Hepatic Artery Infusion Pumps Increase OS Rates for Patients With Intrahepatic CCA

Hepatic artery infusion pumps (HAIPs) are used to deliver chemotherapy directly to the liver through the hepatic artery in patients with cholangiocarcinoma (CCA). By providing a continuous administration of floxuridine via a subcutaneous pump, HAIPs can help shrink tumors in the liver and reduce the risk of tumor recurrence.

A study conducted by Stijn Franssen, MD, and colleagues sought to assess the efficacy of HAIPs paired with systemic chemotherapy in patients with advanced intrahepatic CCA (iCCA). Results of the study were presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

iCCA is a rare but highly aggressive form of CCA that originates in the bile ducts within the liver. Occurrence of iCCA has been increasing over the past 10 to 20 years.

Data from the Advanced Biliary Tract Cancer-01, -02, and -03 trials have shown that the 3-year overall survival (OS) rate of patients with advanced iCCA confined to the liver who received systemic gemcitabine with cisplatin was only 2.8%. Conversely, recent meta-analysis data have shown that HAIPs combined with systemic chemotherapy can provide a pooled 3-year OS rate of 39.5%.

The single-arm, phase 2 trial was conducted at 3 health care centers in the Netherlands. From January 2020 to September 2022, 50 patients with advanced iCCA were administered 6 cycles of floxuridine through an HAIP, with 38 (76.0%) of these patients also receiving 8 cycles of concurrent systemic chemotherapy with gemcitabine and cisplatin, as they had not previously received systemic treatment. One patient died after pump implantation due to COVID-19 complications.

The primary end point was OS, and secondary end points included progression-free survival (PFS) and objective response (OR). The median follow-up was 26.4 months (95% CI, 21.7-39.0), and the median OS was 22.1 months (95% CI, 19.7 to not reached).

The 1-year OS rate was 80.0% (95% CI, 69.6%-91.9%), while the 3-year OS rate was 28.6% (95% CI, 16.0%-51.2%). The median PFS rate was 10 months (95% CI, 8.7-12.2).

Upon imaging, an OR was achieved in 27 (54.05%) patients, and disease control at 6 months was seen in 43 (86.00%). A total of 4 (8%) patients underwent resection after undergoing HAIP chemotherapy, with 2 of these patients achieving a complete pathologic response.

HAIP combined with systemic chemotherapy shows promise as a treatment for patients with advanced iCCA. Further research is needed among larger patient cohorts to solidify these data.