title: Bicalutamide monotherapy versus flutamide plus goserelin in prostate cancer: updated results of a multicentric trial.
abstract: OBJECTIVE
  To compare the efficacy of bicalutamide monotherapy to maximal androgen blockade in advanced prostatic cancer.
  
  
  METHODS
  Previously untreated patients with histologically proven stage C or D (American Urological Association Staging System) disease were randomly allocated to either bicalutamide (B) or goserelin plus flutamide (G+F). After disease progression, patients treated with B were assigned to castration. The primary endpoint for this trial was overall survival. Prostate cancer-specific survival and progression were included among secondary endpoints.
  
  
  RESULTS
  In total 108 patients received B and 112 received G+F. At a median follow-up time of 54 months (range 1-89), 151 patients progressed and 113 died. There was no significant difference in the duration of either progression-free or overall survival. Hazards of progression, death and cancer-specific death, corrected by disease stage, tumor grade and baseline PSA level, showed that patients initially assigned to B had a higher risk of progression but a comparable risk of death and cancer-specific death with the exception of patients with G3 tumors who had an increased risk of death).
  
  
  CONCLUSIONS
  In patients with well or moderately well differentiated tumors, B monotherapy followed by castration may offer the same survival chance as maximal androgen deprivation. In those patients it thus represents a reasonable choice that can avoid the side effects of androgen deprivation for considerable periods of time.
authors.affiliation: Department of Medical Oncology, University and National Cancer Research Institute of Genoa, Largo R. Benzi 10, 16132 Genoa, Italy. francesco.boccardo@istge.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Boccardo
authors.forename: Mario
authors.initials: M
authors.lastname: Barichello
authors.forename: Michele
authors.initials: M
authors.lastname: Battaglia
authors.forename: Giorgio
authors.initials: G
authors.lastname: Carmignani
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comeri
authors.forename: Valentino
authors.initials: V
authors.lastname: Ferraris
authors.forename: Sergio
authors.initials: S
authors.lastname: Lilliu
authors.forename: Franco
authors.initials: F
authors.lastname: Montefiore
authors.forename: Filippo
authors.initials: F
authors.lastname: Portoghese
authors.forename: Pietro
authors.initials: P
authors.lastname: Cortellini
authors.forename: Patrizio
authors.initials: P
authors.lastname: Rigatti
authors.forename: Enzo
authors.initials: E
authors.lastname: Usai
authors.forename: Alessandra
authors.initials: A
authors.lastname: Rubagotti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000813:Anilides / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018450:Disease Progression; D005485:Flutamide / Q000008:administration & dosage; D017273:Goserelin / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D017430:Prostate-Specific Antigen; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D014105:Tosyl Compounds; D016896:Treatment Outcome
chemical_list: D000813:Anilides; D000970:Antineoplastic Agents; D009570:Nitriles; D014105:Tosyl Compounds; D017273:Goserelin; D005485:Flutamide; C053541:bicalutamide; D017430:Prostate-Specific Antigen