紫杉醇联合表阿霉素剂量密集辅助化疗的安全性观察

目的 观察紫杉醇(PTX)联合表阿霉素(EPI)剂鼍密集化疗在高复发风险的乳腺癌辅助化疗中的安全性和耐受性.方法 2004年1月至2006年12月共收治101例乳腺癌术后患者,均具有高复发风险.采用FIX联合EPI的方案进行辅助化疗,随机分为密集组和常规组,计划每例患者接受6个周期的化疗.结果 全组有98例患者按计划完成化疗,中位随访24个月,中位无复发生存和总牛存时间均未达到.密集组和常规组的无复发率分别为89.8%和87.8%,2年生存率分别为100%和93.9%,其中高危患者的无复发率分别为86.8%和81.3%,2年生存率分别为100%和90.6%.全组101例患者均可评价不良反应,主要不良反应为粒细胞减少、恶心、呕吐和脱发.密集组和常规组的Ⅲ～Ⅳ度粒细胞减少发生率分别为16.0%和54.9%(P=0.000),凶不良反应而延迟化疗的发生率分别为2.4%和6.0%(P=0.027),两组间其他不良反应差异无统计学意义.结论 PTX联合EPI剂量密集方案用于高复发风险乳腺癌患者的辅助化疗,不良反应可以耐受,是一个安全的、有潜力的方案.

Safety of adjuvant dose-dense chemotherapy with paclitaxel and epirubicin for high-risk breast cancer

Objective To investigate the safety and tolerance of adjuvant dose-dense chemotherapy with paclitaxel and epirubicin for high-risk breast cancer. Methods From January 2004 to December 2006,101 patietns with high-risk breast cancer after surgical resection were enrolled into this study. The patients were divided into two groups: dose-dense and regular groups. Each patient received 6 cycles of chemotherapy with intravenous administration of paclitaxel (175 mg/m2, on D3) and epirubicin (60 mg/m2, on DI and D2). The dose-dense group had repeated treatment every two weeks, while the regular group repeated it every three weeks. G-CSF was used in a dose of 3 μg/kg on D5-D9 during each cycle in the dose-dense group. While in the regular group, it was used only under the condition that grade Ⅱ neutropenia occurred.Results The toxicity could be evaluated in 101 patients. Major grade Ⅲ-Ⅳ toxicities included:neutropenia, nausea,vomiting and alopecia. The incidence of grade Ⅲ-Ⅳ neutropenia was 16.0% in the dose-dense group versus 54.9% in the regular group ( P = 0. 000) ; postponing of chemotherapy was 2.4% versus 6.0% ( P = 0. 027 ). Ninety-eight patients completed the chemotherapy as planed. After a median follow-up of 24 months, the median DFS and OS were not reached. The relapse-free rate and survival ratewere 89.8% and 100% in the dose-dense group, which were 87.8% and 93.9% in the regular group. The relapse-free rate of the high-risk patients in the dose-dense group was 86.8% versus 81.3% in the regular group, and the corresponding survival rate was 100% versus 90.6%. Conclusion Adjuvant dose-dense chemotherapy with paclitaxel and epirubicin is safe, tolerable and promising for high-risk breast cancer.