1. Modification of the Bu/Cy myeloablative regimen using daily parenteral busulfan: reduced toxicity without the need for pharmacokinetic monitoring.
- Author
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Mamlouk, K, Saracino, G, Berryman, RB, Fay, JW, Pineiro, LA, Vance, EA, White, M, Sandler, I, and Agura, ED
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CELLS ,STEM cells ,BONE marrow ,LIVER diseases ,TOXICOLOGY ,HEMATOPOIETIC system ,IMMUNE system - Abstract
Summary:Pharmacokinetic and clinical outcome measures among three groups of patients undergoing hematopoietic transplant were assessed: group A: Parenteral busulfan (Bu) 3.2?mg/kg i.v. given qd, n=20; group B: parenteral Bu 0.8?mg/kg i.v. given every 6?h, n=11; group C: Bu 1?mg/kg p.o. given every 6?h, n=25. All groups received Bu over 4 days followed by Cy 60?mg/kg i.v. qd over 2 days; followed by an infusion of allogeneic stem cells. Median Bu clearance was 3.21?ml/min/kg and median daily AUC was 4071?µmol/min for the group A patients. The dosing formula for Bu i.v. qd was highly predictive of the AUC for patients whose mass?IBW+20%. For patients of greater mass, the dosing formula uniformly resulted in lower-than-predicted AUC. Neurologic toxicity, hepatic toxicity, hematologic engraftment, and relapse at 100 days were comparable across all three groups. Severe AGVHD was least among group A, followed by group B when compared with group C. Bu i.v. qd is a safe and effective regimen for allogeneic transplantation and is at least clinically equivalent to every 6?h dosing schemes using either oral or parenteral Bu.Bone Marrow Transplantation (2005) 35, 747-754. doi:10.1038/sj.bmt.1704871 Published online 7 March 2005 [ABSTRACT FROM AUTHOR]
- Published
- 2005
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