A Simple Dosing Scheme for Intravenous Busulfan Based on Retrospective Population Pharmacokinetic Analysis in Korean Patients
![]() |
Choe, Sang-Min
(Department of Clinical Pharmacology & Therapeutics, University of Ulsan College of Medicine, Asan Medical Center)
Kim, Gayeong (Department of Clinical Pharmacology & Therapeutics, University of Ulsan College of Medicine, Asan Medical Center) Lim, Hyeong-Seok (Department of Clinical Pharmacology & Therapeutics, University of Ulsan College of Medicine, Asan Medical Center) Cho, Sang-Heon (Department of Clinical Pharmacology & Therapeutics, University of Ulsan College of Medicine, Asan Medical Center) Ghim, Jong-Lyul (Department of Clinical Pharmacology & Therapeutics, University of Ulsan College of Medicine, Asan Medical Center) Jung, Jin-Ah (Department of Clinical Pharmacology & Therapeutics, University of Ulsan College of Medicine, Asan Medical Center) Kim, Un-Jib (Department of Clinical Pharmacology & Therapeutics, University of Ulsan College of Medicine, Asan Medical Center) Noh, Gyu-Jeong (Department of Clinical Pharmacology & Therapeutics, University of Ulsan College of Medicine, Asan Medical Center) Bae, Kyun-Seop (Department of Clinical Pharmacology & Therapeutics, University of Ulsan College of Medicine, Asan Medical Center) Lee, Dong-Ho (Department of Clinical Pharmacology & Therapeutics, University of Ulsan College of Medicine, Asan Medical Center) |
1 | Schiltmeyer B, Klingebiel T, Schwab M, Mürdter TE, Ritter CA, Jenke A, Ehninger G, Gruhn B, Würthwein G, Boos J, Hempel G. Population pharmacokinetics of oral busulfan in children. Cancer Chemother Pharmacol. 2003;52:209-216. DOI ScienceOn |
2 | Poonkuzhali B, Chandy M, Srivastava A, Dennison D, Krishnamoorthy R. Glutathione S-transferase activity influences busulfan pharmacokinetics in patients with beta thalassemia major undergoing bone marrow transplantation. Drug Metabolism and Disposition. 2001;29:264-267. |
3 | Gibbs JP, Liacouras CA, Baldassano RN, Slattery JT. Up-regulation of glutathione S-transferase activity in enterocytes of young children. Drug Metab Dispos. 1999;27:1466-1469. |
4 | Gibbs JP, Gooley T, Corneau B, Murray G, Stewart P, Appelbaum FR, Slattery JT. The impact of obesity and disease on busulfan oral clearance in adults. Blood. 1999;93:4436-4440. |
5 | Devine D. Case study number 25 gentamicin therapy. Drug Intell Clin Pharm. 1974;8:650-655. |
6 | Vaughan WP, Carey D, Perry S, Westfall AO, Salzman DE. A limited sampling strategy for pharmacokinetic directed therapy with intravenous busulfan. Biol Blood Marrow Transplant. 2002;8:619-624. DOI ScienceOn |
7 | Arand M, Muhlbauer R, Hengstler J, Jager E, Fuchs J, Winkler L, Oesch F. A multiplex polymerase chain reaction protocol for the simultaneous analysis of the glutathione S-transferase GSTM1 and GSTT1 polymorphisms. Anal Biochem. 1996;236: 184-186. DOI ScienceOn |
8 | dos Reis EO, Vianna-Jorge R, Suarez-Kurtz G, Lima EL, Azevedo Dde A. Development of a rapid and specific assay for detection of busulfan in human plasma by high-performance liquid chromatography/electrospray ionization tandem mass spectrometry. Rapid Commun Mass Spectrom. 2005;19:1666-1674. DOI ScienceOn |
9 | Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41. DOI |
10 | Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987;317:1098. |
11 | Du Bois D, Du Bois EF. A formula to estimate the approximate surface area if height and weight be known. 1916. Nutrition. 1989;5:303-311. |
12 | Haycock GB, Schwartz GJ, Wisotsky DH. Geometric method for measuring body surface area: a height-weight formula validated in infants, children, and adults. J Pediatr. 1978;93: 62-66. DOI |
13 | Gehan EA, George SL. Estimation of human body surface area from height and weight. Cancer Chemother Rep. 1970;54:225-235. |
14 | Boyd E. The Growth of the Surface Area of the Human Body. London: University of Minnesota; 1935. |
15 | Mandema JW, Verotta D, Sheiner LB. Building population pharmacokinetic--pharmacodynamic models. I. Models for covariate effects. J Pharmacokinet Biopharm. 1992;20:511-528. DOI ScienceOn |
16 | Jonsson EN, Karlsson MO. Xpose--an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed. 1999;58:51-64. |
17 | Wahlby U, Jonsson EN, Karlsson MO. Assessment of actual significance levels for covariate effects in NONMEM. J Pharmacokinet Pharmacodyn. 2001;28:231-252. DOI ScienceOn |
18 | Cook RD, Weisberg S. Residuals and Influence in Regression. New York: Chapman and Hall; 1982. |
