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ECCO11: Zometa (Zoledronic Acid for Injection) Reduces Bone Complications in Multiple Myeloma/Breast Cancer EAST HANOVER, NJ -- October 22, 2001 -- Clinical data published in the September 2001 issue of The Cancer Journal demonstrate that the Novartis drug Zometa® (zoledronic acid for injection) reduces the incidence of cancer-related bone complications called skeletal related events (SREs) in patients with multiple myeloma or advanced breast cancer. The data also show that treatment with Zometa delays the time to onset of the first SRE. Additionally, the authors conclude that the fast and convenient 15-minute infusion time of Zometa offers benefits to clinicians and patients. The breast cancer data from this study was presented at the European Cancer Conference (ECCO) in Lisbon, Portugal on October 21st. Skeletal related events are a serious, painful and sometimes life-threatening complication of bone metastases. They were defined in the study as pathologic fractures, spinal cord compression, surgery to bone, radiation therapy to bone and hypercalcemia of malignancy. Current therapeutic options for complications of bone metastases include: chemotherapy, hormonal therapy, radiotherapy, analgesics for pain management, surgery and the use of intravenous bisphosphonates. "The shorter infusion time of Zometa offers patients and physicians the important benefit of greater convenience than previous generation therapies," said Lee Rosen, MD, Assistant Professor in the Department of Medicine, Hematology and Oncology at the University of California - Los Angeles (UCLA) Medical Center, a primary investigator and study author. "The data, combined with the convenient infusion time, suggest Zometa should be the new standard of treatment for bone complications of breast cancer and multiple myeloma." This international Phase III, randomized, double-blind, double-dummy trial was designed to compare the efficacy of the 15-minute infusion of Zometa (4 or 8/4 mg) to that of Aredia® (pamidronate disodium, 90 mg) infused over two hours. The study included 1,648 patients with either stage III multiple myeloma (a cancer of the plasma cells), or advanced breast cancer. The final efficacy analyses focused on comparisons of 4 mg Zometa versus pamidronate, as the higher Zometa dose did not provide added efficacy, but was associated with reduced tolerability. The primary efficacy endpoint was the proportion of patients experiencing at least one SRE by the 13th month. The proportion of study participants who experienced at least one SRE at month 13 was approximately 44 percent in the Zometa 4 mg group and 46 percent in the pamidronate disodium group. In addition, the median time to first SRE, a secondary endpoint, was approximately one year in both treatment groups. The multiple myeloma portion of the data was presented earlier this month in an abstract at the Recent Advances in The Management of Multiple Myeloma meeting, at the German Cancer Research Centre, in Heidelberg, Germany. SOURCE: Novartis E-mail this page to a friend or colleague! To print, use this version