曲妥珠单抗辅助治疗对HER-2阳性晚期乳腺癌疗效的Meta分析

Meta analysis on efficacy of the application of Trastuzumab adjuvant therapy in treatment of patients with HER-2 positive advanced breast cancer

目的系统评价曲妥珠单抗辅助治疗人表皮生长因子受体-2(HER-2)阳性的晚期乳腺癌的临床疗效,以期为临床制定治疗策略提供依据。方法检索中国知网、万方数据库、Pub Med、Cochrane图书馆和Embase数据库,查找曲妥珠单抗联合其他药物(实验组)对比其他药物单药(对照组)治疗HER-2阳性晚期乳腺癌的随机对照临床试验(RCT),检索时间从建库到2019年4月。对符合纳入标准的研究以Jadad评分标准进行文献质量评价,采用Stata 12.0软件进行Meta分析。结果共纳入23项随机对照研究,合计4 323例患者。Meta分析结果显示,实验组患者的总生存期(HR=0.77,95%CI:0.69~0.87,P<0.001)与无进展生存期(HR=0.72,95%CI:0.60~0.86,P<0.001)较对照组均有显著提高。客观缓解率和临床获益率也有显著改善。但亚组分析结果显示,曲妥珠单抗联合治疗组对比拉帕替尼单药或者拉帕替尼联合治疗组两者在疗效方面无显著差异(P>0.05)。结论曲妥珠单抗辅助治疗可以显著改善HER-2阳性晚期乳腺癌患者的临床疗效。

Objective To evaluate the efficacy of Trastuzumab(TRA)adjuvant therapy in treatment of patients with positive advanced breast cancer and positive human epidermal growth factor receptor-2(HER-2)in order to provide the basis for clinical treatment.Methods The CNKI,Wanfang Database,PubMed,Cochrane Library and Embase were systematically searched for randomized controlled trial(RCT)comparing TRA combined with other drugs(trial group)versus other drugs(control group)in treatment of patients with HER-2 positive advanced breast cancer from inception to April 2019.Including studies were evaluated for quality in accordance with the Jadad grading standard and the statistical analysis was performed by using Stata version 12.0.Results A total of 23 items for RCT including 4 323 patients were enrolled in this study.The results showed that overall survival(OS)and progression free survival(PFS)periods were significantly improved in trial group compared to control group(OS:HR=0.77,95%CI:0.69-0.87,P<0.001;PFS:HR=0.72,95%CI:0.60-0.86,P<0.001;respectively).In addition,objective response rate and clinical benefit rate were significantly increased in patients of trial group.Sub-group analysis demonstrated that there was no significant difference between TRA-containing therapy group and Lapatinib(LAP)monotherapy group or LAP-containing therapy group.Conclusion Trastuzumab adjuvant therapy can significantly raise the clinical efficacy of human epidermal growth factor receptor-2(HER-2)in treatment of patients with advanced breast cancer.