ArticleJournal of cancer research and clinical oncology2025
Significance of busulfan administration route including therapeutic drug monitoring in the conditioning regimen of pediatric patients prior to hematopoietic stem cell transplantation.
Article in Journal of cancer research and clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Defibrotide for prophylaxis of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) in pediatric high-risk patients: consensus guidelines from the European Society for Blood and Marrow Transplantation (EBMT).Bone marrow transplantation · 2026Guideline
- From Therapeutic Drug Monitoring to Model-Informed Precision Dosing: A Review of Busulfan Dosing Optimization in Pediatric Hematopoietic Stem Cell Transplantation.Pharmaceutics · 2026Review
- Association of Busulfan Exposure with Event-Free Survival in a Chinese Pediatric Cohort: A Multicenter, Prospective Cohort Study.Drug design, development and therapy · 2026Observational
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Abstract
purposeBusulfan is an important myeloablative agent in various conditioning regimens prior to hematopoietic stem cell transplantation (HSCT) in pediatric patients. This retrospective study compares three different routes of busulfan administration and their impact on transplantation-related mortality (TRM) and overall survival (OS).
methodsThe study included 250 pediatric patients with malignant and non-malignant diseases who underwent HSCT at the Department of Pediatrics, Jena University Hospital, Jena, Germany. One hundred forty-eight patients received busulfan orally without therapeutic drug monitoring (TDM) (group 1), 62 patients received busulfan intravenously (i.v.) without TDM (group 2) and 40 patients received busulfan i.v. with additional TDM (group 3).
resultsThe TRM rate at 5 years after transplantation for all patients was 40.5% for group 1, 25.2% for group 2, and 8.4% for group 3 (p < 0.001). The TRM rate at 5 years after transplantation for patients with malignant diseases only was 40.3% for group 1 compared to 28.4% for group 2 and 15.3% for group 3 (p = 0.051). For patients with non-malignant diseases, group 1 showed a TRM rate of 43.8% compared to 15.4% in group 2 and 4.6% in group 3 (p = 0.009). In addition, the 5-year OS rate for all patients was 39.9% for group 1, 61.2% for group 2, and 83.9% for group 3 (p < 0.001). Regarding the OS of the groups for patients with only malignant or only non-malignant diseases, we obtained similar results with p-values of p = 0.017 and p = 0.007, respectively. The cumulative incidence of hepatic sinusoidal obstruction syndrome (SOS) for patients with malignant diseases and a cumulative AUC > 85.0 mg/L x h was 55.6%, while patients with malignant diseases and a cumulative AUC < 85.0 mg/L x h showed a cumulative incidence of 11.1% (p = 0.038).
conclusionIn this study, we demonstrate that patients with i.v. administration of busulfan with TDM had a significantly lower rate of TRM and a significantly improved OS compared to patients who received i.v. administration of busulfan without TDM, who, in turn, had a better outcome than patients with oral busulfan administration. Additionally, these data emphasize the clinical relevance of AUC measurements in patients with malignant diseases to prevent hepatic SOS.
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