Bicalutamide 80 mg combined with a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A monotherapy in advanced prostate cancer: findings from a phase III randomized, double-blind, multicenter trial in Japanese patients.
To compare combination therapy with bicalutamide 80 mg and a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A alone in Japanese men with untreated advanced prostate cancer. A total of 205 patients with stage C/D prostate cancer were randomized to either LHRH-A+once-daily oral bicalutamide 80 mg or placebo. Primary study variables have been reported previously. Secondary variables included: time to achieve prostate-specific antigen < or = 4 ng/ml, time-to-treatment failure (TTTF), time-to-disease progression (TTP), overall survival (OS), adverse events and adverse drug reactions. Following combination therapy with bicalutamide 80 mg, there were significant (P<0.001) advantages over LHRH-A alone in terms of TTTF and TTP, but the difference in the interim OS was not statistically significant. First-line combination therapy with bicalutamide 80 mg in Japanese patients with advanced prostate cancer offers significant benefits over LHRH-A alone, with respect to TTTF and TTP. Follow-up for OS continues.
Usami
M
M
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. usami-mi@mc.pref.osaka.jp
Akaza
H
H
Arai
Y
Y
Hirano
Y
Y
Kagawa
S
S
Kanetake
H
H
Naito
S
S
Sumiyoshi
Y
Y
Takimoto
Y
Y
Terai
A
A
Yoshida
H
H
Ohashi
Y
Y
D000368:Aged; D000813:Anilides / Q000008:administration & dosage* / Q000037:antagonists & inhibitors; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D017273:Goserelin / Q000008:administration & dosage*; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage*; D008297:Male; D009570:Nitriles / Q000008:administration & dosage* / Q000037:antagonists & inhibitors; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D014105:Tosyl Compounds / Q000008:administration & dosage* / Q000037:antagonists & inhibitors; D016896:Treatment Outcome
D000813:Anilides; D009570:Nitriles; D014105:Tosyl Compounds; D017273:Goserelin; D007987:Gonadotropin-Releasing Hormone; C053541:bicalutamide; D016729:Leuprolide