Comparison of goserelin and leuprolide in combined androgen blockade therapy

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

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

Objectives. To perform exploratory analyses of data from a controlled trial that assessed the efficacy and tolerability of two antiandrogens, bicalutamide and flutamide, each combined with monthly depot preparations of leuprolide or goserelin, in patients with Stage D2 prostate cancer. One analysis compared goserelin plus antiandrogen therapy with leuprolide plus antiandrogen therapy; a second analysis compared the four combined androgen blockade (CAB) regimens. Methods. This was a randomized, multicenter trial, open-label for luteinizing hormone releasing hormone analogue (LHRH-A) therapy, double-blind for antiandrogen therapy, with a two-by-two factorial design. Eight-hundred thirteen patients were allocated in a ratio of 2:1 to goserelin therapy (3.6 mg every 28 days) or leuprolide therapy (7.5 mg every 28 days) and 1:1 to bicalutamide therapy (50 mg once a day) or flutamide therapy (250 mg three times a day). The end points of time to progression and survival were assessed with a median of 160 weeks of follow-up. Results. The percentages of progression events (70.9% versus 73.3%) and deaths (54.3% versus 56.8%) were similar for goserelin plus antiandrogen and leuprolide plus antiandrogen therapies. The hazard ratios for goserelin plus antiandrogen therapy to leuprolide plus antiandrogen therapy were 0.99 (95% confidence interval [CI] 0.84 to 1.18; P = 0.92) and 0.91 (95% CI 0.75 to 1.11; P = 0.34) for time to progression and survival, respectively. Goserelin plus antiandrogen and leuprolide plus antiandrogen therapies were generally well tolerated, and the side effects associated with depot administration occurred with a low frequency in the two groups. There were no significant differences among the goserelin plus bicalutamide, goserelin plus flutamide, or leuprolide plus bicalutamide therapy groups, but leuprolide plus flutamide therapy had a significantly poorer outcome than the other three therapies. The side-effect profiles for the four CAB groups were generally similar; diarrhea was more common among patients treated with flutamide and hematuria was more common among patients treated with bicalutamide. Conclusions. Although the results of these exploratory analyses should be interpreted with caution, they indicate that goserelin plus antiandrogen and leuprolide plus antiandrogen therapies are similarly well tolerated and have equivalent time to progression and survival, and that leuprolide plus flutamide therapy appears to be the least effective of the four CAB regimens.

Original languageEnglish (US)
Pages (from-to)82-88
Number of pages7
JournalUrology
Volume52
Issue number1
DOIs
StatePublished - Jul 1 1998

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Goserelin
Leuprolide
Androgen Antagonists
Androgens
Flutamide
Therapeutics
Survival
Confidence Intervals
Delayed-Action Preparations

All Science Journal Classification (ASJC) codes

  • Urology

Cite this

Sarosdy, M. F., Schellhammer, P. F., Sharifi, R., Block, N. L., Soloway, M. S., Venner, P. M., ... Kolvenbag, G. J. C. M. (1998). Comparison of goserelin and leuprolide in combined androgen blockade therapy. Urology, 52(1), 82-88. https://doi.org/10.1016/S0090-4295(98)00145-9

Comparison of goserelin and leuprolide in combined androgen blockade therapy. / Sarosdy, Michael F.; Schellhammer, Paul F.; Sharifi, Roohollah; Block, Norman L.; Soloway, Mark S.; Venner, Peter M.; Patterson, Anthony; Vogelzang, Nicholas J.; Chodak, Gerald W.; Klein, Eric A.; Schellenger, Julie Jones; Kolvenbag, Geert J.C.M.

In: Urology, Vol. 52, No. 1, 01.07.1998, p. 82-88.

