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Description
| - Background: Series of observations indicate PK/PD variability challenging the accuracy of the body-weight based busulfan (Bu) dosing schedule for (HSCT) conditioning therapy. The purpose of this communication is to describe the frequency of dose changes in initially body-weight-based fixed IV Bu dose and to emphasize the importance of TDM. Material/Methods: Sixty-two children (ages 2 months-18 years) were treated with IV busulfan doses based on body weight for myeloablation. TDM utilizing a limited sample strategy (trough concentration immediately before the 5th dose, followed by samples immediately after the end of the 2-h infusion peak, 4 h, and 6 h from initiation of the infusion) was performed in 46 of 62 subjects. Busulfan concentrations were determined by high-performance liquid chromatography (HPLC). AUC was calculated according to the trapezoidal rule. Results: We observed trough levels of 25-1244 mu g/L, peak levels of 849-4586 mu g/L, and AUC of 2225-12818 mu g/L.h following body weight-based high-dose busulfan. The doses were changed in 54% of cases. AUC in 5 of 9 patients with VOD were within target, in 3 patients AUC was higher, and in 1 patient AUC was lower. One of the 2 patients with neurotoxicity had higher AUC. Engraftment was 100%, but relapse occurred in 25% of cases. Conclusions: Our results demonstrate that even with IV busulfan, intra-individual PK/PD variability is challenging. Although AUC does not necessarily correspond with outcomes (due to the role of other factors the fact that doses were changed in 54% of cases underlines the importance of TDM.
- Background: Series of observations indicate PK/PD variability challenging the accuracy of the body-weight based busulfan (Bu) dosing schedule for (HSCT) conditioning therapy. The purpose of this communication is to describe the frequency of dose changes in initially body-weight-based fixed IV Bu dose and to emphasize the importance of TDM. Material/Methods: Sixty-two children (ages 2 months-18 years) were treated with IV busulfan doses based on body weight for myeloablation. TDM utilizing a limited sample strategy (trough concentration immediately before the 5th dose, followed by samples immediately after the end of the 2-h infusion peak, 4 h, and 6 h from initiation of the infusion) was performed in 46 of 62 subjects. Busulfan concentrations were determined by high-performance liquid chromatography (HPLC). AUC was calculated according to the trapezoidal rule. Results: We observed trough levels of 25-1244 mu g/L, peak levels of 849-4586 mu g/L, and AUC of 2225-12818 mu g/L.h following body weight-based high-dose busulfan. The doses were changed in 54% of cases. AUC in 5 of 9 patients with VOD were within target, in 3 patients AUC was higher, and in 1 patient AUC was lower. One of the 2 patients with neurotoxicity had higher AUC. Engraftment was 100%, but relapse occurred in 25% of cases. Conclusions: Our results demonstrate that even with IV busulfan, intra-individual PK/PD variability is challenging. Although AUC does not necessarily correspond with outcomes (due to the role of other factors the fact that doses were changed in 54% of cases underlines the importance of TDM. (en)
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Title
| - The importance of Therapeutic Drug Monitoring (TDM) for parenteral busulfan dosing in conditioning regimen for Hematopoietic Stem Cell Transplantation (HSCT) in children
- The importance of Therapeutic Drug Monitoring (TDM) for parenteral busulfan dosing in conditioning regimen for Hematopoietic Stem Cell Transplantation (HSCT) in children (en)
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skos:prefLabel
| - The importance of Therapeutic Drug Monitoring (TDM) for parenteral busulfan dosing in conditioning regimen for Hematopoietic Stem Cell Transplantation (HSCT) in children
- The importance of Therapeutic Drug Monitoring (TDM) for parenteral busulfan dosing in conditioning regimen for Hematopoietic Stem Cell Transplantation (HSCT) in children (en)
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skos:notation
| - RIV/00216208:11130/14:10292876!RIV15-MSM-11130___
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http://linked.open...avai/riv/aktivita
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http://linked.open...avai/riv/aktivity
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http://linked.open...iv/cisloPeriodika
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http://linked.open...vai/riv/dodaniDat
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http://linked.open...aciTvurceVysledku
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http://linked.open.../riv/druhVysledku
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http://linked.open...iv/duvernostUdaju
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http://linked.open...titaPredkladatele
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http://linked.open...dnocenehoVysledku
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http://linked.open...ai/riv/idVysledku
| - RIV/00216208:11130/14:10292876
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http://linked.open...riv/jazykVysledku
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http://linked.open.../riv/klicovaSlova
| - Limited Sampling Strategy TDM; Pediatric HSCT; High-Dose Busulfan Target AUC (en)
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http://linked.open.../riv/klicoveSlovo
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http://linked.open...odStatuVydavatele
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http://linked.open...ontrolniKodProRIV
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http://linked.open...i/riv/nazevZdroje
| - Annals of transplantation : quarterly of the Polish Transplantation Society
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http://linked.open...in/vavai/riv/obor
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http://linked.open...ichTvurcuVysledku
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http://linked.open...cetTvurcuVysledku
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http://linked.open...UplatneniVysledku
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http://linked.open...v/svazekPeriodika
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http://linked.open...iv/tvurceVysledku
| - Keslová, Petra
- Klapková, Eva
- Průša, Richard
- Sedláček, Petr
- Tesfaye, Hundie
- Říha, Petr
- Mališ, Josef
- Janečková, Daniela
- Branova, Romana
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http://linked.open...ain/vavai/riv/wos
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issn
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number of pages
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http://bibframe.org/vocab/doi
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http://localhost/t...ganizacniJednotka
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