BIOMAT Database Logo BIOMAT Database Logo

Intergroup study of fluorouracil plus levamisole as adjuvant therapy for stage II/Dukes' B2 colon cancer. 1995

C G Moertel, and T R Fleming, and J S Macdonald, and D G Haller, and J A Laurie, and C M Tangen, and J S Ungerleider, and W A Emerson, and D C Tormey, and J H Glick
Mayo Clinic, Rochester, MN, USA.

OBJECTIVE To determine the effectiveness of fluorouracil plus levamisole administered postoperatively to patients with resected stage II (Dukes' B2) colon cancer. METHODS This randomized controlled clinical trial (INT-0035) was performed by National Cancer Institute-sponsored cancer clinical trials cooperative groups. Patients were assigned to observation only or to fluorouracil (450 mg/m2 intravenously [IV] daily for 5 days and, beginning at 28 days, weekly for 48 weeks) plus levamisole (50 mg orally three times daily for 3 days repeated every 2 weeks for 1 year). Cancer recurrence, survival, and treatment side effects were assessed. RESULTS Three hundred eighteen eligible patients were analyzed with a median follow-up time of 7 years. Fluorouracil plus levamisole reduced the recurrence rate by 31%, although this trend was not statistically significant (P = .10). A total of 87 patients died: 43 on observation and 44 on fluorouracil plus levamisole. Disparity between effects on recurrence rate and overall survival is partially explained by a higher rate of non-colon cancer-related deaths on fluorouracil plus levamisole (15 v seven) and by the effects of salvage surgery with curative intent. Of seven patients with recurrence who were rendered disease-free by salvage surgery, six were on the observation arm. As was observed in patients treated with fluorouracil plus levamisole for stage III disease, toxicity was acceptable and compliance was excellent. CONCLUSIONS Fluorouracil plus levamisole is tolerable and accepted as standard surgical adjuvant therapy for patients with stage III colon cancer, but the data from this study in stage II patients suggest a decreased relapse rate without a significant improvement in survival.

UI MeSH Term Description Entries
D007978 Levamisole An antihelminthic drug that has been tried experimentally in rheumatic disorders where it apparently restores the immune response by increasing macrophage chemotaxis and T-lymphocyte function. Paradoxically, this immune enhancement appears to be beneficial in rheumatoid arthritis where dermatitis, leukopenia, and thrombocytopenia, and nausea and vomiting have been reported as side effects. (From Smith and Reynard, Textbook of Pharmacology, 1991, p435-6) L-Tetramisole,Levotetramisole,Decaris,Dekaris,Levamisole Hydrochloride,Solaskil,Hydrochloride, Levamisole
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009364 Neoplasm Recurrence, Local The local recurrence of a neoplasm following treatment. It arises from microscopic cells of the original neoplasm that have escaped therapeutic intervention and later become clinically visible at the original site. Local Neoplasm Recurrence,Local Neoplasm Recurrences,Locoregional Neoplasm Recurrence,Neoplasm Recurrence, Locoregional,Neoplasm Recurrences, Local,Recurrence, Local Neoplasm,Recurrence, Locoregional Neoplasm,Recurrences, Local Neoplasm,Locoregional Neoplasm Recurrences,Neoplasm Recurrences, Locoregional,Recurrences, Locoregional Neoplasm
D009367 Neoplasm Staging Methods which attempt to express in replicable terms the extent of the neoplasm in the patient. Cancer Staging,Staging, Neoplasm,Tumor Staging,TNM Classification,TNM Staging,TNM Staging System,Classification, TNM,Classifications, TNM,Staging System, TNM,Staging Systems, TNM,Staging, Cancer,Staging, TNM,Staging, Tumor,System, TNM Staging,Systems, TNM Staging,TNM Classifications,TNM Staging Systems
D011379 Prognosis A prediction of the probable outcome of a disease based on a individual's condition and the usual course of the disease as seen in similar situations. Prognostic Factor,Prognostic Factors,Factor, Prognostic,Factors, Prognostic,Prognoses
D003110 Colonic Neoplasms Tumors or cancer of the COLON. Cancer of Colon,Colon Adenocarcinoma,Colon Cancer,Cancer of the Colon,Colon Neoplasms,Colonic Cancer,Neoplasms, Colonic,Adenocarcinoma, Colon,Adenocarcinomas, Colon,Cancer, Colon,Cancer, Colonic,Cancers, Colon,Cancers, Colonic,Colon Adenocarcinomas,Colon Cancers,Colon Neoplasm,Colonic Cancers,Colonic Neoplasm,Neoplasm, Colon,Neoplasm, Colonic,Neoplasms, Colon
D003131 Combined Modality Therapy The treatment of a disease or condition by several different means simultaneously or sequentially. Chemoimmunotherapy, RADIOIMMUNOTHERAPY, chemoradiotherapy, cryochemotherapy, and SALVAGE THERAPY are seen most frequently, but their combinations with each other and surgery are also used. Multimodal Treatment,Therapy, Combined Modality,Combined Modality Therapies,Modality Therapies, Combined,Modality Therapy, Combined,Multimodal Treatments,Therapies, Combined Modality,Treatment, Multimodal,Treatments, Multimodal
D005260 Female Females
D005472 Fluorouracil A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid. 5-FU,5-FU Lederle,5-FU Medac,5-Fluorouracil,5-Fluorouracil-Biosyn,5-HU Hexal,5FU,Adrucil,Carac,Efudex,Efudix,Fluoro-Uracile ICN,Fluoroplex,Fluorouracil Mononitrate,Fluorouracil Monopotassium Salt,Fluorouracil Monosodium Salt,Fluorouracil Potassium Salt,Fluorouracil-GRY,Fluorouracile Dakota,Fluorouracilo Ferrer Far,Fluoruracil,Fluracedyl,Flurodex,Haemato-FU,Neofluor,Onkofluor,Ribofluor,5 FU Lederle,5 FU Medac,5 Fluorouracil,5 Fluorouracil Biosyn,5 HU Hexal,Dakota, Fluorouracile,Fluoro Uracile ICN,Fluorouracil GRY,Haemato FU

