剂量密度化疗在乳腺癌辅助化疗中的随机对比研究

目的观察剂量密度化疗治疗乳腺癌的不良反应及对无病生存期和总生存期的影响。方法对40例腋窝淋巴结转移≥4个的乳腺癌术后患者随机分为治疗组和对照组,治疗组给予由表阿霉素、5-氟脲嘧啶、环磷酰胺3药组成的每2周间隔给药的序贯剂量密度辅助化疗;对照组给予每3周间隔给药的常规FEC方案化疗;主要观察治疗组的不良反应及对无病生存期和总生存期的影响。结果治疗组和对照组的不良反应类型相似,主要有恶心、呕吐、脱发、白细胞减少、口腔溃疡及肝功能异常。治疗组和对照组相比Ⅲ~Ⅳ度白细胞减少的发生率为31.6%和9.5%,治疗组高于对照组,但无统计学差异;治疗组中有1例发生中性粒细胞减少性发热。其余的毒性反应两组无明显差异。两组均完成了全部化疗,无治疗相关性死亡。中位随访时间26个月,治疗组和对照组的中位无病生存期、1年、2年DFS分别为26个月、100%、73.7%和20个月、95.2%、71.4%;治疗组和对照组的1、2年生存率均为100%。治疗组的中位无病生存期、1年及2年DFS优于对照组。结论患者对本研究中的序贯剂量密度化疗方案的耐受性良好,初步结果显示,剂量密度化疗对腋窝淋巴结转移≥4个的乳腺癌术后患者可能有更好的生存优势。

A RANDOMIZED CONTROLLED STUDY OF POSTOPERATIVE BREAST CANCER TREATED WITH DOSE-DENSE AND ROUTINE ADJUVANT CHEMOTHERAPY

Objective To investigate the adverse effect,disease free survival and overall survival of dose-dense chemotherapy in postoperative breast cancer patients.Methods Forty postoperative breast cancer patients with more than 4 axillary nodes metastasis were randomly divided into dose-dense chemotherapy group and routine treatment group.We evaluated the adverse effect,disease free survival and overall survival in two groups treated with standard FEC(5-fluorouracil,epirubicin,and cyclophosphamide,administered every 3 weeks)or dose-dense FEC(the same agents sequentially repeated every 2 weeks).Results Most of the adverse events were nausea,vomiting,alopecia,leucocytopenia,dental ulcer and hepatic disfunction.The toxicity was similar in two groups.The 3～4 grade leucocytopenia in dose-dense FEC group was higher than that in standard FEC group(31.6% and 9.5% respectively).One patient in dose-dense group had neutrocytopenia fever.All patients in two groups received full chemotherapy.There was no treatment-related death.Median follow-up was 26 months.Median disease free survival in two groups were 26 months and 20 months,one-year disease free survival being 100% and 95.2%,2-year disease free survival being 73.7% and 71.4% respectively.But there was no statistical significance between the groups.Conclusions Dose-dense chemotherapy of FEC is well tolerated in the treatment of postoperative breast cancer patients with more than 4 axillary nodes metastasis,and it may have better survial advantage.