The Christie Hospital adjuvant tamoxifen trial.
A clinical trial was carried out at The Christie Hospital, Manchester, England, between November 1976 and June 1982. Following surgery, patients with clinical stage T1-T3a, N1-N2b, M0 tumors were randomly allocated in the following way: premenopausal women to either tamoxifen 20 mg/day for 1 year or to an irradiation-induced menopause; postmenopausal women to either tamoxifen for 1 year or no further treatment (controls). In the node-negative subgroup, an analysis at a median follow-up of 10 years shows no statistically significant difference in overall or disease-free survival between tamoxifen-treated patients and irradiation-induced menopause and control patients. Side effects were few, and compliance was excellent. There was no significant increase of second primary tumors in target endocrine organs in the tamoxifen-treated patients. For the whole series of 961 patients, a log-rank analysis of events, allowing for node status, still shows a statistically significant benefit for tamoxifen-treated patients (P = .04).
Ribeiro
G
G
Department of Radiotherapy, Christie Hospital, Holt Radium Institute, Manchester, England.
Swindell
R
R
D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D004739:England; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis; D008593:Menopause / Q000502:physiology; D008875:Middle Aged; D016609:Neoplasms, Second Primary / Q000453:epidemiology; D016522:Oncology Service, Hospital; D011182:Postoperative Care / Q000379:methods; D012307:Risk Factors; D015996:Survival Rate; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*
D013629:Tamoxifen