Efficacy and safety of anlotinib as an adjuvant therapy in hepatocellular carcinoma patients with a high risk of postoperative recurrence

Jianguo Wang; Xiaonan Xiang; Zhixiong Shi; Hui Zhang; Quanbao Zhang; Zhikun Liu; Guangjie Zhao; Chuanxing Wu; Qiang Wei; Lin Zhong; Zhengxin Wang; Guoyue Lv; Shusen Zheng; Xiao Xu

doi:10.21147/j.issn.1000-9604.2023.04.06

Efficacy and safety of anlotinib as an adjuvant therapy in hepatocellular carcinoma patients with a high risk of postoperative recurrence

Chin J Cancer Res. 2023 Aug 30;35(4):399-407. doi: 10.21147/j.issn.1000-9604.2023.04.06.

Authors

Jianguo Wang^{1

2}, Xiaonan Xiang², Zhixiong Shi², Hui Zhang², Quanbao Zhang³, Zhikun Liu^{1

2}, Guangjie Zhao⁴, Chuanxing Wu⁵, Qiang Wei^{1

2}, Lin Zhong⁵, Zhengxin Wang³, Guoyue Lv⁴, Shusen Zheng^{6

7}, Xiao Xu^{1

2

6}

Affiliations

¹ Department of Hepatobiliary and Pancreatic Surgery, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou 310006, China.
² Key Laboratory of Integrated Oncology and Intelligent Medicine of Zhejiang Province, Hangzhou 310006, China.
³ Department of General Surgery, Huashan Hospital, Fudan University, Shanghai 200040, China.
⁴ Department of Hepatobiliary and Pancreatic Surgery, the First Bethune Hospital of Jilin University, Changchun 130021, China.
⁵ Department of Hepatobiliary and Pancreatic Surgery, Shanghai General Hospital, Shanghai 200080, China.
⁶ Department of Hepatobiliary and Pancreatic Surgery, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China.
⁷ Department of Hepatobiliary and Pancreatic Surgery, Shulan (Hangzhou) Hospital, Zhejiang Shuren University School of Medicine, Hangzhou 310022, China.

PMID: 37691893
PMCID: PMC10485915
DOI: 10.21147/j.issn.1000-9604.2023.04.06

Abstract

Objective: Hepatocellular carcinoma (HCC) has a high rate of postoperative recurrence and lacks an effective treatment to prevent recurrence. This study aims to investigate the efficacy and safety of anlotinib in postoperative adjuvant therapy for HCC patients with high-risk recurrence factors.

Methods: For this multicenter, retrospective study, we recruited 63 HCC patients who received either anlotinib (n=27) or transcatheter arterial chemoembolization (TACE) (n=36) from six research centers in China between March 2019 and October 2020. The primary endpoint was disease-free survival (DFS) and the secondary endpoints were overall survival (OS) and safety.

Results: In this study, the median follow-up time was 25.9 and 26.8 months in the anlotinib and TACE groups, respectively. There was no significant difference in the median DFS between the anlotinib [26.8 months, 95% confidence interval (95% CI): 6.8-NE] and TACE groups (20.6 months, 95% CI: 8.4-NE). The 12-month OS rates in the anlotinib and TACE groups were 96.3% and 97.2%, respectively. In the anlotinib group, 19 of 27 patients (70.4%) experienced treatment-emergent adverse events, with the most common events (≥10%) being hypertension (22.2%) and decreased platelet count (22.2%).

Conclusions: The results indicate that anlotinib, as a new, orally administered tyrosine kinase inhibitor, has the same efficacy as TACE, and side effects can be well controlled.

Keywords: Hepatocellular carcinoma; adjuvant therapy; anlotinib; transcatheter arterial chemoembolization.