The following table and figures summarize the disease-free survival (DFS) results in the overall randomized population and in patients with stage II and III disease based on an ITT analysis.

Table 18 - Summary of DFS analysis [ITT analysis (minimumfollow-up of 41 months)]

In the overall study population DFS was statistically significantly improved in the ELOXATIN combination armcompared to infusional 5-FU/LV alone. A statistically significant improvement in DFS was noted in Stage III patients, but not in Stage II patients.

Figure 2 shows the Kaplan-Meier DFS curves for the comparison of ELOXATIN and infusional 5-FU/LV combination and infusional 5-FU/LV alone for the overall population (ITT analysis). Figure 3 shows the Kaplan-Meier DFS curves for the comparison of ELOXATIN and infusional 5-FU/LV combination and infusional 5-FU/LV alone for the Stage III Subgroup.

Figure 2 - Kaplan-Meier DFS curves by treatment armfor Overall Population

Figure 3 - Kaplan-Meier DFS curves by treatment armfor Stage III Subgroup

Survival data were not mature at the time of the analysis with a median follow-up of 47 months. No statistically significant difference in overall survival [Hazard Ratio 0.89 (95% CI 0.72, 1.09) p=0.236] was shown between the two treatment arms in the entire population or in the Stage II [Hazard Ratio 0.98 (95% CI 0.63, 1.53) p=0.94] or Stage III [Hazard Ratio 0.86 (95%CI 0.68, 1.08) p=0.196] subgroups.

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