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New Study with Xeloda Demonstrates Important Survival Benefit for Women with Breast Cancer

Xeloda and Taxotere Combination More Effective than Commonly Used Sequential Approach to Treatment

BASEL, SWITZERLAND -- October 31, 2005 -- New data confirm that the Xeloda(R) (capecitabine) and Taxotere(R) (docetaxel) combination improves survival time by an important three months in younger or fitter women with an aggressive form of breast cancer that has spread to other parts of the body (metastatic).1

This is the first study designed to show that taking the two potent drugs together improves women's survival when compared to the more commonly used 'sequential treatment' approach of taking Taxotere alone followed by Xeloda alone. The study noted a slight increase in the known manageable side-effects of the two drugs, but this is more than compensated by the prospect of increased survival.

These new data show how important it is to investigate the benefits of modern, synergistic combinations rather than sequential treatments.1

Improved treatments for younger or fitter women with breast cancer that has rapidly spread are desperately needed. Statistics show that breast cancer spreads in half of women diagnosed, and the average time that these women will live is only 18 to 30 months.2 Xeloda and Taxotere is the only chemotherapy combination proven to prolong the lives of these women beyond Taxotere alone.

"I have witnessed the powerful benefit of the Xeloda and Taxotere combination first-hand. For these women, the extension of life by three months allows them more precious time with family and loved ones," commented Dr. Semir Beslija, lead study investigator. "Now that the survival benefit of Xeloda and Taxotere has been confirmed, patients and physicians alike can be assured of the vital difference this very powerful combination can make."

100 metastatic breast cancer patients were randomised to receive either Xeloda and Taxotere in combination, or Taxotere followed by Xeloda after progression, as first-line chemotherapy. Key findings were:

• Efficacy: A median 3-month survival advantage when Xeloda is used in combination with Taxotere rather than used sequentially

• Efficacy: The combination prevented tumours from growing for a longer period of time as compared to Taxotere alone (9.33 median months for patients on combination vs. 7.66 for patients on Taxotere)

• Safety: The side-effect profile of the combination therapy is generally manageable and consistent with the known toxicities of the individual agents

• Response rate: More than double the amount of patients had complete disappearance of their tumours with combination therapy compared to those on sequential therapy (14% of patients on combination vs. 6% of patients on sequential)

About Xeloda
Xeloda is licensed in more than 90 countries worldwide including the EU, USA, Japan, Australia and Canada.

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(R) (docetaxel) in women with metastatic breast cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed following intravenous (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 is licensed for the first-line treatment of stomach cancer that has spread, in South Korea.

REFERENCES:
1. Semir Beslija et al. A Single Institution Randomized Trial of Taxotere (T) and Xeloda (X) Given in Combination vs. Taxotere (T) followed by Xeloda (X) after progression as First Line Chemotherapy (CT) for Metastatic Breast Cancer (MBC). Poster #407 presented at ECCO 2005.
2. Perez EA. Current Management of Metastatic Breast Cancer. Seminars in Oncology. 1999; 26(Suppl.12): 1-10.


SOURCE: Roche

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