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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 cancer. Casodex Combination Study Group. |
| Title Abreviation: Urology |
Date of Pub: 1995 May |
| Author: Schellhammer P; Sharifi R; Block N; Soloway M; Venner P;
Patterson AL; Sarosdy M; Vogelzang N; Jones J; Kolvenbag G; |
| Issue/Part/Supplement: 5 |
Volume Issue: 45 |
Pagination: 745-52 |
| MESH Headings: Adenocarcinoma (BL/*DT/MO/PA); Adult; Aged; Aged, 80
and over; Anilides (AD/AE); Antineoplastic Agents (AD/AE); Antineoplastic Agents, Combined
(AE/*TU); Comparative Study; Confidence Intervals; Double-Blind Method; Flutamide (AD/AE);
Follow-Up Studies; Goserelin (AD/AE); Human; Leuprolide (AD/AE); Male; Middle Age;
Proportional Hazards Models; Prospective Studies; Prostate-Specific Antigen (BL/DE);
Prostatic Neoplasms (BL/*DT/MO/PA); Regression Analysis; Support, Non-U.S. Gov't; Survival
Rate; Treatment Failure; -RN-; |
| Journal Title Code: WSY |
Publication Type: CLINICAL TRIAL |
| Date of Entry: 950612N |
Entry Month: 9508 |
| Country: UNITED STATES |
Index Priority: 2 |
| Language: Eng |
Unique Identifier: 95266189 |
| Unique Identifier: 95266189 |
ISSN: 0090-4295 |
| Abstract: OBJECTIVES. To compare the efficacy and safety of bicalutamide
and flutamide, each used in combination with luteinizing hormone-releasing analogue
(LHRH-A) therapy, in patients with untreated metastatic (Stage D2) prostate cancer.
METHODS. Randomized, double-blind (for antiandrogen therapy), multicenter study with a 2 x
2 factorial design. Eight hundred thirteen patients were allocated 1:1 to bicalutamide
(50 mg once daily) and flutamide (250 mg three times daily) and 2:1 to goserelin acetate
(3.6 mg every 28 days) and leuprolide acetate (7.5 mg every 28 days). RESULTS. With a
median duration of follow-up of 49 weeks, time to treatment failure, the primary endpoint,
was significantly (P = 0.005) better for the bicalutamide plus LHRH-A group than
for the flutamide plus LHRH-A group. Patients in the flutamide plus LHRH-A group were 34%
more likely to fail treatment over the given time period, as indicated by the hazard ratio
of 0.749 (95% confidence interval, 0.61 to 0.92) for bicalutamide plus LHRH-A to
flutamide plus LHRH-A. Results for secondary endpoints (survival, quality of life, and
subjective response) were similar between groups. Diarrhea occurred in 24% of patients in
the flutamide plus LHRH-A group, compared with 10% of patients in the bicalutamide plus
LHRH-A group (P < 0.001). CONCLUSIONS. In patients with metastatic prostate cancer, bicalutamide
plus LHRH-A is well tolerated and provides superior efficacy to flutamide plus LHRH-A with
respect to time to treatment failure. Assessment of the effects of these regimens on
longer term survival requires additional time for follow-up. |
| Abstract By: Author |
| Address: Eastern Virginia Medical School, Norfolk, USA. |
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