Abstract：
BACKGROUND: Locoregional treatment with transarterial chemoembolization (TACE) or hepatic artery infusion chemotherapy (HAIC) and systemic targeted immunotherapy with tyrosine kinase inhibitors (TKI) and programmed cell death protein-1 (PD-1) inhibitors in the treatment of unresectable hepatocellular carcinoma (uHCC) have achieved promising efficacy. The retrospective study aimed to evaluate the efficacy and safety of TACE and HAIC plus TKI with or without PD-1 for uHCC.
METHODS: From November 2020 to February 2024, the data of 44 patients who received TACE-HAIC + TKI + PD-1 (THKP group) and 34 patients who received TACE-HAIC + TKI (THK group) were retrospectively analyzed. Primary outcomes were overall survival (OS) and progress-free survival (PFS), and secondary outcomes were objective response rate (ORR), disease control rate (DCR), conversion rates, and adverse events (AEs).
RESULTS: A total of 78 patients were recruited in our single-center study. The patients in THKP group had prolonged median OS [25 months, 95% confidence interval (CI) 24.0-26.0 vs 18 months, 95% CI 16.1-19.9; p = 0.000278], median PFS [16 months, 95% CI 14.1-17.9 vs 12 months 95% CI 9.6-14.4; p = 0.004] and higher ORR (38.6% vs 23.5%, p = 0. 156) and DCR (88.6% vs 64.7%, p = 0.011) compared with those in THK group. Multivariate analysis showed that treatment option and alpha-fetoprotein (AFP) level were independent prognostic factors of OS and PFS. The frequency of AEs were similar between the two groups.
CONCLUSIONS: The THKP group had better efficacy for uHCC than the THK group, with acceptable safety.
METHODS: From November 2020 to February 2024, the data of 44 patients who received TACE-HAIC + TKI + PD-1 (THKP group) and 34 patients who received TACE-HAIC + TKI (THK group) were retrospectively analyzed. Primary outcomes were overall survival (OS) and progress-free survival (PFS), and secondary outcomes were objective response rate (ORR), disease control rate (DCR), conversion rates, and adverse events (AEs).
RESULTS: A total of 78 patients were recruited in our single-center study. The patients in THKP group had prolonged median OS [25 months, 95% confidence interval (CI) 24.0-26.0 vs 18 months, 95% CI 16.1-19.9; p = 0.000278], median PFS [16 months, 95% CI 14.1-17.9 vs 12 months 95% CI 9.6-14.4; p = 0.004] and higher ORR (38.6% vs 23.5%, p = 0. 156) and DCR (88.6% vs 64.7%, p = 0.011) compared with those in THK group. Multivariate analysis showed that treatment option and alpha-fetoprotein (AFP) level were independent prognostic factors of OS and PFS. The frequency of AEs were similar between the two groups.
CONCLUSIONS: The THKP group had better efficacy for uHCC than the THK group, with acceptable safety.
摘要：
背景：经动脉化疗栓塞（TACE）或肝动脉灌注化疗（HAIC）的局部治疗以及酪氨酸激酶抑制剂（TKI）和程序性细胞死亡蛋白-1（PD-1）抑制剂的全身靶向免疫治疗在不可切除的肝细胞癌（uHCC）的治疗中取得了有希望的疗效。回顾性研究旨在评估TACE和HAIC加TKI伴或不伴PD-1治疗uHCC的疗效和安全性。
方法：回顾性分析2020年11月至2024年2月接受TACE-HAIC+TKI+PD-1（THKP组）44例患者和接受TACE-HAIC+TKI（THK组）34例患者的资料。主要结果是总生存期（OS）和无进展生存期（PFS），次要结果是客观反应率（ORR），疾病控制率（DCR），转化率，和不良事件（AE）。
结果：我们的单中心研究共招募了78名患者。THKP组患者中位OS延长[25个月，95%置信区间（CI）24.0-26.0vs18个月，95%CI16.1-19.9；p=0.000278]，中位PFS[16个月，95%CI14.1-17.9vs12个月95%CI9.6-14.4；p=0.004]及更高的ORR（38.6%vs23.5%，p=0。156）和DCR（88.6%对64.7%，p=0.011）与THK组相比。多因素分析显示治疗方案和甲胎蛋白(AFP)水平是影响OS和PFS的独立预后因素。两组之间的AE频率相似。
结论：THKP组对uHCC的疗效优于THK组，具有可接受的安全性。
方法：回顾性分析2020年11月至2024年2月接受TACE-HAIC+TKI+PD-1（THKP组）44例患者和接受TACE-HAIC+TKI（THK组）34例患者的资料。主要结果是总生存期（OS）和无进展生存期（PFS），次要结果是客观反应率（ORR），疾病控制率（DCR），转化率，和不良事件（AE）。
结果：我们的单中心研究共招募了78名患者。THKP组患者中位OS延长[25个月，95%置信区间（CI）24.0-26.0vs18个月，95%CI16.1-19.9；p=0.000278]，中位PFS[16个月，95%CI14.1-17.9vs12个月95%CI9.6-14.4；p=0.004]及更高的ORR（38.6%vs23.5%，p=0。156）和DCR（88.6%对64.7%，p=0.011）与THK组相比。多因素分析显示治疗方案和甲胎蛋白(AFP)水平是影响OS和PFS的独立预后因素。两组之间的AE频率相似。
结论：THKP组对uHCC的疗效优于THK组，具有可接受的安全性。
