1. Duration of androgen suppression in the treatment of prostate cancer
- Author
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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, 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, and Radiotherapy
- Subjects
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 - Abstract
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.)
- Published
- 2009