曲妥珠单抗-美坦新(T-DM1)治疗HER-2阳性晚期乳腺癌疗效和安全性的Meta分析

The Meta-analysis of the efficacy and safety of trastuzumab-emtansine(T-DM1)in the treatment of HER-2 positive advanced breast cancer

目的:评估T-DM1治疗HER-2阳性晚期乳腺癌的疗效及安全性。方法:PubMed、Embase、Cochrane、知网、维普、万方数据库,检索自建库以来至2020年04月27日数据库中应用T-DM1治疗HER-2阳性晚期乳腺癌的相关随机对照研究。用Review Manager 5.3软件对数据进行分析。结果:共纳入4项研究,共2 815例患者。Meta分析结果显示,使用T-DM1的患者,无进展生存(PFS)(HR=0.70,95%CI:0.57~0.87,P<0.05)和总生存(OS)(HR=0.79,95%CI:0.71~0.87,P<0.05)较其他药物明显提高,但有效率(ORR)未见明显差异(RR=1.25,95%CI:0.94~1.67)。亚组分析结果显示,T-DM1作为一线治疗对比单靶联合化疗,虽能改善患者的PFS和OS,但未达到统计学差异。作为非一线治疗时,T-DM1可显著改善患者的PFS和OS,并达到统计学差异。安全性方面,T-DM1组≥3级不良事件的发生率较对照组减小(RR=0.79,95%CI:0.73~0.85,P <0.05),但两组间的任何级别不良反应发生率未见明显差异(RR=0.99,95%CI:0.98~1.01,P> 0.05),且接受T-DM1治疗的患者,恶心、ALT升高、AST升高、血小板减少的发生率明显升高。结论:T-DM1治疗HER-2阳性晚期乳腺癌的疗效和安全性良好,可用于HER-2阳性晚期乳腺癌先前经过治疗的患者。

Objective:To evaluate the efficacy and safety of the T-DM1 treatment for HER-2 positive advanced breast cancer.Methods:We searched PubMed,Embase,Cochrane Library,CNKI,VIP,Wan Fang databases from inception to April 27,2020,to find the randomized clinical trials that use the treatment of T-DM1 in HER-2 positive advanced breast cancer patients.Data analysis was done by Review Manager 5.3.Results:Four studies were included in our study,which involved 2815 patients.Meta-analysis showed that compared with others drugs,T-DM1 significantly prolonged the PFS(HR=0.70,95%CI:0.57~0.87,P<0.05)and OS(HR=0.79,95%CI:0.71~0.87,P<0.05)for HER-2 positive advanced breast cancer,but there was no difference in the ORR(RR=1.25,95%CI:0.94~1.67).Subgroup analysis revealed that T-DM1 as the first line treatment,versus to signal-target with chemotherapy,despite improved the patients'PFS and OS,the statistically differences was not reached.When T-DM1 as the non-first line,showed significantly improved the PFS and OS for patients,and approached the statistically differences.In term of security:The incidence of≥3 grade adverse events were decrease in T-DM1 group(RR=0.79,95%CI:0.73~0.85,P<0.05),but there was no difference on any grade adverse events between two groups(RR=0.99,95%CI:0.98~1.01,P>0.05),and the incidence of nausea,increased ALT and AST,and thrombocytopenia were clearly increased in patients who accepted the T-DM1 therapy.Conclusion:The safety and efficacy of treatment for HER-2 positive advanced breast cancer with T-DM1 were well,also can be used to the previously treated advanced HER-2 positive breast cancer.