SO-7 Efficacy and safety of transarterial chemoembolization (TACE) plus apatinib as compared with TACE alone for recurrent hepatocellular carcinoma: A prospective randomized controlled trial

Abstract

Hepatocellular carcinoma (HCC) has been one of the most escalating global malignant diseases with a high risk of postoperative recurrence. Transarterial chemoembolization (TACE) is the main treatment for patients with recurrent HCC within one year after hepatectomy, but the overall effect is not satisfactory. And the optimal treatment strategy for recurrent HCC remains unclear. Therefore, this randomized controlled trial (RCT) aims to compare the efficacy and safety of TACE plus apatinib or TACE alone in the treatment of recurrent HCC. Patients with recurrent HCC between January 2018 and January 2020 underwent clinical, biochemical and imaging evaluation and were randomised to TACE plus apatinib (n=40) or TACE alone (n=40). Patients in the combination group received apatinib 500 mg once daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP), defined as untreatable tumour progression, transient deterioration to Child-Pugh C or appearance of vascular invasion/extrahepatic spread. Clinical information on the patients were collected and all of the participants were followed up until TTUP or the end of the study. Adverse events, overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease-control rate (DCR) based on mRECIST criteria (American Association for the Study of Liver Diseases, 2008) were evaluated, among which PFS was the primary endpoint. All patients had complete follow-up records and median follow-ups of 29 months and 24 months for the TACE plus apatinib group and TACE alone group, respectively. ORR and DCR were significantly higher in the TACE plus apatinib than in the TACE alone group (70.0% vs 55.0%, p=0.046; 90.0% vs 75.0%, p=0.032). Median PFS was significantly longer in the TACE plus apatinib than in the TACE alone group (17.2 vs 12.5 months, p=0.041). Median TTUP (26.3 vs 21.3 months, p=0.026) was also significantly longer in the TACE plus apatinib group. OS at 1 year and 2 years in TACE plus apatinib group and TACE alone group were 95.0%, 85.0% and 90.0%, 75.0%, respectively. There were no unexpected toxicities and procedure-related mortality. This exploratory study suggested that TACE plus apatinib treatment was safe and might improve OS and PFS in patients with recurrent HCC. Further large sample, randomized, controlled trials are needed to clarify the potential role of apatinib in recurrent HCC.