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Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results.
Coleman, R; de Boer, R; Eidtmann, H; Llombart, A; Davidson, N; Neven, P; von Minckwitz, G; Sleeboom, H P; Forbes, J; Barrios, C; Frassoldati, A; Campbell, I; Paija, O; Martin, N; Modi, A; Bundred, N.
Afiliación
  • Coleman R; Academic Unit of Clinical Oncology, CR-UK/YCR Sheffield Cancer Research Centre, Sheffield, UK. Electronic address: r.e.coleman@sheffield.ac.uk.
  • de Boer R; Department of Medical Oncology, Royal Melbourne and Western Hospitals, Melbourne, Australia.
  • Eidtmann H; Clinic for Gynecology and Obstetrics, Universitäts-Frauenklinik Kiel, Kiel, Germany.
  • Llombart A; Medical Oncology Service, Institute Oncologica, Valencia, Spain.
  • Davidson N; Cancer Services Directorate, Broomfield Hospital, Chelmsford, Essex, UK.
  • Neven P; Department of Gynecological Oncology, Breast Clinic, UZ Gasthuisberg, Leuven, Belgium.
  • von Minckwitz G; German Breast Group, Frankfurt, Germany.
  • Sleeboom HP; Department of Internal Medicine, Haga Hospital, Den Haag, The Netherlands.
  • Forbes J; Faculty of Health, School of Medical Practice and Population Health, University of Newcastle, Newcastle, NSW, Australia.
  • Barrios C; Faculty of Medicine, PUCRS School of Medicine, Porto Alegre, Brazil.
  • Frassoldati A; Clinical Oncology Unit, St. Anna University Hospital, Ferrara, Italy.
  • Campbell I; Department of General Surgery, Waikato Hospital, Breast Care Center, Hamilton, New Zealand.
  • Paija O; Department of Medical Oncology, Turku University Central Hospital, Turku, Finland.
  • Martin N; Novartis Oncology, East Hanover, New Jersey, USA.
  • Modi A; Novartis Oncology, East Hanover, New Jersey, USA.
  • Bundred N; Department of Academic Surgery, South Manchester University Hospital, Education and Research Center, Manchester, UK.
Ann Oncol ; 24(2): 398-405, 2013 Feb.
Article en En | MEDLINE | ID: mdl-23047045
BACKGROUND: Aromatase inhibitors are the preferred adjuvant endocrine therapy for the majority of postmenopausal women with hormone-responsive early breast cancer. Although generally more effective than tamoxifen, aromatase inhibitor therapy is associated with increased bone loss and fracture risk. PATIENTS AND METHODS: Postmenopausal women receiving adjuvant letrozole (2.5 mg/day for 5 years; N = 1065) were randomly assigned to immediate zoledronic acid (zoledronate) 4 mg every 6 months for 5 years, or delayed zoledronate (initiated for fracture or on-study bone mineral density [BMD] decrease). The primary end point was the change in lumbar spine BMD at 12 months. Lumbar spine and total hip BMD at subsequent follow-up, disease-free survival (DFS), and overall survival were assessed as secondary end points. RESULTS: At 60 months (final analysis), the mean change in lumbar spine BMD was +4.3% with immediate zoledronate and -5.4% with delayed intervention (P < 0.0001). Immediate zoledronate reduced the risk of DFS events by 34% (hazard ratio [HR] = 0.66; P = 0.0375) with fewer local (0.9% versus 2.3%) and distant (5.5% versus 7.7%) recurrences versus delayed zoledronate. In the delayed group, delayed initiation of zoledronate substantially improved DFS versus no zoledronate (HR = 0.46; P = 0.0334). CONCLUSIONS: Immediate zoledronate in postmenopausal women receiving letrozole preserved BMD and is associated with improved DFS compared with letrozole alone. Clinical Trials Registration No NCT00171340.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Triazoles / Neoplasias de la Mama / Densidad Ósea / Difosfonatos / Conservadores de la Densidad Ósea / Imidazoles / Antineoplásicos / Nitrilos Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2013 Tipo del documento: Article Pais de publicación: Reino Unido
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Triazoles / Neoplasias de la Mama / Densidad Ósea / Difosfonatos / Conservadores de la Densidad Ósea / Imidazoles / Antineoplásicos / Nitrilos Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2013 Tipo del documento: Article Pais de publicación: Reino Unido