The Finnish Breast Cancer Group

Xeloda Shows Strong Promise in Early Breast Cancer

    San Antonio, Texas (ots/PRNewswire) -

    - FOR NON-US DOMESTIC and NON-UK journalists only

    - Early Data Indicate Chemotherapy Pill Xeloda, Already Proven in Advanced Breast Cancer, May Also Reduce Recurrence of Early Breast Cancer

    Data presented today indicate that adding Xeloda to standard chemotherapy allows women to live cancer-free for longer. Preliminary data presented at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) demonstrate that women with early breast cancer taking Xeloda as part of their chemotherapy had a 34% reduction in the risk of the cancer  returning.(1) The trial by the Finnish Breast Cancer Group carried out in  Finland and Sweden also showed that patients in the Xeloda arm were more  likely to live longer overall and less likely to have their cancer spread to  another part of the body.

    "We already know that oral Xeloda on its own, or in combination with other chemotherapies, improves survival in patients with advanced breast cancer, and the positive results presented today highlight the bigger role that Xeloda may have in treating breast cancer." said Professor Heikki Joensuu, Helsinki University Hospital, Finland. "These data suggest that women may benefit from taking Xeloda in the earlier stages of their disease and may live longer without breast cancer."

    Breast cancer is the second most common cancer in the world and the most common cancer among women.(2) There are 1.1 million new cases of female breast cancer each year worldwide.(2)

    Xeloda is an innovative oral chemotherapy drug that is powerful
and effective treatment option that has been shown to significantly
lengthen survival in women with advanced breast cancer (3),(4) and
has been approved  for the treatment of breast cancer for over 10
years. It uniquely activates  the cancer killing agent 5-FU
(5-fluorouracil) directly inside the cancer  cells. Furthermore as
Xeloda is taken as a tablet patients can take it in the comfort of
their own home, while offering them the freedom to carry on with
their lives as normally as possible.        Notes to Editors:        About
the study        Abstract 82: Significant improvement in recurrence-free
survival (RFS) when capecitabine (X) is integrated into docetaxel (T)
5-FU + epirubicin + cyclophosphamide (CEF) adjuvant therapy for
high-risk early breast cancer (BC): interim analysis of the
FinXX-trial.

    Authors: Joensuu H, Kellokumpu-Lehtinen P, Huovinen R, Jukkola-Vuorinen A, Asola R, Kokko R, Ahlgren J, Bono P, Tanner M, Lindman H, for The Finnish Breast Cancer Group

    Presentation: San Antonio Breast Cancer Symposium - December 14, 2008 11:45 AM

    The study, led by the Finnish Breast Cancer Group, is a large open-label, two-arm, randomised multi-centre phase III study in patients with early breast cancer. Recruitment of 1,500 patients in Finland and Sweden with no distant metastases who have a >25% risk of distant recurrence within 5 years from the time of diagnosis, has now been completed

    - The primary objective of the study is to compare the recurrence-free survival of single agent docetaxel, followed by cyclophosphamide, epirubicin and 5-FU (CEF) to docetaxel with capecitabine, followed by cyclophosphamide, epirubicin and capecitabine (CEX) in the adjuvant treatment of patients with early breast cancer

    - Secondary objectives include the evaluation and comparison between the two treatment arms of:

    - Safety profile

    - Overall survival

    Results to date show:

    - 54 women in the Xeloda arm had their cancer return, or died compared to 80 women in the non-Xeloda containing arm of the study

    - 42 women in the Xeloda arm experienced tumour growth in another part of their body compared to 72 women in the non-Xeloda arm

    - Although the results are not yet mature, women on the Xeloda arm showed a trend towards superior overall survival over those women not on the Xeloda arm

    About Xeloda

    Xeloda, capecitabine, is a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs. Xeloda uniquely activates the cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells so avoiding damage to healthy cells. Xeloda tablets can be taken by patients in their own home, reducing the number of hospital visits.

    Licensed and marketed by Roche in more than 100 countries worldwide, Xeloda has over ten years proven clinical experience providing an effective and flexible treatment option to over 1.5 million people with cancer. Xeloda is currently approved in:

    - Metastatic Colorectal Cancer

    - Metastatic Breast Cancer

    - Adjuvant Colon Cancer

    - Advanced Gastric Cancer

    - Metastatic Pancreatic Cancer

    About The Finnish Breast Cancer Group

    The Finnish Breast Cancer Group is a scientific and educational legitimised society for scientists and specialists who are responsible for breast cancer diagnostics and treatment in Finland. With 260 members The Finnish Breast Cancer Group has carried out several clinical trials on advanced breast cancer and in adjuvant setting on academic basis from 1991.

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

    References:

    1. Significant improvement in recurrence-free survival (RFS) when capecitabine (X) is integrated into docetaxel (T) 5-FU + epirubicin + cyclophosphamide (CEF) adjuvant therapy for high-risk early breast cancer (BC): interim analysis of the FinXX-trial. Presented at the San Antonio Breast Cancer Symposium, December 2008 (abstract # 82)

    2. Kamanger F et al Patterns of cancer incidence, mortality and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol 2006; 24: 2137 - 2150

    3. O'Shaughnessy J et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: Phase III trial results. J Clin Oncol 2002; 20:2812-23.

    4. Wardley, A. et al. Evaluation of trastuzumab (Herceptin(R)), docetaxel and capecitabine as first-line therapy for HER2-positive locally advanced or metastatic breast cancer. Presented at the San Antonio Breast Cancer Symposium, December 2007 (abstract # 3001-3115)

ots Originaltext: The Finnish Breast Cancer Group
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
For further information please contact: Finnish Breast Cancer Group,
Professor Hiekki Joensuu, +358-9-471-73208, Heikki.Joensuu@hus.fi



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