were 31 cases of adenocarcinoma and 30 cases of squamous carcinoma. The bOR and mPFS were 27.3% and 11.8 months

respectively

for first-line monotherapy; 47.1% and not reached (NR)

respectively

for first-line combination

and 35.9% and 11.8 months

respectively

for first-line totally. And the bOR and mPFS were 30% and 6.0 months

respectively

for the second-line monotherapy; were 41.7% and NR

respectively

for second-line combination; and were 36.4% and 6.3 months

respectively for second-line totally. The most common irAEs was grade 1~2 skin toxicity (5 cases

8.2%).

Conclusion

2

Our results show that bOR and PFS of first-line monotherapy

first-line combination

second-line monotherapy are better than the results of previous RCT

and bOR and PFS of second-line combination are significantly better than second-line monotherapy. irAEs are controllable study.

关键词

Keywords

references

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