Controlled clinical trial of interferon-γ as postoperative surgical adjuvant therapy for colon cancer

Martin Wiesenfeld, Michael J. O'Connell, H. Sam Wieand, Nick J. Gonchoroff, John H. Donohue, Robert Joseph Fitzgibbons, James E. Krook, James A. Mailliard, James B. Gerstner, Richard Pazdur

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Abstract

Purpose: The primary goal of this study was to assess the effectiveness of interferon gamma (IFN-γ) 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-γ 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-γ, 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-γ 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-γ. 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-γ IP <.05). Significant enhancement of immune function was observed in patients treated with IFN-γ 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-γ 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-γ, this was not associated with any demonstrable antitumor effect.

Original languageEnglish
Pages (from-to)2324-2329
Number of pages6
JournalJournal of Clinical Oncology
Volume13
Issue number9
Publication statusPublished - Sep 1995
Externally publishedYes

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All Science Journal Classification (ASJC) codes

  • Cancer Research
  • Oncology

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Wiesenfeld, M., O'Connell, M. J., Wieand, H. S., Gonchoroff, N. J., Donohue, J. H., Fitzgibbons, R. J., ... Pazdur, R. (1995). Controlled clinical trial of interferon-γ as postoperative surgical adjuvant therapy for colon cancer. Journal of Clinical Oncology, 13(9), 2324-2329.