Maximal Androgen Blockade: Final Analysis of EORTC Phase III Trial 30853Denis L.J. · Keuppens F. · Smith P.H. · Whelan P. · Carneiro de Moura J.L. · Newling D. · Bono A. · Sylvester R.
Departments of Urology, A.Z. Middelheim, Antwerp, and Vrije Universiteit, Brussels, Belgium;St. James’ University Hospital, Leeds, UK;Hospital Santa Maria, Lisbon, Portugal;Free University Hospital, Amsterdam, The Netherlands;Ospedale di Circolo e Fondazione E.S. Macchi, Varese, Italy;EORTC Data Center, Brussels, Belgium
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Objectives: This prospective, randomized phase III study was initiated to compare the efficacy and side effects of bilateral orchiectomy versus a combination of a luteinizing hormone-releasing hormone agonist depot formulation, goserelin acetate (3.6 mg s.c. once every 4 weeks) and flutamide (250 mg 3× daily) in patients with metastatic prostate cancer. Methods: Relative treatment efficacy was assessed by comparing the two treatment groups with respect to response, time to first progression, progression-free survival, duration of survival and time to death due to malignant disease. Results: There was a difference in response only with respect to a more frequent decrease to normal of the serum prostate acid phosphatase in patients assigned to maximal androgen blockade treatment. Additionally, maximal androgen blockade treatment showed significantly better results for duration of survival (p = 0.04), time to death due to malignant disease (p = 0.008), time to first progression (p = 0.009) and progression-free survival (p = 0.02). The most frequent side effects for both treatments included hot flushes and gynaecomastia. Conclusions: Increased time to progression and duration of survival is achieved by the combination of flutamide and goserelin when compared to bilateral orchiectomy.
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- Denis LJ, Whelan P, Carneiro de Moura JL, Newling D, Bono A, De Pauw M, Sylvester R, Members of the EORTC GU Group and EORTC Data Center: Goserelin acetate and flutamide versus bilateral orchiectomy: A phase III EORTC trial (30853). Urology 1993;42:119–130.
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- Keuppens F, Denis L, Smith PH, Pinto Carvalho A, Newling D, Bono A, Sylvester R, De Pauw M, Vermeylen K, Ongena P, Members of the EORTC GU Group: Zoladex R and flutamide versus bilateral orchiectomy: A randomized phase III trial EORTC 30853 study. Cancer 1990;66:1045–1057.
- Crawford ED, Eisenberger M, McLeod DG, Spaulding JT, Benson R, Dorr FA, Blumenstein BA, Davis MA, Goodman PJ: A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. N Engl J Med 1989;321:419–424.
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Iversen P et al. on behalf of the Danish Prostate Cancer Group: ‘Zoladex’ plus flutamide versus orchidectomy for advanced prostate cancer. Eur Urol 1990;18(suppl 3):41–44.
- Robinson MRG, Smith PH, Richards B, et al: The final analysis of the EORTC Genito-Urinary Tract Cancer Cooperative Group Phase III clinical trial (protocol 30805) comparing orchidectomy, orchidectomy plus cyproterone acetate and low dose stilboestrol in the management of metastatic carcinoma of the prostate. Eur Urol 1995;28:273–283.
- de Voogt HJ, Studer U, Schröder F, Sylvester R: Maximum androgen blockade using LHRH agonist buserelin in combination with short-term (2 weeks) or long-term (continuous) cyproterone acetate is not superior to standard androgen deprivation in the treatment of advanced prostate cancer: Final analysis of EORTC GU group trial 30843. Eur Urol 1998;33:152–158.
- Sylvester R, Denis L, de Voogt H: The importance of prognostic factors in the interpretation of metastatic prostate cancer trials. Eur Urol 1998;33:134–143.
- Denis L, Murphy GP: Third international workshop on randomized trials on maximal androgen blockade in M1 prostate cancer patients. Cancer 1993;72:3781–3895.
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