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- Title
Prednisone plus Gefitinib versus Prednisone plus Placebo in the Treatment of Hormone-Refractory Prostate Cancer: A Randomized Phase II Trial.
- Authors
Boccardo, Francesco; Rubagotti, Alessandra; Conti, Giario; Battaglia, Michele; Cruciani, Giorgio; Manganelli, Antonio; Ricci, Sergio; Lapini, Alberto
- Abstract
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. Copyright © 2008 S. Karger AG, Basel
- Subjects
PREDNISONE; PROSTATE cancer; PLACEBOS; CLINICAL trials; EPIDERMAL growth factor
- Publication
Oncology, 2008, Vol 74, Issue 3/4, p223
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000151391