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• W2091312615 abstract "No AccessJournal of UrologyClinical Urology: Original Article1 Dec 1995Bicalutamide in the Treatment of Advanced Prostatic Carcinoma: A Phase II Noncomparative Multicenter Trial Evaluating Safety, Efficacy and Long-Term Endocrine Effects of Monotherapy Mark S. Soloway, Paul F. Schellhammer, Joseph A. Jr. Smith, Gerald W. Chodak, Nicholas J. Vogelzang, and Gerard T. Kennealey Mark S. SolowayMark S. Soloway More articles by this author , Paul F. SchellhammerPaul F. Schellhammer More articles by this author , Joseph A. Jr. SmithJoseph A. Jr. Smith More articles by this author , Gerald W. ChodakGerald W. Chodak More articles by this author , Nicholas J. VogelzangNicholas J. Vogelzang More articles by this author , and Gerard T. KennealeyGerard T. Kennealey More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(01)66709-0AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail 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 percent. Of 150 patients 59 (39 percent) met prostate specific antigen criteria for partial response, and 88 (59 percent) 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 percent and 60 percent of patients, respectively. Mean drug plasma concentration was 8,528 plus/minus 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. References 1 : Use of the nonsteroidal anti-androgen Casodex in advanced prostatic carcinoma.. Urol. Clin. N. Amer.1991; 18: 99. Google Scholar 2 : Casodex: preclinical studies. Eur. Urol., suppl.1990; 18: 2. Google Scholar 3 : The pharmacokinetics of Casodex in prostate cancer patients after single and during multiple dosing. Eur. Urol., suppl.1990; 18: 10. Google Scholar 4 : A new non-steroidal anti-androgen.. Prog. Clin. Biol. Res.1989; 303: 95. Google Scholar 5 : Phase III studies to compare goserelin (ZOLADEX) with orchiectomy and with diethylstilbestrol in the treatment of prostatic carcinoma. Urology, suppl.1989; 33: 45. Google Scholar 6 : Zoladex studies in prostatic and breast cancer. In: LHRH and Its Analogs, part 2.. Edited by . Lancaster, England: MTP Press Limited1987: 397. chapt. 26. Google Scholar 7 : Criteria for response to treatment of metastatic prostatic cancer. In: . New York: Alan R. Liss Inc.1985: 205. sect. II,. Google Scholar 8 : Nonparametric confidence limits for survival probabilities and median survival time.. Cancer Treat. Rep.1982; 66: 37. Google Scholar 9 : Casodex: a pure non-steroidal anti-androgen used as monotherapy in advanced prostate cancer. Prostate, suppl.1992; 4: 97. Google Scholar 10 : Prognostic significance of changes in prostate-specific markers after endocrine treatment of stage D2 prostatic cancer.. Cancer1992; 70: 2302. Google Scholar 11 : Stratification of patients with metastatic prostate cancer based on extent of disease on initial bone scan.. Cancer1988; 61: 95. Google Scholar 12 : Independent prognostic factors in patients with metastatic (stage D2) prostate cancer. The Zoladex study group. J.A.M.A.1991; 265: 2808. Google Scholar 13 : Pre-treatment testosterone levels: significance in androgen deprivation therapy.. J. Urol.1986; 136: 1038. Abstract, Google Scholar 14 : Hormonal pattern in prostatic cancer: II.. Correlation with primary response to endocrine treatment. Acta Endocrinol.1981; 98: 634. Google Scholar 15 : Carcinoma of the prostate: relationship of pre-treatment hormone levels to survival.. Eur. J. Cancer Clin. Oncol.1984; 20: 477. Google Scholar 16 : Prognostic value of serum hormone concentrations in prostatic cancer.. Prostate1988; 13: 249. Google Scholar 17 : Prognostic factors in stage D2 prostate cancer treated with a pure nonsteroidal antiandrogen.. Cancer1993; 72: 1286. Google Scholar 18 : Nilutamide.. Drugs Future1987; 12: 763. Google Scholar 19 : Flutamide therapy for advanced prostatic cancer: a phase II study.. Brit. J. Urol.1985; 57: 172. Google Scholar 20 : Flutamide monotherapy as primary treatment in advanced prostatic carcinoma.. Sem. Oncol.1991; 18: 13. Google Scholar 21 : Flutamide as primary treatment for metastatic prostatic cancer.. Brit. J. Urol.1987; 59: 156. Google Scholar 22 : A controlled trial of bicalutamide (Casodex) versus flutamide (Eulexin), each in combination with luteinizing hormone releasing hormone analogue therapy, in patients with advanced prostate cancer.. The CASODEX Combination Study Group. Urology1995; 45: 745. Google Scholar 23 : The pharmacokinetics of Casodex in laboratory animals.. Xenobiotica1991; 21: 1347. Google Scholar 24 : Casodex--mechanisms of action and opportunities for usage. Cancer, suppl.1993; 72: 3830. Google Scholar University of Tennessee, Memphis, Tennessee, Eastern Virginia Medical School, Norfolk, Virginia, University of Utah, Salt Lake City, Utah, University of Chicago Medical Center, Chicago, Illinois, and ZENECA Pharmaceuticals, Wilmington, Delaware.Other investigators participating in this trial: T. Anderson, Milwaukee and G. Wilding, Madison, Wisconsin; N. L. Block, Miami, Florida; W. Kreis, Manhasset, New York; E. J. Seidmon, Philadelphia, Pennsylvania; D. L. Trump, Durham, North Carolina; P. M. Venner, Edmonton, Alberta, Canada; F. R. Ahmann, Tucson, Arizona, and B. S. Kasimis, East Orange, New Jersey.© 1995 by American Urological Association, Inc.FiguresReferencesRelatedDetails Volume 154Issue 6December 1995Page: 2110-2114 Advertisement Copyright & Permissions© 1995 by American Urological Association, Inc.MetricsAuthor Information Mark S. Soloway More articles by this author Paul F. Schellhammer More articles by this author Joseph A. Jr. Smith More articles by this author Gerald W. Chodak More articles by this author Nicholas J. Vogelzang More articles by this author Gerard T. Kennealey More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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