Duration of androgen suppression in the treatment of prostate cancer

Michel Bolla, Theodorus M. de Reijke, Geertjan van Tienhoven, Alphonsus C. M. van den Bergh, Jorg Oddens, Philip M. P. Poortmans, Eliahu Gez, Paul Kil, Atif Akdas, Guy Soete, Oleg Kariakine, Elsbietha M. van der Steen-Banasik, Elena Musat, Marianne Piérart, Murielle E. Mauer, Laurence Collette

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Abstract

Background: The combination of radiotherapy plus long-term medical suppression of androgens (≥2 years) improves overall survival in patients with locally advanced prostate cancer. We compared the use of radiotherapy plus short-term androgen suppression with the use of radiotherapy plus long-term androgen suppression in the treatment of locally advanced prostate cancer. Methods: We randomly assigned patients with locally advanced prostate cancer who had received external-beam radiotherapy plus 6 months of androgen suppression to two groups, one to receive no further treatment (short-term suppression) and the other to receive 2.5 years of further treatment with a luteinizing hormone-releasing hormone agonist (long-term suppression). An outcome of noninferiority of short-term androgen suppression as compared with long-term suppression required a hazard ratio of more than 1.35 for overall survival, with a one-sided alpha level of 0.05. An interim analysis showed futility, and the results are presented with an adjusted one-sided alpha level of 0.0429. Results: A total of 1113 men were registered, of whom 970 were randomly assigned, 483 to short-term suppression and 487 to long-term suppression. After a median follow-up of 6.4 years, 132 patients in the short-term group and 98 in the long-term group had died; the number of deaths due to prostate cancer was 47 in the short-term group and 29 in the long-term group. The 5-year overall mortality for short-term and long-term suppression was 19.0% and 15.2%, respectively; the observed hazard ratio was 1.42 (upper 95.71% confidence limit, 1.79; P=0.65 for noninferiority). Adverse events in both groups included fatigue, diminished sexual function, and hot flushes. Conclusions: The combination of radiotherapy plus 6 months of androgen suppression provides inferior survival as compared with radiotherapy plus 3 years of androgen suppression in the treatment of locally advanced prostate cancer. (ClinicalTrials.gov number, NCT00003026.) Copyright © 2009 Massachusetts Medical Society.
Original languageEnglish
Pages (from-to)2516-2527
JournalNew England Journal of Medicine
Volume360
Issue number24
DOIs
Publication statusPublished - 2009
Externally publishedYes

Cite this

Bolla, M., de Reijke, T. M., van Tienhoven, G., van den Bergh, A. C. M., Oddens, J., Poortmans, P. M. P., ... Collette, L. (2009). Duration of androgen suppression in the treatment of prostate cancer. New England Journal of Medicine, 360(24), 2516-2527. https://doi.org/10.1056/NEJMoa0810095