FADROZOLE VERSUS MEGESTROL-ACETATE - A DOUBLE-BLIND RANDOMIZED TRIAL IN ADVANCED BREAST-CANCER

Ninety-six patients were entered into a randomised, double-blind, doub le-dummy, clinical trial to assess the efficacy and safety of fadrozol e as compared to megestrol acetate as second-line hormonal treatment f or patients with advanced breast cancer. Analysis of results was on an intention-to-treat basis and included response rate, time to progress ion (TTP), time to treatment failure (TTF) and survival. Forty-six pat ients received fadrozole and 50 were randomised to megestrol acetate. Patients and pretreatment prognostic variables were balanced in the tw o arms of the trial. The objective response rates [3/46 (7 %) for fadr ozole and 3/50 (6 %) for megestrol acetate], TTP, TTF and survival wer e similar in the two arms of the trial. Toxicity was also similar in t he two arms of the trial and consisted mainly of oedema, hypertension and minor gastrointestinal symptoms. Fadrozole appears to be as active as megestrol acetate in second-line hormonal treatment of advanced br east cancer.