| Title | Duration of androgen suppression in the treatment of prostate cancer. | | Author(s) | Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Piérart M, Mauer ME, Collette L, EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group | | Institution | Centre Hospitalier Régional Universitaire de Grenoble, Grenoble, France. mbolla@chu-grenoble.fr | | Source | N Engl J Med 2009 Jun 11; 360(24):2516-27. | | MeSH | Adult
Aged
Aged, 80 and over
Androgen Antagonists
Anilides
Combined Modality Therapy
Disease-Free Survival
Drug Administration Schedule
Flutamide
Follow-Up Studies
Gonadotropin-Releasing Hormone
Heart Diseases
Humans
Male
Middle Aged
Nitriles
Proportional Hazards Models
Prostatic Neoplasms
Quality of Life
Radiotherapy, Conformal
Tosyl Compounds
Treatment Failure
| | 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.) | | Language | eng | | Pub Type(s) | Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
| | PubMed ID | 19516032 |
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