Hepatic artery infusion with 5-fluorouracil and mitomycin-C in metastatic colorectal carcinoma phase II study.

Thirty-two patients with hepatic metastases colorectal carcinoma were treated with hepatic artery infusion (HAI) employing 5-fluorouracil (5-FU) and mitomycin-C (mito-C). Catheters were placed percutaneously via the femoral artery. Two schedules were employed: (I) 5-FU 1,200 mg/m2 IA (D1-4) and mito-C 8 mg/m2 IA (D1 + D4); (2) 5-FU 1,200 mg/m2 IA (D1-6) and mito-C 8 mg/m2 IA (D1 + D4). Courses were repeated every 4 weeks. Thirty patients with measurable disease were evaluable, 22 received schedule I and 8 patients schedule II. Complete response occurred in two patients (6.7%) and partial response in 13 patients (43.3%). Five patients (16.7%) had minimal regression. The overall response rate as 66.7%. Median survival of all patients from start of treatment was 11.2 months. Median survival of responders and nonresponders was 12.4 months and 4.6 months, respectively (P less than 0.05). No differences in response rates, duration of response, or survival was seen between the two schedules. Drug toxicity was moderate to severe, but morbidity of HAI per se was minimal. Intermittent HAI of 5-FU and mito-C is a well-tolerated treatment modality associated with few serious complications. The response rate, duration of response, and the survival is comparable to continuous HAI infusion of 5-FU or floxuridine (FUDR). As given in this study, mito-C did not appear to provide added benefit.