Fluorouracil plus levamisole as effective adjuvant therapy after resection of stage III colon carcinoma: a final report.
Ann Intern Med
; 122(5): 321-6, 1995 Mar 01.
Article
in En
| MEDLINE
| ID: mdl-7847642
ABSTRACT
OBJECTIVE:
To determine the effectiveness of two adjuvant therapy regimens in improving surgical cure rates in stage III (Dukes stage C) colon cancer.DESIGN:
Randomized, concurrently controlled clinical trial.SETTING:
Major cancer centers, universities, and community clinics affiliated with the North Cancer Treatment Group, the Southwest Oncology Group, and the Eastern Cooperative Oncology Group. PATIENTS Those who had had curative-intent resections of stage III colon cancer in the previous 1 to 5 weeks. INTERVENTION Patients were assigned to observation only, to levamisole alone (50 mg orally three times/d for 3 days, repeated every 2 weeks for 1 year), or to this regimen of levamisole plus fluorouracil (450 mg/m2 body surface area intravenously daily for 5 days and then, beginning at 28 days, weekly for 48 weeks). MEASUREMENTS Rates of cancer recurrence and death. Early- and late-treatment side effects.RESULTS:
With all 929 eligible patients able to be followed for 5 years or more (median follow-up, 6.5 years), fluorouracil plus levamisole reduced the recurrence rate by 40% (P < 0.0001) and the death rate by 33% (P = 0.0007). Levamisole reduced the recurrence rate by only 2% and the death rate by only 6%. With few exceptions, toxicity was mild and patient compliance was excellent. No evidence of late side effects was seen.CONCLUSION:
Fluorouracil plus levamisole is tolerable adjuvant therapy to surgery; it has been confirmed to substantially increase cure rates for patients with high-risk (stage III) colon cancer. It should be considered standard treatment for all such patients not entered into clinical trials.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Antineoplastic Combined Chemotherapy Protocols
/
Levamisole
/
Colonic Neoplasms
/
Fluorouracil
Type of study:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Female
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
Ann Intern Med
Year:
1995
Document type:
Article