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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.

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

1 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 (June 2012) DOI: /j.bbmt Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

2 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  , DOI: ( /j.bbmt ) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

3 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  , DOI: ( /j.bbmt ) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

4 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  , DOI: ( /j.bbmt ) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

5 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  , DOI: ( /j.bbmt ) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

6 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  , DOI: ( /j.bbmt ) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

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