Background/Objectives: Prolonged use of denosumab in patients with metastatic breast cancer has raised concerns about the development of medication-related osteonecrosis of the jaw (MRONJ). However, the threshold at which the risk increases remains unclear.Methods: This retrospective cohort study analyzed patients with breast cancer and bone metastases who received denosumab between May 2012 and August 2024. Associations between cumulative denosumab administration and MRONJ were evaluated using univariate and multivariate logistic regression analyses. A receiver operating characteristic (ROC) analysis was used to determine the optimal cutoff for cumulative doses.Results: MRONJ developed in 101 patients (31.2%). Multivariate analysis identified cumulative denosumab administration (odds ratio [OR]: 1.05, 95% confidence interval [CI]: 1.03–1.06;p< 0.001) and a history of tooth extraction (OR: 4.40, 95% CI: 2.23–8.71;p< 0.001) as independent risk factors for MRONJ. ROC analysis determined an optimal cutoff of 32 cumulative doses, with an area under the curve of 0.83 (95% CI: 0.78–0.88;p< 0.0001).Conclusions: Cumulative denosumab administration and history of tooth extraction were independent risk factors for MRONJ in patients with breast cancer and bone metastases. The risk of MRONJ increased after 32 cumulative doses, providing a clinically actionable threshold for risk assessment and patient monitoring.
背景/目的：在转移性乳腺癌患者中长期使用地舒单抗引发了关于药物相关性颌骨坏死风险的担忧，但其风险显著增加的剂量阈值尚不明确。 方法：本回顾性队列研究分析了2012年5月至2024年8月期间接受地舒单抗治疗的乳腺癌骨转移患者。通过单因素及多因素逻辑回归分析评估地舒单抗累积给药与药物相关性颌骨坏死的关联性，并采用受试者工作特征曲线分析确定累积剂量的最佳截断值。 结果：共有101例患者发生药物相关性颌骨坏死（发生率31.2%）。多因素分析显示，地舒单抗累积给药（比值比：1.05，95%置信区间：1.03–1.06；p<0.001）与拔牙史（比值比：4.40，95%置信区间：2.23–8.71；p<0.001）是药物相关性颌骨坏死的独立危险因素。受试者工作特征曲线分析确定32次累积剂量为最佳截断值，曲线下面积为0.83（95%置信区间：0.78–0.88；p<0.0001）。 结论：地舒单抗累积给药和拔牙史是乳腺癌骨转移患者发生药物相关性颌骨坏死的独立危险因素。当累积给药达到32次后，药物相关性颌骨坏死风险显著增加，该阈值为临床风险评估和患者监测提供了可操作的依据。
肿瘤(癌症)患者之家