Department of Oral and Maxillofacial Surgery, Pusan National University Dental Hospital, Yangsan, Republic of Korea.
Department of Oral and Maxillofacial Surgery, Yonsei University College of Dentistry, Seoul, Republic of Korea.
Support Care Cancer. 2024 Nov 5;32(12):774. doi: 10.1007/s00520-024-08974-6.
High-dose denosumab (Xgeva®) is increasingly used for treating bone metastasis and various malignant diseases but carries the risk of medication-related osteonecrosis of the jaw (MRONJ). This study aimed to evaluate the incidence, risk factors, and clinical outcomes of MRONJ in patients treated with high-dose denosumab.
A retrospective review was performed on 1278 patients who received high-dose denosumab at Severance Hospital, Seoul, South Korea, from September 2014 to February 2023. Data on the incidence of MRONJ, patient demographics, primary diseases, and treatment outcomes were analyzed.
Among the 1278 patients (average age 64.72 years; 728 males and 550 females) treated, 34 developed MRONJ, with a 2.66% incidence rate. The average age of those with MRONJ was 68.32 years, and they received more Xgeva® injections on average (13.62) compared to the overall cohort. Factors such as age and the frequency of injections were significantly associated with the risk of MRONJ. Notably, the incidence of MRONJ did not significantly differ between those who underwent oral surgery and those with spontaneous MRONJ, especially if oral surgery occurred within 1 month of injection. Surgical interventions have shown higher recovery rates in advanced MRONJ stages.
This study confirmed a significant MRONJ incidence of 2.66% among high-dose denosumab recipients, highlighting the importance of careful patient selection, monitoring, and education, particularly in older and long-term treatment patients, to mitigate the risk of MRONJ.
高剂量地舒单抗（Xgeva®）越来越多地用于治疗骨转移和各种恶性疾病，但存在药物相关性颌骨坏死（MRONJ）的风险。本研究旨在评估接受高剂量地舒单抗治疗的患者中 MRONJ 的发生率、危险因素和临床结局。
对 2014 年 9 月至 2023 年 2 月在韩国首尔 Severance 医院接受高剂量地舒单抗治疗的 1278 例患者进行回顾性分析。分析了 MRONJ 的发生率、患者人口统计学、主要疾病和治疗结局等数据。
在接受治疗的 1278 例患者（平均年龄 64.72 岁；728 名男性和 550 名女性）中，有 34 例发生 MRONJ，发生率为 2.66%。MRONJ 患者的平均年龄为 68.32 岁，与总体队列相比，他们接受了更多的 Xgeva®注射（平均 13.62 次）。年龄和注射频率等因素与 MRONJ 的风险显著相关。值得注意的是，接受口腔手术和自发性 MRONJ 的患者的 MRONJ 发生率无显著差异，尤其是在注射后 1 个月内进行口腔手术的患者。手术干预在晚期 MRONJ 阶段显示出更高的恢复率。
本研究证实了高剂量地舒单抗治疗患者中 MRONJ 的发生率为 2.66%，这突出了对患者进行仔细选择、监测和教育的重要性，特别是对老年和长期治疗患者，以降低 MRONJ 的风险。
