Roche Pharmaceuticals

Addition of Xeloda to Herceptin and Docetaxel Allows Patients With Breast Cancer to Live Five Months Longer Without Their Cancer Growing

    San Antonio, Texas (ots/PRNewswire) - New data presented today at the San Antonio Breast Cancer Symposium (SABCS) show that adding Xeloda (capecitabine) to the current gold standard combination of Herceptin (trastuzumab) and docetaxel allows patients with advanced HER2-positive breast cancer to live, on average 5 months longer until their cancer starts to grow. The addition of capecitabine in this setting represents an important advance in the treatment of an aggressive form of breast cancer and provides additional hope to women with an otherwise poor prognosis.

    "Trastuzumab's ability to increase survival changed the treatment landscape for advanced breast cancer patients, and now adding capecitabine to the most commonly used first-line regimen of trastuzumab and taxanes allows patients to live even longer without their disease progressing," said Dr Andrew Wardley, lead investigator of the study and Consultant Medical Oncologist from the Christie Hospital in the UK. "As capecitabine is an oral chemotherapy that can be taken at home, the additional therapy does not increase the time patients spend in the hospital. This is a tremendous benefit for patients, which translates into better one and two-year survival rates for the triple combination."

    The results of the CHAT study (Capecitabine, Herceptin and Taxotere) show the addition of capecitabine significantly improves two important measures of treatment efficacy. One measure evaluates the amount of time from the start of treatment until tumour growth, known as time to progression (TTP), the other measures the amount of time from the start of treatment until tumour growth or death, known as progression-free survival (PFS). The observed improvement in both these measures for the CHAT study was both statistically and clinically significant - an improvement in both these measures means that patients are living for longer with their cancer under control.

    Results of the CHAT study show that with the addition of capecitabine:

    - The median TTP increased from 13.6 to 18.6 months (p-value = 0.0295);

    - The median PFS increased from 12.8 months to 17.9 months (p-value = 0.0402).

    In HER2-positive breast cancer, trastuzumab not only offers the best chance of a cure in early disease, but also has proven survival benefits in advanced disease. The study evaluated the addition of oral capecitabine to trastuzumab and docetaxel in patients with HER2-positive breast cancer who were previously untreated for their locally advanced, or metastatic, disease. Additional analysis showed that when capecitabine is added to the trastuzumab and docetaxel combination, there is a 7 percent improvement in complete response, from 16 to 23 percent. Currently the median overall survival for the study is close to 4 years, although data is immature this is one of the longest overall survival rates seen in HER2-positive breast cancer patients whose disease has spread.

    Breast cancer is the leading cause of cancer deaths worldwide in women under the age of 55(1) and more than one million women are diagnosed with breast cancer each year.(2) HER2-positive breast cancer, which affects approximately 20-30 percent(3) of women with breast cancer, demands immediate attention because the tumours are fast-growing and there is a high likelihood of relapse.

    Xeloda is a highly effective and innovative oral chemotherapy drug that targets the cancer-killing agent 5-FU (5-fluorouracil) directly at the site of cancer cells without the inconvenience and burden of traditional intravenous (i.v.) therapy. The unique way in which Xeloda works provides women who have breast cancer with a powerful treatment that has a better side-effect profile compared to i.v. chemotherapy.

    Notes to Editors:

    The abstract is being presented on Friday 14 December 5:30-7:30 pm

    POSTER SESSION 3 & RECEPTION - Exhibit Hall B

    Abstract #3001-3115

    About the CHAT study (Capecitabine, Herceptin and Taxotere)

    222 patients were randomised into the phase II study: 112 received Xeloda plus Herceptin and docetaxel and 110 received Herceptin and docetaxel alone. Herceptin was administered at a dose of 6 mg/kg every 3 weeks until disease progression (after an initial loading dose of 8 mg/kg). Docetaxel was administered at a dose of 100mg/m2 every 3 weeks with Herceptin alone, and 75mg/m2 when Xeloda was added, until disease progression. Xeloda was administered at a dose of 950 mg/m2 twice daily for the first 14 days of each 3-week cycle. Patients in the Herceptin and docetaxel alone arm of the study were given the option to cross over to receive Xeloda, following disease progression.

    The CHAT study has an external Data Safety Monitoring Board (DSMB) that regularly reviews safety data. No unexpected safety concerns were raised by the DSMB.

    About Roche

    Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. Additional information is available on the Internet at http://www.roche.com.

    Further information available:

    - Breast cancer fact sheet

    - Xeloda fact sheet

    - Roche: http://www.roche.com

    - Broadcast quality B-roll including doctor, caregiver and patient interviews is available for download via http://www.thenewsmarket.com

    ---------------------------------

    (1) Brandy A. Box et al. Breast cancer. Manual of clinical oncology, fifth edition, 2004; 233-253

    (2) World Health Organisation (WHO) 2003. http://www.who.int/mediacentre/releases/2003/pr27/en/)

    (3) Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
For further information please contact: Julia Pipe, International
Communications Manager - Xeloda, F.Hoffmann-La Roche, Tel:
+41(0)61-687-4376, Mob: +41-79-263-9715, Email: julia.pipe@roche.com;
Nerea Hinzpeter, ShireHealthPR, Tel: +1-212-625-4178, Mob :
+1-646-407-9015, Email : nerea.hinzpeter@shirehealthpr.com



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