Adjuvant apatinib treatment after resection of hepatocellular carcinoma with portal vein tumor thrombosis: a phase II trial

Abstract

Background: Survival after resection of hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT) still remains poor. Apatinib, a vascular endothelial cell growth factor receptor 2 inhibitor, has been shown to be safe and effective in patients with advanced HCC, so in the present study its efficacy and safety in the adjuvant setting was explored.Methods: In this single-center, open-label phase II trial, the patients received apatinib (500 mg/day) until they experienced disease recurrence or intolerable toxicity. The primary endpoint was recurrence-free survival (RFS); the secondary endpoints included overall survival (OS) and safety.Results: From a total of 49 patients who were screened between August 2017 and December 2018, 30 study participants received apatinib. According to the Liver Cancer Study Group of Japan classification of PVTT, there were 7, 11, and 12 participants with Vp1, Vp2, and Vp3, respectively. The median duration of treatment was 4.8 months [interquartile range (IQR): 2.0-8.8], and the median dose of apatinib was 339.7 mg/day (IQR: 267.7-500 mg/day). The median follow-up was 14.3 months (IQR: 12.3-19.3). The median RFS was 7.6 months [95% confidence interval (CI): 5.7-9.5 months]. The 1-year RFS rate and the 1-year OS rate were 36.1% and 93.3%, respectively. A total of 29 (96.7%) patients experienced adverse events, and 14 (46.7%) had grade 3 or 4 adverse events. No treatment-related deaths occurred.Conclusions: Apatinib was well tolerated in patients after resection of HCC with PVTT. The median RFS in this group was improved compared with that previously reported.

Comparing the effectiveness and safety of Sorafenib plus TACE with Apatinib plus TACE for treating patients with unresectable hepatocellular carcinoma: a multicentre propensity score matching study

“…In the present study, AEs in the TACE-Apatinib group mainly included proteinuria, hypertension, weakness, and HFS, which were in agreement with previous studies [ 33 – 35 ]. Besides, AEs in the TACE-Sorafenib group mainly included diarrhea and poor appetite, which were similar to the findings reported by the SHARP trial [ 27 ].…”

Efficacy and Response Biomarkers of Apatinib in the Treatment of Malignancies in China: A Review

“…This result led to the approval of apatinib by the China Food and Drug Administration in late 2020 as an agent for additional indications in advanced HCC. Other clinical trials also confirmed the efficacy and safety of apatinib in advanced HCC (22,23). Apatinib combined with a PD-1 inhibitor showed promising efficacy and manageable safety in patients with advanced HCC both in the firstand second-line settings, and apatinib at a dose of 250 mg was recommended as a combination therapy for advanced HCC treatment in further studies (24,25).…”

Guidelines for Diagnosis and Treatment of Hepatocellular Carcinoma with Portal Vein Tumor Thrombus in China (2021 Edition)

“…Other treatment recommendations that are controversial include the following: postoperative portal vein chemotherapy [ 31 ] (Evidence level IIb), adjuvant HAIC [ 32 ] (Evidence level IIb), adjuvant molecular-targeted therapy [ 33 ] (Evidence level IIb), and postoperative intravenous chemotherapy [ 34 ] (Evidence level III).…”