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

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 wi...

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Bibliographic Details
Published in:	Urology (Ridgewood, N.J.) Vol. 58; no. 1; pp. 53 - 58
Main Authors:	Kucuk, Omer, Fisher, Emily, Moinpour, Carol M, Coleman, Dorothy, Hussain, Maha H.A, Sartor, A.Oliver, Chatta, Gurkamal S, Lowe, Bruce A, Eisenberger, Mario A, Crawford, E.David
Format:	Journal Article
Language:	English
Published:	New York, NY Elsevier Inc 01-07-2001 Elsevier Science
Subjects:	Adenocarcinoma - drug therapy Aged Aged, 80 and over Androgen Antagonists - therapeutic use Anilides - adverse effects Anilides - therapeutic use Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Chemotherapy Combined Modality Therapy Diethylstilbestrol - administration & dosage Disease Progression Humans Male Medical sciences Middle Aged Nitriles Orchiectomy Pain - drug therapy Pain - etiology Pain Measurement Palliative Care Pharmacology. Drug treatments Prostate-Specific Antigen - analysis Prostatic Neoplasms - complications Prostatic Neoplasms - drug therapy Quality of Life Tosyl Compounds Treatment Outcome Antineoplastic agent Human Urinary system disease Prostate disease Treatment efficiency Antiandrogen Antihormone Malignant tumor Chemotherapy Phase II trial Tumor progression Advanced stage Bicalutamide Male genital diseases Prostate Negative therapeutic reaction
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Summary:	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.
ISSN:	0090-4295 1527-9995
DOI:	10.1016/S0090-4295(01)01010-X