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Busulfex (i.v. BU) and CY regimen before SCT: Japanese-targeted phase II pharmacokinetics combined study.
- Source :
-
Bone Marrow Transplantation . Apr2009, Vol. 43 Issue 8, p611-617. 7p. 3 Charts, 4 Graphs. - Publication Year :
- 2009
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Abstract
- To evaluate the toxicity and efficacy of an i.v. preparation of BU (12.8 mg/kg), combined with CY (120 mg/kg), a prospective study was performed on 30 Japanese patients (median age, 30 years) with hematologic malignancies undergoing hematopoietic SCT (28 allogeneic transplants from an HLA-matched donor and 2 autologous transplants). There were no significant toxicities, and all but one patient showed evidence of granulocyte engraftment at a median of 14 days for allogeneic and 11 days for autologous transplantation. Grades II–IV acute and chronic GVHD occurred in 9 (9/27, 33%) and 16 patients (16/27, 59%), respectively. Non-relapse mortality at days 100 and 365 was 3 and 17%, respectively. The pharmacokinetics of i.v. BU showed close inter- and intrapatient consistency; the area under the plasma concentration–time curve of the first administration remained at less than 1500 μmol min/l in 27 of the 29 patients (93%), and between 900 and 1350 μmol min/l in 22 patients (73%). As all of the profiles overlap with data from non-Japanese patients, we conclude that racial factors may not seriously influence the bioactivity of i.v. BU.Bone Marrow Transplantation (2009) 43, 611–617; doi:10.1038/bmt.2008.372; published online 17 November 2008 [ABSTRACT FROM AUTHOR]
- Subjects :
- *DRUG efficacy
*BLOOD diseases
*PHARMACOKINETICS
*DIAGNOSIS
Subjects
Details
- Language :
- English
- ISSN :
- 02683369
- Volume :
- 43
- Issue :
- 8
- Database :
- Academic Search Index
- Journal :
- Bone Marrow Transplantation
- Publication Type :
- Academic Journal
- Accession number :
- 37922514
- Full Text :
- https://doi.org/10.1038/bmt.2008.372