Efficacy and Safety of Regorafenib Plus Immune Checkpoint Inhibitors with or Without TACE as a Second-Line Treatment for Advanced Hepatocellular Carcinoma: A Propensity Score Matching Analysis

Xuegang Yang; Heping Deng; Yanyuan Sun; Yi Zhang; Yujie Lu; Guohui Xu; Xiaoqi Huang

doi:10.2147/JHC.S399135

Efficacy and Safety of Regorafenib Plus Immune Checkpoint Inhibitors with or Without TACE as a Second-Line Treatment for Advanced Hepatocellular Carcinoma: A Propensity Score Matching Analysis

J Hepatocell Carcinoma. 2023 Feb 27:10:303-313. doi: 10.2147/JHC.S399135. eCollection 2023.

Authors

Xuegang Yang^{1

2}, Heping Deng³, Yanyuan Sun¹, Yi Zhang³, Yujie Lu³, Guohui Xu^#¹, Xiaoqi Huang^#²

Affiliations

¹ Department of Interventional Therapy, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, Chengdu, People's Republic of China.
² Huaxi MR Research Center (HMRRC), Functional and Molecular Imaging Key Laboratory of Sichuan Province, Department of Radiology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
³ Department of Radiology, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, Chengdu, People's Republic of China.

^# Contributed equally.

Abstract

Purpose: We compare the efficacy and safety of regorafenib plus immune checkpoint inhibitors (ICIs) with transarterial chemoembolization (R+ICIs+TACE) versus regorafenib plus ICIs (R+ICIs) as the second-line treatment for patients with advanced hepatocellular carcinoma (HCC).

Methods: This retrospective study included patients with advanced HCC who received R+ICIs+TACE or R+ICIs as the second-line treatment from January 2019 to April 2022. Objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the two groups. The propensity score matching (PSM) was used to reduce the influence of confounding factors on the outcomes. Factors affecting PFS and OS were analyzed using a Cox proportional-hazards regression model.

Results: In total, 52 patients were included in this study, of whom 28 patients received R+ICIs+TACE and 24 patients received R+ICIs. After PSM (n=23 in each group), patients who received R+ICIs+TACE had a higher ORR (34.8% vs 4.3%, P=0.009), a longer PFS (5.8 vs 2.6 months, P<0.0001), and a longer OS (15.0 vs 7.5 months, P=0.014) than those who received R+ICIs. Age ≤ 50 years old, Child-Pugh class A6 and B7, and R+ICIs were found as independent prognostic factors for poor PFS. R+ICIs, α-fetoprotein >400 ng/mL, and platelet-to-lymphocyte ratio >133 were noted as independent prognostic factors for poor OS. The difference in the incidence of TRAEs between the two groups was not statistically significant (P> 0.05).

Conclusion: Compared to regorafenib plus ICIs, regorafenib plus ICIs with TACE was tolerated and improved survival as the second-line treatment for patients with advanced HCC.

Keywords: advanced hepatocellular carcinoma; immune checkpoint inhibitors; regorafenib; second-line treatment; transarterial chemoembolization.

Grants and funding

This study was financially supported by the Natural Science Foundation of Sichuan Province (Grant No. 2022NSFSC0837), the Science and Technology Program of Chengdu, China (Grant No. 2022-YF05-01811-SN), Wu Jieping Medical Foundation (Grant No. 320.6750.2020-10-122), Beijing Medical Award Foundation (Grant No. YXJL-2020-0972-0424), Beijing Xisike Clinical Oncology Research Foundation (Grant No. Y-HR2020MS-0484), and 1.3.5 Project for Disciplines of Excellence, West China Hospital, Sichuan University (Grant No. ZYJC21041), the National Key R&D Program of China (grant number 2022YFC2404105).