Population Pharmacokinetics of PEGylated Asparaginase in Children with Acute Lymphoblastic Leukemia: Treatment Phase Dependency and Predictivity in Case of Missing Data
Jazyk angličtina Země Francie Médium print-electronic
Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie, validační studie
PubMed
33595793
PubMed Central
PMC7935823
DOI
10.1007/s13318-021-00670-8
PII: 10.1007/s13318-021-00670-8
Knihovny.cz E-zdroje
- MeSH
- akutní lymfatická leukemie farmakoterapie MeSH
- asparaginasa aplikace a dávkování farmakokinetika MeSH
- biologické modely * MeSH
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- plocha pod křivkou MeSH
- polyethylenglykoly aplikace a dávkování farmakokinetika MeSH
- předškolní dítě MeSH
- protinádorové látky aplikace a dávkování farmakokinetika MeSH
- tkáňová distribuce MeSH
- Check Tag
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
- validační studie MeSH
- Názvy látek
- asparaginasa MeSH
- pegaspargase MeSH Prohlížeč
- polyethylenglykoly MeSH
- protinádorové látky MeSH
BACKGROUND AND OBJECTIVES: The pharmacokinetics of polyethylene glycol-conjugated asparaginase (PEG-ASNase) are characterized by an increase in elimination over time, a marked increase in ASNase activity levels from induction to reinduction, and high inter- and intraindividual variability. A population pharmacokinetic (PopPK) model is required to estimate individual dose intensity, despite gaps in monitoring compliance. METHODS: In the AIEOP-BFM ALL 2009 trial, two PEG-ASNase administrations (2500 U/m2 intravenously) during induction (14-day interval) and one administration during reinduction were administered in children with acute lymphoblastic leukemia. ASNase activity levels were monitored weekly. A PopPK model was used for covariate modeling and external validation. The predictivity of the model in case of missing data was tested for observations, as well as for the derived parameters of the area under the concentration time curve (AUC0-∞) and time above different thresholds. RESULTS: Compared to the first administration in induction (1374 patients, 6069 samples), the initial clearance and volume of distribution decreased by 11.0% and 15.9%, respectively, during the second administration during induction and by 41.2% and 28.4% during reinduction. Furthermore, the initial clearance linearly increased for children aged > 8 years and was 7.1% lower for females. The model was successfully externally validated (1253 patients, 5523 samples). In case of missing data, > 52% of the predictions for observations and > 82% for derived parameters were within ± 20% of the nominal value. CONCLUSION: A PopPK model that describes the complex pharmacokinetics of PEG-ASNase was successfully externally validated. AUC0-∞ or time above different thresholds, which are parameters describing dose intensity, can be estimated with high predictivity, despite missing data. ( www.clinicaltrials.gov , NCT01117441, first submitted date: May 3, 2010).
Department of Clinical Pharmacy Institute of Pharmacy University of Hamburg Hamburg Germany
Department of Pediatric Hematology and Oncology Hannover Medical School Hannover Germany
Department of Pharmaceutical and Medical Chemistry Clinical Pharmacy Münster Germany
Institute of Biostatistics and Clinical Research University Münster Münster Germany
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ClinicalTrials.gov
NCT01117441
