三联疗法对经动脉化疗栓塞难治性中期肝细胞癌患者的有效性和安全性。

Effectiveness and Safety of TRIPLET Protocol in Patients with Intermediate-Stage Hepatocellular Carcinoma to Transcatheter Arterial Chemoembolization Refractory.

作者信息

Zhao Yue, Wu Yong, Lin Kai, Yang Bin, Deng Xiaojuan, Lu Chunlin, Chen Yifang, Li Chengzhi

机构信息

Department of Interventional Radiology and Vascular Surgery, The First Affiliated Hospital of Jinan University, Avenue., Guangzhou 510630, PR China (Y.Z., C.L.).

Department of Oncology, the Second Affiliated Hospital, School of Medicine, South China University of Technology, Guangzhou, Guangdong 510180, PR China (Y.W.).

出版信息

Acad Radiol. 2025 Sep;32(9):5197-5208. doi: 10.1016/j.acra.2025.05.013. Epub 2025 Jun 6.

DOI:10.1016/j.acra.2025.05.013

PMID:40480939

Abstract

RATIONALE AND OBJECTIVE

The treatment scheme in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE) is still controversial.

OBJECTIVE

To compare the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with apatinib plus camrelizumab (TRIPLET protocol) versus HAIC alone for HCC refractory to TACE.

MATERIALS AND METHODS

From April 2019 to September 2024, a total of 275 patients with intermediate-stage HCC refractory to TACE based on modified Response Evaluation Criteria in Solid Tumors criteria by two radiologists were reviewed, classifying into the HAIC group (n = 117) and TRIPLET group (n = 158). Propensity score matching (PSM) method was used to reduce the selective bias. The overall survival (OS) and post progression-free survival (PPS) were compared using the Kaplan-Meier method with log-rank test. Multivariable analyses of independent prognostic factors were evaluated by means of the forward stepwise Cox regression model.

RESULTS

After PSM 1:1, the median OS was 11.5 months in TRIPLET group was longer significantly than that (median OS was 7.8 months) in HAIC group (P < 0.001). The median PPS was 8.6 months in TRIPLET group was longer significantly than that (4.8 months) in the HAIC group (P < 0.001). Multivariate analyses showed that the factors that ‎significantly affected the OS were‎ α-fetoprotein (hazard ratio [HR]: 2.14; 95% confidence interval [CI]:1.26-3.98; P = 0.006), and HAIC treatment (HR: 1.92; 95% CI: 1.16-3.33; P = 0.012). Multivariate analyses showed that the factors that ‎significantly affected the PPS were albumin-bilirubin grade 2 (HR:‎1.63; 95% CI: 1.03-2.60; P = 0.037), tumor diameter > 5 cm (HR: 1.67; 95% CI: 1.34-2.09; P < 0.001) and HAIC treatment (HR: 1.67; 95% CI: 1.08-2.63; P = 0.025) significantly affected the PPS.

CONCLUSION

This TRIPLET protocol has significant safety and effectiveness in the management of patients with HCC refractory to TACE.

DESIGN

A retrospective, multi-institutional study.

摘要

原理与目的

经动脉化疗栓塞术（TACE）难治性肝细胞癌（HCC）的治疗方案仍存在争议。

目的

比较肝动脉灌注化疗（HAIC）联合阿帕替尼加卡瑞利珠单抗（三联方案）与单纯HAIC治疗TACE难治性HCC的疗效和安全性。

材料与方法

回顾性分析2019年4月至2024年9月期间，两名放射科医生根据实体瘤改良疗效评价标准确定的275例TACE难治性中期HCC患者，分为HAIC组（n = 117）和三联组（n = 158）。采用倾向评分匹配（PSM）方法减少选择偏倚。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（PPS）。通过向前逐步Cox回归模型评估独立预后因素的多变量分析。

结果

PSM 1:1后，三联组的中位OS为11.5个月，显著长于HAIC组的中位OS（7.8个月）（P < 0.001）。三联组的中位PPS为8.6个月，显著长于HAIC组的中位PPS（4.8个月）（P < 0.001）。多变量分析显示，显著影响OS的因素为甲胎蛋白（风险比[HR]：2.14；95%置信区间[CI]：1.26 - 3.98；P = 0.006）和HAIC治疗（HR：1.92；95% CI：1.16 - 3.33；P = 0.012）。多变量分析显示，显著影响PPS的因素为白蛋白-胆红素分级2级（HR：1.63；95% CI：1.03 - 2.60；P = 0.037）、肿瘤直径>5 cm（HR：1.67；95% CI：1.34 - 2.09；P < 0.001）和HAIC治疗（HR：1.67；95% CI：1.08 - 2.63；P = 0.025）。