Lenvatinib, toripalimab, plus hepatic arterial infusion chemotherapy versus lenvatinib alone for advanced hepatocellular carcinoma

Min-Ke He; Run-Bin Liang; Yang Zhao; Yu-Jie Xu; Huan-Wei Chen; Yuan-Min Zhou; Zhi-Cheng Lai; Li Xu; Wei Wei; Yao-Jun Zhang; Min-Shan Chen; Rong-Ping Guo; Qi-Jiong Li; Ming Shi

doi:10.1177/17588359211002720

Lenvatinib, toripalimab, plus hepatic arterial infusion chemotherapy versus lenvatinib alone for advanced hepatocellular carcinoma

Ther Adv Med Oncol. 2021 Mar 25:13:17588359211002720. doi: 10.1177/17588359211002720. eCollection 2021.

Authors

Min-Ke He¹, Run-Bin Liang¹, Yang Zhao¹, Yu-Jie Xu¹, Huan-Wei Chen², Yuan-Min Zhou³, Zhi-Cheng Lai¹, Li Xu¹, Wei Wei¹, Yao-Jun Zhang¹, Min-Shan Chen¹, Rong-Ping Guo¹, Qi-Jiong Li⁴, Ming Shi⁴

Affiliations

¹ Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
² First People's Hospital of Foshan, Foshan, Guangdong, China.
³ Guangzhou No.12 People's Hospital, Guangzhou, China.
⁴ Department of Hepatobiliary Oncology, Cancer Center, Sun Yat-sen University, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, P.R. China.

Abstract

Background: Lenvatinib is the first-line treatment for advanced hepatocellular carcinoma, but prognosis is still unsatisfactory. Recently, hepatic arterial infusion chemotherapy (HAIC), and immune checkpoint inhibitors showed promising results for advanced hepatocellular carcinoma. Considering different anti-malignancy mechanisms, combining these three treatments may improve outcomes. This study aimed to compare the efficacy and safety of lenvatinib, toripalimab, plus HAIC versus lenvatinib for advanced hepatocellular carcinoma.

Methods: This was a retrospective study including patients treated with lenvatinib [8 mg (⩽60 kg) or 12 mg (>60 kg) once daily] or lenvatinib, toripalimab plus HAIC [LeToHAIC group, lenvatinib 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, 5-fluorouracil bolus 400 mg/m² on day 1, and 5-fluorouracil infusion 2400 mg/m² for 46 h, every 3 weeks)]. Progression-free survival, overall survival, objective response rate, and treatment-related adverse events were compared.

Results: From February 2019 to August 2019, 157 patients were included in this study: 71 in the LeToHAIC group and 86 in the lenvatinib group. The LeToHAIC group showed longer progression-free survival (11.1 versus 5.1 months, p < 0.001), longer overall survival (not reached versus 11 months, p < 0.001), and a higher objective response rate (RECIST: 59.2% versus 9.3%, p < 0.001; modified RECIST: 67.6% versus 16.3%, p < 0.001) than the lenvatinib group. In addition, 14.1% and 21.1% of patients in the LeToHAIC group achieved complete response of all lesions and complete response of the intrahepatic target lesions per modified RECIST criteria, respectively. Grade 3/4 treatment-related adverse events that were more frequent in the LeToHAIC group than in the lenvatinib group included neutropenia (8.5% versus 1.2%), thrombocytopenia (5.6% versus 0), and nausea (5.6% versus 0).

Conclusions: Lenvatinib, toripalimab, plus HAIC had acceptable toxic effects and might improve survival compared with lenvatinib alone in advanced hepatocellular carcinoma.

Keywords: FOLFOX; hepatic arterial infusion chemotherapy; hepatocellular carcinoma; lenvatinib; toripalimab.