Lenvatinib is the first-line treatment for advanced hepatocellular carcinoma (HCC), but the prognosis was still unsatisfactory. Recently, hepatic arterial infusion chemotherapy (HAIC), and immune checkpoint inhibitors have shown promising results for patients with advanced HCC. Considering different anti-malignancy mechanisms, combining these three modalities may improve outcomes. This study was to compare the efficacy and safety of lenvatinib, toripalimab, plus HAIC versus lenvatinib alone for advanced HCC patients.
This was a retrospective study including patients treated with lenvatinib alone (8 mg [≤60kg] or 12mg [>60kg] once daily) or lenvatinib, toripalimab plus HAIC (LeToHAIC group, lenvatinib once daily 0-1 week prior to initial HAIC, 240 mg toripalimab 0-1 day prior to every HAIC cycle, and HAIC with FOLFOX regimen [oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, fluorouracil bolus 400 mg/m2 on day 1, and fluorouracil infusion 2400 mg/m2 for 46 hours, every 3 weeks]). Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR) and treatment-related adverse event (TRAE) were compared.
From February 2019 to August 2019, 157 patients were included for this study: 71 in the LeToHAIC group, and 86 in the lenvatinib group. The LeToHAIC group showed a longer PFS (11.1 vs 5.1 months, p<0.001), a longer OS (not reached vs 11 months, p<0.001), a higher DCR (RECIST or mRECIST: 90.1% vs 72.1%, p=0.005), a higher ORR (RECIST: 59.2% vs 9.3%, p<0.001; mRECIST: 67.6% vs 16.3%, p<0.001) than the lenvatinib group. In addition, 14.1% of patients in the LeToHAIC group achieved complete response by mRECIST criteria. Grade 3/4 TRAEs that were more frequent in the LeToHAIC group than in the lenvatinib group included neutropenia (8.5% vs 1.2%), thrombocytopenia (5.6% vs 0), and nausea (5.6% vs 0).
Triple combination therapy of lenvatinib, toripalimab, and HAIC had acceptable toxic effects and might improve survival compared with lenvatinib alone in advanced HCC.
The authors.
National Natural Science Foundation of China Ministry of Science and Technology of the People's Republic of China.
All authors have declared no conflicts of interest.