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Background <p>Transarterial chemoembolization (TACE) is a standard treatment for unresectable hepatocellular carcinoma (HCC). However, a significant proportion of patients develop conventional TACE (cTACE) refractoriness, which is associated with poor prognosis. The optimal treatment strategy for cTACE-refractory HCC remains controversial. This study aimed to evaluate the efficacy and safety of drug-eluting bead TACE (D-TACE) combined with lenvatinib versus cTACE plus lenvatinib in patients with cTACE-refractory HCC.</p> Methods <p>We conducted a retrospective analysis of 103 patients with cTACE-refractory unresectable HCC treated at our institution between January 2019 and June 2021. Patients were divided into two groups: the D-TACE + lenvatinib group (<i>n</i> = 48) and the cTACE + lenvatinib group (<i>n</i> = 55). The primary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) assessed according to mRECIST criteria. Secondary endpoints included safety profiles and changes in liver function parameters.</p> Results <p>The D-TACE + lenvatinib group demonstrated significantly better treatment outcomes compared to the cTACE + lenvatinib group. The ORR was 50.0% versus 21.8% (<i>P</i> = 0.004), and the DCR was 83.3% versus 61.8% (<i>P</i> = 0.017), respectively. The median PFS was significantly longer in the D-TACE combination group (8.7 months vs. 6.6 months, <i>P</i> = 0.002). Similarly, the median OS was significantly improved with D-TACE plus lenvatinib (20.3 months vs. 15.2 months, <i>P</i> = 0.001). The incidence of vomiting (all grades) was lower in the D-TACE group (31.2% vs. 50.9%, <i>P</i> = 0.048), while other adverse events were comparable between groups. No significant differences were observed in liver function parameters or hematological indices at 3-month follow-up.</p> Conclusions <p>For patients with cTACE-refractory unresectable HCC, D-TACE combined with lenvatinib demonstrates superior efficacy compared to cTACE plus lenvatinib, with significantly improved ORR, DCR, PFS, and OS, and a comparable safety profile. This combination represents an effective and safe treatment strategy for this challenging patient population.</p>

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Efficacy and safety analysis of D-TACE combined with lenvatinib in the treatment of hepatocellular carcinoma refractory to C-TACE

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月19日

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  • Haohao Lu,
  • Bin Liang,
  • Chuansheng Zheng,
  • Xiangwen Xia

摘要

Background

Transarterial chemoembolization (TACE) is a standard treatment for unresectable hepatocellular carcinoma (HCC). However, a significant proportion of patients develop conventional TACE (cTACE) refractoriness, which is associated with poor prognosis. The optimal treatment strategy for cTACE-refractory HCC remains controversial. This study aimed to evaluate the efficacy and safety of drug-eluting bead TACE (D-TACE) combined with lenvatinib versus cTACE plus lenvatinib in patients with cTACE-refractory HCC.

Methods

We conducted a retrospective analysis of 103 patients with cTACE-refractory unresectable HCC treated at our institution between January 2019 and June 2021. Patients were divided into two groups: the D-TACE + lenvatinib group (n = 48) and the cTACE + lenvatinib group (n = 55). The primary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) assessed according to mRECIST criteria. Secondary endpoints included safety profiles and changes in liver function parameters.

Results

The D-TACE + lenvatinib group demonstrated significantly better treatment outcomes compared to the cTACE + lenvatinib group. The ORR was 50.0% versus 21.8% (P = 0.004), and the DCR was 83.3% versus 61.8% (P = 0.017), respectively. The median PFS was significantly longer in the D-TACE combination group (8.7 months vs. 6.6 months, P = 0.002). Similarly, the median OS was significantly improved with D-TACE plus lenvatinib (20.3 months vs. 15.2 months, P = 0.001). The incidence of vomiting (all grades) was lower in the D-TACE group (31.2% vs. 50.9%, P = 0.048), while other adverse events were comparable between groups. No significant differences were observed in liver function parameters or hematological indices at 3-month follow-up.

Conclusions

For patients with cTACE-refractory unresectable HCC, D-TACE combined with lenvatinib demonstrates superior efficacy compared to cTACE plus lenvatinib, with significantly improved ORR, DCR, PFS, and OS, and a comparable safety profile. This combination represents an effective and safe treatment strategy for this challenging patient population.