Study evaluated the drug in combination with oxaliplatin in stage III patients.
New Phase III trial data suggests giving colon cancer patients Roche’s oral anticancer drug Xeloda in combination with intravenous oxaliplatin immediately after surgery boosts disease-free survival compared with combined postsurgery chemotherapy using 5-fluorouracil/leucovorin.
The open-label international trial included 1,886 patients with stage III colon cancer who underwent surgery for their cancer. Roche says that it plans to use this data to apply for an extension to the Xeloda label.
Xeloda was first approved as first-line monotherapy for metastastic colorectal cancer in the U.S. and EU in 2001. Since then the drug has been sanctioned in a number of other countries for use as either monotherapy or in combination with other chemotherapies for the treatment of metastatic colorectal, breast, and pancreatic cancers, as well as advanced gastric cancer.
In 2008 Xeloda represented Roche’s eight best-selling pharmaceutical, with sales for that year reaching CHF 1.2 billion ($1.12 billion), up 13% from 2007. Growth in Japan was particularly strong, with sales in this market up 74%.
