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梅奥诊所输注中心多发性骨髓瘤患者皮下和静脉注射达雷妥尤单抗的临床管理特点。

Clinical Administration Characteristics of Subcutaneous and Intravenous Administration of Daratumumab in Patients With Multiple Myeloma at Mayo Clinic Infusion Centers.

机构信息

Department of Pharmacy, Mayo Clinic Rochester, Rochester, MN.

nference Inc, Cambridge, MA.

出版信息

JCO Oncol Pract. 2023 Apr;19(4):e542-e549. doi: 10.1200/OP.22.00421. Epub 2023 Feb 9.


DOI:10.1200/OP.22.00421
PMID:36758192
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10101255/
Abstract

PURPOSE: Median duration of daratumumab (DARA) administration for treatment of multiple myeloma is 3-7 hours for the intravenous formulation (DARA IV) and 3-5 minutes for the subcutaneous formulation (DARA SC). Here, we describe clinical administration characteristics of DARA using a novel method for data extraction from electronic health records. METHODS: Time-based measurements were extracted using a scheduling/pharmacy software program that tracked patient movement through appointments for patients initiating DARA in Mayo Clinic infusion centers from April 5, 2017, to October 14, 2021. Cohorts included patients who received DARA IV or DARA SC, or converted from DARA IV to DARA SC. The DARA SC cohort was further analyzed before (DARA SC initial) and after (DARA SC shortened) a reduction in the postadministration observation time mandated by the treatment plan. Events associated with administration-related reactions (ARRs) were also identified. RESULTS: Median total clinic times were 2.7-3.0 hours shorter for DARA SC versus DARA IV. Median clinic times were highest at dose 1 and decreased with subsequent doses. Median total chair times were 2.7-2.8 hours shorter for DARA SC versus DARA IV. Incidences of ARR-related events with DARA SC were low across doses. CONCLUSION: Reduced clinic times were observed with DARA SC, indicating that use of DARA SC as a treatment option results in time savings that may free clinic resources. Furthermore, novel methods of electronic health record data extraction can provide insights that may help inform clinic resource optimization.

摘要

目的:达雷妥尤单抗(DARA)治疗多发性骨髓瘤的静脉制剂(DARA IV)的给药中位时间为 3-7 小时,皮下制剂(DARA SC)的给药中位时间为 3-5 分钟。在此,我们描述了一种从电子病历中提取数据的新方法,用于描述 DARA 的临床给药特征。

方法:从 2017 年 4 月 5 日至 2021 年 10 月 14 日期间,Mayo 诊所输注中心开始接受 DARA 治疗的患者,使用调度/药房软件程序基于时间进行测量,该程序跟踪患者在预约过程中的移动情况。队列包括接受 DARA IV 或 DARA SC 的患者,或从 DARA IV 转换为 DARA SC 的患者。在治疗计划规定的给药后观察时间缩短之前(DARA SC 初始)和之后(DARA SC 缩短),对 DARA SC 队列进行了进一步分析。还确定了与给药相关不良反应(ARR)相关的事件。

结果:与 DARA IV 相比,DARA SC 的总就诊时间中位数缩短了 2.7-3.0 小时。剂量 1 时的就诊时间中位数最高,随后剂量逐渐降低。与 DARA IV 相比,DARA SC 的总椅位时间中位数缩短了 2.7-2.8 小时。各剂量的 DARA SC 与 ARR 相关事件的发生率均较低。

结论:与 DARA IV 相比,DARA SC 观察到就诊时间缩短,表明将 DARA SC 作为治疗选择可节省时间,从而可能释放诊所资源。此外,电子病历数据提取的新方法可以提供见解,有助于优化诊所资源。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57c1/10101255/b3a4aed42097/op-19-e542-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57c1/10101255/b3a4aed42097/op-19-e542-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57c1/10101255/b3a4aed42097/op-19-e542-g002.jpg

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[7]
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[8]
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本文引用的文献

[1]
Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma.

Haematologica. 2022-10-1

[2]
Results of a Time and Motion Survey Regarding Subcutaneous versus Intravenous Administration of Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma.

Clinicoecon Outcomes Res. 2021-6-8

[3]
Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results.

J Cancer Res Clin Oncol. 2021-2

[4]
Deep immune profiling of patients treated with lenalidomide and dexamethasone with or without daratumumab.

Leukemia. 2021-2

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Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial.

Lancet Haematol. 2020-5

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Split First Dose Administration of Intravenous Daratumumab for the Treatment of Multiple Myeloma (MM): Clinical and Population Pharmacokinetic Analyses.

Adv Ther. 2020-2-20

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Daratumumab Split First Versus Single Dosing Schedule Among Patients With Multiple Myeloma Treated in a US Community Oncology Setting: A Retrospective Observational Study.

Clin Ther. 2019-4-25

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High-Parameter Mass Cytometry Evaluation of Relapsed/Refractory Multiple Myeloma Patients Treated with Daratumumab Demonstrates Immune Modulation as a Novel Mechanism of Action.

Cytometry A. 2018-12-11

[9]
The Therapeutic CD38 Monoclonal Antibody Daratumumab Induces Programmed Cell Death via Fcγ Receptor-Mediated Cross-Linking.

J Immunol. 2016-8-1

[10]
Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma.

Blood. 2016-7-21

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