Billias Christina, Langer Megan, Ursu Sorana, Schorr Rebecca
Allegheny Health Network, Pittsburgh, PA, USA.
Highmark Inc., Pittsburgh, PA, USA.
J Oncol Pharm Pract. 2022 Apr;28(3):523-529. doi: 10.1177/1078155221996039. Epub 2021 Feb 16.
To determine the incidence of skeletal-related events among multiple myeloma patients who received chemotherapy without a bone-modifying agent (zoledronic acid and denosumab) versus those who received chemotherapy with a bone-modifying agent. The secondary objective was to determine the incidence of skeletal-related events in patients without any prior history of skeletal-related events and who were treated with zoledronic acid every four weeks versus those who received zoledronic acid at an extended interval of every twelve weeks. Additional secondary objectives included the incidence of nephrotoxicity, hypocalcemia and osteonecrosis of the jaw in all patients.
This institutional review board-approved, retrospective cohort study included patients 18 to 89 years old with a diagnosis of multiple myeloma, who were being treated with chemotherapy between July 1, 2016 and October 31, 2019. Safety and efficacy were assessed through analysis of pertinent data collected: patient demographics, baseline skeletal-related events, development of new skeletal-related events, number and type of bone-modifying agent doses administered, and drug-related toxicities such as nephrotoxicity, hypocalcemia, and osteonecrosis of the jaw.
A total of 73 patients were included. New skeletal-related events occurred in 12 patients (27%) in the chemotherapy without a bone-modifying agent group and in 5 patients (17%) in the chemotherapy with a bone-modifying agent group (OR = 0.56, 95% CI [0.172-1.8]; P = 0.32). The incidence of skeletal-related events was similar among patients receiving zoledronic acid every four weeks versus every twelve weeks in patients without a prior skeletal-related event (N = 0 vs. N = 2 respectively; P = 0.47). There were no statistically significant differences observed in each of the three secondary safety endpoints: incidence of hypocalcemia, nephrotoxicity and osteonecrosis of the jaw.
Multiple myeloma patients receiving chemotherapy without a bone-modifying agent had higher rates of skeletal-related events compared to those being treated with chemotherapy and a bonemodifying agent. Our results highlight the benefit of utilizing bonemodifying agents for the prevention of skeletal-related events in all multiple myeloma patients being treated with chemotherapy.
确定接受不含骨改良剂(唑来膦酸和地诺单抗)化疗的多发性骨髓瘤患者与接受含骨改良剂化疗的患者发生骨相关事件的发生率。次要目的是确定既往无骨相关事件病史且每四周接受一次唑来膦酸治疗的患者与每十二周延长间隔接受一次唑来膦酸治疗的患者发生骨相关事件的发生率。其他次要目的包括所有患者中肾毒性、低钙血症和颌骨坏死的发生率。
这项经机构审查委员会批准的回顾性队列研究纳入了18至89岁诊断为多发性骨髓瘤且在2016年7月1日至2019年10月31日期间接受化疗的患者。通过分析收集的相关数据评估安全性和有效性:患者人口统计学特征、基线骨相关事件、新骨相关事件的发生情况、骨改良剂给药剂量的数量和类型以及药物相关毒性,如肾毒性、低钙血症和颌骨坏死。
共纳入73例患者。在不含骨改良剂化疗组中,12例患者(27%)发生了新的骨相关事件,在含骨改良剂化疗组中,5例患者(17%)发生了新的骨相关事件(比值比=0.56,95%可信区间[0.172-1.8];P=0.32)。在既往无骨相关事件的患者中,每四周接受一次唑来膦酸治疗的患者与每十二周接受一次唑来膦酸治疗的患者骨相关事件发生率相似(分别为N=0和N=2;P=0.47)。在三个次要安全性终点(低钙血症、肾毒性和颌骨坏死的发生率)中均未观察到统计学显著差异。
与接受化疗并使用骨改良剂的多发性骨髓瘤患者相比,接受不含骨改良剂化疗的患者发生骨相关事件的发生率更高。我们的结果突出了在所有接受化疗的多发性骨髓瘤患者中使用骨改良剂预防骨相关事件的益处。