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Zometa reduces risk of fracture risk in metastatic breast cancerJCO early release has published a new study Zometa (Zoledronic Acid) from Japan. The study shows Zometa significantly reduces skeletal related events in women who have bone metastases from breast cancer. This randomized placebo controlled study from Japan is due to be published in the Journal of Clinical Oncology (JCO), but has been published as an early release at its website, due to its clinical implication on the treatment of breast cancer. Various leading oncology institutions in Japan including Hyogo Medical Center for Adults, Akashi; National Hospital Organization Shikoku Cancer Center, Matsuyama; National Cancer Center Hospital E, Kashiwa; St Luke's International Hospital took part in this study. The study was sponsored by Novartis Pharmaceuticals Corporation, E Hanover, NJ. Kohno and colleagues were the chief investigator for the study. A total of 228 patients participated in the study. Patients who were assigned to Zometa received the drug at a dose of 4mg as a 15 minute infusion every 4 weeks for 1 year. The primary efficacy end point was the skeletal-related event. Skeletal related event (SRE) was defined as pathologic fracture, spinal cord compression, and radiation or surgery to bone. A total of 228 patients participated in the study. The number of patients were equally divided between the two arms of the study with 114 patients enrolled for Zometa group and another 114 enrolled in the placebo group. The results showed that SRE was reduced by 39% (P = .027) with the use of Zometa compared to placebo. Percentage of patients with at least one SRE was reduced by 20% (29.8% Vs 49.6% p=.003). Zometa significantly delayed time to first SRE (p=.007). Zometa was well tolerated and the safety profile was similar to placebo. No significant increase in serum creatinine was noted in patients treated with zometa. Ref: JCO early release at jco.org website. |