[Phase II studies of interferon alpha-2 Sch 30500 in advanced gastrointestinal carcinoma]

Eighteen patients with advanced metastatic gastrointestinal cancer (stomach cancer 7, liver cancer 9, pancreas cancer 2) were treated with human recombinant interferon alpha-2 at doses of 3.0 X 10(6)-10.0 X 10(6) IU/body i.m. daily or every second day, 30 X 10(6) IU/body for five consecutive days every four weeks, or 30 X 10(6) IU/body once weekly. No tumor response was demonstrated in any of our cases. Among fifteen evaluable cases, nine had stabilization of evaluable disease at four weeks, but six showed progressive disease. On the other hand, fever, chills, fatigue, anorexia, nausea and vomiting were pronounced. In two cases, CNS toxicities developed. In some instances, leukopenia, thrombocytopenia, decrease of hemoglobin content and elevation of transaminase were observed. According to these findings, single use of recombinant interferon alpha-2 at the dose schedule outlined above does not seem to be of use for the treatment of advanced gastrointestinal cancer.