Sunday, Jul 19, 2009
South San Francisco, Calif. -- July 19, 2009 --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.
About the Study
The NO16968 trial, also known as XELOXA (Phase III Xeloda with oxaliplatin (XELOX) vs. 5-FU/LV in Adjuvant colon cancer), is an open-label, randomized study of XELOX versus 5-fluorouracil/leucovorin (5-FU/LV) as adjuvant therapy for patients with stage III colon cancer who have undergone surgery and had no previous chemotherapy. The study included 1,886 patients and was conducted at 240 study sites across 29 countries. The primary objective of the study was to demonstrate the superiority of XELOX versus 5-FU/LV in terms of disease-free survival. Secondary endpoints included overall survival, safety profiles and perceived treatment convenience between the treatment arms.
XELOX is an abbreviation for a type of combination chemotherapy used to treat colorectal cancer; it contains Xeloda (capecitabine) plus oxaliplatin.
About XELODA (capecitabine)
Xeloda is the only FDA-approved oral chemotherapy for metastatic breast cancer, adjuvant colon cancer and metastatic colorectal cancer. Inactive in pill form, Xeloda is enzymatically activated within the body; when it comes into contact with a naturally occurring protein called thymidine phosphorylase, or TP, Xeloda is transformed into 5-FU, a cytotoxic (cell-killing) drug. Because many cancers have higher levels of TP than does normal tissue, more 5-FU is delivered to the tumor than to other tissue.
A clinically important drug interaction between Xeloda and warfarin has been demonstrated; altered coagulation parameters and/or bleeding and death have been reported. Clinically significant increases in prothrombin time (PT) and INR have been observed within days to months after starting Xeloda, and infrequently within one month of stopping Xeloda. For patients receiving both drugs concomitantly, frequent monitoring of INR or PT is recommended. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.
Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil, and in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. Xeloda is contraindicated in patients with severe renal impairment. For patients with moderate renal impairment, dose reduction is required.
The most common adverse events (20%) of Xeloda monotherapy were diarrhea, nausea, stomatitis and hand-foot syndrome. As with any cancer therapy, there is a risk of side effects, and these are usually manageable and reversible with dose modification or interruption.
For additional information please go to http://www.xeloda.com.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a wholly-owned member of the Roche Group, has headquarters in South San Francisco, Calif. For additional information about the company, please visit http://www.gene.com.