A limited sampling schedule to estimate individual pharmacokinetics of pemetrexed in patients with varying renal functions

被引:7
作者
de Rouw, Nikki [1 ,2 ]
Visser, Sabine [3 ,4 ]
Koolen, Stijn L. W. [5 ,6 ]
Aerts, Joachim G. J. V. [3 ,4 ]
van den Heuvel, Michel M. [7 ]
Derijks, Hieronymus J. [1 ,2 ]
Burger, David M. [1 ]
ter Heine, Rob [1 ]
机构
[1] Radboud Univ Nijmegen, Med Ctr, Dept Pharm, Radboud Inst Hlth Sci, POB 9101, NL-6500 HB Nijmegen, Netherlands
[2] Jeroen Bosch Hosp, Dept Pharm, Shertogenbosch, Netherlands
[3] Amphia Hosp, Dept Pulm Med, Breda, Netherlands
[4] Erasmus MC, Dept Pulm Med, Inst Canc, Rotterdam, Netherlands
[5] Erasmus MC, Dept Med Oncol, Inst Canc, Rotterdam, Netherlands
[6] Erasmus MC, Dept Pharm, Rotterdam, Netherlands
[7] Radboud Univ Nijmegen, Med Ctr, Dept Pulmonol, Radboud Inst Hlth Sci, Nijmegen, Netherlands
关键词
Pemetrexed; Limited sampling; Pharmacokinetics; TDM; INHIBITION; TOXICITY; CANCER;
D O I
10.1007/s00280-019-04006-x
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
PurposePemetrexed is a widely used cytostatic agent with an established exposure-response relationship. Although dosing is based on body surface area (BSA), large interindividual variability in pemetrexed plasma concentrations is observed. Therapeutic drug monitoring (TDM) can be a feasible strategy to reduce variability in specific cases leading to potentially optimized pemetrexed treatment. The aim of this study was to develop a limited sampling schedule (LSS) for the assessment of pemetrexed pharmacokinetics.MethodsBased on two real-life datasets, several limited sampling designs were evaluated on predicting clearance, using NONMEM, based on mean prediction error (MPE %) and normalized root mean squared error (NRMSE %). The predefined criteria for an acceptable LSS were: a maximum of four sampling time points within 8 h with an MPE and NRMSE <= 20%.ResultsFor an accurate estimation of clearance, only four samples in a convenient window of 8 h were required for accurate and precise prediction (MPE and NRMSE of 3.6% and 5.7% for dataset 1 and of 15.5% and 16.5% for dataset 2). A single sample at t=24 h performed also within the criteria with MPE and NRMSE of 5.8% and 8.7% for dataset 1 and of 11.5% and 16.4% for dataset 2. Bias increased when patients had lower creatinine clearance.ConclusionsWe presented two limited sampling designs for estimation of pemetrexed pharmacokinetics. Either one can be used based on preference and feasibility.
引用
收藏
页码:231 / 235
页数:5
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