Multicenter Pilot Study of 5-Fluorouracil, Folinic Acid, Interferon Alpha-2b and Degradable Starch Microspheres Via Hepatic Arterial Infusion in Patients with Nonresectable Colorectal Liver Metastases

Abstract

Background: It is necessary to establish therapeutic regimens for patients with nonresectable hepatic metastases of colorectal carcinoma. A new regional chemotherapy regimen was tested in a prospective study in three centers. Patients and Methods: An arterial port system was implanted in 95 patients. From January 1994 to March 1999, intra-arterial treatment was applied via the hepatic artery using 450 mg starch microspheres with 5 million IU recombinant interferon-α 2B, 500 mg/m² folinic acid and 600 mg/m² 5-FU body surface for 5 days with a 14-day interval. Results: The tumor response rate was 70%. Median disease progression was 17 months, median survival 24 months. The subgroup analysis shows a significant advantage (p<0.00001) for patients with a liver tumor involvement of <25% and a median survival of 39 months compared to a tumor involvement of 25-50% (24 months) and >50% (14 months). Major toxicity problems were observed in 11%. However, there was no termination of therapy on account of these problems. Conclusion: Intra-arterial chemotherapy with our new regimen was useful in patients with colorectal liver metastases who had only an intrahepatic tumor burden of <50%.