Abstract
This study aims to compare the effectiveness and safety of anti-programmed cell death protein 1 (PD-1) immunotherapy and tyrosine kinase inhibitors (TKIs) combined with intra-arterial therapy (IAT) or systemic chemotherapy, and anti-PD-1 immunotherapy combined with IAT or systemic chemotherapy in patients with advanced biliary tract carcinoma (BTC). Patients with BTC who received IAT combined with anti-PD-1 immunotherapy and/or TKIs or the combination of systemic chemotherapy with anti-PD-1 immunotherapy and/or TKIs were divided into 4 groups according to inclusion and exclusion criteria: the combination of IAT with TKIs and anti-PD-1 immunotherapy group (ITP group), the systemic chemotherapy combined with TKIs and anti-PD-1 immunotherapy group (CTP group), the combination of IAT with anti-PD-1 immunotherapy group (IP group) and the systemic chemotherapy combined with anti-PD-1 immunotherapy group (CP group). The baseline characteristics, progression-free survival (PFS), treatment efficacy and adverse reactions were compared between ITP and CTP groups and between IP and CP groups, and risk factors related to PFS were analyzed. The median PFS in ITP group was 3.975 months, and the 6-month-PFS was 31.6%; the median PFS in CTP group was 3.285 months, and the 6-month-PFS was 11.1%. There was a statistical difference between ITP group and CTP group. The median PFS in the IP and CP groups were 4.534 months and 2.267 months, respectively, which were also statistically significant. The objective response rate and disease control rate (DCR) of ITP and CTP groups were not statistically significant. There was no significant difference in objective response rate and DCR between IP group and CP group. The lymph node metastasis was an independent risk factor for PFS. Compared with the CTP group, the ITP group had a higher incidence of post-treatment fever and difficulty urination, and the IP group had a higher incidence of 3 degree AST elevation and difficulty urination than the CP group. IAT combined with anti-PD-1 immunotherapy and TKIs or IAT combined with anti-PD-1 immunotherapy for advanced BTC were relatively effective and safe. The lymph node metastasis was an independent risk factor affecting the prognosis of advanced BTC.