Observational studyDrug design, development and therapy2026
Association of Busulfan Exposure with Event-Free Survival in a Chinese Pediatric Cohort: A Multicenter, Prospective Cohort Study.
Observational study in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
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Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Therapeutic drug monitoring-based individualized busulfan (Bu) administration improves hematopoietic stem cell transplantation (HSCT) outcomes, but optimal Bu exposure in Chinese pediatric patients remains unclear; we aim to identify the optimal exposure level of Bu in such patients receiving Bu-based conditioning regimens of different intensities. Patients and Methods: Pediatric patients from 5 transplant centers in China who received Bu-based myeloablative conditioning regimens were included. Bu exposure, defined as the area under the concentration-time curve (AUC), was estimated using a population pharmacokinetic model, including the first-dose AUC and cumulative AUC (cAUC). The primary and secondary outcomes included event-free survival (EFS) and transplantation-related complications. Restricted cubic splines and Cox proportional hazards models were used to analyze the exposure‒response relationships between the Bu AUC and outcomes. Results: A total of 455 pediatric patients were enrolled, with 326 receiving a 3-day Bu-based (Bu3) regimen and 129 receiving a 4-day Bu-based (Bu4) regimen. Among all patients, a first-dose Bu AUC ≥ 4.5 mg×h/L was associated with a significantly higher 2-year EFS compared with AUC < 4.5 mg×h/L (84.6% vs 76.4%; Conclusion: This study demonstrated an association between Bu exposure and EFS in Chinese pediatric HSCT patients, with optimal cumulative AUC values of ≥ 54 mg×h/L and 70-90 mg×h/L identified for the Bu3 and Bu4 regimens, respectively. Additionally, a first-dose Bu AUC ≥ 4.5 mg×h/L was associated with a favorable 2-year EFS.
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