30 years' follow up of randomised studies of adjuvant CMF in operable breast cancer: cohort study
30 years' follow up of randomised studies of adjuvant CMF in operable breast cancer: cohort study
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DOI：
10.1136/bmj.38314.622095.8f
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发表时间：
2005-01-29
影响因子：
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通讯作者：
Valagussa, P
中科院分区：
文献类型：
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作者：
Bonadonna, G;Moliterni, A;Valagussa, P
目的在1973年6月至1980年12月进行的三项连续随机试验和一项观察性研究的基础上，评估环磷酰胺、甲氨蝶呤和氟尿嘧啶（CMF）辅助治疗有复发风险的可手术乳腺癌患者的长期有效性。设计队列研究。以意大利米兰国立肿瘤研究所为背景。主要结果测量：通过单变量和多变量分析测量无复发和总生存期。结果初始研究的中位随访时间为28.5年，发现辅助CMF可显著降低相对复发风险（风险比0.71,95%可信区间0.56 ~ 0.91,P = 0.005）和死亡风险（0.79,0.63 ~ 0.98,P = 0.04）。CMF治疗12个周期似乎并不优于6个周期的较短治疗。在淋巴结阴性和雌激素受体阴性试验中，静脉注射CMF显著降低疾病复发的相对风险（0.65,0.47 ~ 0.90,P = 0.009）和死亡（0.65,0.47 ~ 0.92,P = 0.01），中位随访20年。结论：当给予最佳治疗时，CMF对有远处疾病复发风险的患者有益，在任何被检查的亚组中均无不利影响的证据。
Objective To assess the long term effectiveness of adjuvant treatment with cyclophosphamide, methotrexate, and fluorouracil (CMF) in patients with operable breast cancer at risk of relapse, on the basis of three successive randomised trials and one observational study conducted from June 1973 to December 1980.Design Cohort study.Setting Istituto Nazionale Tumori in Milan, Italy.Main outcome measures Relapse free and overall survival, measured by univariate and multivariate analyses.Results After a median follow up of 28.5 years for the initial study, adjuvant CMF was found to reduce the relative risk of relapse significantly (hazard ratio 0.71, 95% confidence interval 0.56 to 0.91, P = 0.005) and death (0.79, 0.63 to 0.98, P = 0.04). Administration of CMF for 12 cycles does not seem superior to a shorter administration of six cycles. Tit the node negative and oestrogen receptor negative trial, intravenous CMF significantly reduced the relative risk of relapse of disease (0.65, 0.47 to 0.90, P = 0.009) and death (0.65, 0.47 to 0.92, P = 0.01) at a median follow up of 20 years.Conclusions When delivered optimally, CMF benefits patients at risk of relapse of distant disease Without evidence of detrimental effects in any of the examined subgroups.