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Clinical Paper

Maximal Androgen Blockade: Final Analysis of EORTC Phase III Trial 30853

Denis L.J. · Keuppens F. · Smith P.H. · Whelan P. · Carneiro de Moura J.L. · Newling D. · Bono A. · Sylvester R.

Author affiliations

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

Related Articles for ""

Eur Urol 1998;33:144–151

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Article / Publication Details

First-Page Preview
Abstract of Clinical Paper

Published online: February 13, 1998
Issue release date: February 1998

Number of Print Pages: 8
Number of Figures: 4
Number of Tables: 5

ISSN: 0302-2838 (Print)
eISSN: 1873-7560 (Online)

For additional information: https://www.karger.com/EUR

Abstract

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.


References

  1. Labrie F, Dupont A, Bélanger A: Complete androgen blockade for the treatment of prostate cancer; in DeVita VT Jr, Hellman S, Rosenberg SA (eds): Important Advances in Oncology. Philadelphia, Lippincott, 1985, pp 193–197.
  2. Robinson MRG, Denis L, Newling DWW, Sylvester R, De Pauw M: EORTC Protocol 30853: Orchidectomy versus Zoladex plus flutamide in the management of metastatic carcinoma of the prostate. Interim statistical analysis of the side effect of treatment. Cancer 1990;66(suppl):1022–1024.
  3. 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.
  4. Smith PH, Bono A, Calais da Silva F, Debruyne F, Denis L, Robinson M, Sylvester R, Armitage RG, Members of the EORTC Urological Group: Some limitations of the radioisotope bone scan in patients with metastatic prostatic cancer: A sub-analysis of EORTC trial 30853. Cancer 1990;66:1009–1016.
    External Resources
  5. 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.
    External Resources
  6. 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.
  7. Tyrrell CJ, Altwein JE, Klippel E, et al: A randomised trial comparing the luteinizing hormone-releasing hormone analogue goserelin acetate alone and with flutamide in the treatment of advanced prostate cancer. J Urol 1991;146:1321–1326.
  8. 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.
  9. 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.
    External Resources
  10. 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.
  11. 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.
  12. Denis L, Murphy GP: Third international workshop on randomized trials on maximal androgen blockade in M1 prostate cancer patients. Cancer 1993;72:3781–3895.
    External Resources
  13. Prostate Cancer Trialists’ Collaborative Group: Maximum androgen blockade in advanced prostate cancer: An overview of 22 randomised trials with 3,283 deaths in 5,710 patients. Lancet 1995;346:265–269.
  14. Blumenstein BA: Some statistical considerations for the interpretation of trials of combined androgen therapy. Cancer 1993;72:834–840.

Article / Publication Details

First-Page Preview
Abstract of Clinical Paper

Published online: February 13, 1998
Issue release date: February 1998

Number of Print Pages: 8
Number of Figures: 4
Number of Tables: 5

ISSN: 0302-2838 (Print)
eISSN: 1873-7560 (Online)

For additional information: https://www.karger.com/EUR


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