Combination of programmed death protein-1 inhibitor improves the efficacy of transarterial chemoembolization plus lenvatinib for unresectable intermediate-stage hepatocellular carcinoma: a real-world multi-center retrospective study.

OBJECTIVES

The feasibility of programmed death protein-1 inhibitors (PD-1i) for intermediate-stage hepatocellular carcinoma (iHCC) is not yet fully understood. This study aimed to compare the efficacy and safety of transarterial chemoembolization (TACE) and lenvatinib (LEN) (TACE-LEN) plus PD-1i (TACE-LEN-PD-1i) with TACE-LEN in patients with unresectable iHCC (uiHCC).

MATERIAL AND

METHODS

From January 01, 2020, to June 30, 2023, 345 patients with uiHCC undergoing TACE-LEN-PD-1i (n = 156) or TACE-LEN (n = 189) were enrolled at five tertiary centers. Tumor responses, progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs) were compared retrospectively.

RESULTS

TACE-LEN-PD-1i resulted in a better objective response rate (ORR) (4 weeks after the first TACE, 67.3% vs. 51.9%, P = 0.004; best response, 72.4% vs. 52.4%, P = 0.001) over TACE-LEN. Patients undergoing TACE-LEN-PD-1i had a better median OS (30.5 vs. 22.0 months, P < 0.001) and PFS (13.0 vs. 8.5 months, P < 0.001) than those undergoing TACE-LEN. Meanwhile, the conversion rate was also higher in TACE-LEN-PD-1i (23.1% vs. 13.8%, P = 0.030). In the whole cohort, the patients with conversion resection were associated with a significantly higher median PFS (15.5 vs. 9.0 months, P < 0.001) and OS (36.0 vs. 23.0 months, P < 0.001) than those without conversion resection. The grade 1-4 TRAEs between TACE-LEN-PD-1i and TACE-LEN were not significantly different. No grade 5 TRAEs were observed.

CONCLUSIONS

TACE-LEN-PD-1i was safe and well-tolerated. Combination of PD-1i improves the efficacy of TACE-LEN by enhancing ORR and PFS in patients with uiHCC.