Research output: Contribution to journalArticle

Sarosdy, MF, Schellhammer, PF, Sharifi, R, Block, NL, Soloway, MS, Venner, PM, Patterson, A, Vogelzang, NJ, Chodak, GW, Klein, EA, Schellenger, JJ & Kolvenbag, GJCM 1998, 'Comparison of goserelin and leuprolide in combined androgen blockade therapy', Urology, vol. 52, no. 1, pp. 82-88. https://doi.org/10.1016/S0090-4295(98)00145-9
Sarosdy MF, Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM et al. Comparison of goserelin and leuprolide in combined androgen blockade therapy. Urology. 1998 Jul 1;52(1):82-88. https://doi.org/10.1016/S0090-4295(98)00145-9
Sarosdy, Michael F. ; Schellhammer, Paul F. ; Sharifi, Roohollah ; Block, Norman L. ; Soloway, Mark S. ; Venner, Peter M. ; Patterson, Anthony ; Vogelzang, Nicholas J. ; Chodak, Gerald W. ; Klein, Eric A. ; Schellenger, Julie Jones ; Kolvenbag, Geert J.C.M. / Comparison of goserelin and leuprolide in combined androgen blockade therapy. In: Urology. 1998 ; Vol. 52, No. 1. pp. 82-88.
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abstract = "Objectives. To perform exploratory analyses of data from a controlled trial that assessed the efficacy and tolerability of two antiandrogens, bicalutamide and flutamide, each combined with monthly depot preparations of leuprolide or goserelin, in patients with Stage D2 prostate cancer. One analysis compared goserelin plus antiandrogen therapy with leuprolide plus antiandrogen therapy; a second analysis compared the four combined androgen blockade (CAB) regimens. Methods. This was a randomized, multicenter trial, open-label for luteinizing hormone releasing hormone analogue (LHRH-A) therapy, double-blind for antiandrogen therapy, with a two-by-two factorial design. Eight-hundred thirteen patients were allocated in a ratio of 2:1 to goserelin therapy (3.6 mg every 28 days) or leuprolide therapy (7.5 mg every 28 days) and 1:1 to bicalutamide therapy (50 mg once a day) or flutamide therapy (250 mg three times a day). The end points of time to progression and survival were assessed with a median of 160 weeks of follow-up. Results. The percentages of progression events (70.9{\%} versus 73.3{\%}) and deaths (54.3{\%} versus 56.8{\%}) were similar for goserelin plus antiandrogen and leuprolide plus antiandrogen therapies. The hazard ratios for goserelin plus antiandrogen therapy to leuprolide plus antiandrogen therapy were 0.99 (95{\%} confidence interval [CI] 0.84 to 1.18; P = 0.92) and 0.91 (95{\%} CI 0.75 to 1.11; P = 0.34) for time to progression and survival, respectively. Goserelin plus antiandrogen and leuprolide plus antiandrogen therapies were generally well tolerated, and the side effects associated with depot administration occurred with a low frequency in the two groups. There were no significant differences among the goserelin plus bicalutamide, goserelin plus flutamide, or leuprolide plus bicalutamide therapy groups, but leuprolide plus flutamide therapy had a significantly poorer outcome than the other three therapies. The side-effect profiles for the four CAB groups were generally similar; diarrhea was more common among patients treated with flutamide and hematuria was more common among patients treated with bicalutamide. Conclusions. Although the results of these exploratory analyses should be interpreted with caution, they indicate that goserelin plus antiandrogen and leuprolide plus antiandrogen therapies are similarly well tolerated and have equivalent time to progression and survival, and that leuprolide plus flutamide therapy appears to be the least effective of the four CAB regimens.",
author = "Sarosdy, {Michael F.} and Schellhammer, {Paul F.} and Roohollah Sharifi and Block, {Norman L.} and Soloway, {Mark S.} and Venner, {Peter M.} and Anthony Patterson and Vogelzang, {Nicholas J.} and Chodak, {Gerald W.} and Klein, {Eric A.} and Schellenger, {Julie Jones} and Kolvenbag, {Geert J.C.M.}",
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T1 - Comparison of goserelin and leuprolide in combined androgen blockade therapy

AU - Sarosdy, Michael F.

AU - Schellhammer, Paul F.

AU - Sharifi, Roohollah

AU - Block, Norman L.

AU - Soloway, Mark S.

AU - Venner, Peter M.

AU - Patterson, Anthony

AU - Vogelzang, Nicholas J.

AU - Chodak, Gerald W.

AU - Klein, Eric A.

AU - Schellenger, Julie Jones

AU - Kolvenbag, Geert J.C.M.

