Fabulous news about Zometa...

This is amazing! So glad that I've been able to have access to Zometa for THREE years and counting:

Zometa data presented at ASCO include a five-year follow-up analysis from the Phase III Austrian Breast & Colorectal Cancer Study Group-12 (ABCSG-12) trial which showed that the addition of Zometa to hormonal therapy following surgery improved disease-free survival by 32% (HR=0.68 [95%CI 0.51,0.91], P=0.009) in premenopausal women with hormone receptor-positive (HR+) early breast cancer[4]. These data confirm earlier results from ABCSG-12 presented at ASCO 2008[5]. Data from the ABCSG-12 study are the basis of the Company's US and European Union regulatory filings for Zometa in the treatment of adjuvant breast cancer.

"These five-year data are exciting for oncologists and patients alike because they confirm that adding zoledronic acid to a post-surgical hormonal treatment regimen can reduce the risk of cancer returning," said Michael Gnant, MD, lead investigator and Professor of surgery at the Medical University of Vienna. "If approved for this indication, zoledronic acid may offer early breast cancer patients the opportunity to further reduce the risk of breast cancer returning, when added to post-surgery hormone therapy."

ABCSG-12 is an open-label, multicenter, Phase III study that 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 surgery and initiation of goserelin treatment for ovarian suppression, and randomly assigned into one of four study groups: (1) anastrozole plus Zometa; (2) anastrozole alone; (3) tamoxifen plus Zometa; (4) tamoxifen alone. The treatment period was three years and the median follow-up period was 62 months.

The primary endpoint for all four study arms was disease-free survival. Recurrence-free survival, overall survival and bone-mineral density were secondary endpoints. Disease-free survival was defined as the length of time after randomization during which patients had no local recurrence, contralateral breast cancer, distant metastasis, secondary carcinoma and/or death from any cause. Recurrence-free survival was defined as the length of time after randomization during which patients had no local recurrence, contralateral breast cancer, distant metastasis and/or secondary carcinoma. Bone-mineral density was a primary endpoint of the sub-study. Exploratory endpoints included bone metastasis-free survival.

At the median follow-up of 62 months, disease-free survival events were reduced by 32% (P=0.009) with Zometa added to hormone therapy versus hormone therapy alone. This updated analysis continues to show no difference between tamoxifen and anastrozole use, but that adding Zometa significantly improves disease-free survival (HR=0.68 for both arms). Overall, side effects were consistent with known drug profile. There were no cases of renal failure or confirmed cases of ONJ in the study.


Just another weapon in my arsenal to kick Cancer's ass.
xoxo
Anna