Addition of Xeloda to Herceptin and Docetaxel Allows Patients With Breast Cancer to Live Five Months Longer Without Their Cancer Growing
15/12/2007 00:31
PR Newswire
SAN ANTONIO, Texas, December 14 /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.
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