Randomized comparison of four-times-daily versus once-daily intravenous Busulfan in conditioning therapy for hematopoietic cell transplantation
- Authors
- Ryu, Seong-Gil; Lee, Je-Hwan; Choi, Seong-Jun; Lee, Jung-Hee; Lee, Young-Shin; Seol, Miee; Hur, Eun-Hye; Lee, Soo Han; Bae, Kyun Seop; Noh, Gyu Jeong; Lee, Moo-Song; Yun, Sung-Cheol; Han, Sang Beom; Lee, Kyoo-Hyung
- Issue Date
- Sep-2007
- Publisher
- ELSEVIER SCIENCE INC
- Keywords
- intravenous busulfan; once-daily administration; conditioning therapy; hematopoietic cell transplantation; pharmacokinetics
- Citation
- BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION, v.13, no.9, pp 1095 - 1105
- Pages
- 11
- Journal Title
- BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION
- Volume
- 13
- Number
- 9
- Start Page
- 1095
- End Page
- 1105
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/24001
- DOI
- 10.1016/j.bbmt.2007.06.005
- ISSN
- 1083-8791
1523-6536
- Abstract
- Sixty patients were randomized to receive intravenous busulfan (iBU) either as 0.8 mg/kg, over 2 hours 4 times a day (BU4 arm) or 3.2 mg/kg, over 3 hours once a day (BU1 arm) in conditioning therapy for hematopoietic cell transplantation. The complete pharmacokinetic parameters for the first busulfan dose were obtained from all patients and were comparable between the 2 arms: for the BU4 and BU1 groups, elimination half-fife (mean +/- SD) was 2.75 +/- 0.22 versus 2.83 +/- 0.21 hours, estimated daily AUC was 6058.0 +/- 1091.9 versus 6475.5 1099.4 mu M center dot min per day, and clearance was 2.05 +/- 0.36 versus 1.91 +/- 0.31 mL/min/kg, respectively. Times to engraftment after transplantation were similar between the 2 arms. No significant differences were evident in the occurrence of acute graft-versus-host disease (aGVHD) and hepatic veno-occlusion disease (VOD). Moreover, other toxicities observed within 100 days after transplantation were not significantly different between the 2 arms. The cumulative incidence of nonrelapse mortality was 20.8% in BU4 arm and 13.3% in BU1 arm. In conclusion, our randomized study demonstrates that the pharmacokinetic profiles and posttransplant complications are similar for once-daily iBU and traditional 4-times-daily iBU. (c) 2007 American Society for Blood and Marrow Transplantation
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