Mouridsen H T, Andersen A P, Brincker H, Dombernowsky P, Rose C, Andersen K W
NCI Monogr. 1986(1):115-8.
The aim of the present study was to analyze the efficacy of adjuvant tamoxifen (TAM) in postmenopausal patients with high-risk breast cancer. The primary surgical treatment was total mastectomy with axillary sampling. There were 1,650 eligible patients; 829 were randomized to receive postoperative radiotherapy (RT) and 821, to receive RT + TAM (10 mg three times daily for 1 yr). The 2 groups were identical with respect to age, tumor size, number of positive lymph nodes, degree of anaplasia, and estrogen and progesterone receptor content. Overall recurrence-free survival at 6 years was 39% in the RT group, compared to 48% in the RT + TAM group (P = 0.0008), but there was no significant difference in survival (P = 0.14). From retrospective analyses of recurrence-free survival according to prognostic variables, it appears that 4 subgroups of patients benefited from adjuvant TAM: those less than 69 years of age, those with 4 or more positive nodes, those with grade I-II tumors, and those with high estrogen receptor values (greater than 100 fmol/mg cytosol protein).
本研究的目的是分析辅助性他莫昔芬（TAM）对绝经后高危乳腺癌患者的疗效。主要手术治疗方式为全乳切除加腋窝取样。共有1650例符合条件的患者；829例被随机分配接受术后放疗（RT），821例接受RT + TAM（每日3次，每次10 mg，共1年）。两组在年龄、肿瘤大小、阳性淋巴结数目、间变程度以及雌激素和孕激素受体含量方面相同。RT组6年时的总体无复发生存率为39%，而RT + TAM组为48%（P = 0.0008），但生存率无显著差异（P = 0.14）。根据预后变量对无复发生存率进行回顾性分析发现，有4个亚组的患者从辅助性TAM中获益：年龄小于69岁的患者、有4个或更多阳性淋巴结的患者、I-II级肿瘤患者以及雌激素受体值高（大于100 fmol/mg胞浆蛋白）的患者。
