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目的根据1973年6月至1980年12月期间的3项连续随机试验和1项观察研究,评价有复发风险的可手术乳腺癌患者使用环磷酰胺、甲氨蝶呤和氟尿嘧啶(CMF)辅助治疗的长期有效性。设计队列研究。地点意大利米兰国家肿瘤研究所。主要结局指标无复发生存和总生存,采用单变量和多变量分析。结果在首项研究随访平均28.5年后,发现辅助CMF能显著降低复发的相对危险度(危险比为0.71,95%可信区间0.56～0.91,P=0.005)并减少死亡(0.79,0.63～0.98,P=0.04)。12个周期的CMF似乎并不优于6个周期的相对短期治疗。在淋巴结和雌激素受体阴性的研究中,平均随访20年后,静脉使用CMF能显著降低疾病复发的相对危险度(0.65,0.47～0.90,P=0.009)以及死亡的相对危险度(0.65,0.470.92,P=0.01)。结论如应用适当,CMF方案能使具有远处复发风险的患者获益,没有证据显示它对任何研究亚组有不良影响。
Objective To evaluate the efficacy and safety of cyclophosphamide, methotrexate and fluorouracil (CMF) adjuvant therapy in patients with operable breast cancer who are at risk of recurrence, based on three consecutive randomized trials and one observational study from June 1973 to December 1980 Long-term effectiveness. Design a cohort study. Location Milan, Italy National Cancer Institute. The main outcome measures were recurrence-free and overall survival, using univariate and multivariate analyzes. Results After an average of 28.5 years of follow-up in the first study, it was found that adjuvant CMF significantly reduced the relative risk of relapse (hazard ratio 0.71, 95% confidence interval 0.56-0.91, P = 0.005) and decreased mortality (0.79, 0.63-0.98 , P = 0.04). The 12-cycle CMF does not seem to outperform the 6-cycle relatively short-term treatment. In a study of lymph node and estrogen receptor negative, mean follow-up of 20 years, the use of CMF intravenously significantly reduced the relative risk of relapse (0.65, 0.47-0.90, P = 0.009) and the relative risk of death (0.65, 0.470.92, P = 0.01). Conclusions CMF regimens, if used appropriately, benefit patients at risk of distant recurrence without evidence of adverse effects on any subgroup of studies.