32P - Clinical efficacy and safety of an immune checkpoint inhibitor in combination with regorafenib therapy as second-line regimen for patients with unresectable hepatocellular carcinoma

Background

This study aimed to evaluate the safety and efficacy of a combination of programmed death-1 (PD-1) inhibitor and regorafenib as second-line treatment for advanced hepatocellular carcinoma (HCC).

Methods

We retrospectively analyzed the data of 38 patients with unresectable HCC who were treated with PD-1 inhibitor in combination with regorafenib as a second-line therapy as well as the data of 32 patients treated with regorafenib only therapy as a control. The clinical data including the baseline data from blood routine test, liver function test, renal function test, tumor staging, tumor imaging features, previous treatment strategies, follow-up imaging results, and adverse events during follow-ups were recorded. The mRECIST were used to evaluate the treatment outcome of intrahepatic lesions, and the Kaplan–Meier method was used to evaluate survival time.

Results

Up to the last follow-up, the rego-PD-1 group had higher objective response rate (39.5% vs. 15.6%, P=0.028), longer progression-free survival (median 5.9 vs. 4.6 months; P=0.044), and better overall survival (OS) (median 14.5 vs. 9.5 months; P=0.041) than the regorafenib only group. Among the 38 patients treated with PD-1 inhibitor and regorafenib combination, 1 patient (2.7%) achieved complete response, 14 patients (36.8%) achieved partial response, 14 patients (36.8%) achieved stable disease, and 9 patients (23.7%) achieved progressive disease. Among the 32 patients treated with regorafenib alone, 5 (15.6%) achieved partial response, 12 (37.5%) achieved stable disease, and 15 (46.9%) achieved progressive disease. Regorafenib alone, Child–Pugh B, and presence of more than 3 tumors > 3 were independent prognostic factors for poor OS. The difference in the incidence of grade 3/4 adverse events between the two groups was not statistically significant (36.8% vs. 28.1%; P=0.439). Grade ≥3 treatment-related adverse events (TRAEs) included hypertension and diarrhea.

Conclusions

PD-1 inhibitor combined with regorafenib is a promising regimen in treating patients with unresectable HCC owing to its safety and effectiveness as well as low incidence of serious adverse events with its use.

Clinical trial identification

Editorial acknowledgement

NO

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.