ArticleTurkish journal of haematology : official journal of Turkish Society of Haematology2026
Asparaginase-Based Treatment Modifications and Their Effect on Pediatric Acute Lymphoblastic Leukemia Outcomes: A Single-Center Experience
Article in Turkish journal of haematology : official journal of Turkish Society of Haematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objective: Asparaginase is essential in acute lymphoblastic leukemia (ALL) therapy, but toxicity frequently necessitates formulation switching or discontinuation. This study evaluates real-world patterns of asparaginase use and the frequency and causes of formulation switching, and it assesses the impact of formulation switching and incomplete dosing on survival outcomes. Materials and Methods: We conducted a retrospective single-center study of 313 children with ALL treated according to Berlin-Frankfurt-Munster-based protocols between January 2009 and January 2024. Three asparaginase preparations were used: native Results: The median age of the patients was 6.9 years, 58.1% were male, and 86.6% had B-cell ALL while 13.4% had T-cell ALL. Asparaginase formulation change occurred for 78 patients (24.9%), increasing across risk groups (standard: 4.0%, intermediate: 15.4%, high: 42.9%), most often due to hypersensitivity (64 patients, 20.4%). After a median follow-up of 5.2 years, 5-year OS and EFS for the whole cohort were 87.4% and 81.6%, respectively. Among 302 evaluable patients, 5-year EFS was 83.1% in the standard complete treatment group, 93.8% in the formulation-switch group, and 69.1% in the incomplete treatment group (p=0.027 for three-group comparison); the corresponding 5-year CIR rates were 13.3%, 2.2%, and 15.9%. Formulation switch with preserved dose was not associated with inferior EFS (adjusted hazard ratio [HR]: 0.23, 95% confidence interval [CI]: 0.07-0.77), and discontinuation showed a numerically lower EFS that was not statistically significant (HR: 1.03, 95% CI: 0.36-2.91). Conclusion: Formulation switching with preserved total cumulative exposure did not compromise outcomes, supporting the safety of substituting alternative preparations to maintain asparaginase exposure. Incomplete treatment showed a nonsignificant trend toward inferior EFS that warrants confirmation in larger cohorts. Ensuring access to alternative asparaginase formulations is critical, particularly where drug supply is constrained.
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