Aims: To evaluate possible differences in effect on recurrence-free survival (RFS) and overall survival (OS) in node positive postmenopausal breast cancer patients receiving Tamoxifen or cyclic Tam and Megestrol acetate as adjuvant treatment.
Methods: Between 1989 and 1994, 489 patients with pT(1-2)pN+ hormone receptor positive or unknown tumours were included in a randomized national multicenter study to receive either Tam alone or cyclic Tam (8 weeks) and MA (8 weeks) for 2 years. Final follow-up was completed as of June 2002. Time from start of treatment to first recurrence and novel primary breast tumour, overall survival and cancer specific survival were estimated.
Results: No differences in RFS, OS or cancer specific survival were observed between the two treatment groups.
Conclusions: Adjuvant treatment used as standard Tam alone, compared to Tam and MA, as employed in this group of patients gave similar outcomes. Side effects that led to cessation of study medication were observed in both arms.