Journal Mobile Options
Table of Contents
Vol. 33, No. 2, 1998
Issue release date: February 1998
Eur Urol 1998;33:144–151
(DOI:10.1159/000019546)

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.
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

Individual Users: Register with Karger Login Information

Please create your User ID & Password





Contact Information











I have read the Karger Terms and Conditions and agree.

To view the fulltext, please log in

To view the pdf, please log in

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.



Copyright / Drug Dosage

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

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.


Pay-per-View Options
Direct payment This item at the regular price: USD 38.00
Payment from account With a Karger Pay-per-View account (down payment USD 150) you profit from a special rate for this and other single items.
This item at the discounted price: USD 26.50