Immediate zoledronate in postmenopausal women receiving letrozole preserved BMD and is associated with improved DFS compared with letrozole alone. Clinical Trials Registration No NCT00171340.

Integration of capecitabine into a regimen that contains docetaxel, epirubicin, and cyclophosphamide did not improve RFS significantly compared with a similar regimen without capecitabine.

Aromatase inhibitors (AIs), an increasingly common adjuvant treatment option for postmenopausal women with hormone receptor-positive early breast cancer, are associated with bone loss that can impair patient quality of life. This study (E-ZO-FAST; Clinical Trials Identifier: NCT00171314) demonstrates that initiation of zoledronic acid therapy concurrent with adjuvant AI treatment improved skeletal health compared with zoledronic acid therapy initiated after deterioration of bone health. Background: Letrozole is a proven and effective adjuvant therapy in postmenopausal women with hormone receptor-positive (HR ϩ ) early breast cancer (EBC). As with other aromatase inhibitors (AIs), long-term letrozole administration is associated with decreased bone mineral density (BMD) and increased fracture risk. This study compared potential bone-protecting effects of immediate vs. delayed administration of zoledronic acid (ZOL) in patients with EBC receiving adjuvant letrozole. Patients and Methods: Patients with HR ϩ EBC in whom adjuvant letrozole treatment was initiated (2.5 mg/day for 5 years) were randomized to immediate ZOL treatment (immediate ZOL) or delayed ZOL treatment (delayed ZOL) (both at 4 mg every 6 months). Patients in the delayed ZOL group received ZOL only for a BMD T-score that decreased to Ͻ -2.0 (lumbar spine [LS] or total hip [TH]) or for fracture. The primary endpoint was percentage change in the LS BMD at month 12. Patients were stratified by established or recent postmenopausal status, baseline T-scores, and adjuvant chemotherapy history. Results: At 12 months, the LS BMD increased in the immediate ZOL group (ϩ2.72%) but decreased in the delayed ZOL group (-2.71%); the absolute difference between groups was significant (5.43%; P Ͻ .0001). Across all subgroups, patients receiving immediate ZOL had significantly increased LS and TH BMD vs. those who received delayed ZOL (P Ͻ .0001). Differences in fracture incidence or disease recurrence could not be ascertained because of early data cutoff and low incidence of events. Adverse events were generally mild, transient, and consistent with the known safety profiles of both agents. Conclusion: Immediate ZOL administration effectively prevented BMD loss and increased BMD in postmenopausal women with HR ϩ EBC receiving adjuvant letrozole, regardless of BMD status at baseline.

No abstract