What is the efficacy of denosumab for the management of bone health in breast cancer?

Updated: Nov 06, 2019
  • Author: Winston W Tan, MD, FACP; Chief Editor: Marie Catherine Lee, MD, FACS  more...
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In September 2011, denosumab (Prolia) gained US Food and Drug Administration (FDA) approval to increase bone mass in women at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer. Denosumab is a fully human monoclonal antibody that targets the receptor activator of the nuclear factor-kappa-B ligand (RANKL) protein, which acts as the primary signal to promote bone removal. By inhibiting the development and activity of osteoclasts, denosumab decreases bone resorption and increases bone density. A dose of 60 mg SC is administered once every 6 months.

FDA approval was based on a 2-year, double-blind, placebo-controlled study of 252 postmenopausal women with breast cancer receiving aromatase inhibitor therapy. Bone mineral density (BMD) was higher at 1 year in the lumbar spine in those treated with denosumab (+4.8%) compared with placebo (-0.7%). The treatment difference was 5.5% (95% confidence interval [CI], 4.8-6.3%; P<0.0001). After 2 years, differences in BMD favoring denosumab were 7.6% in the lumbar spine, 4.7% in the (total) hip, and 3.6% in the femoral neck. [24]

Current American Society of Clinical Oncology (ASCO) guidelines recommend denosumab (Xgeva) at 120 mg SC every 4 weeks as an option for patients with breast cancer and evidence of bone metastases. [25]

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