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Herceptin
added to hormonal therapy prolongs progression-free survival for
patients with advanced HER2-positive breast cancer
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Basel,
29 May 2006
Roche announced today that data from a new study show
that the addition of Herceptin (trastuzumab) to the hormonal
therapy, Arimidex (anastrozole), increases the length
of time that patients live without their cancer progressing
(progression-free survival) for patients whose advanced
breast cancer is hormone receptor-positive, as well as
HER2-positive.
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Herceptin:
a medicine to treat breast cancer |
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Hormone receptor-positive
breast cancer affects two-thirds1 of patients with breast cancer
and is typically considered ‘lower-risk’ due to successful treatment
with hormonal therapies. However, up to a quarter of these breast
cancers are also HER2-positive,2
an aggressive form of the disease that requires special and immediate
attention because the tumours are fast-growing and there is a
higher likelihood of relapse. This was the first randomised study
in this specific subset of ‘co-positive’ patients, whose prognosis
has been uncertain thus far.
Eduard Holdener, Global Head of Roche Pharma Development said:
“We are glad to learn from this study that the combination therapy
offers a new treatment regimen for these breast cancer patients
who suffer from an extremely aggressive form of the disease. We
will now work with trial investigators to analyse the full set
of data from this trial, and submit it for presentation at an
upcoming medical meeting in the second half of 2006. We will start
preparations to file these data with health authorities around
the world.”
To date, over 230,000 patients with HER2-positive breast cancer
have been treated with Herceptin worldwide. Herceptin consistently
benefits patients regardless of whether it is given in the early
stage or advanced settings, or whether it is in combination with
chemotherapy, hormonal therapy, or as a single agent.
About the Study
The TAnDEM study, conducted by Roche is a randomised, Phase III
trial, which evaluated Herceptin plus Arimidex versus Armidex
alone as first-line therapy (or second line hormonal therapy)
in postmenopausal women with advanced (metastatic), HER2-positive
and hormone receptor-positive (ER-positive and/or PR-positive)
breast cancer. Enrolment to the trial began in 2001, and 208 HER2
and hormone receptor co-positive patients were enrolled at 134
sites in 25 countries across the world. Arimidex was scheduled
at a dose of 1 mg daily until progression. Herceptin was administered
in 2 mg/kg weekly doses (after an initial loading dose of 4 mg/kg)
until disease progression.
According to the analysis, the primary efficacy endpoint was met,
showing that patients who received Herceptin had a statistically
significant improvement in progression-free survival.
Overall safety data in both arms of the trial were acceptable
given the known safety profile of each of the drugs in the advanced
breast cancer setting. Patients in this study will continue to
be followed for any side-effects.
About breast cancer and Herceptin
Eight to nine percent of women will develop breast cancer during
their lifetime, making it one of the most common types of cancer
in women.3 Each year more
than one million new cases of breast cancer are diagnosed worldwide,
with a death rate of nearly 400,000 people per year.
In HER2-positive breast cancer, increased quantities of the HER2
protein are present on the surface of the tumour cells. This is
known as ‘HER2 positivity.’ High levels of HER2 are present in
a particularly aggressive form of the disease which responds poorly
to chemotherapy. Research shows that HER2-positivity affects approximately
20% – 30%4 of women with breast
cancer.
Herceptin is a humanised antibody, designed to target and block
the function of HER2, a protein produced by a specific gene with
cancer-causing potential. In addition to its efficacy in the early-stage
breast cancer setting, Herceptin also has demonstrated improved
survival in the advanced (metastatic) setting, where its addition
to chemotherapy allows patients to live up to one-third longer
than chemotherapy alone.5
Herceptin received approval in the European Union in 2000 for
use in patients with advanced (metastatic) breast cancer, whose
tumours overexpress the HER2 protein. In addition to being indicated
for use in combination with docetaxel as a first-line therapy
in HER2-positive patients who have not received chemotherapy for
their metastatic disease, it is also indicated as a first-line
therapy in combination with paclitaxel where anthracyclines are
unsuitable, and as a single agent in third-line therapy. Herceptin
also received approval in the European Union in May 2006 for use
in early-stage HER2-positive patients following standard chemotherapy.
Herceptin is marketed in the United States by Genentech, in Japan
by Chugai and internationally by Roche. Since 1998, Herceptin
has been used to treat over 230,000 HER2-positive breast cancer
patients worldwide.
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 a supplier of innovative products and services
for the early detection, prevention, diagnosis and treatment of
disease, the Group contributes on a broad range of fronts to improving
people’s health and quality of life. Roche is a world leader in
diagnostics, the leading supplier of medicines for cancer and
transplantation and a market leader in virology. In 2005 sales
by the Pharmaceuticals Division totalled 27.3 billion Swiss francs,
and the Diagnostics Division posted sales of 8.2 billion Swiss
francs. Roche employs roughly 70,000 people in 150 countries and
has R&D agreements and strategic alliances with numerous partners,
including majority ownership interests in Genentech and Chugai.
Additional information about the Roche Group is available on the
Internet (http://www.roche.com/).
All trademarks used or mentioned
in this release are legally protected.
Additional information:
- About Genentech
- Roche
in Oncology
- Roche Health Kiosk on cancer
- Video
clips - in broadcast standard, free of charge
References:
1 K. C. Chu and W. F. Anderson. Rates for breast cancer
characteristics by estrogen and progesterone receptor status in
the major racial/ethnic groups. Breast Cancer Research and Treatment
74: 199-211, 2002.
2 F. Penault-Llorca, A. Vincent-Salomon, M. C. Mathieu,
et al. On Behalf Of The Esther Study Group. Incidence and implications
of HER2 and hormonal receptor overexpression in newly diagnosed
metastatic breast cancer (MBC). American Society of Clinical Oncology
(ASCO) Meeting Meeting Abstracts, 23: 764, 2005.
3 World Health Organization, 2000.
4 Harries M, Smith I. The development and clinical use of
trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.
5 Extra JM, Cognetti F, Maraninchi D et al. Long-term survival
demonstrated with trastuzumab plus docetaxel: 24-month data from
a randomised trial (M77001) in HER2-positive metastatic breast
cancer. Abstract #555, American Society for Clinical Oncology
(ASCO) Annual Meeting 2005.
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