Data Sheet 1_Efficacy and safety of transarterial chemoembolization plus donafenib with or without camrelizumab for unresectable hepatocellular carcinoma: a propensity score matching analysis.docx

PurposeTo compare the efficacy and safety of transarterial chemoembolization plus donafenib (TACE+D) and TACE plus donafenib combined with camrelizumab (TACE+D+C) in unresectable hepatocellular carcinoma (uHCC), using propensity score matching (PSM) to minimize selection bias.
MethodsA single-center retrospective study analyzed 278 patients with uHCC who received treatment between 2021 and 2024, and they were divided into TACE+D and TACE+D+C groups. PSM was used to perform 1:1 matching (58 patients per group). Tumor response, progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs) were compared; Cox regression was used to identify prognostic factors.
ResultsAfter PSM, 58 patients were included in each group. Compared with the TACE+D group, the TACE+D+C group demonstrated a significantly higher partial response (PR) (37.93% vs 20.69%, P = 0.041), objective response rate (ORR) (62.07% vs 36.21%, P = 0.005) and disease control rate (DCR) (86.21% vs 70.69%, P = 0.042). Notably, the TACE+D+C group achieved a remarkably longer mOS than the TACE+D group (23.1 months vs 12.0 months, P = 0.022). Similarly, median PFS was significantly prolonged in the TACE+D+C group compared with the TACE+D group (13.0 months vs 7.8 months, P = 0.007). Multivariable Cox regression identified Barcelona Clinic Liver Cancer (BCLC) stage (hazard ratio [HR] = 1.69, P = 0.029), Protein Induced by Vitamin K Absence or Antagonist-II (PIVKA-II) (HR = 3.66, P < 0.001), and alpha-fetoprotein (AFP) level (HR = 2.38, P < 0.001) as independent prognostic factors for OS. For PFS, independent prognostic factors were PIVKA-II (HR = 3.07, P < 0.001) and AFP level (HR = 2.52, P < 0.001). Although the TACE+D+C group exhibited immune-related adverse events (irAEs) (e.g., hypothyroidism and reactive cutaneous capillary endothelial proliferation), no significant differences were observed between the two groups in drug-related TRAEs, TRAEs after TACE, or Grade 3 TRAEs.
ConclusionThe TACE+D+C group significantly improves ORR, PFS and OS in uHCC patients with a comparable safety profile to the TACE+D group, while the single-center retrospective design limits generalizability, warranting prospective studies.