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

Oncology
Francesco BoccardoAlberto Lapini

Abstract

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. 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. 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. pG showed a good tolerability profile but only a limited therapeutic activity in hormone-refractory prostate cancer.

Citations

Dec 10, 2009·Nature Reviews. Clinical Oncology·Dale R Shepard, Derek Raghavan
Aug 10, 2011·Nature Reviews. Clinical Oncology·Timothy A YapJohann S de Bono
Mar 25, 2011·Chemotherapy·S LeoV Lorusso
May 28, 2011·International Journal of Oncology·Yong Gu ChoMyoung Sook Kim
Nov 19, 2015·Journal of Bone Oncology·Aude I SégalinyDominique Heymann
Jul 18, 2015·Cancer Letters·Arndt Katzenwadel, Philipp Wolf
Jul 6, 2014·Pathogens and Disease·Mabel Lum, Renato Morona
Mar 7, 2021·Cancers·Amaal Ali, George Kulik

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