Hepatic Arterial Infusion Pump Chemotherapy in Patients With Unresectable Intrahepatic Cholangiocarcinoma—PUMP-2 Trial

Author(s): Stijn Franssen, MD, PhD¹; Merve Rousian, MD¹; Wills F. Filipe, MD, PhD¹; Florian E. Buisman, MD, PhD¹; Britte H.E.A. ten Haaft, MD²; Rutger-Jan Swijnenburg, MD, PhD²; Bianca Mostert, MD, PhD³; Nadia Haj Mohammad, MD, PhD⁴; Jeroen Hagendoorn, MD, PhD⁵; Michael Doukas, MD, PhD⁶; Heinz-Josef Klümpen, MD, PhD⁷; Marjolein Y.V. Homs, MD, PhD³; Bas Groot Koerkamp, MD, PhD¹;

Source: DOI: 10.1200/JCO-25-00923

Dr. Maen Hussein's Thoughts

With the addition of intrahepatic chemotherapy, median overall survival was 22.3 months. One year overall survival reached 80.0%, exceeding the historical control rate of 47%, while three year overall survival was 31.5%. For patients who can tolerate this approach, it appears to be a reasonable and potentially worthwhile option.

PURPOSE

The 3-year overall survival (OS) for advanced intrahepatic cholangiocarcinoma (iCCA) confined to the liver after systemic chemotherapy with gemcitabine-cisplatin (gem-cis) is only 3%. Hepatic arterial infusion pump (HAIP) chemotherapy with floxuridine aims to control the liver disease and improve survival. The aim of this study was to assess the effectiveness of HAIP chemotherapy with floxuridine and concurrent systemic gem-cis in patients with unresectable liver-confined iCCA in the Netherlands.

METHODS

We performed a nonrandomized multicenter phase II trial. Treatment-naïve patients and patients previously treated with systemic therapy were eligible. Up to six cycles of HAIP floxuridine and eight cycles of concurrent systemic gem-cis were administered. The primary endpoint was 1-year OS compared with a historical cohort.

RESULTS

From January 2020 to September 2022, 50 patients had a pump placed. Two patients (4%) did not start HAIP floxuridine; one patient died due to COVID-19, and one patient had a hepatic arterial dissection. The remaining 48 patients (96%) started HAIP chemotherapy, combined with systemic gem-cis in the 37 patients (74%) who had not received gem-cis previously. Twenty-two patients (44%) achieved a partial response and 42 patients (84%) disease control 6 months. Five patients (10%) converted to resection, of whom one had a complete pathologic response. The median OS was 22.3 months (95% CI, 19.7 to 35.9 months). The 1-year OS of 80.0% (95% CI, 69.6% to 91.9%) was superior to the historical control of 47% (P < .001). The 3-year OS was 31.5% (95% CI, 20.4% to 48.6%).

CONCLUSION

Combining HAIP chemotherapy with floxuridine and systemic gem-cis in patients with unresectable liver-confined iCCA had a 1- and 3-year OS superior to gem-cis alone in historical cohorts.

Author Affiliations

¹Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; ²Department of Surgery, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands; ³Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; ⁴Department of Medical Oncology, UMC Utrecht, Utrecht University, Utrecht, the Netherlands; ⁵Department of Surgery, UMC Utrecht, Utrecht University, Utrecht, the Netherlands; ⁶Department of Pathology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; ⁷Department of Medical Oncology, Amsterdam UMC, Amsterdam, the Netherlands

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