OBJECTIVE: To determine the efficacy and safety of @entity12195 , at the dose of 150 mg per day, as first-line monotherapy or as curative adjuvant therapy in @entity1 with non-metastatic @entity263 , and to investigate the possibility of a greater benefit for certain @entity1 subgroups. MATERIAL AND METHODS: This article recalls the preliminary results of an international endocrine therapy programme comprising three double-blind placebo-controlled clinical trials in @entity1 with non-metastatic @entity263 (T1-T4. Nx/N0/N1, M0). @entity1 were randomized to receive either 150 mg/day of @entity12195 , 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 @entity1 , objective clinical progression was observed in 9% of @entity1 of the @entity12195 group (4,052 @entity1 ) and in 13.8% of @entity1 of the placebo group (4,061 @entity1 ), 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 @entity1 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 @entity12195 group were gynaecomastia and @entity5026 . CONCLUSION: After a median follow-up of three years, @entity12195 , as first-line monotherapy or as curative adjuvant therapy, significantly reduced the risk of objective clinical disease progression in @entity1 with non-metastatic @entity263 . Exploratory analyses demonstrate that the benefit of @entity12195 appeared to be greater for @entity1 with poor prognostic factors. Survival data are not yet available.

[Effect of @entity12195 150 mg, after 3 years of median follow-up, in non-metastatic XXXX ].

@entity12195 :: ('MESH:C053541', 'Chemical') :: ['bicalutamide'] @entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity5026 :: ('MESH:D059373', 'Disease') :: ['breast pain'] @entity263 :: ('MESH:D011471', 'Disease') :: ['prostate cancer']
@entity263 :: (MESH:D011471,Disease) :: ['prostatic cancer']
