Bicalutamide in the treatment of advanced prostatic carcinoma: A phase II multicenter trial

Mark S. Soloway, Paul F. Schellhammer, Joseph A. Smith, Gerald W. Chodak, Gerard T. Kennealey

Research output: Contribution to journalArticle

21 Citations (Scopus)

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 languageEnglish
Pages (from-to)33-37
Number of pages5
JournalUrology
Volume47
Issue number1 SUPPL. 1
StatePublished - Dec 1 1996
Externally publishedYes

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Multicenter Studies
Prostate-Specific Antigen
Carcinoma
Nonsteroidal Anti-Androgens
Androgen Antagonists
Castration
Prostatic Neoplasms
Therapeutics
Pharmacokinetics
Safety
Research
bicalutamide
Neoplasms

ASJC Scopus subject areas

  • Urology

Cite this

Soloway, M. S., Schellhammer, P. F., Smith, J. A., Chodak, G. W., & Kennealey, G. T. (1996). Bicalutamide in the treatment of advanced prostatic carcinoma: A phase II multicenter trial. Urology, 47(1 SUPPL. 1), 33-37.

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 journalArticle

Soloway, MS, Schellhammer, PF, Smith, JA, Chodak, GW & Kennealey, GT 1996, 'Bicalutamide in the treatment of advanced prostatic carcinoma: A phase II multicenter trial', Urology, vol. 47, no. 1 SUPPL. 1, pp. 33-37.
Soloway MS, Schellhammer PF, Smith JA, Chodak GW, Kennealey GT. Bicalutamide in the treatment of advanced prostatic carcinoma: A phase II multicenter trial. Urology. 1996 Dec 1;47(1 SUPPL. 1):33-37.
Soloway, Mark S. ; Schellhammer, Paul F. ; Smith, Joseph A. ; Chodak, Gerald W. ; Kennealey, Gerard T. / Bicalutamide in the treatment of advanced prostatic carcinoma : A phase II multicenter trial. In: Urology. 1996 ; Vol. 47, No. 1 SUPPL. 1. pp. 33-37.
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