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"These results represent a tremendous advance for women hoping to prevent the return of their cancer," said David Epstein, President and CEO of Novartis Oncology. "We continue to explore the anticancer benefit of Zometa in a large clinical program with nearly 20,000 patients in 10 trials worldwide. We anticipate additional results over the next two to three years."
The ABCSG-12 study, in which women were treated for three years and observed for an additional two years, demonstrated that the addition of Zometa to hormone therapy (tamoxifen or anastrozole) significantly prolonged both disease-free survival and recurrence-free survival. With Zometa, the risk of disease-free survival events (which include death from any cause) fell by 36% (P=0.01), compared to hormone therapy alone. Furthermore, the risk of recurrence-free survival events fell by 35% (P=0.015) with Zometa, compared to hormone therapy alone. A positive but non-significant trend toward an overall survival benefit was also seen in patients who received Zometa(1).
Zometa is the world's leading treatment for the prevention or delay of skeletal-related events (SREs) in patients with advanced malignancies involving bone across a broad range of tumors. Laboratory research had suggested that Zometa may also help protect patients from the spread of cancer to other parts of the body (distant metastatic sites) and help keep patients recurrence-free.
Zometa slows the bone-destroying effect that occurs with bone metastases by fighting abnormal activation of osteoclasts, cells that normally break down old bone, and osteoblasts, cells that normally build new bone. Growth factors produced by cancer cells overstimulate osteoclasts and osteoblasts, causing excessive erosion of bone and/or the abnormal buildup of new but unstable bone.
Laboratory research has suggested that Zometa may also have anticancer
effects, including helping to protect against the return and spread of
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