Comparison of Two Analytical Methods for Busulfan Therapeutic Drug Monitoring.
Adolescent
Adult
Alkylating Agents
/ administration & dosage
Busulfan
/ administration & dosage
Child
Child, Preschool
Chromatography, High Pressure Liquid
/ methods
Cohort Studies
Drug Monitoring
/ methods
Female
Humans
Infant
Infusions, Intravenous
Male
Mass Spectrometry
/ methods
Middle Aged
Young Adult
Journal
European journal of drug metabolism and pharmacokinetics
ISSN: 2107-0180
Titre abrégé: Eur J Drug Metab Pharmacokinet
Pays: France
ID NLM: 7608491
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
pubmed:
25
11
2020
medline:
24
9
2021
entrez:
24
11
2020
Statut:
ppublish
Résumé
Busulfan (Bu) is an old drug, but is still well recommended as an alkylating agent during conditioning therapy, before hematopoietic stem cell transplantation. Although its dose administration is standardized and based on patient weight, therapeutic drug monitoring is required in order to maintain its exposure [as area under the concentration-time curve (AUC) from 0 to infinity AUC We analyzed 221 plasma samples from 37 children (0.25-16 years; 4-62.5 kg) and 11 adults (21-59 years; 45-80 kg), corresponding to 52 AUC values (ng h/mL). The drug exposure was calculated, simultaneously, by two validated analytical methods. The reference method was a high-performance liquid chromatography (HPLC) assay combined with an ultraviolet detector (UV). The test method had a triple quadrupole mass spectrometer (MS) as detector; the clean-up procedures of the samples were different and faster. The agreement between the two methods (reference and test) was evaluated in terms of Bu exposure differences based on Lin's concordance correlation coefficient (CCC) and represented by the Bland-Altman plot. The CCC between the AUC of the two methods was excellent (0.868; 95% CI: 0.802-0.935). The precision of the measures (expressed by Pearson's italic "r") was 0.872, and the accuracy (accounted by the bias correction factor) was 0.996. We can conclude that the HPLC-MS/MS assay represents a very good alternative to the reference.
Sections du résumé
BACKGROUND AND OBJECTIVES
OBJECTIVE
Busulfan (Bu) is an old drug, but is still well recommended as an alkylating agent during conditioning therapy, before hematopoietic stem cell transplantation. Although its dose administration is standardized and based on patient weight, therapeutic drug monitoring is required in order to maintain its exposure [as area under the concentration-time curve (AUC) from 0 to infinity AUC
METHODS
METHODS
We analyzed 221 plasma samples from 37 children (0.25-16 years; 4-62.5 kg) and 11 adults (21-59 years; 45-80 kg), corresponding to 52 AUC values (ng h/mL). The drug exposure was calculated, simultaneously, by two validated analytical methods. The reference method was a high-performance liquid chromatography (HPLC) assay combined with an ultraviolet detector (UV). The test method had a triple quadrupole mass spectrometer (MS) as detector; the clean-up procedures of the samples were different and faster.
RESULTS
RESULTS
The agreement between the two methods (reference and test) was evaluated in terms of Bu exposure differences based on Lin's concordance correlation coefficient (CCC) and represented by the Bland-Altman plot. The CCC between the AUC of the two methods was excellent (0.868; 95% CI: 0.802-0.935). The precision of the measures (expressed by Pearson's italic "r") was 0.872, and the accuracy (accounted by the bias correction factor) was 0.996.
CONCLUSIONS
CONCLUSIONS
We can conclude that the HPLC-MS/MS assay represents a very good alternative to the reference.
Identifiants
pubmed: 33231835
doi: 10.1007/s13318-020-00660-2
pii: 10.1007/s13318-020-00660-2
pmc: PMC7811982
doi:
Substances chimiques
Alkylating Agents
0
Busulfan
G1LN9045DK
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
155-159Références
Biol Blood Marrow Transplant. 2009 Feb;15(2):231-41
pubmed: 19167683
Bone Marrow Transplant. 2010 Feb;45(2):261-7
pubmed: 19584821
Cancer Chemother Pharmacol. 2003 Sep;52(3):209-16
pubmed: 12811512
Ther Drug Monit. 2018 Feb;40(1):84-92
pubmed: 29189665
Bone Marrow Transplant. 2000 Sep;26(5):463-70
pubmed: 11019834
Biol Blood Marrow Transplant. 2015 Aug;21(8):1471-8
pubmed: 25977229
Biometrics. 2002 Dec;58(4):1020-7
pubmed: 12495158
Bone Marrow Transplant. 1997 Dec;20(11):909-13
pubmed: 9422468
Biochem Med (Zagreb). 2015 Jun 05;25(2):141-51
pubmed: 26110027
Anticancer Drugs. 2006 Oct;17(9):1099-105
pubmed: 17001185
Bone Marrow Transplant. 1998 Aug;22(3):241-4
pubmed: 9720736
Pharmacogenomics. 2009 Nov;10(11):1729-32
pubmed: 19891548
Br J Clin Pharmacol. 2002 Apr;53(4):386-9
pubmed: 11966670
Pediatr Transplant. 2003;7 Suppl 3:12-8
pubmed: 12603688
Bone Marrow Transplant. 2005 Jan;35(1):17-23
pubmed: 15502853
J Clin Pharmacol. 2007 Jan;47(1):101-11
pubmed: 17192508
Theriogenology. 2010 Jun;73(9):1167-79
pubmed: 20138353