Efficacy and safety of donafenib plus transarterial chemoembolization and immunotherapy for hepatocellular carcinoma.

BACKGROUND

Hepatocellular carcinoma (HCC) is a leading cause of cancer-related deaths worldwide and currently lacks effective treatment options. This is particularly true for advanced HCC, for which conventional therapies often lead to a poor prognosis.

AIM

To assess the safety and efficacy of transarterial chemoembolization (TACE) with donafenib and immune checkpoint inhibitors (ICIs) for unresectable HCC.

METHODS

We retrospectively assessed the data of patients with HCC who underwent TACE combined with donafenib and an ICI (tislelizumab or cedilimumab). Patients received oral donafenib daily for 2 weeks before TACE, followed by tislelizumab or cedilimumab 200 mg intravenously on day 1 of a 21-day therapeutic cycle. The primary endpoints were objective response rate, disease control rate, and duration of response according to the modified RECIST criteria. The secondary endpoint was presence of treatment-related adverse events (TRAEs).

RESULTS

The median follow-up was 7.8 months (95%CI: 5.0-11.8 months). The objective response rate was 60.0% (18/30), while the disease control rate was 93.3%. The median duration of response in confirmed responders was 6.6 months (95%CI: 1.3-12.9 months). The median progression-free survival was 11.8 months (95%CI: 8.3-15.4 months). More than half of the patients survived until the end of the study. Grade > 3 TRAEs occurred in 40% of the patients with no grade 5 TRAEs reported. The most common grade 3/4 TRAE was palmar-plantar erythrodysesthesia, a dermatologic condition characterized by painful redness and swelling of the palms and soles, with an incidence of 56.7%. No ICI-related adverse effects were observed.

CONCLUSION

TACE combined with donafenib and ICI is a promising and safe therapeutic regimen for unresectable HCC.