多柔比星和表柔比星治疗转移性乳腺癌的系统评价

A System Review: Comparison of Doxorubicin and Epirubicin Containing Regimens for Metastatic Breast Cancer

目的评价多柔比星和表柔比星应用于转移性乳腺癌的疗效和安全性。方法检索Cochrane图书馆、Pub Med、Embase、CNKI、CBM和万方期刊数据库,筛选相关文献,对符合纳入标准的文献进行资料提取和质量评价,采用Meta分析和描述统计分析。结果最终纳入6篇研究。总生存期分析结果表示,多柔比星和表柔比星的总生存期效应相似(549 d和480 d)。客观缓解率Meta分析结果显示,多柔比星治疗转移性乳腺癌的疗效与表柔比星相当[RR=1.12,95%CI(0.99,1.26),P=0.07]。不良反应分析表明,表柔比星的血液学毒性和脱发的发生率与多柔比星相当,但表柔比星的心脏毒性低于多柔比星。结论多柔比星和表柔比星均能有效治疗转移性乳腺癌,但多柔比星的心脏毒性高于表柔比星,不建议用于患有心脏疾病的转移性乳腺癌患者。

OBJECTIVE To compare the efficacy and safety of doxorubicin with epirubicin in patients with metastatic breast cancer （MBC） by systematic review and Meta-analysis to provide reference for clinicians. METHODS Randomized controlled trials （RCTs） that compared the efficacy, safety, or both, of doxorubicin with epirubicin in treatment of metastatic breast cancer were collected from the Cochrane library, PubMed, Embase, CNKI, CBM and Wanfang database using the following terms： doxorubicin, epirubicin, breast cancer, randomized controlled trials. In addition, the reference lists of relevant trials or reviews were screened. Trials that provided sufficient data on objective response rate （ORR） and/or overall survival （OS） were considered eligible for inclusion. Studies were assessed for quality. A fixed-effect model was used for Meta-analysis unless there was significant between-study heterogeneity. Meta-analysis was performed by Revman 5.3 software, with results expressed as odds ratio （OR）, 95% confidence interval （CI） and P value. The other parameters were summarized by descriptive analysis. RESULTS A total of 1 221 patients from six RCTs were included for final analysis, with 614 patients in the doxorubicin group and 607 patients in the epirubicin group. The median OS was 549 d for the doxorubicin group and 480 d for the epirubicin group. The pooled risk ratio（RR） suggested that there was not statistically significant difference in the ORRs between the doxorubicin （general type and liposomal type） group and the epirubicin group for the treatment of MBC [ for doxorubicin vs epirubicin, RR = 1.12, 95% CI（0. 99,1.26）, P = 0. 07; for liposomal doxorubicin vs epirubiein, RR = 1.24, 95% CI（0. 94,1.62） , P = 0. 12] ; and for general doxorubiein vs epirubicin RR = 1.09, 95% CI（0. 96, 1.24 ） , P = 0. 12 ）. Descriptive analysis of safety showed that doxorubicin had similar incidences of hematologic toxicity and alopecia to epirubicin but was superior to epirubicin in aspect of cardiac toxicity. There was no significant heterogeneity among the included studies in most of the Meta-analyses. CONCLUSION Epirubicin and doxorubicin are equally effective and the safety profile of the former is at least not worse than the latter in the first-line treatment of patients with metastatic breast cancer. But compared to doxorubicin, epirubicin might be a better choice for MBC patients especially those with cardiac diseases.