Therapeutic drug monitoring of imatinib in paediatric chronic myeloid leukaemia: Data from a real-world setting

Suttorp M, Sembill S, Lensker P, Hildebrand V, Schirmer E, Karow A, Krumbholz M, Rauh M, Metzler M (2025)

Publication Type: Journal article

Publication year: 2025

Journal

British Journal of Haematology Wiley-Blackwell

DOI: 10.1111/bjh.20047

Abstract

Imatinib (IMA) therapy for paediatric chronic myeloid leukemia (pCML) requires age-dependent dose adjustments. Assessment of therapeutic drug monitoring (TDM) under ‘real-world’ conditions was performed. Collection of blood and TDM-relevant data, calculation of individual dosage exposure, measurement of plasma Cmin (IMA, Nor-IMA) by HPLC/MS-MS and recording of adverse event (AE). Two hundred and forty-six specimens from 66 patients were analysed. Individual median IMA dosage exposure was 253 mg/m2 (range: 128–504). Children <13 years received a median of 43 mg/m2 more than older patients (p < 0.0001). Median Cmin of IMA and Nor-IMA was 1017 ng/mL (range: 51–3976) and 269 ng/mL (range: 21–981), respectively, correlating significantly with the prescribed dose. At 5/246 visits, non-adherence was confirmed by very low IMA Cmin in 3/66 patients, all ≥13 years old. Correlation of IMA Cmin >1000 ng/mL with achieving OMR demonstrated in each 63% (N = 24/37, N = 27/43, respectively) patients at months 3 and 6. In the cohort with lower levels, only 23% and 50%, respectively, achieved these milestones. This difference was significant only at month 3. Of 66 patients, 30 reported 125 AEs with gastrointestinal and musculoskeletal as leading complaints. In 9.3% of AEs, the correlated IMA Cmin was ≥3000 ng/mL. TDM is a simple and rapid additional tool for managing pCML under ‘real-world conditions’.

Authors with CRIS profile

Stephanie Sembill Department of Paediatrics and Adolescent Medicine Phyllis Lensker Lehrstuhl für Klinische Pharmakologie und Klinische Toxikologie Verena Hildebrand Professur für Kinder- und Jugendmedizin mit dem Schwerpunkt Pädiatrische Onkologie und Hämatologie Axel Karow Medizinische Fakultät Manuela Krumbholz Department of Paediatrics and Adolescent Medicine Manfred Rauh Department of Paediatrics and Adolescent Medicine Markus Metzler Professur für Kinder- und Jugendmedizin mit dem Schwerpunkt Pädiatrische Onkologie und Hämatologie

Involved external institutions

Universitätsklinikum Carl Gustav Carus Dresden DE Germany (DE)

How to cite

APA:

Suttorp, M., Sembill, S., Lensker, P., Hildebrand, V., Schirmer, E., Karow, A.,... Metzler, M. (2025). Therapeutic drug monitoring of imatinib in paediatric chronic myeloid leukaemia: Data from a real-world setting. British Journal of Haematology. https://doi.org/10.1111/bjh.20047

MLA:

Suttorp, Meinolf, et al. "Therapeutic drug monitoring of imatinib in paediatric chronic myeloid leukaemia: Data from a real-world setting." British Journal of Haematology (2025).

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