Predictive performance of a busulfan pharmacokinetic model in children and young adults

Therapeutic Drug Monitoring

Volumn 34, Issue 5, 2012, Pages 574-583

  Bartelink, Imke H ^a,b   Van Kesteren, Charlotte ^b   Boelens, Jaap J ^a   Egberts, Toine C G ^a,c   Bierings, Marc B ^a   Cuvelier, Geoff D E ^d   Wynn, Robert F ^e   Slatter, Mary A ^f   Chiesa, Robert ^g,h   Danhof, Meindert ^b   Knibbe, Catherijne A J ^b,i  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b LEIDEN UNIVERSITY   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

^d UNIVERSITY OF MANITOBA   (Canada)

^e ROYAL MANCHESTER CHILDREN S HOSPITAL   (United Kingdom)

^f NEWCASTLE UNIVERSITY   (United Kingdom)

^g GREAT ORMOND STREET HOSPITAL   (United Kingdom)

^h SAN RAFFAELE SCIENTIFIC INSTITUTE   (Italy)

ⁱ ST ANTONIUS HOSPITAL   (Netherlands)

Author keywords

children; external validation; hematopoeitic stem cell transplantation; population pharmacokinetics; under overweight

Indexed keywords

BUSULFAN;

AGE DISTRIBUTION; ARTICLE; BODY MASS; BODY WEIGHT; DRUG BLOOD LEVEL; ETHNICITY; HEALTH CARE FACILITY; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; MAJOR CLINICAL STUDY; OBESITY; PEDIATRICS; POPULATION; PREDICTION; PRIORITY JOURNAL; THALASSEMIA; UNDERWEIGHT;

ADOLESCENT; ADULT; AGE FACTORS; AREA UNDER CURVE; BODY MASS INDEX; BODY WEIGHT; BUSULFAN; CHILD; CHILD, PRESCHOOL; DISEASE-FREE SURVIVAL; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INFANT; INFANT, NEWBORN; MODELS, BIOLOGICAL; PREDICTIVE VALUE OF TESTS; YOUNG ADULT;

EID: 84866556540     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e31826051bb     Document Type: Article

References (30)

