Bicalutamide 150 mg as adjuvant to radiotherapy significantly increases progression-free survival in early prostate cancer

Abstract

Purpose/Objective: The potent non-steroidal antiandrogen bicalutamide (‘Casodex’) 150 mg is being evaluated in the largest treatment trial in prostate cancer to date — The Early Prostate Cancer (EPC) program. In a preliminary analysis at a median follow-up of 3 years, bicalutamide 150 mg in addition to standard care (radical prostatectomy, radiotherapy [RT], or watchful waiting), reduced the risk of objective progression by 42% (hazard ratio [HR] 0.58; 95% confidence intervals [CI] 0.51, 0.66; p<0.0001) relative to standard care alone in men with localized or locally advanced prostate cancer (See et al. J Urol 2002;168:429–435). In subsequent subgroup analyses, significant treatment benefits were observed irrespective of the type of standard care. A statistical analysis, that estimates the relative increase in the time to an event (event time ratio [ETR]), has now been conducted. The ETR can be used to estimate relative differences in progression-free survival (PFS) before the median PFS has been achieved. Results are presented for the 1370 patients in the RT subgroup.