e16154

Background: Transcatheter arterial chemoembolization (TACE) is not effective for intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria (substage B2) and also impairs the hepatic functional reserve, resulting in poor prognosis. This study aimed to investigate the efficacy and safety of lenvatinib combined transarterial infusion chemotherapy with FOLFOX regimen (FOLFOX-HAIC) for substage B2 HCC. Methods: This study retrospectively enrolled and analyzed 18 patients with substage B2 HCC from Nov. 2019 to Nov. 2021. Patients were orally administered with 8 mg(≤60kg) or 12mg(> 60kg) lenvatinib once daily initially, and FOLFOX-HAIC (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, fluorouracil bolus 400 mg/m² on day 1, and fluorouracil infusion 2,400 mg/m² for 46 hours) was performed every 3 weeks and up to 6 sessions. Then patients were treated with lenvatinib alone. Patients with downsizing HCC was allowed for potential curative therapies (surgical resection or ablation). Best response according to the RECIST 1.1 and mRECIST criteria, progression-free survival (PFS) and treatment-related adverse events (TRAE) were evaluated. Results: 18 patients (median age: 63.0 years) underwent a total of 77 cycles of HAIC therapy (mean: 4.3; range: 2-6). All patients were classified as Child-Pugh A class. The ORR were 83.3% (RECIST 1.1) and 94.4% (mRECIST), the disease control rate (DCR) was 100% (RECIST1.1/mRECIST). With a median follow-up period of 12.9 months, the median PFS was 10 months. During the follow-up period, no patient died, and 8 of 18 (44.4%) patients experienced progression. 6-, 9-, and 12-months PFS rates were 94%, 74%, and 55%, respectively. TRAE occurred in 15 of 18 patients (83.3%). Two grade 3 TRAE (hepatic encephalopathy and hypertension) was observed. Conclusions: Lenvatinib combined with FOLFOX-HAIC was well tolerated and had shown promising ORR, PFS rates in patients with intermediate-stage HCC beyond up-to-seven criteria. A prospective large-scale trial is needed to justify these results.

Summary of best response.

e16154

背景：经导管动脉化疗栓塞术 (TACE) 对超过 7 个标准（B2 亚期）的中期肝细胞癌 (HCC) 无效，并且还会损害肝功能储备，导致预后不良。本研究旨在探讨乐伐替尼联合经动脉灌注化疗联合FOLFOX方案（FOLFOX-HAIC）治疗B2亚期HCC的疗效和安全性。方法：本研究回顾性纳入并分析了 2019 年 11 月至 2021 年 11 月的 18 例 B2 亚期 HCC 患者。患者最初口服 8 mg（≤60kg）或 12mg（>60kg）乐伐替尼，每日 1 次，FOLFOX-HAIC（奥沙利铂 85 mg/m2，亚叶酸 400 mg/m2，第 1 天 400 mg/m2 氟尿嘧啶推注^，氟尿嘧啶输注 2,400 mg/m^{2 次}，持续 46 小时）每 3 周进行一次，最多 6 次。然后患者单独接受乐伐替尼治疗。缩小 HCC 的患者被允许接受潜在的治愈性治疗（手术切除或消融）。根据 RECIST 1.1 和 mRECIST 标准评估最佳反应、无进展生存期 (PFS) 和治疗相关不良事件 (TRAE)。结果：18 名患者（中位年龄：63.0 岁）共接受了 77 个周期的 HAIC 治疗（平均：4.3；范围：2-6）。所有患者均被归类为 Child-Pugh A 级。ORR分别为83.3%（RECIST 1.1）和94.4%（mRECIST），疾病控制率（DCR）为100%（RECIST1.1/mRECIST）。中位随访期为 12.9 个月，中位 PFS 为 10 个月。在随访期间，没有患者死亡，18 名患者中有 8 名（44.4%）出现进展。6 个月、9 个月和 12 个月的 PFS 率分别为 94%、74% 和 55%。18 名患者中有 15 名（83.3%）发生 TRAE。观察到两个 3 级 TRAE（肝性脑病和高血压）。结论：Lenvatinib 联合 FOLFOX-HAIC 具有良好的耐受性，并且在超过 7 个标准的中期 HCC 患者中显示出有希望的 ORR、PFS 率。需要一项前瞻性的大规模试验来证明这些结果的合理性。