Women with metastatic breast cancer treated with Xgeva® (denosumab) experienced significantly fewer bone-related complications than those treated with Zometa® (zoledronic acid), according to the results of a study published in Clinical Cancer Research. What’s more, they maintained their health-related quality of life (HRQoL).

Metastatic cancer refers to cancer that has spread to distant sites in the body. Several types of cancer—including breast cancer—have a tendency to spread to the bone. Bone metastases can lead to serious problems such as fracture and spinal cord compression and may require treatment with surgery or radiation therapy.

Bisphosphonate drugs such as Zometa are commonly used to reduce the risk of complications from bone metastases. Researchers continue, however, to explore new approaches to treatment.

Xgeva is a drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Xgeva is approved for the prevention of bone complications such as fracture in patients with bone metastases from solid (not blood-related) cancers.

Researchers compared Xgeva and Zometa to compare skeletal complications and health-related quality of life (HRQoL). The study included over 2,000 women who were randomly assigned to receive either subcutaneous Xgeva and intravenous placebo or subcutaneous placebo and intravenous Zometa every four weeks. The primary endpoint of the study was time to first on-study skeletal-related event SRE (pathologic fracture, radiation or surgery to bone, spinal cord compression). The researchers also evaluated time to first and subsequent SRE, time to first radiation to bone and time to first SRE or hypercalcemia of malignancy.

The results indicated that women receiving Xgeva had fewer SREs compared with those receiving Zometa. During follow-up, 31 percent of patients in the Xgeva group experienced SREs compared to 36 percent in the Zometa group. Xgeva prolonged the time to first radiation to bone by 26 percent compared to Zometa and prolonged the time to first SRE or hypercalcemia of malignancy by 18 percent. Plus, Xgeva improved HRQoL.

The researchers concluded that Xgeva was superior to Zometa in reducing bone-related complications of metastatic breast cancer. They suggest that it is an effective and well-tolerated treatment option for patients with bone metastases from breast cancer and one that may improve HRQoL.


Martin M, Bell R, Bourgeois H, et al. Bone-related complications and quality of life in advanced breast cancer: Results from a randomized phase III rrial of denosumab versus zoledronic acid. Clinical Cancer Research. Published early online August 14, 2012: doi: 10.1158/1078-0432.CCR-11-3310

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