FOLFOX-Based Hepatic Arterial Infusion Chemotherapy with Sequential Drug-Eluting Bead Transarterial Chemoembolization for Unresectable Large Hepatocellular Carcinoma: A Single-Center Retrospective Cohort Study.

Background: For patients with large unresectable hepatocellular carcinoma (HCC), the effectiveness of conventional transarterial chemoembolization (TACE) remains suboptimal, which necessitates the administration of substantial volumes of chemotherapy drugs and lipiodol, thereby increasing the risk of liver failure and other chemotherapy-related complications. Therefore, we devised a strategy of initial hepatic arterial infusion chemotherapy (HAIC) followed by sequential drug-eluting bead TACE (DEB-TACE). In our treatment design, a lower tumor burden after HAIC facilitated complete embolization of tumor vasculature, and the use of less amount of embolic agents reduced the incidence of liver failure and embolization syndromes. Methods: This retrospective study evaluated consecutive patients with unresectable large HCC with a maximum tumor diameter of ≥7 cm who received FOLFOX-HAIC combined with sequential DEB-TACE from April 2019 to February 2024. Efficacy was evaluated using the objective response rate (ORR), overall survival (OS), and progression-free survival (PFS); and safety was assessed using the frequency of key adverse events (AEs). Results: Among the 76 patients included, the median maximum tumor diameter was 12.4 cm (range, 7.0-23.4 cm). The overall ORRs based on mRECIST and RECIST 1.1 criteria were 94.1% and 51.5%, respectively. The median OS was 28.1 months (95% CI, 22.7-33.4), and the median PFS was 11.7 months (95% CI, 7.7-15.8). All patients experienced AEs, but only 18.4% experienced grade 3 or 4 AEs, there was no treatment-related mortality. Conclusion: In this single-center, retrospective study, our results suggested that FOLFOX-HAIC with sequential DEB-TACE demonstrated promising efficacy and safety for patients with unresectable HCC with a maximum tumor diameter of ≥7 cm.