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1 Indications And Usage Capecitabine Tablets Are A Nucleoside Metabolic Inhibitor With Antineoplastic Activity Indicated For: • Adjuvant Colon Cancer ( 1.1 ) • Patients With Dukes’ C Colon Cancer • Metastatic Colorectal Cancer ( 1.1 ) • First-Line As Monotherapy When Treatment With Fluoropyrimidine Therapy Alone Is Preferred • Metastatic Breast Cancer ( 1.2 ) • In Combination With Docetaxel After Failure Of Prior Anthracycline-Containing Therapy • As Monotherapy In Patients Resistant To Both Paclitaxel And An Anthracycline-Containing Regimen 1.1 Colorectal Cancer • Capecitabine Tablets Are Indicated As A Single Agent For Adjuvant Treatment In Patients With Dukes’ C Colon Cancer Who Have Undergone Complete Resection Of The Primary Tumor When Treatment With Fluoropyrimidine Therapy Alone Is Preferred. Capecitabine Tablets Were Non-Inferior To 5-Fluorouracil And Leucovorin (5-Fu/lv) For Disease-Free Survival (Dfs). Physicians Should Consider Results Of Combination Chemotherapy Trials, Which Have Shown Improvement In Dfs And Os, When Prescribing Single-Agent Capecitabine Tablets In The Adjuvant Treatment Of Dukes’ C Colon Cancer. • Capecitabine Tablets Are Indicated As First-Line Treatment Of Patients With Metastatic Colorectal Carcinoma When Treatment With Fluoropyrimidine Therapy Alone Is Preferred. Combination Chemotherapy Has Shown A Survival Benefit Compared To 5-Fu/lv Alone. A Survival Benefit Over 5-Fu/lv Has Not Been Demonstrated With Capecitabine Tablets Monotherapy. Use Of Capecitabine Tablets Instead Of 5-Fu/lv In Combinations Has Not Been Adequately Studied To Assure Safety Or Preservation Of The Survival Advantage. 1.2 Breast Cancer • Capecitabine Tablets In Combination With Docetaxel Are Indicated For The Treatment Of Patients With Metastatic Breast Cancer After Failure Of Prior Anthracycline-Containing Chemotherapy. • Capecitabine Tablets Monotherapy Is Also Indicated For The Treatment Of Patients With Metastatic Breast Cancer Resistant To Both Paclitaxel And An Anthracycline-Containing Chemotherapy Regimen Or Resistant To Paclitaxel And For Whom Further Anthracycline Therapy Is Not Indicated (E.g., Patients Who Have Received Cumulative Doses Of 400 Mg/m 2 Of Doxorubicin Or Doxorubicin Equivalents). Resistance Is Defined As Progressive Disease While On Treatment, With Or Without An Initial Response, Or Relapse Within 6 Months Of Completing Treatment With An Anthracycline-Containing Adjuvant Regimen.
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