多纳非尼与乐伐替尼联合经动脉化疗栓塞术作为不可切除肝细胞癌的初始治疗：一项回顾性真实世界研究

Donafenib lenvatinib combined with transarterial chemoembolization as initial therapy for unresectable hepatocellular carcinoma: a retrospective real-world study.

作者信息

Yan Huzheng, Li Guohong, Zhao Chenghao, Li Mingan, Huang Mingsheng, Liu Huan, Liu Mingming, Xiang Zhanwang

机构信息

Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.

Department of Radiology, The Affiliated Guangdong Second Provincial General Hospital of Jinan University, Guangzhou, China.

出版信息

Quant Imaging Med Surg. 2025 Aug 1;15(8):7235-7245. doi: 10.21037/qims-2025-364. Epub 2025 Jul 15.

BACKGROUND

The combination of tyrosine kinase inhibitors (TKIs) with transarterial chemoembolization (TACE) holds promise for unresectable hepatocellular carcinoma (HCC). This study aimed to directly compare the efficacy and safety of donafenib (Dona)-TACE lenvatinib (LEN)-TACE as first-line therapies.

METHODS

In this retrospective study, 93 unresectable HCC patients (49 Dona-TACE, 44 LEN-TACE; 93% hepatitis B virus-infected) treated between October 2020 and May 2023 were analyzed. Patients received TACE (conventional or drug-eluting beads) combined with Dona (200 mg twice daily) or LEN (8-12 mg/day). Outcomes included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). Survival analyses employed Kaplan-Meier and log-rank tests.

RESULTS

Median OS (mOS) was 14.00 months (Dona-TACE) 19.00 months (LEN-TACE) [hazard ratio (HR) =1.25; 95% confidence interval (CI): 0.78-1.99; P=0.330]. Median PFS was 7.37 5.77 months (HR =0.785; 95% CI: 0.46-1.33; P=0.354), with no significant differences. ORR (55.10% 61.36%, P=0.541) and DCR (75.51% 81.82%, P=0.460) were comparable. Dona-TACE showed significantly lower overall AE rates (any grade: 85.71% 100.00%, P=0.013; grade ≥3: 22.45% 45.45%, P=0.027), including reduced hypertension (2.04% 36.36%, P<0.001), diarrhea (6.12% 25.00%, P=0.011), and vomiting (0.00% 40.91%, P<0.001).

CONCLUSIONS

Dona-TACE and LEN-TACE demonstrated comparable efficacy in unresectable HCC, but Dona-TACE exhibited a superior safety profile, suggesting its potential as a preferable option for patients with higher comorbidity risks. Further prospective studies are warranted to validate these findings.

背景

酪氨酸激酶抑制剂（TKIs）与经动脉化疗栓塞术（TACE）联合应用有望用于不可切除的肝细胞癌（HCC）治疗。本研究旨在直接比较多纳非尼（Dona）-TACE与仑伐替尼（LEN）-TACE作为一线治疗方案的疗效和安全性。

方法

在这项回顾性研究中，分析了2020年10月至2023年5月期间接受治疗的93例不可切除HCC患者（49例接受Dona-TACE，44例接受LEN-TACE；93%为乙型肝炎病毒感染患者）。患者接受TACE（传统或载药微球）联合Dona（每日2次，每次200 mg）或LEN（8 - 12 mg/天）治疗。观察指标包括总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、疾病控制率（DCR）和不良事件（AE）。生存分析采用Kaplan-Meier法和对数秩检验。

结果

中位总生存期（mOS）分别为14.00个月（Dona-TACE组）和19.00个月（LEN-TACE组）[风险比（HR）=1.25；95%置信区间（CI）：0.78 - 1.99；P = 0.330]。中位无进展生存期分别为7.37和5.77个月（HR = 0.785；95% CI：0.46 - 1.33；P = 0.354），差异无统计学意义。客观缓解率（55.10%对61.36%，P = 0.541）和疾病控制率（75.51%对81.82%，P = 0.460）相当。Dona-TACE组的总体不良事件发生率显著更低（任何级别：85.71%对100.00%，P = 0.013；3级及以上：22.45%对45.45%，P = 0.027），包括高血压发生率降低（2.04%对36.36%，P < 0.001）、腹泻发生率降低（6.12%对25.00%，P = 0.011）以及呕吐发生率降低（0.00%对40.91%，P < 0.001）。