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Roche Pharmaceuticals

Colorectal Cancer Patients Treated With XELOX Spend Over 160 Fewer Hours Receiving Intravenous Treatment

Chicago (ots/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:
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/stat
istics/bodprojections2030/en/index.html

Contact:

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

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