Objective: to analyze clinical effectivity of chemotherapy based on Irinotecan, 5-Fluorouracyl and Folinic acid in patients with colorectal carcinoma.
Methods: prospective, randomized, open-label trial in group of 204 patients with advanced colorectal cancer randomized to either chemotherapy with irinotecan+5-FU+leucovorin or supportive care alone (control group) between January 1999--January 2005 was performed. Efficacy and safety of treatment was analysed.
Results: Administration of the irinotecan, 5FU, LV regimen to patients with stages II and III significantly improved 5-year survival (81% versus 66% and 66% versus 38%, respectively; p < 0.05). Palliative chemotherapy improved survivals also in stage IV, four patients survived 5 years. Adverse event occurred in 44 of 102 patients (43.1%).
Conclusions: study confirms benefits of irinotecan chemotherapy administered to patients with advanced colorectal cancer. Preliminary data suggests that this chemotherapy regimen should be considered for first-line therapy in the adjuvant and palliative treatment of advanced colorectal cancer.