A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer

Paul Schellhammer, A. Lynn Patterson, Roohollah Sharifi, Michael Sarosdy, Norman L Block, Nicholas Vogelzang, Mark Soloway, Julie Jones, Peter Venner, Geert Kolvenbag

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Abstract

Objectives: To compare the efficacy and safety of bicalutamide and flutamide, each used in combination with luteinizing hormone-releasing hormone 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 × 2 factorial design. Eight hundred thirteen patients were allocated 1:1 to bcalutamide (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.

Original languageEnglish
Pages (from-to)745-752
Number of pages8
JournalUrology
Volume45
Issue number5
DOIs
StatePublished - Jan 1 1995
Externally publishedYes

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ASJC Scopus subject areas

  • Urology

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Schellhammer, P., Lynn Patterson, A., Sharifi, R., Sarosdy, M., Block, N. L., Vogelzang, N., Soloway, M., Jones, J., Venner, P., & Kolvenbag, G. (1995). A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Urology, 45(5), 745-752. https://doi.org/10.1016/S0090-4295(99)80077-6