Department of Minimally Invasive Interventional Therapy, Sun Yat-Sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, 510060, People's Republic of China.
State Key Laboratory of Oncology in South China, Guangzhou, People's Republic of China.
Hepatol Int. 2024 Oct;18(5):1486-1498. doi: 10.1007/s12072-024-10690-6. Epub 2024 Jul 3.
There is limited information on combination of hepatic arterial infusion chemotherapy (HAIC) and systemic therapy for advanced hepatocellular carcinoma (Ad-HCC). We aim to compare the efficacy and safety of HAIC plus camrelizumab (a PD-1 inhibitor) and apatinib (an VEGFR-2 inhibitor) versus camrelizumab and apatinib for Ad-HCC.
From April 2019 to October 2022, 416 patients with Ad-HCC who received either HAIC plus camrelizumab and apatinib (TRIPLET protocol, n = 207) or camrelizumab and apatinib (C-A protocol, n = 209) were reviewed retrospectively. The propensity score matching (PSM) was used to reduce selective bias. Overall survival (OS) and progression-free survival (PFS) were compared using the Kaplan-Meier method with the log-rank test. Cox regression analyses of independent prognostic factors were evaluated.
After PSM 1:1, 109 patients were assigned to two groups. The median OS of not reached in the TRIPLET group was significantly longer than that of 19.9 months in the C-A group (p < 0.001), while in the TRIPLET group, the median PFS of 11.5 months was significantly longer than that of 9.6 months in the C-A group (p < 0.001). Multivariate analyses showed that the factors significantly affected the OS were CTP grade, tumor number > 3, and TRIPLET treatment (p < 0.001). Grade 3/4 adverse events occurred at a rate of 82.1% vs. 71.3% in TRIPLET and C-A groups, respectively.
The TRIPLET protocol has promising survival benefits in the management of patients with Ad-HCC, with acceptable safety.
The study has been retrospectively registered at Chinese Clinical Trial Registry ( https://www.chictr.org.cn/ , ChiCTR2300075828).
对于晚期肝细胞癌（Ad-HCC），联合肝动脉灌注化疗（HAIC）和系统治疗的相关信息有限。我们旨在比较 HAIC 联合卡瑞利珠单抗（PD-1 抑制剂）和阿帕替尼（VEGFR-2 抑制剂）与卡瑞利珠单抗和阿帕替尼用于 Ad-HCC 的疗效和安全性。
2019 年 4 月至 2022 年 10 月，回顾性分析了 416 例接受 HAIC 联合卡瑞利珠单抗和阿帕替尼（TRIPLET 方案，n=207）或卡瑞利珠单抗和阿帕替尼（C-A 方案，n=209）治疗的 Ad-HCC 患者。采用倾向性评分匹配（PSM）减少选择性偏倚。采用 Kaplan-Meier 法和对数秩检验比较总生存期（OS）和无进展生存期（PFS）。采用 Cox 回归分析独立预后因素。
PSM 1:1 后，109 例患者被分配至两组。TRIPLET 组的中位 OS 未达到，明显长于 C-A 组的 19.9 个月（p<0.001），而 TRIPLET 组的中位 PFS 为 11.5 个月，明显长于 C-A 组的 9.6 个月（p<0.001）。多因素分析显示，影响 OS 的因素有 CTP 分级、肿瘤数目>3 个和 TRIPLET 治疗（p<0.001）。TRIPLET 和 C-A 组分别有 82.1%和 71.3%的患者发生 3/4 级不良事件。
TRIPLET 方案在治疗 Ad-HCC 患者方面具有良好的生存获益，安全性可接受。
本研究已在中国临床试验注册中心（ https://www.chictr.org.cn/ ，ChiCTR2300075828）进行了回顾性注册。
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