Bicalutamide monotherapy versus flutamide plus goserelin in prostate cancer: updated results of a multicentric trial.
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.
Boccardo
Francesco
F
Department of Medical Oncology, University and National Cancer Research Institute of Genoa, Largo R. Benzi 10, 16132 Genoa, Italy. francesco.boccardo@istge.it
Barichello
Mario
M
Battaglia
Michele
M
Carmignani
Giorgio
G
Comeri
Giancarlo
G
Ferraris
Valentino
V
Lilliu
Sergio
S
Montefiore
Franco
F
Portoghese
Filippo
F
Cortellini
Pietro
P
Rigatti
Patrizio
P
Usai
Enzo
E
Rubagotti
Alessandra
A
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
D000813:Anilides; D000970:Antineoplastic Agents; D009570:Nitriles; D014105:Tosyl Compounds; D017273:Goserelin; D005485:Flutamide; C053541:bicalutamide; D017430:Prostate-Specific Antigen