Highly Variable Pharmacokinetics of Once-Daily Intravenous Busulfan When Combined with Fludarabine in Pediatric Patients: Phase I Clinical Study for Determination.

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Highly Variable Pharmacokinetics of Once-Daily Intravenous Busulfan When Combined with Fludarabine in Pediatric Patients: Phase I Clinical Study for Determination of Optimal Once-Daily Busulfan Dose Using Pharmacokinetic Modeling Ji Won Lee, Hyoung Jin Kang, Seung Hwan Lee, Kyung-Sang Yu, Nam Hee Kim, Yen Ju Yuk, Mi Kyoung Jang, Eun Jong Han, Hyery Kim, Sang Hoon Song, Kyung Duk Park, Hee Young Shin, In-Jin Jang, Hyo Seop Ahn Biology of Blood and Marrow Transplantation Volume 18, Issue 6, Pages 944-950 (June 2012) DOI: 10.1016/j.bbmt.2011.11.025 Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Variability of the first day AUC. Patients showed AUC that ranged from 12,079 to 31,660 μg∗h/L (median 16,824 μg∗h/L) after infusion of 120 mg/m2 busulfan on the first day. Biology of Blood and Marrow Transplantation 2012 18, 944-950DOI: (10.1016/j.bbmt.2011.11.025) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 Intraindividual variability of busulfan pharmacokinetics. Even after daily dose adjustment, AUC was highly variable among the days. Biology of Blood and Marrow Transplantation 2012 18, 944-950DOI: (10.1016/j.bbmt.2011.11.025) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 3 Clearances of the first and the last day. Clearances on the last day were significantly different from those of the first day (P = .001). Biology of Blood and Marrow Transplantation 2012 18, 944-950DOI: (10.1016/j.bbmt.2011.11.025) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 4 First day AUC according to the GST genotype. The first day AUC had a tendency to be high in patients with the GSTA1 ∗A/∗B genotype or the GSTT1 null genotype. Biology of Blood and Marrow Transplantation 2012 18, 944-950DOI: (10.1016/j.bbmt.2011.11.025) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 5 Liver toxicity according to the total and target AUC. Grade III/IV hepatic toxicities were more common in patients whose total AUC was over 77,000 μg∗h/L (P = .006) and in patients of group 1 (P = .007). Biology of Blood and Marrow Transplantation 2012 18, 944-950DOI: (10.1016/j.bbmt.2011.11.025) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions