Maximal androgen blockade: final analysis of EORTC phase III trial 30853. EORTC Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center.
OBJECTIVE
This prospective, randomized phase III study was initiated to compare the efficacy and side effects of bilateral orchiectomy versus a combination of a luteinizing hormone-releasing hormone agonist depot formulation, goserelin acetate (3.6 mg s.c. once every 4 weeks) and flutamide (250 mg 3 x daily) in patients with metastatic prostate cancer.


METHODS
Relative treatment efficacy was assessed by comparing the two treatment groups with respect to response, time to first progression, progression-free survival, duration of survival and time to death due to malignant disease.


RESULTS
There was a difference in response only with respect to a more frequent decrease to normal of the serum prostate acid phosphatase in patients assigned to maximal androgen blockade treatment. Additionally, maximal androgen blockade treatment showed significantly better results for duration of survival (p = 0.04), time to death due to malignant disease (p = 0.008), time to first progression (p = 0.009) and progression-free survival (p = 0.02). The most frequent side effects for both treatments included hot flushes and gynaecomastia.


CONCLUSIONS
Increased time to progression and duration of survival is achieved by the combination of flutamide and goserelin when compared to bilateral orchiectomy.
Denis
L J
LJ
Department of Urology, A.Z. Middelheim, Antwerp, Belgium.
Keuppens
F
F
Smith
P H
PH
Whelan
P
P
de Moura
J L
JL
Newling
D
D
Bono
A
A
Sylvester
R
R
D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary / Q000601:surgery; D002277:Carcinoma / Q000401:mortality / Q000556:secondary* / Q000628:therapy*; D018450:Disease Progression; D018572:Disease-Free Survival; D005485:Flutamide / Q000008:administration & dosage; D017273:Goserelin / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009919:Orchiectomy / Q000009:adverse effects; D011379:Prognosis; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate; D016896:Treatment Outcome
D018931:Antineoplastic Agents, Hormonal; D017273:Goserelin; D005485:Flutamide