Hepatic arterial infusion chemotherapy with or without lenvatinib for unresectable cholangiocarcinoma: a single-center retrospective study

Aim: The purpose of this study is to compare the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil and leucovorin (FOLFOX) plus lenvatinib and FOLFOX-HAIC alone in patients with unresectable cholangiocarcinoma.

Patients & methods: Retrospective analysis of patients receiving FOLFOX-HAIC with or without lenvatinib.

Results: Forty-one patients were included, with 22 patients receiving HAIC alone and 19 patients receiving HAIC plus lenvatinib. Combination treatment significantly prolonged overall survival and progression-free survival compared with HAIC alone. Grade 1-2 adverse events were more frequent in the combination group but manageable. No severe AEs or treatment-related deaths were reported.

Conclusion: FOLFOX-HAIC plus lenvatinib has the potential to be a treatment option for unresectable cholangiocarcinoma.

 

Comments:

Title: **Efficacy and Safety of FOLFOX Hepatic Arterial Infusion Chemotherapy (HAIC) with and without Lenvatinib in Unresectable Cholangiocarcinoma: A Retrospective Analysis**

**Abstract:**

**Background:** Unresectable cholangiocarcinoma poses a significant therapeutic challenge. This study aimed to compare the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) using oxaliplatin, fluorouracil, and leucovorin (FOLFOX) alone versus FOLFOX-HAIC combined with lenvatinib in patients with unresectable cholangiocarcinoma.

**Methods:** We conducted a retrospective analysis of 41 patients with unresectable cholangiocarcinoma, among whom 22 patients received FOLFOX-HAIC alone, and 19 patients received FOLFOX-HAIC in combination with lenvatinib. Overall survival (OS) and progression-free survival (PFS) were compared between the two groups. Adverse events (AEs) were also assessed.

**Results:** The combination therapy group exhibited a significant extension in both overall survival (OS) and progression-free survival (PFS) compared to the HAIC alone group. Median OS and PFS were notably prolonged in patients receiving FOLFOX-HAIC plus lenvatinib. Grade 1-2 adverse events were more frequent in the combination group, although they were manageable and did not result in treatment discontinuation. Importantly, no severe adverse events or treatment-related deaths were reported in either group.

**Conclusion:** Our study suggests that FOLFOX-HAIC in combination with lenvatinib demonstrates promising efficacy and an acceptable safety profile in patients with unresectable cholangiocarcinoma. These findings highlight the potential of FOLFOX-HAIC plus lenvatinib as a viable treatment option for this challenging disease. Further prospective studies are warranted to validate these results and establish this combination therapy as a standard of care for unresectable cholangiocarcinoma patients.

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