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Clinical Trial
. 2007 Oct 22;97(8):1021-7.
doi: 10.1038/sj.bjc.6604011. Epub 2007 Sep 25.

A prospective randomised phase III trial of adjuvant chemotherapy with 5-fluorouracil and leucovorin in patients with stage II colon cancer

W Schippinger  1 , H Samonigg, R Schaberl-Moser, R Greil, R Thödtmann, J Tschmelitsch, M Jagoditsch, G G Steger, R Jakesz, F Herbst, F Hofbauer, H Rabl, P Wohlmuth, M Gnant, J Thaler; Austrian Breast and Colorectal Cancer Study Group
Affiliations
Clinical Trial

A prospective randomised phase III trial of adjuvant chemotherapy with 5-fluorouracil and leucovorin in patients with stage II colon cancer

W Schippinger et al. Br J Cancer. .

Abstract

The purpose of this trial was to investigate the efficacy of adjuvant chemotherapy with 5-fluorouracil (5-FU) and leucovorin (LV) in stage II colon cancer. Patients with stage II colon cancer were randomised to either adjuvant chemotherapy with 5-FU/LV (100 mg m(-2) LV+450 mg m(-2) 5-FU weekly, weeks 1-6, in 8 weeks cycles x 7) or surveillance only. Five hundred patients were evaluable for analyses. After a median follow-up of 95.6 months, 55 of 252 patients (21.8%) have died in the 5-FU/LV arm and 58 of 248 patients (23.4%) in the surveillance arm. There was no statistically significant difference in overall survival (OS) between the two treatment arms (hazard ratios, HR 0.88, 95% CI 0.61-1.27, P=0.49). The relative risk for tumour relapse was higher for patients on the surveillance arm than for those on the 5-FU/LV arm; however, this difference was not statistically significant (HR 0.69, 95% CI 0.45-1.06, P=0.09). Consequently, disease-free survival (DFS) was not significantly different between the two trial arms. In conclusion, results of this trial demonstrate a trend to a lower risk for relapse in patients treated with adjuvant 5-FU/LV for stage II colon cancer. However, in this study with limited power to detect small differences between the study arms, adjuvant chemotherapy failed to significantly improve DFS and OS.

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Figures

Figure 1
Figure 1
Relapse-free survival: adjuvant chemotherapy with 5-fluorouracil (5-FU)/leucovorin (LV) vs surveillance.
Figure 2
Figure 2
Overall survival: adjuvant chemotherapy with 5-fluorouracil (5-FU)/leucovorin (LV) vs surveillance.
Figure 3
Figure 3
Cancer-specific survival: adjuvant chemotherapy with 5-fluorouracil (5-FU)/leucovorin (LV) vs surveillance.
See this image and copyright information in PMC

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