996P - Transarterial chemoembolization combined donafenib with/without programmed death-1 inhibitors for initially unresectable hepatocellular carcinoma in a multicenter retrospective study

Background

For unresectable hepatocellular carcinoma (uHCC), the efficacy of transarterial chemoembolization (TACE) monotherapy is not satisfactory. Some studies have shown that TACE combined with molecular targeted drugs and programmed death-1 (PD-1) inhibitors shows potential synergistic effects that can prolong the overall survival (OS) of patients with uHCC. Donafenib is a new generation of multi-kinase inhibitor which is approved as the first line treatment for uHCC. This study aimed to evaluate the efficacy and safety of TACE combined with donafenib plus PD-1 inhibitor (TACE+DP) and of TACE combined with donafenib (TACE+D) for uHCC in a multicenter retrospective study.

Methods

The clinical data of patients with uHCC who had received TACE+DP or TACE+D as first-line treatment from six Chinese academic centers, from July 2021 to July 2022, were collected and retrospectively analyzed. In the TACE+DP group, patients received intravenous administration of PD-1 inhibitor every three weeks and oral donafenib (0.2 g) twice daily until intolerable toxicity or disease progression. In the TACE+D group, patients received the same dose of donafenib 3-5 days after TACE. Overall survival (OS), progression-free survival (PFS), and tumor responses were evaluated between the two groups according to the modified RECIST criteria.

Results

A total of 157 patients in the TACE+D group and 166 patients in TACE+DP group were included in this study. Patients in the TACE+DP group had longer median OS (18.1 vs 13.2 months, P<0.001) and longer median PFS (10.6 vs 7.9 months, P<0.001) than those in the TACE+D group. Patients in the TACE+DP group achieved a higher ORR (50.6% vs 41.4%, P=0.019) and a higher disease control rate (DCR) (89.2% vs 82.8%, P=0.010) than those in the TACE+D group. There was no significant difference in the incidence and severity of adverse events in the TACE+DP and TACE+D groups (any grade, 92.9% vs. 94.6%, P=0.270; grade 3 or 4, 33.8% vs. 37.3%, P=0.253).

Conclusions

With favorable safety and tolerability, TACE combined donafenib with PD-1 inhibitors significantly improves PFS, OS, and ORR over TACE combined with donafenib.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The First Affiliated Hospital of Zhengzhou University.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.