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Bone Marrow Transplant. 2019 May 14. doi: 10.1038/s41409-019-0521-5. [Epub ahead of print]

Pharmacokinetics analysis results are similar for oral compared to intravenous busulfan in patients undergoing hematopoietic stem cell transplantation, except for the earlier onset of mucositis. A controlled clinical study.

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Oncology and Hematology Center, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Department of Bone Marrow Transplantation, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Bone Marrow Transplantation Unit, Itaci Hospital, Faculdade de Medicina, Universidade de São Paulo (FMUSP), São Paulo, Brazil.
Hospital Samaritano, São Paulo, Brazil.
Universidade Federal de São Paulo (Unifesp), São Paulo, Brazil.
Hematology and Bone Marrow Transplantation Centers, Albert Einstein Hospital, São Paulo, Brazil.
Hematology and Hemotherapy Department, Universidade Federal de São Paulo (Unifesp), São Paulo, Brazil.
Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Case Western Reserve University, University Hospitals of Cleveland, Cleveland, OH, USA.


Busulfan is used in myeloablative schemes for hematopoietic stem cell transplantation (HSCT), with monitoring of dosage through the area under the curve (AUC) of the drug plasma concentration (µMol min). In this study, we compared the complete pharmacokinetics of busulfan administered orally (Bu-Oral) and intravenously (Bu-IV). We evaluated 40 patients who underwent HSCT with different types of conditioning regimens. After one dose, in the Bu-Oral group (n = 21), the median AUC was 1174 µMol min (799-4000), reaching a median of 4440 µMol min (3428-7181.5) during conditioning in 24 h. In the Bu-IV group (n = 19), it was 1244.8 µMol min (1001.2-2021), reaching 5598.0 µMol min (3102-8818) during conditioning in 24 h. Measuring plasma concentration of Bu in patients undergoing HSCT is important, regardless of the formulation, and the inclusion of a pre-HSCT test can predict the optimal dose during conditioning. Pharmacokinetics of the oral administration of busulfan, as well as clearance, are extremely variable, and this can potentially compromise the clinical results of the treatment since it makes it difficult to predict clinical results.


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