Real-world efficacy and safety of transarterial chemoembolization plus sintilimab and bevacizumab biosimilar for intermediate-advanced hepatocellular carcinoma: a propensity score matching study.

[OBJECTIVES] This study aimed to investigate the efficacy and safety of transarterial chemoembolization (TACE) plus sintilimab and bevacizumab biosimilar as first-line therapy for intermediate-advanced hepatocellular carcinoma (HCC).

[MATERIALS AND METHODS] A total of 253 patients with HCC who received either TACE plus sintilimab and bevacizumab biosimilar (combination group, n=74) or TACE alone (monotherapy group, n=179) were included retrospectively. Propensity score matching (PSM) analysis was used to match patients. The objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety of two groups were compared.

[RESULTS] After propensity score matching (1:2), 65 patients in the combination group were matched to 100 patients in the monotherapy group. The ORR (63.1% vs. 40.0%,  = 0.004) was better in the combination group than those in monotherapy group. The combination group had higher median PFS (13.3 vs. 7.1 months; hazard ratio [HR] = 0.63, 95% confidence interval [CI], 0.41-0.87;  = 0.017) and OS (20.1 vs. 14.6 months; HR = 0.53, 95% CI, 0.35-0.81;  = 0.010) than those in the monotherapy group. Multivariate analysis confirmed that BCLC stage B, ECOG PS of 0, and combination therapy were associated with higher PFS and OS. Grade 3/4 TRAEs occurred in 21.5% of the patients in the combination group, and 14.0% of the patients in the monotherapy group.

[CONCLUSION] Compared to TACE monotherapy, TACE plus sintilimab and bevacizumab biosimilar showed significantly better ORR, PFS, and OS for intermediate-advanced HCC.