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3American Society of Health-System PharmacistsASHP Guidelines on Handling Hazardous DrugsAm J Health-Syst Pharm2006;63:1172-1193.

Table 6 Pooled Phase 3 Colorectal TrialsPercent Incidence of Adverse Reactions in5of Patients.

Figure 3 Kaplan-Meier Curve for Overall Survival of Pooled DataStudies 1 and 2)

Among the 67 patients60 years of age receiving XELODA in combination with docetaxelthe incidence of grade 3 or 4 treatment-related adverse reactionstreatment-related serious adverse reactionswithdrawals due to adverse reactionstreatment discontinuations due to adverse reactions and treatment discontinuations within the first two treatment cycles was higher than in the 2daydisturbed estrus and consequently caused a decrease in fertilityIn mice that became pregnantno fetuses survived this doseThe disturbance in estrus was reversibleIn malesthis dose caused degenerative changes in the testesincluding decreases in the number of spermatocytes and spermatidsIn separate pharmacokinetic studiesthis dose in mice produced 5DFUR AUC values about 0.7 times the corresponding values in patients administered the recommended daily dose.

Capecitabine is extensively metabolized enzymatically to 5-FUIn the livera 60 kDa carboxylesterase hydrolyzes much of the compound to 5deoxy-5-fluorocytidine5DFCRCytidine deaminasean enzyme found in most tissuesincluding tumorssubsequently converts 5DFCR to 5DFURThe enzymethymidine phosphorylasedThdPasethen hydrolyzes 5DFUR to the active drug 5-FUMany tissues throughout the body express thymidine phosphorylaseSome human carcinomas express this enzyme in higher concentrations than surrounding normal tissuesFollowing oral administration of XELODA 7 days before surgery in patients with colorectal cancerthe median ratio of 5-FU concentration in colorectal tumors to adjacent tissues was 2.9range from 0.9 to 8.0These ratios have not been evaluated in breast cancer patients or compared to 5-FU infusion.

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