ABSTRACT

During 10 years, 332 premenopausal women with node-positive breast cancer were randomized, after mastectomy or conservative therapy, to receive either ovarian ablation or CMF chemotherapy, each with or without prednisolone 7.5 mg daily for 5 years. After a maximum follow-up of 12 years, no significant overall differences were detected in relapse rates or in event-free or overall survival for ovarian ablation compared with chemotherapy or for prednisolone versus no prednisolone, nor was there any suggestion of interaction between these factors. Actuarial survival at 8 years was 60% overall, irrespective of treatment, with hazard ratio and confidence interval 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 tumours, but these results played no part in the randomization procedure. When patient outcome was analysed in relation to the concentration of ER in the tumour, there was a statistically significant interaction between ER content and treatment, such that ovarian ablation was associated with improved survival in patients with ER concentrations 20 fmol/mg protein or more, and CMF was more beneficial for patients with values less than 20 fmol/mg protein. No such interaction was seen for prednisolone therapy. The authors pointed out that ER content has a role to play in decisions about treatment for primary breast cancer.