Phase II study of intra-arterial fluorouracil and mitomycin-C for liver metastases of colorectal cancer.

Effectiveness, toxicity and complications of 5-fluorouracil (FU) and mitomycin-C (MMC) treatment were analyzed in 30 patients with metastatic colorectal cancer confined to the liver. The treatment schedule was FU 2.0-2.5 g/day for 5 days followed by MMC 10 mg/m2 every 2 h on day 6 to a maximum total dose of 60 mg. Treatment courses were repeated every 6 weeks and were given on an outpatient basis via external pump and arterial port systems. In 30 fully evaluable patients, one complete response, 17 partial responses (overall response rate 60%), and stabilization of disease in 8 patients (26%) were obtained for a median duration of 13 months. Median overall survival was 18.2 months (25.5 months for responding patients, 15 months for nonresponders). Grade 1-2 toxicity (WHO classification) consisted of leukopenia (23%), mucositis (20%), nausea/vomiting (16%), and abdominal pain (10%). Two patients (7%) developed severe mucositis. No life-threatening side effects were observed; in particular, there was no sclerosing cholangitis or chemical hepatitis. Catheter-related problems (occlusion, displacement, rupture, infection) occurred in 10 patients (33%) at a median follow-up time of 12 months. We conclude that intra-arterial FU and MMC constitute an effective, safe, and nontoxic treatment in metastatic colorectal cancer confined to the liver. Catheter-related problems are the most important factors limiting treatment.