Prospective validation of a novel dosing scheme for intravenous busulfan in adult patients undergoing hematopoietic stem cell transplantation
The objective of this study was to externally validate a new dosing scheme for busulfan. Thirty-seven adult patients who received busulfan as conditioning therapy for hematopoietic stem cell transplantation (HCT) participated in this prospective study. Patients were randomized to receive intravenous...
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| Published in | The Korean journal of physiology & pharmacology Vol. 20; no. 3; pp. 245 - 251 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Korea (South)
The Korean Physiological Society and The Korean Society of Pharmacology
01.05.2016
대한약리학회 |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1226-4512 2093-3827 |
| DOI | 10.4196/kjpp.2016.20.3.245 |
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| Abstract | The objective of this study was to externally validate a new dosing scheme for busulfan. Thirty-seven adult patients who received busulfan as conditioning therapy for hematopoietic stem cell transplantation (HCT) participated in this prospective study. Patients were randomized to receive intravenous busulfan, either as the conventional dosage (3.2 mg/kg daily) or according to the new dosing scheme based on their actual body weight (ABW) (23×ABW(0.5) mg daily) targeting an area under the concentration-time curve (AUC) of 5924 µM·min. Pharmacokinetic profiles were collected using a limited sampling strategy by randomly selecting 2 time points at 3.5, 5, 6, 7 or 22 hours after starting busulfan administration. Using an established population pharmacokinetic model with NONMEM software, busulfan concentrations at the available blood sampling times were predicted from dosage history and demographic data. The predicted and measured concentrations were compared by a visual predictive check (VPC). Maximum a posteriori Bayesian estimators were estimated to calculate the predicted AUC (AUCPRED). The accuracy and precision of the AUCPRED values were assessed by calculating the mean prediction error (MPE) and root mean squared prediction error (RMSE), and compared with the target AUC of 5924 µM·min. VPC showed that most data fell within the 95% prediction interval. MPE and RMSE of AUCPRED were -5.8% and 20.6%, respectively, in the conventional dosing group and -2.1% and 14.0%, respectively, in the new dosing scheme group. These fi ndings demonstrated the validity of a new dosing scheme for daily intravenous busulfan used as conditioning therapy for HCT. |
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| AbstractList | The objective of this study was to externally validate a new dosing scheme for busulfan. Thirty-seven adult patients who received busulfan as conditioning therapy for hematopoietic stem cell transplantation (HCT) participated in this prospective study. Patients were randomized to receive intravenous busulfan, either as the conventional dosage (3.2 mg/kg daily) or according to the new dosing scheme based on their actual body weight (ABW) (23×ABW
0.5
mg daily) targeting an area under the concentration-time curve (AUC) of 5924 µM·min. Pharmacokinetic profiles were collected using a limited sampling strategy by randomly selecting 2 time points at 3.5, 5, 6, 7 or 22 hours after starting busulfan administration. Using an established population pharmacokinetic model with NONMEM software, busulfan concentrations at the available blood sampling times were predicted from dosage history and demographic data. The predicted and measured concentrations were compared by a visual predictive check (VPC). Maximum a posteriori Bayesian estimators were estimated to calculate the predicted AUC (AUC
PRED
). The accuracy and precision of the AUC
PRED
values were assessed by calculating the mean prediction error (MPE) and root mean squared prediction error (RMSE), and compared with the target AUC of 5924 µM·min. VPC showed that most data fell within the 95% prediction interval. MPE and RMSE of AUC
PRED
