【摘要】 目的:观察表阿霉素(EPI)联合或序贯紫杉醇(PTX)剂量密集化疗在高复发风险乳腺癌辅助化疗中的疗效和耐受性,与EPI联合PTX3周方案比较,得出初步结论。方法:选取2003年12月至2006年12月中国医学科学院肿瘤医院173例具有高复发风险乳腺癌术后患者,将患者随机分为三组,分别采用EPI联合CTX序贯PTX的2周方案(EC→T密集组)、EPI联合PTX的2周方案(ET密集组)和EPI联合PTX的3周方案(ET常规组)进行辅助化疗。结果:EC→T密集组、ET密集组和ET常规组各入组56例、57例和60例患者。共有168例患者按计划完成化疗,中位随访36个月,密集组和常规组的3年无复发率分别为84.1%和80.0%(P=0.501),3年总生存率分别为95.6%和90.0%(P=0.153)。EC→T密集纽和ET密集组的3年无复发率分别为85.7%和82.5%(P=0.636),3年总生存率分别为92.9%和98.2%(P=0.164)。全组173例可评价毒性,Ⅲ～Ⅳ度主要的毒性为粒细胞减少、恶心、呕吐、肝功能损害和脱发。密集组与常规组的Ⅲ～Ⅳ度粒细胞减少发生率分别为14.2%和58.3%(P=0.000),其他毒性差异无统计学意义。比较两个密集组间毒性,差异无统计学意义。结论:EPI联合或序贯PTX密集辅助化疗是可行的,具有较好的疗效和耐受性,有改善患者无复发生存和总生存的趋势,粒细胞减少明显减轻,其他毒性未明显增加,化疗时间得以缩短。EPI联合或序贯PTX密集辅助化疗的两个方案,疗效和毒性相近。更多还原

【Abstract】 Objective:To investigate the efficacy and tolerance of dose dense chemotherapy with epirubicin and paclitaxel concurrently or sequentially in the postoperative adjuvant treatment for high-risk breast cancer and to draw a basic conclusion by comparing dose dense regimens with the regular regimen. Methods:A total of 173 high-risk breast cancer patients took part in the trial from December 2003 to December 2006. The postoper ative patients were randomly divided into three groups:the EC→T dose dense group, the ET dose dense group and the ET regular group. Results:There were 56 patients in the EC→T dpse dense group, 57 patients in the ET dose dense group and 60 patients in the ET regular group. One hundred and sixty-eight patients completed chemotherapy as planned. After the median follow-up of 36 months, the 3-year relapse-free and overall survival rates of the dose dense group and the regular group were 84.1% and 80.0% (P=0.501), 95.6% and 90.0% (P=0.153), respectively. The 3-year relapse-free survival rates and overall survival rates of the EC→T and the ET dose dense group were 85.7% and 82.5% (P=0.636), 92.9% and 98.2% (P=0.164), respectively. The toxicities were evaluated in 173 patients. The major grade Ⅲ-Ⅳ toxicities included neutropenia, nausea, vomiting, hepatic lesion and alopecia. The incidence of grade Ⅲ-Ⅳ neutropenia was 14.2% in the dose dense group and 58.3% in the regular group (P=0.000). All toxicities were similar between the EC→ T and the ET dose dense group. The median DFS and OS were not obtained. Conclusion:Dose dense chemotherapy, concurrently or sequentially, with epirubicin and paclitaxel used as adjuvant chemotherapy for high-risk postoperative breast cancer was safe and effective and can improve the DFS and OS. The side effects were tolerable and the incidence of grade Ⅲ-Ⅳ neutropenia was reduced when compared to the stan- dard treatment. Comparing the two dose dense regimens, concurrently or sequentially with epirubicin and paclitaxel, the efficacy and tolerance were similar.更多还原