Safety and Feasibility of Adjuvant Hepatic Arterial Infusion Pump Chemotherapy in Patients with Resectable Colorectal Liver Metastasis; A Phase II Trial in the Netherlands

Introduction: Adjuvant hepatic arterial infusion pump (HAIP) chemotherapy after resection of colorectal liver metastasis (CRLM) was associated with a 2-year increased survival in Memorial Sloan Kettering Cancer Center. Due to the promising results published on HAIP chemotherapy we have started a HAIP program in the Netherlands. We now present our long-term safety and feasibility results. Methods: A phase II study was performed in 2 centers in The Netherlands. Patients with resectable CRLM without extrahepatic disease were eligible. All patients underwent 6 cycles of adjuvant HAIP chemotherapy with floxuridine. Safety was determined by HAIP chemotherapy-related complications grade III or higher from surgery until 90 days after finishing the last cycle. Feasibility was determined by the number of completed cycles. Results: Twenty patients were included. The median number of floxuridine cycles completed was 5 and all patients completed at least 3 cycles at full dose. Nine patients (45%) had 14 grade III or higher complications. Two patients (10%) required a reoperation for a malfunctioning or flipped pump. One patient (5%) developed biliary obstruction that resolved with temporary stent placement. One patient (5%) developed hepatic artery thrombosis after 4 cycles with subsequent pancreatitis, portal vein thrombosis, and died from liver failure. None of the patients developed arterial bleeding or dissection, pseudo-aneurysm, extrahepatic perfusion, or pump pocket infection. Conclusion: Adjuvant HAIP chemotherapy was safely introduced in the Netherlands in a phase II trial. Long-term follow-up of this trial and an ongoing phase III trial are required to determine survival benefit.