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, Anthony Patterson, Roohollah Sharifi, Michael Sarosdy, Norman Block, Nicholas Vogelzang, Mark Soloway, Julie Jones, Peter Venner, Geert Kolvenbag

Research output: Contribution to journalArticle

90 Citations (Scopus)

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 - Jan 1 1995
Externally publishedYes

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Flutamide
Gonadotropin-Releasing Hormone
Prostatic Neoplasms
Therapeutics
Treatment Failure
Goserelin
bicalutamide
Leuprolide
Androgen Antagonists
Survival
Double-Blind Method
Multicenter Studies
Diarrhea
Quality of Life
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Urology

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A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. / Schellhammer, Paul; Patterson, Anthony; Sharifi, Roohollah; Sarosdy, Michael; Block, Norman; Vogelzang, Nicholas; Soloway, Mark; Jones, Julie; Venner, Peter; Kolvenbag, Geert.

In: Urology, Vol. 45, No. 5, 01.01.1995, p. 745-752.

Research output: Contribution to journalArticle

Schellhammer, Paul ; Patterson, Anthony ; Sharifi, Roohollah ; Sarosdy, Michael ; Block, Norman ; Vogelzang, Nicholas ; Soloway, Mark ; Jones, Julie ; Venner, Peter ; Kolvenbag, Geert. / A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. In: Urology. 1995 ; Vol. 45, No. 5. pp. 745-752.
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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.",
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T1 - A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer

AU - Schellhammer, Paul

AU - Patterson, Anthony

AU - Sharifi, Roohollah

AU - Sarosdy, Michael

AU - Block, Norman

AU - Vogelzang, Nicholas

AU - Soloway, Mark

AU - Jones, Julie

AU - Venner, Peter

AU - Kolvenbag, Geert

PY - 1995/1/1

Y1 - 1995/1/1

N2 - 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.

AB - 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.

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