XELODA (capecitabine) is 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 XELODA (capecitabine) monotherapy.
5-Fluorouracil has been a mainstay in the treatment of colorectal cancer for nearly five decades; however, the use of oral formulations of the medication has been gaining since capecitabine was approved for use in adjuvant settings by the US Food and Drug Administration in 2005. The use of capecitabine has become popular in a number of off-label indications, including the treatment of advanced or metastatic colorectal cancer and the neoadjuvant treatment of rectal cancer. Increasing evidence suggests that capecitabine is noninferior as monotherapy and in combination with oxaliplatin when compared to 5-FU in the advanced and metastatic settings.
NCCN on p. REC-1 lists capecitabine alone for patients not appropriate for agressive therapy.
Anna Pessino, Alberto Sobrero Optimal treatment of metastatic colorectal cancer Expert Review of Anticancer Therapy 2006 6:5, 801-812
Dan S. Zuckerman, Jeffrey W. Clark Systemic therapy for metastatic colorectal cancer Cancer
nccn.org, 2011, REC-E, 2