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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.
Biol Blood Marrow Transplant. 2008 Jan; 14(1):88-98.BB

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.

Authors+Show Affiliations

Department of Hematology, University Medical Center Utrecht, the Netherlands. i.bartelink@umcutrecht.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

18158965

Citation

Bartelink, Imke H., et al. "Once-daily Intravenous Busulfan With Therapeutic Drug Monitoring Compared to Conventional Oral Busulfan Improves Survival and Engraftment in Children Undergoing Allogeneic Stem Cell Transplantation." Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation, vol. 14, no. 1, 2008, pp. 88-98.
Bartelink IH, Bredius RG, Ververs TT, et al. Once-daily intravenous busulfan with therapeutic drug monitoring compared to conventional oral busulfan improves survival and engraftment in children undergoing allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2008;14(1):88-98.
Bartelink, I. H., Bredius, R. G., Ververs, T. T., Raphael, M. F., van Kesteren, C., Bierings, M., Rademaker, C. M., den Hartigh, J., Uiterwaal, C. S., Zwaveling, J., & Boelens, J. J. (2008). Once-daily intravenous busulfan with therapeutic drug monitoring compared to conventional oral busulfan improves survival and engraftment in children undergoing allogeneic stem cell transplantation. Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation, 14(1), 88-98.
Bartelink IH, et al. Once-daily Intravenous Busulfan With Therapeutic Drug Monitoring Compared to Conventional Oral Busulfan Improves Survival and Engraftment in Children Undergoing Allogeneic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2008;14(1):88-98. PubMed PMID: 18158965.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Once-daily intravenous busulfan with therapeutic drug monitoring compared to conventional oral busulfan improves survival and engraftment in children undergoing allogeneic stem cell transplantation. AU - Bartelink,Imke H, AU - Bredius,Robbert G M, AU - Ververs,Tessa T, AU - Raphael,Martine F, AU - van Kesteren,Charlotte, AU - Bierings,Marc, AU - Rademaker,Carin M A, AU - den Hartigh,J, AU - Uiterwaal,Cuno S P M, AU - Zwaveling,Juliette, AU - Boelens,Jaap J, PY - 2007/07/23/received PY - 2007/09/24/accepted PY - 2007/12/27/pubmed PY - 2008/1/23/medline PY - 2007/12/27/entrez SP - 88 EP - 98 JF - Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation JO - Biol Blood Marrow Transplant VL - 14 IS - 1 N2 - 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. SN - 1523-6536 UR - https://www.unboundmedicine.com/medline/citation/18158965/Once_daily_intravenous_busulfan_with_therapeutic_drug_monitoring_compared_to_conventional_oral_busulfan_improves_survival_and_engraftment_in_children_undergoing_allogeneic_stem_cell_transplantation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1083-8791(07)00486-7 DB - PRIME DP - Unbound Medicine ER -