COMBINATION GOSERELIN AND TAMOXIFEN THERAPY IN PREMENOPAUSAL ADVANCEDBREAST-CANCER - A MULTICENTER STUDY BY THE ITMO GROUP

It has been suggested that tamoxifen may improve the efficacy of medic al castration with luteinising hormone-releasing hormone analogues, bu t very few data have so far been published concerning the clinical and endocrinological activity of this therapeutic modality. In this phase II multicentre trial conducted by the Italian Trials in Medical Oncol ogy group (ITMO), 64 premenopausal patients with hormone receptor-posi tive or unknown breast cancer were treated with monthly s.c. injection s of goserelin 3.6 mg, in association with a tamoxifen daily dose of 2 0 mg, as first-line therapy for their advanced disease. All of the pat ients were evaluable for efficacy and there was an overall response ra te of 41% (95% confidence interval 28-52%), with 7 of the 26 responder s achieving complete remission. The median time to response was 4 mont hs (range 2-17), and the median response duration was 13 months (range 6-37 +). Better responses were observed in soft tissues (51%); the re sponse in visceral and bone metastases was respectively 19% and 37%. S erum concentrations of gonadotrophins and oestradiol were significantl y decreased by the treatment, oestrogen levels being constantly suppre ssed to within the range observed in post-menopausal women. No signifi cant change was detected in serum testosterone levels. In our experien ce, although it was not associated with any increased clinical efficac y, the concurrent use of goserelin and tamoxifen proved to be a feasib le approach in the management of premenopausal advanced breast cancer.