Journal of Clinical Oncology, Vol 7, 1447-1456, Copyright © 1989 by American Society of Clinical Oncology
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
JA Laurie, CG Moertel, TR Fleming, HS Wieand, JE Leigh, J Rubin, GW McCormack, JB Gerstner, JE Krook and J Malliard
Grand Forks Clinic, Ltd, ND.
A total of 401 eligible patients with resected stages B and C colorectal
carcinoma were randomly assigned to no-further therapy or to adjuvant
treatment with either levamisole alone, 150 mg/d for 3 days every 2 weeks
for 1 year, or levamisole plus fluorouracil (5-FU), 450 mg/m2/d
intravenously (IV) for 5 days and beginning at 28 days, 450 mg/m2 weekly
for 1 year. Levamisole plus 5-FU, and to a lesser extent levamisole alone,
reduced cancer recurrence in comparison with no adjuvant therapy. These
differences, after correction for imbalances in prognostic variables, were
only suggestive for levamisole alone (P = .05) but quite significant for
levamisole plus 5-FU (P = .003). Whereas both treatment regimens were
associated with overall improvements in survival, these improvements
reached borderline significance only for stage C patients treated with
levamisole plus 5-FU (P = .03). Therapy was clinically tolerable with
either regimen and severe toxicity was uncommon. These promising results
have led to a large national intergroup confirmatory trial currently in
progress.
This article has been cited by other articles:

