Three sample preparation methods for clinical determination of CDK4/6 inhibitors with endocrine therapy in breast cancer patient plasma using LC-MS: Cross-validation (red), ecological (green) and economical (blue) assessment.

Autor: Turković L; University of Zagreb Faculty of Pharmacy and Biochemistry, Department of Pharmaceutical Analysis, Ante Kovačića 1, Zagreb, Croatia., Mlinarić Z; University of Zagreb Faculty of Pharmacy and Biochemistry, Department of Pharmaceutical Analysis, Ante Kovačića 1, Zagreb, Croatia., Lovrić M; University Hospital Centre Zagreb, Department of Laboratory Diagnostics, Analytical Toxicology and Pharmacology Division, Kišpatićeva 12, Zagreb 10000, Croatia., Silovski T; University Hospital Centre Zagreb, Department of Oncology, Kišpatićeva 12, Zagreb 10000, Croatia; University of Zagreb School of Medicine, Šalata 2, Zagreb 10000, Croatia., Nigović B; University of Zagreb Faculty of Pharmacy and Biochemistry, Department of Pharmaceutical Analysis, Ante Kovačića 1, Zagreb, Croatia., Sertić M; University of Zagreb Faculty of Pharmacy and Biochemistry, Department of Pharmaceutical Analysis, Ante Kovačića 1, Zagreb, Croatia. Electronic address: miranda.sertic@pharma.unizg.hr.
Jazyk: angličtina
Zdroj: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2024 Nov 28; Vol. 255, pp. 116586. Date of Electronic Publication: 2024 Nov 28.
DOI: 10.1016/j.jpba.2024.116586
Abstrakt: Cyclin D-dependent kinase 4/6 inhibitors palbociclib, ribociclib and abemaciclib, in combination with aromatase inhibitors anastrozole and letrozole or oestrogen receptor degrader fulvestrant, are being assessed as candidates for therapeutic drug monitoring. An ideal bioanalytical method for their determination in patient plasma samples is therefore of high interest, as there is no routine reference method yet available in the clinical practice. In this work, three sample preparation approaches - dispersive liquid-liquid microextraction (DLLME), solid-phase extraction (SPE), and newly developed phospholipid removal (PLR) for LC-MS determination of these six drugs are comprehensively assessed. The methods are validated in the clinically relevant linear ranges with remarkable precision (RSD ≤6.9 %) and accuracy (bias -13.6 - 11.8 %). To compare the procedures in a real-world setting, they are applied on 38 samples from breast cancer patients. The differences between paired results are below 20 % for more than 92 % of the repeats and the RSD is ≤13.1 % between the corresponding results. Statistical comparison of the results reveals excellent overall agreement between the methods (Lin's concordance correlation coefficient ≥0.9969, maximal Bland-Altman bias 6.3 %). DLLME proved to be the most ecologically acceptable method due to the high degree of miniaturisation (AGREEprep score 0.44), PLR enabled very high sample throughput and cost-effectiveness (BAGI 72.5), while SPE showed the best analytical performance (redness score 100). All three methods are suitable for their designated purpose, and the choice of the ideal method can be made based on the scope of application, available funds and equipment and desired ecological footprint.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Tajana Silovski reports a relationship with Novartis Pharmaceuticals that includes: speaking and lecture fees. Tajana Silovski reports a relationship with Pfizer Inc that includes: speaking and lecture fees. Tajana Silovski reports a relationship with Elly Lili that includes: speaking and lecture fees. Other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024. Published by Elsevier B.V.)
Databáze: MEDLINE
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