Sacituzumab Govitecan治疗晚期HER2阴性乳腺癌的疗效及安全性Meta分析

Efficacy and Safety of Sacituzumab Govitecan on Advanced HER2-negative Breast Cancer:A Meta-analysis

目的探究Sacituzumab govitecan对晚期HER2阴性乳腺癌患者的疗效及安全性。方法分类整理截至2021年5月发表的相关的Ⅱ期或Ⅲ期临床试验,并使用Stata12.0软件包分析Sacituzumab govitecan在晚期HER2阴性乳腺癌患者中的疗效和不良反应。结果最终纳入3篇文献,420例晚期HER2阴性乳腺癌患者。其中随机对照试验研究1篇,队列研究2篇。Meta分析结果显示:使用Sacituzumab govitecan的患者,缓解率为34.0%(95%CI:29.4%~38.6%)、临床获益率为45.0%(95%CI:40.2%~49.8%)、中位无进展生存为5.59月(95%CI:4.95~6.31)、中位总生存为12.59月(95%CI:11.58~13.68)、中位反应持续时间为7.4月(95%CI:6.23~8.77)。最常见的严重不良反应为中性粒细胞减少、贫血、白细胞减低、腹泻、恶心、呕吐等,需警惕严重的中性粒细胞减少、贫血、白细胞减低及严重腹泻的发生。结论Sacituzumab govitecan可为晚期HER2阴性乳腺癌患者带来显著的生存获益,使用过程中需警惕严重不良反应的发生。

Objective To explore the efficacy and safety of Sacituzumab govitecan on patients with advanced HER2-negative breast cancer.Methods We classified and analyzed the relevant phaseⅡorⅢclinical trials published by May 2021,and used the Stata 12.0 software package for analyzing efficacy and toxicity of Sacituzumab govitecan on the patients with advanced HER2-negative breast cancer.Results Three studies involving 420 patients with advanced HER2-negative breast cancer were included.Among them,one randomized controlled trial(RCT)study and two cohort studies were conducted.Meta-analysis results showed that total objective response rate of breast cancer to Sacituzumab govitecan was 34%(95%CI:29.4%-38.6%),and the clinical benefit rate was 45.0%(95%CI:40.2%-49.8%),the median progression-free survival was 5.59 months(95%CI:4.95-6.31),the median overall survival was 12.59 months(95%CI:11.58-13.68),and the median duration of response was 7.40 months(95%CI:6.23-8.77).The most common serious adverse reactions were neutropenia,anemia,leukopenia,diarrhea,nausea,vomiting,etc.The serious neutropenia,anemia,leukopenia and severe diarrhea should be vigilant.Conclusion Sacituzumab govitecan can bring significant survival benefits to patients with advanced HER2-negative breast cancer,and severe adverse reactions should be vigilant during use procedure.