A recent phase II study has shown that Hepatic Arterial Infusion Pump (HAIP) chemotherapy with floxuridine has significantly improved overall survival (OS) in patients with advanced intrahepatic cholangiocarcinoma (iCCA). The study conducted by Bas Groot Koerkamp, MD, PhD, of the Erasmus MC Cancer Institute in Rotterdam, the Netherlands, reported that patients treated with HAIP chemotherapy combined with systemic chemotherapy achieved a 1-year OS of 80%, compared to 47% in the historical cohort treated with systemic chemotherapy. The 3-year OS rates were 33% and 3%, respectively. These results have been consistent with previous phase II studies assessing HAIP chemotherapy in patients with advanced iCCA.
Standard systemic chemotherapy has been the standard of care for advanced iCCA. In a subgroup analysis of the Advanced Biliary Tract Cancer (ABC)-01, -02, and -03 trials, the median OS was 16.7 months, with 1-, 2-, and 3-year OS rates of 63%, 25%, and 3%, respectively. While new systemic treatments and targeted therapies have shown promise, none have yet demonstrated a 3-year overall survival rate of one in three patients for advanced iCCA. This highlights the importance of finding alternative treatments, such as HAIP chemotherapy.
HAIP chemotherapy involves the implantation of a pump connected by a small catheter into the hepatic artery. This allows for the direct delivery of high-dose chemotherapy to the liver, while minimizing the toxicities associated with systemic treatment. The rationale behind this approach is that liver tumors receive most of their blood supply from the hepatic artery, and the drug floxuridine has a high first-pass effect, resulting in a significantly higher exposure in cancer cells.
The study included 50 patients with unresectable iCCA confined to the liver. The patients received 6 cycles of HAIP chemotherapy and 8 cycles of systemic chemotherapy. Among these patients, 48 started HAIP treatment, and 42 received at least 4 cycles of HAIP chemotherapy. The study revealed a partial response in 46% of patients, which was superior to the response rate observed with gemcitabine/cisplatin alone (21%). These findings are consistent with previously published phase II trials evaluating HAIP chemotherapy.
During a question and answer session following the presentation, the comparison between HAIP and selective internal radiation therapy (SIRT) with yttrium-90 (Y-90) was discussed. While there are no head-to-head comparisons between the two approaches, experts in the field believe that HAIP therapy has more robust data and provides better results. HAIP treatment is advantageous as it treats the entire liver, while SIRT is used when the liver lesion is encroaching on the hilum and the pump cannot be offered to the patient.
The results from this phase II study assessing Hepatic Arterial Infusion Pump (HAIP) chemotherapy with floxuridine have demonstrated significant improvements in overall survival for patients with advanced intrahepatic cholangiocarcinoma (iCCA). The study showed superior outcomes compared to standard systemic chemotherapy, with a higher response rate observed and better 3-year survival rates. HAIP chemotherapy offers a targeted approach that delivers high-dose chemotherapy directly to the liver, minimizing systemic toxicities. While direct comparisons with other liver-directed therapies are lacking, the results from this study suggest that HAIP chemotherapy is a promising treatment option for advanced iCCA patients. Further research and larger studies are necessary to confirm these findings and explore the potential benefits and limitations of HAIP therapy in a broader patient population.
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