Lenvatinib plus drug-eluting bead transarterial chemoembolization with or without hepatic arterial infusion chemotherapy for hepatocellular carcinoma (> 7 cm) with portal vein tumor thrombosis: A retrospective multicenter cohort study

BackgroundThe management of large hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT) remains a great challenge. We aimed to investigate the efficacy and safety of lenvatinib plus drug-eluting bead transarterial chemoembolization (DEB-TACE) and hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, fluorouracil and leucovorin (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for HCC larger than 7.0 cm accompanied with PVTT.MethodsThis multicenter retrospective study evaluated consecutive patients with HCC (> 7.0 cm) and PVTT who received Len+DEB-TACE+HAIC (Len+DEB-TACE+HAIC group) or Len+DEB-TACE (Len+DEB-TACE group) between July 2019 and June 2021 from six institutions in China. Objective response rate (ORR), time to progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the two groups by propensity score matching (PSM).ResultsA total of 201 patients were included. After PSM, 83-paired patients remained in the study cohorts. Patients in the Len+DEB-TACE+HAIC group had higher ORR (66.3% vs. 38.6%, P < 0.001), longer TTP (median, 10.1 vs. 6.1 months, P < 0.001), and prolonged OS (median, 17.3 vs. 12.9 months, P < 0.001) than those in the Len+DEB-TACE group. The ORR and TTP of both intrahepatic tumor (ORR, 68.7% vs. 39.8%, P < 0.001; median TTP, 11.0 vs. 7.0 months, P < 0.001) and PVTT (ORR, 72.3% vs. 48.2%, P = 0.002; median TTP, 17.7 vs. 8.4 months, P < 0.001) were better in the Len+DEB-TACE+HAIC group than the Len+DEB-TACE group. The frequency of grade 3-4 TRAEs in the Len+DEB-TACE+HAIC group were comparable to those in the Len+DEB-TACE group (38.6% vs. 33.7%, P = 0.518).ConclusionsThe addition of HAIC to Len+DEB-TACE significantly improved ORR, TTP, and OS over Len+DEB-TACE with an acceptable safety profile for large HCC with PVTT.Legal entity responsible for the studyThe authors.FundingThe National Natural Science Foundation of China (82172043 and 82202273), the Plan on Enhancing Scientific Research in GMU (198), the Innovative and Featured Clinical Technique of Guangzhou, the Basic and Applied Basic Research Foundation of Guangdong Province (2020A1515110654), and the Clinical Study Project of the Second Affiliated Hospital of Guangzhou Medical University (2021-LCYJ-DZX-01, 2022-LCYJ-YY-02, 2022-LCYJ-YYDZX-01, and 2023-LCYJ-ZF-47).DisclosureAll authors have declared no conflicts of interest.