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在复发/难治性急性淋巴细胞白血病成人患者中管理博纳吐单抗毒性的真实世界经验。

Real-world experience managing blinatumomab toxicities in adults with relapsed/refractory acute lymphoblastic leukemia.

作者信息

Crist MacKenzie, Emadi Ashkan, Duffy Alison

机构信息

Department of Pharmacy Practice and Science, University of Maryland School of Pharmacy, Baltimore, MD, USA.

Department of Medicine and Pharmacology, University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center, Baltimore, MD, USA.

出版信息

J Oncol Pharm Pract. 2020 Jul;26(5):1080-1085. doi: 10.1177/1078155219881680. Epub 2019 Oct 21.

DOI:10.1177/1078155219881680
PMID:31635546
Abstract

PURPOSE

The purpose of this study was to determine the effect of blinatumomab toxicities on drug therapy modifications in an intended 28-day course of blinatumomab therapy.

METHODS

Patients with acute lymphoblastic leukemia who received blinatumomab at the University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center from March 1, 2015 to April 30, 2018 were included. The primary objective of this study was to identify the frequency and severity of blinatumomab toxicities that led to drug therapy modifications; secondary objectives were to identify the frequency and duration of modifications and the total dose and duration of therapy received.

RESULTS

This study included 23 patients. Seventy-eight percent of patients experienced cytokine release syndrome and/or neurotoxicity. Eighteen drug therapy modifications occurred due to toxicity with a median interruption time of nine hours. Drug therapy was continued for the majority of grade 1 or 2 events and discontinued during grade 3 or 4 neurotoxicity. The median number of days of therapy delivered was 28 days (range, 27-35). A median of 2 h (range, 0-16) of therapy or 0.2% (range, 0-2.4) of a total 28-day cycle was lost due to transition of care.

CONCLUSION

This retrospective study demonstrates a single center experience with blinatumomab toxicity management and appropriate delivery of drug during transitions of care. Overall, these results support to the importance of institutional guidelines in place to facilitate safe and effective delivery of blinatumomab.

摘要

目的

本研究的目的是确定在预定为期28天的blinatumomab治疗过程中,blinatumomab毒性对药物治疗调整的影响。

方法

纳入2015年3月1日至2018年4月30日在马里兰大学玛琳与斯图尔特·格林ebaum综合癌症中心接受blinatumomab治疗的急性淋巴细胞白血病患者。本研究的主要目的是确定导致药物治疗调整的blinatumomab毒性的频率和严重程度;次要目的是确定调整的频率和持续时间以及接受治疗的总剂量和持续时间。

结果

本研究纳入了23例患者。78%的患者出现细胞因子释放综合征和/或神经毒性。因毒性发生了18次药物治疗调整,中位中断时间为9小时。对于大多数1级或2级事件,药物治疗继续进行,而在3级或4级神经毒性期间停药。给药的中位天数为28天(范围为27 - 35天)。由于护理转接,治疗损失的中位时间为2小时(范围为0 - 16小时),占整个28天周期的0.2%(范围为0 - 2.4%)。

结论

这项回顾性研究展示了单中心在blinatumomab毒性管理及护理转接期间药物合理给药方面的经验。总体而言,这些结果支持了机构指南对于促进blinatumomab安全有效给药的重要性。

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