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Video: Major Independent Trial Demonstrates Significant Anticancer Benefit of Zometa(R) in Women With Early-Stage Breast Cancer

Sunday, June 1, 2008 General News J E 4
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EAST HANOVER, N.J., May 31 New data presented today showedthat Zometa(R) (zoledronic acid) offered a significant anticancer benefit forpremenopausal women with hormone-sensitive, early-stage breast cancer. Thestudy found that Zometa when added to hormone therapy, following surgery,significantly reduced the risk of cancer returning or death by 36% beyondclinical benefits achieved with hormone therapy alone.

Investigators from the Austrian Breast & Colorectal Cancer Study Group(ABCSG) announced the findings during a plenary presentation today at the 44thAnnual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago,Illinois, USA.

"This study is the first large-scale trial to demonstrate the significantantitumor benefit of zoledronic acid," said lead investigator Michael Gnant,M.D., of the Medical University of Vienna. "These new findings may allowoncologists to further improve the standard of care for premenopausal womenwith hormone-sensitive breast cancer."

According to the World Health Organization (WHO), each year approximately500,000 women die worldwide because their breast cancer has returned orspread(2). Moreover, the incidence of breast cancer has been rising in recentdecades(3).

"These results represent a tremendous advance for women hoping to preventthe return of their cancer," said David Epstein, President and CEO of NovartisOncology. "We continue to explore the anticancer benefit of Zometa in a largeclinical program with nearly 20,000 patients in 10 trials worldwide. Weanticipate additional results over the next two to three years."

The ABCSG-12 study, in which women were treated for three years andobserved for an additional two years, demonstrated that the addition of Zometato hormone therapy (tamoxifen or anastrozole) significantly prolonged bothdisease-free survival and recurrence-free survival. With Zometa, the risk ofdisease-free survival events (which include death from any cause) fell by 36%(P=0.01), compared to hormone therapy alone. Furthermore, the risk ofrecurrence-free survival events fell by 35% (P=0.015) with Zometa, compared tohormone therapy alone. A positive but non-significant trend toward an overallsurvival benefit was also seen in patients who received Zometa(1).

Zometa is the world's leading treatment for the prevention or delay ofskeletal-related events (SREs) in patients with advanced malignanciesinvolving bone across a broad range of tumors. Laboratory research hadsuggested that Zometa may also help protect patients from the spread of cancerto other parts of the body (distant metastatic sites) and help keep patientsrecurrence-free.

Zometa slows the bone-destroying effect that occurs with bone metastasesby fighting abnormal activation of osteoclasts, cells that normally break downold bone, and osteoblasts, cells that normally build new bone. Growth factorsproduced by cancer cells overstimulate osteoclasts and osteoblasts, causingexcessive erosion of bone and/or the abnormal buildup of new but unstablebone.

Laboratory research has suggested that Zometa may also have anticancereffects, including helping to protect against the return and spread of cancerbefore it reaches an advanced stage. A tumor passes through six stages on itspath to metastasizing (spreading)(4). In the laboratory, Zometa has been shownto make passage through these stages more difficult by inhibiting angiogenesis(formation of blood vessels that grow and feed cancer cells), stimulatingcancer-fighting T-cells, inducing tumor cell apoptosis (programmed cell death)and increasing the activity of anticancer agents that target tumor cellmetastases(5).

A growing number of clinical studies are examining the potentialanticancer impact of Zometa. One of the largest of these studies, AZURE(Adjuvant Zoledronic acid to redUce REcurrence), has completed enrollment. Thestudy will evaluate the
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