FOLINIC ACID AND 5-FLUOROURACIL AS ADJUVANT CHEMOTHERAPY IN COLON-CANCER

Background/Aims: Colon cancer is one of the major health problems in i ndustrialized countries, and its incidence appears to be increasing. S urgical resectability is the most important prognostic determinant, al though despite apparently curative surgery, recurrent tumors are commo n. Metastatic disease cannot be cured, and thus, there is a need for b etter adjuvant therapies. Methods: Two hundred and thirty-nine patient s with surgically resected colon cancer in Dukes' stage B2 or C were r andomly assigned to chemotherapy or observation alone to determine whe ther adjuvant chemotherapy could effectively reduce the rate of cancer recurrence. One hundred and twenty-one patients in stage B2 and 118 p atients in stage C were enrolled in the study. Adjuvant treatment cons isted of folinic acid 200 mg/m2, intravenously, plus 5-fluorouracil 40 0 mg/m2, intravenously, on days 1-5 every 4 weeks for 12 cycles. Resul ts: In stage B2, no significant difference between the adjuvant arm an d the observation arm was noted. In stage C, adjuvant chemotherapy pro duced an advantage over observation in terms of a reduction in cancer recurrence rate with prolongation of a disease-free interval (P = 0.00 16) and an improvement in overall survival (P = 0.0025). Conclusions: This study shows that folinic acid plus 5-fluorouracil adjuvant chemot herapy is effective in patients with surgically resected Dukes' stage C colon carcinoma.