Efficacy and safety of drug-eluting bead transarterial chemoembolization (DEB-TACE) plus apatinib versus DEB-TACE alone in treating huge hepatocellular carcinoma patients

Background Apatinib, a tyrosine kinase inhibitor, inhibits angiogenesis under the tumor hypoxic environment induced by drug-eluting bead transarterial chemoembolization (DEB-TACE), which is hypothesized to have synergic effect with DEB-TACE in treating hepatocellular carcinoma (HCC) patients. This study aimed to evaluate the efficacy and safety of DEB-TACE plus apatinib in treating huge HCC patients. Methods Totally, 73 huge HCC patients (tumor size > 10 cm) were screened and divided into DEB-TACE plus apatinib group (N = 34) or DEB-TACE group (N = 39) based on the treatment they received. Their clinical response and adverse events were retrieved. The progression-free survival (PFS) and overall survival (OS) were calculated. Results DEB-TACE plus apatinib achieved a trend of higher objective response rate (64.7% vs. 43.6%, P = 0.071), but similar disease control rate (88.2% vs. 79.5%, P = 0.314) than DEB-TACE alone. Moreover, DEB-TACE plus apatinib reached an improved PFS (median (95%CI): 19.0 months (15.5-22.5) vs. 10.9 months (8.0-13.8), P = 0.025) and OS (median (95%CI): 25.1 months (20.3-29.9) vs. 13.7 months (9.8-17.6), P = 0.042) than DEB-TACE alone. After adjustment by multivariate Cox's regression analyses, DEB-TACE plus apatinib (vs. DEB-TACE alone) was independently correlated with better PFS (HR: 0.420, P = 0.004) and OS (HR: 0.477, P = 0.022). Regarding safety, adverse events were mostly mild and manageable; also, they were of no difference between DEB-TACE plus apatinib and DEB-TACE alone (all P > 0.05). Conclusion DEB-TACE plus apatinib achieves prolonged PFS and OS, while similar adverse events occurrence compared to DEB-TACE alone in huge HCC treatment.