Friday, February 25, 2011 (Last Updated: 02/28/2011)
FRIDAY, Feb. 25 (HealthDay News) -- Denosumab prevents skeletal-related events for longer than zoledronic acid in patients with castration-resistant prostate cancer with bone metastases, according to research published online Feb. 25 in The Lancet.
Karim Fizazi, M.D., Ph.D., from the University of Paris Sud in Villejuif, France, and colleagues compared the efficacy of denosumab and zoledronic acid in preventing skeletal-related events in 1,901 patients with castration-resistant prostate cancer with bone metastasis. In this phase-3 study, 950 men received denosumab and 951 men received zoledronic acid. The patients were followed up for an average 12.2 and 11.2 months, respectively. The first on-study skeletal-related event (radiation therapy, pathological fracture, surgery to bone, or spinal cord compression) was the primary study end point.
The investigators found that the average time to first on-study skeletal-related event in the denosumab group was 20.7 months compared to 17.1 months in the zoledronic acid group (hazard ratio, 0.82). In both the groups, 97 percent of the patients reported adverse events, with 63 percent of the denosumab group reporting serious adverse events compared to 60 percent of the zoledronic acid group. The denosumab group experienced more cases of hypocalcaemia (13 percent) compared to the zoledronic acid group (6 percent). Osteonecrosis of the jaw was infrequent in both groups.
"Denosumab represents a novel potential treatment option for the prevention of skeletal complications in patients with metastatic castration-resistant prostate cancer," the authors write.
Several study authors disclosed financial relationships with pharmaceutical companies, including Amgen, which also funded the study.
Hematology & Oncology
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