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Media Release
STRICT EMBARGO: Friday 14 December 17:30
(Central Standard Time, CST; GMT-6hrs)
For Non-US Media Only
Addition of Xeloda to Herceptin and docetaxel allows patients with breast
cancer to live five months longer without their cancer growing
SAN ANTONIO, TEXAS, 14 December, 2007 – 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).
F. Hoffmann-La Roche Ltd
4070 Basel, Switzerland
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 percent3 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 5FU (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.
** ENDS **
Notes to editors:
The abstract is being presented on Friday 14 December 5:30-7:30 pm (Central Standard Time, CST;
GMT-6hrs), 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.
2
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 www.roche.com.
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: [email protected]
Nerea Hinzpeter
ShireHealthPR
Tel: +1 212 625 4178
Mob : +1 646 407 9015
Email : [email protected]
Further information available:

Breast cancer fact sheet

Xeloda fact sheet

Roche: www.roche.com

Broadcast quality B-roll including doctor, caregiver and patient interviews is available
for download via 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.
3