Clinical benefits of bicalutamide compared with flutamide in combined androgen blockade for patients with advanced prostatic carcinoma

Final report of a double-blind, randomized, multicenter trial

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

Research output: Contribution to journalArticle

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Abstract

Objectives. To compare the efficacy and tolerability of bicalutamide and flutamide, each combined with luteinizing hormone-releasing hormone analogue (LHRH-A) therapy, in patients with metastatic (Stage D2) prostate cancer. Methods. This was a randomized, double-blind (for antiandrogen therapy), multicenter study with a two by two 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. The median times to progression and death were 97 and 180 weeks for the bicalutamide plus LHRH-A group compared with 77 and 148 weeks for the flutamide plus LHRH- A group. The hazard ratio for time to progression for bicalutamide plus LHRH- A to flutamide plus LHRH-A was 0.95 (95% confidence interval [CI] 0.79 to 1.10, P = 0.41) and that for survival time was 0.87 (95% CI 0.72 to 1.05, P = 0.15). The therapies were generally well tolerated. The most common adverse event in the two groups was hot flashes. The incidence of hematuria was significantly higher for the bicalutamide plus LHRH-A group than for the flutamide plus LHRH-A group (12% versus 6%, P = 0.007), but no patient withdrew from therapy because of hematuria. There was a significantly (26% versus 12%, P <0.001) higher incidence of diarrhea and more withdrawals for diarrhea (25 patients versus 2) for the flutamide plus LHRH-A group relative to the bicalutamide plus LHRH-A group. Conclusions. With a median follow-up time of 160 weeks, the combination of bicalutamide plus LHRH-A was well tolerated and had equivalent time to progression and survival compared with flutamide plus LHRH-A. Treatment with bicalutamide plus LHRH-A resulted in longer median survival than treatment with flutamide plus LHRH-A.

Original languageEnglish
Pages (from-to)330-336
Number of pages7
JournalUrology
Volume50
Issue number3
DOIs
StatePublished - Sep 1 1997
Externally publishedYes

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Flutamide
Gonadotropin-Releasing Hormone
Androgens
Multicenter Studies
Carcinoma
Hematuria
bicalutamide
Survival
Diarrhea
Therapeutics
Goserelin
Confidence Intervals
Hot Flashes
Leuprolide
Androgen Antagonists
Incidence

ASJC Scopus subject areas

  • Urology

Cite this

Clinical benefits of bicalutamide compared with flutamide in combined androgen blockade for patients with advanced prostatic carcinoma : Final report of a double-blind, randomized, multicenter trial. / Schellhammer, Paul F.; Sharifi, Roohollah; Block, Norman L; Soloway, Mark S.; Venner, Peter M.; Patterson, A. Lynn; Sarosdy, Michael F.; Vogelzang, Nicholas J.; Schellenger, Julie Jones; Kolvenbag, Geert J C M.

In: Urology, Vol. 50, No. 3, 01.09.1997, p. 330-336.

Research output: Contribution to journalArticle

Schellhammer, PF, Sharifi, R, Block, NL, Soloway, MS, Venner, PM, Patterson, AL, Sarosdy, MF, Vogelzang, NJ, Schellenger, JJ & Kolvenbag, GJCM 1997, 'Clinical benefits of bicalutamide compared with flutamide in combined androgen blockade for patients with advanced prostatic carcinoma: Final report of a double-blind, randomized, multicenter trial', Urology, vol. 50, no. 3, pp. 330-336. https://doi.org/10.1016/S0090-4295(97)00279-3
Schellhammer, Paul F. ; Sharifi, Roohollah ; Block, Norman L ; Soloway, Mark S. ; Venner, Peter M. ; Patterson, A. Lynn ; Sarosdy, Michael F. ; Vogelzang, Nicholas J. ; Schellenger, Julie Jones ; Kolvenbag, Geert J C M. / Clinical benefits of bicalutamide compared with flutamide in combined androgen blockade for patients with advanced prostatic carcinoma : Final report of a double-blind, randomized, multicenter trial. In: Urology. 1997 ; Vol. 50, No. 3. pp. 330-336.
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title = "Clinical benefits of bicalutamide compared with flutamide in combined androgen blockade for patients with advanced prostatic carcinoma: Final report of a double-blind, randomized, multicenter trial",
abstract = "Objectives. To compare the efficacy and tolerability of bicalutamide and flutamide, each combined with luteinizing hormone-releasing hormone analogue (LHRH-A) therapy, in patients with metastatic (Stage D2) prostate cancer. Methods. This was a randomized, double-blind (for antiandrogen therapy), multicenter study with a two by two 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. The median times to progression and death were 97 and 180 weeks for the bicalutamide plus LHRH-A group compared with 77 and 148 weeks for the flutamide plus LHRH- A group. The hazard ratio for time to progression for bicalutamide plus LHRH- A to flutamide plus LHRH-A was 0.95 (95{\%} confidence interval [CI] 0.79 to 1.10, P = 0.41) and that for survival time was 0.87 (95{\%} CI 0.72 to 1.05, P = 0.15). The therapies were generally well tolerated. The most common adverse event in the two groups was hot flashes. The incidence of hematuria was significantly higher for the bicalutamide plus LHRH-A group than for the flutamide plus LHRH-A group (12{\%} versus 6{\%}, P = 0.007), but no patient withdrew from therapy because of hematuria. There was a significantly (26{\%} versus 12{\%}, P <0.001) higher incidence of diarrhea and more withdrawals for diarrhea (25 patients versus 2) for the flutamide plus LHRH-A group relative to the bicalutamide plus LHRH-A group. Conclusions. With a median follow-up time of 160 weeks, the combination of bicalutamide plus LHRH-A was well tolerated and had equivalent time to progression and survival compared with flutamide plus LHRH-A. Treatment with bicalutamide plus LHRH-A resulted in longer median survival than treatment with flutamide plus LHRH-A.",
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T1 - Clinical benefits of bicalutamide compared with flutamide in combined androgen blockade for patients with advanced prostatic carcinoma

