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免疫检查点抑制剂联合化疗作为复发性或转移性鼻咽癌一线治疗的疗效和安全性:一项随机对照试验的网络荟萃分析。

Efficacy and Safety of Immune Checkpoint Inhibitors Combined With Chemotherapy as First-line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma: A Network Meta-analysis of Randomized Controlled Trials.

机构信息

Department of Pharmacy, Eye & ENT Hospital, Fudan University, Shanghai, China.

出版信息

Ann Pharmacother. 2024 Apr;58(4):349-359. doi: 10.1177/10600280231188171. Epub 2023 Jul 24.

Abstract

BACKGROUND

Different clinical trials for recurrent or metastatic nasopharyngeal carcinoma have studied different combinations of immuno-oncology in first-line treatment, but the optimal choice has not been determined.

OBJECTIVE

To systematically examine and compare the efficacy and safety of different immune checkpoint inhibitors (ICIs) combined with chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.

METHODS

Several electronic databases were systematically searched up to February 2023. Articles meeting the inclusion criteria were included.

RESULTS

Three RCTs were eligible in the study. Compared with placebo plus gemcitabine-cisplatin (GP), toripalimab plus GP (HR = 0.59, 95% CI: 0.37-0.95) was significantly associated with a better OS. Tislelizumab plus GP generated best progression-free survival (PFS) benefit (HR = 0.50, 95% CI: 0.37-0.67), greatest improvement in 1-year PFS rate (RR = 3.00, 95% CI: 1.84-5.22), and objective response rate (ORR) (RR = 1.26, 95% CI: 1.04-1.53) over the placebo plus GP. Furthermore, tislelizumab plus GP appeared to be safer than toripalimab plus GP and camrelizumab plus GP in terms of adverse events (AEs)-grade ≥3, treatment-related AEs (TRAEs)-grade ≥3, serious AEs (SAEs), treatment-related SAEs (TRSAEs), and AEs leading to discontinuation of treatment.

CONCLUSION AND RELEVANCE

In recurrent or metastatic nasopharyngeal carcinoma, programmed death 1 (PD-1) inhibitors plus GP as first-line treatment have better survival outcomes than placebo plus GP with comparable toxicity. Toripalimab plus GP shows the best OS benefit over placebo plus GP, while tislelizumab plus GP generates the best PFS, 1-year PFS rate, ORR, and safety. Tislelizumab plus GP could be the best choice among the ICIs combined with chemotherapy regimens as first-line treatment in recurrent or metastatic nasopharyngeal carcinoma.

摘要

背景

不同的复发或转移性鼻咽癌临床试验研究了免疫肿瘤学在一线治疗中的不同联合方案,但最佳选择尚未确定。

目的

系统地评估和比较不同免疫检查点抑制剂(ICI)联合化疗作为复发或转移性鼻咽癌一线治疗的疗效和安全性。

方法

系统检索了截至 2023 年 2 月的多个电子数据库。纳入符合纳入标准的文章。

结果

本研究有 3 项 RCT 符合条件。与安慰剂加吉西他滨-顺铂(GP)相比,特瑞普利单抗加 GP(HR=0.59,95%CI:0.37-0.95)显著改善了 OS。替雷利珠单抗加 GP 带来了最佳的无进展生存期(PFS)获益(HR=0.50,95%CI:0.37-0.67),1 年 PFS 率(RR=3.00,95%CI:1.84-5.22)和客观缓解率(ORR)(RR=1.26,95%CI:1.04-1.53)均显著高于安慰剂加 GP。此外,与特瑞普利单抗加 GP 和卡瑞利珠单抗加 GP 相比,替雷利珠单抗加 GP 在不良反应(AE)-≥3 级、治疗相关不良反应(TRAEs)-≥3 级、严重不良反应(SAE)、治疗相关 SAE(TRSAE)和导致治疗中断的不良反应方面似乎更安全。

结论和相关性

在复发或转移性鼻咽癌中,PD-1 抑制剂联合 GP 作为一线治疗较安慰剂联合 GP 具有更好的生存获益,且毒性相当。特瑞普利单抗加 GP 较安慰剂加 GP 具有最佳的 OS 获益,而替雷利珠单抗加 GP 则带来了最佳的 PFS、1 年 PFS 率、ORR 和安全性。替雷利珠单抗加 GP 可能是复发或转移性鼻咽癌中免疫检查点抑制剂联合化疗方案作为一线治疗的最佳选择。

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