Efficacy and safety of Nivolumab in advanced gastric and gastroesophageal junction cancer: a meta-analysis of randomized controlled trials.

IF 2.5 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

BMC Gastroenterology Pub Date : 2024-11-21 DOI:10.1186/s12876-024-03508-0

Xinming Lei, Weimin Huo, Tian Xu, Jianguang Xu, Maoning Liu, Chengjiang Liu, Zhangyuan Gu

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引用次数: 0

Abstract

Background: *CoNivolumab, an immune checkpoint inhibitor, has shown promise in treating advanced unresectable gastric and gastroesophageal junction cancer. This meta-analysis aims to evaluate the efficacy and safety of Nivolumab, alone and in combination with chemotherapy, in this patient population.

Methods: A systematic review and meta-analysis were conducted according to PRISMA guidelines, using data from PubMed, Embase, CENTRAL, Web of Science, and CNKI up to June 3, 2024. Eight randomized controlled trials (RCTs) involving 3729 patients were included. The primary outcomes were overall survival (OS) and progression-free survival (PFS), while safety was assessed through adverse events (AEs) and grade ≥ 3 AEs. Effect sizes were measured using mean differences (MD) and relative risks (RR), with 95% confidence intervals (CIs).

Results: Nivolumab significantly extended OS (MD = 2.29, 95% CI: 1.48, 3.09) and PFS (MD = 0.69, 95% CI: 0.32, 1.06) compared to controls. Subgroup analysis showed that both Nivolumab monotherapy (OS: MD = 2.52, 95% CI: 0.81, 4.23; PFS: MD = 0.16, 95% CI: 0.11, 0.22) and Nivolumab combined with chemotherapy (OS: MD = 2.06, 95% CI: 0.56, 3.57; PFS: MD = 1.53, 95% CI: 0.32, 1.06) improved OS and PFS. While the overall risk of AEs was not significantly increased, Nivolumab monotherapy significantly increased the risk of AEs (RR = 1.47, 95% CI: 1.16, 1.87), whereas Nivolumab combined with chemotherapy did not (RR = 1.03, 95% CI: 0.97, 1.09). Both treatments increased the risk of grade ≥ 3 AEs (RR = 1.24, 95% CI: 1.12, 1.36).

Conclusion: Nivolumab, both alone and in combination with chemotherapy, improves OS and PFS in patients with advanced gastric and gastroesophageal junction cancer. However, careful patient monitoring is necessary due to the increased risk of severe AEs, particularly with monotherapy.

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Nivolumab对晚期胃癌和胃食管交界癌的疗效和安全性：随机对照试验荟萃分析。

背景：*免疫检查点抑制剂CoNivolumab有望治疗晚期不可切除的胃癌和胃食管交界癌。本荟萃分析旨在评估Nivolumab单药或联合化疗在这一患者群体中的疗效和安全性：根据PRISMA指南，利用PubMed、Embase、CENTRAL、Web of Science和CNKI截至2024年6月3日的数据进行了系统综述和荟萃分析。共纳入八项随机对照试验（RCT），涉及 3729 名患者。主要结果为总生存期（OS）和无进展生存期（PFS），安全性通过不良事件（AE）和≥3级AE进行评估。效应大小用平均差（MD）和相对风险（RR）以及95%置信区间（CI）来衡量：与对照组相比，Nivolumab可明显延长OS（MD = 2.29，95% CI：1.48, 3.09）和PFS（MD = 0.69，95% CI：0.32, 1.06）。亚组分析显示，Nivolumab单药治疗（OS：MD = 2.52，95% CI：0.81，4.23；PFS：MD = 0.16，95% CI：0.11，0.22）和Nivolumab联合化疗（OS：MD = 2.06，95% CI：0.56，3.57；PFS：MD = 1.53，95% CI：0.32，1.06）均改善了OS和PFS。虽然AEs的总体风险没有显著增加，但Nivolumab单药治疗显著增加了AEs风险（RR = 1.47，95% CI：1.16，1.87），而Nivolumab联合化疗则没有增加AEs风险（RR = 1.03，95% CI：0.97，1.09）。两种治疗方法都会增加≥3级AEs的风险（RR=1.24，95% CI：1.12，1.36）：结论：Nivolumab单药或联合化疗均可改善晚期胃癌和胃食管交界处癌患者的OS和PFS。结论：Nivolumab单药或联合化疗均可改善晚期胃癌和胃食管交界处癌患者的OS和PFS。

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

BMC Gastroenterology 医学-胃肠肝病学

CiteScore

4.20

自引率

0.00%

发文量

465

审稿时长

6 months

期刊介绍： BMC Gastroenterology is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of gastrointestinal and hepatobiliary disorders, as well as related molecular genetics, pathophysiology, and epidemiology.