Zometa reduces risk of skeletal complications
A new study from Japan has shown that use of Zometa (Zoledronic Acid) significantly reduces bone complications in Japanese women who have bone metastases from breast cancer. This is a randomized placebo controlled study that is due to be published in the Journal of Clinical Oncology (JCO), but has been published as an early release due to its clinical implication on the treatment of breast cancer.
This study was done by Norio Kohno and colleagues, and the study was conducted in various Japanese cancer centers 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. The study was sponsored by Novartis Pharmaceuticals Corporation, E Hanover, NJ. A total of 228 patients participated in the study. Patients who were assigned to Zometa receivied 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
The following were the highlights of the study:
Ref: JCO early release
- Treatment: Zometa 4 mg Vs Placebo
- Number of patients: 114 in Zometa group Vs 114 in the placebo group
- Skelitel related event (SRE) was defined as pathologic fracture, spinal cord compression, and radiation or surgery to bone.
- 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.