A CONTROLLED TRIAL OF ADJUVANT TAMOXIFEN, WITH OR WITHOUT PREDNISOLONE, IN POSTMENOPAUSAL WOMEN WITH OPERABLE BREAST-CANCER

A randomised clinical trial has been conducted to compare adjuvant tam oxifen, 20 mg daily, with tamoxifen and prednisolone, 7.5 mg daily, in post-menopausal women with operable breast cancer. There were 254 eva luable patients, of whom 128 were given tamoxifen alone and 126 receiv ed tamoxifen and prednisolone. After a median follow-up of 48 months t here was no significant difference in relapse-free or overall survival of the two groups. Furthermore, with survival slightly favouring tamo xifen, confidence intervals on the hazard ratio established that a dif ference in favour of tamoxifen plus prednisolone of even 5% at 5 years was very unlikely (P<0.02). Thus, despite the relatively small number of patients in this trial, the data clearly establish that prednisolo ne is not of value as an additional adjuvant agent.