Lipton, A., Fizazi, K., Stopeck, A.T. et al. (12 more authors) (2016) Effect of denosumab versus zoledronic acid in preventing skeletal-related events in patients with bone metastases by baseline characteristics. EUROPEAN JOURNAL OF CANCER, 53. pp. 75-83. ISSN 0959-8049
Abstract
Background: Analyses of phase III trials showed that denosumab was superior to zoledronic acid (ZA) in preventing skeletal-related events (SREs) irrespective of age, history of SREs, or baseline pain status. This analysis assessed the risk of SREs across additional baseline characteristics. Patients and Methods: Patients (N Z 5543) from three phase III trials who had breast cancer, prostate cancer, or other solid tumours and one or more bone metastasis were included. Superiority of denosumab versus ZA in reducing risk of first SRE and first and subsequent SREs was assessed in subgroups defined by the Eastern Cooperative Oncology Group performance status (ECOG PS), bone metastasis location, bone metastasis number, visceral metastasis presence/absence, and urinary N-telopeptide (uNTx) level using Cox proportional hazards and AndersoneGill models. Subgroups except bone metastasis location were also assessed for each solid tumour type. Results: Compared with ZA, denosumab significantly reduced the risk of first SRE across all subgroups (hazard ratio [HR] ranges: ECOG PS, 0.79e0.84; bone metastasis location, 0.78e0.83; bone metastasis number, 0.78e0.84; visceral metastasis presence/absence, 0.80e0.82; uNTx level, 0.73e0.86) and reduced the risk of first and subsequent SREs in all subgroups (HR ranges: ECOG PS, 0.76e0.83; bone metastasis location, 0.78e0.84; bone metastasis number, 0.79e0.81; visceral metastasis presence/absence, 0.79e0.81; uNTx level, 0.74e0.83). Similar results were observed in subgroups across tumour types. Conclusion: Denosumab was superior to ZA in preventing SREs in patients with bone metastases from advanced cancer, regardless of ECOG PS, bone metastasis number, baseline visceral metastasis presence/absence, and uNTx level
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
Keywords: | Denosumab; Zoledronic acid; Bone metastases; Skeletal-related event; Subgroup |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > The Medical School (Sheffield) > Division of Genomic Medicine (Sheffield) > Department of Oncology and Metabolism (Sheffield) The University of Sheffield > Sheffield Teaching Hospitals |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 07 Jul 2016 15:56 |
Last Modified: | 07 Jul 2016 15:57 |
Published Version: | http://dx.doi.org/10.1016/j.ejca.2015.09.011 |
Status: | Published |
Publisher: | Elsevier |
Refereed: | Yes |
Identification Number: | 10.1016/j.ejca.2015.09.011 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:101663 |