3501 Background: MOSAIC trial was designed to demonstrate an increase in Disease Free Survival (DFS) in stage II and III colon cancer. Methods: 2246 patients with completely resected stage II (40%) or III (60%) colon cancer were randomly assigned to receive LV5FU2 or FOLFOX4 every 2 weeks for 12 cycles. Results: Final results of the study have been reported for the overall population, with a median follow-up (mFUP) of 3 years (Andre et Al, NEJM, 2004). With a mFUP of 4 years (48.6 months), a 24% reduction in the relative risk of relapse was observed with the FOLFOX4 combination in the overall population (p=0.0008). For stage III patients, the probability of remaining disease free at 4 years is 61.0% in the LV5FU2 arm and 69.7% in the FOLFOX4 arm, translating into a relative risk reduction of 25% in this subset of patients For stage II patients, 4-year DFS was 81.3% in the LV5FU2 arm versus 85.1% in the FOLFOX4 arm (relative risk reduction of 20%). In the overall population, 84.3% and 82.7% patients are still alive respectively in the FOLFOX4 and LV5FU2 arms. Follow-up is ongoing for a minimum of 5 years for each patient for final survival analysis. After mFUP of 4 years, about 3% (3.4%) of patients presented either with persisting localized paresthesias of moderate intensity (2.7%) or with paresthesias that may interfere with functional activities (0.7%). Conclusions: Based on these results, FOLFOX4 is now a standard treatment for patients with early stage colon cancer. No significant financial relationships to disclose.
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Gramont et al. (2005) studied this question.