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

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.

• Authors: O Kucuk, E Fisher, C M Moinpour, D Coleman, M H Hussain, A O Sartor, G S Chatta, B A Lowe, M A Eisenberger, E D Crawford
• Journal: Urology (Urology) Vol. 58 Issue 1 Pg. 53-8 (Jul 2001) ISSN: 1527-9995 [Electronic] United States
• PMID: 11445479 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Androgen Antagonists
• Anilides
• Nitriles
• Tosyl Compounds
• Diethylstilbestrol
• bicalutamide
• Prostate-Specific Antigen

Topics

• Adenocarcinoma (drug therapy)
• Aged
• Aged, 80 and over
• Androgen Antagonists (therapeutic use)
• Anilides (adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Combined Modality Therapy
• Diethylstilbestrol (administration & dosage)
• Disease Progression
• Humans
• Male
• Middle Aged
• Nitriles
• Orchiectomy
• Pain (drug therapy, etiology)
• Pain Measurement
• Palliative Care
• Prostate-Specific Antigen (analysis)
• Prostatic Neoplasms (complications, drug therapy)
• Quality of Life
• Tosyl Compounds
• Treatment Outcome