Related Publications

C G Moertel, and T R Fleming, and J S Macdonald, and D G Haller, and J A Laurie, and C M Tangen, and J S Ungerleider, and W A Emerson, and D C Tormey, and J H Glick
Adjuvant chemotherapy for patients with resected Dukes' C and high-risk B2 colon cancer with fluorouracil and levamisole.
September 1998, Annals of the Academy of Medicine, Singapore,
C G Moertel, and T R Fleming, and J S Macdonald, and D G Haller, and J A Laurie, and C M Tangen, and J S Ungerleider, and W A Emerson, and D C Tormey, and J H Glick
Optimal duration of fluorouracil plus levamisole colon cancer surgical adjuvant therapy.
October 1996, Journal of clinical oncology : official journal of the American Society of Clinical Oncology,
C G Moertel, and T R Fleming, and J S Macdonald, and D G Haller, and J A Laurie, and C M Tangen, and J S Ungerleider, and W A Emerson, and D C Tormey, and J H Glick
5-Fluorouracil plus levamisole: effective adjuvant treatment for colon cancer.
January 1990, Important advances in oncology,
C G Moertel, and T R Fleming, and J S Macdonald, and D G Haller, and J A Laurie, and C M Tangen, and J S Ungerleider, and W A Emerson, and D C Tormey, and J H Glick
[Should adjuvant chemotherapy be also used in Dukes stage B2 colon cancer?].
September 1996, Zeitschrift fur Gastroenterologie,
C G Moertel, and T R Fleming, and J S Macdonald, and D G Haller, and J A Laurie, and C M Tangen, and J S Ungerleider, and W A Emerson, and D C Tormey, and J H Glick
Adjuvant 5-fluorouracil plus levamisole in colon cancer: the plot thickens?
June 1994, British journal of cancer,
C G Moertel, and T R Fleming, and J S Macdonald, and D G Haller, and J A Laurie, and C M Tangen, and J S Ungerleider, and W A Emerson, and D C Tormey, and J H Glick
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.
March 2005, Journal of clinical oncology : official journal of the American Society of Clinical Oncology,
C G Moertel, and T R Fleming, and J S Macdonald, and D G Haller, and J A Laurie, and C M Tangen, and J S Ungerleider, and W A Emerson, and D C Tormey, and J H Glick
Consensus panel considers adjuvant therapy for colon and rectal cancer, identifies levamisole--fluorouracil as standard in colon cancer.
July 1990, Clinical pharmacy,
C G Moertel, and T R Fleming, and J S Macdonald, and D G Haller, and J A Laurie, and C M Tangen, and J S Ungerleider, and W A Emerson, and D C Tormey, and J H Glick
[Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer].
February 2012, Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],
C G Moertel, and T R Fleming, and J S Macdonald, and D G Haller, and J A Laurie, and C M Tangen, and J S Ungerleider, and W A Emerson, and D C Tormey, and J H Glick
Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer.
April 2011, Journal of clinical oncology : official journal of the American Society of Clinical Oncology,
C G Moertel, and T R Fleming, and J S Macdonald, and D G Haller, and J A Laurie, and C M Tangen, and J S Ungerleider, and W A Emerson, and D C Tormey, and J H Glick
Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma.
July 1990, The New England journal of medicine,
Copied contents to your clipboard!