AUTHOR=Chen Song , Cai Hongjie , Wu Zhiqiang , Tang Shuangyan , Chen Ludan , Wang Fan , Zhuang Wenquan , Guo Wenbo 

TITLE=Anlotinib combined with transarterial chemoembolization for unresectable hepatocellular carcinoma associated with hepatitis B virus: a retrospective controlled study

JOURNAL=Frontiers in Oncology

VOLUME=13

YEAR=2023

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1235786

DOI=10.3389/fonc.2023.1235786

ISSN=2234-943X

ABSTRACT=<sec><title>Purpose</title><p>To investigate the efficacy and safety of combined treatment of anlotinib and transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (uHCC) associated with hepatitis B virus (HBV) infection.</p></sec><sec><title>Methods</title><p>We retrospectively collected the data of 96 uHCC patients associated with HBV infection who received either TACE only (TO group; n = 64) or anlotinib combined with TACE (TA group; n = 32) from January 2017 to January 2021. The primary endpoint was overall survival (OS). The secondary outcomes included progression-free survival (PFS), tumor response according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST 1.1, and adverse events (AEs).</p></sec><sec><title>Results</title><p>The median OS and median PFS were significantly longer in the TA group compared to the TO group (17.6 months <italic>vs.</italic> 9.4 months, <italic>p</italic> = 0.018; 6.7 months <italic>vs.</italic> 3.8 months, <italic>p</italic> = 0.003, respectively). In addition, the overall objective response rate (ORR) and disease control rate (DCR) numerically increased in the TA group (mRECIST, ORR 65.6% <italic>vs.</italic> 46.9%, <italic>p</italic> = 0.064, DCR 90.6% <italic>vs.</italic> 85.9%, <italic>p</italic> = 0.382; RECIST 1.1, ORR 46.9% <italic>vs.</italic> 15.6%, <italic>p</italic> = 0.001, DCR 90.6% <italic>vs.</italic> 85.9%, <italic>p</italic> = 0.382, respectively). It was worth noting that no treatment-related mortality occurred during the study. The most common AEs included elevated transaminases (56.3%), decreased appetite (46.9%), and abdominal pain (37.5%) in the TA group. Although the incidence rate of grade 3/4 AEs was higher in the TA group, all of them were controllable.</p></sec><sec><title>Conclusions</title><p>The combination of anlotinib and TACE has shown promising results in improving outcomes for patients with HBV-related uHCC, as compared to TACE monotherapy. In addition, this combination therapy has demonstrated a controllable safety profile. However, further validation is urgently needed through randomized controlled trials with large sample sizes.</p></sec>