A phase II randomized trial of megestrol acetate or dexamethasone in the treatment of hormonally refractory advanced carcinoma of the prostate.
The results of a randomized, multicenter, cooperative group trial evaluating hormonal therapy with either megestrol acetate or dexamethasone in advanced, hormonally refractory prostate cancer are reported. Three of 29 patients (approximately 10%) on the megestrol acetate arm experienced an objective response lasting 41, 84, and 202 days, respectively, whereas two of 29 patients (approximately 7%) on the dexamethasone arm achieved an objective response lasting 359 and 512 days, respectively. Twenty of 29 patients (approximately 69%) on the megestrol acetate arm had stable disease lasting for a median duration of 117 days, whereas 21 of 29 patients (72%) on the dexamethasone arm had stable disease for a median duration of 86 days. Median survival of all patients was 9 months from initiation of treatment. The median survival of all patients on the megestrol acetate arm was 268 days compared to 246 days for patients on the dexamethasone arm (P = 0.2). Neither dexamethasone nor megestrol acetate would seem to be of substantive value in altering the progression of advanced, hormonally refractory prostate cancer.
Patel
S R
SR
Mayo Clinic, Rochester, Minnesota 55905.
Kvols
L K
LK
Hahn
R G
RG
Windschitl
H
H
Levitt
R
R
Therneau
T
T
D000368:Aged; D000369:Aged, 80 and over; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use*; D004341:Drug Evaluation; D006801:Humans; D008297:Male; D008535:Megestrol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019290:Megestrol Acetate; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction; D015996:Survival Rate
D003907:Dexamethasone; D008535:Megestrol; D019290:Megestrol Acetate