MEGESTROL-ACETATE PLUS ALPHA-2A-INTERFERON AS 2ND LINE THERAPY FOR POSTMENOPAUSAL PATIENTS WITH ADVANCED BREAST-CANCER - RESULTS OF A MULTICENTRIC PHASE-II TRIAL

This phase II study was aimed to evaluate the activity of a combinatio n of megestrol acetate (MA) and alpha 2a interferon (IFN) in a group o f tamoxifen-responsive breast cancer patients. Thirty patients with me tastatic breast cancer either previously treated with adjuvant tamoxif en for at least 24 months or treated with tamoxifen for metastatic dis ease and showing an objective response or stability of disease, were g iven MA (single daily dose of 160 mg per os) and alpha 2a IFN (3 milli on units - MU - three times per week intramuscularly i.m. -). Of the 2 9 evaluable patients, 2 (6.8%) achieved a complete response and 4 (13. 8%) a partial response for an overall response rate of 20.6% (95% conf idence limits = 5.9%-35.4%). Treatment toxicity was mild and no patien t had to discontinue or delay the treatment due to IFN side effects. O ur results seem to rule out that alpha 2a IFN is able to improve the a ctivity of MA as second-line therapy in tamoxifen-responsive patients.