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Objective <p>This retrospective study aimed to evaluate the safety and efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) combined with hepatic arterial infusion chemotherapy (HAIC) and donafenib in the treatment of unresectable hepatocellular carcinoma (uHCC).</p> Materials and methods <p>This dual-center retrospective study collected and analyzed clinical data from 87 patients with unresectable hepatocellular carcinoma (uHCC) who received either DEB-TACE combined with HAIC and donafenib or DEB-TACE combined with donafenib between November 2022 and December 2023 at two hospitals in China. Patients were stratified into two groups based on whether HAIC was administered: the DEB-TACE + H + D group and the DEB-TACE + D group. Treatment efficacy was evaluated using objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Prognostic factors for PFS and OS were assessed using Cox proportional hazards regression models. Treatment safety was evaluated by the incidence and severity of adverse events (AEs).</p> Results <p>In terms of treatment efficacy, the DEB-TACE + H + D group showed significantly higher objective response rate (ORR; 69.0% vs. 44.4%, <i>P</i> = 0.021) compared with the DEB-TACE + D group. Moreover, the disease control rate (DCR) in the DEB-TACE + H + D group was higher than that in the DEB-TACE + D group (90.5% vs. 73.3%, <i>P</i> = 0.039).The median progression-free survival (PFS) was significantly longer in the DEB-TACE + H + D group than in the DEB-TACE + D group (9.00 months vs. 7.00 months, <i>P</i> = 0.0078), as was the median overall survival (OS) (19.00 months vs. 13.00 months, <i>P</i> = 0.0031).Cox regression analysis identified treatment method as the only independent prognostic factors for PFS, while tumor diameter, BCLC staging, and treatment method were independent predictors of OS. Regarding safety, there were no significant differences between the two groups in the incidence or severity of adverse events (AEs) (<i>P</i> &gt; 0.05), and most AEs were mild to moderate in intensity.</p> Conclusion <p>Compared with DEB-TACE combined with donafenib, the combination of DEB-TACE, HAIC, and donafenib demonstrated superior tumor control and survival benefit in patients with uHCC, with an acceptable safety profile.&#xa0;Further prospective randomized controlled trials are warranted to validate the long-term efficacy and safety of this combination strategy.</p>

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Efficacy and safety of DEB-TACE combined with HAIC and donafenib in the treatment of unresectable hepatocellular carcinoma: a dual-center retrospective study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月31日

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  • Xuexian Zhang,
  • Xinyi Fang,
  • Ruidong Wang,
  • Bin Xiong,
  • Jian Long,
  • Qikun Guo,
  • Menglan Chu,
  • Wei Luo,
  • Shangbo Shi

摘要

Objective

This retrospective study aimed to evaluate the safety and efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) combined with hepatic arterial infusion chemotherapy (HAIC) and donafenib in the treatment of unresectable hepatocellular carcinoma (uHCC).

Materials and methods

This dual-center retrospective study collected and analyzed clinical data from 87 patients with unresectable hepatocellular carcinoma (uHCC) who received either DEB-TACE combined with HAIC and donafenib or DEB-TACE combined with donafenib between November 2022 and December 2023 at two hospitals in China. Patients were stratified into two groups based on whether HAIC was administered: the DEB-TACE + H + D group and the DEB-TACE + D group. Treatment efficacy was evaluated using objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Prognostic factors for PFS and OS were assessed using Cox proportional hazards regression models. Treatment safety was evaluated by the incidence and severity of adverse events (AEs).

Results

In terms of treatment efficacy, the DEB-TACE + H + D group showed significantly higher objective response rate (ORR; 69.0% vs. 44.4%, P = 0.021) compared with the DEB-TACE + D group. Moreover, the disease control rate (DCR) in the DEB-TACE + H + D group was higher than that in the DEB-TACE + D group (90.5% vs. 73.3%, P = 0.039).The median progression-free survival (PFS) was significantly longer in the DEB-TACE + H + D group than in the DEB-TACE + D group (9.00 months vs. 7.00 months, P = 0.0078), as was the median overall survival (OS) (19.00 months vs. 13.00 months, P = 0.0031).Cox regression analysis identified treatment method as the only independent prognostic factors for PFS, while tumor diameter, BCLC staging, and treatment method were independent predictors of OS. Regarding safety, there were no significant differences between the two groups in the incidence or severity of adverse events (AEs) (P > 0.05), and most AEs were mild to moderate in intensity.

Conclusion

Compared with DEB-TACE combined with donafenib, the combination of DEB-TACE, HAIC, and donafenib demonstrated superior tumor control and survival benefit in patients with uHCC, with an acceptable safety profile. Further prospective randomized controlled trials are warranted to validate the long-term efficacy and safety of this combination strategy.