Pharmacokinetically based dosing of weekly paclitaxel to reduce drug-related neurotoxicity based on a single sample strategy

Cancer Chemotherapy and Pharmacology
Stefanie KraffMarkus Joerger

Abstract

The present simulation study was initiated to develop a limited sampling strategy and pharmacokinetically based dosing algorithm of weekly paclitaxel based on pharmacokinetic (PK) and chemotherapy-induced peripheral neuropathy (CIPN) data from a large database. We used paclitaxel plasma concentrations from 200 patients with solid tumors receiving weekly paclitaxel infusions to build a population PK model and a proportional odds model on CIPN. Different limited sampling strategies were tested on their accuracy to estimate the individual paclitaxel time-above-threshold-concentration of 0.05 µmol/L (T c>0.05µM), which is a common threshold for paclitaxel. A dosing algorithm was developed based on the population distribution of paclitaxel T c>0.05µM and the correlation between paclitaxel T c>0.05µM and CIPN. A trial simulation based on paclitaxel PK and CIPN was performed using empirical Bayes estimations, applying the proposed dosing algorithm and a single 24-h paclitaxel PK sample. A single paclitaxel plasma concentration taken 18-30 h after the start of chemotherapy infusion adequately predicted T c>0.05µM. By using an empirical dosing algorithm to target an average paclitaxel T c>0.05µM between 10 and 14 h, Bayesian simulations...Continue Reading

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Citations

Sep 25, 2017·Therapeutic Drug Monitoring·Markus JoergerSalvatore J Salamone
Oct 4, 2017·Expert Opinion on Drug Discovery·Silvia Maria LavezziItalo Poggesi
Jan 9, 2019·Pharmaceutical Research·Marie-Rose B S CrombagAlwin D R Huitema
Dec 7, 2018·Pharmacogenomics·Lauren A MarcathDaniel L Hertz
Oct 17, 2019·Pharmaceutical Research·Marie-Rose B S CrombagAlwin D R Huitema
Apr 29, 2018·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Daniel L HertzN Lynn Henry
Apr 26, 2019·Journal of Pharmaceutical and Biomedical Analysis·Susan M ChristnerJan H Beumer

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