PY - 1998/7/1

Y1 - 1998/7/1

N2 - Objectives. To perform exploratory analyses of data from a controlled trial that assessed the efficacy and tolerability of two antiandrogens, bicalutamide and flutamide, each combined with monthly depot preparations of leuprolide or goserelin, in patients with Stage D2 prostate cancer. One analysis compared goserelin plus antiandrogen therapy with leuprolide plus antiandrogen therapy; a second analysis compared the four combined androgen blockade (CAB) regimens. Methods. This was a randomized, multicenter trial, open-label for luteinizing hormone releasing hormone analogue (LHRH-A) therapy, double-blind for antiandrogen therapy, with a two-by-two factorial design. Eight-hundred thirteen patients were allocated in a ratio of 2:1 to goserelin therapy (3.6 mg every 28 days) or leuprolide therapy (7.5 mg every 28 days) and 1:1 to bicalutamide therapy (50 mg once a day) or flutamide therapy (250 mg three times a day). The end points of time to progression and survival were assessed with a median of 160 weeks of follow-up. Results. The percentages of progression events (70.9% versus 73.3%) and deaths (54.3% versus 56.8%) were similar for goserelin plus antiandrogen and leuprolide plus antiandrogen therapies. The hazard ratios for goserelin plus antiandrogen therapy to leuprolide plus antiandrogen therapy were 0.99 (95% confidence interval [CI] 0.84 to 1.18; P = 0.92) and 0.91 (95% CI 0.75 to 1.11; P = 0.34) for time to progression and survival, respectively. Goserelin plus antiandrogen and leuprolide plus antiandrogen therapies were generally well tolerated, and the side effects associated with depot administration occurred with a low frequency in the two groups. There were no significant differences among the goserelin plus bicalutamide, goserelin plus flutamide, or leuprolide plus bicalutamide therapy groups, but leuprolide plus flutamide therapy had a significantly poorer outcome than the other three therapies. The side-effect profiles for the four CAB groups were generally similar; diarrhea was more common among patients treated with flutamide and hematuria was more common among patients treated with bicalutamide. Conclusions. Although the results of these exploratory analyses should be interpreted with caution, they indicate that goserelin plus antiandrogen and leuprolide plus antiandrogen therapies are similarly well tolerated and have equivalent time to progression and survival, and that leuprolide plus flutamide therapy appears to be the least effective of the four CAB regimens.

AB - Objectives. To perform exploratory analyses of data from a controlled trial that assessed the efficacy and tolerability of two antiandrogens, bicalutamide and flutamide, each combined with monthly depot preparations of leuprolide or goserelin, in patients with Stage D2 prostate cancer. One analysis compared goserelin plus antiandrogen therapy with leuprolide plus antiandrogen therapy; a second analysis compared the four combined androgen blockade (CAB) regimens. Methods. This was a randomized, multicenter trial, open-label for luteinizing hormone releasing hormone analogue (LHRH-A) therapy, double-blind for antiandrogen therapy, with a two-by-two factorial design. Eight-hundred thirteen patients were allocated in a ratio of 2:1 to goserelin therapy (3.6 mg every 28 days) or leuprolide therapy (7.5 mg every 28 days) and 1:1 to bicalutamide therapy (50 mg once a day) or flutamide therapy (250 mg three times a day). The end points of time to progression and survival were assessed with a median of 160 weeks of follow-up. Results. The percentages of progression events (70.9% versus 73.3%) and deaths (54.3% versus 56.8%) were similar for goserelin plus antiandrogen and leuprolide plus antiandrogen therapies. The hazard ratios for goserelin plus antiandrogen therapy to leuprolide plus antiandrogen therapy were 0.99 (95% confidence interval [CI] 0.84 to 1.18; P = 0.92) and 0.91 (95% CI 0.75 to 1.11; P = 0.34) for time to progression and survival, respectively. Goserelin plus antiandrogen and leuprolide plus antiandrogen therapies were generally well tolerated, and the side effects associated with depot administration occurred with a low frequency in the two groups. There were no significant differences among the goserelin plus bicalutamide, goserelin plus flutamide, or leuprolide plus bicalutamide therapy groups, but leuprolide plus flutamide therapy had a significantly poorer outcome than the other three therapies. The side-effect profiles for the four CAB groups were generally similar; diarrhea was more common among patients treated with flutamide and hematuria was more common among patients treated with bicalutamide. Conclusions. Although the results of these exploratory analyses should be interpreted with caution, they indicate that goserelin plus antiandrogen and leuprolide plus antiandrogen therapies are similarly well tolerated and have equivalent time to progression and survival, and that leuprolide plus flutamide therapy appears to be the least effective of the four CAB regimens.

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