CHICAGO, June 4 /PRNewswire/ --
-- Oral Xeloda(R) Combination Effective and Time-Saving
Data presented today at the American Society of Clinical Oncology Annual Meeting (ASCO) in Chicago showed that not only is XELOX as effective as intravenous (i.v.) drug regimens, but that colorectal cancer patients who receive XELOX (a combination of the oral chemotherapy Xeloda with i.v. oxaliplatin) spend over 160 fewer hours receiving treatment, have fewer clinic visits and are able to reduce travelling and waiting time. Analysis of data from a large Phase III international trial clearly demonstrate the quality of life advantages of using XELOX rather than traditional i.v. regimens consisting of i.v. 5-FU and i.v. oxaliplatin (FOLFOX-4), while providing treatment that is as effective.
Results from the study (NO 16966) show that XELOX is as effective as i.v. chemotherapy in terms of overall survival. Furthermore, patients receiving the XELOX combination:
-- Save time, spending over 160 fewer hours receiving treatment;
-- Save time, 22-27 fewer hours travelling to clinics and waiting to receive their treatment;
-- Require only 7-9 administration visits compared to 22-27 visits for the i.v. chemotherapy.
"These results clearly show the tremendous quality of life advantage that XELOX can make for colorectal cancer patients," said Professor Jim Cassidy, co-lead investigator for study NO16966 and Cancer Research UK Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre, at the University of Glasgow, Scotland. "The data have shown that Xeloda is as effective as i.v. chemotherapy in treating advanced colorectal cancer. As oral treatments become available to treat more types of cancer, why should we ask patients to undergo infusional treatments that increase the patient's burden?"
In 2004, colorectal cancer was one of the leading cancers accounting for 13 percent of all cancers in Europe.(1) A World Health Organization report suggested that in 2005, 655,000 people worldwide died from colorectal cancer.(2)
Notes to Editors:
Roche has filed in Europe to extend the label of Xeloda for use in combination with oxaliplatin (XELOX) and Avastin for the treatment of 1st and 2nd line metastatic (advanced) colorectal cancer. Similarly, the label extension for Avastin aims to broaden its use as 1st line treatment to include combination with fluoropyrimidine-based chemotherapy (FOLFOX and XELOX) in patients with metastatic carcinoma of the colon or rectum.
In the US, Roche has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for the use of Xeloda (capecitabine) in combination with oxaliplatin -- XELOX -- with or without Avastin (bevacizumab) in the treatment of metastatic colorectal cancer.
About the Study NO16966
NO16966 is a large, international Phase III trial which finally recruited 2,034 patients. It was originally planned to compare XELOX vs FOLFOX as first-line treatment in metastatic colorectal cancer: The primary objective was to answer two questions: 1) whether the XELOX regimen is non-inferior to FOLFOX; 2) whether the addition of Avastin to chemotherapy improved results compared to chemotherapy alone. The secondary endpoints included overall survival, overall response rates, time to, and duration of, response and safety profile.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com.
Results presented at ASCO:
Monday, 4 June 2007 8:00 AM - 12:00 PM
A comparison of medical resource use for 4 chemotherapy regimens as first-line treatment for metastatic colorectal cancer (MCRC): XELOX vs. FOLFOX4 plus or minus bevacizumab (A).
Poster Number: J4 abstract No: 4098
About Xeloda (capecitabine): see attached factsheet
About Avastin (bevacizumab): For more information, please visit www.avastin-info.com
Roche in Oncology please refer to: http://www.roche.com/med_mbcancer.pdf
Further information available from media relations contacts:
-- Colorectal cancer fact sheet
-- Xeloda in colorectal cancer fact sheet
-- Xeloda fact sheet
-- Roche in oncology: http://www.roche.com/med_mbcancer.pdf
-- Roche: www.roche.com
-- Broadcast quality B-roll including doctor, caregiver and patient interviews is available for download via www.thenewsmarket.com
References:
(1). Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004. Annals of Oncology 2005;16:481-488
(2). World Health Organization, http://www.who.int/healthinfo/statistics...
For further information please contact: Julia Pipe, International Communications Manager - Xeloda, F.Hoffmann-La Roche, Mob: +41-79-263-9715, Email: julia.pipe@roche.com; Nerea Hinzpeter, ShireHealthPR, Tel: +1-212-625-4178, Mob : +1-646-407-9015, Email : nerea.hinzpeter@shirehealthpr.com
