Dataset Information

Harmonization of Busulfan Plasma Exposure Unit (BPEU): A Community-Initiated Consensus Statement.

ABSTRACT: Busulfan therapeutic drug monitoring (TDM) is often used to achieve target plasma exposures. Variability in busulfan plasma exposure units (BPEU) is a potential source for misinterpretation of publications and protocols and is a barrier to data capture by hematopoietic cell transplantation (HCT) registry databases. We sought to harmonize to a single BPEU for international use. Using Delphi consensus methodology, iterative surveys were sent to an increasing number of relevant clinical stakeholders. In survey 1, 14 stakeholders were asked to identify ideal properties of a BPEU. In survey 2, 52 stakeholders were asked (1) to evaluate BPEU candidates according to ideal BPEU properties established by survey 1 and local position statements for TDM and (2) to identify potential facilitators and barriers to adoption of the harmonized BPEU. The most frequently used BPEU identified, in descending order, were area under the curve (AUC) in ?M?×?min, AUC in mg?×?h/L, concentration at steady state (Css) in ng/mL, AUC in ?M?×?h, and AUC in ?g?×?h/L. All respondents conceptually agreed on the ideal properties of a BPEU and to adopt a harmonized BPEU. Respondents were equally divided between selecting AUC in ?M?×?min versus mg?×?h/L for harmonization. AUC in mg?×?h/L was finally selected as the harmonized BPEU, because it satisfied most of the survey-determined ideal properties for the harmonized BPEU and is read easily understood in the clinical practice environment. Furthermore, 10 major professional societies have endorsed AUC in mg?×?h/L as the harmonized unit for reporting to HCT registry databases and for use in future protocols and publications.

SUBMITTER: McCune JS

PROVIDER: S-EPMC6755045 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

Harmonization of Busulfan Plasma Exposure Unit (BPEU): A Community-Initiated Consensus Statement.

McCune Jeannine S JS Quinones Christine M CM Ritchie James J Carpenter Paul A PA van Maarseveen Erik E Yeh Rosa F RF Anasetti Claudio C Boelens Jaap J JJ Hamerschlak Nelson N Hassan Moustapha M Kang Hyoung Jin HJ Kanda Yoshinobu Y Paci Angelo A Perales Miguel-Angel MA Shaw Peter J PJ Seewaldt Victoria L VL Savani Bipin N BN Hsieh Angela A Poon Betsy B Mohty Mohamad M Pulsipher Michael A MA Pasquini Marcelo M Dupuis L Lee LL

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation 20190525 9

Busulfan therapeutic drug monitoring (TDM) is often used to achieve target plasma exposures. Variability in busulfan plasma exposure units (BPEU) is a potential source for misinterpretation of publications and protocols and is a barrier to data capture by hematopoietic cell transplantation (HCT) registry databases. We sought to harmonize to a single BPEU for international use. Using Delphi consensus methodology, iterative surveys were sent to an increasing number of relevant clinical stakeholder ...[more]

PMID: 31136799

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Dataset Information

Harmonization of Busulfan Plasma Exposure Unit (BPEU): A Community-Initiated Consensus Statement.

Publications

Harmonization of Busulfan Plasma Exposure Unit (BPEU): A Community-Initiated Consensus Statement.

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