title: [Effect of bicalutamide 150 mg, after 3 years of median follow-up, in non-metastatic prostatic cancer].
abstract: OBJECTIVE
  To determine the efficacy and safety of bicalutamide, at the dose of 150 mg per day, as first-line monotherapy or as curative adjuvant therapy in patients with non-metastatic prostate cancer, and to investigate the possibility of a greater benefit for certain patient subgroups.
  
  
  METHODS
  This article recalls the preliminary results of an international endocrine therapy programme comprising three double-blind placebo-controlled clinical trials in patients with non-metastatic prostate cancer (T1-T4. Nx/N0/N1, M0). Patients were randomized to receive either 150 mg/day of bicalutamide, or placebo, as an adjuvant to radical prostatectomy, external beam radiotherapy or in the context of watchful waiting. The main endpoints were the time to objective clinical progression and overall survival. The combined data of the three trials were submitted to intent-to-treat analysis. The authors also report the results of exploratory studies performed as a function of the type of treatment and prognostic factors.
  
  
  RESULTS
  After a median follow-up of 3 years of a sample size of 8,113 patients, objective clinical progression was observed in 9% of patients of the bicalutamide group (4,052 patients) and in 13.8% of patients of the placebo group (4,061 patients), corresponding to a 42% relative risk reduction (RR: 0.58; p << 0.0001). Reduction of the risk of disease progression was observed for the entire study population regardless of primary treatment, stage of disease or usual prognostic factors. This reduction was more marked for patients presenting poor prognostic factors. Data concerning overall survival are not available due to insufficient follow-up. Treatment was well tolerated. The adverse effects most frequently reported in the bicalutamide group were gynaecomastia and breast pain.
  
  
  CONCLUSIONS
  After a median follow-up of three years, bicalutamide, as first-line monotherapy or as curative adjuvant therapy, significantly reduced the risk of objective clinical disease progression in patients with non-metastatic prostate cancer. Exploratory analyses demonstrate that the benefit of bicalutamide appeared to be greater for patient with poor prognostic factors. Survival data are not yet available.
authors.affiliation: Service d'Urologie, Centre Hospitalier d'Auxerre, Boulevard de Verdun, 89000 Auxerre. rfourcade@fc.horus-medical.fr
authors.forename: Richard-Olivier
authors.initials: RO
authors.lastname: Fourcade
authors.forename: Pierre
authors.initials: P
authors.lastname: Richaud
authors.forename: Daniel
authors.initials: D
authors.lastname: Brune
authors.forename: Paul
authors.initials: P
authors.lastname: Colombel
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Sarramon
authors.forename: Georges
authors.initials: G
authors.lastname: Fournier
authors.forename: Pierre
authors.initials: P
authors.lastname: Colombeau
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000813:Anilides / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D013997:Time Factors; D014105:Tosyl Compounds
chemical_list: D000813:Anilides; D000970:Antineoplastic Agents; D009570:Nitriles; D014105:Tosyl Compounds; C053541:bicalutamide