Bone-related complications and quality of life in advanced breast cancer: results from a randomized phase III trial of denosumab versus zoledronic acid

Martin, Miguel, Bell, Richard, Bourgeois, Hugues, Brufsky, Adam, Diel, Ingo, Eniu, Alexandru, Fallowfield, Lesley, Fujiwara, Yasuhiro, Jassem, Jacek, Paterson, Alexander H.G., Ritchie, Diana, Steger, Günther G., Stopeck, Alison, Vogel, Charles, Fan, Michelle, Jiang, Qi, Chung, Karen, Dansey, Roger and Braun, Ada (2012) Bone-related complications and quality of life in advanced breast cancer: results from a randomized phase III trial of denosumab versus zoledronic acid. Clinical Cancer Research, 18 (17). pp. 4841-4849. ISSN 1078-0432

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Abstract

Purpose: Denosumab was shown to be superior to zoledronic acid in preventing skeletal related events (SRE) in patients with breast cancer and bone metastases in a randomized, double-blind phase III study. We evaluated further results from this study related to skeletal complications and health-related quality of life (HRQoL).Experimental Design: Patients were randomized 1:1 to receive subcutaneous denosumab 120 mg (n = 1,026) and intravenous placebo, or intravenous zoledronic acid 4 mg (n = 1,020) and subcutaneous placebo every 4 weeks. Analyses reported here include the proportion of patients with one or multiple on-study SREs, time to first radiation to bone, time to first SRE or hypercalcemia of malignancy, and change in HRQoL (functional assessment of cancer therapy–general).Results: Fewer patients receiving denosumab than zoledronic acid had an on-study SRE (31% vs. 36%, P = 0.006). The incidence of first radiation to bone was 12% (n = 123) with denosumab versus 16% (n = 162) with zoledronic acid. Denosumab prolonged the time to first radiation to bone by 26% versus zoledronic acid (HR, 0.74; 95% confidence interval [CI], 0.59–0.94, P = 0.012) and prolonged the time to first SRE or hypercalcemia of malignancy by 18% (HR, 0.82; 95% CI, 0.70–0.95; P = 0.007). Ten percent more patients had a clinically meaningful improvement in HRQoL with denosumab relative to zoledronic acid, regardless of baseline pain levels.Conclusions: Denosumab was superior to zoledronic acid in reducing bone-related complications of metastatic breast cancer and maintained HRQoL, providing an efficacious, well-tolerated treatment option for patients with bone metastases from breast cancer. Clin Cancer Res; 18(17); 4841–9. ©2012 AACR.

Item Type: Article
Keywords: metastatic bone disease, bone pain, skeletal-related events, denosumab, zoledronic acid, quality of life
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
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens > RC0280 By region, system, or organ of the body, or type of tumor, A-Z > RC0280.B8 Breast. Mammary glands
Depositing User: Kathryn Monson
Date Deposited: 26 Oct 2012 09:32
Last Modified: 26 Oct 2012 09:32
URI: http://sro.sussex.ac.uk/id/eprint/40910
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