T2 - Final report of a double-blind, randomized, multicenter trial

AU - Schellhammer, Paul F.

AU - Sharifi, Roohollah

AU - Block, Norman L

AU - Soloway, Mark S.

AU - Venner, Peter M.

AU - Patterson, A. Lynn

AU - Sarosdy, Michael F.

AU - Vogelzang, Nicholas J.

AU - Schellenger, Julie Jones

AU - Kolvenbag, Geert J C M

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N2 - Objectives. To compare the efficacy and tolerability of bicalutamide and flutamide, each combined with luteinizing hormone-releasing hormone analogue (LHRH-A) therapy, in patients with metastatic (Stage D2) prostate cancer. Methods. This was a randomized, double-blind (for antiandrogen therapy), multicenter study with a two by two 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. The median times to progression and death were 97 and 180 weeks for the bicalutamide plus LHRH-A group compared with 77 and 148 weeks for the flutamide plus LHRH- A group. The hazard ratio for time to progression for bicalutamide plus LHRH- A to flutamide plus LHRH-A was 0.95 (95% confidence interval [CI] 0.79 to 1.10, P = 0.41) and that for survival time was 0.87 (95% CI 0.72 to 1.05, P = 0.15). The therapies were generally well tolerated. The most common adverse event in the two groups was hot flashes. The incidence of hematuria was significantly higher for the bicalutamide plus LHRH-A group than for the flutamide plus LHRH-A group (12% versus 6%, P = 0.007), but no patient withdrew from therapy because of hematuria. There was a significantly (26% versus 12%, P <0.001) higher incidence of diarrhea and more withdrawals for diarrhea (25 patients versus 2) for the flutamide plus LHRH-A group relative to the bicalutamide plus LHRH-A group. Conclusions. With a median follow-up time of 160 weeks, the combination of bicalutamide plus LHRH-A was well tolerated and had equivalent time to progression and survival compared with flutamide plus LHRH-A. Treatment with bicalutamide plus LHRH-A resulted in longer median survival than treatment with flutamide plus LHRH-A.

AB - Objectives. To compare the efficacy and tolerability of bicalutamide and flutamide, each combined with luteinizing hormone-releasing hormone analogue (LHRH-A) therapy, in patients with metastatic (Stage D2) prostate cancer. Methods. This was a randomized, double-blind (for antiandrogen therapy), multicenter study with a two by two 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. The median times to progression and death were 97 and 180 weeks for the bicalutamide plus LHRH-A group compared with 77 and 148 weeks for the flutamide plus LHRH- A group. The hazard ratio for time to progression for bicalutamide plus LHRH- A to flutamide plus LHRH-A was 0.95 (95% confidence interval [CI] 0.79 to 1.10, P = 0.41) and that for survival time was 0.87 (95% CI 0.72 to 1.05, P = 0.15). The therapies were generally well tolerated. The most common adverse event in the two groups was hot flashes. The incidence of hematuria was significantly higher for the bicalutamide plus LHRH-A group than for the flutamide plus LHRH-A group (12% versus 6%, P = 0.007), but no patient withdrew from therapy because of hematuria. There was a significantly (26% versus 12%, P <0.001) higher incidence of diarrhea and more withdrawals for diarrhea (25 patients versus 2) for the flutamide plus LHRH-A group relative to the bicalutamide plus LHRH-A group. Conclusions. With a median follow-up time of 160 weeks, the combination of bicalutamide plus LHRH-A was well tolerated and had equivalent time to progression and survival compared with flutamide plus LHRH-A. Treatment with bicalutamide plus LHRH-A resulted in longer median survival than treatment with flutamide plus LHRH-A.

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