PMID- 7666090
OWN - NLM
STAT- MEDLINE
DCOM- 19951006
LR  - 20170210
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 13
IP  - 9
DP  - 1995 Sep
TI  - Controlled clinical trial of interferon-gamma as postoperative surgical adjuvant 
      therapy for colon cancer.
PG  - 2324-9
AB  - 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.
FAU - Wiesenfeld, M
AU  - Wiesenfeld M
AD  - Cedar Rapids Oncology Project Community Clinical Oncology Program, IA, USA.
FAU - O'Connell, M J
AU  - O'Connell MJ
FAU - Wieand, H S
AU  - Wieand HS
FAU - Gonchoroff, N J
AU  - Gonchoroff NJ
FAU - Donohue, J H
AU  - Donohue JH
FAU - Fitzgibbons, R J Jr
AU  - Fitzgibbons RJ Jr
FAU - Krook, J E
AU  - Krook JE
FAU - Mailliard, J A
AU  - Mailliard JA
FAU - Gerstner, J B
AU  - Gerstner JB
FAU - Pazdur, R
AU  - Pazdur R
LA  - eng
GR  - CA-25224/CA/NCI NIH HHS/United States
GR  - CA-35269/CA/NCI NIH HHS/United States
GR  - CA-37404/CA/NCI NIH HHS/United States
GR  - etc.
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (HLA-DR Antigens)
RN  - 0 (Receptors, Fc)
RN  - 82115-62-6 (Interferon-gamma)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Colonic Neoplasms/immunology/surgery/*therapy
MH  - Combined Modality Therapy
MH  - Female
MH  - Follow-Up Studies
MH  - HLA-DR Antigens/metabolism
MH  - Humans
MH  - Interferon-gamma/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Monocytes/metabolism
MH  - Multivariate Analysis
MH  - Neoplasm Recurrence, Local/prevention & control
MH  - Postoperative Care
MH  - Proportional Hazards Models
MH  - Prospective Studies
MH  - Receptors, Fc/metabolism
MH  - Regression Analysis
EDAT- 1995/09/01 00:00
MHDA- 2001/03/28 10:01
CRDT- 1995/09/01 00:00
PHST- 1995/09/01 00:00 [pubmed]
PHST- 2001/03/28 10:01 [medline]
PHST- 1995/09/01 00:00 [entrez]
AID - 10.1200/JCO.1995.13.9.2324 [doi]
PST - ppublish
SO  - J Clin Oncol. 1995 Sep;13(9):2324-9. doi: 10.1200/JCO.1995.13.9.2324.