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ABCSG-12: Previous improvements in DFS with zoledronic acid in early breast cancer upheld

Gnant M. Lancet Oncol. 2011;12:631-641.

Issue: August 10, 2011

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Previously observed improvements in DFS associated with zoledronic acid were still in effect at 62 months, according to updated results of the Austrian Breast and Colorectal Cancer Study Group trial-12, or ABCSG-12.

Researchers conducting the ABCSG-12 initially released 48-month findings showing that zoledronic acid could extend DFS for patients assigned to anastrozole or tamoxifen for early-stage breast cancer at the 2008 ASCO Annual Meeting.

ABSCG-12 is a randomized, controlled, open-label, two-by-two factorial, multicenter trial. Premenopausal women (n=1,803) with ER-positive stage I/stage II breast cancer were assigned 1 mg daily anastrozole or 20 mg daily tamoxifen with or without zoledronic acid for 3 years.

At a median follow-up of 62 months, researchers recorded 53 DFS events in patients assigned to tamoxifen alone (n=450), 57 events in the anastrozole-alone group (n=453), 36 events in the tamoxifen plus zoledronic acid group (n=450) and 40 events in the anastrozole plus zoledronic acid group (n=450). Zoledronic acid was associated with reduced risk for overall DFS (HR=0.68; 95% CI, 0.51-0.91).

There was no difference in DFS between the tamoxifen-alone and anastrozole-alone arms (HR=1.08; 95% CI, 0.81-1.44). On separate assessment, risk reduction was not significant in the tamoxifen-alone (HR=0.67; 95% CI, 0.44-1.03) and anastrozole-alone arms (HR=0.68; 95% CI, 0.45-1.02).

There were 30 deaths in patients assigned to zoledronic acid vs. 43 deaths without (HR=0.67; 95% CI, 0.41-1.07). OS was poorer in the anastrozole groups compared with tamoxifen (HR=1.75; 95% CI, 1.08-2.83).

Results from the Adjuvant Zoledronic Acid to Reduce Recurrence (AZURE) trial presented in 2010 at the 33rd Annual San Antonio Breast Cancer Symposium contradicted those 48-month findings. Researchers in AZURE concluded that zoledronic acid added to standard chemotherapy had no significant effect.

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