Results of a prospective randomized study of hepatic artery infusion with 5-fluorouracil versus intravenous 5-fluorouracil in patients with hepatic metastases from colorectal cancer: A Central Oncology Group study.

In a controlled, prospectively randomized trial, 74 patients with hepatic metastases from colorectal cancer were randomized to either intra-arterial hepatic artery infusion with 5-fluorouracil (5-FU) or systemic chemotherapy with 5-FU. In 61 acceptable patients, there was no significant difference in terms of response rate, time to progression, duration of the response, and survival rate. Though the response rate for the intra-arterial infusion arm was slightly higher than for the systemic arm, the difference was not significant, and the intra-arterial infusion arm was associated with a greater incidence of nausea, vomiting, diarrhea, in addition to complications of femoral-arterial thrombosis, bleeding, and infection at the catheter site not seen in patients treated by systemic chemotherapy. Patients with an objective response to chemotherapy on either treatment arm survived twice as long as the nonresponders. Long-term survival in one patient, 77 months, can occasionally be achieved in patients with hepatic metastases.

RCT Entities:   Population Interventions Outcomes