Intrahepatic interleukin-2 with chemotherapy for unresectable liver metastases: A randomized multicenter trial

BAGKGROUND/AIMS: A pilot study of Interleukin-2 (IL-2) with chemotherapy fo r unresectable colorectal liver metastases revealed a favorable response ra te (76%). This prospective, randomized, multicenter study was conducted to evaluate the efficacy of this treatment protocol. METHODOLOGY: Over a period of 32 months, 46 patients with unresectable live r metastases were randomly assigned to 1 of 3 treatment groups: group A: ch emotherapy alone, group B: chemotherapy plus high-dose, intermittent IL-2 ( 2.1x10(6) U twice weekly) or group C: chemotherapy plus low-dose, continuou s IL-2 (7x10(5) U daily). Treatment continued for 4 weeks in the hospital a nd on an outpatient basis according to the clinical response. No crossover between treatment arms was permitted. RESULTS: IL-2 combined with chemotherapy produced a higher complete and par tial response-rate of 40% in group A, 60% in group B, and 78% in group C. T oxicity related to IL-2 included fever, chills, malaise, and eosinophilia. CONCLUSIONS: Hepatic arterial infusion of chemotherapy plus IL-2 resulted i n an increased tumor response when compared with chemotherapy alone. To con firm the efficacy of this treatment protocol, we have started a large-scale , randomized, multi-institution trial.