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1Clinical Oncology and Nuclear Medicine, 2Gastro-entrology, Faculty of Medicine, Mansoura University, Egypt. ABSTRACT Introduction: Fluorouracil and leucovorin has been accepted as the standard adjuvant therapy in colon cancer for many years. The aim is to demonstrate the benefit from addition of oxaliplatin to infusional fluorouracil plus leucovorin as adjuvant therapy for stage III and high risk stage II colon cancer. Patients and Methods: From April 2005 to Marsh 2006, 100 patients who had undergone curative surgery for colon cancer, stage III or high risk stage II disease, were randomized to receive either 2-hour intravenous infusion of 200 mg/ m2 of leucovorin followed by bolus of 400 mg/m2 of fluorouracil and then 22-hour infusion of 600 mg/m2 of fluorouracil on 2 consecutive days every 14 days, for 12 cycles (50 patients) or receive the same regimen with oxaliplatin, 85 mg/ m2 as two-hour infusion concurrent with leucovorin on day 1(50 patients). Results: Eight patients in the group received oxaliplatin (16.7%) had relapsed as compared with 18 patients (36%) in the group received fluorouracil plus leucovorin without oxaliplatin, the difference was statistically significant (P=0.03). The disease-free survival was higher in the group of patients received oxaliplatin than in the Group of patients received fluorouracil plus leucovorin without oxaliplatin, (P=0.03). Overall survival was not statistically different between the two groups (P=0.14). The incidence of neutropenia and neurosensory symptoms were statistically significantly higher with oxaliplatin. Conclusions: Patients with stage III and high-risk stage II colon cancer obtain benefit from the addition of oxaliplatin to infusional fluorouracil plus leucovorin.

ADJUVANT INFUSIONAL FLUOROURACIL AND LEUCOVORIN WITH OR WITHOUT OXALIPLATIN IN TREATMENT OF STAGE II AND III COLON CANCER