阿柏西普联合化疗治疗转移性结直肠癌的疗效和安全性：一项非比较性临床研究和随机对照试验的系统评价和 PRISMA 符合的单臂荟萃分析。

Efficacy and safety of aflibercept plus chemotherapy in metastatic colorectal cancer: A systematic review and PRISMA-Compliant single-arm Meta-Analysis of noncomparative clinical studies and randomized controlled trials.

机构信息

Institute of Chinese Medical Sciences, University of Macau, Macau, China.

State Key Laboratory of Quality Research in Chinese Medicine, University of Macau, Macau, China.

出版信息

J Clin Pharm Ther. 2022 Jun;47(6):798-808. doi: 10.1111/jcpt.13610. Epub 2022 Mar 1.

DOI:10.1111/jcpt.13610

PMID:35229901

Abstract

WHAT IS KNOWN AND OBJECTIVE

Aflibercept, a recombinant protein designed to suppress the vascular endothelial growth factor (VEGF) signalling pathway, has been used in patients with metastatic colorectal cancer (mCRC). We conducted the first meta-analysis to systematically review the efficacy and safety of aflibercept in mCRC.

METHODS

PubMed Central/Medline, Embase and cochrane library were systematically searched for randomized controlled trials and single-arm clinical trials on aflibercept plus chemotherapy for the treatment of mCRC through 9 September 2021.

RESULTS

Ten studies comprising 2049 patients met the inclusion criteria. The pooled estimate rates were 16.0% for 12mPFS, 64.4% for 12mOS, 32.5% for ORR, 83.5% for DCR, while the rates of III/IV AEs rate were 80.2% respectively. The pooled estimate rates were 16.8% for III/IV diarrhoea, 22.3% for III/IV hypertension, 29.5% for III/IV neutropenia, 7.3% for III/IV proteinuria and 8.6% for III/IV oral mucositis.

CONCLUSIONS

Analysis of data from randomized controlled trials(RCT) and single-arm clinical trials confirmed the good efficacy of aflibercept plus chemotherapy in mCRC, while the safety of the treatment is concerning.

摘要

已知和目的

阿柏西普是一种旨在抑制血管内皮生长因子（VEGF）信号通路的重组蛋白，已用于转移性结直肠癌（mCRC）患者。我们进行了首次荟萃分析，以系统地回顾阿柏西普在 mCRC 中的疗效和安全性。

方法

通过 2021 年 9 月 9 日，系统地在 PubMed Central/Medline、Embase 和 Cochrane 图书馆中搜索了关于阿柏西普联合化疗治疗 mCRC 的随机对照试验和单臂临床试验。

结果

符合纳入标准的 10 项研究共纳入 2049 例患者。12mPFS 的汇总估计率为 16.0%，12mOS 的汇总估计率为 64.4%，ORR 的汇总估计率为 32.5%，DCR 的汇总估计率为 83.5%，而 III/IV 级不良反应发生率分别为 80.2%。III/IV 级腹泻的汇总估计率为 16.8%，III/IV 级高血压的汇总估计率为 22.3%，III/IV 级中性粒细胞减少的汇总估计率为 29.5%，III/IV 级蛋白尿的汇总估计率为 7.3%，III/IV 级口腔黏膜炎的汇总估计率为 8.6%。