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Table 6 shows the adverse reactions occurring in5of patients from pooling the two phase 3 trials in first line metastatic colorectal cancerA total of 596 patients with metastatic colorectal cancer were treated with 1250 mg/m 2 twice a day of XELODA administered for 2 weeks followed by a 1-week rest periodand 593 patients were administered 5-FU and leucovorin in the Mayo regimen20 mg/m 2 leucovorin IV followed by 425 mg/m 2 IV bolus 5-FUon days 1-5every 28 daysIn the pooled colorectal database the median duration of treatment was 139 days for capecitabine-treated patients and 140 days for 5-FU/LV-treated patientsA total of 7813and 6311capecitabine and 5-FU/LVtreated patientsrespectivelydiscontinued treatment because of adverse reactions/intercurrent illnessA total of 82 deaths due to all causes occurred either on study or within 28 days of receiving study drug508.4patients randomized to XELODA and 325.4randomized to 5-FU/LV.

The dose reduction schedule for docetaxel when used in combination with XELODA for the treatment of metastatic breast cancer is shown in Table 3.

In both trialsoverall survivaltime to progression and response ratecomplete plus partial responseswere assessedResponses were defined by the World Health Organization criteria and submitted to a blinded independent review committeeIRCDifferences in assessments between the investigator and IRC were reconciled by the sponsorblinded to treatment armaccording to a specified algorithmSurvival was assessed based on a non-inferiority analysis.

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