In 251 patients with metastatic breast cancer who received a combination of xeloda and docetaxel, grade 3 1.

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Figure 2 Kaplan-Meier Estimates of Overall SurvivalAll Randomized Population)

Table 19 Response Rates in Doubly-Resistant Patients Single-Arm Breast Cancer Trial.

Based on postmarketing reportspatients with certain homozygous or certain compound heterozygous mutations in the DPD gene that result in complete or near complete absence of DPD activity are at increased risk for acute early-onset of toxicity and severelife-threateningor fatal adverse reactions caused by XELODAe.gmucositisdiarrheaneutropeniaand neurotoxicityPatients with partial DPD activity may also have increased risk of severelife-threateningor fatal adverse reactions caused by XELODA.

This drug contains lactosemilk sugarIf you have an intolerance to lactosecontact your doctor before taking this medicine.

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XELODAcapecitabineis a fluoropyrimidine carbamate with antineoplastic activityIt is an orally administered systemic prodrug of 5deoxy-5-fluorouridine5DFURwhich is converted to 5fluorouracil.

Figure 4 Kaplan-Meier Estimates for Time to Disease Progression XELODA and Docetaxel vs Docetaxel.

Care should be exercised in the handling of XELODAXELODA tablets should not be cut or crushedProcedures for the proper handling and disposal of anticancer drugs should be consideredAny unused product should be disposed of in accordance with local requirementsor drug take back programsSeveral guidelines on the subject have been published.

Figure 1 Kaplan-Meier Estimates of Disease-Free SurvivalAll Randomized Population)

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XELODA in combination with docetaxel was assessed in an open-labelmulticenterrandomized trial in 75 centers in EuropeNorth AmericaSouth AmericaAsiaand AustraliaA total of 511 patients with metastatic breast cancer resistant toor recurring during or after an anthracycline-containing therapyor relapsing during or recurring within 2 years of completing an anthracycline-containing adjuvant therapy were enrolledTwo hundred and fifty-five255patients were randomized to receive XELODA 1250 mg/m 2 twice daily for 14 days followed by 1 week without treatment and docetaxel 75 mg/m 2 as a 1hour intravenous infusion administered in 3-week cyclesIn the monotherapy arm256 patients received docetaxel 100 mg/m 2 as a 1-hour intravenous infusion administered in 3-week cyclesPatient demographics are provided in Table 16.

Metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel when further anthracycline therapy is not indicatedegprior cumulative doses of 400mg/m 2 of doxorubicin or its equivalentsWith docetaxel for metastatic breast cancer after failure of prior anthracycline-containing regimen.

XELODA can cause fetal harm when administered to a pregnant womanCapecitabine at doses of 198 mg/kg/day during organogenesis caused malformations and embryo death in miceIn separate pharmacokinetic studiesthis dose in mice produced 5DFUR AUC values about 0.2 times the corresponding values in patients administered the recommended daily doseMalformations in mice included cleft palateanophthalmiamicrophthalmiaoligodactylypolydactylysyndactylykinky tail and dilation of cerebral ventriclesAt doses of 90 mg/kg/daycapecitabine given to pregnant monkeys during organogenesis caused fetal deathThis dose produced 5DFUR AUC values about 0.6 times the corresponding values in patients administered the recommended daily dose.

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xeloda capecitabine belongs to the group of medicines called antimetabolites.