TACE-HAIC plus TKIs with/without PD-1 inhibitors for unresectable hepatocellular carcinoma: a propensity score...

Patients with unresectable hepatocellular carcinoma (uHCC) have a poor prognosis, and effective systemic treatment options remain limited. We aimed to evaluate the safety and efficacy of adding programmed death-1 (PD-1) inhibitors to transarterial chemoembolization combined with hepatic arterial infusion chemotherapy (TACE-HAIC)+lenvatinib.

We retrospectively analyzed data from patients with uHCC who received TACE-HAIC+lenvatinib, without or with PD-1 inhibitors (n = 124). Patients were stratified into a triple-therapy group (TACE-HAIC+lenvatinib; n = 71) and a quadruple-therapy group (TACE-HAIC+lenvatinib+PD-1 inhibitors; n = 53), based on whether PD-1 inhibitors were included in the first-line regimen. Overall survival (OS), progression-free survival (PFS), and adverse event rate were compared between the groups. Propensity score matching was performed to reduce confounding bias.

After propensity score matching (PSM), 43 matched pairs were identified. The median OS was 11.0 months [95% confidence interval (CI), 10.0-16.0] in the triple-therapy group and 25.0 months (95% CI: 12.0-not reached) in the quadruple-therapy group. The median PFS was 8.6 months (95% CI: 6.37-11.77) and 12.1 months (95% CI: 8.7-not reached), respectively. Both OS and PFS were significantly improved in the quadruple-therapy group (P < 0.05).

The addition of PD-1 inhibitors to TACE-HAIC plus lenvatinib significantly improved both OS and PFS without a statistically significant increase in adverse events. However, careful monitoring and prompt management of immune-related adverse events remain warranted during treatment.