Transarterial chemoembolization combined with apatinib in the treatment of advanced hepatocellular carcinoma: a prospective, multicenter, real-world study (Ahend-HAP02)

Hang Yuan¹Zhen Li²Guang-Shao Cao³Fei Xu⁴Gang Wu²Peng-Xu Ding²Qiu-Liang Wei⁵Zu-Kuan Chang⁶Cheng Xing⁷Huan-Zhang Niu⁸Jun Yin⁹Quan-Jun Yao¹Lin Zheng¹Jin-Cheng Xiao¹Cheng-Shi Chen¹Hong-Tao Cheng¹Deng-Wei Zong¹Wei-Li Xia¹Xiang Geng¹Xiao-Hui Zhao¹⁰Hai Liang Li¹Hong-Tao Hu^1*

• ¹Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China
• ²First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
• ³Henan Provincial People's Hospital, Zhengzhou, Henan Province, China
• ⁴Center for National Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing Municipality, China
• ⁵Anyang Tumor Hospital, Anyang, Henan Province, China
• ⁶Xinxiang Central Hospital / the Fourth Clinical College of Xinxiang Medical University, Xixiang, China
• ⁷Zhoukou Central Hospital, Zhoukou, China
• ⁸The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan Province, China
• ⁹Xinyang Central Hospital, Xinyang, Shaanxi Province, China
• ¹⁰National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin Municipality, China

To analyze the efficacy and safety of transarterial chemoembolization (TACE) with apatinib (TACE-A) for the treatment of advanced hepatocellular carcinoma (HCC).Methods: Data from advanced HCC patients treated with TACE-A between January 2019 and June 2022 were evaluated. The patients from 8 medical centers were included. The primary endpoints were overall survival (OS) and progression-free survival (PFS). The secondary endpoints were objective response rate (ORR) and adverse events (AEs). Prognostic factors affecting OS were analyzed, and the tumor imaging response at the first follow-up was evaluated to study the survival differences among patients.Results: A total of 389 patients were included, the median PFS was 7.0 months (95% confidence interval [CI]: 6.3-7.7), and the median OS (mOS) was 18.9 months (95% CI: 17.5-20.3). The median time of the first follow-up was 1.2 months, the ORR was 33.7%, and the mOS of the complete response, partial response, stable disease, and progressive disease groups were 30.1, 20.9, 18.5, and 12.9 months, respectively. The difference was statistically significant (p < 0.05). Univariate and multivariate Cox regression analyses demonstrated that the prognostic factors affecting OS were distant metastasis, maximum tumor diameter, TACE duration, and alpha-fetoprotein (AFP) level (p < 0.05). The overall incidence of grade 3 and above AEs was 18.0% (70/389), and the overall safety was controllable.TACE-A significantly improved OS, PFS, and ORR in advanced HCC patients. At the first follow-up patients with a poor tumor response had a poor prognosis. Distant metastasis, maximum tumor diameter, TACE frequency, and AFP levels are important prognostic factors that affect OS in patients. AEs of combination therapy are safe and manageable.