曲妥珠单抗的药代动力学及其对 HER2 阳性癌症患者的疗效和安全性。

IF 2.7 4区 医学 Q3 ONCOLOGY Cancer Chemotherapy and Pharmacology Pub Date : 2024-11-01 Epub Date: 2024-08-23 DOI:10.1007/s00280-024-04707-y
Xinyu Luo, Nan Wang, Yue Xing, Xinyue Gao, Yang Yu, Tong Liu, Shuai Jiang, Mei Dong
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引用次数: 0

摘要

曲妥珠单抗是一种针对 HER2 阳性癌症患者的强效靶向治疗药物。全面了解曲妥珠单抗的作用机制、药动学(PK)参数以及不同治疗方案和给药途径下的稳态暴露量,对于彻底评估该药物的安全性和有效性至关重要。由于曲妥珠单抗的药代动力学、适应症和给药方法各不相同,因此了解其药代动力学至关重要。药物暴露可通过酶联免疫吸附试验(ELISA)或液相色谱-串联质谱法(LC-MS/MS)等检测方法测量曲妥珠单抗的峰浓度、谷浓度或曲线下面积来评估。剂量-反应(D-R)和暴露-反应(E-R)关系确定了药物剂量/暴露与治疗效果和安全性之间的相关性。此外,体重、天冬氨酸转氨酶和白蛋白水平等各种协变量也会影响药物暴露。本综述全面概述了曲妥珠单抗的作用机制、多种给药途径和适应症下的稳态浓度和 PK 参数数据、PK 参数影响因素讨论,以及 E-R 和 D-R 在不同 HER2 阳性癌症患者中的有效性和安全性评估。
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Pharmacokinetics of trastuzumab and its efficacy and safety in HER2-positive cancer patients.

Trastuzumab is a potent targeted therapy drug for HER2-positive cancer patients. A comprehensive understanding of trastuzumab's mechanism of action, pharmacokinetic (PK) parameters, and steady-state exposure in different treatment regimens and administration routes is essential for a thorough evaluation of the drug's safety and effectiveness. Due to the distinctive pharmacokinetics, indications, and administration methods of trastuzumab, this understanding becomes crucial. Drug exposure can be assessed by measuring trastuzumab's peak concentration, trough concentration, or area under the curve through assays like enzyme-linked immunosorbent assay (ELISA) or liquid chromatography-tandem mass spectrometry (LC-MS/MS). The dose-response (D-R) and exposure-response (E-R) relationships establish the correlation between drug dosage/exposure and the therapeutic effect and safety. Additionally, various covariates such as body weight, aspartate transaminase, and albumin levels can influence drug exposure. This review provides a comprehensive overview of trastuzumab's mechanism of action, data on steady-state concentration and PK parameters under multiple administration routes and indications, discussions on factors influencing PK parameters, and evaluations of the effectiveness and safety of E-R and D-R in diverse HER2-positive cancer patients.

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来源期刊
CiteScore
6.10
自引率
3.30%
发文量
116
审稿时长
2.5 months
期刊介绍: Addressing a wide range of pharmacologic and oncologic concerns on both experimental and clinical levels, Cancer Chemotherapy and Pharmacology is an eminent journal in the field. The primary focus in this rapid publication medium is on new anticancer agents, their experimental screening, preclinical toxicology and pharmacology, single and combined drug administration modalities, and clinical phase I, II and III trials. It is essential reading for pharmacologists and oncologists giving results recorded in the following areas: clinical toxicology, pharmacokinetics, pharmacodynamics, drug interactions, and indications for chemotherapy in cancer treatment strategy.
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