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SUMMARY: The role of fluorouracil and folinic acid and adjuvant therapy for colon cancer is not clear.We undertook independently three randomised trials to find out the efficacy of fluorouracil and high-dose folinic acid after surgery for Dukes' B and C stage colon cancer. The three studies by the Gruppo Interdisciplinare Valutazione Interventi Oncologia (GIVIO), the National Cancer Institute Canada Clinical Trials Group (NCIC-CTG), and the Fondation Francaise de Cancerologie Digestive (FFCD) were pooled for combined analysis.

Each trial was multicentre and used the same treatment regimen (fluorouracil 370-400 mg/m2 plus folinic acid 200 mg/m2 daily for 5 days, every 28 days for 6 cycles). A pooled analysis of the results was done on the basis of a previously agreed protocol when there were sufficient events to detect at least a 10% reduction in mortality with 80% power. 1526 patients with resected B (56%) and C (44%) carcinoma of the colon were enrolled and 1493 were confirmed as eligible. 736 were assigned to the treatment group and 757 to the control group. Fluorouracil/folinic acid significantly reduced mortality by 22% (95% CI 3-38; p=0.029) and events by 35% (22-46; p<0.0001), increasing 3-year event-free survival from 62% to 71% and overall survival from 78% to 83%. Compliance with treatment was good; more than 80% of patients completed the planned treatment. Side-effects were clinically acceptable with only 1 treatment-related death. The commonest side-effects were gastrointestinal, but severe toxic effects (WHO grade 4) occurred in fewer than 3% of cases.

We conclude that fluorouracil plus high-dose folinic acid is a well-tolerated and effective 6-month adjuvant regimen for colon cancer.

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