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 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 (US)
Pages (from-to)745-752
Number of pages8
JournalUrology
Volume45
Issue number5
DOIs
StatePublished - May 1995

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ASJC Scopus subject areas

  • Urology

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Schellhammer, P., Lynn Patterson, A., Sharifi, R., Sarosdy, M., Block, N., 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