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| Title: Bicalutamide in the treatment of advanced prostatic
carcinoma: a phase II multicenter trial. |
| Title Abreviation: Urology |
Date of Pub: 1996 Jan |
| Author: Soloway MS; Schellhammer PF; Smith JA; Chodak GW; Kennealey
GT; |
| Issue/Part/Supplement: 1A Suppl |
Volume Issue: 47 |
Pagination: 33-7; discussion 48-53 |
| MESH Headings: Acid Phosphatase (BL); Adult; Aged; Aged, 80 and
over; Androgen Antagonists (*TU); Anilides (*TU); Human; Male; Middle Age; Prostate;
Prostate-Specific Antigen (BL); Prostatic Neoplasms (BL/*DT); Support, Non-U.S. Gov't;
-RN-; |
| Journal Title Code: WSY |
Publication Type: CLINICAL TRIAL |
| Date of Entry: 960226N |
Entry Month: 9605 |
| Country: UNITED STATES |
Index Priority: 2 |
| Language: Eng |
Unique Identifier: 96149764 |
| Unique Identifier: 96149764 |
ISSN: 0090-4295 |
| Abstract: OBJECTIVES. The safety, efficacy, and pharmacokinetics of
the nonsteroidal antiandrogen bicalutamide were investigated in a Phase II trial in
150 patients with metastatic prostate cancer. METHODS. Patients took bicalutamide,
50 mg daily, in an open-label multicenter North American trial. RESULTS. The objective
response rate (modified European Organization on Research and Treatment of Cancer [EORTC]
criteria) was 70% (57% partial, 13% stable); 59 (39%) of 150 patients had either a >
90% decrease in prostate-specific antigen (PSA) levels or a decline to < 4 ng/mL.
Extent of disease on the bone scan was a significant predictor of response. Patients with
< 6 metastatic lesions were more likely to respond. Breast pain and gynecomastia
occurred in 76% and 60% of patients, respectively. Gastrointestinal toxicity was very
infrequent (diarrhea, 5%) The mean drug plasma concentration was 8528 (+/- 2928) ng/mL.
CONCLUSIONS. Bicalutamide, 50 mg daily, was well tolerated and has efficacy in
metastatic prostate cancer. The percentage of men who had > 90% decline in PSA levels
is less than observed with surgical or medical castration and has led to trials using this
antiandrogen at higher doses as monotherapy. |
| Abstract By: Author |
| Address: Department of Urology, University of Miami School of
Medicine, FL 33101, USA. |
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