Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma

New England Journal of Medicine

Volumn 322, Issue 6, 1990, Pages 352-358

  Moertel, Charles G ^a   Fleming, Thomas R ^b   Macdonald, John S ^c   Haller, Daniel G ^d   Laurie, John A ^e   Goodman, Phyllis J ^b   Ungerleider, James S ^f   Emerson, William A ^g   Tormey, Douglas C ^h   Glick, John H ^d   Veeder, Michael H ⁱ   Mailliard, James A ^j  

^a MAYO CLINIC   (United States)

^b FRED HUTCHINSON CANCER RESEARCH CENTER   (United States)

^c TEMPLE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF PENNSYLVANIA   (United States)

^e Grand Forks Clinic   (United States)

^f Dayton Clinical Oncology Program   (United States)

^g St Louis Comm Clin Oncol Program   (United States)

^h UNIVERSITY OF WISCONSIN   (United States)

ⁱ Illinois Oncology Research Association   (United States)

^j CREIGHTON UNIVERSITY   (United States)

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Author keywords

[No Author keywords available]

Indexed keywords

FLUOROURACIL; LEVAMISOLE;

ADJUVANT THERAPY; ARTICLE; CANCER RECURRENCE; CANCER SURGERY; CLINICAL TRIAL; COLON CARCINOMA; CONTROLLED STUDY; DERMATITIS; FOLLOW UP; HUMAN; LEUKOPENIA; MAJOR CLINICAL STUDY; MORTALITY; NAUSEA; PRIORITY JOURNAL;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA; COLONIC NEOPLASMS; COMBINED MODALITY THERAPY; COMPARATIVE STUDY; FEMALE; FLUOROURACIL; HUMAN; LEVAMISOLE; LYMPHATIC METASTASIS; MALE; MIDDLE AGE; NEOPLASM STAGING; PATIENT COMPLIANCE; POSTOPERATIVE CARE; RANDOM ALLOCATION; SUPPORT, U.S. GOV'T, P.H.S.;

EID: 0025060806     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJM199002083220602     Document Type: Article

References (24)

1. Silverberg E, Lubera JA. Cancer statistics, 1989. CA 1989; 39: 3–20.
2. Buyse M, Zeleniuch-Jacquotte A, Chalmers TC. Adjuvant therapy of colorectal cancer: why we still don't know. JAMA 1988; 259: 3571–8.
3. Laurie JA, Moertel CG. Fleming TR, et al. Surgical adjuvant therapy of large-bowel carcinoma: an evaluation of levamisole and the combination of levamisole and fluorouracil: the North Central Cancer Treatment Group and the Mayo Clinic. J Clin Oncol 1989; 7: 1447–56.
4. Janssen PA. The levamisole story. Prog Drug Res 1976; 20: 347–83.
5. Renoux G. The general immunopharmacology of levamisole. Drugs 1980; 19: 89–99.
6. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975; 31: 103–15.
7. SAS Institute Inc. SUGI supplemental library users' guide, version 5 edition. Cary, N.C.: SAS Institute, 1986:662.
8. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457–81.
9. Mantel H, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959; 22: 719–48.
10. Cox DR. Regression models and life-tables. J R Stat Soc [B] 1972; 34: 187–220.
11. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35: 549–56.
12. Emerson SS, Fleming TR. Symmetric group sequential test designs. Biometrics 1989; 45: 905–23.
13. Gastrointestinal Tumor Study Group. Prolongation of the disease-free interval in surgically treated rectal carcinoma. N Engl J Med 1985; 312: 1465–72.
14. Krook J, Moertel C, Wieand H, et al. Radiation vs sequential chemotherapy-radiation-chemotherapy: a study of the North Central Cancer Treatment Group, Duke University, and the Mayo Clinic. Proc Am Soc Clin Oncol 1986; 5: 82. abstract.
15. Borden EC, Davis TE, Crowley JJ, Wolberg WH, McKnight B, Chirigos MA. Interim analysis of a trial of levamisole and 5-fluorouracil in metastatic colorectal carcinoma. In: Terry WD, Rosenberg SA, eds. Immunotherapy of human cancer. New York: Excerpta Medica, 1982:231–5.
16. Buroker TR, Moertel CG, Fleming TR, et al. A controlled evaluation of recent approaches to biochemical modulation or enhancement of 5-fluorouracil therapy in colorectal carcinoma. J Clin Oncol 1985; 3: 1624–31.
17. Windle R, Bell PR, Shaw D. Five year results of a randomized trial of adjuvant 5-fluorouracil and levamisole in colorectal cancer. Br J Surg 1987; 74: 569–72.
18. Goldin A, Chirigos MA. Macdonald JS, Fefer A, Mihich E. Biologic response modifiers and adjuvant chemotherapy: consideration of selected preclinical investigations in relation to clinical potential. Recent Results Cancer Res 1982; 80: 351–6.
19. Arnaud J-P, Buyse M, Nordlinger B, et al. Adjuvant therapy of poor prognosis colon cancer with levamisole: results of an EORTC double-blind randomized clinical trial. Br J Surg 1989; 76: 284–9.
20. Guminska M, Kedryna T, Marchut E. Effect of levamisole on energy metabolism in Erlich ascites tumour cells in vitro. Biochem Pharmacol 1986; 35: 4369–74.
21. Chirigos MA, Amery WK. Combined levamisole therapy: a overview of its protective effects. In: Immunotherapy of human cancer: present status of trials in man. New York: Raven Press, 1978:181–95.
22. Munoz A, Garcia RA, Perez-Aranda A. Potentiation by levamisole, methisoprinol, and adenine or adenosine of the inhibitory activity of human interferon against encephalomyocarditis virus. Antimicrob Agents Chemother 1986; 30: 192–5.
23. Redondo JM, Lopen-Guerrero JA, Fresno M. Potentiation of interleukin-2 activity by levamisole and imidazole. Immunol Lett 1987; 14: 111–6.
24. Grem JL, Allegra CS. Toxicity of levamisole and 5-fluorouracil in human colon carcinoma cells. J Natl Cancer Inst 1989; 81: 1413–7.