To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Canada Approves Oral Chemotherapeutic Agent, Xeloda (Capecitabine) For Colorectal Cancer URL: http://www.pslgroup.com/dg/1E8026.htm Doctor's Guide October 25, 2000
OTTAWA, ON -- October 25, 2000 -- Xeloda® (capecitabine), Canada's first oral chemotherapy for treatment of patients with metastatic colorectal cancer, has been approved by Health Canada for first-line use in patients with colorectal cancer that has spread to other organs or grown inoperable beyond the colon wall. Its oral formulation means patients do not have to travel to a clinic or hospital for daily intravenous treatment. Colorectal cancer is the second leading cause of cancer deaths in Canada and the third most common cancer, representing 10 to 15 per cent of newly diagnosed cases. According to the National Cancer Institute of Canada, each year approximately 17,000 new cases of colorectal cancer are reported and 6,500 Canadians die from the disease. Xeloda has shown to have superior efficacy in terms of tumour response rates and has a significantly improved safety profile over the Mayo Clinic regimen, which is a standard care for the treatment of colorectal cancer. In clinical trials, Xeloda was well tolerated and caused minimal hair loss, bone marrow depression and a significantly lower incidence of treatment-related hospitalizations compared to standard intravenous therapy. "I speak to people with colorectal cancer on a daily basis," says Barry Stein, President of the Colorectal Cancer Association of Canada, "and many patients tell me about their experiences and how they are battling their disease. New treatments that reduce the effects from chemotherapy without tying the patient to a clinic and make it easier for patients to receive treatment are certainly welcome." Xeloda's ability to provide efficacy with fewer side effects may be attributed to its unique mechanism of action. "Xeloda is preferentially tumour- activated, remaining mostly inactive until it enters the tumour site," explains Dr. Jean Maroun, Professor of Medicine at the University of Ottawa and Head of Medical Oncology at the Ottawa Regional Cancer Centre. "Xeloda is triggered into action right at the tumour site, focusing the attack on the cancer cells." Xeloda, only the third treatment for colorectal cancer approved in Canada over the last 40 years, has shown to reduce the size of tumours by more than half in 21 per cent of patients with metastatic colorectal cancer compared to the standard IV bolus Mayo Clinic regimen. In a further 48 per cent of patients, Xeloda stops the growth of the tumour. The clinical trials also showed an at least equivalent time to progression and survival benefit compared to the Mayo Clinic regimen. "Xeloda is an important new weapon in the fight against colorectal cancer," says Dr. Gerald Batist, Director of the McGill Centre for Translational Research in Cancer at the Jewish General Hospital. "The clinical trials show for the first time that an oral agent has demonstrated superior response rates and equivalent survival to the Mayo Clinic regimen" The most common reported adverse events with Xeloda were reversible after temporary interruption of the treatment and/or dose reduction. These included diarrhea, nausea, stomatitis (mouth ulcers), fatigue, and hand-foot syndrome (a localized, cutaneous syndrome affecting the hands and soles of the feet). Xeloda is under regulatory review for metastastic colorectal cancer in over 50 countries and has recently been approved in the European Union, Russia and New Zealand. It is also approved in 40 countries, including Canada, for patients with metastatic breast cancer who have either not responded to prior chemotherapy that included a taxane, or who could not tolerate taxane-based therapy. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.