Hubay C A, Pearson O H, Manni A, Gordon N H, McGuire W L
J Steroid Biochem. 1985 Dec;23(6B):1147-50. doi: 10.1016/0022-4731(85)90034-2.
Six-year results of a prospective, randomized clinical trial of three treatment regimens [(1) cytoxan, methotrexate and 5-fluorouracil (CMF); (2) CMF plus the antiestrogen drug, tamoxifen (CMFT); (3) CMFT plus Bacillus Calmette-Guerin (BCG) vaccinations] in 312 women with stage II breast cancer are reported. Addition of tamoxifen to CMF therapy significantly decreased the number of recurrences at 6 years in ER + patients with greater than or equal to 4 positive axillary lymph nodes, and in those with tumor diameter in excess of 3 cm. The beneficial effect of tamoxifen appeared to be independent of the menopausal status. Addition of tamoxifen to CMF had no effect on disease-free survival in ER + patients with 1-3 positive axillary lymph nodes or in patients with ER--tumors. Addition of BCG vaccinations had no discernible effect on disease-free survival. ER measurements in the primary tumor provide important prognostic information regardless of treatment, with ER + patients having increased overall survival after 6 years. Further follow-up is needed to determine whether tamoxifen is delaying recurrence or preventing it in a subset of these patients.
报告了一项针对312例II期乳腺癌女性患者的前瞻性随机临床试验的六年结果，该试验采用了三种治疗方案：（1）环磷酰胺、甲氨蝶呤和5-氟尿嘧啶（CMF）；（2）CMF加抗雌激素药物他莫昔芬（CMFT）；（3）CMFT加卡介苗（BCG）接种。在CMF治疗中添加他莫昔芬可显著降低6年时ER +且腋窝淋巴结阳性数大于或等于4个以及肿瘤直径超过3 cm患者的复发次数。他莫昔芬的有益效果似乎与绝经状态无关。在CMF中添加他莫昔芬对腋窝淋巴结阳性1-3个的ER +患者或ER-肿瘤患者的无病生存期没有影响。接种卡介苗对无病生存期没有明显影响。无论采用何种治疗，原发肿瘤中的ER测量都提供重要的预后信息，ER +患者6年后的总生存期有所增加。需要进一步随访以确定他莫昔芬是否在这些患者的一部分中延迟复发或预防复发。
