Efficacy and safety of intravenous bisphosphonates beyond two years

E. Gilliam, J. Winters, E. A. McGuire, Sang-Joon Lee, M. Purdy, M. Fekrazad, M. Royce, K. Choi
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Abstract

Background: Metastatic bone disease, a common complication of malignancy, causes significant morbidity in affected patients. Intravenous bisphosphonates (IBPs) have shown efficacy in preventing skeletal morbidity, however few studies have investigated their efficacy and safety in cancer patients beyond 2 years of use. This retrospective study documents long term clinical use of IBPs among a variety of patient populations and clinical settings. Methods: This study is a multi-center retrospective chart review of patients who received IBPs (Pamidronate or Zoledronic Acid) for more than 24 months. Patients were at least 18 years of age and had tumor-associated bone disease. Data analysis focused on skeletal related events (SREs) and drug related toxicities such as renal failure and osteonecrosis of the jaw (ONJ). Results: Ninety-two patients were included with the most common diagnosis being multiple myeloma. A total of 44 SREs occurred among 23 patients. Mean time to first SRE was 515 days. The rate of skeletal events in the first 2 years of treatment was 0.70, while skeletal morbidity rate (SMR) in subsequent years was 0.16. Thirteen patients experienced renal toxicity; most patients’ renal function normalized after brief or permanent cessation of IBP therapy. ONJ was associated with 5 patients. Conclusion: Continuation of IBP therapy for skeletal metastasis after 2 years of treatment may improve skeletal morbidity. Similar to the first 2 years of treatment, significant toxicities such as renal failure and ONJ are uncommon.
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静脉注射双膦酸盐两年以上的疗效和安全性
背景:转移性骨病是恶性肿瘤的常见并发症,在患者中引起显著的发病率。静脉注射双膦酸盐(IBPs)已显示出预防骨骼疾病的疗效,但很少有研究调查其在使用2年以上的癌症患者中的疗效和安全性。这项回顾性研究记录了IBPs在各种患者群体和临床环境中的长期临床使用情况。方法:本研究是对接受IBPs(帕米膦酸盐或唑来膦酸)治疗超过24个月的患者进行多中心回顾性研究。患者年龄≥18岁,患有肿瘤相关骨病。数据分析主要集中在骨骼相关事件(SREs)和药物相关毒性,如肾衰竭和颌骨骨坏死(ONJ)。结果:92例患者中最常见的诊断是多发性骨髓瘤。23例患者共发生44例SREs。到第一次SRE的平均时间为515天。治疗前2年的骨骼事件发生率为0.70,随后几年的骨骼发病率(SMR)为0.16。13例出现肾毒性;大多数患者在短暂或永久停止IBP治疗后肾功能恢复正常。ONJ与5例患者相关。结论:骨骼转移患者在治疗2年后继续IBP治疗可改善骨骼发病率。与治疗的前2年相似,肾功能衰竭和ONJ等显著毒性并不常见。
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