Evaluating the benefits of denosumab on bone health in women with early-stage breast cancer.

This study evaluated the benefits of denosumab (Xgeva) on the bone health of women with early-stage breast cancer (BC). The data showed that denosumab improved bone-related outcomes in women with high-risk early-stage BC

BC is one of the most common forms of cancer in women. Early-stage BC is used to describe BC that is early in its growth and has not spread beyond the breast. In metastatic BC, the cancer has spread to the lymph nodes and other distant organs. Bone metastasis is typically observed in 65-80% of all metastatic BC cases.

Denosumab is a targeted drug that blocks the action of osteoclasts (cells that degrade bone). Denosumab treatment has been shown to reduce the occurrence of skeletal-related events (SREs) such as bone metastases, fractures and delay the time to first SRE in patients with solid metastatic tumors. However, the benefits of denosumab on bone health have not been studied in patients with early-stage BC.

This study involved 4509 patients with early-stage BC. Patients were randomly assigned to receive either denosumab 120 mg (2256) or placebo (2253). Patients were followed for 4.5 years.

Overall, denosumab slightly reduced the time until the first bone metastasis by 18% compared to placebo. In patients younger than 50 years, denosumab reduced the time until the first bone metastasis by 30% compared to a placebo. In patients older than 50 years, there was no benefit of denosumab over placebo regarding the time until first bone metastasis. 

Denosumab reduced the time until a first fracture by 24% compared to placebo. Denosumab reduced the time until the occurrence of a first SRE by 48% compared to placebo.

This study concluded that denosumab improves bone-related outcomes for women with high-risk early-stage BC, particularly in younger patients.

This study was sponsored by Amgen Inc., the manufacturers of denosumab. Many patients initially included in the study withdrew consent and were not included in the final analysis. This may have influenced the results.