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Previous Volume 360:2516-2527 June 11, 2009 Number 24 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set CME Exam Supplementary Material Editorial by Albertsen, P. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

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 [ClinicalTrials.gov] .)

Source Information

From Centre Hospitalier Régional Universitaire de Grenoble, Grenoble, France (M.B.); Academisch Medisch Centrum, Amsterdam (T.M.R., G.V.T.), University Medical Center Groningen, University of Groningen, Groningen (A.C.M.V.B.), Jeroen Bosch Medicentrum, s'-Hertogenbosch (J.O.), Doctor Bernard Verbeeten Institute, Tilburg (P.M.P.P.), Sint-Elisabeth Ziekenhuis, Tilburg (P.K.), and Arnhem's RadioTherapeutisch Instituut, Arnhem (E.M.S.-B.) — all in the Netherlands; Rambam Medical Center, Haïfa, Israel (E.G.); Marmara University Hospital, Istanbul, Turkey (A.A.); Universitair Ziekenhuis (G.S.) and EORTC Headquarters (E.M., M.P., M.E.M., L.C.) — both in Brussels; and Medical Oncological Research Center, Obninsk, Russia (O.K.).

Address reprint requests to Dr. Bolla at the Department of Radiation Oncology, Grenoble University Hospital, BP 217, 38043 Grenoble CEDEX 9, France, or at mbolla{at}chu-grenoble.fr.

Full Text of this Article

Related Letters:

Duration of Androgen Suppression in Prostate Cancer
Badiozamani K. R., Bolla M., Collette L.
Extract | Full Text | PDF  
N Engl J Med 2009; 361:1212-1213, Sep 17, 2009. Correspondence

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