|
 |

|
 |
 
I. Zlobec, L. M. Terracciano, and A. Lugli
Local Recurrence in Mismatch Repair-Proficient Colon Cancer Predicted by an Infiltrative Tumor Border and Lack of CD8+ Tumor-Infiltrating Lymphocytes
Clin. Cancer Res.,
June 15, 2008;
14(12):
3792 - 3797.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. R Fleming, K. Sharples, J. McCall, A. Moore, A. Rodgers, and R. Stewart
Maintaining confidentiality of interim data to enhance trial integrity and credibility
Clinical Trials,
April 1, 2008;
5(2):
157 - 167.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
C. J. Bradley, C. W. Given, B. Dahman, and T. L. Fitzgerald
Adjuvant Chemotherapy After Resection in Elderly Medicare and Medicaid Patients With Colon Cancer
Arch Intern Med,
March 10, 2008;
168(5):
521 - 529.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. Berglund, B. Cedermark, and B. Glimelius
Is it deleterious to delay the start of adjuvant chemotherapy in colon cancer stage III?
Ann. Onc.,
February 1, 2008;
19(2):
400 - 402.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
B. M. Wolpin, J. A. Meyerhardt, H. J. Mamon, and R. J. Mayer
Adjuvant Treatment of Colorectal Cancer
CA Cancer J Clin,
May 1, 2007;
57(3):
168 - 185.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Y. Shen and Y. Cheng
Adaptive design: estimation and inference with censored data in a semiparametric model
Biostat.,
April 1, 2007;
8(2):
306 - 322.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M J White, R L O'Gorman, E M Charles-Edwards, P A Kane, J B Karani, M O Leach, and J J Totman
Parametric mapping of the hepatic perfusion index with gadolinium-enhanced volumetric MRI
Br. J. Radiol.,
February 1, 2007;
80(950):
113 - 120.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. R. Smalley, J. K. Benedetti, S. K. Williamson, J. M. Robertson, N. C. Estes, T. Maher, B. Fisher, T. A. Rich, J. A. Martenson, J. W. Kugler, et al.
Phase III Trial of Fluorouracil-Based Chemotherapy Regimens Plus Radiotherapy in Postoperative Adjuvant Rectal Cancer: GI INT 0144
J. Clin. Oncol.,
August 1, 2006;
24(22):
3542 - 3547.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J M Carethers
Prospective evaluation of fluorouracil chemotherapy based on the genetic makeup of colorectal cancer.
Gut,
June 1, 2006;
55(6):
759 - 761.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. M. Goldberg, D. Niedzwiecki, M. Bertagnolli, A. W. Blackstock, J. E. Tepper, and R. J. Mayer
Cancer and leukemia group B gastrointestinal cancer committee.
Clin. Cancer Res.,
June 1, 2006;
12(11):
3589s - 3595s.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
V. R. Grann and F. M. Muggia
Completion rates of adjuvant chemotherapy for colon cancer: a historical perspective.
J Natl Cancer Inst,
May 3, 2006;
98(9):
570 - 571.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. A. Dobie, L.-M. Baldwin, J. A. Dominitz, B. Matthews, K. Billingsley, and W. Barlow
Completion of therapy by Medicare patients with stage III colon cancer.
J Natl Cancer Inst,
May 3, 2006;
98(9):
610 - 619.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Y.-A. Park, K. Y. Lee, N. K. Kim, S. H. Baik, S. K. Sohn, and C. W. Cho
Prognostic Effect of Perioperative Change of Serum Carcinoembryonic Antigen Level: A Useful Tool for Detection of Systemic Recurrence in Rectal Cancer
Ann. Surg. Oncol.,
May 1, 2006;
13(5):
645 - 650.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. M. Jessup, A. Stewart, F. L. Greene, and B. D. Minsky
Adjuvant Chemotherapy for Stage III Colon Cancer: Implications of Race/Ethnicity, Age, and Differentiation
JAMA,
December 7, 2005;
294(21):
2703 - 2711.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
E. Van Cutsem and F. Costa
Progress in the Adjuvant Treatment of Colon Cancer: Has It Influenced Clinical Practice?
JAMA,
December 7, 2005;
294(21):
2758 - 2760.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. G. Haller, P. J. Catalano, J. S. Macdonald, M. A. O'Rourke, M. S. Frontiera, D. V. Jackson, and R. J. Mayer
Phase III Study of Fluorouracil, Leucovorin, and Levamisole in High-Risk Stage II and III Colon Cancer: Final Report of Intergroup 0089
J. Clin. Oncol.,
December 1, 2005;
23(34):
8671 - 8678.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. J. Sargent, H. S. Wieand, D. G. Haller, R. Gray, J. K. Benedetti, M. Buyse, R. Labianca, J. F. Seitz, C. J. O'Callaghan, G. Francini, et al.
Disease-Free Survival Versus Overall Survival As a Primary End Point for Adjuvant Colon Cancer Studies: Individual Patient Data From 20,898 Patients on 18 Randomized Trials
J. Clin. Oncol.,
December 1, 2005;
23(34):
8664 - 8670.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
B. K. Edwards, M. L. Brown, P. A. Wingo, H. L. Howe, E. Ward, L. A. G. Ries, D. Schrag, P. M. Jamison, A. Jemal, X. C. Wu, et al.
Annual Report to the Nation on the Status of Cancer, 1975-2002, Featuring Population-Based Trends in Cancer Treatment
J Natl Cancer Inst,
October 5, 2005;
97(19):
1407 - 1427.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
P. Alhopuro, H. Alazzouzi, H. Sammalkorpi, V. Davalos, R. Salovaara, A. Hemminki, H. Jarvinen, J.-P. Mecklin, S. Schwartz Jr., L. A. Aaltonen, et al.
SMAD4 Levels and Response to 5-Fluorouracil in Colorectal Cancer
Clin. Cancer Res.,
September 1, 2005;
11(17):
6311 - 6316.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
K. Ohrling, D. Edler, M. Hallstrom, P. Ragnhammar, and H. Blomgren
Detection of Thymidylate Synthase Expression in Lymph Node Metastases of Colorectal Cancer Can Improve the Prognostic Information
J. Clin. Oncol.,
August 20, 2005;
23(24):
5628 - 5634.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. M. Scott, F.-T. Lee, R. Jones, W. Hopkins, D. MacGregor, J. S. Cebon, A. Hannah, G. Chong, P. U, A. Papenfuss, et al.
A Phase I Trial of Humanized Monoclonal Antibody A33 in Patients with Colorectal Carcinoma: Biodistribution, Pharmacokinetics, and Quantitative Tumor Uptake
Clin. Cancer Res.,
July 1, 2005;
11(13):
4810 - 4817.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
E. A. Kidd, J. Yu, X. Li, W. D. Shannon, M. A. Watson, and H. L. McLeod
Variance in the Expression of 5-Fluorouracil Pathway Genes in Colorectal Cancer
Clin. Cancer Res.,
April 1, 2005;
11(7):
2612 - 2619.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
E. A. Poplin, J. K. Benedetti, N. C. Estes, D. G. Haller, R. J. Mayer, R. M. Goldberg, G. R. Weiss, S. E. Rivkin, and J. S. Macdonald
Phase III Southwest Oncology Group 9415/Intergroup 0153 Randomized Trial of Fluorouracil, Leucovorin, and Levamisole Versus Fluorouracil Continuous Infusion and Levamisole for Adjuvant Treatment of Stage III and High-Risk Stage II Colon Cancer
J. Clin. Oncol.,
March 20, 2005;
23(9):
