Bicalutamide ('Casodex') 150 mg in addition to standard care in patients with nonmetastatic prostate cancer: updated results from a randomised double-blind phase III study (median follow-up 5.1 y) in the early prostate cancer programme.
Trial 24 is one of three placebo-controlled trials within the ongoing bicalutamide ('Casodex') Early Prostate Cancer (EPC) programme evaluating bicalutamide 150 mg/day in addition to radical prostatectomy, radiotherapy or watchful waiting for T1b-4, any N, M0 prostate cancer. In Trial 24, at 5.1 y median follow-up, the addition of bicalutamide significantly (P < 0.0001) improved objective progression-free survival (PFS) and prostate-specific antigen PFS compared with standard care alone. There was no significant difference in overall survival (P = 0.746). In the context of the whole EPC programme, long-term bicalutamide is not appropriate for localised disease, yet provides advantages in delaying disease progression in patients with locally advanced prostate cancer.
Wirth
M
M
Technical University of Dresden Medical School, Dresden, Germany. wirth-m@rcs.urz.tu-dresden.de
Tyrrell
C
C
Delaere
K
K
Sánchez-Chapado
M
M
Ramon
J
J
Wallace
D M A
DM
Hetherington
J
J
Pina
F
F
Heyns
C
C
Borchers
T
T
Morris
T
T
Armstrong
J
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000813:Anilides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D010919:Placebos; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D016019:Survival Analysis; D014105:Tosyl Compounds; D016896:Treatment Outcome
D000813:Anilides; D000970:Antineoplastic Agents; D009570:Nitriles; D010919:Placebos; D014105:Tosyl Compounds; C053541:bicalutamide