Posted on February 25th, 2011 by
Among men with bone metastases from prostate cancer, Xgeva™ (denosumab) was more effective than Zometa® (zoledronic acid) at delaying or preventing bone complications such as fracture. Results from this Phase III clinical trial were published in The Lancet.
Metastatic cancer refers to cancer that has spread to distant sites in the body. Several types of cancer—including prostate 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 have been commonly used to reduce the risk of complications from bone metastases. Xgeva is a newer type of drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Xgeva was approved by the U.S. Food and Drug Administration (FDA) in 2010 for the prevention of bone complications in patients with bone metastases from solid (not blood-related) cancers, including prostate cancer.
To directly compare Xgeva to Zometa among prostate cancer patients with bone metastases, researchers conducted a Phase III clinical trial. The study enrolled 1,901 patients with metastatic, hormone-refractory prostate cancer. Study participants were assigned to receive either Xgeva or Zometa. Xgeva is given as a subcutaneous (under-the-skin) injection; Zometa is given intravenously (IV).
The objective of the study was to determine whether the occurrence of bone complications (“skeletal related events”) differed between the two study groups. The bone complications that were evaluated were fracture, radiation to the bone, surgery to the bone, and spinal cord compression.
The results of this study suggest that Xgeva is more effective than Zometa at delaying or preventing skeletal complications in prostate cancer patients with bone metastases.
Reference: Fizazi K, Carducci M, Smith M et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomized, double-blind study. The Lancet. Early online publication February 25, 2011.
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