Language
NEWS & EVENTS
/ Back to the News List
06.04.2006
Basel, 6 April 2006
Oral chemotherapy Xeloda shown to be effective in stomach
cancer
New treatment option for patients with this debilitating
disease
Roche today announced that the first-ever phase III
study investigating Xeloda (capecitabine) in the first-line
treatment in advanced gastric (stomach) cancer successfully
met its primary endpoint. The data show that Xeloda, added
to another chemotherapy called cisplatin, is at least
as effective as the current standard treatment (intravenous
5-fluorouracil plus cisplatin) in terms of time to disease
progression. Full results from the study have been submitted
to the American Society of Clinical Oncology (ASCO) for
presentation at their Annual Meeting taking place from
2nd-6th June 2006, in Atlanta, GA, USA.
“These new data are encouraging. For many patients
the prognosis has been poor, despite recent advances in
managing this common, yet often fatal, disease.”
said Ed Holdener, Head of Global Development at Roche.
“Compared to the current standard, where patients
spend five days every three weeks in hospital receiving
treatment, Xeloda has the additional benefit of reducing
that amount of time to only one day, which helps patients
to live as normal life as possible.”
Gastric cancer is the fourth most commonly diagnosed
cancer and the second leading cause of cancer-related
deaths worldwide.1 In Europe alone, nearly 140,000 people
die from gastric cancer each year.2 Gastric cancer affects
twice as many men as women and occurs more frequently
in people aged over 55 years.3
Based on the results of this study, Roche plans to file
for an indication in advanced gastric cancer with worldwide
regulatory authorities.
About the study
This international study is a randomised, open-label study
of the effect of first-line chemotherapy with Xeloda plus
cisplatin versus intravenous 5-fluorouracil plus cisplatin
on time to disease progression in patients with advanced
or metastatic gastric cancer. The secondary endpoints
included overall response rate, overall survival, duration
of response, time to response and the safety results between
the treatment arms.
About Xeloda
Xeloda is licensed in more than 90 countries worldwide
including the EU, USA, Japan, Australia and Canada and
has been shown to be effective, safe, simple and convenient
oral chemotherapy.
Roche received marketing authorisation for Xeloda as
a first-line monotherapy (by itself) in the treatment
of metastatic colorectal cancer (colorectal cancer that
has spread to other parts of the body) in most countries
(including the EU and USA) in 2001. Xeloda has also been
approved by the European Medicines Agency (EMEA) and U.S.
Food and Drug Administration (FDA) for adjuvant (post-surgery)
treatment of colon cancer in March and June 2005, respectively.
Xeloda is licensed in combination with Taxotere (docetaxel)
in women with metastatic breast cancer (breast cancer
that has spread to other parts of the body) and whose
disease has progressed following intravenous (i.v.) chemotherapy
with anthracyclines. Xeloda monotherapy is also indicated
for treatment of patients with metastatic breast cancer
that is resistant to other chemotherapy drugs such as
paclitaxel and anthracyclines. Xeloda is licensed for
the first-line treatment of stomach cancer that has spread,
in South Korea.
The most commonly reported adverse events with Xeloda
include diarrhoea, abdominal pain, nausea, stomatitis
and hand-foot syndrome.
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 a
supplier of innovative products and services for the early
detection, prevention, diagnosis and treatment of disease,
the Group contributes on a broad range of fronts to improving
people’s health and quality of life. Roche is a
world leader in diagnostics, the leading supplier of medicines
for cancer and transplantation and a market leader in
virology. In 2005 sales by the Pharmaceuticals Division
totalled 27.3 billion Swiss francs, and the Diagnostics
Division posted sales of 8.2 billion Swiss francs. Roche
employs roughly 70,000 people in 150 countries 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 (www.roche.com).
All trademarks used or mentioned in this release are
protected by law.
References:
1. Ajani, J. Evolving Chemotherapy for Advanced Gastric
Cancer. The Oncologist, Oct. 2005; Vol. 10, Sup. 3, 49-58
2. Boyle, P & Ferlay, J. Cancer incidence and mortality
in Europe. 2004. Annals of Oncology 2005; 16(3):481-488
3. Oncology Channel. http://www.oncologychannel.com/gastriccancer/.
Visited on 15th March 2006.
Archive
