Duration of androgen suppression in the treatment of prostate cancer
Autor: | Bolla , Michel, De Reijke , Theodorus M, Van Tienhoven , Geertjan, Van Den Bergh , Alphonsus C M, Oddens , Jorg, Poortmans , Philip M P, Gez , Eliahu, Kil , Paul, Akdas , Atif, Soete , Guy, Kariakine , Oleg, Van Der Steen-Banasik , Elsbietha M, Musat , Elena, Piérart , Marianne, Mauer , Murielle E, Collette , Laurence, Renseigné , Non, Bosset , Jean-François |
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Přispěvatelé: | Département de cancérologie et radiothérapie, CHU Grenoble, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Faculteit Medische Wetenschappen/UMCG, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Medical Imaging and Physical Sciences, Radiation Therapy, CCA -Cancer Center Amsterdam, Urology, Radiotherapy |
Jazyk: | angličtina |
Rok vydání: | 2009 |
Předmět: |
Oncology
Male MESH: Treatment Failure medicine.medical_treatment MESH : Aged [ SDV.CAN ] Life Sciences [q-bio]/Cancer Tosyl Compounds 0302 clinical medicine MESH : Nitriles MESH: Middle Aged MESH: Heart Diseases Hazard ratio General Medicine MESH: Follow-Up Studies MESH: Nitriles 3. Good health 030220 oncology & carcinogenesis Prostatic Neoplasms/drug therapy MESH: Tosyl Compounds MESH : Prostatic Neoplasms medicine.medical_specialty MESH : Androgen Antagonists MESH : Drug Administration Schedule MESH: Drug Administration Schedule Disease-Free Survival Drug Administration Schedule MESH : Anilides 03 medical and health sciences MESH : Treatment Failure Humans MESH : Middle Aged MESH : Aged 80 and over Anilides/adverse effects Aged MESH: Humans Proportional hazards model Heart Diseases/mortality MESH : Humans Androgen Antagonists MESH: Adult MESH : Follow-Up Studies medicine.disease Androgen Interim analysis MESH : Proportional Hazards Models Flutamide RANDOMIZED-TRIAL Radiation therapy MESH : Flutamide MESH: Disease-Free Survival aged 80 and over MESH: Combined Modality Therapy 030232 urology & nephrology ADJUVANT Androgen suppression MESH : Radiotherapy Conformal Gonadotropin-Releasing Hormone MESH: Proportional Hazards Models Prostate cancer MESH: Aged 80 and over QUALITY-OF-LIFE MESH: Gonadotropin-Releasing Hormone Anilides Treatment Failure Quality Of Life MESH: Aged Radiotherapy Conformal/adverse effects Nitriles/adverse effects PHASE-III TRIAL Middle Aged MESH : Adult Combined Modality Therapy EORTC MESH: Androgen Antagonists oncology MESH: Radiotherapy Conformal MESH : Disease-Free Survival RADIOTHERAPY Adult Heart Diseases medicine.drug_class MESH : Male [SDV.CAN]Life Sciences [q-bio]/Cancer MESH: Anilides Internal medicine RADIATION-THERAPY Nitriles medicine MANAGEMENT Androgen Antagonists/administration & dosage Proportional Hazards Models Tosyl Compounds/adverse effects Flutamide/adverse effects business.industry Prostatic Neoplasms Cancer MESH: Quality of Life MESH : Tosyl Compounds MESH : Heart Diseases Gonadotropin-Releasing Hormone/analogs & derivatives MESH : Quality of Life MESH: Flutamide MESH: Male Surgery IRRADIATION MESH: Prostatic Neoplasms DEPRIVATION THERAPY Radiotherapy Conformal MESH : Gonadotropin-Releasing Hormone business MESH : Combined Modality Therapy Follow-Up Studies |
Zdroj: | New England Journal of Medicine New England Journal of Medicine, Massachusetts Medical Society, 2009, 360 (24), pp.2516-2527. 〈10.1056/NEJMoa0810095〉 New England Journal of Medicine, Massachusetts Medical Society, 2009, 360 (24), pp.2516-2527. ⟨10.1056/NEJMoa0810095⟩ New England Journal of Medicine, 360(24), 2516-2527. MASSACHUSETTS MEDICAL SOC New England journal of medicine, 360(24), 2516-2527. Massachussetts Medical Society |
ISSN: | 0000-3026 0028-4793 1533-4406 |
DOI: | 10.1056/NEJMoa0810095〉 |
Popis: | International audience; 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.) |
Databáze: | OpenAIRE |
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