Abstract
<b><i>Introduction:</i></b> Lenvatinib is the first-line treatment for advanced hepatocellular carcinoma (HCC). We aimed to compare the clinical outcomes of lenvatinib plus drug-eluting beads transarterial chemoembolization (DEB-TACE) versus lenvatinib alone in real-world practice. <b><i>Methods:</i></b> This retrospective analysis included 142 consecutive patients who received lenvatinib plus DEB-TACE and 69 patients who received lenvatinib alone as first-line treatment from 15 Chinese academic centers from November 2018 to November 2019. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) were evaluated by modified Response Evaluation Criteria in Solid Tumors criteria, and safety profiles were compared between the two groups. <b><i>Results:</i></b> The median OS and PFS were significantly longer in the combined therapy group than in the monotherapy group in whole cohort (median OS, 15.9 vs. 8.6 months, <i>p</i> = 0.0022; median PFS, 8.6 vs. 4.4 months, <i>p</i> < 0.001) and after propensity score matching analysis (median OS, 13.8 vs. 7.8 months, <i>p</i> = 0.03; median PFS, 7.8 vs. 4.5 months, <i>p</i> = 0.009). Moreover, the treatment option was an independent prognostic factor for OS and PFS with adjustment based upon baseline characteristics (adjusted hazard ratio [HR]: 0.53, 95% confidence interval [CI]: 0.36–0.78, <i>p</i> = 0.001, and adjusted HR: 0.42, 95% CI: 0.30–0.60, <i>p</i> < 0.001, respectively) and propensity score (adjusted HR: 0.52, 95% CI: 0.36–0.76, <i>p</i> = 0.001, and adjusted HR: 0.46, 95% CI: 0.33–0.64, <i>p</i> < 0.001, respectively). Moreover, a greater ORR was observed in the combined group (ORR: 46.48% vs. 13.05%, <i>p</i> < 0.001). Furthermore, the most common adverse events (AEs) were elevated aspartate aminotransferase (54.9%) and fatigue (46.4%) in the lenvatinib plus DEB-TACE group and lenvatinib group, respectively. Most AEs were mild-to-moderate and manageable. <b><i>Conclusions:</i></b> With well-tolerated safety, lenvatinib plus DEB-TACE was more effective than lenvatinib monotherapy in improving OS, PFS, and ORR. Thus, it may be a promising treatment for advanced HCC. Future prospective studies confirming these findings are warranted.