Duration of androgen suppression in the treatment of prostate cancer.

Michel Bolla (1) , 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 , Non Renseigné , Jean-François Bosset (2)

1 Département de cancérologie et radiothérapie
2 CEF2P / CARCINO - Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181)

BACKGROUND: The combination of radiotherapy plus long-term medical suppression of androgens (> or = 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.)

Domaines: Cancer

Michel Bolla, Theodorus M de Reijke, Geertjan van Tienhoven, Alphonsus C M van den Bergh, Jorg Oddens, et al.. Duration of androgen suppression in the treatment of prostate cancer.. New England Journal of Medicine, 2009, 360 (24), pp.2516-2527. ⟨10.1056/NEJMoa0810095⟩. ⟨hal-00492521⟩