Bicalutamide in the treatment of advanced prostatic carcinoma: a phase II noncomparative multicenter trial evaluating safety, efficacy and long-term endocrine effects of monotherapy.

Abstract

PURPOSE:

The safety, efficacy and pharmacokinetics of bicalutamide were investigated in 150 patients with stage D2 prostate cancer.

MATERIALS AND METHODS:

Patients received 50 mg. bicalutamide daily in an open label multicenter North American trial.

RESULTS:

The objective response rate (modified European Organization for Research in Cancer Therapy criteria) was 70%. Of 150 patients 59 (39%) met prostate specific antigen criteria for partial response, and 88 (59%) reached treatment failure end points and withdrew. Extent of disease was a significant predictor of response but baseline testosterone was not. Breast pain and gynecomastia developed in 76% and 60% of patients, respectively. Mean drug plasma concentration was 8,528 +/- 2,928 ng/ml.

CONCLUSIONS:

Bicalutamide (50 mg.) daily was well tolerated and efficacious. However, suboptimal effects on prostate specific antigen have led to additional trials to evaluate monotherapy at higher doses.

• Authors: M S Soloway, P F Schellhammer, J A Smith Jr, G W Chodak, N J Vogelzang, G T Kennealey
• Journal: The Journal of urology (J Urol) Vol. 154 Issue 6 Pg. 2110-4 (Dec 1995) ISSN: 0022-5347 [Print] United States
• PMID: 7500470 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anilides
• Antineoplastic Agents
• Nitriles
• Tosyl Compounds
• bicalutamide
• Acid Phosphatase
• Prostate-Specific Antigen

Topics

• Acid Phosphatase (blood)
• Adult
• Aged
• Aged, 80 and over
• Anilides (pharmacokinetics, therapeutic use)
• Antineoplastic Agents (pharmacokinetics, therapeutic use)
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Neoplasm Staging
• Nitriles
• Prostate-Specific Antigen (blood)
• Prostatic Neoplasms (blood, drug therapy, pathology)
• Time Factors
• Tosyl Compounds