Journal of Clinical Oncology, Vol 13, 2324-2329, Copyright © 1995 by American Society of Clinical Oncology
Controlled clinical trial of interferon-gamma as postoperative surgical adjuvant therapy for colon cancer
M Wiesenfeld, MJ O'Connell, HS Wieand, NJ Gonchoroff, JH Donohue, RJ Fitzgibbons Jr, JE Krook, JA Mailliard, JB Gerstner and R Pazdur
Cedar Rapids Oncology Project Community Clinical Oncology Program, IA, USA.
PURPOSE: The primary goal of this study was to assess the effectiveness of
interferon gamma (IFN-gamma) to prevent tumor relapse following potentially
curative surgery in patients with high-risk colon cancer. A secondary goal
was to determine the effect of IFN-gamma on immune function and to
correlate alterations in immune parameters with survival. PATIENTS AND
METHODS: Three to 4 weeks after undergoing resection of all known malignant
disease, 99 patients with stage II, III, or IV colon cancer were randomly
assigned to receive IFN-gamma 0.2 mg total dose by subcutaneous injection
daily for 6 months or observation. Serial assessment of human leukocyte
antigen (HLA)-DR expression and Fc receptors on peripheral-blood monocytes
was conducted in 24 patients who received IFN-gamma and 27 control
patients. RESULTS: With a median follow-up duration of 59 months in
patients still alive, there was evidence of a detrimental effect on time to
relapse (P = .03) among patients who received IFN-gamma. There was no
significant difference in patient survival (P = .12). This study has
sufficient power to rule out a 25% reduction in death rate for patients who
received IFN-gamma (P < .05). Significant enhancement of immune function
was observed in patients treated with IFN-gamma as measured by HLA-DR
expression (P < .01) and Fc receptors (P < .001) on peripheral- blood
monocytes. CONCLUSION: This study effectively rules out any clinically
meaningful benefit for IFN-gamma as surgical adjuvant treatment for
patients with high-risk colon cancer. Although significant enhancement of
nonspecific immune function was seen with this dosage administration
schedule of IFN-gamma, this was not associated with any demonstrable
antitumor effect.

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