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Old 06-16-2005, 11:57 AM   #1
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Zoledronic acid reduces skeletal complications of metastatic breast cancer

Reuters Health
Posting Date: June 16, 2005

Last Updated: 2005-06-16 9:23:52 -0400 (Reuters Health)

NEW YORK (Reuters Health) - In women who have bone metastases from breast cancer, treatment with the highly potent bisphosphonate zoledronic acid leads to a significant reduction in skeletal complications, such as spinal cord compression, according to Japanese and US researchers.

"Absolute 20% reduction in the percentage of patients with a skeletal-related event is striking and appears greater than that achieved in randomized, placebo-controlled trials of pamidronate and ibandronate in similar patient populations," lead investigator Dr. Norio Kohno, of told Reuters Health.

Dr. Kohno, of Hyogo Medical Center for Adults, Akashi, and colleagues randomized 228 women with bone metastases to 4 mg of zoledronic acid via 15-minute infusions every 4 weeks or placebo. Skeletal-related events were defined as pathologic fracture, spinal cord compression, or need for bone surgery or radiation.

At 1 year, excluding hypercalcemia of malignancy and after adjusting for prior fracture, the rate of skeletal events was 39% lower in the active treatment group than in the placebo group (p = .027), according to the report in the May 20th issue of the Journal of Clinical Oncology.

The proportion of patients with one skeletal event was 29.8% in the zoledronic acid group and 49.6% in the placebo group (p = .003). The active treatment also significantly delayed time to the first skeletal event.

At almost all time points, zoledronic acid patients had a significant decrease in their mean pain score. Placebo patients generally experienced no change or increases in pain scores. The agent was also well tolerated with a safety profile similar to that of placebo.

These findings, the researchers conclude, have "confirmed the significant clinical benefits of zoledronic acid in patients with bone metastases from breast cancer."

J Clin Oncol 2005;23:3314-3321.
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