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

This study aimed to investigate the protective role of deferoxamine (DFO) in the prevention of doxorubicin (DOX)-induced hepatic fibrosis in children.

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.

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.

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.