Safety profile and risk factors associated with incadronate disodium treatment in breast cancer patients with bone metastases: A retrospective analysis.

e13113 Background: Bone metastases are frequent in advanced breast cancer, often leading to skeletal-related events (SREs). Bisphosphonates like incadronate disodium are effective in reducing bone resorption, but their safety profile requires further evaluation. Methods: We conducted a single-center, retrospective analysis of 84 breast cancer patients with bone metastases who received incadronate disodium between February 2022 and August 2024. The primary endpoint was the incidence of dental-related issues and acute phase reactions (APRs), along with an analysis of associated risk factors. The secondary endpoint was the incidence of other adverse events (AEs). All AEs were monitored during treatment and for 90 days post-treatment. Statistical analyses included both univariate and multivariate logistic regression. Results: Dental-related issues were observed in 33.3% of patients, and only one (1.2%) developed medication-related osteonecrosis of the jaw. Prolonged treatment duration (OR = 4.33, 95% CI: 1.21-15.50), secondary bone metastases (OR = 6.3, 95% CI: 1.58-25.00), and lower hemoglobin levels (OR = 4.16, 95% CI: 1.31-13.2) were significant predictors in multivariate analysis. APRs occurred in 26.2% of patients, with higher doses (OR = 1.41, 95% CI: 1.07-2.05), multiple metastatic sites (OR = 4.22, 95% CI: 1.39-15.89), and lower hemoglobin levels (OR = 3.27, 95% CI: 1.21-9.22) identified as significant in univariate but not multivariate analysis. Rare AEs included renal dysfunction (1.2%) and hypocalcemia (4.76%). Conclusions: Incadronate disodium demonstrates a favorable safety profile in managing bone metastases in breast cancer patients. Prolonged treatment duration and lower hemoglobin levels were identified as key risk factors, underscoring the need for proactive dental health management and tailored therapeutic strategies to minimize adverse outcomes.