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Safe administration of oral BU twice daily during conditioning for stem cell transplantation in a paediatric population: a comparative study between the standard 4-dose and a 2-dose regimen.

Journal article
Authors Karin Mellgren
C Nilsson
Anders Fasth
Jonas Abrahamsson
J Winiarski
O Ringdén
M Hassan
Published in Bone marrow transplantation
Volume 41
Issue 7
Pages 621-5
ISSN 0268-3369
Publication year 2008
Published at Institute of Clinical Sciences
Pages 621-5
Language en
Links dx.doi.org/10.1038/sj.bmt.1705947
Keywords Administration, Oral, Busulfan, administration & dosage, adverse effects, Child, Child, Preschool, Dose-Response Relationship, Drug, Female, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, methods, Hepatic Veno-Occlusive Disease, Humans, Infant, Leukemia, therapy, Male, Myeloablative Agonists, administration & dosage, adverse effects, Survival Analysis, Transplantation Conditioning, methods, Transplantation, Autologous, Transplantation, Homologous
Subject categories Pediatrics

Abstract

We compared outcome and toxicity in two paediatric groups undergoing SCT and treated with busulphan (BU) by the oral route of administration. One group receiving the standard dose of 1 mg/kg q.i.d. for a total of 16 doses was compared with age- and disease-matched patients receiving 2 mg/kg of BU b.i.d. for a total of eight doses. Seventy-two patients from two Swedish paediatric transplantation centres were included; one centre used a standard q.i.d. administration (n=37) and the second centre used a b.i.d. administration setting (n=35). Our primary objective was to determine the incidence of veno-occlusive disease (VOD), graft-versus-host disease (GVHD), relapse frequency and transplant-related mortality in both cohorts. A total of 17 autologous and 55 allogeneic transplantations was performed for malignant (n=47) and non-malignant (n=25) diseases in the two centres during the period 1990-2005. No significant difference in the incidence of VOD, graft rejection, GVHD, relapse rate or overall survival was observed between the two centres. The clinical outcome of SCT for paediatric patients conditioned with oral BU at a dose of 2 mg/kg for eight doses is comparable to that found for children conditioned using the standard regimen given 1 mg/kg q.i.d. for 16 doses.

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