982P - Transarterial chemoembolization with idarubicin versus epirubicin for hepatocellular carcinoma: An interim analysis of a multicentre, randomized controlled phase III trial

Background

Transarterial chemoembolization (TACE) is a treatment option for hepatocellular carcinoma (HCC), but the optional agent for TACE is limited. We compared the efficacy and safety of TACE with idarubicin versus epirubicin in HCC patients.

Methods

This is a non inferiority randomized controlled trial registered in clinicaltrials.gov with NCT05053386. 186 patients was needed according to calculation. Patients with liver-confined HCC, Eastern Cooperative Oncology Group (ECOG) score 0-1, Child-Pugh class A/B, and Barcelona Clinic Liver Cancer (BCLC) Stage A-C were randomly assigned in a 1:1 ratio to receive TACE with 10mg idarubicin (experimental group) or 50mg epirubicin (control group). The primary endpoint was objective response rate (ORR). The secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety.

Results

110 patients were recruited from October 2021 to April 2023 at 14 centers in China and randomly assigned to undergo TACE with idarubicin (n=55) or epirubicin (n=55). The median age was 63 years (range 35, 79), most were male (83.6%), ECOG score 0 (85.5%), Child-Pugh A (90.9%), hepatitis B (81.8%), there were no significant differences between groups in baseline characteristics (p>0.05). The experimental group has a good tumor response, as shown by higher ORR ( 66.0% vs 59.5%, p=0.530) and DCR (89.4% vs 81.0%, p=0.262) versus control group. The median PFS and median OS were not observed yet. No significant differences were found between groups in postembolization syndrome and liver toxicity (p>0.05). The incidence of thrombocytopenia was higher in control group than in experimental group (9.8% vs 25.0%, p=0.046). Grade 3 or 4 adverse events mainly included increased ALT/AST (ALT, 14.8% vs 22.2%, p=0.350; AST, 23.0% vs 19.4%, p=0.686).

Conclusions

Our interim results suggest that idarubicin could be a safe and effective treatment option for lipiodol TACE of HCC. This trial will progress as planned.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.