1819 - 1825.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. Figueredo, M. L. Charette, J. Maroun, M. C. Brouwers, and L. Zuraw
Adjuvant Therapy for Stage II Colon Cancer: A Systematic Review From the Cancer Care Ontario Program in Evidence-Based Care's Gastrointestinal Cancer Disease Site Group
J. Clin. Oncol.,
August 15, 2004;
22(16):
3395 - 3407.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. B. Benson III, D. Schrag, M. R. Somerfield, A. M. Cohen, A. T. Figueredo, P. J. Flynn, M. K. Krzyzanowska, J. Maroun, P. McAllister, E. Van Cutsem, et al.
American Society of Clinical Oncology Recommendations on Adjuvant Chemotherapy for Stage II Colon Cancer
J. Clin. Oncol.,
August 15, 2004;
22(16):
3408 - 3419.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
L. L. Gunderson, D. J. Sargent, J. E. Tepper, N. Wolmark, M. J. O'Connell, M. Begovic, C. Allmer, L. Colangelo, S. R. Smalley, D. G. Haller, et al.
Impact of T and N Stage and Treatment on Survival and Relapse in Adjuvant Rectal Cancer: A Pooled Analysis
J. Clin. Oncol.,
May 15, 2004;
22(10):
1785 - 1796.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. Gill, C. L. Loprinzi, D. J. Sargent, S. D. Thome, S. R. Alberts, D. G. Haller, J. Benedetti, G. Francini, L. E. Shepherd, J. Francois Seitz, et al.
Pooled Analysis of Fluorouracil-Based Adjuvant Therapy for Stage II and III Colon Cancer: Who Benefits and by How Much?
J. Clin. Oncol.,
May 15, 2004;
22(10):
1797 - 1806.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. M. Ribic, D. J. Sargent, M. J. Moore, S. N. Thibodeau, A. J. French, R. M. Goldberg, S. R. Hamilton, P. Laurent-Puig, R. Gryfe, L. E. Shepherd, et al.
Tumor Microsatellite-Instability Status as a Predictor of Benefit from Fluorouracil-Based Adjuvant Chemotherapy for Colon Cancer
N. Engl. J. Med.,
July 17, 2003;
349(3):
247 - 257.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. Z. Ayanian, A. M. Zaslavsky, C. S. Fuchs, E. Guadagnoli, C. M. Creech, R. D. Cress, L. C. O'Connor, D. W. West, M. E. Allen, R. E. Wolf, et al.
Use of Adjuvant Chemotherapy and Radiation Therapy for Colorectal Cancer in a Population-Based Cohort
J. Clin. Oncol.,
April 1, 2003;
21(7):
1293 - 1300.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
H. T. Arkenau, A. Bermann, K. Rettig, G. Strohmeyer, and R. Porschen
5-Fluorouracil plus leucovorin is an effective adjuvant chemotherapy in curatively resected stage III colon cancer: long-term follow-up results of the adjCCA-01 trial
Ann. Onc.,
March 1, 2003;
14(3):
395 - 399.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. J. Iwashyna and E. B. Lamont
Effectiveness of Adjuvant Fluorouracil in Clinical Practice: A Population-Based Cohort Study of Elderly Patients With Stage III Colon Cancer
J. Clin. Oncol.,
October 1, 2002;
20(19):
3992 - 3998.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. Schrag, S. Rifas-Shiman, L. Saltz, P. B. Bach, and C. B. Begg
Adjuvant Chemotherapy Use for Medicare Beneficiaries With Stage II Colon Cancer
J. Clin. Oncol.,
October 1, 2002;
20(19):
3999 - 4005.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. Edler, B. Glimelius, M. Hallstrom, A. Jakobsen, P. G. Johnston, I. Magnusson, P. Ragnhammar, and H. Blomgren
Thymidylate Synthase Expression in Colorectal Cancer: A Prognostic and Predictive Marker of Benefit From Adjuvant Fluorouracil-Based Chemotherapy
J. Clin. Oncol.,
April 1, 2002;
20(7):
1721 - 1728.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Summerhayes
Capecitabine: a novel, orally administered, tumour-activated treatment for colorectal cancer
Journal of Oncology Pharmacy Practice,
December 1, 2001;
7(4):
107 - 125.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
D. J. Sargent, R. M. Goldberg, S. D. Jacobson, J. S. Macdonald, R. Labianca, D. G. Haller, L. E. Shepherd, J. F. Seitz, and G. Francini
A Pooled Analysis of Adjuvant Chemotherapy for Resected Colon Cancer in Elderly Patients
N. Engl. J. Med.,
October 11, 2001;
345(15):
1091 - 1097.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. Schrag, L. D. Cramer, P. B. Bach, and C. B. Begg
Age and Adjuvant Chemotherapy Use After Surgery for Stage III Colon Cancer
J Natl Cancer Inst,
June 6, 2001;
93(11):
850 - 857.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. C. Hodgson, C. S. Fuchs, and J. Z. Ayanian
Impact of Patient and Provider Characteristics on the Treatment and Outcomes of Colorectal Cancer
J Natl Cancer Inst,
April 4, 2001;
93(7):
501 - 515.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. Porschen, A. Bermann, T. Loffler, G. Haack, K. Rettig, Y. Anger, and G. Strohmeyer
Fluorouracil Plus Leucovorin as Effective Adjuvant Chemotherapy in Curatively Resected Stage III Colon Cancer: Results of the Trial adjCCA-01
J. Clin. Oncol.,
March 15, 2001;
19(6):
1787 - 1794.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. Anthony, C. Jones, J. Antoine, S. Sivess-Franks, and R. Turnage
The Effect of Treatment for Colorectal Cancer on Long-Term Health-Related Quality of Life
Ann. Surg. Oncol.,
January 1, 2001;
8(1):
44 - 49.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. Mahoney, Y.-H. Kuo, A. Topilow, and J. Mihran Davis
Stage III Colon Cancers: Why Adjuvant Chemotherapy Is Not Offered to Elderly Patients
Arch Surg,
February 1, 2000;
135(2):
182 - 185.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
O. W. Brawley and H. P. Freeman
Race and Outcomes: Is This the End of the Beginning for Minority Health Research?
J Natl Cancer Inst,
November 17, 1999;
91(22):
1908 - 1909.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
N. Wolmark, H. Rockette, E. Mamounas, J. Jones, S. Wieand, D.L. Wickerham, H. D. Bear, J. N. Atkins, N. V. Dimitrov, A. G. Glass, et al.
Clinical Trial to Assess the Relative Efficacy of Fluorouracil and Leucovorin, Fluorouracil and Levamisole, and Fluorouracil, Leucovorin, and Levamisole in Patients With Dukes' B and C Carcinoma of the Colon: Results From National Surgical Adjuvant Breast and Bowel Project C-04
J. Clin. Oncol.,
November 1, 1999;
17(11):
3553 - 3559.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
L. D. Recht and J. M. Primavera
Case 24-1999- Neurologic Disorder in a 65-Year-Old Man after Treatment of Colon Cancer
N. Engl. J. Med.,
August 12, 1999;
341(7):
512 - 519.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
K. C. Halling, A. J. French, S. K. McDonnell, L. J. Burgart, D. J. Schaid, B. J. Peterson, L. Moon-Tasson, M. R. Mahoney, D. J. Sargent, M. J. O'Connell, et al.
Microsatellite Instability and 8p Allelic Imbalance in Stage B2 and C Colorectal Cancers
J Natl Cancer Inst,
August 4, 1999;
91(15):
1295 - 1303.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Summerhayes
Raltitrexed and the treatment of advanced colorectal cancer
Journal of Oncology Pharmacy Practice,
December 1, 1996;
2(4):
225 - 235.
[Abstract]
[PDF]
|
 |
|

