Genentech, Inc. announced today that an international Phase III study demonstrated that oral Xeloda® plus oxaliplatin (XELOX) is superior to a commonly used intravenous chemotherapy, 5-FU/LV (infused 5-fluorouracil plus leucovorin), in increasing the time people with adjuvant colon cancer lived without their cancer returning when given immediately after surgery.
The data show those who participated in the study and took XELOX immediately after surgery lived longer without their cancer being detectable than those who took intravenous 5U/LV. No new adverse events related to Xeloda were observed in the study.
Data from the trial will be submitted for presentation at upcoming international scientific meetings. Xeloda is currently the only FDA-approved oral chemotherapy for metastatic breast cancer, adjuvant (Dukes' C) colon cancer and metastatic colorectal cancer.
"We now have compelling evidence that combining Xeloda and oxaliplatin may offer a new option which could help prevent colon cancer from returning," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. "These data further support Xeloda as an important cornerstone for treating different types of colon and breast cancer."
Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S., responsible for an estimated 49,960 deaths in 2008. The American Cancer Society estimated that approximately 108,070 new cases of colon cancer and 40,740 new cases of rectal cancer were diagnosed last year. When colorectal cancer is detected at an early, localized stage, the five-year survival is 90 percent; however, only 39 percent of colorectal cancers are diagnosed at this stage, mostly due to low rates of screening. Patients with stage IV metastatic colorectal cancer have a five-year survival rate of 8 percent.