Livi L, Saieva C, Borghesi S, De Luca Cardillo C, Scotti V, Mangoni M, Greto D, Cataliotti L, Paiar F, Bianchi S, Biti G P
Radiotherapy Unit, University of Florence, Italy.
J Chemother. 2009 Nov;21(5):558-65. doi: 10.1179/joc.2009.21.5.558.
This study evaluated whether doxorubicin and cyclophosphamide are superior to cyclophosphamide, methotrexate and 5-fluorouracil as adjuvant chemotherapy in breast cancer patients. Between July 1976 and December 2004, 1045 breast cancer patients received adjuvant chemotherapy at the Radiotherapy Unit of the University of florence. 927 were administered i.v. CMF (cyclophosphamide 600 mg/m(2), methotrexate 40 mg/m(2) and 5-fluorouracil 600 mg/m(2) on days 1 and 8, repeated every 28 days for a total of six cycles) and 118 i.v. DC (doxorubicin 60 mg/m(2) and cyclophosphamide 600 mg/m(2) on day 1 repeated every 21 days for a total of four cycles). All patients underwent adjuvant radiotherapy as well. The survival analysis, stratified according to treatment, did not show any significant difference in metastasis occurrence between the two groups (log rank test p=0.42). According to multivariate analysis four parameters emerged as independent prognostic factors for distant metastases in patients treated with the Cmf regimen: pt (p=0.0005), number of positive axillary lymph nodes (p=<0.0001), tamoxifen use (p=0.0109) and local relapses (p=<0.0001). Only number of positive axillary lymph nodes and local relapses were significant predictors of metastases occurrence according to multivariate analysis in the DC group, 17 and p=0.028, respectively. No significant difference between the two regimens was observed with regards to number of involved nodes. DC and CMF produced similar outcome in breast cancer patients.
本研究评估了在乳腺癌患者中,多柔比星与环磷酰胺联合使用作为辅助化疗,是否优于环磷酰胺、甲氨蝶呤和5-氟尿嘧啶联合使用。1976年7月至2004年12月期间,1045例乳腺癌患者在佛罗伦萨大学放疗科接受辅助化疗。927例接受静脉注射CMF方案(环磷酰胺600mg/m²、甲氨蝶呤40mg/m²和5-氟尿嘧啶600mg/m²,于第1天和第8天给药,每28天重复一次,共六个周期),118例接受静脉注射DC方案(多柔比星60mg/m²和环磷酰胺600mg/m²,于第1天给药,每21天重复一次,共四个周期)。所有患者均接受了辅助放疗。根据治疗进行分层的生存分析显示,两组之间转移发生率无显著差异(对数秩检验p = 0.42)。多因素分析显示,在接受CMF方案治疗的患者中,有四个参数是远处转移的独立预后因素:病理分期(p = 0.0005)、腋窝阳性淋巴结数量(p < 0.0001)、他莫昔芬使用情况(p = 0.0109)和局部复发情况(p < 0.0001)。在DC组中,根据多因素分析,只有腋窝阳性淋巴结数量和局部复发情况是转移发生的显著预测因素,分别为p = 0.017和p = 0.028。在受累淋巴结数量方面,两种方案之间未观察到显著差异。DC方案和CMF方案在乳腺癌患者中产生了相似的结果。