Xeloda (capecitabine) Shown to be Superior to IV 5-FU in Advanced Stomach and Oesophageal Cancer

Stockholm (ots/PRNewswire) -

- Patients Live Longer After Treatment With Capecitabine
Chemotherapy Combinations Compared With Standard IV 5-FU/FA

- For Non-US and Non-UK Media Only

Pooled results of two phase III trials have shown that stomach
and oesophageal cancer patients treated with oral chemotherapy Xeloda
(capecitabine) lived approximately one month longer than those that
were treated with infused intravenous (IV) 5FU/FA.*(1) The individual
trials compared capecitabine with the previous standard IV 5-FU/FA,
in chemotherapy combinations for the treatment of incurable stomach
and oesophageal cancer. The results were presented today at the
European Society of Medical Oncology (ESMO).

"The fact that this analysis shows capecitabine to be superior
for overall survival to IV 5-FU in chemotherapy combinations for
advanced oesophageal and stomach cancers is welcome news for
patients," said Professor David Cunningham, Department of Medicine,
The Royal Marsden Hospital, Surrey, United Kingdom. "Intravenous 5-FU
based regimens can be burdensome for patients because they require
additional hospital visits during the treatment cycle and are usually
given via a pump that the patient has to wear at home. Capecitabine
appears to offer a survival advantage in addition to the convenience
of a tablet that can be taken at home. These data provide further
evidence that capecitabine can replace IV 5-FU in combination
chemotherapy regimens in the treatment of stomach and oesophageal
cancers."

Stomach cancer is a particularly aggressive and debilitating type
of cancer. It is the second leading cause of cancer worldwide, after
lung cancer, causing an estimated 866,000 deaths worldwide each
year,(2) and nearly 140,000 deaths in Europe alone.(3)

Further Evidence

Data from a separate study of capecitabine trials was presented
at the World Congress of Gastrointestinal Cancers in Barcelona in
June. The study involved analysing data from six phase III trials and
showed that patients taking oral capecitabine actually lived longer
than those receiving IV 5-FU/FA for the treatment of a range of
gastrointestinal cancers including colon, colorectal and stomach.(4)

"These new data from ESMO confirm what we have seen in previous
studies: that capecitabine can replace intravenous 5-FU in the
treatment of a number of serious gastrointestinal cancers because it
may offer better survival coupled with improved patient
acceptability," Prof Cunningham concluded.

Xeloda is approved in Europe in combination with platinum based
chemotherapy in first-line treatment of advanced stomach cancer.(5)
The most commonly reported treatment-related adverse reactions are
gastrointestinal disorders (especially diarrhoea, nausea, vomiting,
abdominal pain, stomatitis), fatigue and hand-foot syndrome
(palmar-plantar erythrodysaesthesia).(5)

Since its first licence for advanced breast cancer in 1998,
capecitabine has been proven to be a highly effective and well
tolerated treatment for over 1.5 million breast, colon, colorectal
and stomach cancer patients worldwide.

* FA: Folinic Acid

Notes to editors:

About the meta-analysis

- Pooled data on 1318 patients from the ML17032 and REAL 2
      studies showed oral chemotherapy pill Xeloda is superior to intravenous
      (IV) 5-FU within doublet and triplet combination chemotherapy regimens
      for overall survival in the treatment of advanced stomach and
      oesophageal cancer.
    - The individual trials compared the efficacy of Xeloda with
      previous standard infused IV 5-FU/FA chemotherapy treatment in two
      trials:
    - REAL 2: A trial of 1002 patients with previously untreated
      advanced oesophagogastric cancer in a two-by-two design. Patients
      received either triple combination therapy with epirubicin and
      cisplatin plus IV 5-FU/FA or Xeloda, or epirubicin and oxaliplatin
      plus IV 5-FU or Xeloda.
    - ML17032: A trial of 316 patients with untreated advanced
      stomach cancer who received cisplatin and either infused IV 5-FU/FA
      or Xeloda as part of double combination chemotherapy.
    - The primary endpoint of the meta-analysis was overall survival
      and secondary endpoints were progression free survival and response
      rate.
    - Results of the meta-analysis showed that overall survival was
      superior in the 654 patients treated with Xeloda combinations compared
      to the 664 patients treated with IV 5-FU combinations. (adjusted
      HR 0.87; 95% CI 0.77-0.98, p=0.02).
    - Differences in progression free survival were not statistically
      significant (HR 0.91 (95% CI 0.81-1.02, P=0.095).
    - Patients with measurable disease who were treated with Xeloda
      based combinations were more likely to have an objective response than
      those treated with IV 5-FU/FA combinations.