were -5.8% and 20.6%, respectively, in the conventional dosing group and −2.1% and 14.0%, respectively, in the new dosing scheme group. These fi ndings demonstrated the validity of a new dosing scheme for daily intravenous busulfan used as conditioning therapy for HCT. The objective of this study was to externally validate a new dosing scheme for busulfan. Thirty-seven adult patients who received busulfan as conditioning therapy for hematopoietic stem cell transplantation (HCT) participated in this prospective study. Patients were randomized to receive intravenous busulfan, either as the conventional dosage (3.2 mg/kg daily) or according to the new dosing scheme based on their actual body weight (ABW) (23×ABW(0.5) mg daily) targeting an area under the concentration-time curve (AUC) of 5924 µM·min. Pharmacokinetic profiles were collected using a limited sampling strategy by randomly selecting 2 time points at 3.5, 5, 6, 7 or 22 hours after starting busulfan administration. Using an established population pharmacokinetic model with NONMEM software, busulfan concentrations at the available blood sampling times were predicted from dosage history and demographic data. The predicted and measured concentrations were compared by a visual predictive check (VPC). Maximum a posteriori Bayesian estimators were estimated to calculate the predicted AUC (AUCPRED). The accuracy and precision of the AUCPRED values were assessed by calculating the mean prediction error (MPE) and root mean squared prediction error (RMSE), and compared with the target AUC of 5924 µM·min. VPC showed that most data fell within the 95% prediction interval. MPE and RMSE of AUCPRED were -5.8% and 20.6%, respectively, in the conventional dosing group and -2.1% and 14.0%, respectively, in the new dosing scheme group. These fi ndings demonstrated the validity of a new dosing scheme for daily intravenous busulfan used as conditioning therapy for HCT.The objective of this study was to externally validate a new dosing scheme for busulfan. Thirty-seven adult patients who received busulfan as conditioning therapy for hematopoietic stem cell transplantation (HCT) participated in this prospective study. Patients were randomized to receive intravenous busulfan, either as the conventional dosage (3.2 mg/kg daily) or according to the new dosing scheme based on their actual body weight (ABW) (23×ABW(0.5) mg daily) targeting an area under the concentration-time curve (AUC) of 5924 µM·min. Pharmacokinetic profiles were collected using a limited sampling strategy by randomly selecting 2 time points at 3.5, 5, 6, 7 or 22 hours after starting busulfan administration. Using an established population pharmacokinetic model with NONMEM software, busulfan concentrations at the available blood sampling times were predicted from dosage history and demographic data. The predicted and measured concentrations were compared by a visual predictive check (VPC). Maximum a posteriori Bayesian estimators were estimated to calculate the predicted AUC (AUCPRED). The accuracy and precision of the AUCPRED values were assessed by calculating the mean prediction error (MPE) and root mean squared prediction error (RMSE), and compared with the target AUC of 5924 µM·min. VPC showed that most data fell within the 95% prediction interval. MPE and RMSE of AUCPRED were -5.8% and 20.6%, respectively, in the conventional dosing group and -2.1% and 14.0%, respectively, in the new dosing scheme group. These fi ndings demonstrated the validity of a new dosing scheme for daily intravenous busulfan used as conditioning therapy for HCT. The objective of this study was to externally validate a new dosing scheme for busulfan. Thirty-seven adult patients who received busulfan as conditioning therapy for hematopoietic stem cell transplantation (HCT) participated in this prospective study. Patients were randomized to receive intravenous busulfan, either as the conventional dosage (3.2 mg/kg daily) or according to the new dosing scheme based on their actual body weight (ABW) (23×ABW(0.5) mg daily) targeting an area under the concentration-time curve (AUC) of 5924 µM·min. Pharmacokinetic profiles were collected using a limited sampling strategy by randomly selecting 2 time points at 3.5, 5, 6, 7 or 22 hours after starting busulfan administration. Using an established population pharmacokinetic model with NONMEM software, busulfan concentrations at the available blood sampling times were predicted from dosage history and demographic data. The predicted and measured concentrations were compared by a visual predictive check (VPC). Maximum a posteriori Bayesian estimators were estimated to calculate the predicted AUC (AUCPRED). The accuracy and precision of the AUCPRED values were assessed by calculating the mean prediction error (MPE) and root mean squared prediction error (RMSE), and compared with the target AUC of 5924 µM·min. VPC showed that most data fell within the 95% prediction interval. MPE and RMSE of AUCPRED were -5.8% and 20.6%, respectively, in the conventional dosing group and -2.1% and 14.0%, respectively, in the new dosing scheme group. These fi ndings demonstrated the validity of a new dosing scheme for daily intravenous busulfan used as conditioning therapy for HCT. The objective of this study was to externally validate a new dosing scheme for busulfan. Thirty-seven adult patients who received busulfan as conditioning therapy for