Study: Oral Xeloda is equivalent IV chemo in adjuvant colon cancer.

2004 JUL 7 - (NewsRx.com & NewsRx.net) -- Xeloda, an oral tablet, could replace the most widely-used intravenous (IV) chemotherapy for colon cancer, according to new results from a large international phase III study presented at the 40th annual American Society of Clinical Oncology (ASCO) meeting.

The X-ACT (Xeloda in adjuvant colon cancer therapy) study successfully met its primary endpoint in demonstrating that disease-free survival for Xeloda is at least equivalent to intravenous 5-fluorouracil/leucovorin (5-FU/LV), also known as the Mayo Clinic Regimen, in the adjuvant treatment of stage III colon cancer patients (or patients whose cancer has spread to the lymph nodes). The results show that treatment with Xeloda produced a 13% reduction in the risk of disease relapse or death from any cause when compared to intravenous 5-FU/LV. Xeloda also caused significantly fewer serious side effects, such as neutropenia and stomatitis compared to 5-FU/LV.

Hand-and-foot syndrome - a common toxicity seen with fluoropyrimidines - was significantly higher in the Xeloda arm in this study.

"This data shows the significant potential of Xeloda to treat more patients with early stage colon cancer," said Professor Jim Cassidy, cancer research U.K. professor of oncology and chair of medical oncology, Beatson Oncology Centre, and University of Glasgow in Glasgow, Scotland, and presenter of the X-ACT data at ASCO. He also said, "The results of the trial further justify the ongoing and planned adjuvant studies of Xeloda in combination with other chemotherapies and targeted therapies in the treatment of colorectal cancer."

While intravenous 5-FU/LV regimens have been the foundation of colon cancer treatment for 40 years, researchers have long noted the need for more convenient treatment regimens. Intravenous therapy for colon cancer negatively impacts patient convenience: the Mayo Clinic Regimen typically requires at least 30 clinic visits over the 24-week treatment course, compared to a minimum of 8 visits for patients receiving Xeloda.

Xeloda is currently indicated as first-line treatment of patients with metastatic colorectal cancer when treatment with fluoropyrimidine therapy alone is preferred. The X-ACT results will be submitted to the U.S. Food and Drug Administration to support the use of Xeloda in the adjuvant treatment setting later this year.

This international, randomized, open-label efficacy and safety study evaluated 1987 patients receiving 24 weeks of treatment with either Xeloda 1250 mg/m[superscript]2, ...