Evidence map›Paper›PMID 42154176›Full record

Observational studyClinical pharmacokinetics2026

Therapeutic Drug Monitoring of Imatinib in Paediatric Chronic Myeloid Leukaemia: Towards Practical Implementation and Interpretation of Measured Plasma Concentrations.

Phyllis Lensker, Andrea Gottschalk, Thomas Zerjatke, Ingo Roeder, Martin F Fromm, Frank Dörje, Meinolf Suttorp, Manfred Rauh, Ingmar Glauche, Markus Metzler

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Phyllis Lensker *Pharmacy Department, Universitätsklinikum Erlangen and Friedrich-Alexander-Universität Erlangen-Nürnberg, Palmsanlage 3, 91054 Erlangen, Germany. phyllis.lensker@fau.de.ORCID http://orcid.org/0009-0005-8024-2839
Andrea Gottschalk *Institute for Medical Informatic and Biometry, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany.ORCID http://orcid.org/0000-0003-0378-9601
Thomas ZerjatkeInstitute for Medical Informatic and Biometry, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany.ORCID http://orcid.org/0000-0002-2125-9084
Ingo RoederInstitute for Medical Informatic and Biometry, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany.ORCID http://orcid.org/0000-0002-6741-0608
Martin F FrommInstitute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.ORCID http://orcid.org/0000-0002-0334-7478
Frank DörjePharmacy Department, Universitätsklinikum Erlangen and Friedrich-Alexander-Universität Erlangen-Nürnberg, Palmsanlage 3, 91054 Erlangen, Germany.ORCID http://orcid.org/0000-0003-0227-9212
Meinolf SuttorpPediatric Hemato-Oncology, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany.ORCID http://orcid.org/0000-0002-9522-8838
Manfred RauhDepartment of Paediatrics and Adolescent Medicine, Universitätsklinikum Erlangen and Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.ORCID http://orcid.org/0000-0002-4852-7157
Ingmar GlaucheInstitute for Medical Informatic and Biometry, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany.ORCID http://orcid.org/0000-0002-2524-1199
Markus MetzlerComprehensive Cancer Center Erlangen-EMN, Universitätsklinikum Erlangen, Erlangen, Germany.ORCID http://orcid.org/0000-0002-4523-1676

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

introductionImatinib (IMA) revolutionised the treatment of chronic myeloid leukaemia (CML). Therapeutic drug monitoring (TDM) of IMA is recommended to improve treatment outcomes in adults, but guidance for reliable interpretation of plasma concentrations in children is limited. Using real-world paediatric data, we aimed to develop a practical algorithm with recommendations for an IMA TDM procedure in paediatric oncology.

methodsImatinib plasma concentrations and clinical data were collected from patients enrolled in the multicentre CML-PAED-II study and subsequent registry. We evaluated the method of exponential extrapolation for estimating interpretable IMA trough concentrations and used linear mixed effects models to assess plasma concentration predictors. Associations between IMA trough concentrations and molecular response were analysed, and a paediatric-specific target threshold was evaluated. Findings were integrated into an algorithm for clinical application of IMA TDM.

resultsIn total, 269 IMA trough concentrations from 72 patients and BCR::ABL1/ABL1 transcript ratios from 50 patients were included. Using a correction tool, we obtained estimates of trough concentration by exponential extrapolation. Administered IMA dose was the main predictor of plasma concentrations. Higher trough concentrations tended to correlate with faster initial molecular response. The adult-derived target threshold of 1000 ng/mL proved applicable in paediatric practice. The developed algorithm outlines clinical decision points and consequences, which are key elements of existing intensified clinical pharmacological/pharmaceutical care programmes during oral antitumour therapy.

conclusionThe algorithm supports the use of TDM during paediatric IMA treatment, enabling early identification of exposure below the targeted concentration and variations in treatment efficacy to further improve treatment outcomes.

Indexed as

Antineoplastic AgentsDrug MonitoringImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositiveProtein Kinase InhibitorsAdolescentAlgorithmsChildChild, PreschoolFemaleFusion Proteins, bcr-ablHumansInfantMaleAntineoplastic AgentsFusion Proteins, bcr-ablImatinib MesylateProtein Kinase Inhibitors

Identifiers

PMID42154176
PMCPMC13356057

What Socratic holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.