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| Title: A controlled trial of bicalutamide versus flutamide,
each in combination with luteinizing hormone-releasing hormone analogue therapy, in
patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX
Combination Study Group. |
| Title Abreviation: Cancer |
Date of Pub: 1996 Nov 15 |
| Author: Schellhammer PF; Sharifi R; Block NL; Soloway MS; Venner
PM; Patterson AL; Sarosdy MF; Vogelzang NJ; Chen Y; Kolvenbag GJ; |
| Issue/Part/Supplement: 10 |
Volume Issue: 78 |
Pagination: 2164-9 |
| MESH Headings: Adenocarcinoma (*DT/PA); Androgen Antagonists (*TU);
Anilides (*TU); Antineoplastic Agents, Hormonal (*TU); Comparative Study; Double-Blind
Method; Flutamide (*TU); Goserelin (*TU); Human; Leuprolide (TU); Male; Prostatic
Neoplasms (*DT/PA); Support, Non-U.S. Gov't; -RN-; |
| Journal Title Code: CLZ |
Publication Type: CLINICAL TRIAL |
| Date of Entry: 961217N |
Entry Month: 9702 |
| Country: UNITED STATES |
Index Priority: 1 |
| Language: Eng |
Unique Identifier: 97076087 |
| Unique Identifier: 97076087 |
ISSN: 0008-543X |
| Abstract: BACKGROUND: A randomized, multicenter trial, double-blind
for antiandrogen therapy, compared the antiandrogens bicalutamide and flutamide,
each combined with luteinizing hormone-releasing hormone analogue therapy (LHRH-A) in 813
patients with Stage D2 prostate carcinoma. An analysis of time to progression (median
follow-up, 95 weeks) was performed to augment previous analyses of time to treatment
failure and time to death. METHODS: Patients were randomly assigned 1:1 to double-blind
antiandrogen therapy, receiving either bicalutamide (50 mg once daily) or flutamide
(250 mg three times daily), and were assigned 2:1 to LHRH-A with goserelin acetate (3.6 mg
every 28 days) or leuprolide acetate (7.5 mg every 28 days). The primary endpoint of the
trial was time to treatment failure, defined as an adverse event leading to withdrawal of
randomized therapy, objective progression, death, or withdrawal from study therapy for any
reason. Secondary endpoints were time to death, quality of life, and subjective response.
The current analysis of time to progression included progression data collected
prospectively for 561 patients (69%) and retrospectively for 252 patients (31%). RESULTS:
Disease progression occurred for 223 of 404 patients (55%) in the bicalutamide plus
LHRH-A group and for 235 of 409 patients (58%) in the flutamide plus LHRH-A group. The
hazard ratio for time to progression of bicalutamide plus LHRH-A to that of
flutamide plus LHRH-A was 0.9 (two-sided 95% confidence interval [CI], 0.75 to 1.08; P =
0.26). The upper one-sided 95% CI was 1.05, which met the definition of equivalence (<
1.25). CONCLUSIONS: At a median follow-up time of 95 weeks, bicalutamide plus
LHRH-A and flutamide plus LHRH-A had equivalent time to progression. |
| Abstract By: Author |
| Address: Department of Urology, Eastern Virginia Medical School,
Norfolk, Virginia, USA. |
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