Zhang Yi-Min, Wu Xin-Tong, Yi Jun-Zhe, Xu Jie, Zhang Yu-Nan, Lyu Ning, Zhao Ming
Department of Minimally Invasive Interventional Therapy, Liver Cancer Study and Service Group, Sun Yat-Sen University Cancer Center, Guangzhou, China.
State Key Laboratory of Oncology in South China, Guangzhou, China.
Liver Cancer. 2025 Apr 22:1-18. doi: 10.1159/000545891.
INTRODUCTION: A previous phase 3 FOHAIC-1 study demonstrated that hepatic arterial infusion chemotherapy (HAIC) of FOLFOX regimen displayed favorable outcomes in advanced hepatocellular carcinoma (HCC) patients, including those with high-risk features (main portal tumor invasion and >50% liver infiltration). This study aimed to compare the treatment efficacy of HAIC-FOLFOX versus atezolizumab-bevacizumab in HCC patients. METHODS: Individual patient data from the Chinese FOHAIC-1 study and aggregate data from the global IMbrave150 study were used to conduct an anchored matching-adjusted indirect comparison. Hazard ratios (HR) and restricted mean survival times (RMST) were calculated to assess survival differences. Landmark analysis was performed to evaluate time-sensitive treatment effects, and simulated treatment comparison (STC) was conducted as a sensitivity analysis. Rates of treatment-related adverse events (TRAEs) and TRAE-related discontinuations were also compared. RESULTS: After matching baseline characteristics, HAIC showed a numerical OS benefit (HR 0.57, 95% CI, 0.30-1.08) and similar PFS benefit (HR 0.79, 95% CI, 0.43-1.47) compared to atezolizumab-bevacizumab in the overall population. In high-risk patients, HAIC demonstrated significantly improved OS (HR 0.30, 95% CI, 0.12-0.72) and 2.89-month longer RMST compared to atezolizumab-bevacizumab (95% CI, 0.15-5.64 months). Additionally, HAIC showed superior PFS (HR 0.25, 95% CI, 0.10-0.64) and 2.88-month longer RMST over atezolizumab-bevacizumab (95% CI, 0.90-4.86). Landmark analysis in the high-risk group revealed that HAIC was associated with significant improvements in both OS (HR 0.32, 95% CI, 0.13-0.79) and PFS (HR 0.24, 95% CI, 0.09-0.63) during the 0-12 months following treatment initiation. Sensitivity analysis using the anchored STC analysis yielded consistent results. HAIC was associated with lower rates of grade 3-4 TRAEs and TRAE-related discontinuation in both the overall population and the high-risk group. CONCLUSION: HAIC treatment provided superior survival benefits and a favorable safety profile compared to atezolizumab-bevacizumab in high-risk HCC patients.
引言：先前的一项3期FOHAIC - 1研究表明，FOLFOX方案的肝动脉灌注化疗（HAIC）在晚期肝细胞癌（HCC）患者中显示出良好的疗效，包括那些具有高危特征（主要门静脉肿瘤侵犯和>50%肝脏浸润）的患者。本研究旨在比较HAIC - FOLFOX与阿替利珠单抗 - 贝伐单抗在HCC患者中的治疗效果。 方法：使用来自中国FOHAIC - 1研究的个体患者数据和来自全球IMbrave150研究的汇总数据进行锚定匹配调整间接比较。计算风险比（HR）和受限平均生存时间（RMST）以评估生存差异。进行里程碑分析以评估时间敏感的治疗效果，并进行模拟治疗比较（STC）作为敏感性分析。还比较了治疗相关不良事件（TRAEs）的发生率和与TRAEs相关的停药率。 结果：在匹配基线特征后，与阿替利珠单抗 - 贝伐单抗相比，HAIC在总体人群中显示出数值上的总生存期（OS）获益（HR 0.57，95%CI，0.30 - 1.08）和相似的无进展生存期（PFS）获益（HR 0.79，95%CI，0.43 - 1.47）。在高危患者中，与阿替利珠单抗 - 贝伐单抗相比，HAIC显示出显著改善的OS（HR 0.30，95%CI，0.12 - 0.72）和RMST延长2.89个月（95%CI，0.15 - 5.64个月）。此外，与阿替利珠单抗 - 贝伐单抗相比，HAIC显示出更优的PFS（HR 0.25，95%CI，0.10 - 0.64）和RMST延长2.88个月（95%CI，0.90 - 4.86）。高危组的里程碑分析显示，HAIC在治疗开始后的0 - 12个月内与OS（HR 0.32，95%CI，0.13 - 0.79）和PFS（HR 0.24，95%CI，0.09 - 0.63）的显著改善相关。使用锚定STC分析的敏感性分析产生了一致的结果。在总体人群和高危组中，HAIC与3 - 4级TRAEs和与TRAEs相关的停药率较低相关。 结论:在高危HCC患者中，与阿替利珠单抗 - 贝伐单抗相比，HAIC治疗提供了更优的生存获益和良好的安全性。
Res Synth Methods. 2024-7
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