Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases; a phase II trial

Abstract

Introduction: Adjuvant hepatic arterial infusion pump (HAIP) chemotherapy demonstrated promising results with a median overall survival of 67 months (n=785) versus 44 months without HAIP (n=1.583, p<0.001) in a propensity scored analysis in patients with resectable colorectal liver metastases (CRLM).[J Clin Onc;35(17):1938] However, its general application is limited. Previous results from Memorial Sloan Kettering Cancer Center (MSKCC) should be confirmed in a randomized controlled trial (RCT) outside MSKCC. The aim of this study was to investigate the feasibility and safety of HAIP chemotherapy in a multicenter setting in the Netherlands. Materials & Methods: A phase II study was performed in two high-volume centers in the Netherlands. Patients with resectable CRLM without extrahepatic disease were eligible. All patients were scheduled for 6 cycles of adjuvant HAIP chemotherapy with floxuridine, after complete resection of CRLM with pump placement. The main endpoints were feasibility (defined as successful administration of at least one cycle of HAIP chemotherapy) and safety (defined as 90-day postoperative complications). Result(s): Twenty patients with resectable CRLM were included. The median age of patients was 57 years (range 42-75). The median clinical risk score was 2 (range 1-5). All 20 patients (100%) received at least one dose of HAIP chemotherapy at a median of 42.5 days (range 26-57) after surgery. Pump related postoperative complications occurred in 2 patients (10%); replacement of a malfunctioning pump and repositioning of a flipped (upside down) pump. No arterial hemorrhage or dissection, extrahepatic perfusion, catheter related problems, pump pocket hematoma or pump pocket infections were found within 90-days after resection and implantation. Conclusion(s): Adjuvant HAIP chemotherapy in patients with resectable CRLM is safe and feasible as demonstrated in a phase II study of 20 patients. The PUMP trial (NTR 7493) has started to investigate the effectiveness of adjuvant HAIP chemotherapy in a randomized controlled trial.