紫杉类联合蒽环类及环磷酰胺方案治疗乳腺癌的Meta分析

Meta-analysis of Taxane Combined with Anthracycline and Cyclophosphamide as Neoadjuvant Chemotherapy Regimen in the Treatment of Breast Cancer

目的 系统评价紫杉类联合蒽环类药物及环磷酰胺新辅助化疗方案（TEC/TAC）治疗乳腺癌的疗效及安全性.方法 采用计算机检索和手工检索相结合的方法搜索PubMed、Cochrane Central、Embase等外文数据库及中国知网（CNKI）、中国生物医学文献数据库（CBMdisc）、重庆维普（VIP）、万方数据等中文数据库,时间为从建库至2012年5月1日.收集TEC/TAC方案治疗乳腺癌的随机对照试验（randomized controlled trial,RCT）,对符合纳入标准的研究采用RevMan5.1软件进行Meta分析.结果 共纳入11篇文献,包括633例TEC/TAC方案治疗病例和513例5-氟尿嘧啶联合蒽环类药物及环磷酰胺（FEC/FAC方案）治疗病例.Meta分析显示,TEC/TAC方案在完全缓解率[OR=2.28,95%CI（1.54,3.38）,P〈0.0 001]、部分缓解率[OR=1.42,95%CI（1.09,1.85）,P=0.010]及临床有效率[OR=2.68,95%CI（1.87,3.83）,P〈0.00 001]方面明显优于FEC/FAC方案.两组在化疗后淋巴结阴转率[OR=1.27,95%CI（0.83,1.95）,P=0.26]和肿瘤降期率[OR=1.65,95%CI（0.96,2.83）,P=0.07]方面无统计学差异.TEC/TAC方案的毒副反应发生率明显高于FEC/FAC方案.结论 TEC/TAC方案治疗乳腺癌的疗效优于FEC/FAC方案,但毒副反应有所增加,反应较轻,患者多可耐受.

Objective To assess the efficacy and adverse events of taxane combined with anthracycline and cy-clophosphamide as neoadjuvant chemotherapy regimen in the treatment of breast cancer. Methods Databases such as Pubmed, Cochrane Central, Embase, CNKI, CBMdisc, VIP and WanFang were searched till June 2012, and randomized controlled trials of taxane combined with anthracycline and cyclophosphamide as neoadjuvant chemotherapy regimen in the treatment of breast cancer were collected. For all the included studies,we performed meta - analysis using RevMan 5.1. Results Eleven literatures were reviewed including 633 cases received TEC/TAC and 513 cases received FEC/ FAC. Meta - analysis revealed these outcomes ： complete response rate [ OR = 2.28,95% CI （ 1.54,3.38 ） , P 〈0. 0001 ], partial response rate[ OR = 1.42,95% CI （ 1.09,1.85 ）, P = 0. 010 ], clinical response rate [ OR = 2.68, 95% CI（1.87,3.83） ,P 〈 0.00001 ] had statistical significance, while there was no significant difference in lymph node negative conversion rate[ OR = I. 27,95% CI（0. 83,1.95） ,P =0.26] and down period of the rate[ OR = 1.65, 95% CI（0.96,2.83）, P = 0. 07 ]. Adverse events were more frequently seen in TEC/TAC group than FEC/FAC group. Conclusion The efficacy of taxane combined with anthracycline and cyclophosphamide as neoadjuvant chemo-therapy regimen in the treatment of breast cancer is superior to that of 5 - FU combined with anthracycline and cyclo-phosphamide. However, the combination of taxane, anthracycline and cyclophosphamide increases the adverse events, which are not serious and could be tolerated.