About Xeloda

Xeloda is a highly effective targeted oral chemotherapy offering
patients a survival advantage when taken on its own or in combination
with other anticancer drugs. Xeloda uniquely activates the
cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer
cells so avoiding damage to healthy cells. Xeloda tablets can be
taken by patients in their own home, reducing the number of hospital
visits.

Licensed in more than 100 countries worldwide, Xeloda has over
ten years proven clinical experience providing an effective and
flexible treatment option to over 1.5 million people with cancer.
Xeloda is currently approved in:

- Metastatic Colorectal Cancer
    - Monotherapy 1st line (US & EU) - 2001
    - In combination with any chemotherapy in all lines of treatment with or
      without Avastin (EU) - 2008
    - Metastatic Breast Cancer
    - Monotherapy 1st line in patients with tumours resistant to other
      chemotherapy drugs such as paclitaxel and anthracyclines - (US) 1998
      and (EU) 2002
    - In combination with docetaxel in patients whose disease has progressed
      following I.V. chemotherapy with anthracyclines - (US) 2001 and (EU)
      2002
    - In patients with inoperable or recurrent breast cancer - (Japan) 2003
    - Adjuvant Colon Cancer
    - Monotherapy (US & EU) - 2005
    - Monotherapy (Japan) - 2007
    - Advanced Gastric Cancer
    - 1st line treatment (South Korea) 2002 and (China) 2008
    - In combination with platinum-based chemotherapy 1st line (EU) - 2007
    - Metastatic Pancreatic Cancer
    - In combination with gemcitabine 1st line (South Korea) - 2006

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, and is a market
leader in virology. It is also active in other major therapeutic
areas such as autoimmune diseases, inflammatory and metabolic
disorders and diseases of the central nervous system. In 2007 sales
by the Pharmaceuticals Division totalled 36.8 billion Swiss francs,
and the Diagnostics Division posted sales of 9.3 billion francs.
Roche has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai, and invested over 8 billion Swiss francs in R&D in 2007.
Worldwide, the Group employs about 80,000 people. Additional
information is available on the Internet at http://www.roche.com.

About The Royal Marsden

The Royal Marsden Hospital was the first hospital in the world
dedicated to cancer treatment and research into the causes of cancer.
Today the hospital with its academic partner, The Institute of Cancer
Research, forms the largest comprehensive cancer centre in Europe
with over 40,000 patients from the UK and abroad seen each year. It
provides inpatient, day care and outpatient services for all areas of
cancer treatment. For further information please contact: Catherine
O'Mara on +44(0)207-808-2605 or catherine.omara@rmh.nhs.uk

http://www.royalmarsden.nhs.uk

All trademarks used or mentioned in this release are protected by
law.

Further information available:

- Xeloda in stomach cancer fact sheet
    - Xeloda fact sheet
    - Roche: http://www.roche.com
    - Broadcast quality B-roll including doctor, caregiver and patient
      interviews is available for download via http://www.thenewsmarket.com

References:

1. Meta-analysis of the REAL 2 and ML17032 Trials Comparing
Capecitabine with 5-FU in Advanced Gastroesophageal Cancer. Presented
at the European Society for Medical Oncology, 2008. Poster no. 513PD

2. Word Health Organisation: Cancer Fact Sheet No. 297.
http://www.who.int/mediacentre/factsheets/fs297/en/index.html
Accessed July 2008

3. Boyle, P & Ferlay, J. Cancer incidence and mortality in Europe
2004. Annals of Oncology 2005; 16(3):481-4883.

4. Meta-analysis of overall survival in 6 randomised phase III
clinical trials of capecitabine vs. 5-FU in colorectal and gastric
cancer. Presented at the World Congress of Gastrointestinal Cancers
2008. [Abstract no.: 1296]

5. Xeloda European Summary of Product Characteristics.
E-medicines Compendium: http://emc.medicines.org.uk. Accessed August
2008

Rückfragehinweis:
For further information please contact: Catherine O'Mara on
+44(0)20-7808-2605 or catherine.omara@rmh.nhs.uk; Julia Pipe,
International Communications Manager - Xeloda, F.Hoffmann-La Roche,
Mob: +41-79-263-9715, Email: julia.pipe@roche.com; Nerea Hinzpeter,
OgilvyHealthPR, Tel: +1-646-407-9015, Email: nerea.hinzpeter@ohpr.com

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