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.

摘要

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-alpha 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 theseproblems. 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%.