免疫检查点抑制剂对表皮生长因子受体酪氨酸激酶抑制剂治疗进展的晚期表皮生长因子受体突变非小细胞肺癌患者的疗效和安全性:系统综述、荟萃分析和网络荟萃分析。

IF 41.6 1区 医学 Q1 ONCOLOGY Lancet Oncology Pub Date : 2024-10-01 Epub Date: 2024-08-16 DOI:10.1016/S1470-2045(24)00379-6
Yi Zhao, Ying He, Wei Wang, Qi Cai, Fan Ge, Zisheng Chen, Jianqi Zheng, Yuan Zhang, Hongsheng Deng, Ying Chen, Shen Lao, Hengrui Liang, Wenhua Liang, Jianxing He
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引用次数: 0

摘要

背景:基于免疫检查点抑制剂(ICI)的治疗方法在治疗表皮生长因子受体酪氨酸激酶抑制剂(TKIs)治疗进展的晚期表皮生长因子受体突变非小细胞肺癌(NSCLC)患者中的临床获益仍存在争议。我们旨在回顾文献,全面研究基于 ICI 的各种治疗策略在这一人群中的个体和比较临床结果:在本系统综述和荟萃分析中,我们采用了单臂、配对和网络荟萃分析方法。我们检索了PubMed、Embase、Cochrane图书馆、Web of Science、ClinicalTrials.gov以及相关国际会议论文集,检索时间从数据库建立之初到2024年1月31日,没有语言限制,以确定符合条件的临床试验,这些临床试验评估了基于ICI的治疗方法,用于EGFR-TKIs治疗进展的晚期EGFR突变NSCLC患者。符合条件的研究是已发表和未发表的 1、2 或 3 期临床试验,这些试验招募了组织学或细胞学确诊的晚期表皮生长因子受体突变 NSCLC 患者,这些患者在接受至少一种表皮生长因子受体-TKI 治疗后病情有所进展,而且这些试验评估了 ICI 治疗策略对至少一种相关临床结果的影响。分析的主要结果是无进展生存期。该方案已在 PROSPERO 注册,编号为 CRD42021292626:17项单臂试验和15项随机对照试验涉及2886名参与者和7种基于ICI的治疗策略(ICI单药治疗、ICI加化疗[ICI-chemo]、ICI加抗血管生成[ICI-antiangio]、ICI加抗血管生成加化疗[ICI-antiangio-chemo]、双ICIs[ICI-ICI]、双ICIs加化疗[ICI-ICI-chemo]和ICI加EGFR-TKI[ICI-TKI])。其中三种策略--ICI 单药治疗、ICI-抗组胺化疗和 ICI-化疗--在纳入的研究中有足够的数据进行配对荟萃分析。成对荟萃分析表明,与化疗相比,ICI单药治疗导致的无进展生存期更短(危险比[HR] 1-73 [95% CI 1-30-2-29],I2=0%),而ICI-抗血管化疗(HR 0-54 [0-44-0-67], I2=0%)和ICI-化疗(HR 0-77 [0-67-0-88], I2=0%)延长了无进展生存期。网络荟萃分析表明,ICI-抗强直-化疗的无进展生存率最佳,与ICI-化疗(HR 0-71 [95% 可信区间为0-59-0-85])、ICI单药治疗(HR 0-30 [0-22-0-41])以及包括抗强直-化疗(HR 0-76 [0-58-1-00])和单纯化疗(HR 0-54 [0-45-0-64])在内的非ICI治疗策略相比,ICI-抗强直-化疗获益巨大。在网络荟萃分析中,与ICI-化疗和化疗相比,ICI-抗强化疗发生任何级别和3级或更严重不良事件的风险更高:对于EGFR-TKIs治疗进展的晚期EGFR突变NSCLC患者,ICI-抗肿瘤化疗被认为是最佳治疗方案。这种治疗方法的毒性是可以接受的,但需要谨慎对待。ICI-化疗的疗效明显优于常规化疗。这些研究结果明确了基于ICI的治疗策略在这一难以治疗的难治性人群中的作用,有可能对近期的指南起到补充作用:无。
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Efficacy and safety of immune checkpoint inhibitors for individuals with advanced EGFR-mutated non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitors: a systematic review, meta-analysis, and network meta-analysis.

