BASEL, Switzerland, November 20 /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 therapy.

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 platelets.

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 providers.

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 http://www.rocheuk.com.

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

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

References:

(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 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: nerea.hinzpeter@shirehealthpr.com

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: nerea.hinzpeter@shirehealthpr.com