title: Randomized comparison of four-times-daily versus once-daily intravenous busulfan in conditioning therapy for hematopoietic cell transplantation.
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-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.
authors: Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Seong-Gil
authors: SG
authors: Ryu
authors: Je-Hwan
authors: JH
authors: Lee
authors: Seong-Jun
authors: SJ
authors: Choi
authors: Jung-Hee
authors: JH
authors: Lee
authors: Young-Shin
authors: YS
authors: Lee
authors: Miee
authors: M
authors: Seol
authors: Eun-Hye
authors: EH
authors: Hur
authors: Soo Han
authors: SH
authors: Lee
authors: Kyun Seop
authors: KS
authors: Bae
authors: Gyu Jeong
authors: GJ
authors: Noh
authors: Moo-Song
authors: MS
authors: Lee
authors: Sung-Cheol
authors: SC
authors: Yun
authors: Sang Beom
authors: SB
authors: Han
authors: Kyoo-Hyung
authors: KH
authors: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D002066:Busulfan / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000633:toxicity; D004334:Drug Administration Schedule; D005260:Female; D006085:Graft Survival; D006086:Graft vs Host Disease; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D006504:Hepatic Veno-Occlusive Disease; D006801:Humans; D008297:Male; D008875:Middle Aged; D010599:Pharmacokinetics; D015996:Survival Rate; D019172:Transplantation Conditioning / Q000009:adverse effects / Q000379:methods* / Q000401:mortality
chemical_list: D002066:Busulfan