新辅助化疗TE和TEC方案治疗Ⅱ~Ⅲ期乳腺癌有效性和安全性系统评价

Evaluation of the efficacy and safety of TE regimen and TEC regimen in the treatment of stage Ⅱ-Ⅲ breast cancer

目的对比TE方案(多西他赛联合表柔比星治疗方案)和TEC方案(多西他赛、表柔比星、环磷酰胺联合治疗方案)治疗女性乳腺癌患者(TNM分期Ⅱ~Ⅲ)在有效性和安全性的差异,为乳腺癌辅助化疗方案选择提供临床参考。方法计算机检索以TE与TEC作为乳腺癌新辅助化疗方案的随机对照试验(RCT),数据库包括Cochrane Library、PubMed、Embase、CBM、CNKI、VIP、WanFang Data,排除其他用药方案和不符合纳入标准的文献,提取文献数据并进行质量评价,采用RevMan 5.3软件进行统计分析。结果初检出1067篇文献,经筛选纳入10篇RCTs,共946个病例;Meta分析结果显示:①有效性方面,TE组临床完全缓解率(CR)与TEC组相比差异无统计学意义(OR=0.91,95%CI:0.66-1.25,P=0.55,I2=0%);TE组总有效率与TEC组相比差异无统计学意义(OR=0.75,95%CI:0.55-1.02,P=0.07,I2=0%);②安全性方面,TE组血液学毒性(中性粒细胞减少,血小板减少,白细胞减少)明显低于TEC组,差异有统计学意义;两组的非血液学毒性(脱发,心脏毒性,胃肠反应,肝功能损害)差异无统计学意义。结论新辅助化疗TE方案对比TEC方案治疗Ⅱ~Ⅲ期女性乳腺癌患者,两者的近期疗效相近,但TE方案表现出更低的血液学毒性,安全性更好。

Objective To study the efficacy and safety of TE regimen(docetaxel combined with epirubicin)and TEC regimen(docetaxel,epirubicin and cyclophosphamide)in the treatment of female breast cancer patients(TNM stageⅡ-Ⅲ).Methods The randomized controlled trials(RCTs)with TE and TEC as neoadjuvant chemotherapy regimens for breast cancer were searched by computer.The databases included Cochrane Library,PubMed,EMBASE,CBM,CNKI,VIP and Wanfang Data.Other drug regimens and literatures that did not meet the inclusion criteria were excluded.The literature data were extracted and evaluated for quality.The Revman 5.3 software was used for statistical analysis.Results A total of 1067 literatures were detected,and 10 RCTs were included in the study.The results of meta-analysis showed that:(1)in terms of efficacy,there was no significant difference in clinical complete remission rate(CR)between TE group and TEC group(OR=0.91,95%CI:0.66-1.25,P=0.55,I2=0%);The total effective rate of TE group was not significantly different from that of TEC group(OR=0.75,95%CI:0.55-1.02,P=0.07,I2=0%);(2)In terms of safety,hematological toxicity such as neutropenia,thrombocytopenia and leucopenia in TE group was significantly lower than that in TEC group,with statistical difference;there was no significant difference in non-hematological toxicity such as alopecia,cardiotoxicity,gastrointestinal reaction and liver function damage between the two groups.Conclusion The short-term efficacy of TE regimen is similar to that of TEC regimen in the treatment of stageⅡ-Ⅲfemale breast cancer patients,but TE regimen shows lower hematologic toxicity and better safety.