Harmonization of Busulfan Plasma Exposure Unit (BPEU): A Community-Initiated Consensus Statement.
Biol Blood Marrow Transplant
; 25(9): 1890-1897, 2019 09.
Article
em En
| MEDLINE
| ID: mdl-31136799
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 µMâ¯×â¯min, AUC in mgâ¯×â¯h/L, concentration at steady state (Css) in ng/mL, AUC in µMâ¯×â¯h, and AUC in µgâ¯×â¯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 µMâ¯×â¯min versus mgâ¯×â¯h/L for harmonization. AUC in mgâ¯×â¯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 mgâ¯×â¯h/L as the harmonized unit for reporting to HCT registry databases and for use in future protocols and publications.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Bussulfano
/
Sistema de Registros
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Bases de Dados Factuais
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Monitoramento de Medicamentos
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Transplante de Células-Tronco Hematopoéticas
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Consenso
Tipo de estudo:
Guideline
/
Prognostic_studies
Limite:
Female
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Humans
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Male
Idioma:
En
Revista:
Biol Blood Marrow Transplant
Assunto da revista:
HEMATOLOGIA
/
TRANSPLANTE
Ano de publicação:
2019
Tipo de documento:
Article