Novartis drug cuts breast cancer death by 36%

A study published in The New England Journal of Medicine shows that, in pre-menopausal women with early breast cancer, administering Novartis'  Zometa (zoledronic acid) along with post-surgery hormone therapy  provided a reduction in risk of recurrence or death that was 36% beyond  that achieved with hormone therapy alone.

The randomized, open-label, multicenter, Phase III ABCSG-12 trial  enrolled 1,803 premenopausal women with estrogen 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 plus Zometa;  anastrozole alone; tamoxifen plus Zometa; and tamoxifen alone.

At the median follow-up of 48 months, disease-free survival events were  reduced by 36% (p=0.01) and the risk of recurrence-free survival events  fell by 35% (p=0.02) with Zometa added to hormone therapy versus hormone  therapy alone. 16 deaths had occurred among patients who received Zometa  with hormone therapy versus 26 in patients who received hormone therapy  alone, which resulted in a non-significant reduction in the risk of  mortality in patients who received Zometa compared with those who  received hormone therapy alone (p=0.11). A similar trend was noted  toward a reduction in bone metastases among patients who received Zometa  compared with those who received hormone therapy alone (p=0.22).