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news.Novartis Pharmaceuticals has presented new data which showed that Zometa offered a significant anticancer benefit for premenopausal women with hormone-sensitive, early-stage breast cancer.
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The Austrian Breast & Colorectal Cancer Study Group Trial 12 (ABCSG-12) is an open-label, multicenter, Phase III study that enrolled 1,803 premenopausal women with oestrogen-receptor-positive Stage I or II breast cancer, with fewer than 10 axillary lymph nodes involved.
Patients were recruited for the study after curative surgery and initiation of goserelin treatment for ovarian suppression, and randomly assigned into one of four study groups: anastrozole 1mg/d plus Zometa 4mg q6m; anastrozole 1mg/d alone; tamoxifen 20mg/d plus Zometa 4mg q6m; tamoxifen 20mg/d alone. The treatment period was three years and the median follow-up period was an additional two years.
The primary endpoint of the study was disease-free survival for all four study groups. Recurrence-free survival, overall survival and safety were secondary endpoints. 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%, compared to hormone therapy alone. Furthermore, the risk of recurrence-free survival events fell by 35% with Zometa, compared to hormone therapy alone. A positive but nonsignificant trend toward an overall survival benefit was also seen in patients who received Zometa.
Sixteen deaths had occurred among patients who received Zometa with hormone therapy versus 26 deaths in patients who received hormone therapy alone, which resulted in a nonsignificant reduction in the risk of death in patients who received Zometa compared with those who received hormone therapy alone (P=0.103). A similar trend was noted toward a reduction in bone metastases among patients who received Zometa compared with those who received hormone therapy alone (16 versus 23).