Continuous hepatic arterial infusion of 5-fluorouracil for unresectable colorectal liver metastases: phase II study.

BACKGROUND

Although hepatic arterial infusion therapy (HAIT) with 5-fluoro-2'-deoxyuridine for colorectal liver metastases yielded a good response, the treatment may be limited by hepatic toxicities. This study was designed to evaluate HAIT by using 5-fluorouracil (5-FU), with the expectation of a good response with little hepatic toxicities.

METHODS

HAIT was begun at a dose of 360 mg/m2 of 5-FU for 7 days by using an extracorporeal infusion pump, followed by 180 mg/m2 of 5-FU for 21 days. After a 7-day interval, 180 mg/m2 of 5-FU was infused for 7 days; this 7-day infusion/7-day no infusion cycle was repeated.

RESULTS

Fifty-three of the 68 patients who were referred to this study were evaluable. Complete response was observed in two patients and partial response in 25 (response rate of 50.9%), with a median survival time of 11 months: 18 months for 27 responders and 7 months for 26 nonresponders. Gastrointestinal complications were observed in 18 patients: abdominal pain in nine, vomiting in five, and bleeding in four. No hepatobiliary or hematologic toxicities occurred. Infusion-related complications occurred in 20 patients.

CONCLUSIONS

HAIT with 5-FU may provide an effect similar to HAIT with fluoro-2' deoxyuridine but without hepatobiliary complications.