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).

@@start.t1@@      - 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).@@end@@

    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:

@@start.t2@@      - 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.@@end@@

    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:

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



    [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:

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,

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