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Zoledronic Acid Improves Early Breast Cancer TreatmentAdapted from the NCI Cancer Bulletin, vol. 5/no. 12, June 10, 2008 (see the current issue).
The addition of zoledronic
acid (Zometa®) to adjuvant endocrine therapy in premenopausal women with early stage breast cancer significantly improves clinical outcomes beyond those achieved with endocrine therapy alone, researchers reported at the 2008 annual meeting of the American Society of Clinical Oncology. The results
are from a phase III randomized trial of 1,800 women conducted by the
Austrian Breast and Colorectal Cancer Study Group.
Zoledronic acid, part of a class of drugs known as
bisphosphonates, is already used to treat
bone metastases, and this trial was conducted based on data
from preclinical and early phase trials indicating that the drug can
also shrink tumors and block metastatic activity. The results bear this
out, said principal investigator Dr. Michael Gnant from the Medical
University of Vienna.
Overall, the trial showed no difference in disease-free survival between women treated with tamoxifen or anastrozole. But the addition of zoledronic acid to either therapy decreased the risk of a disease-free survival event by 36 percent compared with hormone therapy alone, Dr. Gnant said. At a median follow-up of 60 months, overall disease-free survival was 92.4 percent and overall survival was 97.7 percent.
Women in the trial - all of whom were premenopausal with stage
I or II breast cancer that was responsive to endocrine therapy - were
treated with surgery and, if needed, radiation therapy. They also
received the drug goserelin to temporarily suppress the function of the
ovaries. Each was randomly assigned to one of four adjuvant therapy
arms: tamoxifen
alone, the aromatase inhibitor anastrozole alone, or either drug plus zoledronic acid. Treatment lasted three years.
The drug was also well tolerated, with no indication of
increased risk of liver problems or damage to the jaw bone - two side
effects which have been associated with higher doses of bisphosphonate
drugs.
[Note: Results from a smaller bone-density substudy of this trial were published in 2007.]
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