Denosumab Provides Bone Benefits in Advanced Cancer

Posted on September 21st, 2009 by

Among patients with bone metastases from cancers other than breast or prostate cancer, denosumab is at least as effective as Zometa® (zoledronic acid) at reducing the risk of bone complications. These results were presented at a major European cancer conference.

Metastatic cancer refers to cancer that has spread to distant sites in the body. Several types of 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.

Denosumab is an investigational drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Denosumab has shown promising results in the management of patients with bone metastases as well as the management of bone loss due to cancer treatment. Among women with bone metastases from breast cancer, denosumab appears to be more effective than Zometa at reducing the risk of bone complications.[1]

To directly compare denosumab to Zometa among patients with bone metastases from cancers other than breast cancer or prostate cancer, researchers conducted a Phase III clinical trial among more than 1,700 patients.[2] Study participants were assigned to receive either denosumab or Zometa.

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 indicated that denosumab and Zometa were similarly effective against bone complications. Median time to first skeletal-related event was 20.6 months among patients treated with denosumab and 16.3 months among patients treated with Zometa. Overall survival and time to cancer progression were also similar in the two study groups.

Osteonecrosis of the jaw (ONJ)—an uncommon but serious condition involving death of bone in the jaw—occurred with similar frequency in the two study groups. Out of the more than 1,700 study participants, ONJ developed in ten patients treated with denosumab and 11 patients treated with Zometa.

The results of this study suggest that denosumab is at least as effective as Zometa in the management of patients with bone metastases from cancers other than breast or prostate.

References:

[1] Stopeck A, Body JJ, Fujiwara Y et al. Denosumab versus zoledronic acid for the treatment of breast cancer patients with bone metastases: results of a randomized phase 3 study. Presented at the Joint ECCO 15-34th ESMO Multidisciplinary Congress. Berlin, Germany, September 20-24, 2009. Abstract 14LBA.

[2] Henry D, von Moos R, Vadhan-Raj S et al. A double-blind, randomized study of denosumab versus zoledronic acid for the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. Presented at the Joint ECCO 15-34th ESMO Multidisciplinary Congress. Berlin, Germany, September 20-24, 2009. Abstract 20LBA.

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