Pharmacokinetics and Model-Based Dosing to Optimize Fludarabine Therapy in Pediatric Hematopoietic Cell Transplant Recipients Vijay Ivaturi, Christopher.

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Pharmacokinetics and Model-Based Dosing to Optimize Fludarabine Therapy in Pediatric Hematopoietic Cell Transplant Recipients Vijay Ivaturi, Christopher C. Dvorak, Danna Chan, Tao Liu, Morton J. Cowan, Justin Wahlstrom, Melisa Stricherz, Cathryn Jennissen, Paul J. Orchard, Jakub Tolar, Sung-Yun Pai, Liusheng Huang, Francesca Aweeka, Janel Long-Boyle Biology of Blood and Marrow Transplantation Volume 23, Issue 10, Pages 1701-1713 (October 2017) DOI: 10.1016/j.bbmt.2017.06.021 Copyright © 2017 The American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Individual fit plots of observed and predicted time concentration data of (A) f-ara-a and (B) f-ara-ATP for several representative patients. Open circles represent the observed concentrations, black solid line is the population prediction, and the dashed line is the individual prediction. Biology of Blood and Marrow Transplantation 2017 23, 1701-1713DOI: (10.1016/j.bbmt.2017.06.021) Copyright © 2017 The American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 Model-predicted dose of fludarabine in mg/kg aimed to achieve an daily AUC target of 4.5 mg*hour/L for (A) ages .2 to 20 years of age with varying degrees of renal function and (B) ages 0 to 2 years of age with varying degrees of renal function. Biology of Blood and Marrow Transplantation 2017 23, 1701-1713DOI: (10.1016/j.bbmt.2017.06.021) Copyright © 2017 The American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 3 OS for all subjects at 1 year after HCT. (A) Shows the proportion of patients surviving plotted by observed f-ara- cAUC quartile and regardless of diagnosis. (B) displays the OS stratified by malignant or nonmalignant diagnosis. Biology of Blood and Marrow Transplantation 2017 23, 1701-1713DOI: (10.1016/j.bbmt.2017.06.021) Copyright © 2017 The American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 4 OS at 1 year after HCT for patients with a nonmalignant diagnosis presented by f-ara-a cAUC quartiles. Biology of Blood and Marrow Transplantation 2017 23, 1701-1713DOI: (10.1016/j.bbmt.2017.06.021) Copyright © 2017 The American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 5 DFS in patients with malignant disease only at 1 year after HCT. (A) Shows box plots of the proportion of patients with DFS by observed f-ara- cAUC quartiles. (B) Displays survival curves for the proportion of patients with DFS stratified by f-ara-a cAUC quartiles of observed data. Biology of Blood and Marrow Transplantation 2017 23, 1701-1713DOI: (10.1016/j.bbmt.2017.06.021) Copyright © 2017 The American Society for Blood and Marrow Transplantation Terms and Conditions