Prednisone plus gefitinib versus prednisone plus placebo in the treatment of hormone-refractory prostate cancer: a randomized phase II trial.
BACKGROUND
Abnormal epidermal growth factor receptor expression and pre-clinical data prompted us to investigate the activity of gefitinib, a selective epidermal growth factor receptor tyrosine kinase inhibitor, in hormone-refractory prostate cancer.


METHODS
Eighty-two patients were randomly assigned to receive prednisone plus gefitinib (pG; n = 44) or prednisone plus placebo (ppl; n = 38). On progression, patients initially assigned to placebo were offered the possibility to receive gefitinib. Best prostate-specific antigen response was the primary endpoint.


RESULTS
At a median follow-up time of 29.0 months (26.0-32.0), 77 patients progressed and 51 died. Prostate-specific antigen response was recorded in 6/38 (15.8%; 95% CI 4.2-27.4) and in 5/44 (11.4%; 95% CI 2.0-20.8) patients in pG and ppl groups, respectively. There was no difference between groups in time to progression (median pG 4.0 months, range 3.5-4.5; median ppl 4.5 months, range 3.5-5.0) and survival (median pG 26.5 months, range 16.0-37.0; median ppl 20.5 months, range 14.0-27.0). Adverse events occurred in 19 patients in each arm and were generally mild.


CONCLUSIONS
pG showed a good tolerability profile but only a limited therapeutic activity in hormone-refractory prostate cancer.
Boccardo
Francesco
F
The National Cancer Research Institute and the University of Genoa, Genoa, Italy. f.boccardo@unige.it
Rubagotti
Alessandra
A
Conti
Giario
G
Battaglia
Michele
M
Cruciani
Giorgio
G
Manganelli
Antonio
A
Ricci
Sergio
S
Lapini
Alberto
A
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D004311:Double-Blind Method; D000077156:Gefitinib; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy* / Q000473:pathology; D010919:Placebos; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011799:Quinazolines / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome
D010919:Placebos; D011799:Quinazolines; D000077156:Gefitinib; D011241:Prednisone