Clinical validation study of dried blood spot for determining everolimus concentration in patients with cancer

Autor: Sander Croes, Y. M. de Beer, Roger J. M. Brüggemann, Lotte M. Knapen, Annelieke E.C.A.B. Willemsen, N. P. van Erp, C.M.L. van Herpen
Přispěvatelé: RS: CAPHRI - R5 - Optimising Patient Care, Promovendi PHPC, MUMC+: DA KFT Medische Staf (9), MUMC+: DA KFT Laboratorium (9)
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Method agreement
Male
PHARMACOKINETICS
CYCLOSPORINE-A
TACROLIMUS
Dried blood spot
Hematocrit
030226 pharmacology & pharmacy
0302 clinical medicine
RENAL-CELL CARCINOMA
Tandem Mass Spectrometry
Neoplasms
Pharmacology (medical)
Drug Dosage Calculations
Everolimus/administration & dosage
GeneralLiterature_REFERENCE(e.g.
dictionaries
encyclopedias
glossaries)
Whole blood
Cancer
Chromatography
Liquid
medicine.diagnostic_test
General Medicine
Middle Aged
3. Good health
Antineoplastic Agents/administration & dosage
PHASE-I
Urological cancers Radboud Institute for Health Sciences [Radboudumc 15]
030220 oncology & carcinogenesis
Predictive value of tests
Neoplasms/blood
Female
Drug Monitoring
HEMATOCRIT
Drug Monitoring/methods
Rare cancers Radboud Institute for Health Sciences [Radboudumc 9]
medicine.drug
Adult
medicine.medical_specialty
Urology
Antineoplastic Agents
Therapeutic drug monitoring
03 medical and health sciences
All institutes and research themes of the Radboud University Medical Center
Predictive Value of Tests
medicine
Humans
Clinical significance
Everolimus
EXPOSURE
TANDEM MASS-SPECTROMETRY
Dried Blood Spot Testing
Aged
Pharmacology
business.industry
Reproducibility of Results
Pharmacokinetics and Disposition
PERFORMANCE
lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4]
business
NEUROENDOCRINE TUMORS
Chromatography
Liquid
Zdroj: European Journal of Clinical Pharmacology
European Journal of Clinical Pharmacology, 74, 465-471
European Journal of Clinical Pharmacology, 74(4), 465-471. Springer
European Journal of Clinical Pharmacology, 74, 4, pp. 465-471
ISSN: 1432-1041
0031-6970
DOI: 10.1007/s00228-017-2394-0
Popis: Purpose Everolimus treatment is seriously hampered by its toxicity profile. As a relationship between everolimus exposure and effectiveness and toxicity has been established, early and ongoing concentration measurement can be key to individualize the dose and optimize treatment outcomes. Dried blood spot (DBS) facilitates sampling at a patients’ home and thereby eases dose individualization. The aim of this study is to determine the agreement and predictive performance of DBS compared to whole blood (WB) to measure everolimus concentrations in cancer patients. Methods Paired DBS and WB samples were collected in 22 cancer patients treated with everolimus and analyzed using UPLC-MS/MS. Bland-Altman and Passing-Bablok analysis were used to determine method agreement. Limits of clinical relevance were set at a difference of ± 25%, as this would lead to a different dosing advice. Using DBS concentration and Passing-Bablok regression analysis, WB concentrations were predicted. Results Samples of 20 patients were suitable for analysis. Bland-Altman analysis showed a mean ratio of everolimus WB to DBS concentrations of 0.90, with 95% of data points within limits of clinical relevance. Passing-Bablok regression of DBS compared to WB revealed no constant bias (intercept 0.02; 95% CI 0.93–1.35) and a small proportional bias (slope 0.89; 95% CI 0.76–0.99). Predicted concentrations showed low bias and imprecision and 90% of samples had an absolute percentage prediction error of
Databáze: OpenAIRE
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