Goserelin acetate with or without flutamide in the treatment of patients with locally advanced or metastatic prostate cancer. The Italian Prostatic Cancer Project (PONCAP) Study Group.
From March 1987 to December 1990, 373 patients with stage C and D prostate cancer were randomized to receive either goserelin acetate alone or goserelin acetate plus flutamide. At a median follow-up time of 24 months, there was no significant difference in the response rate, progression-free and overall survival between the two treatment groups. In particular, median time to progression was 18 months in the goserelin arm and 24 months in the combined treatment arm (P = 0.09). However, median time to progression in stage D patients was 12 months in both treatment groups. Median time to death was 32 and 34 months, respectively. The combination regimen produced a more rapid normalisation of prostatic acid phosphatase levels and a prompt relief of bone pain. However, significantly more patients in the combination arm experienced treatment-related side-effects such as diarrhoea and increases in transaminase levels. The concurrent use of goserelin acetate and flutamide does not seem to significantly improve the results that can be achieved with goserelin acetate alone.
Instituto Nazionale per la Ricerca sul Cancro, V. le Benedetto XV, Genova, Italy.
F
F
Boccardo
M
M
Pace
A
A
Rubagotti
D
D
Guarneri
A
A
Decensi
F
F
Oneto
G
G
Martorana
L
L
Giuliani
F
F
Selvaggi
M
M
Battaglia
D000135:Acid Phosphatase / Q000378:metabolism; D000368:Aged; D000369:Aged, 80 and over; D005485:Flutamide / Q000627:therapeutic use*; D017273:Goserelin / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D013997:Time Factors
D017273:Goserelin; D005485:Flutamide; D000135:Acid Phosphatase