hematopoietic stem cell transplantation (HCT) participated in this prospective study. Patients were randomized to receive intravenous busulfan, either as the conventional dosage (3.2 mg/kg daily) or according to the new dosing scheme based on their actual body weight (ABW) (23×ABW0.5 mg daily) targeting an area under the concentration-time curve (AUC) of 5924 μM∙min. Pharmacokinetic profiles were collected using a limited sampling strategy by randomly selecting 2 time points at 3.5, 5, 6, 7 or 22 hours after starting busulfan administration. Using an established population pharmacokinetic model with NONMEM software, busulfan concentrations at the available blood sampling times were predicted from dosage history and demographic data. The predicted and measured concentrations were compared by a visual predictive check (VPC). Maximum a posteriori Bayesian estimators were estimated to calculate the predicted AUC (AUCPRED). The accuracy and precision of the AUCPRED values were assessed by calculating the mean prediction error (MPE) and root mean squared prediction error (RMSE), and compared with the target AUC of 5924 μM∙min. VPC showed that most data fell within the 95% prediction interval. MPE and RMSE of AUCPRED were -5.8% and 20.6%, respectively, in the conventional dosing group and –2.1% and 14.0%, respectively, in the new dosing scheme group. These findings demonstrated the validity of a new dosing scheme for daily intravenous busulfan used as conditioning therapy for HCT. KCI Citation Count: 1 |
| Author | Lim, Hyeong-Seok Kim, Dae-Young Lee, Je-Hwan Lee, Jung-Hee Choe, Sangmin Cho, Sang-Heon Lee, Kyoo-Hyung Bae, Kyun-Seop |
| AuthorAffiliation | 1 Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon 22332, Korea 4 Department of Clinical Pharmacology and Therapeutics, Pusan National University Hospital, Busan 49241, Korea 2 Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea 3 Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea |
| AuthorAffiliation_xml | – name: 1 Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon 22332, Korea – name: 3 Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea – name: 2 Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea – name: 4 Department of Clinical Pharmacology and Therapeutics, Pusan National University Hospital, Busan 49241, Korea |
| Author_xml | – sequence: 1 givenname: Sang-Heon surname: Cho fullname: Cho, Sang-Heon organization: Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon 22332, Korea – sequence: 2 givenname: Jung-Hee surname: Lee fullname: Lee, Jung-Hee organization: Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea – sequence: 3 givenname: Hyeong-Seok surname: Lim fullname: Lim, Hyeong-Seok organization: Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea – sequence: 4 givenname: Kyoo-Hyung surname: Lee fullname: Lee, Kyoo-Hyung organization: Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea – sequence: 5 givenname: Dae-Young surname: Kim fullname: Kim, Dae-Young organization: Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea – sequence: 6 givenname: Sangmin surname: Choe fullname: Choe, Sangmin organization: Department of Clinical Pharmacology and Therapeutics, Pusan National University Hospital, Busan 49241, Korea – sequence: 7 givenname: Kyun-Seop surname: Bae fullname: Bae, Kyun-Seop organization: Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea – sequence: 8 givenname: Je-Hwan surname: Lee fullname: Lee, Je-Hwan organization: Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea |
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| Cites_doi | 10.1038/sj.bmt.1701322 10.2165/00003088-200746030-00003 10.1016/j.cmpb.2003.11.003 10.1016/j.bbmt.2007.10.028 10.1053/bbmt.2002.v8.pm12374451 10.1038/sj.bmt.1703207 10.1038/sj.bmt.1705252 10.1517/17425250903107764 10.1053/bbmt.2002.v8.pm12374454 10.1053/bbmt.2002.v8.pm12374453 10.1007/s11095-006-9067-5 10.1038/sj.bmt.1704707 10.1182/blood.V64.4.852.852 10.1111/j.1749-6632.1985.tb17212.x 10.1016/j.bbmt.2007.06.005 10.4196/kjpp.2012.16.4.273 10.1016/j.bbmt.2007.09.015 10.1007/s10928-005-0016-4 10.1097/00007890-198506000-00004 10.1038/sj.bmt.1701334 10.1038/sj.bmt.1700994 10.1007/BF00694339 10.1056/NEJM198312013092202 10.1007/s00280-005-0029-0 10.1002/j.1552-4604.1997.tb04326.x 10.1182/blood.V89.8.3055 |
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| Keywords | Drug dosage calculations Adult Busulfan Pharmacokinetics Hematopoietic stem cell transplantation |
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| Title | Prospective validation of a novel dosing scheme for intravenous busulfan in adult patients undergoing hematopoietic stem cell transplantation |
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