19 | Christensen R, Pearson LM, Johnson W. Case-Deletion diagnostics for mixed models. Technometrics. 1992;34:38-45. DOI ScienceOn |
20 | Booth BP, Rahman A, Dagher R, Griebel D, Lennon S, Fuller D, Sahajwalla C, Mehta M, Gobburu JV. Population pharmacokinetic- based dosing of intravenous busulfan in pediatric patients. J Clin Pharmacol. 2007;47:101-111. DOI ScienceOn |
21 | Takama H, Tanaka H, Nakashima D, Ueda R, Takaue Y. Population pharmacokinetics of intravenous busulfan in patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant. 2006;37:345-351. DOI ScienceOn |
22 | Sandstrom M, Karlsson MO, Ljungman P, Hassan Z, Jonsson EN, Nilsson C, Ringden O, Oberg G, Bekassy A, Hassan M. Population pharmacokinetic analysis resulting in a tool for dose individualization of busulphan in bone marrow transplantation recipients. Bone Marrow Transplant. 2001;28:657-664. DOI ScienceOn |
23 | Slattery JT, Clift RA, Buckner CD, Radich J, Storer B, Bensinger WI, Soll E, Anasetti C, Bowden R, Bryant E, Chauncey T, Deeg HJ, Doney KC, Flowers M, Gooley T, Hansen JA, Martin PJ, Mcdonald GB, Nash R, Petersdorf EW, Sanders JE, Schoch G, Stewart P, Storb R, Sullivan KM, Thomas ED, Witherspoon RP, Appelbaum FR. Marrow transplantation for chronic myeloid leukemia: the influence of plasma busulfan levels on the outcome of transplantation. Blood. 1997;89:3055-3060. |
24 | Nguyen L, Leger F, Lennon S, Puozzo C. Intravenous busulfan in adults prior to haematopoietic stem cell transplantation: a population pharmacokinetic study. Cancer Chemother Pharmacol. 2006;57:191-198. DOI ScienceOn |
25 | Ehrsson H, Hassan M, Ehrnebo M, Beran M. Busulfan kinetics. Clin Pharmacol Ther. 1983;34:86-89. DOI ScienceOn |
26 | Hassan M, Oberg G, Ehrsson H, Ehrnebo M, Wallin I, Smedmyr B, Tötterman T, Eksborg S, Simonsson B. Pharmacokinetic and metabolic studies of high-dose busulphan in adults. Eur J Clin Pharmacol. 1989;36:525-530. DOI ScienceOn |
27 | Grochow LB. Busulfan disposition: the role of therapeutic monitoring in bone marrow transplantation induction regimens. Semin Oncol. 1993;20(4 Suppl 4):18-25. |
28 | Dix SP, Wingard JR, Mullins RE, Jerkunica I, Davidson TG, Gilmore CE, York RC, Lin LS, Devine SM, Geller RB, Heffner LT, Hillyer CD, Holland HK, Winton EF, Saral R. Association of busulfan area under the curve with veno-occlusive disease following BMT. Bone Marrow Transplant. 1996;17:225-230. |
29 | Andersson BS, Thall PF, Madden T, Couriel D, Wang X, Tran HT, Anderlini P, de Lima M, Gajewski J, Champlin RE. Busulfan systemic exposure relative to regimen-related toxicity and acute graft-versus-host disease: defining a therapeutic window for i.v. BuCy2 in chronic myelogenous leukemia. Biol Blood Marrow Transplant. 2002;8:477-485. DOI ScienceOn |
30 | Drugs@FDA. [cited 2009 11 Sep]; Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=BUSULFEX. |
31 | Hassan M, Oberg G, Ehrsson H, Ehrnebo M, Wallin I, Smedmyr B, Totterman T, Eksborg S, Simonsson B. Pharmacokinetic and metabolic studies of high-dose busulphan in adults. Eur J Clin Pharmacol. 1989;36:525-530. DOI ScienceOn |
32 | Hassan M, Oberg G, Bekassy AN, Aschan J, Ehrsson H, Ljungman P, Lönnerholm G, Smedmyr B, Taube A, Wallin I, et al. Pharmacokinetics of high-dose busulphan in relation to age and chronopharmacology. Cancer Chemother Pharmacol. 1991;28:130-134. DOI ScienceOn |
33 | Grochow LB, Jones RJ, Brundrett RB, Braine HG, Chen TL, Saral R, Santos GW, Colvin OM. Pharmacokinetics of busulfan: correlation with veno-occlusive disease in patients undergoing bone marrow transplantation. Cancer Chemother Pharmacol. 1989;25:55-61. DOI ScienceOn |
34 | Ryu SG, Lee JH, Choi SJ, Lee JH, Lee YS, Seol M, Hur EH, Lee SH, Bae KS, Noh GJ, Lee MS, Yun SC, Han SB, Lee KH. Randomized comparison of four-times-daily versus once-daily intravenous busulfan in conditioning therapy for hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2007;13: 1095-1105. DOI ScienceOn |
35 | Schag CC, Heinrich RL, Ganz PA. Karnofsky performance status revisited: reliability, validity, and guidelines. J Clin Oncol. 1984;2:187-193. DOI |
36 | Schuler US, Ehrsam M, Schneider A, Schmidt H, Deeg J, Ehninger G. Pharmacokinetics of intravenous busulfan and evaluation of the bioavailability of the oral formulation in conditioning for haematopoietic stem cell transplantation. Bone Marrow Transplant. 1998;22:241-244. DOI ScienceOn |
![]() |