title: Bicalutamide (150 mg) versus placebo as immediate therapy alone or as adjuvant to therapy with curative intent for early nonmetastatic prostate cancer: 5.3-year median followup from the Scandinavian Prostate Cancer Group Study Number 6.
abstract: OBJECTIVE
  We evaluated the benefits of adding 150 mg bicalutamide to standard care, that is radical prostatectomy, radiotherapy or watchful waiting (WW), in patients with localized or locally advanced prostate cancer.
  
  
  METHODS
  A total of 1,218 men with T1-4, M0, any N prostate cancer were recruited from 62 Scandinavian centers and randomized 1:1 to 150 mg bicalutamide or placebo plus standard care. Primary end points were progression-free survival (PFS) and overall survival.
  
  
  RESULTS
  At a median 5.3-year followup patients with locally advanced disease had improved survival with bicalutamide (HR 0.68, 95% CI 0.50 to 0.92), while those with localized disease had decreased survival with bicalutamide (HR 1.47, 95% CI 1.06 to 2.03). Bicalutamide significantly improved PFS, decreasing the risk of disease progression by 43% compared with placebo (HR 0.57, 95% CI 0.48 to 0.68, p<0.0001). The rate of events was 35.4% for bicalutamide and 46.2% for placebo. Patients with locally advanced disease gained the greatest PFS benefits with bicalutamide (HR 0.40, 95% CI 0.31 to 0.52). Since 81% of the trial population were untreated before entry and would otherwise have undergone WW, the findings essentially reflect the results of immediate hormone therapy vs WW.
  
  
  CONCLUSIONS
  Bicalutamide (150 mg) provides significant benefit in patients with locally advanced disease. In previously untreated patients there may be a tumor burden below which endocrine therapy provides no benefit or may even decrease survival.
authors.affiliation: Department of Urology, University of Copenhagen, Rigshospitalet and Herlev Hospital, Copenhagen, Denmark. piv@rh.dk
authors.forename: Peter
authors.initials: P
authors.lastname: Iversen
authors.forename: Jan-Erik
authors.initials: JE
authors.lastname: Johansson
authors.forename: Pär
authors.initials: P
authors.lastname: Lodding
authors.forename: Olavi
authors.initials: O
authors.lastname: Lukkarinen
authors.forename: Per
authors.initials: P
authors.lastname: Lundmo
authors.forename: Peter
authors.initials: P
authors.lastname: Klarskov
authors.forename: Teuvo L J
authors.initials: TL
authors.lastname: Tammela
authors.forename: Ilker
authors.initials: I
authors.lastname: Tasdemir
authors.forename: Tom
authors.initials: T
authors.lastname: Morris
authors.forename: Kevin
authors.initials: K
authors.lastname: Carroll
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000813:Anilides / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D017024:Chemotherapy, Adjuvant; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D015996:Survival Rate; D013997:Time Factors; D014105:Tosyl Compounds
chemical_list: D000813:Anilides; D000970:Antineoplastic Agents; D009570:Nitriles; D014105:Tosyl Compounds; C053541:bicalutamide