Xeloda

- Data show significant survival benefit in fighting aggressive cancer -

NUTLEY, N.J., Nov. 2 /PRNewswire/ -- The interim analysis of one of the largest phase III studies investigating the first-line treatment of advanced pancreatic cancer revealed that adding the oral chemotherapy pill Xeloda (capecitabine) to standard chemotherapy (gemcitabine) in the trial significantly extended patient survival. The study showed that after a year, one patient out of every four was still alive when treated with Xeloda plus standard chemotherapy, compared to one in five taking standard chemotherapy alone. These findings were unveiled today at the European Cancer Conference (ECCO) in Paris.

The American Cancer Society estimates that more than 32,000 Americans will be diagnosed with cancer of the pancreas during 2005. The 5-year relative survival rate for the disease is only 4% and few effective treatment options exist for the disease.

"These data show there are new possibilities for pancreatic cancer patients who, in general, have a short life expectancy once diagnosed," said Julie Fleshman, JD, MBA, President & CEO of Pancreatic Cancer Action Network (PanCAN). "Because pancreatic cancer is one of the most aggressive forms of cancers, it is even more critical to discover and offer these patients more treatment options."

About the Study

This randomized study, designed by Cancer Research UK and funded in part by Roche, compared the survival of patients on a combination of gemcitabine and Xeloda with the survival of patients on gemcitabine monotherapy. Patients (n=533) were previously untreated and had locally advanced or metastatic pancreatic cancer. Patients receiving the combination therapy of gemcitabine and capcitabine lived significantly longer than those with standard therapy alone (median survival 7.4 vs. 6 months, HR= 0.80). A higher percentage of patients were alive at 12 months in the group treated with Xeloda plus gemcitabine, compared to those treated with gemcitabine alone (26% v 19%). The most common Grade 3-4 adverse events (equal to or greater than two percent) in the gemcitabine-capecitabine (GEM-CAP) combination arm of the study include neutropenia, increased white blood cell count, platelets, fatigue and hand/foot syndrome. The most common adverse events in the GEM arm alone included increased white blood cell count, neutropenia, platelets, hemoglobin, fatigue and nausea and vomitting.

"Some of my patients with advanced, inoperable pancreatic cancer are seeing improvement in their tumor size by adding Xeloda to their traditional chemotherapy," said lead investigator, Professor David Cunningham, Royal Marsden Hospital, London. "This is the first time that adding another cytotoxic drug to gemcitabine has improved the outcome for patients with inoperable pancreatic cancer and the trial results are, therefore, an important milestone."

About Xeloda

Xeloda is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Xeloda is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.

For treatment of metastatic breast cancer, Xeloda is indicated in combination with docetaxel after failure of prior anthracyline-containing chemotherapy. Xeloda monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalence.

About Roche - More Than a Century in the U.S. and the World

Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people's health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.

Roche's U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: http://www.roche.com/ and U.S.: http://www.roche.us/).

About PanCAN

The Pancreatic Cancer Action Network, Inc. (PanCAN) is a 501(c)(3) nonprofit organization founded in 1999 and chartered as the first, national public-benefit organization for the pancreatic cancer community. The organization works to focus national attention on the need to find a cure for pancreatic cancer, and provides patient services to families and patients around the country, as well as public and professional education embracing the urgent need for more research, effective treatments, prevention programs and early detection methods. PanCAN currently has volunteers and members throughout the United States and around the world. Visit http://www.pancan.org/ to obtain more information, e-mail info@pancan.org, or call 1-877-272-6226.

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2. Ibid.

CONTACT: Ginny Valenze, Roche, Office: +1-973-562-2783, Cell: +1-973-943-9219, virginia.valenze@roche.com; Christine Ennis, Manning Selvage & Lee, Office: +1-212-468-3986, Cell: +1-917-620-5291, christine.ennis@mslpr.com

Web site: http://www.pancan.org/ http://www.roche.us/ http://www.roche.com/

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