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Duration of Androgen Suppression in the Treatment of Prostate Cancer
Open accessAbstract
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.)
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Cox, D. R. (1972) · Journal of the Royal Statistical Society Series B: Statistical Methodology · doi:10.1111/j.2517-6161.1972.tb00899.x · Cited by 39,793
Bolla, M., Collette, L., Blank, L., Warde, P., Dubois, J. B., Mirimanoff, R.-O., Storme, G., Bernier, J., Kuten, A., Sternberg, C., et al. (2002) · The Lancet · doi:10.1016/s0140-6736(02)09408-4 · Cited by 1,686
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Carrie, C., Hasbini, A., de Laroche, G., Richaud, P., Guerif, S., Latorzeff, I., Supiot, S., Bosset, M., Lagrange, J.-L., Beckendorf, V., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)00111-x · Cited by 365
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Metadata
- Authors
- Bolla, M., de Reijke, T. M., Van Tienhoven, G., Van den Bergh, A. C. M., Oddens, J., Poortmans, P. M. P., Gez, E., Kil, P., Akdas, A., Soete, G., Kariakine, O., van der Steen-Banasik, E. M., Musat, E., Piérart, M., Mauer, M. E., & Collette, L.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2009-06-11
- Volume
- 360
- Issue
- 24
- Pages
- 2516-2527
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1985587689
- Cited by
- 970
- References
- 2
- FWCI
- 69.88
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Bolla, M., de Reijke, T. M., Van Tienhoven, G., Van den Bergh, A. C. M., Oddens, J., Poortmans, P. M. P., Gez, E., Kil, P., Akdas, A., Soete, G., Kariakine, O., van der Steen-Banasik, E. M., Musat, E., Piérart, M., Mauer, M. E., & Collette, L. (2009). Duration of Androgen Suppression in the Treatment of Prostate Cancer. New England Journal of Medicine. https://doi.org/10.1056/nejmoa0810095
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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