Prednisone plus gefitinib versus prednisone plus placebo in the treatment of hormone-refractory prostate cancer: A randomized phase II trial

Francesco Boccardo, Alessandra Rubagotti, Giario Conti, Michele Battaglia, Giorgio Cruciani, Antonio Manganelli, Sergio Ricci, Alberto Lapini

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)223-228
Number of pages6
JournalOncology
Volume74
Issue number3-4
DOIs
Publication statusPublished - Sep 2008

Keywords

  • Gefitinib
  • Hormone-refractory prostate cancer
  • Prednisone

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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