Background: Adjuvant postoperative treatment with 5-fluo-rouracil (5-FU) and levamisole in curatively resected stage III colon cancer significantly reduces the risk of cancer recurrence. Biochemical modulation of (5-FU) with leucovorin improves remission rates in metastatic colon cancer. Patients and Methods: Therefore, the effectiveness and toxicity of 5-FU (400 mg/m2 in the first chemotherapy course, then 450 mg/ m2×5 d; 12 cycles, arm A) and leucovorin (100 mg/m2) were compared with 5-FU/levamisole (Moertel scheme; arm B) in patients with a curative resection of a stage III colon cancer in a prospective multicentric trial. Randomization was stratified according to T, N and G stage. Results: 703 patients were entered into this study. The interval between surgery and start of therapy was 29 and 31 days (arm A and B, respectively). Adjuvant chemotherapy with 5-FU/levamisole as well as with 5-FU/leucovorin was generally well tolerated. Grade 3 or 4 toxic effects were documented in 3.5 to 8.3% of all chemotherapy cycles. Conclusion: This interim analysis demonstrates that both chemotherapy schedules can be used in the adjuvant setting because of a low percentage of moderate to severe side effects. These interim results constitute the basis for a new multicentric adjuvant trial evaluating the impact of chemotherapy on tumor recurrence with high-dose 5-FU/leucovorin and of monotherapy with high-dose 5-FU in comparison to 5-FU/leucovorin given for 5 days every 4 weeks.

Keywords:
Adjuvant chemotherapy, 5-Fluorouracil, Leucovorin Levamisole, Colon cancer
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© 1997 S. Karger AG, Basel
1997
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