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

Vadhan-Raj, S, von Moos, R, Fallowfield, L J, Patrick, D L, Goldwasser, F, Cleeland, C S, Henry, D H, Novello, S, Hungria, V, Qian, Y, Feng, A, Yeh, H and Chung, K (2012) Clinical benefit in patients with metastatic bone disease: results of a phase 3 study of denosumab versus zoledronic acid. Annals of Oncology, 23 (12). pp. 3045-3051. ISSN 1569-8041 on-line, 0923-7534 print

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Abstract

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.

Item Type: Article
Keywords: bone pain, denosumab, metastatic bone disease, quality of life, skeletal-related events, zoledronic acid
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Subjects: R Medicine
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens
Depositing User: Kathryn Monson
Date Deposited: 26 Oct 2012 09:35
Last Modified: 26 Jun 2013 15:26
URI: http://sro.sussex.ac.uk/id/eprint/40928
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