Benefits of Oral Xeloda Over Continuous Intravenous Chemotherapy Confirmed for Advanced Stomach Cancer

Basel, Switzerland (ots/PRNewswire) -

- For non US or non UK Media Only

- Oral Chemotherapy Tablet Option Reduces the Time Patients Need
to Spend in the Hospital

Data recently published in the New England Journal of Medicine
confirm oral chemotherapy tablet Xeloda (capecitabine) as a
first-line treatment for advanced stomach cancer. The publication
reinforces the drug's use for this difficult-to-treat disease,
enabling clinicians to prescribe Xeloda in combination with
platinum-based chemotherapy. Stomach cancer is the fourth most
commonly diagnosed cancer and the second leading cause of
cancer-related deaths worldwide(1.). Annually, there are an estimated
911,000 deaths worldwide(2.), with nearly 140,000 deaths in Europe
alone(3.).

Thanks to this advance, patients with stomach cancer will also
benefit from this effective and flexible oral treatment option. This
is another example of how the oral chemotherapy pill Xeloda is
replacing standard continuous intravenous (i.v.) therapies for
patients with gastrointestinal cancers.

"As an oral chemotherapy, capecitabine gives patients a valuable
option over the current standard of intravenous treatment," said
Professor David Cunningham, Head of the Gastrointestinal and Lymphoma
Units of the Royal Marsden NHS Foundation Trust, London.
"Capecitabine is at least as effective as intravenous treatment and
reduces the time patients need to spend in the hospital allowing
patients to lead more routine lives and have more personal time. It
may also avoid the need for a central intravenous line with its
associated inconvenience and complications."

There is growing consensus that oral therapies should replace i.v.
alternatives as long as they can demonstrate at least equivalent
efficacy and that tolerability is not compromised. 82% of US
oncologists interviewed in a survey stated that their key
consideration in selecting an oral chemotherapy agent was efficacy at
least equivalent to iv alternatives.(4.)

The approval of Xeloda in combination with platinum-based
chemotherapy (with or without epirubicin), was based on two trials
called ML17032(5.) and REAL-2 (6.); the latter was published this
week in the New England Journal of Medicine. Both these trials showed
that patients on the Xeloda-containing arms lived as long overall as
those on the 5-FU arms.

Furthermore, the REAL-2 study showed patients on one of the
Xeloda-containing arms (EOX; epirubicin, oxaliplatin and Xeloda)
lived longer than the reference 5-FU arm (ECF; epirubicin, cisplatin
and 5-FU).(6.)

For patients with advanced gastric cancer, oral Xeloda in
combination with a platinum-based regimen is a well tolerated
alternative to combination regimens using continuous infusion 5-FU,
as shown in both the REAL-2 and ML17032 studies. (5.),(6.)

Notes to editors:

Stomach cancer:

- is the fourth most commonly diagnosed cancer(1.)

- is the 2nd leading cause of cancer-related deaths worldwide(1.)

- annually accounts for an estimated 911,000 deaths worldwide(2.)

- annually accounts for approximately 140,000 deaths in Europe
alone(3.)

- is nearly twice as common in men as in women(3.)

About the REAL-2 Study

The largest-ever phase III study in advanced gastro-oesophageal
cancer.

- It was conducted in 1002 advanced gastro-oesophageal cancer
patients from 61 centres mainly in the UK

- The study aimed to establish the potential use of Xeloda (X) and
oxaliplatin (O) in previously untreated patients

- Patients were randomised to one of four regimens: epirubicin,
cisplatin and 5-FU (ECF), epirubicin, oxaliplatin and 5-FU (EOF),
epirubicin, cisplatin and Xeloda (ECX) or epirubicin, oxaliplatin and
Xeloda (EOX)

- The primary comparison was overall survival between the Xeloda
and 5-FU containing arms (ECX + EOX versus ECF + EOF) and the
oxaliplatin and cisplatin containing arms (EOF + EOX versus ECF +
ECX). The study objective was to show Xeloda to be as effective as
5-FU, and oxaliplatin to be as effective as cisplatin

- The study showed that Xeloda was at least as effective as 5-FU
and could replace 5-FU

- The study showed that patients treated with the combination of
Xeloda plus oxaliplatin and epirubicin (EOX) live longer overall,
compared to patients treated with standard epirubicin, cisplatin and
5-FU (ECF)

About Study ML17032

The study, led by Professor Y K Kang and his team of the Asan
Medical Centre, Seoul, South Korea, is a large randomised,
open-label, international phase III study in advanced stomach cancer.

- It was conducted in 316 patients enrolled in 46 centres across
13 countries in Asia, South America and Europe

- The study compared the efficacy and safety of Xeloda and
cisplatin (XP) with intravenous (i.v.) 5-FU and cisplatin (FP): FP is
a standard treatment for advanced stomach cancer in many countries
including Asia and the USA

- The primary end point was non-inferiority in progression-free
survival comparing XP to the standard FP

- Patients receiving the XP combination therapy lived as long
without the cancer progressing as those treated with FP

- Patients on XP also lived as long overall as those on FP,
showing XP to be at least as effective as FP

- The study confirms that Xeloda can effectively replace the old
standard i.v. 5-FU, in combination with cisplatin, as first-line
therapy for advanced stomach cancer

Xeloda (capecitabine)

Known as a 'smart pill' Xeloda is designed to be activated by an
enzyme present at higher levels in cancer cells, preserving more
normal, healthy cells. This results in favourable tolerability and
more convenient treatment, as compared with current standard i.v.
chemotherapy.

Xeloda is an oral chemotherapy pill that is licensed for advanced
gastric cancer, advanced breast cancer and colorectal (bowel) cancer
including colorectal cancer that has spread (metastatic), and
following potentially curative surgery for colon cancer.

The most commonly reported adverse events with Xeloda include
diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome
(palmar-plantar erythrodysesthaesia).

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.

All trademarks used or mentioned in this release are legally
protected.

References:

(1.) Ajani, J. Evolving Chemotherapy for Advanced Gastric Cancer.
The Oncologist, Oct. 2005; Vol. 10, Sup. 3, 49-582

(2.) World Health Organisation, 2005.

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

(4.) Decision Resources Survey. Oral chemotherapeutic agents: key
success factors and reimbursement issues. A survey of US Oncologists
and HMO pharmacy directors. June 2005

(5.) Kang Y.K. Abstract LBA4018 presented at ASCO 2006

(6.) Cunningham et al, NEJM 2008, Vol 358:36-46.

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

$story.getcontactHeadline()
For further information please contact: Julia Pipe, Roche, T:
+41-61-687-4376, M: +41-79-263-9715, Email : julia.pipe@roche.com;
Nicole Lynch, OgilvyHealthPR, T: +1-212-625-4173, Email:
nicole.lynch@ohpr.com