Li Wei, Wu Xinyu, Yu Heng, Zhu Zekai, Li Wenjie, Huang Xiang
Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Department of Medicine, Nanjing Medical University, Nanjing, China.
Clin Med Insights Oncol. 2023 Jul 10;17:11795549231182266. doi: 10.1177/11795549231182266. eCollection 2023.
Denosumab entered the Chinese market for the first time in 2020. Since it is a short period of time, there is a lack of data on its effectiveness and safety in Chinese people. The objective of this study was to evaluate the effectiveness and safety of denosumab in delaying skeletal-related events (SREs) in patients with breast cancer metastatic to bone.
The study retrospectively analyzed data from breast cancer patients with bone metastases (BM) who were treated with denosumab in the First Affiliated Hospital of Nanjing Medical University from September 2020 to January 2022. The primary endpoint was SRE incidence at 1 year after receiving denosumab treatment. The secondary endpoints included time to first on-study SRE and safety. Descriptive analysis was utilized to display clinicopathological features. The Kaplan-Meier method was used to estimate the median time to first on-study SRE in total population and subgroups. Logistic regression analysis and χ test were employed to determine the potential factors influencing the occurrence of SREs.
Fifty breast cancer patients with BM were enrolled in our study, and 54.0% of the patients had 5 or more metastatic bone lesions. After a median follow-up of 17.00 months, 24% of the patients developed SREs at 1 year after receiving denosumab treatment, and the median time to first on-study SREs was not reached. Five or more metastatic bone lesions were an independent risk factor for SRE occurrence (odds ratio = 6.06, 95% CI: 1.09-33.54, = .039). The adverse events (AEs) associated with denosumab mainly included hypocalcemia (68.0%), periodontitis (28.0%), and myalgia (14.0%). Only 3 cases of grade III/IV AEs were reported, and no serious AEs occurred.
Denosumab was effective and well tolerated in Chinese breast cancer patients with BM.
地诺单抗于2020年首次进入中国市场。由于时间较短，缺乏其在中国人群中的有效性和安全性数据。本研究的目的是评估地诺单抗在延迟骨转移乳腺癌患者骨骼相关事件（SREs）方面的有效性和安全性。
本研究回顾性分析了2020年9月至2022年1月在南京医科大学第一附属医院接受地诺单抗治疗的骨转移乳腺癌患者的数据。主要终点是接受地诺单抗治疗1年后的SRE发生率。次要终点包括首次出现研究中SRE的时间和安全性。采用描述性分析展示临床病理特征。采用Kaplan-Meier方法估计总体人群和亚组中首次出现研究中SRE的中位时间。采用逻辑回归分析和χ检验确定影响SRE发生的潜在因素。
本研究纳入了50例骨转移乳腺癌患者，54.0%的患者有5个或更多的骨转移病灶。中位随访17.00个月后，24%的患者在接受地诺单抗治疗1年后发生了SREs，且未达到首次出现研究中SREs的中位时间。5个或更多的骨转移病灶是SRE发生的独立危险因素（比值比=6.06，95%置信区间：1.09-33.54，P=0.039）。与地诺单抗相关的不良事件（AEs）主要包括低钙血症（68.0%）、牙周炎（28.0%）和肌痛（14.0%）。仅报告了3例III/IV级AEs，未发生严重AEs。
地诺单抗在骨转移中国乳腺癌患者中有效且耐受性良好。