|
 |

|
 |
 
M. L Slevin
Author's reply
BMJ,
June 1, 1996;
312(7043):
1417c - 1418.
[Full Text]
|
 |
|

|
 |

|
 |
 
M. L Slevin
Adjuvant treatment for colorectal cancer
BMJ,
February 17, 1996;
312(7028):
392 - 393.
[Full Text]
|
 |
|

|
 |

|
 |
 
L. B. Saltz and N. E. Kemeny
Adjuvant Chemotherapy of Colorectal Cancer
Oncologist,
February 1, 1996;
1(1):
22 - 29.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
P. Gilbar
A possible allergic reaction to levamisole
Journal of Oncology Pharmacy Practice,
December 1, 1995;
1(4):
49 - 50.
[PDF]
|
 |
|

|
 |

|
 |
 
J. Jen, H. Kim, S. Piantadosi, Z.-F. Liu, R. C. Levitt, P. Sistonen, K. W. Kinzler, B. Vogelstein, and S. R. Hamilton
Allelic Loss of Chromosome 18q and Prognosis in Colorectal Cancer
N. Engl. J. Med.,
July 28, 1994;
331(4):
213 - 221.
[Abstract]
[Full Text]
|
 |
|

|
 |

|
 |
 
M. Tempero and J. Anderson
Progress in Colon Cancer -- Do Molecular Markers Matter?
N. Engl. J. Med.,
July 28, 1994;
331(4):
267 - 268.
[Full Text]
|
 |
|

|
 |

|
 |
 
C. G. Moertel
Chemotherapy for Colorectal Cancer
N. Engl. J. Med.,
April 21, 1994;
330(16):
1136 - 1142.
[Full Text]
|
 |
|

|
 |

|
 |
 
J. M. Scholtz
General Principles and Pharmacology of Antineoplastic Agents
Journal of Pharmacy Practice,
January 1, 1991;
4(1):
3 - 10.
[PDF]
|
 |
|

|
 |

|
 |
 
A NEW AGENT FOR COLON CANCER
Journal Watch (General),
October 31, 1989;
1989(1031):
1 - 1.
[Full Text]
|
 |
|
|