Department of Oncology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jixangxi, China.
Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jixangxi, China.
Cancer Med. 2024 May;13(9):e7105. doi: 10.1002/cam4.7105.
BACKGROUND: Hepatic arterial infusion chemotherapy (HAIC) has demonstrated remarkable local therapeutic efficacy in treating patients with large unresectable hepatocellular carcinoma (HCC). Additionally, the combination of lenvatinib and programmed cell death protein-1 (PD-1) inhibitors has demonstrated promising antitumor effects in unresectable HCC. Therefore, we conducted a retrospective analysis to evaluate the efficacy and safety of combining HAIC with lenvatinib and PD-1 inhibitors as a first-line therapeutic approach in high-burden HCC patients. METHODS: We conducted a retrospective analysis on patients diagnosed with high-burden HCC who had major portal vein tumor thrombosis (Vp3 and Vp4) or tumor occupancy exceeding 50% of the liver. These patients received a first-line treatment consisting of HAIC with a combination of 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX), along with lenvatinib and PD-1 inhibitors between November 2020 and June 2023. The primary endpoints of this study included progression-free survival (PFS) and overall survival (OS), while the secondary endpoints were objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (TRAEs). RESULTS: Ninety-one patients were enrolled in this study, with a median PFS of 8.8 months (95% confidence interval [CI]: 5.75-11.78) and a median OS of 14.3 months (95% CI: 11.23-17.31). According to RECIST 1.1 criteria, the ORR was 52.7%, and DCR was 95.6%. According to the mRECIST criteria, the ORR was 72.5%, and the DCR was 96.5%. Among all patients, 86 (94.5%) experienced TRAEs, and there were no instances of treatment-related deaths. CONCLUSION: The combination of HAIC-FOLFOX with lenvatinib and PD-1 inhibitors as a first-line therapy has exhibited notable therapeutic efficacy and well-tolerated adverse events among patients with high-burden HCC.
背景：肝动脉灌注化疗（HAIC）在治疗大不可切除肝细胞癌（HCC）患者方面显示出显著的局部治疗效果。此外，仑伐替尼联合程序性细胞死亡蛋白-1（PD-1）抑制剂在不可切除 HCC 中显示出有前途的抗肿瘤作用。因此，我们进行了一项回顾性分析，以评估 HAIC 联合仑伐替尼和 PD-1 抑制剂作为高负担 HCC 患者一线治疗方法的疗效和安全性。
方法：我们对诊断为高负担 HCC 的患者进行了回顾性分析，这些患者有主要门静脉肿瘤血栓形成（Vp3 和 Vp4）或肿瘤占据肝脏的 50%以上。这些患者接受了一线治疗，包括 HAIC 联合 5-氟尿嘧啶、亚叶酸钙和奥沙利铂（FOLFOX），以及仑伐替尼和 PD-1 抑制剂，治疗时间为 2020 年 11 月至 2023 年 6 月。本研究的主要终点包括无进展生存期（PFS）和总生存期（OS），次要终点包括客观缓解率（ORR）、疾病控制率（DCR）和治疗相关不良事件（TRAEs）。
结果：本研究共纳入 91 例患者，中位 PFS 为 8.8 个月（95%置信区间[CI]：5.75-11.78），中位 OS 为 14.3 个月（95% CI：11.23-17.31）。根据 RECIST 1.1 标准，ORR 为 52.7%，DCR 为 95.6%。根据 mRECIST 标准，ORR 为 72.5%，DCR 为 96.5%。所有患者中，86 例（94.5%）发生 TRAEs，无治疗相关死亡。
结论：HAIC-FOLFOX 联合仑伐替尼和 PD-1 抑制剂作为一线治疗方案，在高负担 HCC 患者中显示出显著的治疗效果和良好的耐受不良事件。
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