ALPHA-INTERFERON IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN IN METASTATIC COLORECTAL-CANCER - A PHASE-I STUDY

A high rate of response to 5-fluorouracil (5FU) and alpha-interferon (alpha-IFN) combination therapy has been reported in metastatic colorectal cancer patients. Therefore, designed a trial of high-dose continuous-infusion 5FU, oral leucovorin (LV), and alpha-IFN in this group of patients. Because this combination has not previously been tested and severe toxicity has been reported for 5FU and alpha-IFN combination therapy, we conducted a phase I trial in which 11 patients presenting with previously untreated metastatic colorectal cancer were treated with escalating doses of alpha-IFN together with fixed doses of 5FU and LV. WHO grade III toxicity consisting mainly of oral mucositis was noted in four patients. No grade IV toxicity occurred. Although alpha-IFN may enhance the toxicity of 5FU, the toxicity of this regimen remained manageable. Three partial responses were noted.