STOCKHOLM, SWEDEN (UroToday.com) - Patients who develop bone metastases from prostate cancer are at risk for skeletal complications that may seriously impact function and quality of life. Denosumab and zoledronic acid (ZA) are approved for the prevention of skeletal complications from bone metastases in solid tumors. Denosumab has demonstrated superiority over ZA for the prevention of skeletal-related events (SREs). An alternative study endpoint of symptomatic skeletal events (SSE), defined as symptomatic fracture, surgery or radiation to bone, or spinal cord compression) was introduced to describe these bone complications. Dr. K. Fizazi and colleagues compared the benefit of denosumab versus ZA in preventing SSEs in patients with advanced GU tumors and bone metastases.
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Patients with advanced GU tumors, at least one bone metastasis, and no prior IV bisphosphonate use were randomized to receive either denosumab or ZA every 4 weeks in a double-blind fashion. The risk of first SSE was reduced by 22% in patients treated with denosumab versus ZA. There were also fewer overall SSEs and a longer time to first-and-subsequent on-study SSEs in patients treated with denosumab versus ZA. Fewer SSEs of all types were observed in the denosumab treatment group. Denosumab reduced the risk of skeletal complications in patients with GU cancers and bone metastases regardless of whether the endpoint was defined as SRE or SSE. Because all skeletal complications from bone metastases have the potential to negatively affect patients’ function and quality of life, preventive treatment should be considered even when symptoms are not present.
Presented by K. Fizazi at the 29th Annual European Association of Urology (EAU) Congress - April 11 - 15, 2014 - Stockholmsmässan - Stockholm, Sweden.
Institut Gustave Roussy, University of Paris-Sud, Paris, France
Written by Jeffrey J. Tomaszewski, MD, medical writer for UroToday.com