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      Once-daily intravenous busulfan with therapeutic drug monitoring compared to conventional oral busulfan improves survival and engraftment in children undergoing allogeneic stem cell transplantation.

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          Abstract

          Because of intra- and interindividual variability, bioavailability, and pharmacokinetics of busulfan (Bu) in children, oral busulfan without therapeutic drug monitoring (TDM) is assumed to be associated with higher graft failure rates as well as higher toxicity (eg, veno-occlusive disease [VOD]). This study compares the outcome of hematopoietic stem cell transplantation (HSCT) of 2 groups: 1) 30 patients who received myeloablation with once-daily intravenous (i.v.) dose-targeted busulfan (BUdtIV) based on TDM and 2) 30 patients who received the current practice of untargeted oral busulfan (BUPO). Patients received a 3-hour infusion of Bu at a first dose of 120 mg/m(2) (age >or=1 year) or 80 mg/m(2) (<1 year), or BUPO 1 mg/kg 4 times daily. Both regimens were continued for 4 days. The target area under the curve (AUC) was defined as 17,500 microg *h/l. BUdtIV resulted in higher event-free survival (EFS) and survival rates compared to BUPO (EFS: 30% versus 83%, P < .001, survival: 53% versus 83%, P = .016). BUdtIV was associated with more cases of VOD. TDM was feasible in routine clinical practice. The results show that i.v. Bu using TDM is preferable over oral Bu in children undergoing allogeneic stem cell transplantation, especially in those at high risk for graft failure/relapse.

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          Author and article information

          Journal
          Biol. Blood Marrow Transplant.
          Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation
          Elsevier BV
          1523-6536
          1083-8791
          Jan 2008
          : 14
          : 1
          Affiliations
          [1 ] Department of Hematology, University Medical Center Utrecht, the Netherlands. i.bartelink@umcutrecht.nl
          Article
          S1083-8791(07)00486-7
          10.1016/j.bbmt.2007.09.015
          18158965
          a356fd15-22da-4c34-a705-cd8afa4e4e32
          History

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