Analytical Validation of a Volumetric Absorptive Microsampling Method for Therapeutic Drug Monitoring of the Oral Targeted Anticancer Agents, Abiraterone, Alectinib, Cabozantinib, Imatinib, Olaparib, and Sunitinib, and Metabolites.

IF 2.8 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Therapeutic Drug Monitoring Pub Date : 2024-08-01 Epub Date: 2024-01-30 DOI:10.1097/FTD.0000000000001175
Marinda Meertens, Niels de Vries, Hilde Rosing, Neeltje Steeghs, Jos H Beijnen, Alwin D R Huitema
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引用次数: 0

Abstract

Background: Volumetric Absorptive Microsampling (VAMS) is a useful tool for therapeutic drug monitoring (TDM) of oral targeted anticancer agents. VAMS aims to improve safety and efficacy by enabling at-home blood sample collection by patients. This study aimed to develop and validate an ultra-high performance liquid chromatography-tandem mass spectrometry method for the quantitative determination of abiraterone, alectinib, cabozantinib, imatinib, olaparib, sunitinib, and the metabolites, Δ(4)-abiraterone (D4A), alectinib-M4, imatinib-M1, and N -desethyl sunitinib, in dried whole blood samples using VAMS to support TDM.

Methods: After the collection of 10 μL of whole blood sample using the VAMS device, the analytes were extracted from the tip using methanol with shaking, evaporated, and reconstituted in acetonitrile:0.1 mol/L ammonium hydroxide in water (1:1, vol/vol). The extracts were then analyzed using ultra-high performance liquid chromatography-tandem mass spectrometry. Validation experiments based on the ICH M10 guideline were carried out, and stability was evaluated under shipping and storage conditions. VAMS specimens were collected in the outpatient clinic to demonstrate the applicability of the assay.

Results: The validated range of the method was considered accurate and precise for all analytes. Accordingly, the validation experiments met the relevant requirements, except for cross-analyte interference. Based on the stability data, shipment can be performed at room temperature within 14 days after sample collection and the VAMS specimen can be stored up to 9 months at -20 and -70°C. Samples from 59 patients were collected at the hospital.

Conclusions: The developed method could be used to successfully quantify the concentrations of abiraterone, D4A, alectinib, alectinib-M4, cabozantinib, imatinib, imatinib-M1, olaparib, sunitinib, and N -desethyl sunitinib within the validated range using VAMS. Therefore, the method can be used to estimate the dried whole blood-to-plasma ratios for TDM in the clinic.

用于口服靶向抗癌药阿比特龙、阿埃替尼、卡博赞替尼、伊马替尼、奥拉帕利和舒尼替尼及代谢物治疗药物监测的体积吸收微采样方法的分析验证。
背景:体积吸收微采样(VAMS)是口服靶向抗癌药物治疗药物监测(TDM)的有效工具。VAMS 旨在通过让患者在家采集血样来提高安全性和疗效。本研究旨在开发和验证一种超高效液相色谱-串联质谱方法,利用VAMS定量测定干全血样中的阿比特龙、阿来替尼、卡博替尼、伊马替尼、奥拉帕利、舒尼替尼以及代谢物Δ(4)-阿比特龙(D4A)、阿来替尼-M4、伊马替尼-M1和N-去乙基舒尼替尼,以支持TDM:使用 VAMS 装置采集 10 μL 全血样本后,使用甲醇振荡提取尖端的分析物,蒸发后用乙腈:0.1 mol/L 氢氧化铵水溶液(1:1,vol/vol)重构。然后使用超高效液相色谱-串联质谱法对提取物进行分析。根据 ICH M10 指南进行了验证实验,并评估了运输和储存条件下的稳定性。在门诊采集了 VAMS 标本,以证明该检测方法的适用性:结果:对所有分析物而言,该方法的验证范围都是准确和精确的。因此,除交叉分析物干扰外,验证实验符合相关要求。根据稳定性数据,样品采集后 14 天内可在室温下进行装运,VAMS 标本可在 -20 和 -70°C 温度下保存长达 9 个月。结论:所开发的方法可用于使用VAMS成功地定量检测阿比特龙、D4A、阿埃替尼、阿埃替尼-M4、卡博替尼、伊马替尼、伊马替尼-M1、奥拉帕利、舒尼替尼和N-去乙基舒尼替尼在有效范围内的浓度。因此,该方法可用于估算干全血与血浆的比率,以便在临床中进行 TDM。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Therapeutic Drug Monitoring
Therapeutic Drug Monitoring 医学-毒理学
CiteScore
5.00
自引率
8.00%
发文量
213
审稿时长
4-8 weeks
期刊介绍: Therapeutic Drug Monitoring is a peer-reviewed, multidisciplinary journal directed to an audience of pharmacologists, clinical chemists, laboratorians, pharmacists, drug researchers and toxicologists. It fosters the exchange of knowledge among the various disciplines–clinical pharmacology, pathology, toxicology, analytical chemistry–that share a common interest in Therapeutic Drug Monitoring. The journal presents studies detailing the various factors that affect the rate and extent drugs are absorbed, metabolized, and excreted. Regular features include review articles on specific classes of drugs, original articles, case reports, technical notes, and continuing education articles.
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