FOLFOX-HAIC versus first-line systemic chemotherapy in HBsAg-positive patients with unresectable intrahepatic cholangiocarcinoma: A propensity score matched cohort study.

BACKGROUND: The optimal treatment strategy for hepatitis B surface antigen (HBsAg)-positive patients with unresectable intrahepatic cholangiocarcinoma (ICC) remains unclear. This study aimed to compare the efficacy and safety of FOLFOX (oxaliplatin, 5-fluorouracil, and leucovorin)-based hepatic arterial infusion chemotherapy (HAIC) versus first-line systemic chemotherapy (SC) in this population to identify a more effective treatment. METHODS: We included 165 HBsAg-positive patients with unresectable ICC treated at Sun Yat-sen University Cancer Center from July 2015 to April 2024. After propensity score matching, 68 patients were assigned to each group. The matched cohorts were compared in terms of progression-free survival (PFS), intrahepatic PFS, overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety. RESULTS: Compared to the SC group, the HAIC group demonstrated significantly longer median PFS (6.90 vs. 4.53 months; P < 0.001) and intrahepatic PFS (10.00 vs. 8.20 months; P = 0.006). The ORR was also significantly higher in the HAIC group according to both Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (38% vs. 15%; P = 0.004) and modified Response Evaluation Criteria in Solid Tumors (mRECIST) (43% vs. 15%; P = 0.001) criteria. Conversion surgery was achieved in 14 patients (21%) in the HAIC group versus 1 patient (1%) in the SC group (P = 0.001). The incidence of any grade (P = 0.476) and grade 3-4 (P = 0.384) adverse events were comparable between the two groups. CONCLUSIONS: In HBsAg-positive patients with unresectable ICC, FOLFOX-HAIC provided superior local control with a trend toward improved long-term prognosis compared to SC while maintaining an acceptable safety profile.