Lenvatinib plus hepatic arterial infusion of modified FOLFOX regime(FOHAIC) in patients with BCLC stage C hepatocellular carcinoma.

Abstract

e16000 Background: Lenvatinib is the first-line TKI treatment for BCLC stage C hepatocellular carcinoma (HCC) with better objective response rate (ORR) and longer progression free survival (PFS) than sorafenib, but the prognosis is still unsatisfactory. Hepatic arterial infusion chemotherapy of modified FOLFOX regime (FOHAIC) has shown promising results for patients with advanced HCC. This study aimed to update the result of efficacy and safety for lenvatinib plus FOHAIC in patients with BCLC stage C hepatocellular carcinoma. Methods: This was a retrospective study including 46 patients from Nov 2018 to April 2021 Patients with BCLC stage C hepatocellular carcinoma. Patients were treated with 8 mg(≤60kg) or 12mg(> 60kg) lenvatinib once daily initially and FOHAIC (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). Best response according to the RECIST 1.1 and mRECIST criteria. PFS, overall survival (OS) and treatment-related adverse events(TRAE) were also evaluated. Results: 46 patients(median age: 54.9 years) underwent a total of 223 cycles of HAIC therapy (mean: 4.8 cycles). 43 (93.5%) patients with HBV infection.35(76.1%). Patients were diagnosed with vascular invasion. 45 (97.8%) patients were classified as Child-pugh A class and 1 (2.2%) patients were Child-pugh B class. The ORR were 58.7% (RECIST 1.1, 27 of 46) and 76.1% (mRECIST, 35 of 46), the disease control rate (DCR) was 93.5% (RECIST 1.1/mRECIST). With a median follow-up period of 14.9 months, the median PFS and median OS were 15.9 months and 27.9 months, respectively.TRAE occurred in 36 of 46 patients (78.3%), most common TRAE were hypertension (41.3%), diarrhea (34.8%), fatigue(34.8%), abdominal pain(32.6%), hand-foot skin reaction(23.9%),and weight loss(19.6%). The grade 3/4 TRAE were more frequent in abdominal pain(8.7%), hypertension (6.5%) and diarrhea(6.5%). Conclusions: This study demonstrated that lenvatinib plus FOHAIC had acceptable toxic effects and shown promising ORR, PFS and OS in BCLC stage C hepatocellular carcinoma. Warrants its further investigation in a large-scale trial.[Table: see text]