984P - Regorafenib as second-line therapy in patients with advanced hepatocellular carcinoma: Interim results from the multicenter real-world study

Background

Regorafenib is the standard second-line therapeutic strategy for advanced hepatocellular carcinoma (HCC). However, there is still a lack of large-scale multicenter real-world evidence concerning the current use of regorafenib in China. This study investigated the efficacy of regorafenib as second-line therapy in patients with advanced HCC in the real-world.

Methods

This multicenter, retrospective real-world study was conducted at 41 healthcare centers across China. Patients with histologically or clinically confirmed HCC who received regorafenib treatment for at least 28 days after failed first-line therapy were included between January 2018 to December 2021. Tumor response was evaluated by RECIST1.1 criteria. The primary endpoint was overall survival (OS). The secondary endpoint includes progression-free disease (PFS) and objective response rate (ORR).

Results

A total 707 patients were included with median age of 57 (range: 51, 64) and 85% were male. Of them, 567 patients (80.2%) had received at least one TACE therapy. The prior first-line TKIs therapies included lenvatinib (38.3%) and sorafenib (47.7%). Among these patients, 425 patients (60.1%) received TKIs monotherapy, while others received TKIs plus PD-1 inhibitor combination therapy. There were 398 patients (56.3%) still combined with PD-1 inhibitor in second-line therapy. After regorafenib treatment, the 1 -year OS rate was 84.4%. The median PFS was 6.8 months (95%CI: 5.6-7.9). A total of 62 patients (8.6%) achieved complete response (CR) and 171 patients (24.2%) achieved partial response (PR). The best ORR was 34.8%.

Conclusions

Regorafenib is an effective second-line treatment option for advanced HCC patients who progressed after first-line therapy.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.