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Bicalutamide (Casodex) 150 mg as immediate therapy in patients with localized or locally advanced prostate cancer significantly reduces the risk of disease progression

dc.contributor.authorWirth M.
dc.contributor.authorTyrrell C.
dc.contributor.authorWallace M.
dc.contributor.authorDelaere K.P
dc.contributor.authorSanchez-Chapado M.
dc.contributor.authorRamon J.
dc.contributor.authorHetherington J.
dc.contributor.authorPina F.
dc.contributor.authorHeynes C.F
dc.contributor.authorBorchers T.M
dc.contributor.authorMorris T.
dc.contributor.authorStone A.
dc.date.accessioned2011-05-15T16:18:20Z
dc.date.available2011-05-15T16:18:20Z
dc.date.issued2001
dc.identifier.citationUrology
dc.identifier.citation58
dc.identifier.citation2
dc.identifier.issn00904295
dc.identifier.other10.1016/S0090-4295(01)01213-4
dc.identifier.urihttp://hdl.handle.net/10019.1/14615
dc.description.abstractObjectives. To investigate the efficacy and tolerability of bicalutamide (Casodex) as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with localized or locally advanced (T1b-T4, any nodal status, M0) prostate cancer. Methods. This was a multicenter, prospective, randomized, double-blind, placebo-controlled trial in Europe, South Africa, Australia, and Mexico and is part of the Casodex Early Prostate Cancer program. Results. A total of 3603 men were randomized to receive bicalutamide (n = 1798) or placebo (n = 1805). The patient demographics were well balanced between the two groups. Prior therapy of curative intent had been given to 64% of the patients (prostatectomy [44%], radiotherapy [18%], and prostatectomy and radiotherapy [2%]) and 36% had been monitored with watchful waiting. After a median follow-up of 2.6 years and a median exposure to the study drug of 2.2 years, a significant 43% reduction in the risk of objective progression was observed for the bicalutamide group compared with the placebo group (hazard ratio 0.57, 95% confidence interval 0.48 to 0.69, P ≪0.0001). The time to prostate-specific antigen doubling was significantly delayed for the bicalutamide group compared with the placebo group (hazard ratio 0.37, 95% confidence interval 0.32 to 0.43, P ≪0.001). The survival data were immature, with 7.2% overall mortality. The most frequently reported adverse events with bicalutamide were gynecomastia alone (17.4%), breast pain alone (17.6%), and gynecomastia with breast pain (47.5%). Conclusions. Bicalutamide 150 mg daily as immediate therapy, alone or as adjuvant to treatment of curative intent, significantly reduced the risk of disease progression in patients with localized or locally advanced prostate cancer. Longer follow-up is underway to assess any benefit in overall survival. © 2001, Elsevier Science Inc.
dc.subjectantineoplastic agent
dc.subjectbicalutamide
dc.subjectplacebo
dc.subjectprostate specific antigen
dc.subjectadult
dc.subjectadvanced cancer
dc.subjectaged
dc.subjectarticle
dc.subjectcancer adjuvant therapy
dc.subjectcancer growth
dc.subjectcancer mortality
dc.subjectcancer risk
dc.subjectcancer survival
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdouble blind procedure
dc.subjectdrug activity
dc.subjectdrug effect
dc.subjectdrug efficacy
dc.subjectdrug mechanism
dc.subjectdrug tolerability
dc.subjectfollow up
dc.subjectgynecomastia
dc.subjecthuman
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmastalgia
dc.subjectmulticenter study
dc.subjectpatient monitoring
dc.subjectpriority journal
dc.subjectprospective study
dc.subjectprostate carcinoma
dc.subjectprostatectomy
dc.subjectrandomized controlled trial
dc.subjectstatistics
dc.subjecttreatment outcome
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectAndrogen Antagonists
dc.subjectAnilides
dc.subjectConfidence Intervals
dc.subjectDisease Progression
dc.subjectDisease-Free Survival
dc.subjectDouble-Blind Method
dc.subjectFollow-Up Studies
dc.subjectGynecomastia
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectPain
dc.subjectProspective Studies
dc.subjectProstate-Specific Antigen
dc.subjectProstatic Neoplasms
dc.subjectSurvival Rate
dc.subjectTumor Markers, Biological
dc.titleBicalutamide (Casodex) 150 mg as immediate therapy in patients with localized or locally advanced prostate cancer significantly reduces the risk of disease progression
dc.typeArticle
dc.description.versionArticle


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