Feasibility study of ambulatory continuous infusion of 5-fluorouracil followed by cisplatin through hepatic artery for metastatic colorectal cancer.

PURPOSE: A great synergy has been reported in a number of preclinical studies when 5-fluorouracil (5-FU) precedes cisplatin (CDDP). The objective of this study was to determine the feasibility of ambulatory continuous infusion of 5-FU followed by CDDP through hepatic artery for metastatic colorectal cancer. PATIENTS AND METHODS: Seventeen patients with unresectable liver metastases, who underwent primary tumor resection, were treated with 5-FU (450 mg/m2/day) for seven consecutive days followed by CDDP (100 mg/body/week) for seven consecutive days, each administered continuously by using a balloon pump via Infuse-A-Port catheter inserted into common hepatic artery. The doses of drugs were reduced 20% in patients older than 70 years. The treatment was repeated every 4-6 weeks until disease progression. RESULTS: Of 17 assessable patients, nine patients showed PR (53%; 95% CI, 29.3-76.7%) and eight patients had SD (47%; 95% CI, 23.3-70.7%), with disease control rate of 100%. The median overall survival was 26 months (95% CI: 17.5-41 months) and TTP 14 months (95% CI: 11-20.3 months). Two patients (11.8%), who showed progression due to collateral feeding arteries, responded to HAI again after occlusion. Grade 3 toxicity included leukopenia (12%) and anemia (24%). Grade 4 toxicity was absent. Four patients (23.5%) progressed at extrahepatic sites. CONCLUSIONS: This sequential combination of 5-FU followed by CDDP through hepatic artery is active and safe in an outpatient setting, and warrants further multi-institutional study, although prevention of micrometastasis would be mandatory to further prolong overall survival.