Fluorouracil plus Levamisole as Effective Adjuvant Therapy after Resection of Stage III Colon Carcinoma: A Final Report
Publication: Annals of Internal Medicine
Volume 122, Number 5
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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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Information & Authors
Information
Published In
Annals of Internal Medicine
Volume 122 • Number 5 • 1 March 1995
Pages: 321 - 326
History
Published in issue: 1 March 1995
Published online: 15 August 2000
Keywords
Copyright
© 1995 American College of Physicians.
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Fluorouracil plus Levamisole as Effective Adjuvant Therapy after Resection of Stage III Colon Carcinoma: A Final Report. Ann Intern Med.1995;122:321-326. doi:10.7326/0003-4819-122-5-199503010-00001
Fluorouracil plus Levamisole as Effective Adjuvant Therapy after Resection of Stage III Colon Carcinoma: A Final Report. Ann Intern Med.1995;122:321-326. doi:10.7326/0003-4819-122-5-199503010-00001
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