Data Shows Oral Chemotherapy Is an Alternative to Standard IV Treatment

The FDA has approved Roche's Xeloda, an innovative oral chemotherapy, for the adjuvant treatment of patients with Dukes' C colon cancer.

Adjuvant chemotherapy is the standard treatment approach for Dukes' C colon cancer (cancer that has spread to the lymph nodes), where chemotherapy is given after the tumor has been surgically removed. This approval will now give patients who have undergone complete resection of their primary tumor the option of an oral chemotherapy when fluoropyrimidine therapy alone is preferred.

The adjuvant indication was based on data from the X-ACT (Xeloda in Adjuvant Colon Cancer Therapy) trial. This pivotal trial showed that Xeloda (capecitabine) met its primary endpoint of non-inferiority to 5-FU/LV for disease-free survival (DFS). At this time, neither Xeloda nor combination chemotherapy has been shown to prolong overall survival; combination chemotherapy has demonstrated an improvement in disease-free survival compared to 5-FU/LV.

Although intravenous 5-FU/LV (also known as the Mayo Clinic Regimen) has been the foundation of such treatment for 40 years, researchers have long recognized the need for more convenient treatment regimens. The Mayo Clinic intravenous regimen for colon cancer can require up to 30 clinic visits over the 24-week treatment course, compared to a minimum of eight visits for patients receiving Xeloda.