A randomised phase III intergroup trial comparing high-dose infusional 5-fluorouracil with or without folinic acid with standard bolus 5-fluorouracil/folinic acid in the adjuvant treatment of stage III colon cancer: The Pan-European Trial in Adjuvant Colon Cancer 2 study

作者：Koehne Claus Henning; Bedenne Laurent; Carrato Alfredo; Bouche Olivier; Popov Ivan; Gaspa Losa; Valladares Manuel; Rougier Phillipe; Gog Christiane; Reichardt Peter; Wils Jacques; Pignatti Francesco; Biertz Frank

来源：European Journal of Cancer, 2013, 49(8): 1868-1875.

DOI：10.1016/j.ejca.2013.01.030

• Colon cancer
• Adjuvant treatment
• 5-Flurouracil
• Bolus
• Infusional
• High-dose

Purpose: To investigate whether infusional high-dose 5-flurouracil(HD-FU) provides a significant improvement in recurrence-free survival (RFS) and overall survival (OS) compared with a standard bolus 5-FU regimen (Mayo Clinic) inpatients with curatively resectable stage III colon cancer. %26lt;br%26gt;Methods: Patients (n = 1601) were randomised to receive either the Mayo Clinic regimen or one of the three HD-FU regimens; LV5FU2, the Arbeitsgemeinschaft Internistische Onkologie (AIO) orthe Grupo Espanol para el Tratamiento Digestivos (TTD), the data from which were combined to provide the HD-FU arm for final analysis. %26lt;br%26gt;Results: Patients were evenly balanced for age, TMN, tumor grade and vascular and lymphatic invasion. Median follow-up was approximately 42 months, RFS (hazard ratio [ HR] = 0.997) and OS(HR = 0.96)(primary end-point) were not statistically different between the two treatment arms. Infusional HD-FU was generally better tolerated than bolus 5-FU regimen. %26lt;br%26gt;Conclusions: Infusional HD-FU does not improve RFS and OS in curatively resected stage III colon cancer patients compared to the Mayo Clinic regimen, but is less toxic.

• 出版日期2013-5