Bicalutamide 80 mg combined with a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A monotherapy in advanced prostate cancer: Findings from a phase III randomized, double-blind, multicenter trial in Japanese patients

M. Usami, H. Akaza, Y. Arai, Y. Hirano, S. Kagawa, H. Kanetake, S. Naito, Y. Sumiyoshi, Y. Takimoto, A. Terai, H. Yoshida, Y. Ohashi

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36 Citations (Scopus)

Abstract

To compare combination therapy with bicalutamide 80 mg and a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A alone in Japanese men with untreated advanced prostate cancer. A total of 205 patients with stage C/D prostate cancer were randomized to either LHRH-+once-daily oral bicalutamide 80 mg or placebo. Primary study variables have been reported previously. Secondary variables included: time to achieve prostate-specific antigen ≤4 ng/ml, time-to-treatment failure (TTTF), time-to-disease progression (TTP), overall survival (OS), adverse events and adverse drug reactions. Following combination therapy with bicalutamide 80 mg, there were significant (P=0.001) advantages over LHRH-A alone in terms of TTTF and TTP, but the difference in the interim OS was not statistically significant. First-line combination therapy with bicalutamide 80 mg in Japanese patients with advanced prostate cancer offers significant benefits over LHRH-A alone, with respect to TTTF and TTP. Follow-up for OS continues.

Original languageEnglish
Pages (from-to)194-201
Number of pages8
JournalProstate Cancer and Prostatic Diseases
Volume10
Issue number2
DOIs
Publication statusPublished - 2007 May

ASJC Scopus subject areas

  • Oncology
  • Urology
  • Cancer Research

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