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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
Full text not available from this repository.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://srodev.sussex.ac.uk/id/eprint/40910 |