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A prospective randomised phase III trial of adjuvant chemotherapy with 5-fluorouracil and leucovorin in patients with stage II colon cancer
British Journal of Cancer, 09/26/07

Schippinger, W., et al. - In a trial to investigate the efficacy of adjuvant chemotherapy with 5-fluorouracil (5-FU) and leucovorin (LV) in stage II colon cancer, results demonstrate a trend to a lower risk for relapse in patients treated with adjuvant 5-FU/LV, but with limited power to detect small differences between the study arms, adjuvant chemotherapy failed to improve disease-free survival (DFS) and overall survival (OS)

Methods

Patients with stage II colon cancer were randomised to either adjuvant chemotherapy with 5-FU/LV or surveillance only
500 patients were evaluable for analyses

Results

After a median of 95.6 months, 21.8% of patients in the 5-FU/LV arm and 23.4% in the surveillance arm died
There was no statistically significant difference in OS between the 2 treatment arms
The relative risk for tumour relapse was higher for patients on the surveillance arm than for those on the 5-FU/LV arm, but the difference was not statistically significant
Thus, DFS was not significantly different between the 2 trial arms

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