High-concentration doxorubicin in cTACE: a retrospective cohort study of efficacy and safety

Abstract Purpose TACE is the standard treatment for intermediate-stage unresectable hepatocellular carcinoma. However, the optimal concentration of doxorubicin in cTACE remains uncertain. This study evaluates the efficacy and safety of high-concentration doxorubicin (25 mg/mL) compared to a lower concentration (2 mg/mL) in patients undergoing cTACE. Methods A retrospective cohort study was conducted on HCC patients who underwent conventional TACE with either 2 mg/mL or 25 mg/mL doxorubicin. The primary outcome was overall survival, and secondary outcomes included disease response, disease-free survival, and adverse events. Kaplan–Meier analysis and Cox proportional hazards regression were used to assess survival outcomes, adjusting for baseline characteristics such as Barcelona Clinic Liver Cancer stage, Child–Pugh score, and ECOG performance status. Results No statistically significant difference in overall survival was observed between the two groups ( p = 0.757), with median survival of 788 days (25.6 months) in the low-concentration group and 710 days (23.3 months) in the high-concentration group. Cox regression analysis revealed significantly increased mortality risk in advanced BCLC stages (Stage B: HR 5.51, p = 0.004; Stage C: HR 8.83, p = 0.003) compared to Stage A. Disease response and DFS at 1, 2, and 3-year intervals showed no significant differences. Adverse event rates were comparable, with no significant increase in post-embolization syndrome in the high-concentration group ( p = 0.617). Conclusion No significant difference in survival, treatment response, or adverse events was demonstrated between groups. Baseline differences suggest a shift towards offering treatment to patients with more advanced disease in the later cohort.