Efficacy and Safety of Transarterial Chemoembolization Combined with Lenvatinib Plus Programmed Death-1 Inhibitor for Hepatocellular Carcinoma with the Hepatic Vein and/or Inferior Vena Cava Tumor Thrombus

The aim of this study was to assess the safety and effectiveness of transarterial chemoembolization (TACE) plus lenvatinib with a programmed death-1 (PD-1) inhibitor compared with TACE plus lenvatinib and TACE alone for hepatocellular carcinoma (HCC) with the hepatic vein and/or inferior vena cava tumor thrombus (HVTT and IVCTT).

Data on HCC accompanied by HVTT and IVCTT from June 2015 to August 2022 were analyzed in this single-center retrospective study. Drug-eluting bead TACE (DEB-TACE) or conventional TACE (cTACE) was used. The primary study outcomes were overall survival (OS) and progression-free survival (PFS). Univariate and multivariate Cox analyses were performed to determine the predictive factors for OS and PFS. A subgroup analysis was conducted.

Overall, 214 patients were enrolled. Among them, 60 received triple therapy consisting of TACE, lenvatinib, and PD-1 inhibitors (TACE + L + P), 72 received dual therapy consisting of TACE and lenvatinib (TACE + L), and 82 received TACE alone. The TACE + L + P group (16.2; 95% confidence interval [CI]: 12.8–19.5 months) had a significantly longer median OS compared with the TACE + L group (11.2; 95% CI: 10.0–12.3 months) (P = 0.001) and the TACE group (8.3; 95% CI: 7.7–8.5 months) (P < 0.001); the TACE + L + P group (12.3; 95% CI: 10.9–13.7 months) had a significantly longer median PFS compared with the TACE + L group (8.5; 95% CI: 7.7–9.2 months) (P < 0.001) and the TACE group (6.2; 95% CI: 5.8 ~ 6.3 months) (P < 0.001). Multivariate Cox analysis demonstrated that treatment strategy was a significant factor for OS and PFS. Skin rash was more common in the triple therapy group and might be attributed to PD-1 ligand inhibitor therapy (33.33% vs. 16.66%, P = 0.026).

Triple therapy consisting of TACE plus lenvatinib with a PD-1 inhibitor showed promising efficacy for advanced HCC patients with HVTT and IVCTT, with manageable safety profiles.