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Clinical benefit in patients with metastatic bone disease: results of a phase 3 study of denosumab versus zoledronic acid

journal contribution
posted on 2023-06-08, 12:31 authored by S Vadhan-Raj, R von Moos, Lesley FallowfieldLesley Fallowfield, D L Patrick, F Goldwasser, C S Cleeland, D H Henry, S Novello, V Hungria, Y Qian, A Feng, H Yeh, K Chung
Background Patients with metastatic bone disease are living longer in the metastatic stage due to improvements in cancer therapy, making strategies to prevent the aggravation of bone disease and its complications, such as skeletal-related events (SREs) and pain, increasingly important.Patients and results In this phase 3 trial in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma, denosumab reduced the risk of radiation to bone by 22% relative to zoledronic acid (P = 0.026), prevented worsening of pain and pain interference (2-point increase in Brief Pain Inventory score; P < 0.05 versus zoledronic acid), and reduced the frequency of a shift from no/weak opioid analgesic use to strong opioids (P < 0.05 versus zoledronic acid at months 3–5). Denosumab delayed the time to moderate-to-severe pain compared with zoledronic acid in patients with mild or no pain at the baseline (P = 0.04), supporting early treatment. Health-related quality-of-life scores were similar in both groups. The number needed to treat to avoid one SRE for denosumab was 3 patient-years versus placebo and 10 patient-years versus zoledronic acid.Conclusion The use of denosumab was associated with better prevention of the complications of metastatic bone disease secondary to solid tumors or multiple myeloma versus zoledronic acid.

History

Publication status

  • Published

Journal

Annals of Oncology

ISSN

1569-8041 on-line, 0923-7534 print

Publisher

Oxford University Press

Issue

12

Volume

23

Page range

3045-3051

Department affiliated with

  • Sussex Health Outcomes Research & Education in Cancer (SHORE-C) Publications

Full text available

  • No

Peer reviewed?

  • Yes

Legacy Posted Date

2012-10-26

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