Population pharmacokinetics of oral busulfan in young Japanese children before hematopoietic stem cell transplantation

Therapeutic Drug Monitoring

Volumn 30, Issue 1, 2008, Pages 75-83

  Nakamura, Hiroyoshi ^a   Sato, Takeyuki ^a   Okada, Kenji ^a   Miura, Go ^a   Ariyoshi, Noritaka ^a   Nakazawa, Kazuyoshi ^a   Kitada, Mitsukazu ^a  

^a CHIBA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

Busulfan; Hematopoietic stem cell transplantation; Population pharmacokinetics; Therapeutic drug monitoring; Young children

Indexed keywords

ASPARTATE AMINOTRANSFERASE; BUSULFAN; CLONAZEPAM; VALPROIC ACID;

ACUTE LYMPHOBLASTIC LEUKEMIA; ACUTE NONLYMPHOCYTIC LEUKEMIA; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; CHILD; CHRONIC MYELOID LEUKEMIA; COMPARTMENT MODEL; CONTROLLED STUDY; DEMOGRAPHY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG MEGADOSE; DRUG MONITORING; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; INFANT; JAPANESE; LYMPHOMA; MAJOR CLINICAL STUDY; MALE; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; SEIZURE; TREATMENT INDICATION; TREATMENT RESPONSE;

AGE FACTORS; AREA UNDER CURVE; ASIAN CONTINENTAL ANCESTRY GROUP; ASPARTATE AMINOTRANSFERASES; BUSULFAN; CHILD; CHILD, PRESCHOOL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INFANT; JAPAN; MALE; METABOLIC CLEARANCE RATE; MODELS, BIOLOGICAL;

EID: 38549155710     PISSN: 01634356     EISSN: None     Source Type: Journal    
DOI: 10.1097/FTD.0b013e3181621cde     Document Type: Article

References (30)

