Through clinical practice, lenvatinib-based combination treatments are commonly used in patients with unresectable hepatocellular carcinoma (uHCC), but their curative effect warrants further investigation. This study compares the efficacy and safety of lenvatinib plus PD-1 inhibitor and TACE (LPT) vs. lenvatinib plus PD-1 inhibitor (LP) in uHCC.
Between January 2019 and June 2022, clinical data for patients with uHCC treated with LPT or LP were reviewed from multicenter in China. The treatment effects, overall survival (OS), progression-free survival (PFS), time to failure (TTF), and treatment-related advent events (TRAEs) are compared between the groups.
A total of 63 patients were enrolled, including 27 in LPT and 36 in LP. The median follow-up time was 16.17 months and 13.93 months. Patients in the LPT group had a significantly higher ORR (66.70% vs. 37.00%, P=0.02*) and a considerably longer OS (HR=0.29, 95%CI 0.09-0.87, P=0.03*), PFS (HR=0.39, 95%CI 0.18-0.82, P=0.01*), and mTTF (14.47 months vs. 9.87 months, P=0.049*) than the LP group. The LPT group had significantly higher 1-year and 2-year OS rates (93.87% vs. 71.25%,82.09% vs. 42.22%). A comparable 1-year and 2-year PFS rates advantages were reported in the LPT group (74.14% vs. 47.17%, 52.66% vs. 8.85%). Among the subgroup analysis, we revealed that in non-surgery patients, the LPT group (n=26) had superior OS (HR=0.27, 95%CI 0.07-0.95, P=0.04*) and PFS (HR=0.35, 95%CI 0.14-0.85, P=0.01*) to the LP group (n=19) (1-year OS rate 91.09% vs. 63.66%,1-year PFS rate 65.84% vs. 34.63% ). The total incidence and severity of adverse events were similar in both groups (63.90% vs. 66.70%, P=0.82). Multivariate analysis showed that the choice of LP and hepatic vein thrombus were the independent risk factors for OS, whereas LP was the independent risk factor for PFS.
For uHCC, our research found that LPT therapy was safe and beneficial. In terms of effectiveness and survival time, the LPT therapy model outperforms the LP mode. The potential of the LPT should be evaluated in prospective cohort investigations.
The First Affiliated Hospital of Dalian Medical University.
Has not received any funding.
All authors have declared no conflicts of interest.