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.
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。