在NSCLC中的双免疫疗法:随机临床试验的系统审查和元分析
Yike Zhang1, Haozhe Wang1, Xinyue Yang1
1Department of Biophysics, College of Basic Medical Sciences, Naval Medical University, Shanghai, China.
Frontiers in immunology
|September 26, 2025
概括
双重向免疫疗法可以改善晚期非小细胞肺癌 (NSCLC) 的无进展生存率 (PFS) 和客观反应率 (ORR). 然而,这些新型疗法增加了毒性风险,需要进一步研究以优化安全性和患者选择.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 尽管目前的治疗方法,但高级非小细胞肺癌 (NSCLC) 的预后不佳.
- 双特异性抗体 (BsAbs) 是新兴的双重向免疫疗法.
- 关于BsAbs在NSCLC中的比较疗效和安全性的定量数据有限.
研究的目的:
- 系统地审查和元分析III期RCT,比较双向免疫疗法与先进NSCLC的常规疗法.
- 评估双重向免疫疗法对无进展生存 (PFS),总生存 (OS),客观反应率 (ORR) 和疾病控制率 (DCR) 的影响.
- 评估安全性,包括与治疗相关的不良事件 (AE).
主要方法:
- 在PubMed,科学网,Scopus和Embase的系统文献搜索.
- 包括六项III期随机对照试验 (RCT),涉及3063名患者.
- 随机效应模型用于PFS,OS,ORR,DCR和AE的元分析.
主要成果:
- 与传统疗法相比,双重向免疫疗法显著改善了PFS (HR=0.58) 和ORR (RR=1.29).
- 在OS (HR=0.84) 或DCR (RR=1.09) 中没有观察到显著改善.
- 任何副作用的风险增加 (RR=1.05),等级≥3的副作用 (RR=1.63),严重的副作用 (RR=1.49),以及因副作用而中止治疗 (RR=2.49) 与双重向免疫疗法有关.
结论:
- 双向免疫疗法在晚期NSCLC中显示出优异的PFS和ORR,但与毒性增加有关.
- 特别是EGFR/MET向剂与高毒性有关.
- 进一步的研究对于安全优化,生物标志物驱动的患者选择和长期生存益处的验证至关重要.
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