Population pharmacokinetic modeling of pyrotinib in patients with HER2-positive advanced or metastatic breast cancer

医学 相伴的 肿瘤科 乳腺癌 药代动力学 内科学 卡培他滨 癌症 非金属 人口 药理学 结直肠癌 环境卫生
作者
Haini Wen,Yi-xi Liu,Da Xu,Kaijing Zhao,Zheng Jiao
出处
期刊:European Journal of Pharmaceutical Sciences [Elsevier BV]
卷期号:159: 105729-105729 被引量:10
标识
DOI:10.1016/j.ejps.2021.105729
摘要

Pyrotinib, a new oral irreversible pan-ErbB tyrosine kinase inhibitor (TKI), has been approved in China for the treatment of HER2-positive advanced or metastatic breast cancer. This study aimed to conduct a population pharmacokinetics (PK) analysis of pyrotinib and to evaluate the impact of patient characteristics on pyrotinib's PK. A total of 1152 samples, provided by 59 adult female patients from two phase I clinical trials, were analyzed by nonlinear mixed-effects modeling. Monte Carlo simulation was conducted to assess impact of covariates on the exposure to pyrotinib. The PK of pyrotinib was adequately described by a one-compartment model with first-order absorption and elimination. Patient's age and total protein levels could affect pyrotinib's apparent volume of distribution, and concomitant use of montmorillonite could decrease the bioavailability of pyrotinib by 50.3%. No PK interactions were observed between capecitabine and pyrotinib. In this study, a population PK model of pyrotinib was developed to determine the influence of patient characteristics on the PK of pyrotinib. While patient age and total protein levels can significantly affect the apparent distribution volume of pyrotinib, the magnitude of the impact was limited, thus no dosage adjustment was recommended. Furthermore, concomitant use of montmorillonite for diarrhea needs to be taken with precaution.
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