CYCLOPHOSPHAMIDE, METHOTREXATE, AND FLUOROURACIL IN NODE-POSITIVE BREAST-CANCER - THE RESULTS OF 20 YEARS OF FOLLOW-UP
CYCLOPHOSPHAMIDE, METHOTREXATE, AND FLUOROURACIL IN NODE-POSITIVE BREAST-CANCER - THE RESULTS OF 20 YEARS OF FOLLOW-UP
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DOI：
10.1056/nejm199504063321401
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发表时间：
1995-04-06
影响因子：
158.5
通讯作者：
BRAMBILLA, C
中科院分区：
文献类型：
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作者：
BONADONNA, G;VALAGUSSA, P;BRAMBILLA, C
背景对腋窝淋巴结组织学阳性的原发性乳腺癌行根治性乳房切除术后给予环磷酰胺、甲氨蝶呤和氟尿嘧啶辅助联合化疗，以评估与单纯手术相比是否能改善治疗结局。在这里，我们报告一个20年的后续调查。1973年，我们开始了一项试验，386名妇女被随机分配接受根治性乳房切除术后不进一步治疗（179名妇女）或12个月周期的辅助联合化疗（207名妇女）。所有患者均入住意大利米兰的国家肿瘤研究所。辅助化疗在内科肿瘤科门诊进行。在中位随访19.4年后，接受辅助联合化疗的患者的无复发生存率明显更高（未校正的复发相对风险为0.71; 95%置信区间为0.56至0.90; P=0.004;校正的相对风险为0.65; 95%置信区间为0.51至0.83; P = 0.005）。
Background. Adjuvant combination chemotherapy with cyclophosphamide, methotrexate, and fluorouracil was administered after radical mastectomy for primary breast cancer with histologically positive axillary lymph nodes to assess whether it would improve treatment outcome as compared with surgery alone. Here we report a 20-year follow-up of this investigation.Methods. In 1973 we began a trial involving 386 women who were randomly assigned to receive either no further treatment after radical mastectomy (179 women) or 12 monthly cycles of adjuvant combination chemotherapy (207 women). All patients were admitted to the Istituto Nazionale Tumori in Milan, Italy. Adjuvant chemotherapy was delivered in the outpatient clinic of the Division of Medical Oncology.Results. After a median follow-up of 19.4 years, the patients given adjuvant combination chemotherapy had significantly better rates of relapse-free survival (unadjusted relative risk of relapse, 0.71; 95 percent confidence interval, 0.56 to 0.90; P=0.004; adjusted relative risk, 0.65; 95 percent confidence interval, 0.51 to 0.83; P