地舒单抗对比唑来膦酸治疗乳腺癌骨转移的疗效和安全性:一项倾向评分匹配队列研究  

Efficacy and safety of denosumab versus zoledronic acid for treatment of bone metastasis in breast cancer patients:a propensity score-matched cohort study

作　　者：黄香[1] 刘谦 吴昕煜 金楠 殷咏梅[1] Huang Xiang;Liu Qian;Wu Xinyu;Jin Nan;Yin Yongmei(Department of Oncology,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China)

机构地区：[1]南京医科大学第一附属医院肿瘤科,江苏南京210029

出　　处：《实用肿瘤杂志》2024年第6期542-548,共7页Journal of Practical Oncology

摘　　要：目的比较地舒单抗与唑来膦酸治疗乳腺癌骨转移患者的有效性与安全性。方法回顾性收集2020年9月至2022年7月南京医科大学第一附属医院肿瘤科收治的经骨改良药物治疗(地舒单抗90例,唑来膦酸86例)的晚期乳腺癌骨转移患者的临床资料。通过倾向评分后进行1∶1匹配,分为地舒单抗组66例和唑来膦酸组66例。比较两组患者无骨相关事件(skeletal-related event,SRE)生存率和不良事件的发生情况。结果截至2023年7月20日,中位随访时间为18.3个月,两组患者中位至首次SRE发生时间均未达到。地舒单抗组和唑来膦酸组治疗后1年无SRE生存率分别为80.3%(95%CI:68.7%~89.1%)和63.6%(95%CI:50.9%~75.1%)。与唑来膦酸组比较,地舒单抗组降低SRE发生风险(HR=0.48,95%CI:0.26~0.90,P=0.022)。两组发生的不良事件主要为低钙血症,唑来膦酸组关节痛发生率更高(P=0.028)。结论与唑来膦酸比较,地舒单抗治疗晚期乳腺癌骨转移患者可延迟SRE的发生,且关节痛不良事件的发生率更低。Objective To compare the effectiveness and safety of denosumab versus zoledronic acid for the treatment of bone metastasis in patients with breast cancer.Methods The clinical data of 176 advanced breast cancer patients with bone metastasis treated with bone-modifying agents of denosumab(n=90)or zoledronic acid(n=86)in the Department of Oncology,the First Affiliated Hospital of Nanjing Medical University from September 2020 to July 2022 was retrospectively analyzed.After 1∶1 propensity score matching,66 patients in denosumab group and 66 patients in zoledronic acid group were selected.The skeletal-related events(SREs)and adverse events in the denosumab group and the zoledronic acid group were evaluated.Results After a median follow-up of 18.3 months,the median time to first on-study SRE was not reached in neither the denosumab group nor the zoledronic acid group.The one-year SRE-free survival rate was 80.3%(95%CI:68.7%-89.1%)in the denosumab group,as compared with 63.6%(95%CI:50.9%-75.1%)in the zoledronic acid group.Denosumab reduced the risk of SREs(HR=0.48,95%CI:0.26-0.90,P=0.022).Adverse events were predominantly hypocalcemia in both groups,with a higher incidence of arthralgia in the zoledronic acid group(P=0.028).Conclusions Compared with zoledronic acid,denosumab delayed the occurrence of SREs in advanced breast cancer patients with bone metastasis and had a lower incidence of arthralgia.

关 键 词：乳腺癌 骨转移 骨改良药物 地舒单抗 唑来膦酸 骨相关事件 

分 类 号：R737.9[医药卫生—肿瘤]