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.de

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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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