1004P - Comparative efficacy of systemic sequential regorafenib after sorafenib or lenvatinib treatment failure for advanced hepatocellular carcinoma: A retrospective, multi-center, real-world study

Background

Regorafenib is an oral multikinase inhibitor and has been approved as the 2^nd-line systemic treatment for advanced hepatocellular carcinoma (HCC) based on the RESORCE trial. However, the efficacy of systemic sequential regorafenib after lenvatinib treatment failure in advanced HCC patients remains unclear.

Methods

A total of 94 patients with advanced HCC who failed sorafenib or lenvatinib treatment and received regorafenib from three cancer centers were included between January 2019 and December 2022. The 1^st-line therapeutic plans, disease control rate (DCR) (defined by the RECIST 1.1), and progression-free survival (PFS) were recorded and compared.

Results

A higher percentage of patients with BCLC C stage was observed in the 1^st-line lenvatinib group (n=50) than in the sorafenib group (n=44) when we compared the clinical characteristics before regorafenib treatment (81% vs. 41%, p = 0.002). The median treatment duration of regorafenib was 4.73 months in the sorafenib group and 2.60 months in the lenvatinib group. The intrahepatic, extrahepatic, and overall DCRs of sequential regorafenib after sorafenib or lenvatinib treatment failed were 0.82 and 0.67 (p = 0.20), 0.69 and 0.72 (p = 0.50), 0.76 and 0.63 (p = 0.20), respectively. The overall DCRs of regorafenib were 0.73 and 0.67 in those with and without a combination of immune checkpoint inhibitor (ICI) treatment (p = 0.20), respectively. Survival analysis indicated that the median PFS (mPFS) were 4.13, 2.78, and 3.53 months in the 1^st-line sorafenib, lenvatinib, and entire groups, respectively (p = 0.30). No survival differences were observed between the patients who received 1^st-line treatment with or without a combination of ICI reagents (mPFS: 3.2 and 3.7, p = 0.07, respectively).

Conclusions

This retrospective, multi-center, real-world study demonstrated that regorafenib could improve the prognosis of patients after lenvatinib treatment failure. Combined ICIs or not in the 1^st-line treatment may not affect the short-term efficacy of 2^nd-line regorafenib treatment. This study is ongoing, and further conclusions related to overall survival are expected to be published in the future.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

All authors in this study.

Funding

Zhejiang Medical and Health Science and Technology Plan Project (Grant number: 2023KY600, 2023KY593).

Disclosure

All authors have declared no conflicts of interest.