Background: The clinical benefits of immune checkpoint inhibitor (ICI)-based treatments in treating individuals with advanced EGFR-mutated non-small-cell lung cancer (NSCLC) who have progressed on EGFR tyrosine-kinase inhibitors (TKIs) remain controversial. We aimed to review the literature to comprehensively investigate the individual and comparative clinical outcomes of various ICI-based treatment strategies in this population.

Methods: In this systematic review and meta-analysis, we used single-arm, pairwise, and network meta-analytical approaches. We searched PubMed, Embase, Cochrane Library, Web of Science, ClinicalTrials.gov, and relevant international conference proceedings from database inception to Jan 31, 2024, without language restrictions, to identify eligible clinical trials that assessed ICI-based treatments for individuals with advanced EGFR-mutated NSCLC who progressed on EGFR-TKIs. Studies considered eligible were published and unpublished phase 1, 2, or 3 clinical trials enrolling participants with histologically or cytologically confirmed advanced EGFR-mutated NSCLC who had progressed after at least one EGFR-TKI treatment, and that evaluated ICI-based treatment strategies on at least one of the clinical outcomes of interest. The primary outcome analysed was progression-free survival. The protocol is registered with PROSPERO, CRD42021292626.

Findings: 17 single-arm trials and 15 randomised controlled trials, involving 2886 participants and seven ICI-based treatment strategies (ICI monotherapy, ICI plus chemotherapy [ICI-chemo], ICI plus antiangiogenesis [ICI-antiangio], ICI plus antiangiogenesis plus chemotherapy [ICI-antiangio-chemo], dual ICIs [ICI-ICI], dual ICIs plus chemotherapy [ICI-ICI-chemo], and ICI plus EGFR-TKI [ICI-TKI]), were included. Three of these strategies-ICI monotherapy, ICI-antiangio-chemo, and ICI-chemo-had sufficient data across the included studies to perform a pairwise meta-analysis. The pairwise meta-analysis showed that, compared with chemotherapy, ICI monotherapy led to shorter progression-free survival (hazard ratio [HR] 1·73 [95% CI 1·30-2·29], I2=0%), whereas ICI-antiangio-chemo (HR 0·54 [0·44-0·67], I2=0%) and ICI-chemo (HR 0·77 [0·67-0·88], I2=0%) prolonged progression-free survival. The network meta-analysis showed that ICI-antiangio-chemo yielded the best progression-free survival results, with substantial benefits over ICI-chemo (HR 0·71 [95% credible interval 0·59-0·85]), ICI monotherapy (HR 0·30 [0·22-0·41]), and non-ICI treatment strategies including antiangio-chemo (HR 0·76 [0·58-1·00]) and chemotherapy alone (HR 0·54 [0·45-0·64]). ICI-antiangio-chemo was associated with higher risks of both any-grade and grade 3 or worse adverse events over ICI-chemo and chemotherapy in the network meta-analysis.

Interpretation: For individuals with advanced EGFR-mutated NSCLC who progressed on EGFR-TKIs, ICI-antiangio-chemo was identified as the optimal treatment option. The toxicity of this treatment was acceptable but needs careful attention. ICI-chemo showed appreciably greater efficacy than the standard-of-care chemotherapy. These findings clarified the roles of ICI-based treatment strategies in this difficult-to-treat refractory population, potentially complementing recent guidelines.

Funding: None.

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来源期刊
Lancet Oncology
Lancet Oncology 医学-肿瘤学
CiteScore
62.10
自引率
1.00%
发文量
913
审稿时长
3-8 weeks
期刊介绍: The Lancet Oncology is a trusted international journal that addresses various topics in clinical practice, health policy, and global oncology. It covers a wide range of cancer types, including breast, endocrine system, gastrointestinal, genitourinary, gynaecological, haematological, head and neck, neurooncology, paediatric, thoracic, sarcoma, and skin cancers. Additionally, it includes articles on epidemiology, cancer prevention and control, supportive care, imaging, and health-care systems. The journal has an Impact Factor of 51.1, making it the leading clinical oncology research journal worldwide. It publishes different types of articles, such as Articles, Reviews, Policy Reviews, Personal Views, Clinical Pictures, Comments, Correspondence, News, and Perspectives. The Lancet Oncology also collaborates with societies, governments, NGOs, and academic centers to publish Series and Commissions that aim to drive positive changes in clinical practice and health policy in areas of global oncology that require attention.
期刊最新文献
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