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

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