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.
| Original language | English |
|---|---|
| Pages (from-to) | 33-37 |
| Number of pages | 5 |
| Journal | Urology |
| Volume | 47 |
| Issue number | 1 SUPPL. 1 |
| State | Published - Dec 1 1996 |
| Externally published | Yes |
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- Urology
Cite this
Bicalutamide in the treatment of advanced prostatic carcinoma : A phase II multicenter trial. / Soloway, Mark S.; Schellhammer, Paul F.; Smith, Joseph A.; Chodak, Gerald W.; Kennealey, Gerard T.
In: Urology, Vol. 47, No. 1 SUPPL. 1, 01.12.1996, p. 33-37.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Bicalutamide in the treatment of advanced prostatic carcinoma
T2 - A phase II multicenter trial
AU - Soloway, Mark S.
AU - Schellhammer, Paul F.
AU - Smith, Joseph A.
AU - Chodak, Gerald W.
AU - Kennealey, Gerard T.
PY - 1996/12/1
Y1 - 1996/12/1
N2 - 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.
AB - 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.
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UR - http://www.scopus.com/inward/citedby.url?scp=0029565070&partnerID=8YFLogxK
M3 - Article
C2 - 8560676
AN - SCOPUS:0029565070
VL - 47
SP - 33
EP - 37
JO - Urology
JF - Urology
SN - 0090-4295
IS - 1 SUPPL. 1
ER -