Phase II trial of bicalutamide in patients with advanced prostate cancer in whom conventional hormonal therapy failed: A Southwest Oncology Group study (SWOG 9235

Omer Kucuk, Emily Fisher, Carol M. Moinpour, Dorothy Coleman, Maha H.A. Hussain, A. Oliver Sartor, Gurkamal S. Chatta, Bruce A. Lowe, Mario A. Eisenberger, E. David Crawford

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives. To determine the efficacy and tolerability of bicalutamide in patients with advanced prostate cancer with progression after conventional hormonal therapy. Methods. Fifty-two patients received bicalutamide, 150 mg once daily, as second-line therapy after progressing following treatment with orchiectomy or luteinizing hormone-releasing hormone analogue or diethylstilbestrol, alone or in combination. Patients had measurable (n = 8) or assessable (n = 44) disease, a Southwest Oncology Group performance status of 0 to 2, and no prior antiandrogen therapy or chemotherapy. The objective response to treatment was assessed every 12 weeks; symptoms and pain were assessed monthly with questionnaires for 6 months. Results. There was evidence of palliation with three measures of pain and, to a lesser extent, with a measure of overall symptom status after 3 months of taking bicalutamide. No complete or partial responses occurred. However, 9 (20%) of 44 subjects with adequate prostate-specific antigen data had a 50% or higher decrease in their prostate-specific antigen levels, which did not correlate with symptom improvement. The median survival time was 15 months. The most common side effects were hot flashes (23%) and nausea (21%). Conclusions. These data suggest that bicalutamide decreases pain and improves symptom status in patients with prostate cancer in whom first-line hormonal therapy failed.

Original languageEnglish (US)
Pages (from-to)53-58
Number of pages6
JournalUrology
Volume58
Issue number1
DOIs
StatePublished - 2001

ASJC Scopus subject areas

  • Urology

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