Korean J Hematol.
2002 May;37(2):127-133.
Safety and Pharmacokinetics of Intravenous Busulfan as Conditioning prior to Allogeneic Stem Cell Transplantation
- Affiliations
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- 1Catholic Hematopoietic Stem Cell Transplantation Center, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- 2Department of Internal Medicine, College of Medicine, Chosun University, Kwangju, Korea.
- 3Department of Internal Medicine, College of Medicine, Busan National University, Busan, Korea.
Abstract
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BACKGROUND: The unpredictable intestinal absorption and bioavailability of oral busulfan (BU) has limited the drug's use in high-dose pretransplant conditioning therapy. To overcome these problems, several trials for the evaluation of pharmacokinetics and clinical usefulness of an intravenous BU (IVBU) formulation have been reported. Here we present clinical and pharmacokinetic data on patients receiving IVBU as a component of conditioning regimens for allogeneic stem cell transplantation (SCT) in our center.
METHODS
A total of 6 adult patients were entered onto this study. All patients were treated with IVBU (0.8mg/kg every 6 hours x 8~16)-containing conditioning regimen followed by HLA-identical allogeneic SCT. We also investigated the pharmacokinetics of IVBU using high-performance liquid chromatography in two cases.
RESULTS
All patients achieved successful engraftment. No patient experienced hepatic veno-occlusive disease or neurologic toxicity. Five of 6 patients still alive in complete remission have been followed for 8~12 months after SCT. The measured maximum concentration for the first dose was 1,175ng/mL and 951ng/mL, and the half-life was 2.25h and 3.09h, respectively. The area under the plasma concentration-time curve was 4,596ng h/ mL and 3,067ng h/mL, respectively. There was no significant difference between the first and last dose pharmacokinetic parameters.
CONCLUSION
We suggest that IVBU should be considered as appropriate replacement for oral BU in pretransplant conditioning therapy prior to SCT in Korea. Further studies with sizable patients are needed to define the role of IVBU in SCT setting.
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