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• W2068128522 abstract "In Brief Background: The benefit of adjuvant therapy in curatively resected lymph node-positive colon cancer was established using 5-fluorouracil (5-FU) and levamisole (LEV) for 12 months. 5-FU cytotoxicity can be modulated by folinic acid (FA) or interferon-α (INF-α). The aim of this study was to investigate the efficacy of modulating 5-FU+ LEV by either FA or IFN-α in the adjuvant treatment of high-risk colon cancer. Methods: Patients with curatively resected colon cancer (stages UICC IIb and III) were stratified according to T, N, and participating center and randomized to receive a 12-month treatment using 5-FU + LEV alone or in combination with FA or IFN-α. Results: A total of 855 of 904 entered patients (94.6%) were eligible. The median follow-up of all eligible patients was 4.6 years. Addition of FA to 5-FU + LEV improved recurrence-free and overall survival in comparison with 5-FU + LEV alone (P = 0.007 and P = 0.004, respectively, 1-sided). The 5-year overall survival rates were 60.5% (95% confidence interval, 54.3–66.7) and 72.0% (95% confidence interval, 66.5–77.5) for 5-FU + LEV and 5-FU + LEV + FA, respectively. Addition of INF-α showed a tendency to improve recurrence-free survival, however, without altering overall survival. Toxicities (WHO III + IV) were generally tolerable except one toxic death in the control arm and were observed in 9.9% of the patients receiving 5-FU + LEV alone and in 13.3% and in 30.7% of patients receiving additional FA and IFN-α, respectively. Conclusions: Addition of IFN-α was associated with increased toxicity without markedly influencing the outcome and should therefore not be recommended for adjuvant treatment. Addition of FA increased the 5-year recurrence-free and overall survival rate by 9.3 and 11.5 percentage points, respectively. 5-FU + LEV + FA for 12 months may be an effective adjuvant treatment option for locally advanced high-risk colon cancer. For more than a decade, standard adjuvant treatment of locally advanced colon cancer consisted of 5-fluorouracil and levamisol for 12 months. In the largest German adjuvant trial, we now demonstrate that addition of folinic acid to 5-fluorouracil + levamisole for 12 months increased the 5-year recurrence-free and overall survival rate by 9.3 and 11.5 percentage points, respectively. These results suggest that addition of folinic acid to 5-fluorouracil for 12 months can improve the outcome of adjuvant treatment of colon cancer." @default.
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• W2068128522 date "2005-08-01" @default.
• W2068128522 modified "2023-10-10" @default.
• W2068128522 title "Increase of Survival Benefit in Advanced Resectable Colon Cancer by Extent of Adjuvant Treatment" @default.
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• W2068128522 doi "https://doi.org/10.1097/01.sla.0000171033.65639.a9" @default.
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