紫杉醇联合表阿霉素剂量密集辅助化疗的安全性观察

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

目的观察紫杉醇（PTX）联合表阿霉素（EPI）剂量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PTX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生存时间均未达到。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），因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。

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/m^2, on D3） and epirubicin （60 mg/m^2, on D1 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 DS-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 rate were 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.