Goserelin acetate with or without antiandrogen or estrogen in the treatment of patients with advanced prostate cancer: a multicenter, randomized, controlled trial in Japan. Zoladex Study Group.
OBJECTIVE
The aims of this randomized, controlled study were to investigate the efficacy and safety of long-term monotherapy with the luteinizing hormone-releasing hormone agonist goserelin acetate compared with both short- and long-term combined androgen blockade.


METHODS
Patients with advanced prostate cancer (n = 371) were randomized to treatment with goserelin acetate alone or a combination of goserelin acetate plus either long-term or short-term antiandrogen (chlormadinone acetate) or short-term estrogen (diethylstilbestrol diphosphate).


RESULTS
There were no significant differences between the treatment groups with respect to objective progression, overall survival or disease-specific survival. Nevertheless, subgroup analysis suggested that patients with minimal disease or a good prognosis might benefit more from combined androgen blockade than other patients. Combined androgen blockade significantly reduced the incidence of disease flare compared with goserelin acetate treatment alone.


CONCLUSIONS
Neither short- nor long-term combined androgen blockade had a survival advantage over goserelin acetate alone.
Kotake
T
T
Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
Usami
M
M
Akaza
H
H
Koiso
K
K
Homma
Y
Y
Kawabe
K
K
Aso
Y
Y
Orikasa
S
S
Shimazaki
J
J
Isaka
S
S
Yoshida
O
O
Hirao
Y
Y
Okajima
E
E
Naito
S
S
Kumazawa
J
J
Kanetake
H
H
Saito
Y
Y
Ohi
Y
Y
Ohashi
Y
Y
D000368:Aged; D000726:Androgen Antagonists / Q000008:administration & dosage*; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D002715:Chlormadinone Acetate / Q000008:administration & dosage*; D004054:Diethylstilbestrol / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D017273:Goserelin / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D017273:Goserelin; D002715:Chlormadinone Acetate; D004054:Diethylstilbestrol