Comparison of adjuvant FOLFOX4 chemotherapy and oral UFUR/LV following adjuvant FOLFOX4 chemotherapy in patients with stage III colon cancer subsequent to radical resection.

The present study aimed to demonstrate the potential advantage of oral uracil-tegafur (UFUR)/leucovorin (LV) as the subsequent therapy in patients with stage III colon cancer following adjuvant LV, 5-fluorouracil and oxaliplatin (FOLFOX4) chemotherapy. Of a total 143 patients, 62 patients received only FOLFOX adjuvant chemotherapy (FOLFOX4 biweekly x 12 cycles for 6 months), and 81 patients received FOLFOXU adjuvant treatment (which consisted of FOLFOX4 biweekly x 12 cycles for 6 months followed by oral UFUR/LV for an additional 6 months). The 3-year disease-free survival (DFS) rate of the FOLFOXU group was 74.3%; which was superior to that of the FOLFOX4 group (59.9%). The average DFS time of the FOLFOXU group was superior to that of the FOLFOX4 group (P=0.003). The 5-year overall survival (OS) rate of the FOLFOXU group was 76.9%, which was also superior to that of the FOLFOX4 group (63.8%). The average OS time of patients in the FOLFOXU group was longer than that of the patients in the FOLFOX4 group (hazard ratio, 0.155; 95% confidence interval, 0.054-0.450; P=0.001). In comparison to the FOLFOX regimen, the FOLFOXU regimen achieved a more favorable response and survival time without a significant increase of toxicities in patients with stage III colon cancer as the adjuvant chemotherapy.