Multicenter pilot study administering 5-fluorouracil, folinic acid, interferon alpha–2b and degradable starch microspheres via hepatic arterial infusion in patients with nonresectable colorectal liver metastases

Background: Patients with an advanced colorectal tumor have a poor prognosis. Thus, it is necessary to establish therapeutic regimens for patients with nonresectable hepatic metastases. 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 with nonresectable liver metastases of a colorectal carcinoma. From January 1994 to March 1999, intra-arterial treatment was applied via the hepatic artery using 450mg starch microspheres with 5 million IU recombinant interferon-a 2B, 500mg/m 2 folinic acid and 600mg/m 2 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 12%. 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%.