PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone for TKIs-resistant, EGFR-Mutant, advanced non-small-cell lung cancer: a phase 3 RCTs based meta-analysis.

IF 2.9 3区医学 Q2 ONCOLOGY

Expert Review of Anticancer Therapy Pub Date : 2025-06-18 DOI:10.1080/14737140.2025.2522980

Xi Chen, Jianhua Zhao, Wenxiong Zhang, Xueming Ying

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引用次数: 0

Abstract

Background: Immunotherapy combined with chemotherapy has emerged as a potential strategy to overcome tyrosine kinase inhibitors (TKIs)-resistant for advanced non-small-cell lung cancer (NSCLC); however, the efficacy and safety of PD-1/PD-L1 inhibitors plus chemotherapy (PIC) compared to chemotherapy alone require further investigation.

Research design and methods: Phase III randomized controlled trials (RCTs) were systematically searched from 6 databases. Pooled hazard ratios (HRs) for survival outcomes and risk ratios (RRs) for responses and adverse events (AEs) were calculated.

Results: Three phase III RCTs were included in the final analysis. The PIC therapy significantly improved overall survival (OS) (HR: 0.86, 95% CI: 0.75-1.00, p = 0.04) and progression-free survival (PFS) (HR: 0.78, 95% CI: 0.68-0.90, p = 0.0005) compared to chemotherapy alone. While PIC therapy improved survival in the overall population, no significant benefit was observed for patients with brain metastases and non-sensitizing EGFR mutations. However, the incidence of immune-related AEs (irAEs) (RR: 2.02, 95% CI: 1.45-2.81, p < 0.0001) and grade 3-5 irAEs (RR: 2.02, 95% CI: 1.03-3.98, p = 0.04) were increased.

Conclusions: PIC therapy may provide a survival benefit for patients with TKIs-resistant, EGFR-mutant advanced NSCLC. Moreover, this potential benefit should be weighed against the increased risk of irAEs.

Registration: PROSPERO (CRD42024615907).

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PD-1/PD-L1抑制剂联合化疗与单独化疗治疗tkis耐药、egfr突变的晚期非小细胞肺癌：一项基于3期随机对照试验的meta分析

背景：免疫治疗联合化疗已成为克服晚期非小细胞肺癌（NSCLC）酪氨酸激酶抑制剂（TKIs）耐药的潜在策略；然而，PD-1/PD-L1抑制剂联合化疗（PIC）与单独化疗相比的有效性和安全性需要进一步研究。研究设计与方法：系统检索6个数据库中的III期随机对照试验（rct）。计算生存结果的合并风险比（hr）以及反应和不良事件（ae）的合并风险比（rr）。结果：最终分析纳入3项III期rct。与单独化疗相比，PIC治疗显著改善了总生存期（OS）（HR: 0.86, 95% CI: 0.75-1.00, p = 0.04）和无进展生存期（PFS）（HR: 0.78, 95% CI: 0.68-0.90, p = 0.0005）。虽然PIC治疗提高了总体人群的生存率，但对于脑转移和非致敏性EGFR突变的患者没有观察到显著的益处。但免疫相关不良事件（irAEs）发生率增高（RR: 2.02, 95% CI: 1.45-2.81, p = 0.04）。结论：PIC治疗可能为tkis耐药、egfr突变的晚期NSCLC患者提供生存益处。此外，应该权衡这种潜在的好处与irae增加的风险。注册：普洛斯彼罗（CRD42024615907）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Review of Anticancer Therapy 医学-肿瘤学

CiteScore

5.10

自引率

3.00%

发文量

100

审稿时长

4-8 weeks

期刊介绍： Expert Review of Anticancer Therapy (ISSN 1473-7140) provides expert appraisal and commentary on the major trends in cancer care and highlights the performance of new therapeutic and diagnostic approaches. Coverage includes tumor management, novel medicines, anticancer agents and chemotherapy, biological therapy, cancer vaccines, therapeutic indications, biomarkers and diagnostics, and treatment guidelines. All articles are subject to rigorous peer-review, and the journal makes an essential contribution to decision-making in cancer care. Comprehensive coverage in each review is complemented by the unique Expert Review format and includes the following sections: Expert Opinion - a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results Article Highlights – an executive summary of the author’s most critical points.