Video: Major Independent Trial Demonstrates Significant Anticancer Benefit of Zometa(R) in Women With Early-Stage Bre... (two years(1). The primary endpoint of...)

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Video: Major Independent Trial Demonstrates Significant Anticancer Benefit of Zometa(R) in Women With Early-Stage Breast Cancer

Date:5/31/2008

two years(1).

The primary endpoint of the study was disease-free survival for all four study groups. Recurrence-free survival, overall survival, and safety 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.) Exploratory endpoints included bone-metastases-free survival(1).

At the median follow-up of five years, disease-free survival events were reduced by 36% (P=0.01) with Zometa and the risk of recurrence-free survival events fell by 35% (P=0.015) versus hormone therapy alone. Sixteen deaths had occurred among patients who received Zometa with hormone therapy versus 26 deaths in patients who received hormone therapy alone, which resulted in a nonsignificant reduction in the risk of death in patients who received Zometa compared with those who received hormone therapy alone (P=0.103). A similar trend was noted toward a reduction in bone metastases among patients who received Zometa compared with those who received hormone therapy alone (16 versus 23). Longer follow-up and a larger number of events will be necessary to determine if any significant differences exist between the groups for overall survival and bone-metastases-free survival. Overall, treatment was generally well-tolerated and side effects were consistent with known drug safety profile(1).

About Zometa

Zometa is indicated for patients with multiple myeloma and documented bone metastases from solid tumors in conjunction with standard antineoplastic therapy; prostate cancer should have progressed after treatment with at least one hormonal therapy.

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Video: Major Independent Trial Demonstrates Significant Anticancer Benefit of Zometa(R) in Women With Early-Stage Bre...(two years(1). The primary endpoint of...),Health