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Population pharmacokinetics of sirolimus in pediatric patients with kaposiform hemangioendothelioma: A retrospective study

Authors
  • Wang, Dongdong1
  • Chen, Xiao1, 2
  • Li, Zhiping1
  • 1 Department of Pharmacy, Children's Hospital of Fudan University, Shanghai 201102, P.R. China
  • 2 Department of Pharmacy, The People's Hospital of Jiangyin, Jiangyin, Jiangsu 214400, P.R. China
Type
Published Article
Journal
Oncology Letters
Publisher
Spandidos Publications
Publication Date
Jul 04, 2019
Volume
18
Issue
3
Pages
2412–2419
Identifiers
DOI: 10.3892/ol.2019.10562
PMID: 31452734
PMCID: PMC6676569
Source
PubMed Central
Keywords
License
Green

Abstract

Numerous studies have established population pharmacokinetics (PPK) models of sirolimus in various populations. However, a PPK model of sirolimus in Chinese patients with pediatric kaposiform hemangioendothelioma (PKHE) has yet to be established; therefore, this was the purpose of the present study. The present study was a retrospective analysis that utilized the trough concentration data obtained from traditional therapeutic drug monitoring-based dose adjustments. A total of 17 Chinese patients with PKHE from a real-world study were characterized by non-linear mixed-effects modeling. The impact of demographic features, biological characteristics and concomitant medications was assessed. The developed final model was evaluated via bootstrap and a prediction-corrected visual predictive check. A one-compartment model with first-order absorption and elimination was used for modeling of data for PKHE. The typical values of apparent oral clearance (CL/F) and apparent volume of distribution (V/F) in the final model were 3.19 l/h and 165 liters, respectively. Age, alanine transaminase levels and sex were included as significant covariates for CL/F, while the duration of treatment with sirolimus was a significant covariate for V/F. In conclusion, the present study developed and validated the first sirolimus PPK model for Chinese patients with PKHE.

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