Abstract：
BACKGROUND: Local treatment may function synergistically with immunotherapy and targeted agents. This study aimed to assess the effectiveness and safety of transcatheter arterial chemoembolization (TACE) and hepatic artery infusion chemotherapy (HAIC) combined with tyrosine kinase inhibitors (TKIs) and programmed death-1 (PD-1) inhibitors in patients with initially unresectable hepatocellular carcinoma (uHCC).
METHODS: A retrospective study was conducted on patients diagnosed with initially uHCC who received combined treatment of TACE-HAIC combined with TKIs and PD-1 inhibitors from July 2020 to February 2023. The primary endpoints were overall survival (OS) and progression free survival (PFS) and adverse events (AEs). Objective response rate (ORR), disease control rate (DCR) and conversion surgery rate (CSR), whereas the secondary endpoints.
RESULTS: After screening, a total of 62 patients were selected for this study. The overall median OS was 18.2 (95% CI 16.24-20.16) months and median PFS was 9.2 (95% CI 7.24-11.16) months. Based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria and RECIST v1.1 criteria, ORR was 67.7% (42/62), and the DCR was 90.3% (56/62), the CSR was 27.4% (17/62). The most common treatment-emergent adverse events (TEAEs) were transaminitis (56.4%, 35/62), nausea and vomiting (43.5%, 27/62), thrombocytopenia (37.1%, 23/62), abdominal pain (33.9%, 21/62), and fever (33.9%, 21/62).
CONCLUSIONS: TKIs combined with PD-1 inhibitors plus TACE-HAIC therapy represents an effective and tolerable treatment option in patients with uHCC. Patients undergoing surgery after combination therapy may have survival benefits.
METHODS: A retrospective study was conducted on patients diagnosed with initially uHCC who received combined treatment of TACE-HAIC combined with TKIs and PD-1 inhibitors from July 2020 to February 2023. The primary endpoints were overall survival (OS) and progression free survival (PFS) and adverse events (AEs). Objective response rate (ORR), disease control rate (DCR) and conversion surgery rate (CSR), whereas the secondary endpoints.
RESULTS: After screening, a total of 62 patients were selected for this study. The overall median OS was 18.2 (95% CI 16.24-20.16) months and median PFS was 9.2 (95% CI 7.24-11.16) months. Based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria and RECIST v1.1 criteria, ORR was 67.7% (42/62), and the DCR was 90.3% (56/62), the CSR was 27.4% (17/62). The most common treatment-emergent adverse events (TEAEs) were transaminitis (56.4%, 35/62), nausea and vomiting (43.5%, 27/62), thrombocytopenia (37.1%, 23/62), abdominal pain (33.9%, 21/62), and fever (33.9%, 21/62).
CONCLUSIONS: TKIs combined with PD-1 inhibitors plus TACE-HAIC therapy represents an effective and tolerable treatment option in patients with uHCC. Patients undergoing surgery after combination therapy may have survival benefits.
摘要：
背景：局部治疗可能与免疫治疗和靶向药物协同作用。本研究旨在评估经导管动脉化疗栓塞（TACE）和肝动脉灌注化疗（HAIC）联合酪氨酸激酶抑制剂（TKIs）和程序性死亡-1（PD-1）抑制剂在最初不可切除的肝细胞癌（uHCC）患者中的有效性和安全性。
方法：对2020年7月至2023年2月接受TACE-HAIC联合TKIs和PD-1抑制剂联合治疗的最初诊断为uHCC的患者进行了回顾性研究。主要终点是总生存期（OS）和无进展生存期（PFS）和不良事件（AE）。客观反应率（ORR），疾病控制率(DCR)和转换手术率(CSR)，而次要终点。
结果：筛选后，本研究共选择62例患者.总体中位OS为18.2个月（95%CI16.24-20.16），中位PFS为9.2个月（95%CI7.24-11.16）。基于改良的实体瘤反应评估标准（mRECIST）标准和RECISTv1.1标准，ORR为67.7%(42/62)，DCR为90.3%(56/62)，CSR为27.4%(17/62)。最常见的治疗引起的不良事件（TEAE）是转氨酶（56.4％，35/62),恶心和呕吐（43.5%，27/62),血小板减少症（37.1%，23/62),腹痛（33.9%，21/62),和发烧(33.9%，21/62).
结论：TKIs与PD-1抑制剂联合TACE-HAIC治疗是uHCC患者的一种有效且可耐受的治疗选择。联合治疗后接受手术的患者可能具有生存益处。
方法：对2020年7月至2023年2月接受TACE-HAIC联合TKIs和PD-1抑制剂联合治疗的最初诊断为uHCC的患者进行了回顾性研究。主要终点是总生存期（OS）和无进展生存期（PFS）和不良事件（AE）。客观反应率（ORR），疾病控制率(DCR)和转换手术率(CSR)，而次要终点。
结果：筛选后，本研究共选择62例患者.总体中位OS为18.2个月（95%CI16.24-20.16），中位PFS为9.2个月（95%CI7.24-11.16）。基于改良的实体瘤反应评估标准（mRECIST）标准和RECISTv1.1标准，ORR为67.7%(42/62)，DCR为90.3%(56/62)，CSR为27.4%(17/62)。最常见的治疗引起的不良事件（TEAE）是转氨酶（56.4％，35/62),恶心和呕吐（43.5%，27/62),血小板减少症（37.1%，23/62),腹痛（33.9%，21/62),和发烧(33.9%，21/62).
结论：TKIs与PD-1抑制剂联合TACE-HAIC治疗是uHCC患者的一种有效且可耐受的治疗选择。联合治疗后接受手术的患者可能具有生存益处。
