Review Publication Confirms the Benefits of Highly Effective Oral Cancer Drug Xeloda(R) (capecitabine) Over Intravenous Chemotherapy in Advanced Breast Cancer

Geschrieben am 20-11-2007

Basel, Switzerland, November 20 (ots/PRNewswire) -

- Annals of Oncology Paper Suggests That Oral Agents Such as
Xeloda, Which are Proven to be Equally Effective and Have a
Tolerable Side Effect Profile, Should Replace Traditional
Intravenous Chemotherapy

A review paper in Annals of Oncology now published on-line
concludes that the oral cancer drug Xeloda (capecitabine) offers an
effective and more cost- effective treatment option than current
intravenous (iv) cytotoxic chemotherapy treatments for patients with
advanced breast cancer. This treatment also results in fewer days
spent in hospital to manage adverse events when compared to iv

The paper in the Annals of Oncology includes a recent study
comparing first-line capecitabine versus the well-known chemotherapy
combination of cyclophosphamide, methotrexate and 5-FU (CMF). Women
receiving capecitabine lived significantly longer than those
receiving this traditional iv chemotherapy regimen. Further
information on this trial presented recently showed that as well as
extending the life expectancy of these women, their quality of life
was better with capecitabine than with traditional iv CMF (1).

However, there is growing consensus that oral therapies should
only replace iv alternatives when they have demonstrated 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 (2).

According to the review, chemotherapy treatment for cancer has
traditionally been dominated by intravenous drug therapies, despite
their considerable impact on patients' lives. The time and money
spent travelling to, waiting for, and receiving treatment at a clinic
can place a major burden on patients, preventing them from spending
precious time with their family and friends. In rural or remote
areas, intravenous chemotherapy is particularly difficult because
patients may live hours away from their nearest clinic.

"Traditionally, oncologists have favoured intravenous chemotherapy
as they have had more confidence in efficacy with its minimal
bioavailability and patient compliance problems and because
intravenous chemotherapy had an established reimbursement framework."
said Professor Michael Findlay, University of Auckland, New Zealand,
and lead author of the article. "However, with the progressive
evidence indicating particular oral chemotherapy drugs have
equivalent or superior efficacy oncologists are increasingly
integrating these drugs into their practice. Capecitabine
particularly has established a place as an oral chemotherapy of
choice in breast cancer both as a single agent and as a component of
a drug combination."

Unlike traditional chemotherapies, capecitabine targets the cancer
cells directly, with less impact on healthy cells. Capecitabine has
an unusual safety profile, characterised by gastrointestinal
toxicities and hand-foot syndrome, but has a particularly low
incidence of hair loss or decreased production of blood cells and

Pharmacoeconomic studies (3),(4) also suggest that in pretreated
patients with metastatic breast cancer, capecitabine as a
monotherapy is more cost-effective than intravenous comparator
therapies (e.g. infused 5-FU, gemcitabine, or vinorelbine). NICE
approved capecitabine as a cost effective option for metastatic
breast cancer in March 2003.

The authors conclude that the most important characteristic of a
chemotherapeutic agent is efficacy. Once efficacy is unequivocally
established, the development and refinement of oral chemotherapy
treatments like capecitabine are likely to offer numerous benefits to
patients, oncologists, oncology nurses, pharmacists and healthcare

About Xeloda

Xeloda is licensed in more than 100 countries worldwide including
the EU, USA, Japan, Australia and Canada and has been shown to be an
effective, safe, and convenient oral chemotherapy in treating over
1.4 million patients to date.

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
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 recently received approval in South Korea for
the first-line treatment of patients with locally advanced
(metastatic) pancreatic cancer, in combination with gemcitabine.
Xeloda is licensed in South Korea for the first-line treatment of
stomach cancer, and has recently received EU approval for the
first-line treatment of advanced stomach cancer in combination with a
platinum agent.

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. 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, metabolic disorders and diseases
of the 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 has R&D
agreements and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai, and invests
approximately 7 billion Swiss francs a year in R&D. Worldwide, the
Group employs about 75,000 people.

For further information about Xeloda please refer to the Summary
of Product Characteristics which is available on our website

All trademarks used or mentioned in this release are protected by

Further information available:

- Breast cancer fact sheet

- Xeloda in breast cancer fact sheet

- Xeloda fact sheet

- Roche in oncology: http://www.roche.com/med_mbcancer.pdf

- Roche: http://www.roche.com

- Broadcast quality B-roll including doctor, caregiver and patient
interviews is available for download via http://www.thenewsmarket.com


(1) Stockler MR, Sourjina T, Harvey V et al. A randomized trial of
capecitabine given intermittently versus continuously versus
classical CMF as first line chemotherapy for women with advanced
breast cancer unsuited to more intensive treatment. Breast Cancer Res
Treat 2006; 100 (Suppl 1): S278 (Abstr 6066).

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

(3) Silberman G, Gupta S, Berkowitz N et al. Cost-effectiveness of
capecitabine, continuous infusion 5-FU, gemcitabine and vinorelbine
in the treatment of metastatic breast cancer. Proc Am Soc Clin Oncol
1999; 18: 422a (Abstr 1629).

(4) Baran RW, Dupere W, Susan M et al. Clinical and economic
outcomes associated with metastatic breast cancer in managed care
populations: capecitabine (Xeloda) versus comparison therapies. Proc
Am Soc Clin Oncol 2002; 21: 1942.

Media relations contacts:
Julia Pipe
International Communications Manager - Xeloda
Tel: +41-61-687-4376
Mobile: +41(0)79-263-9715
Email: julia.pipe@roche.com
Nerea Hinzpeter
Tel: +1-212-625-4178
Mobile: +1-646-407-9015
Email: nerea.hinzpeter@shirehealthpr.com

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

Media relations contacts: Julia Pipe; International Communications
Manager - Xeloda, Roche, Tel: +41-61-687-4376, Mobile:
+41(0)79-263-9715, Email: julia.pipe@roche.com; Nerea Hinzpeter,
ShireHealthPR, Tel: +1-212-625-4178, Mobile: +1-646-407-9015, Email:


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