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 Eisenberger, E. David Crawford

Research output: Contribution to journalArticle

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

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Prostatic Neoplasms
Prostate-Specific Antigen
Pain
Therapeutics
Hot Flashes
Androgen Antagonists
Diethylstilbestrol
Orchiectomy
Gonadotropin-Releasing Hormone
Nausea
bicalutamide
Drug Therapy
Survival

ASJC Scopus subject areas

  • Urology

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Phase II trial of bicalutamide in patients with advanced prostate cancer in whom conventional hormonal therapy failed : A Southwest Oncology Group study (SWOG 9235. / Kucuk, Omer; Fisher, Emily; Moinpour, Carol M.; Coleman, Dorothy; Hussain, Maha H A; Sartor, A. Oliver; Chatta, Gurkamal S.; Lowe, Bruce A.; Eisenberger, Mario; Crawford, E. David.

In: Urology, Vol. 58, No. 1, 2001, p. 53-58.

Research output: Contribution to journalArticle

Kucuk, Omer ; Fisher, Emily ; Moinpour, Carol M. ; Coleman, Dorothy ; Hussain, Maha H A ; Sartor, A. Oliver ; Chatta, Gurkamal S. ; Lowe, Bruce A. ; Eisenberger, Mario ; Crawford, E. David. / Phase II trial of bicalutamide in patients with advanced prostate cancer in whom conventional hormonal therapy failed : A Southwest Oncology Group study (SWOG 9235. In: Urology. 2001 ; Vol. 58, No. 1. pp. 53-58.
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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.",
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AU - Fisher, Emily

AU - Moinpour, Carol M.

AU - Coleman, Dorothy

AU - Hussain, Maha H A

AU - Sartor, A. Oliver

AU - Chatta, Gurkamal S.

AU - Lowe, Bruce A.

AU - Eisenberger, Mario

AU - Crawford, E. David

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N2 - 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.

AB - 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.

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