1. Giorgiani G, Bozzola M, Locatelli F, et al. Role of busulfan and total body irradiation on growth of prepubertal children receiving bone marrow transplantation and results of treatment with recombinant human growth hormone. Blood. 1995;86:825-831.
2. Santos GW, Tutschka PJ, Brookmeyer R, et al. Marrow transplantation for acute nonlymphocytic leukemia after treatment with busulfan and cyclophosphamide. N Engl J Med. 1983;309:1347-1353.
3. Grochow LB, Krivit W, Whitley CB, et al. Busulfan disposition in children. Blood. 1990;75:1723-1727.
4. Hassan M, Oberg G, Bekassy AN, et al. Pharmacokinetics of high-dose busulfan in relation to age and chronopharmacology. Cancer Chemother Pharmacol. 1991;28:130-134.
5. Parkman R, Rappeport JM, Hellman S, et al. Busulfan and total body irradiation asantihematopoietic stem cell agents in the preparation of patients with congenital bone marrow disorders for allogeneic bone marrow transplantation. Blood. 1984;64:852-857.
6. McDonald GB, Sharma P, Matthews DE, et al. Venoocclusive disease of the liver after bone marrow transplantation: diagnosis, incidence, and predisposing factors. Hepatology. 1984;4:116-122.
7. Lucarelli G, Polchi P, Izzi T, et al. Marrow transplantation for thalassemia after treatment with busulfan and cyclophosphamide. Ann NY Acad Sci. 1985;445:428-431.
8. Blazar BR, Ramsay NK, Kersey JH, et al. Pre-transplant conditioning with busulfan (Myleran) and cyclophosphamide for non-malignant diseases. Assessment of engraftment following histocompatible allogeneic bone marrow transplantation. Transplantation. 1985;39:597-603.
9. Hartmann O, Benhamou E, Beaujean F, et al. High-dose busulfan and cyclophosphamide with autologous bone marrow transplantation support in advanced malignancies in children: a phase II study. J Clin Oncol. 1986;4:1804-1810.
10. Jones RJ, Lee KS, Beschorner WE, et al. Venoocclusive disease of the liver following bone marrow transplantation. Transplantation. 1987;44:778-783.
11. Slattery JT, Sanders JE, Buckner CD, et al. Graft-rejection and toxicity following bone marrow transplantation in relation to busulfan pharmacokinetics. Bone Marrow Transplant. 1995;16:31-42.
12. Boelinger AM, Zangwill AB, Slattery JT, et al. An evaluation of engraftment, toxicity and busulfan concentration in children receiving bone marrow transplantation for leukemia or genetic disease. Bone Marrow Transplant. 2000;25:925-930.
13. Chattergoon DS, Saunders EF, Klein J, et al. An improved limited sampling method for individualized busulfan dosing in bone marrow transplantation in children. Bone Marrow Transplant. 1997;20:347-354.
14. Schuler U, Schroer S, Kuhnle A, et al. Busulphan pharmacokinetics in bone marrow transplant patient patients: is drug monitoring warranted? Bone Marrow Transplant. 1994;14:759-765.
15. Vassal G, Fischer A, Challine D, et al. Busulphan disposition below the age of three: alteration in children with lysosomal storage disease. Blood. 1993;82:1030-1034.
16. Hassan M, Ljungman P, Bolme P, et al. Busulfan bioavailability. Blood. 1994;84:2144-2150.
17. Hassan M, Fath A, Gerritsen B, et al. Busulfan kinetics and limit sampling model in children with leukemia and inherited disorders. Bone Marrow Transplant. 1996;18:843-850.
18. Vassal G, Koscielny S, Challine D, et al. Busulfan disposition and hepatic veno-occlusive disease in children undergoing bone marrow transplantation. Cancer Chemother Pharmacol. 1996;37:247-253.
19. Tran HT, Madden T, Petropous D, et al. Individualization high-dose oral busulfan: prospective dose adjustment in a pediatric population undergoing allogeneic stem cell transplantation for advanced hematologic malignancies. Bone Marrow Transplant. 2000;26:463-470.
20. US Food and Drug Administration (FDA). Guidance for Industry: Population Pharmacokinetics. Washington, DC: US FDA; 1999.
21. Peris JE, Latorre JA, Castel V, et al. Determination of busulfan in human plasma using high-performance liquid chromatography with precolumn derivatization and fluorescence detection. J Chromatogr B. 1999;730:33-40.
22. Johnsson EN, Karlsson MO. Xpose - an S-PLUS based population pharmacokinetic-pharmacodynamic model building aid for NONMEM. Comp Meth Prog Biomed. 1998;58:51-64.
23. Parke V, Halford NHG, Charles BG. A procedure for generating bootstrap samples for the validation of non linear mixed-effects population models. Comput Methods Program Biomed. 1999;59:19-29.
24. Nguyen L, Fuller D, Lennon S, et al. IV busulfan in pediatrics: a novel dosing to improve safety/efficacy for hematopoietic progenitor cell transplantation recipients. Bone Marrow Transplant. 2004;33:979-987.
25. Gibbs JP, Czerwinski M, Slattery JT. Busulfan-glutathione conjugation catalyzed by human liver cytosolic glutathione S-transferases. Cancer Res. 1996;56:3678-3681.
26. Strange RC, Howie AF, Hume R, et al. The development expression of alpha-, mu- and pi-class glutathione S-transferases in human liver. Biochim Biophys Acta. 1989;993:186-190.
27. Czerwinski M, Gibbs JP, Slattery JT. Busulfan conjugation by glutathione S-transferases alpha, mu, and pi. Drug Metab Dispos. 1996;24:1015-1019.
28. Bredschneider M, Klein K, Murdter TE, et al. Genetic polymorphisms of glutathione S-transferase A1, the major glutathione S-transferase in human liver: consequences for enzyme expression and busulfan conjugation. Clin Pharmacol Ther. 2002;71:479-487.
29. Kusama M, Kubota T, Matsukura Y, et al. Influence of glutathione Stransferase A1 polymorphism on the pharmacokinetics of busulfan. Clin Chim Acta. 2006;368:93-98.
30. Hassan M, Oberg G, Bjorkholm M, et al. Influence of prophylactic anticonvulsant therapy on high-dose busulphan kinetics. Cancer Chemother Pharmacol. 1993;33:181-186.