• Seong-Gil Ryu, Je-Hwan Lee, Seong-Jun Choi, Jung-Hee Lee, Young-Shin Lee, Miee Seol, Eun-Hye Hur, Soo Han Lee, Kyun Seop Bae, Gyu Jeong Noh, Moo-Song Lee, Sung-Cheol Yun, Sang Beom Han, and Kyoo-Hyung Lee.
• Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
• Biol. Blood Marrow Transplant. 2007 Sep 1; 13 (9): 1095-105.

AbstractSixty 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-life (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 microM.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.

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