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A randomised trial of 4- versus 12-weekly administration of bone-targeted agents in patients with bone metastases from breast or castration-resistant prostate cancer.
Clemons, Mark; Ong, Michael; Stober, Carol; Ernst, Scott; Booth, Christopher; Canil, Christina; Mates, Mihaela; Robinson, Andrew; Blanchette, Phillip; Joy, Anil Abraham; Hilton, John; Aseyev, Olexiy; Pond, Gregory; Jeong, Ahwon; Hutton, Brian; Mazzarello, Sasha; Vandermeer, Lisa; Kushnir, Igal; Fergusson, Dean.
Afiliación
  • Clemons M; Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada; Clinical Epid
  • Ong M; Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.
  • Stober C; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
  • Ernst S; Division of Medical Oncology, Department of Oncology, London Regional Cancer Program, London Health Sciences Centre and University of Western Ontario, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.
  • Booth C; Cancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.
  • Canil C; Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.
  • Mates M; Cancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.
  • Robinson A; Cancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.
  • Blanchette P; Division of Medical Oncology, Department of Oncology, London Regional Cancer Program, London Health Sciences Centre and University of Western Ontario, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.
  • Joy AA; Division of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, 11560 University Avenue, Edmonton, Alberta, T6G 1Z2, Canada.
  • Hilton J; Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
  • Aseyev O; Regional Cancer Care Northwest, Thunder Bay Regional Health Sciences Centre, 980 Oliver Road, Thunder Bay, Ontario, P7B 6V4, Canada.
  • Pond G; Department of Oncology, McMaster University, 699 Concession Street, Suite 4-204, Hamilton, Ontario, L8V 5C2, Canada.
  • Jeong A; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
  • Hutton B; Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
  • Mazzarello S; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
  • Vandermeer L; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
  • Kushnir I; Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.
  • Fergusson D; Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
Eur J Cancer ; 142: 132-140, 2021 01.
Article en En | MEDLINE | ID: mdl-33023785
BACKGROUND: Optimal dosing of bone-targeted agents (BTAs), in patients with bone metastases remains an important clinical question. This trial compared 4-weekly versus 12-weekly therapy. PATIENTS AND METHODS: Patients with bone metastases from breast or castration-resistant prostate cancer (CRPC), who were going to start or already on BTAs, were randomised 1:1 to 4-weekly or 12-weekly BTA treatment for one year. Primary end point was change in health-related quality of life (HRQoL)-physical function European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30). Secondary end points included pain (EORTC-QLQ-BM22), global health status (EORTC-QLQ-C30), symptomatic skeletal events (SSEs) rates and time to SSEs. Primary analysis was per protocol and a non-inferiority margin of 5 points was used. RESULTS: Of 263 patients (160 breast cancer, 103 CRPC), 133 (50.6%) and 130 (49.4%) were randomised to the 4- and 12-weekly groups, respectively. BTAs included denosumab (56.3%), zoledronate (24.0%) and pamidronate (19.8%). Using repeated-measures analysis, across all time points, patients in the 4-weekly arm had a mean HRQL-physical subdomain score which was 1.2 (95% confidence interval: -1.6 to 4.0) higher than the 12-weekly arm. The study met the definition of non-inferiority for our primary outcome. Secondary outcomes showed no significant difference in scores for pain, global health status, SSE rates and SSE-free survival between arms. Subgroup analyses for cancer type, prior BTA use or BTA type showed no significant difference between arms. CONCLUSION: These results in addition to those previously reported for de-escalating zoledronate and systematic reviews in both breast and prostate cancers, would support that de-escalation of commonly used BTAs is a reasonable treatment option.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Óseas / Neoplasias de la Mama / Conservadores de la Densidad Ósea / Neoplasias de la Próstata Resistentes a la Castración Tipo de estudio: Clinical_trials / Guideline Aspecto: Patient_preference Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Cancer Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Óseas / Neoplasias de la Mama / Conservadores de la Densidad Ósea / Neoplasias de la Próstata Resistentes a la Castración Tipo de estudio: Clinical_trials / Guideline Aspecto: Patient_preference Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Cancer Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido