Xeloda use Associated With Better Re-Growth of Hair in Women With Breast Cancer

Zurich (ots/PRNewswire) -

- Hair Recovery was Quicker Following new Xeloda-Containing
Chemotherapy Regimen

- For Non-US Domestic Media Only

Poster nos: 0145. First Safety Data from a Randomised Phase III
Trial Comparing Adjuvant Epirubicin-Cyclophosphamide followed by
Docetaxel (EC followed by T) vs. ET followed by Capecitabine (X) in
Node-Positive Operable Breast Cancer (BC)

Authors: Martín M. et al.

Presentation: St Gallen Oncology conference 'Primary Therapy of
Early Breast Cancer' on Friday, 13 March 2009 10:30-11.30 and
12.30-14.00hrs.

New findings presented today report that incomplete hair recovery
affected fewer women (nearly 20% fewer) 1-2 years following their
treatment, when the chemotherapy pill Xeloda was included in their
treatment regimen for breast cancer following surgery. The initial
safety results from the trial by a Spanish breast cancer
investigation group (GEICAM) show that the average length of time
that women needed to wear wigs was reduced by over a third in the
Xeloda-containing treatment group compared to those on standard
chemotherapy treatment where some women's hair loss meant they had to
permanently wear a wig.[1]

Reducing the effect of hair loss for women with breast cancer is
an important issue; it is a common and distressing side-effect of
chemotherapy occurring in 77% - 95% of chemotherapy cycles.[2] Hair
loss is often considered one of the worst experiences of
chemotherapy; some women view it worse than losing a breast and may
refuse chemotherapy because of the risk of hair loss.[3] Patients can
feel angry or depressed, it can remind them of their cancer and cause
them to worry about how it will affect their relationships with
family and friends and their social/work life.[4]

"Hair loss is a highly sensitive issue for women with breast
cancer, so identifying chemotherapies that reduce this distress is
important," said Professor Miguel Martin, investigator for the GEICAM
study group and oncologist at Hospital Clínico, University of San
Carlos, Madrid. "These findings suggest that oral Xeloda may have a
bigger role to play than just improving survival in breast cancer."

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.[5],[6] Xeloda
has been approved for the treatment of breast cancer for over 10
years. It 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.

Breast cancer is the second most common cancer in the world and
the most common cancer among women with 1.1 million new cases each
year worldwide. [7],[8]

Notes to editors

About the study:

The GEICAM/2003-10 study is investigating whether adjuvant
therapy with Xeloda in an experimental regimen (epirubicin plus
docetaxel followed by capecitabine) offers a superior treatment
option for patients with operable breast cancer compared to standard
care (epirubicin plus cyclophosphamide followed by docetaxel).

- The primary endpoint of the study is 5-year disease-free survival from
the time of diagnosis.
- Secondary endpoints include overall survival, safety (NCI CTCAE v2.0)
and Quality of Life (QoL).

Interim safety data from 1,260 of the enrolled 1,347 patients are
available to date.

Questionnaire responses from a group of 262 breast cancer
patients specifically on scalp hair loss, 1-2 years after ending
chemotherapy showed that:

- Incomplete hair recovery was reported by 28 (11%) patients in the
Xeloda treatment arm and by 73 (28%) patients in the non-Xeloda
Containing treatment arm.
- On average women wore wigs for a significantly shorter time in the
Xeloda treatment arm, 5.85 months, compared to those in the non-Xeloda
containing arm of the study, 8.35 months.
- Some patients in the non-Xeloda containing treatment arm had persistent
grade 2 hair loss and had to wear a wig permanently, compared to none
in the Xeloda treatment 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 GEICAM Group:

http://www.geicam.org

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

References:

---------------------------------

[1] Martín M. et al., First Safety Data from a Randomised Phase
III Trial Comparing Adjuvant Epirubicin-Cyclophosphamide followed by
Docetaxel (EC followed by T) vs. ET followed by Capecitabine (X) in
Node-positive Operable Breast Cancer (BC). Presented St Galen
Oncology conference `Primary Therapy of Early Breast Cancer' 13
March 2009; Poster nos 0154

[2] Lemieux J. et al., Chemotherapy-induced alopecia and effect
on quality of life among women with breast cancer: a literature
review. Psycho-Oncology 2008;17:317-328

[3] Browall M. et al., Post menopausal women with breast cancer:
their experiences of the chemotherapy treatment period. Cancer Nurs
2006;29(1): 34-42

[4] Luoma and Hakamies-Blomqvist. The meaning of quality of life
in patients being treated for advanced breast cancer: a qualitative
study. Psycho-Oncology 2004; 13(10):729-739

[5] 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.

[6] Stockler M, et al., J Clin Oncol 2007;25(18S):1031

[7] Batchelor et al., Euro J Cancer Care 2001; 10(3)147-163

[8] 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

ots Originaltext: GEICAM
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information please contact: Lydia Blanco, GEICAM, Head of
Department, Events & Communication, Tel:+34-91-659-28-70; Professor M
Martín, GEICAM, Tel: +34-91-659-28-70, mmartin@geicam.org