The protective role of deferoxamine in the prevention of doxorubicin-induced hepatic fibrosis in children: A randomized controlled clinical trial

Deferoxamine Doxorubicin Hepatic fibrosis ChildrenBackground: This study aimed to investigate the protective role of deferoxamine (DFO) in the prevention of doxorubicin (DOX)-induced hepatic fibrosis in children. Methods:In this prospective randomized controlled trial, 61 treatment-naïve children (2-18 years) with different types of cancer who referred to a tertiary teaching hospital in the South of Iran were enrolled.They were randomly assigned to 3 groups; group 1 (control, n=21), group 2 (DFO 10 times DOX dose, n=20), group 3 (DFO 50mg/kg, n=20).DFO was administered as an 8-hour continuous intravenous infusion during and after DOX infusion in each chemotherapy cycle.Non-invasive serum markers of liver fibrosis, including AST-to-platelet ratio index (APRI), Fibrosis-4 (FIB-4) score and Fibro Test were measured in each individual.Besides, hepatic Fibro Scan was used after the last course of chemotherapy to estimate the fibrosis degree.Results: Alanine aminotransferase was mildly increased after treatment compared to before treatment.The treatment with DFO 10 times DOX dose was associated with a significant decline in post-treatment APRI (adjusted odds ratio 0.17; 95% confidence interval 0.03-0.84.P-value=0.015).The METAVIR fibro scores were in the F0-F1 zone in all participants, and the results were comparable in study groups.No adverse drug effects were reported in the treatment groups.Conclusion: DOX may not lead to severe liver fibrosis if the maximum cumulative dose allowed is not exceeded.DFO at the dose of 10 times of DOX dose may have a potential protective role against liver fibrosis.More studies with longer follow-up are needed to further assess this issue.