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辅助性经动脉化疗栓塞术(TACE)联合酪氨酸激酶抑制剂(TKI)治疗在根治性肝切除术后复发高危的肝癌患者中是否比单纯TACE更有效。

Whether Adjuvant TACE Plus TKI Therapy is More Effective Than TACE Alone in HCC Patients at High Risks of Recurrence Following Radical Hepatectomy.

作者信息

Li Yaohua, Wang Kai, Qin Huixia, Huo Shengjun, Jiang Kaiwen, Xia Jing, Gu Jing, Ya Houxiang, Suo Liya, Wang Dejie, Huang Xiaowang, Li Shuqun

机构信息

Department of Hepatobiliary Pancreatic Surgery, Affiliated Hospital of Guilin Medical University, Guilin, Guangxi, People's Republic of China.

Department of Hepatobiliary Pancreatic Surgery, Affiliated Hospital Shenzhen Baoan Central Hospital of Guangdong Medical University, Shenzhen, Guangdong, People's Republic of China.

出版信息

J Hepatocell Carcinoma. 2025 Aug 11;12:1767-1780. doi: 10.2147/JHC.S534143. eCollection 2025.

DOI:10.2147/JHC.S534143
PMID:40822085
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12356218/
Abstract

PURPOSE

To compare the efficacy and safety of postoperative adjuvant therapy with transarterial chemoembolization (TACE) plus tyrosine kinase inhibitor (TKI) (TPT) versus TACE alone in hepatocellular carcinoma (HCC) patients at high risks of recurrence after radical hepatectomy.

PATIENTS AND METHODS

We retrospectively analyzed 264 HCC patients who underwent radical hepatectomy (R0 resection) between August 2016 and August 2023. To mitigate selection bias, propensity score matching (PSM) was employed. The primary endpoints were recurrence-free survival (RFS) and overall survival (OS), analyzed using Kaplan-Meier curves and Log rank tests. Treatment-related adverse events (TRAEs) were graded according to CTCAE v4.0. Prognostic factors were evaluated via Cox proportional hazards regression.

RESULTS

Before PSM, the cohort comprised 141 patients receiving TPT and 123 patients treated with TACE alone. After PSM, 81 well-balanced patients were selected per group (all p > 0.05). The TPT group exhibited significantly prolonged median recurrence-free survival (mRFS: 37.1 vs 27.7 months; p < 0.05) and median overall survival (mOS: 41.3 vs 38.3 months; p < 0.05) compared to the TACE alone group. The 1-, 2-, and 3-year RFS rates in the TPT group were 95.1%, 67.9%, and 48.1%, respectively, significantly higher than those in the TACE alone group (76.5%, 55.6%, and 40.7%; all p < 0.05). Similarly, the corresponding OS rates were 95.1%, 75.3%, and 54.3% (TPT) versus 81.5%, 66.7%, and 53.1% (TACE alone; all p < 0.05). Multivariable Cox regression analyses confirmed TPT as an independent protective factor for both RFS and OS. No significant increase in treatment-related adverse events (TRAEs) was observed with the TPT regimen compared to TACE alone. The overall TRAE rate was 51.8% in the TPT group, with grade ≥3 events occurring in 14.8% of patients, indicating an acceptable safety profile.

摘要

目的

比较经动脉化疗栓塞术(TACE)联合酪氨酸激酶抑制剂(TKI)(TPT)与单纯TACE用于根治性肝切除术后复发风险高的肝细胞癌(HCC)患者的术后辅助治疗的疗效和安全性。

患者与方法

我们回顾性分析了2016年8月至2023年8月期间接受根治性肝切除术(R0切除)的264例HCC患者。为减轻选择偏倚,采用了倾向评分匹配(PSM)。主要终点为无复发生存期(RFS)和总生存期(OS),使用Kaplan-Meier曲线和对数秩检验进行分析。治疗相关不良事件(TRAEs)根据CTCAE v4.0进行分级。通过Cox比例风险回归评估预后因素。

结果

在PSM之前,队列包括141例接受TPT治疗的患者和123例仅接受TACE治疗的患者。PSM后,每组选择81例均衡良好的患者(所有p>0.05)。与单纯TACE组相比,TPT组的中位无复发生存期(mRFS:37.1个月对27.7个月;p<0.05)和中位总生存期(mOS:41.3个月对38.3个月;p<0.05)显著延长。TPT组的1年、2年和3年RFS率分别为95.1%、67.9%和48.1%,显著高于单纯TACE组(76.5%、55.6%和40.7%;所有p<0.05)。同样,相应的OS率分别为95.1%、75.3%和54.3%(TPT)对81.5%、66.7%和53.1%(单纯TACE;所有p<0.05)。多变量Cox回归分析证实TPT是RFS和OS的独立保护因素。与单纯TACE相比,TPT方案未观察到治疗相关不良事件(TRAEs)显著增加。TPT组的总体TRAEs发生率为51.8%,≥3级事件发生在14.8%的患者中,表明安全性可接受。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bed/12356218/17bac371a2a0/JHC-12-1767-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bed/12356218/67f2d4fa0cd3/JHC-12-1767-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bed/12356218/a74d00f00322/JHC-12-1767-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bed/12356218/567a43c90735/JHC-12-1767-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bed/12356218/67516034e7e8/JHC-12-1767-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bed/12356218/17bac371a2a0/JHC-12-1767-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bed/12356218/67f2d4fa0cd3/JHC-12-1767-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bed/12356218/a74d00f00322/JHC-12-1767-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bed/12356218/567a43c90735/JHC-12-1767-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bed/12356218/67516034e7e8/JHC-12-1767-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bed/12356218/17bac371a2a0/JHC-12-1767-g0005.jpg

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