Abstract
Due to uncertainties regarding clinically meaningful gains from adjuvant chemotherapy after colorectal cancer surgery,several Nordic Groups in the early 1990s initiated randomised trials to prove or reject such gains. This report gives the jointanalyses after a minimum 5-year follow-up. Between October 1991 and December 1997, 2 224 patients under 76 years ofage with colorectal cancer stages II and III were randomised to surgery alone (n = 1 121) or adjuvant chemotherapy(n = 1 103) which varied between trials (5FU/levamisole for 12 months, n = 444; 5FU/leucovorin for 4–5 months accordingto either a modified Mayo Clinic schedule (n = 262) or the Nordic schedule (n = 397). Some centres also randomisedpatients treated with 5FU/leucovorin to ± levamisole). A total of 812 patients had colon cancer stage II, 708 colon cancerstage III, 323 rectal cancer stage II and 368 rectal cancer stage III. All analyses were according to intention-to-treat. Nostatistically significant difference in overall survival, stratified for country or region, could be found in any group of patientsaccording to stage or site. In colon cancer stage III, an absolute difference of 7% (p = 0.15), favouring chemotherapy, wasseen. The present analyses corroborate a small but clinically meaningful survival gain from adjuvant chemotherapy in coloncancer stage III, but not in the other presentations.
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