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.

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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.de

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