Ineffectiveness of levamisole as adjuvant to surgery with two lines of transplanted rat colonic carcinoma

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.

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Levamisole/Fluorouracil

Chrisp¹,

McTavish²

1991

Drugs & Aging

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The combination of the antimetabolite fluorouracil plus the immunomodulator levamisole is used as adjuvant therapy following surgical tumour removal in patients with Dukes' stage C colon cancer. Fluorouracil given alone in this setting results in only a modest improvement in survival rate, and levamisole monotherapy is clinically ineffective. Well controlled studies, however, demonstrate that combined levamisole/fluorouracil reduces the recurrence rate by between 31 and 41% and the total mortality rate by between 13 and 33% compared with surgery alone in patients with Dukes' stage C colon cancer after median follow-up of 3 or 7.75 years. The median time to recurrence and median survival time are also extended significantly by levamisole/fluorouracil compared with fluorouracil alone or no adjuvant treatment. Thus, levamisole/fluorouracil has been recommended as the standard adjuvant therapy for patients with Dukes' C colon cancer, against which new investigative regimens should be compared. Methods for optimising the impressive results already achieved with this combination, and using this as a basis for further progress should be the thrust of future trials.

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Ineffectiveness of levamisole as adjuvant to surgery with two lines of transplanted rat colonic carcinoma

Cited by 3 publications

References 8 publications

Adjuvant Therapy in Colorectal Cancer

Adjuvant Therapy in Colorectal Cancer

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.

Levamisole/Fluorouracil

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