AUTHOR=Zheng Liyun , Fang Shiji , Wu Fazong , Chen Weiqian , Chen Minjiang , Weng Qiaoyou , Wu Xulu , Song Jingjing , Zhao Zhongwei , Ji Jiansong 

TITLE=Efficacy and Safety of TACE Combined With Sorafenib Plus Immune Checkpoint Inhibitors for the Treatment of Intermediate and Advanced TACE-Refractory Hepatocellular Carcinoma: A Retrospective Study

JOURNAL=Frontiers in Molecular Biosciences

VOLUME=7

YEAR=2021

URL=https://www.frontiersin.org/journals/molecular-biosciences/articles/10.3389/fmolb.2020.609322

DOI=10.3389/fmolb.2020.609322

ISSN=2296-889X

ABSTRACT=<p><bold>Purpose:</bold> The study aims to retrospectively investigate the efficacy and safety of sorafenib combined with transarterial chemoembolization (TACE) (TACE+Sor) vs. TACE combined with sorafenib plus immune checkpoint inhibitors (TACE+Sor+ICIs) in treating intermediate and advanced TACE-refractory hepatocellular carcinoma (HCC).</p><p><bold>Materials and Methods:</bold> This study was approved by the ethics committee of Lisui Hospital, Zhejiang University, China. From January 2016 to June 2020, 51 eligible patients with intermediate or advanced TACE-refractory HCC received TACE+Sor (<italic>n</italic> = 29) or TACE+Sor+ICIs (<italic>n</italic> = 22). The differences in tumor response, adverse events (AEs), progression-free survival (PFS), and overall survival (OS) were compared between the two groups. Factors affecting PFS and OS were determined by Cox regression.</p><p><bold>Results:</bold> The disease control rate was higher in the TACE+Sor+ICIs group than in the TACE+Sor group (81.82 vs. 55.17%, <italic>P</italic> = 0.046). Compared with the TACE+Sor group, PFS and OS were prolonged in the TACE+Sor+ICIs group (median PFS: 16.26 vs. 7.30 months, <italic>P</italic> &lt; 0.001; median OS: 23.3 vs. 13.8 months, <italic>P</italic> = 0.012). Multivariate analysis showed that BCLC stage, alpha-fetoprotein and treatment were independent factors of PFS; BCLC, Child-Pugh class, ablation after disease progression and treatment were independent predictive factors of OS. Four patients in the TACE+Sor+ICIs group and three patients in the TACE+Sor group suffered from dose reduction or interruption (18.18 vs. 10.34%, <italic>P</italic> = 0.421). The incidence of ICI-related AEs in the TACE+Sor+ICIs group was well-controlled.</p><p><bold>Conclusion:</bold> The therapeutic schedule of TACE+Sor+ICIs demonstrated efficacy and safety in intermediate and advanced TACE-refractory HCC.</p>