Every Six-Month versus Single-Dose Adjuvant Zoledronate in Early Breast Cancer

作者：M. Clemons, Carol Stober, Gregory R. Pond, Henry Conter, Demetrios Simos, Sukhbinder Dhesy-Thind, Mihaela Mates, Mateya Trinkaus, John Hilton, Marie-France Savard, Dean Fergusson, Lisa Vandermeer, Arif Ali Awan · 发表于：NEJM Evidence · 年份：2026 · DOI：10.1056/evidoa2500202 · 被引用次数：1 · 研究领域：Bone health and treatments、Proteoglycans and glycosaminoglycans research、Bone Metabolism and Diseases

BACKGROUND: Three-year data from a randomized trial comparing a single zoledronate infusion with infusions every 6 months were previously reported showing that a single infusion was associated with increased patient convenience, less toxicity, and lower rates of treatment discontinuation at 3 years. We now report the trial's final, prespecified 5-year follow-up data. METHODS: Patients who were postmenopausal (either naturally or treatment induced) with early breast cancer were randomly assigned to receive a single infusion of zoledronate (4 mg intravenously) or an infusion every 6 months for 3 years. Final 5-year preplanned secondary outcomes included recurrence-free survival, bone metastasis-free survival, overall survival, confirmed osteonecrosis of the jaw, and fragility fracture rates. RESULTS: A total of 211 patients were randomly assigned to receive either a single infusion (n=107) or an infusion every 6 months (n=104). After 5 years of follow-up, there were no clearly apparent differences between the groups for recurrence-free survival (88.7% vs. 84.1%; hazard ratio, 0.71; 95% confidence interval [CI], 0.34-1.51), bone metastasis-free survival (90.6% vs. 86.0%; hazard ratio, 0.68; 95% CI, 0.30-1.52), or overall survival (91.6% vs. 88.0%; hazard ratio, 0.79; 95% CI, 0.34-1.82) in the single-infusion group versus the group receiving infusions every 6 months, respectively. After 5 years of follow-up, there were no significant differences in the incidence of osteonecrosis ...