ADJUVANT OVARIAN ABLATION VERSUS CMF CHEMOTHERAPY IN PREMENOPAUSAL WOMEN WITH PATHOLOGICAL STAGE-II BREAST-CARCINOMA - THE SCOTTISH TRIAL

There are no previous reports of trials that have directly compared th e effects of adjuvant chemotherapy with oophorectomy in premenopausal women with node-positive breast cancer. During 10 years we recruited 3 32 such women who were randomised, after mastectomy or conservation th erapy, to receive either ovarian ablation or cyclophosphamide/methotre xate/5-fluorouracil (CMF) chemotherapy, each with or without prednisol one 7.5 mg daily for 5 years. After a maximum follow-up of 12 years, w e detected no significant overall differences in relapse rates, or in event-free or total survival for ovarian ablation compared with chemot herapy or for prednisolone versus no prednisolone, nor any suggestion of an interaction between these factors. Actuarial total survival at 8 years was 60% overall, irrespective of treatment, with a hazard ratio and 95% CI of 1.12 (0.76-1.63) for the comparison of CMF with ovarian ablation and 1.26 (0.86-1.84) for prednisolone versus no prednisolone . Oestrogen receptor (ER) assays were done in 270 (81%) primary tumour s but these results played no part in the randomisation procedure. Whe n patient outcome was analysed in relation to the concentration of ER in the tumour, there was a statistically significant interaction betwe en ER content and treatment, such that ovarian ablation was associated with improved survival in patients with E R concentrations 20 fmols/m g protein or more and CMF was more beneficial for patients with values less than 20 fmols/mg protein. No such interaction was seen for predn isolone therapy. Oestrogen receptor content has a role in decisions ab out treatment for primary breast cancer.