Observational studyCancer chemotherapy and pharmacology2026
Effect of high-dose methotrexate infusion duration on 48-hour drug levels and toxicity in children with acute lymphoblastic leukaemia: a quality-of-care study.
Observational study in Cancer chemotherapy and pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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.
- High-dose methotrexate toxicokinetic variability persists despite standardized 24-hour infusion in childhood ALL.Cancer chemotherapy and pharmacology · 2026Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHigh‑dose methotrexate (HD‑MTX) is a cornerstone of pediatric acute lymphoblastic leukaemia (ALL) therapy. However, deviations from protocol-mandated infusion durations need regular monitoring as part of standard quality care. Hence, an observational quality assessment study was planned with a secondary objective to evaluate the acute toxicity in patients who did not receive the infusion within the recommended time period.
methodsThis study enrolled 42 children (75 cycles) who received HD-MTX (3-5 g/m
resultsOnly 35% of cycles were completed within the targeted 24-h window [Median (IQR): 23.75 h (21.25, 25.33)]. Prolonged infusions (> 25 h) resulted in significantly higher 48-h MTX levels compared to shortened infusions (median 0.475 vs 0.270 µmol/L; p = 0.015). Multivariable analysis identified male sex (OR, 12.24), T-ALL immunophenotype (OR, 8.36), and the infusion duration (OR, 1.50 per hour) as independent predictors of delayed clearance. A 48-h level > 0.315 µmol/L predicted development of toxicity (AUC 0.686), though no life-threatening event or mortality was recorded in any cycle. Additionally, MTX levels did not differ significantly across the four HD-MTX cycles that each patient received, and elevated levels in one cycle did not predict delayed clearance in subsequent cycles.
conclusionsDeviations in infusion duration were high and independently drive pharmacokinetic variability and toxicity. Ensuring timely drug delivery is as critical as dose precision.
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Registered trials
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