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SAN FRANCISCO -- Hepatic arterial infusion pump (HAIP) chemotherapy with floxuridine significantly improved overall survival (OS) in patients with advanced intrahepatic cholangiocarcinoma (iCCA), according to results from a phase II study.

Patients treated with HAIP chemotherapy combined with systemic chemotherapy achieved a 1-year OS of 80% compared with 47% in the historical cohort treated with systemic chemotherapy. The 3-year OS rates were 33% and 3%, respectively, reported Bas Groot Koerkamp, MD, PhD, of the Erasmus MC Cancer Institute in Rotterdam, the Netherlands.

The results replicated previous phase II studies that evaluated the use of HAIP chemotherapy in patients with advanced iCCA, he observed.

"I want to point out that I do share the enthusiasm of all my colleagues in the room about immunotherapy and about targeted treatments in intrahepatic cholangiocarcinoma," Koerkamp said in a presentation at the Gastrointestinal Cancers Symposium. "However, currently none of these treatments have shown a 3-year overall survival of one in three patients for advanced disease. Moreover, HAIP chemotherapy works regardless of the genomic alterations."

Koerkamp noted that the standard of care for advanced iCCA is systemic chemotherapy, pointing out that in a , which analyzed the use of gemcitabine and cisplatin for liver-confined iCCA, the median was 16.7 months, with 1-, 2-, and 3-year OS rates of 63%, 25%, and 3%, respectively.

This 3-year OS is the "benchmark," not only for new systemic treatments, but also for locoregional treatments, such as HAIP, he said.

Koerkamp observed that the treatment has been involved in several phase II studies, all of which demonstrated a consistent response rate of about 50%, with 3-year OS rates ranging from 29% to 43%. Thus his group was looking to replicate those results in the current study.

With HAIP, surgeons implant a pump that is connected by a small catheter into the hepatic artery, allowing for the delivery of high-dose chemotherapy directly to the liver while minimizing toxicities associated with systemic treatment.

"The rationale is that liver tumors derive most of their blood supply from the hepatic artery rather than the portal vein," Koerkamp said. "Moreover, the drug floxuridine has a high first-pass effect, allowing for a 200-fold higher exposure in the cancer cell."

The study took place in three Dutch academic centers between January 2020 and September 2022 with 50 patients (median age 65) with unresectable iCCA confined to the liver. Two-thirds had multifocal disease and 22% had received prior systemic chemotherapy. They received 6 cycles of HAIP as well as 8 cycles of systemic chemotherapy.

Among the 50 patients, 48 started HAIP and 42 received at least 4 HAIP cycles. About one in five (22%) had a postoperative complication resolved with a reintervention.

Koerkamp and colleagues reported that a partial response was observed in 46% of patients, which was superior to gemcitabine/cisplatin alone (21%), and similar to the rates observed in the published phase II trials evaluating HAIP.

During a post-presentation question and answer session, Benjamin Schlechter, MD, of the Dana-Farber Cancer Institute in Boston, asked how selective internal radiation therapy (SIRT) with yttrium-90 (Y-90) compares with HAIP.

"If we think about systemic therapy versus liver-directed therapy, it seems clear there is a benefit to liver-directed therapy," he said. Schlechter asked Koerkamp for his impression of SIRT with Y-90 considering that retrospective analyses of that technique "report 3-year survival that is pretty comparable to what you just presented."

"The Y-90 results are quite impressive," Koerkamp acknowledged. He noted that while there have been no head-t0-head comparisons between Y-90 and HAIP, "I think the results are still better from the pump."

"I think the data is more robust," he said, adding that a main advantage of HAIP is that it "treats the entire liver."

"We do use SIRT as well if we have a large lesion in the liver that is encroaching on the hilum and we cannot offer the patient the pump," Koerkamp stated.

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