Interferon synergistically augments the antitumor activity of 5-FU in vitro, and the combination has clinical efficacy in colorectal carcinoma. So, we have started in February 1992, a phase II study of 5-FU plus gamma-interferon(5-FU 12mg/kg/day
iv
bolus for 4 days, 6mg/kg/day on day 6, 8, 10, 12, 15mg/kg/day on day 22 and then weekly iv bolus, with gamma-interferon 2×10E6IU/㎡/day im three times per week) to determine the antitumor activity of this combination in advanced colorectal
carcinoma.
Eighteen patients with a good performance status with measurable lesion entered into this study, and all patients were evaluable for response and toxicity. With median follow-up of 40 weeks, there were 3(16.7%) partial responders, 7(38.9%) in
stable
disease, 8(44.4%) progressed, and none with complete response. The median duration of response in partial responders and stable diseases were 24 weeks. The median survival of total patients were 35 weeks. Prognostic factors which significantly
influenced survival were sex, performance, site, and history of chemotherapy. The side effects were anemia 33%, leukocytopenia 78%, thrombocytopenia 6%, stomatitis 6%, nausea/vomiting 61%, diarrhea 22%, fever 78%, and alopecia 11%. Treatment was
associated with an increase in peripheral blood natural killer cell activity.
In conclusion, this regimen of 5-FU with gamma-interferon administration does not appear to be superior to previously published schedules of 5-FU.
|