25.06.2008 – 15:07

Roche Pharmaceuticals

Confirmed: Oral Xeloda Should Consistently Replace IV 5-FU in Treatment of all GI Cancers

Barcelona (ots/PRNewswire)

• Not for US Media
• Comparative Analysis Shows Chemotherapy Pill Xeloda Should Become Standard of Care in Colon, Colorectal and Stomach Cancers

Results from a meta-analysis involving data from six phase III
studies show that patients taking the chemotherapy pill Xeloda
actually live longer than those receiving intravenous (IV)
chemotherapy 5-FU/FA*. The pooled results showed that patients taking
Xeloda survived for an average of 23.1 months while patients
receiving the IV chemotherapy survived for an average of 22.5
months,. These findings reinforce extensive evidence that Xeloda
either alone or in combination, is as effective as IV 5-FU/FA across
different stages of colorectal cancer (CRC) and different
gastrointestinal (GI) cancers, confirming that Xeloda should be used
as the standard of care for all CRC patients.

"Time after time, Xeloda has proven to be effective at keeping
patients with CRC, colon and stomach cancers alive, with the added
benefit of being an oral treatment," said Professor Jim Cassidy, lead
author of the study, Cancer Research UK Professor of Oncology and
Chair of Medical Oncology, Beatson Oncology Centre, at the University
of Glasgow, Scotland. "We should now accept Xeloda is as effective as
infusional 5-FU and that Xeloda can be prescribed in any line and in
any combination for the treatment of various GI cancers with added
benefit that Xeloda allows patients to get on with their lives by
reducing the time they spend in hospital for infusional therapy."

The meta-analysis evaluated data from six large randomised phase
III studies involving 6171 patients including:

- 2 studies of Xeloda as a single agent in the first-line treatment of
    CRC that has spread to other parts of the body
    - 2 studies of XELOX (Xeloda plus oxaliplaitin chemotherapy) in first and
    second-line treatment of CRC that has spread to other parts of the body
    - 1 study of Xeloda as a single agent in treatment of colon cancer
    after-surgery
    - 1 study of Xeloda in combination with another chemotherapy agent
    cisplatin in first-line treatment of stomach cancer

In all six of the studies patients taking the Xeloda tablets
lived at least as long those receiving IV 5-FU/FA.

An update to one of the studies in the meta-analysis was also
presented at the Congress. An additional pre-planned multivariate
analysis of the X-ACT trial, looked at the effect of Xeloda on the
survival of patients receiving the chemotherapy after surgery as
treatment for colon cancer. Results showed that Xeloda chemotherapy
is superior to IV 5-FU/FA in this setting. Data from the X-ACT trial
is being presented at 15.20 on Saturday 28th June.

* FA: Folinic Acid

Notes to editors:

About the phase III meta-analysis

A meta-analysis of the efficacy of Xeloda versus that of IV
5-FU/FA was performed on the advice of European health authorities.
The meta-analysis included 6171 patients (3074 treated with
5-FU-based regimens and 3097 treated with Xeloda) with colon,
colorectal or gastric cancer from six large randomised phase III
studies.

The unstratified meta-analysis demonstrated a median overall
survival of 23.1 months (95% CI, 22.1-24.4) for the Xeloda based
regimens versus 22.5 months (95% CI, 21.3-23.5) for 5-FU-based
regimens (HR 0.96, 95% CI, 0.90-1.02). The same HR was observed in
the stratified analysis.

About Xeloda (capecitabine)

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 iv 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
    - 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. Additional information is available
on the Internet at http://www.roche.com.

    Further information available:
    - Xeloda in GI 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

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; Aba Edwards-Idun
OgilvyHealthPR Mob : +44-7790-038-579 Email
:aba.edwards-idun@ohpr.com