The Christie Hospital tamoxifen (Nolvadex) adjuvant trial for operable breast carcinoma--7-yr results.

The Christie Hospital Tamoxifen Trial was a randomised trial to assess the efficacy of tamoxifen (Nolvadex) as an adjunct to surgical treatment for operable breast carcinoma. From 1 November 1976 to 1 June 1982 1005 patients were registered, of whom 961 are evaluable. Following surgery, premenopausal women were randomly allocated to either tamoxifen (TAM) 20 mg/day for 1 yr or to have an irradiation menopause. Postmenopausal women had TAM 20 mg/day for 1 yr or no further treatment (controls). The analysis at 7 yr shows that there is no statistically significant difference in the overall survival for premenopausal women between those given TAM and those given ovarian irradiation. Similarly for the postmenopausal women there was no significant difference in overall survival between the TAM and control groups. However, if the series of 961 patients is analysed as a whole and allowance is made for node status then the TAM-treated patients show a significant survival benefit (P = 0.05). There was also a statistically significant delay in first relapse for the TAM-treated patients (P = 0.04); with a particularly marked reduction in distant metastases in postmenopausal patients (P = 0.06). TAM was extremely well tolerated, with very few side-effects.