Investor Update
Basel, 17 Dec 2007
Addition
of Xeloda to Herceptin and docetaxel allows patients with breast cancer to live five months longer without
their cancer growing
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 551
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 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. As the world’s biggest biotech company and an innovator of
products and services for the early detection, prevention, diagnosis and treatment of diseases, the
Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche
is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic
disorders and diseases of the central nervous system. In 2006, sales by the Pharmaceuticals Division
totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs.
Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership
interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D.
Worldwide, the Group employs about 75,000 people. Additional information is available on the Internet
at www.roche.com.
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Further information available:
- Broadcast quality B-roll including doctor, caregiver and patient interviews is available for download via www.thenewsmarket.com
References
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.