Transarterial chemoembolization plus lenvatinib with or without programmed death-1 inhibitors for patients with unresectable hepatocellular carcinoma: A propensity score matching study

PURPOSE: We conducted a retrospective study to compare transarterial chemoembolization (TACE) plus lenvatinib plus programmed death-1 (PD-1) inhibitors with TACE plus lenvatinib in patients with unresectable hepatocellular carcinoma (HCC). PATIENTS AND METHODS: Patients with HCC were analyzed from January 2018 to January 2022 in three hospitals. Patients received TACE plus lenvatinib with or without PD-1 inhibitors (TACE+L+PD-1 or TACE+L, respectively). The baseline characteristics of the two groups were compared, and propensity score matching (PSM) was performed. Overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) of the two groups were compared. Adverse events in the two groups were analyzed. RESULTS: A total of 166 patients were evaluated (TACE+L+PD-1, n = 75; TACE+L, n = 91). Before PSM, OS was prolonged in the TACE+L+PD-1 group (p = 0.010), but PFS was similar between the two groups (p = 0.18). ORR was higher in the TACE+L+PD-1 group (p = 0.047). After PSM, estimated OS rates at 6, 12, and 24 months were 97.9%, 84.6%, and 74.1%, respectively, in the TACE+L+PD-1 group (n = 48) and 93.1%, 66.1%, and 43.4%, respectively, in the TACE+L group (n = 48). Estimated PFS rates at 3, 6, and 12 months were 81.9%, 61.8%, and 30.9%, respectively, in the TACE+L group and 95.7%, 82.1%, and 68.4%, respectively, in the TACE+L+PD-1 group. OS, PFS, and ORR were improved in the TACE+L+PD-1 group compared to the TACE+L group (p = 0.030; p = 0.027; p = 0.013). The safety of the TACE+L+PD-1 regimen was acceptable. CONCLUSIONS: The addition of PD-1 inhibitors to TACE+L significantly improved clinical outcomes in patients with unresectable HCC. Side effects were manageable.