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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This study evaluated combined 5-fluorouracil (5FU) and doxorubicin as postoperative adjuvant chemotherapy for patients who had undergone potentially curative resection of a primary gastric adenocarcinoma. One hundred twenty-five eligible and evaluable patients were stratified according to extent of surgical resection, location of the primary tumor within the stomach, and lymph node status. They were then randomized to either receive three cycles of chemotherapy or be observed. The median time from patient entry was 7 years. Results showed no significant difference in time to recurrence. The 5-year survival rate was 33% for the observation arm and 32% for the adjuvant therapy arm. The data excluded a 16% improvement in the 5-year survival rate for patients receiving chemotherapy with a P value less than 0.05. There were two drug-related fatalities due to sepsis. These results demonstrate no substantive benefit for this chemotherapy regimen as postoperative adjuvant treatment of resected gastric cancer.

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