TY - JOUR
T1 - Phase II trial of bicalutamide in patients with advanced prostate cancer in whom conventional hormonal therapy failed
T2 - A Southwest Oncology Group study (SWOG 9235
AU - Kucuk, Omer
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 A.
AU - Crawford, E. David
N1 - Funding Information:
This investigation was supported in part by the following PHS Cooperative Agreement grant numbers awarded by the National Cancer Institute, DHHS: CA38926, CA42028, CA32102, CA58658, CA37981, CA46113, CA32734, and CA42777. It was also supported in part by a grant from Zeneca Pharmaceuticals.
PY - 2001
Y1 - 2001
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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U2 - 10.1016/S0090-4295(01)01010-X
DO - 10.1016/S0090-4295(01)01010-X
M3 - Article
C2 - 11445479
AN - SCOPUS:0034943531
SN - 0090-4295
VL - 58
SP - 53
EP - 58
JO - Urology
JF - Urology
IS - 1
ER -