Efficacy and safety of transarterial chemoembolization and radiofrequency ablation plus tyrosine kinase inhibitors with or without PD-1 inhibitors for unresectable hepatocellular carcinoma.

Abstract

Objective: The purpose of this study was to compare the efficacy and safety of transarterial chemoembolization combined with radiofrequency ablation (TACE-RFA) plus tyrosine kinase inhibitors (TKI) with or without programmed cell death protein-1(PD-1) inhibitors in the treatment of unresectable hepatocellular carcinoma (uHCC).

Materials and methods: From January 2020 to October 2024, 87 patients with uHCC who received TACE-RFA plus TKI with or without PD-1 inhibitors in our center were retrospectively analyzed, and divided into TACE-RFA + TKI (TRK) group and TACE-RFA + TKI + PD-1 (TRKP) group. Kaplan-Meier method and log-rank test were used to analyze overall survival (OS) and progression-free survival (PFS) of the two groups. Adverse events (AEs) between the two groups were evaluated according to Common Adverse Event Evaluation Criteria (CTCAEs) Version 5.0.

Results: The patients in the TRKP group had longer median OS (mOS) (24 [95% confidence interval (CI): 17.7-30.3] vs 18[95% CI: 15.1-20.9]months, p = 0.04) and median PFS (mPFS) (15[95% CI: 13.4-16.6] vs 12 [95% CI: 10.8-13.2]months, p = 0.01) than that in the TRK group. The objective response rate (ORR) (44.19% vs 36.36%, p = 0.03) and disease control rate (DCR) (86.05% vs. 70.45%, p = 0.08) in the TRKP group were better than those in the TRK group. There was no significant difference in the frequency and severity of AEs between the two groups.

Conclusions: The treatment of TACE-RFA+TKI+PD-1 inhibitors is effective and safe for uHCC.

Advances in knowledge: This study advances knowledge by showing that the TACE-RFA+TKI+PD-1 (TRKP) regimen is more effective than TACE-RFA+TKI (TRK) in improving median overall survival, median progression-free survival and objective response rate for unresectable hepatocellular carcinoma (uHCC) with controllable adverse events, and identifies TRKP as an independent favorable prognostic factor, while AFP ≥ 400 ng/mL and BCLC stage C as adverse prognostic factors for uHCC.