1. Ciurea SO, Andersson BS. Busulfan in hematopoietic stem cell transplantation 1. Biol Blood Marrow Transplant. 2009;15:523-536.
2. Kletzel M, Jacobsohn D, Duerst R. Pharmacokinetics of a test dose of intravenous busulfan guide dose modifications to achieve an optimal area under the curve of a single daily dose of intravenous busulfan in children undergoing a reduced-intensity conditioning regimen with hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2006;12:472-479.
3. Poonkuzhali B, Chandy M, Srivastava A, et al. Glutathione S-transferase activity influences busulfan pharmacokinetics in patients with beta thal-assemia major undergoing bone marrow transplantation. Drug Metab Dispos. 2001;29:264-267.
4. Russell JA, Kangarloo SB. Therapeutic drug monitoring of busulfan in transplantation. Curr Pharm Des. 2008;14:1936-1949.
5. Tse WT, Duerst R, Schneiderman J, et al. Age-dependent pharmacoki-netic profile of single daily dose i.v. busulfan in children undergoing reduced-intensity conditioning stem cell transplant. Bone Marrow Transplant. 2009;44:145-156.
6. Wall DA, Chan KW, Nieder ML, et al. Safety, efficacy, and pharmaco-kinetics of intravenous busulfan in children undergoing allogeneic he-matopoietic stem cell transplantation. Pediatr Blood Cancer. 2010;54:291-298.
7. Zwaveling J, Press RR, Bredius RG, et al. Glutathione S-transferase polymorphisms are not associated with population pharmacokinetic parameters of busulfan in pediatric patients. Ther Drug Monit. 2008;30:504-510.
8. McCune JS, Gibbs JP, Slattery JT. Plasma concentration monitoring of busulfan: does it improve clinical outcome? Clin Pharmacokinet. 2000; 39:155-165.
9. Slattery JT, Clift RA, Buckner CD, et al. Marrow transplantation for chronic myeloid leukemia: the influence of plasma busulfan levels on the outcome of transplantation. Blood. 1997;89:3055-3060.
10. Bartelink IH, Bredius RG, Belitser SV, et al. Association between busulfan exposure and outcome in children receiving intravenous busul-fan before hematologic stem cell transplantation. Biol Blood Marrow Transplant. 2009;15:231-241.
11. Bartelink IH, Boelens JJ, Bredius RGM, et al. Body weight-dependent pharmacokinetics of busulfan in pediatric hematopoietic stem cell transplantation patients: towards individualized dosing. Clinical Pharmacoki-netics. 2012;51:331-345.
12. Ince I, de Wildt SN, Tibboel D, et al. Tailor-made drug treatment for children: creation of an infrastructure for data-sharing and population PK-PD modeling. Drug Discov Today. 2009;14:316-320.
13. Chiesa R, Cappelli B, Crocchiolo R, et al. Unpredictability of intravenous busulfan pharmacokinetics in children undergoing hematopoietic stem cell transplantation for advanced beta thalassemia: limited toxicity with a dose-adjustment policy1. Biol Blood Marrow Transplant. 2010;16:622-628.
14. Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/growthcharts/percentile-data-files.htm. Accessed May 30, 2000. September 1, 2011.
15. Ogden CL, Kuczmarski RJ, Flegal KM, et al. Centers for Disease Control and Prevention 2000 growth charts for the United States: improvements to the 1977 National Center for Health Statistics version. Pediatrics. 2002;109:45-60.
16. Brendel K, Comets E, Laffont C, et al. Metrics for external model evaluation with an application to the population pharmacokinetics of glicla-zide. Pharm Res. 2006;23:2036-2049.
17. Comets E, Brendel K, Mentre F. Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: the NPDE addon package for R. Comput Methods Programs Biomed. 2008;90:154-166.
18. Inokuchi M, Matsuo N, Takayama JI, et al. BMI z-score is the optimal measure of annual adiposity change in elementary school children. Ann Hum Biol. 2011;38:747-751.
19. Cole TJ, Faith MS, Pietrobelli A, et al. What is the best measure of adiposity change in growing children: BMI, BMI %, BMI z-score or BMI centile? Eur J Clin Nutr. 2005;59:419-425.
20. Tod M, Jullien V, Pons G. Facilitation of drug evaluation in children by population methods and modelling. Clin Pharmacokinet. 2008;47:231-243.
21. Brendel K, Dartois C, Comets E, et al. Are population pharmacokinetic and/or pharmacodynamic models adequately evaluated? A survey of the literature from 2002 to 2004. Clin Pharmacokinet. 2007;46:221-234.
22. Krekels EH, DeJongh J, van Lingen RA, et al. Predictive performance of a recently developed population pharmacokinetic model for morphine and its metabolites in new datasets of (preterm) neonates, infants and children. Clin Pharmacokinet. 2011;50:51-63.
23. Abdi ZD, Paci A, Moshous D, et al. Screening fo potential covariates influencing the pharmacokinetics of intravenous busulfan: results from a large pediatric cohort undergoing hematopoietic stem-cell transplantation. Available at: http://ash.confex.com/ash/2010/webprogram/Paper28407.html. 9-15-0011. Accessed September 1, 2011.
24. Browning B, Thormann K, Donaldson A, et al. Busulfan dosing in children with BMIs./=85% undergoing HSCT: a new optimal strategy. Biol. Blood Marrow Transplant. 2011;17:1383-1388.
25. Gibbs JP, Gooley T, Corneau B, et al. The impact of obesity and disease on busulfan oral clearance in adults. Blood. 1999;93:4436-4440.
26. Nguyen L, Leger F, Lennon S, et al. Intravenous busulfan in adults prior to haematopoietic stem cell transplantation: a population pharmacoki-netic study. Cancer Chemother Pharmacol. 2006;57:191-198.
27. Kearns GL, bdel-Rahman SM, Alander SW, et al. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349:1157-1167.
28. Boullata JI. Drug disposition in obesity and protein-energy malnutrition. Proc Nutr Soc. 2010;69:543-550.
29. Ince I, de Wildt SN, Tibboel D, et al. Tailor-made drug treatment for children: creation of an infrastructure for data-sharing and population PK-PD modeling. Drug Discov Today. 2009;14:316-320.
30. Wahlby U, Jonsson EN, Karlsson MO. Comparison of stepwise covariate model building strategies in population pharmacokinetic-pharmacodynamic analysis. AAPS.PharmSci. 2002;4:E27.