Xeloda for positive HER2 breast cancer patients

The new combination provides an effective option for women with advanced breast cancer.

Istanbul, October 2 (ANTARA/PRNewswire/AsiaNet)
New data presented today at the European Society for Medical Oncology (ESMO) exhibition shows that adding Xeloda (capecitabine) to the combination of Herceptin (trastuzumab) and Taxotere (docetaxel) greatly increases the amount of time spent obtained by patients with advanced HER2-positive breast cancer without aggravating their disease. The mean time to disease progression to severe increased markedly from 13.8 to 18.2 months (p value = 0.045).

HER2-positive breast cancer, which affects about 20-30 percent(1) of women with breast cancer, demands immediate attention because the tumors grow quickly and are likely to recur. These results provide the first evidence that adding a third chemotherapy regimen to the first most commonly used regimen, Herceptin and taxane, provides major additional benefit in patients with the malignant form of this disease. This drug combination is also generally well received.

"Patients with advanced HER2-positive breast cancer usually have a poor prognosis because their type of cancer does not always respond well to standard chemotherapy regimens," said Dr Andrew Wardley, lead researcher of the study and Consultant Hospital Medical Oncologist at Christie's Hospital in England. "We must continue to assess the potential benefits of both treatment and combination therapy to find better options for patients. These results indicate a number of signs encouraging triple combination therapy, and further follow-up of this and other studies will help us move forward. investigate its potential."

This study evaluated the addition of Xeloda orally to Herceptin and Taxotere in HER2-positive breast cancer patients who were not previously treated for locally advanced, or metastatic, disease. In addition to significant results for time to disease progression (time from randomization to tumor growth) for patients in the triple combination, there was also a positive trend in survival without disease progression (time from randomization to tumor growth or death) of mean 12.8 to 14.8 months (p value = 0.060). For the ultimate goal of overall response rate (tumor shrinkage), patients in both branches achieved a similarly high yield of about 70 percent, with no statistical difference between the study groups (p value = 0.717). At the time of analysis, overall survival results are immature due to short follow-up. Follow-up studies are ongoing and final data analysis is expected in 2007.

About the CHAT study
A total of 222 patients were randomized to a phase II study: 112 received Xeloda plus Herceptin and Taxotere and 110 received Herceptin and Taxotere alone. Herceptin was given at 6 mg/kg every 3 weeks until the disease progressed (after a loading dose of 8 mg/kg). Taxotere was given at a dose of 100mg/m2 every 3 weeks with Herceptin alone, and 75mg/m2 when Xeloda was added, until the disease progressed. Xeloda was given at a dose of 950 mg/m2 twice daily for the first 14 days of each 3-week cycle. Patients in the Herceptin and Taxotere-only branch of the study were given the option of crossing over to receive Xeloda, once their disease had progressed.

The CHAT study has an external Data Security Monitoring Agency (DSMB) that regularly reviews security data. DSMB did not pose any unexpected safety concerns, and the incidence of heart failure was low (one patient in each treatment arm).

About breast cancer
Breast cancer is the most common cancer among women worldwide.(2) Each year, more than one million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die from the disease each year.(3) )

In HER2 positive breast cancer, an increased amount of HER2 protein is present on the surface of the tumor cells. This is known as 'HER2 positivity.' High HER2 levels are present in the malignant forms of the disease which do not respond very well to chemotherapy. Research shows that HER2 positivity affects about 20-30 percent of women with breast cancer.

About Herceptin (trastazumab)
Herceptin is a humanized antibody, and aims to target and inhibit the function of HER2, a protein produced by a specific gene that can cause cancer. It has been shown to be effective in treating breast cancer, both early and advanced (metastatic). As alone as monotherapy and also in combination with or after standard chemotherapy, Herceptin has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2 positive breast cancer. Herceptin was approved for use in European Union countries for advanced (metastatic) HER2-positive breast cancer in 2000 and for early-stage HER2-positive breast cancer in 2006. In advanced stages, Herceptin is now approved for use as first therapy in combination with paclitaxel where anthracyclines are not suitable, as first therapy in combination with docetaxel, and as single agent in third therapy. In its early stages, Herceptin is approved for use after standard (adjuvant) chemotherapy. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat more than 310,000 people with HER2 positive breast cancer worldwide. Herceptin is approved for use after standard (adjuvant) chemotherapy. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat more than 310,000 people with HER2 positive breast cancer worldwide. Herceptin is approved for use after standard (adjuvant) chemotherapy. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat more than 310,000 people with HER2 positive breast cancer worldwide.

About Xeloda (capecitabine)
Xeloda is licensed in more than 90 countries worldwide including the European Union, United States, Japan, Australia and Canada and has been proven to be an effective, safe, simple and easy oral chemotherapy in treating more than 1 million sufferers today .

Roche was licensed to market Xeloda as the first monotherapy (by the drug itself) in the treatment of metastatic colon and rectal cancer (cancer of the colon and rectum that has spread to other parts of the body) in most countries (including EU and US) in 2001. Xeloda has also been approved by the European Medical Service (EMEA) and the US Food and Drug Administration (FDA) for the adjuvant (postoperative) treatment of colon cancer in March and June 2005, respectively.

Xeloda is licensed together with Taxotere (docetaxel) to women with metastatic breast cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed after intravenous chemotherapy with anthracyclines. Xeloda monotherapy is also indicated for the treatment of metastatic breast cancer patients who are resistant to a number of other chemotherapy drugs such as paclitaxel and anthracyclines. Xeloda recently received approval in South Korea for the early-stage treatment of patients with advanced (metastatic) pancreatic cancer, in combination with gemcitabine. Xeloda is licensed in South Korea for the treatment of early-stage stomach cancer.

The most commonly reported side effects with Xeloda include diarrhea, abdominal pain, nausea, stomach ulcers and palmar-plantar erythrodysestaesia.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of medicine and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the group contributes to a wide range of pharmaceuticals to improve people's health and quality of life. Roche is a world leader in diagnostics, a leading supplier of cancer and transplant drugs and a market leader in virology.

In 2005, sales by the Pharmaceuticals Division totaled: 27.3 billion Swiss Franks, and the Diagnostics Division posted sales of 8.2 billion Swiss Franks. Roche employs approximately 70,000 people in 150 countries and has R&D agreements and strategic alliances with a large number of partners, including majority owners in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

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

Reference :

1. Harries M, Smith I. Development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.
2. World Health Organization, www.who.int
3. Ferlay J, et al., GLOBOCAN 2002. Cancer incidence, mortality and prevalence worldwide. IARC Cancer base No.5, Version 2.0. IARCPress, Lyon, 2004.

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SOURCE : Roche

CONTACT :
Julia Pipe,
International Communications Manager - Xeloda
+41-61-687-4376,
Julia.pipe@roche.com or

Holly Kania ,
International Communications Manager-Herceptin
+41-61-688-3773,
holly.kania@roche.com

Joanne Marlin
Shire Health International
New York, +1-212-625-4174
Joanne.marlin@shirehealthinternational.com

Or

Amanda Stefton
Ketchum, London
+44-207-611-3653,
Amanda.sefton@ketchum.com

Website: www.roche.com
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