Yaohua Li, Kai Wang, Huixia Qin, Shengjun Huo, Kaiwen Jiang, Jing Xia, Jing Gu, Houxiang Ya, Liya Suo, Dejie Wang, Xiaowang Huang, Shuqun Li
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Treatment-related adverse events (TRAEs) were graded according to CTCAE v4.0. Prognostic factors were evaluated via Cox proportional hazards regression.</p><p><strong>Results: </strong>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.</p>","PeriodicalId":15906,"journal":{"name":"Journal of Hepatocellular Carcinoma","volume":"12 ","pages":"1767-1780"},"PeriodicalIF":3.4000,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12356218/pdf/","citationCount":"0","resultStr":"{\"title\":\"Whether Adjuvant TACE Plus TKI Therapy is More Effective Than TACE Alone in HCC Patients at High Risks of Recurrence Following Radical Hepatectomy.\",\"authors\":\"Yaohua Li, Kai Wang, Huixia Qin, Shengjun Huo, Kaiwen Jiang, Jing Xia, Jing Gu, Houxiang Ya, Liya Suo, Dejie Wang, Xiaowang Huang, Shuqun Li\",\"doi\":\"10.2147/JHC.S534143\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Patients and methods: </strong>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.</p><p><strong>Results: </strong>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. 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引用次数: 0
摘要
目的：比较经动脉化疗栓塞（TACE）联合酪氨酸激酶抑制剂（TKI） （TPT）与单独TACE在肝根治术后复发风险高的肝细胞癌（HCC）患者术后辅助治疗的疗效和安全性。患者和方法：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切除术）的264例HCC患者。为了减轻选择偏差，采用倾向得分匹配（PSM）。主要终点为无复发生存期（RFS）和总生存期（OS），采用Kaplan-Meier曲线和Log rank检验进行分析。治疗相关不良事件（TRAEs）按照CTCAE v4.0分级。通过Cox比例风险回归评估预后因素。结果：在PSM之前，该队列包括141例接受TPT的患者和123例单独接受TACE治疗的患者。PSM后，每组选择81例平衡良好的患者（均p < 0.05）。与TACE单独治疗组相比，TPT组的中位无复发生存期（mRFS: 37.1 vs 27.7个月，p < 0.05）和中位总生存期（mOS: 41.3 vs 38.3个月，p < 0.05）显著延长。TPT组1、2、3年RFS分别为95.1%、67.9%、48.1%，显著高于单独TACE组（76.5%、55.6%、40.7%，均p < 0.05）。TPT组相应的OS率为95.1%、75.3%、54.3%，TACE组为81.5%、66.7%、53.1%，均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。与单独使用TACE相比，TPT方案未观察到治疗相关不良事件（TRAEs）的显著增加。TPT组总体TRAE发生率为51.8%，14.8%的患者发生≥3级事件，表明可接受的安全性。
Whether Adjuvant TACE Plus TKI Therapy is More Effective Than TACE Alone in HCC Patients at High Risks of Recurrence Following Radical Hepatectomy.
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.
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