RANDOMIZED COMPARISON OF CASODEX(TM) (BICALUTAMIDE) 150 MG MONOTHERAPY VERSUS CASTRATION IN THE TREATMENT OF METASTATIC AND LOCALLY ADVANCED PROSTATE-CANCER

Objectives: To evaluate the efficacy and tolerability of 'Casodex'(TM) monotherapy(l50 mg daily) for metastatic and locally advanced prostat e cancer. Methods: A total of 1,453 patients with either confirmed met astatic disease (M-1), or T-3/T-4 non-metastatic disease with elevated prostate-specific antigen (M-0) were recruited into one of two identi cal, multicentre, randomsied studies to compare 'Casodex' 150 mg/day w ith castration The protocols allowed for combined analysis. Results: A t a median follow-up period of approximately 100 weeks for both studie s,'Casodex' 150 mg was found to be less effective than castration in p atients with metastatic disease (M-1) at entry (hazard ratio of 1.30 f or time to death) with a difference in median survival of 6 weeks. In symptomatic M-1 patients,'Casodex' was associated with a statistically significant improvement in subjective response (70%) compared with ca stration (58%). Analysis of a validated quality-of-life questionnaire proved an advantage for 'Casodex' in sexual interest and physical capa city. 'Casodex' had a substantially lower incidence of hot flushes com pared to castration (6-13% compared with 39-44%) and the most commonly reported adverse events were those expected for a potent antiandrogen . However, in patients with Mo disease at entry, the data are still im mature with only 13% of M-0 patients having died. An initial analysis of this immature data has suggested that the results in these patients may be different to those obtained in patients with M-1 disease. A fu rther survival analysis in patients with M-0 disease is therefore plan ned when the data are more mature. Conclusions: 'Casodex' 150 mg is le ss effective than castration in patients with M-1 disease. However,'Ca sodex' Key Words has shown a benefit in terms of quality of life and s ubjective response when Anti-androgen compared to castration and has a n acceptable tolerability profile. Thus 'Casodex'(TM) sodex'; 150 mg m onotherapy is an option for patients with M-1 prostate cancer Prostate cancer for whom surgical or medical castration is not indicated or is not acceptable.