国际肿瘤学杂志

国际肿瘤学杂志 ›› 2025, Vol. 52 ›› Issue (7): 419-425.doi: 10.3760/cma.j.cn371439-20241030-00073

• 论著 • 上一篇    下一篇

驱动基因阴性晚期NSCLC一线免疫及其联合治疗进展后不同二线治疗策略疗效的真实世界研究

张露莹1, 梁嘉欣2, 赵可雷1, 袁晓晗1, 刘亮博1, 路平1, 张桂芳2, 张敏1()   

  1. 1新乡医学院第一附属医院肿瘤内二科，新乡 453000
    2新乡市中心医院肿瘤内二科，新乡 453000
  • 收稿日期:2024-10-30 修回日期:2025-04-24 出版日期:2025-07-08 发布日期:2025-07-23
  • 通讯作者: 张敏 E-mail:zhangmin1982@xxmu.edu.cn
  • 基金资助:
    河南省医学科技攻关计划(LHGJ20230508);吴阶平医学基金会临床科研专项资助基金(320.6750.19088-33);希思科-领航肿瘤研究基金(Y-2019AZON-0431);河南省引进国外智力专项计划(HNGD2024029);新乡医学院研究生科研创新支持计划(YJSCX202449Y)

A real-world study on efficacy of different second-line treatment strategies following the progression of first-line immunotherapy and its combination therapies in driver gene-negative advanced non-small cell lung cancer

Zhang Luying1, Liang Jiaxin2, Zhao Kelei1, Yuan Xiaohan1, Liu Liangbo1, Lu Ping1, Zhang Guifang2, Zhang Min1()   

  1. 1Second Department of Oncology，First Affiliated Hospital of Xinxiang Medical University，Xinxiang 453000，China
    2Second Department of Oncology，Xinxiang Central Hospital，Xinxiang 453000，China
  • Received:2024-10-30 Revised:2025-04-24 Online:2025-07-08 Published:2025-07-23
  • Contact: Zhang Min E-mail:zhangmin1982@xxmu.edu.cn
  • Supported by:
    Medical Science and Technology Research Key Project of Henan Province of China(LHGJ20230508);Wu Jieping Medical Foundation Special Fund for Clinical Research(320.6750.19088-33);Xisike-leader Oncology Research Foundation(Y-2019AZON-0431);Special Program for the Introduction of Foreign Talent of Henan Province of China(HNGD2024029);Graduate Student Research and Innovation Support Program of Xinxiang Medical University(YJSCX202449Y)

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摘要：

目的 探讨驱动基因阴性晚期非小细胞肺癌（NSCLC）患者一线免疫及其联合治疗进展后不同二线治疗策略在真实世界的疗效。方法 回顾性分析2018年1月1日至2023年12月31日在新乡医学院第一附属医院、新乡市中心医院收治的93例一线行免疫及其联合治疗的驱动基因阴性晚期NSCLC患者的临床资料。根据一线治疗后无进展生存期（PFS）是否超过6个月，将患者分为免疫检查点抑制剂（ICI）耐药组（n=43）和ICI应答组（n=50）；根据一线免疫及其联合治疗进展后的不同二线治疗策略，将患者分为ICI治疗组（n=55）和非ICI治疗组（n=38）、抗血管生成治疗组（n=51）和非抗血管生成治疗组（n=42）。比较各组患者二线治疗的中位PFS2（mPFS2）及中位总生存期（mOS）2。采用Kaplan-Meier法进行生存分析。结果 93例一线ICI治疗后进展的晚期NSCLC患者的mPFS2为4.9个月（95%CI为4.1~5.7个月），mOS2为14.7个月（95%CI为11.2~18.2个月）。一线ICI应答组和ICI耐药组患者的mPFS2分别为6.0、3.8个月，差异无统计学意义（χ2=2.00，P=0.157），mOS2分别为25.3、11.3个月，差异有统计学意义（χ2=12.13，P<0.001）。二线ICI治疗组与非ICI治疗组患者的mPFS2分别为5.2、4.6个月，差异无统计学意义（χ2=0.16，P=0.687），mOS2分别为15.1、12.7个月，差异无统计学意义（χ2=0.01，P=0.930）。二线抗血管生成治疗组和非抗血管生成治疗组患者的mPFS2分别为4.5、6.0个月，差异无统计学意义（χ2=0.41，P=0.525），mOS2分别为14.7、16.8个月，差异无统计学意义（χ2=0.01，P=0.943）。结论 驱动基因阴性晚期NSCLC患者一线ICI治疗进展后，一线ICI应答患者较ICI耐药患者二线治疗的OS显著延长。一线ICI治疗进展后患者二线治疗的疗效并不因治疗策略不同而存在差异。

关键词: 癌，非小细胞肺, 免疫检查点抑制剂, 治疗结果

Abstract:

Objective To explore the efficacy of different second-line treatment strategies in the real world after progression of first-line immunotherapy and its combination therapies in patients with driver gene-negative advanced non-small cell lung cancer （NSCLC）. Methods A retrospective analysis was conducted on the clinical data of 93 driver gene-negative advanced NSCLC patients who received first-line immunotherapy and its combination therapies from January 1，2018 to December 31，2023 at the First Affiliated Hospital of Xinxiang Medical University and Xinxiang Central Hospital. Patients were categorized into immune checkpoint inhibitors （ICIs）-resistant （n=43） and ICIs-responsive （n=50） groups according to whether progression free survival （PFS） exceeded 6 months after first-line treatment. Patients were categorized into ICIs-treated （n=55） and non-ICIs-treated （n=38），anti-angiogenic-treated （n=51） and non-anti-angiogenic-treated （n=42） groups according to the different second-line treatment strategies after progression of first-line immunotherapy and its combination therapies. The median PFS2 （mPFS2） and median overall survival （mOS）2 after second-line treatment of each group were compared. The Kaplan-Meier method was used for survival analysis. Results The mPFS2 and mOS2 of 93 advanced NSCLC patients who progressed after first-line ICIs treatment were 4.9 months （95%CI： 4.1-5.7 months） and 14.7 months （95%CI： 11.2-18.2 months）. The mPFS2 of patients in the first-line ICIs-responsive and ICIs-resistant groups were 6.0 and 3.8 months，respectively，with no statistically significant difference （χ2=2.00，P=0.157），and the mOS2 were 25.3 and 11.3 months，respectively，with a statistically significant difference （χ2=12.13，P<0.001）. The mPFS2 of patients in the second-line ICIs-treated group and the non-ICIs-treated group were 5.2 and 4.6 months，respectively，with no statistically significant difference （χ2=0.16，P=0.687）. The mOS2 were 15.1 and 12.7 months，respectively，with no statistically significant difference （χ2=0.01，P=0.930）. The mPFS2 of patients in the second-line anti-angiogenic-treated and non-anti-angiogenic-treated groups were 4.5 and 6.0 months，respectively，with no statistically significant difference （χ2=0.41，P=0.525），the mOS2 were 14.7 and 16.8 months，respectively，with no statistically significant difference （χ2=0.01，P=0.943）. Conclusions After progression of first-line ICIs therapy in patients with driver gene-negative advanced NSCLC，first-line ICIs-responsive patients have significantly longer OS after second-line treatment compared with ICIs-resistant patients. The efficacy of second-line therapy in patients after progression of first-line ICIs therapy does not show significant differences due to the type of treatment strategies.

Key words: Carcinoma，non-small-cell lung, Immune checkpoint inhibitors, Treatment outcome