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| |  Zoledronic Acid Safe in Men With Advanced Prostate or Renal Cancer: Presented at EAU By Jill Stein MILAN, Italy -- March 28, 2008 -- New data demonstrate a favourable safety profile for zoledronic acid in men with bone metastases from advanced hormone-refractory prostate cancer or renal cell carcinoma, according to research presented here at the 23rd Annual European Society of Urology (EAU) Congress. Per-Anders Abrahamsson, MD, Chairman, Urology Division, Malmö University Hospital, Malmö, Sweden, and colleagues assessed the safety of zoledronic acid in adult patients with malignant bone disease. "Approximately 70% of patients with advanced hormone-refractory prostate cancer and 25% with advanced renal cell carcinoma will develop bone metastases during the course of their disease," Dr. Abrahamsson pointed out in a presentation on March 27. Bone metastases can result in debilitating and potentially life-limiting skeletal-related events (SREs), including pathological fracture, spinal cord compression, the need for surgery or palliative radiotherapy to bone, and hypercalcaemia of malignancy. Bone pain, he added, is the most common cause of cancer-related pain. For their phase 3 trial, Dr. Abrahamsson and colleagues enrolled 274 patients with advanced prostate cancer (mean age 73 years) and 5 patients with advanced renal cancer (mean age 60 years) being treated in more than 60 hospitals in 3 different countries. Results showed that the 4-mg dose of zoledronic acid in patients with bone metastases from hormone-refractory prostate cancer significantly decreased the percentage of patients who experienced an SRE compared with placebo. Active treatment also prolonged significantly the median time to first SRE, and provided significant and durable palliation of bone pain. Data from the present trial showed that the adverse event profile of zoledronic acid was consistent with that previously reported in patients with prostate cancer or renal cell carcinoma. There were no reports of osteonecrosis of the jaw in patients with either of the 2 cancers or in the entire study cohort. In patients with prostate cancer and normal baseline serum creatinine values, 2.6% experienced serum creatinine increases greater than 44 umol/L by the 6-month assessment. Zoledronic acid, given at a dose of 4 mg via 15-minute infusion every 3 to 4 weeks, effectively controlled pain levels in the study population. In addition, pain reductions occurred without significant increases in analgesic use. "These data support the use of zoledronic acid in patients with bone metastases from hormone-refractory prostate cancer or renal cell carcinoma," Dr. Abrahamsson said. [Presentation title: Nordic Observational Study Evaluating Safety and Analgesic Consumption in Patients With Advanced Cancer Under Zoledronic Acid (Zometa) Treatment: NOSAZ-Interim Analysis. Abstract 645]
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