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, EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group, T M de Reijke, G van Tienhoven, A C M van den Bergh, J Oddens, P M P Poortmans, P Kil, G van Andel, E M van der Steen-Banasik, C van de Beek, E Schimmel, M Bolla, J L Descotes, J-F Bosset, M H Hay, J-M Bachaud, P Maingon, A Courdi, I Barillot, C Carrie, F Rothe-Thomas, E Gez, A Akdas, M Lekili, G Soete, H van Poppel, K Vekemans, P Van Houtte, A Verbaeys, L Hoekx, O Kariakine, C L Cutajar, R Mirimanoff, S M Magrini, M Busetto, A Bono, S Villa, L Arribas, X Maldonado, H Kynaston, J Barber, M Saxby, N Obralic, 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, EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group, T M de Reijke, G van Tienhoven, A C M van den Bergh, J Oddens, P M P Poortmans, P Kil, G van Andel, E M van der Steen-Banasik, C van de Beek, E Schimmel, M Bolla, J L Descotes, J-F Bosset, M H Hay, J-M Bachaud, P Maingon, A Courdi, I Barillot, C Carrie, F Rothe-Thomas, E Gez, A Akdas, M Lekili, G Soete, H van Poppel, K Vekemans, P Van Houtte, A Verbaeys, L Hoekx, O Kariakine, C L Cutajar, R Mirimanoff, S M Magrini, M Busetto, A Bono, S Villa, L Arribas, X Maldonado, H Kynaston, J Barber, M Saxby, N Obralic
Abstract
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.)
2009 Massachusetts Medical Society
Source: PubMed