title: Combined androgen blockade with bicalutamide for advanced prostate cancer: long-term follow-up of a phase 3, double-blind, randomized study for survival.
abstract: BACKGROUND
  A previously reported, double-blind, randomized, multicenter phase 3 trial in 205 patients with stage C/D prostate cancer compared combined androgen blockade (CAB) with luteinizing hormone-releasing hormone agonist (LHRH-A) plus bicalutamide 80 mg versus LHRH-A plus bicalutamide-matching placebo (LHRH-A monotherapy). The analysis at a median follow-up of 2.4 years indicated that CAB significantly (P<.001) prolonged the time to progression and the time to treatment failure. In the current report, survival data from a long-term follow-up (median, 5.2 years) were analyzed.
  
  
  METHODS
  All deaths irrespective of cause and all prostate cancer-specific deaths were recorded. The data were analyzed using Cox regression analysis and the log-rank test.
  
  
  RESULTS
  At a median follow-up of 5.2 years, a significant overall survival advantage was observed in favor of CAB over LHRH-A monotherapy (Cox regression analysis: hazard ratio, 0.78; 95% confidence interval, 0.60-0.99; P=.0498; log-rank test: P=.0425). The difference in cause-specific survival between the 2 groups was not significant. The achievement of a prostate-specific antigen (PSA) nadir concentration<or=1 ng/mL was a prognostic factor for improved survival. More patients attained PSA nadir concentrations<or=1 ng/mL with CAB compared with patients who received LHRH-A monotherapy (81.4% vs 33.7%; P<.001).
  
  
  CONCLUSIONS
  CAB with bicalutamide 80 mg offered a significant overall survival benefit compared with LHRH-A monotherapy without reducing tolerability in patients with locally advanced or metastatic prostate cancer.
authors.affiliation: Department of Urology, Institute of Clinical Medicine, University of Tsukuba, Ibaraki, Japan. akazah@md.tsukuba.ac.jp
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Akaza
authors.forename: Shiro
authors.initials: S
authors.lastname: Hinotsu
authors.forename: Michiyuki
authors.initials: M
authors.lastname: Usami
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Arai
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kanetake
authors.forename: Seiji
authors.initials: S
authors.lastname: Naito
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Hirao
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use*; D000813:Anilides / Q000008:administration & dosage*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D018450:Disease Progression; D004311:Double-Blind Method; D005500:Follow-Up Studies; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D009570:Nitriles / Q000008:administration & dosage*; D017430:Prostate-Specific Antigen / Q000032:analysis; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016019:Survival Analysis; D014105:Tosyl Compounds / Q000008:administration & dosage*
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D018931:Antineoplastic Agents, Hormonal; D009570:Nitriles; D014105:Tosyl Compounds; D007987:Gonadotropin-Releasing Hormone; C053541:bicalutamide; D017430:Prostate-Specific Antigen