Population Pharmacokinetics of Intravenous Busulfan in Japanese Pediatric Patients With Primary Immunodeficiency Diseases

Ishiwata, Yasuo; Nagata, Masashi; Tsuge, Kohta; Takahashi, Hiromitsu; Suzuki, Sayo; Imai, Kohsuke; Takagi, Motoki; Kanegane, Hirokazu; Morio, Tomohiro; Yasuhara, Masato

doi:10.1002/jcph.1027

Cited by 13 publications

(25 citation statements)

References 19 publications

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“…21,22 There are some reports of busulfan 1-compartment model analyses in Japanese patients. 9,15,17 However, in the present analysis, the 2-compartment model showed good fit. Therefore, if sufficient sampling points are available, a 2-compartment model would be more suitable for describing busulfan pharmacokinetics in Japanese patients.…”

Section: Discussioncontrasting

confidence: 58%

“…The Bartelink and McCune models are 2‐compartment models, and analyses using these models have shown statistically significant results compared with 1‐compartment models . There are some reports of busulfan 1‐compartment model analyses in Japanese patients . However, in the present analysis, the 2‐compartment model showed good fit.…”

Section: Discussionmentioning

confidence: 99%

“…It was possible to use McCune's model for analysis combining adult and pediatric busulfan data by including a maturation function. Body weight is correlated with age, and therefore other models for busulfan PopPK analysis generally do not include the maturation of clearance . busulfan clearance is empirically known to decrease over time, and it was 12% lower at Days 2 through 4 than at Day 1 .…”

Section: Discussionmentioning

confidence: 99%

“…Body weight is correlated with age, and therefore other models for busulfan PopPK analysis generally do not include the maturation of clearance. [9][10][11][12][13][14][15][16][17][18][19][20][21]23 busulfan clearance is empirically known to decrease over time, and it was 12% lower at Days 2 through 4 than at Day 1. 21 Long-Boyle et al described busulfan clearance using Michaelis-Menten elimination, 23 and this is the only report that uses Michaelis-Menten elimination.…”

Section: Discussionmentioning

confidence: 99%

“…The use of incorrect population pharmacokinetic (PopPK) modeling strategies for TDM lead to erroneous dosing design, 8 and therefore an appropriate PopPK model is needed. Numerous PopPK model analyses of busulfan have been reported, [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] including 3 PopPK analyses in Japanese patients. 9,15,17 In the Japanese PopPK analyses, only a 1-compartment model was used.…”

mentioning

confidence: 99%

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Population Pharmacokinetic Analysis of Busulfan in Japanese Pediatric and Adult HCT Patients

Kawazoe

Funaki

Kim

2018

The Journal of Clinical Pharma

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Busulfan is the most common chemotherapy agent used in allogeneic hematopoietic cell transplant (HCT) conditioning regimens. As narrow therapeutic index and interpatient variability exists in the effectiveness and toxicity of conditioning regimens, personalizing intravenous busulfan therapy is desirable. Population pharmacokinetic-based approaches have been applied to therapeutic drug monitoring for the purpose of personalizing therapy. A population pharmacokinetic analysis with the objective of personalizing therapy in Japanese patients was conducted by integrating pediatric patient data with adult patient data. McCune's model, a 2-compartment model that includes maturation of clearance and allometric scaling of clearance and volume of distribution, was used for the analysis. McCune's model could precisely describe the Japanese data, and the estimated parameters were similar to McCune's results for non-Japanese, indicating that there are no racial differences in busulfan pharmacokinetics. Using this model, the plasma concentrations for once-daily dosing were simulated to adapt new dosage regimens for the benefit and convenience of both patients and medical staff. The predicted busulfan concentrations were within the therapeutic range.

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Section: Discussioncontrasting

confidence: 58%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Population Pharmacokinetic Analysis of Busulfan in Japanese Pediatric and Adult HCT Patients

Kawazoe

Funaki

Kim

2018

The Journal of Clinical Pharma

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Can Published Population Pharmacokinetic Models of Busulfan Be Used for Individualized Dosing in Chinese Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation? An External Evaluation

Huang

Liu

Ren

et al. 2021

The Journal of Clinical Pharma

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Busulfan is a bifunctional alkylating agent that is widely used before hematopoietic stem cell transplantation (HSCT), in combination with other chemotherapeutic drugs. As of 2020, there is no population pharmacokinetic (popPK) model for busulfan in Chinese pediatric patients. A systemic external evaluation of 11 published popPK models was conducted in Chinese pediatric patients undergoing HSCT. Forty pediatric patients were enrolled in this study, with a total of 183 blood concentrations. The relative prediction error (PE%), median PE%, median absolute PE%, and percentage of PE% within ±20% and ±30% were calculated in prediction-based diagnostics. Simulation-based diagnostics were conducted through a predictionand variability-corrected visual predictive check and the normalized prediction distribution error. The relative individual prediction error was calculated using Bayesian forecasting with 1 to 3 concentration points. The 1-compartment open linear popPK model, which was built by Su-jin Rhee et al (model H), incorporating the patient's body surface area, age, dosing day, and aspartate aminotransferase as significant covariates had preferable predictability than other popPK models. In prediction-based diagnostics, the median PE%, percentage of PE% within ±20%, and percentage of PE% within ±30% of model H were 8.48%, 45.35%, and 59.56%, respectively. The normalized prediction distribution error of model H showed that it followed the normal distribution. Based on Bayesian forecasting, model H showed good predictive performance. Thus, model H was the most appropriate model that can be used clinically for individualized dosage adjustments in Chinese pediatric HSCT patients.

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Precision dosing of intravenous busulfan in pediatric hematopoietic stem cell transplantation: Results from a multicenter population pharmacokinetic study

Hassine

Nava

Théôret

et al. 2021

CPT Pharmacom & Syst Pharma

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Population Pharmacokinetics of Intravenous Busulfan in Japanese Pediatric Patients With Primary Immunodeficiency Diseases

Cited by 13 publications

References 19 publications

Population Pharmacokinetic Analysis of Busulfan in Japanese Pediatric and Adult HCT Patients

Population Pharmacokinetic Analysis of Busulfan in Japanese Pediatric and Adult HCT Patients

Can Published Population Pharmacokinetic Models of Busulfan Be Used for Individualized Dosing in Chinese Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation? An External Evaluation

Precision dosing of intravenous busulfan in pediatric hematopoietic stem cell transplantation: Results from a multicenter population pharmacokinetic study

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