曲妥珠单抗生物类似药对比原研药治疗HER-2阳性乳腺癌有效性和安全性的Meta分析

A meta-analysis of the effectiveness and safety of trastuzumab biosimilars versus original drugs in the treatment of HER-2 positive breast cancer

目的系统评价曲妥珠单抗生物类似药与原研药治疗人表皮生长因子受体2(HER-2)阳性乳腺癌的有效性和安全性,为临床治疗提供循证证据。方法计算机检索PubMed、Embase、Web of Science、Cochrane Library、中国期刊全文数据库、中国生物医学文献数据库、维普网、万方数据、ClinicalTrials和中国临床试验中心等数据库,收集曲妥珠单抗生物类似药(试验组)对比原研药(对照组)治疗HER-2阳性乳腺癌的随机对照试验(RCT)。经资料提取、质量评价后,采用RevMan 5.4软件进行Meta分析。结果共纳入11项RCT,合计5812例患者。Meta分析结果显示,两组患者的客观缓解率(无论是按意向性治疗分配人群还是按完成方案分配人群)、病理完全缓解率、无进展生存人群比例、总生存人群比例、抗药抗体阳性率、中和抗体阳性率、不良反应发生率比较,差异均无统计学意义(P>0.05)。结论曲妥珠单抗生物类似药与原研药的有效性和安全性相当。

OBJECTIVE To evaluate the effectiveness and safety of trastuzumab biosimilars and original drugs in the treatment of human epidermal growth factor receptor-2(HER-2)positive breast cancer systematically,and to provide evidence-based basis for the selection of clinical treatment.METHODS Retrieved from PubMed,Embase,Web of Science,Cochrane Library,CNKI,CBM,VIP,Wanfang database,ClinicalTrials and Clinical Trial Center of China,randomized controlled trials(RCTs)about trastuzumab biosimilars(trial group)versus original drugs(control group)in the treatment of HER-2 positive breast cancer were collected.After data extraction and quality evaluation,RevMan 5.4 statistical software was used for meta-analysis.RESULTS Totally 11 RCTs were enrolled,involving 5812 patients.Results of meta-analysis showed that there was no significant difference in objective response rate(based on whether intention-to-treat population nor per-protocol population),pathologic complete response,proportion of progression free survival population,proportion of overall survival population,anti-drug antibody positive rate,neutralizing antibody positive rate,and incidence of adverse drug reactions between 2 groups(P>0.05).CONCLUSIONS The effectiveness and safety of trastuzumab biosimilars are equivalent to those of trastuzumab original drugs.