Adjuvant tamoxifen for operable carcinoma of the breast: report of clinical trial by the Christie Hospital and Holt Radium Institute.

A large controlled clinical trial with the admission of 1005 patients was carried out using tamoxifen as adjuvant treatment for women with operable carcinoma of the breast. Results were analysed for the first 906 evaluable patients randomised up to December 1981. After mastectomy premenopausal women were randomised to receive either an irradiation menopause or tamoxifen 20 mg daily for one year. Postmenopausal women were randomised to receive either tamoxifen 20 mg daily for one year or no systemic treatment (controls). Analysis at five years suggested that for premenopausal women there was no significant difference between an irradiation menopause and tamoxifen in terms of survival, local recurrence, or distant metastases. Tamoxifen had no appreciable side effects. For postmenopausal women there was a trend in favour of tamoxifen with regard to survival and incidence of distant metastases, and the difference became statistically significant for those patients with four or more positive axillary nodes. If long term results of these studies show only an improved quality of remaining life with tamoxifen, then this drug could be an important contribution to adjuvant treatment.