Hepatic Arterial Infusion (HAI). Comparison of 5-Fluorouracil, Folinic Acid, Interferon Alpha-2b and Degradable Starch Microspheres versus 5-Fluorouracil and Folinic Acid in Patients with Non-resectable Colorectal Liver Metastases

Background: The prognosis of patients with advanced colorectal tumor is poor. Therefore, other therapy regimes for non-resectable hepatic metastases are necessary. In this prospective study, two regional chemotherapy protocols were compared. Patients and Methods: An arterial port system was implanted in 64 patients. Sixty patients were assigned to the two therapy protocols for hepatic arterial infusion (HAI): protocol A (n=24): 5-FU/FA (300 mg/m 2 folinic acid and 600 mg/m 2 5-fluorouracil daily for 5 days with a 14-day interval); protocol B (n=36): 5-FU/FA/IFN/DSM (450 mg starch microspheres (DSM) with 5 million IU recombinant interferon (IFN), · 2b 500 mg/m 2 FA and 600 mg/m 2 5-FU). Results: The response rate was 50% in protocol A patients and 69.4% in protocol B. The median times for disease progression were 11 months for protocol A and 20 months for protocol B (p=0.038), while median survival times of 14 months and 26 months, respectively, were obtained (p=0.015). There were no significant differences in terms of toxic side-effects. Major toxicity problems were observed in 12% of the protocol A-treated patients and in 11% of the protocol B-treated patients. Conclusion: Combination therapy with HAI 5-FU/FA/IFN/DSM was superior to HAI-5- FU/FA, with a high response rate (69% vs. 55%) and few toxic side-effects. These findings suggest that these combinations should be evaluated in larger studies as first- or second-line therapy in patients with hepatic metastases of colorectal cancer.