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XELODA is indicated as a single agent for adjuvant treatment in patients with DukesC colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferredXELODA was non-inferior to 5-fluorouracil and leucovorin5-FU/LVfor disease-free survivalDFSPhysicians should consider results of combination chemotherapy trialswhich have shown improvement in DFS and OSwhen prescribing single-agent XELODA in the adjuvant treatment of DukesC colon cancerXELODA is indicated as first-line treatment of patients with metastatic colorectalcarcinoma when treatment with fluoropyrimidine therapy alone is preferredCombination chemotherapy has shown a survival benefit compared to 5-FU/LV aloneA survival benefit over 5-FU/LV has not been demonstrated with XELODA monotherapyUse of XELODA instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.

The baseline demographics for XELODA and 5-FU/LV patients are shown in Table 13.

Table 17 Efficacy of XELODA and Docetaxel Combination vs Docetaxel Monotherapy.

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