Hepatic arterial infusion chemotherapy in combination with lenvatinib and durvalumab versus standard first-line treatment gemcitabine and cisplatin plus durvalumab in advanced intrahepatic cholangiocarcinoma.

Abstract

In patients with advanced intrahepatic cholangiocarcinoma (ICC), clinical outcomes remain unsatisfactory despite the recommended first-line treatment of gemcitabine with cisplatin and durvalumab (GCD). We recently reported that hepatic arterial infusion chemotherapy (HAIC) in combination with lenvatinib and durvalumab (HLD) exhibited promising antitumor activity and manageable adverse events in patients with unresectable ICC. Here, we aimed to compare HLD with GCD in patients with advanced ICC. This retrospective study included consecutive patients with advanced ICC administered HLD or GCD between January 2020 and March 2024. Safety and patient outcomes, including overall and progression-free survival and objective response rate, were compared between the two groups. The study cohort included 31 and 28 patients in the HLD and GCD groups, respectively. Compared to the GCD group, the HLD group experienced significantly better overall survival (median, 15.8 vs. 9.6 months; P = 0.033), longer progression-free survival (median, 10.3 vs. 4.1 months; P = 0.007), and a higher objective response rate (46.2% vs. 13.1%; P = 0.009). By subgroup analysis, patients with single tumor, intrahepatic tumors >5 cm, or unilobar tumors benefited more from HLD treatment. Additionally, the rates of any grade and grade 3-4 adverse events were not significantly different between the two groups (100% vs. 92.9%, P = 0.221; 32.3% vs. 42.9%, P = 0.401; respectively). In conclusion, HLD treatment was tolerable and associated with better survival benefits compared to the standard first-line GCD treatment in patients with advanced ICC, especially in those with single tumor, intrahepatic tumors >5 cm, and unilobar tumors.