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贝伐珠单抗治疗非鳞状非小细胞肺癌的安全性和有效性：一项随机对照试验的荟萃分析。

The Safety and Effectiveness of Bevacizumab in the Treatment of Nonsquamous Non-Small-Cell Lung Cancer: A Meta-Analysis of Randomized Controlled Trials.

机构信息

Department of Pharmacy, Affiliated Hospital of North Sichuan Medical College, China.

出版信息

Biomed Res Int. 2021 Sep 7;2021:5537899. doi: 10.1155/2021/5537899. eCollection 2021.

DOI:10.1155/2021/5537899
PMID:34532503
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8440089/
Abstract

OBJECTIVE

Bevacizumab was currently available for nonsquamous non-small-cell lung cancer (NSqNSCLC) patients and has been studied in several randomized controlled trials (RCTs) for treatment of these patients. This meta-analysis summarizes the most up-to-date evidences regarding the effects and adverse reactions of bevacizumab in the treatment of NSqNSCLC patients.

METHODS

The authors searched for RCTs from electronic database including PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials. Experimental arm was defined as the bevacizumab-containing group and the control arm as the bevacizumab-free group. Data of objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and adverse reactions were synthetically extracted. A protocol for this meta-analysis has been registered on PROSPERO (http://www.crd.york.ac.uk/prospero).

RESULTS

Ten RCTs that involved a total of 3134 patients were included. The experimental group was associated with significant superior ORR (RR 1.63, 95% CI 1.24 to 2.14, < 0.001), OS (HR 0.90, 95% CI 0.82 to 0.99, < 0.001), and prolonged PFS (HR 0.68, 95% CI 0.62 to 0.74, < 0.001) compared to the control. No significant difference was observed regarding DCR (RR 1.13, 95% CI 0.99 to 1.30, = 0.08). The experimental group showed higher rate of hypertension (RR 6.91, 95% CI 4.62 to 10.35, < 0.00001) and hemorrhagic events (RR 3.07, 95% CI 1.78 to 5.30, < 0.0001) than the control group. The experimental group showed lower rate of anemia (RR 0.72, 95% CI 0.55 to 0.96, = 0.02) than the control group. No significant difference was observed regarding treatment-related adverse event grade 3-5 (TRAE3-5) (RR 1.23, 95% CI 0.99 to 1.53, = 0.06), thrombocytopenia (RR 1.11, 95% CI 0.92 to 1.33, = 0.29), and neutropenia (RR 1.11, 95% CI 0.88 to 1.40, = 0.36).

CONCLUSION

This meta-analysis showed that bevacizumab could increase ORR, OS, and prolonged PFS for treatment of NSqNSCLC patients. However, no significant improvement in DCR was observed and bevacizumab could increase the rate of hypertension and hemorrhagic events. Bevacizumab was an acceptable option for NSqNSCLC patients. This trial is registered with : CRD42021226790.

摘要

目的

贝伐珠单抗目前可用于非鳞状非小细胞肺癌（NSqNSCLC）患者，并已在多项随机对照试验（RCT）中用于治疗这些患者。本荟萃分析总结了贝伐珠单抗治疗 NSqNSCLC 患者的最新疗效和不良反应证据。

方法

作者从包括 PubMed、EMBASE 和 Cochrane 对照试验中心注册库在内的电子数据库中搜索 RCT。实验组定义为贝伐珠单抗组，对照组为贝伐珠单抗组。综合提取客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和不良反应的数据。本荟萃分析的方案已在 PROSPERO（http://www.crd.york.ac.uk/prospero）上注册。

结果

共纳入 10 项 RCT，共 3134 例患者。实验组与对照组相比，ORR（RR 1.63，95%CI 1.24 至 2.14，<0.001）、OS（HR 0.90，95%CI 0.82 至 0.99，<0.001）和 PFS（HR 0.68，95%CI 0.62 至 0.74，<0.001）均显著升高。两组间 DCR（RR 1.13，95%CI 0.99 至 1.30，=0.08）无显著差异。实验组高血压（RR 6.91，95%CI 4.62 至 10.35，<0.00001）和出血事件（RR 3.07，95%CI 1.78 至 5.30，<0.0001）发生率高于对照组。实验组贫血（RR 0.72，95%CI 0.55 至 0.96，=0.02）发生率低于对照组。两组间治疗相关不良事件 3-5 级（TRAE3-5）（RR 1.23，95%CI 0.99 至 1.53，=0.06）、血小板减少症（RR 1.11，95%CI 0.92 至 1.33，=0.29）和中性粒细胞减少症（RR 1.11，95%CI 0.88 至 1.40，=0.36）发生率无显著差异。

结论

本荟萃分析表明，贝伐珠单抗可提高 NSqNSCLC 患者的 ORR、OS 和 PFS。然而，DCR 无显著改善，贝伐珠单抗可增加高血压和出血事件的发生率。贝伐珠单抗是 NSqNSCLC 患者的一种可接受的选择。本试验在：CRD42021226790 注册。

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