title: Bicalutamide 150 mg in addition to standard care for patients with early non-metastatic prostate cancer: updated results from the Scandinavian Prostate Cancer Period Group-6 Study after a median follow-up period of 7.1 years.
abstract: OBJECTIVE
  The Early Prostate Cancer (EPC) programme is evaluating the efficacy and tolerability of bicalutamide following standard care (radiotherapy, radical prostatectomy or watchful waiting) in patients with localized (T1-2, N0/Nx) or locally advanced (T3-4, any N; or any T, N + ) non-metastatic prostate cancer. Herein we report the latest findings after a median follow-up period of 7.1 years from the Scandinavian Prostate Cancer Group (SPCG)-6 study, one of three trials in the EPC programme.
  
  
  METHODS
  A total of 1218 patients were randomized on a 1:1 basis to either bicalutamide 150 mg/day (n=607) or placebo (n=611) following standard care; 81.4% were followed conservatively (watchful waiting). The primary endpoints were objective progression-free survival (PFS) and overall survival (OS).
  
  
  RESULTS
  In patients with localized disease there was no significant difference in PFS [hazard ratio (HR) 0.85; 95% CI 0.69-1.06; p=0.15] and a trend towards decreased OS with bicalutamide plus standard care compared with standard care alone (HR 1.23; 95% CI 0.96-1.58; p=0.11). In patients with locally advanced disease, bicalutamide significantly improved PFS, reducing the risk of progression by 53% compared with standard care alone (HR 0.47; 95% CI 0.37-0.59; p<0.001). The median time to progression was 8.8 years for bicalutamide plus standard care and 7.1 years for standard care alone. There was a significant improvement in OS with bicalutamide plus standard care, with a reduction in the risk of death of 35% versus standard care alone (HR 0.65; 95% CI 0.50-0.85; p=0.001).
  
  
  CONCLUSIONS
  This analysis of the SPCG-6 study showed that bicalutamide plus standard care offers significant PFS and OS benefits for patients with locally advanced disease, but not for those with localized disease.
authors.affiliation: Departments of Urology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. piv@rh.hosp.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: Timo
authors.initials: T
authors.lastname: Kylmälä
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: Thomas
authors.initials: T
authors.lastname: Morris
authors.forename: Jon
authors.initials: J
authors.lastname: Armstrong
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000813:Anilides / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004361:Drug Tolerance; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D014105:Tosyl Compounds
chemical_list: D000813:Anilides; D000970:Antineoplastic Agents; D009570:Nitriles; D014105:Tosyl Compounds; C053541:bicalutamide