Researchers affiliated with the Austrian Breast & Colorectal Cancer Study Group Trial 12 (ABCSG-21) have reported that the addition of adjuvant Zometa® (zoledronic acid) to endocrine therapy for the treatment of hormone-positive, early breast cancer significantly improved disease-free survival in premenopausal women. These results were published in the February 12, 2009 issue of the New England Journal of Medicine and were also presented as a late-breaking abstract at the 2008 annual American Society for Clinical Oncology (ASCO) meeting in Chicago, Illinois May 30 to June 2.[1]
The bisphosphonate Zometa is approved for the treatment of hypercalcemia of malignancy, as well as the treatment of documented bone metastases from solid tumors or multiple myeloma, in conjunction with antineoplastic therapy. Research has indicated that Zometa may have direct antineoplastic effects.
The ABCSG-21 trial was a multicenter, open-label Phase III study that included 1,803 premenopausal women with Stages I-II, hormone-positive breast cancer. Patients had fewer than 10 involved axillary lymph nodes. Following curative surgery and initiation of the gonadotropin-releasing hormone analog goserelin for ovarian suppression, patients were enrolled and randomized into one of four treatment groups: 1) Arimidex® (anastrozole) plus Zometa; 2) Arimidex alone; 3) Nolvadex® (tamoxifen) plus Zometa; 4) Nolvadex alone. Treatment was continued for three years; the median follow-up of the trial was 47.8 months.
- There were no differences in disease-free survival between women receiving Arimidex or Nolvadex; disease-free survivals were 92.0% and 92.8%, respectively.
- Disease-free survival was 94% for women receiving Zometa compared with 90.8% for patients receiving endocrine therapy alone. Compared with hormone therapy alone, the addition of Zometa improved disease-free survival by 36% (p=0.01).
- There was a reduction in the risk of death (hazard ratio of 0.60), but this was not statistically significant (P=0.11).
Comments: These updated data confirm that the addition of Zometa decreases relapses in premenopausal women with hormone-positive breast cancer. Further follow-up will be of interest to determine if there is a survival benefit.
Reference:
[1] Gnant M, Mlineritsch B, Schippinger W, et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. New England Journal of Medicine. 2009;360:679-691.
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