Herceptin Eradicates Tumours and may Reduce the Need for Mastectomies in Women With Inflammatory HER2-Positive Breast Cancer - one of the Most Aggressive and Fastest Growing Forms of the Disease
26/09/2007 09:01
PR Newswire
BARCELONA, Spain, September 26 /PRNewswire/ --
- Abstract no: 2030, Being Presented at ECCO in the "Proffered Papers:
Breast Cancer - Early Disease" Session in the Forum, Starting at 09.00am
on Wednesday 26th September 2007
- For non-US Media Only
New data show that the addition of Herceptin(R) (trastuzumab) to
chemotherapy prior to breast cancer surgery (neoadjuvant therapy) completely
eradicates tumours in nearly three times as many women with inflammatory
HER2-positive breast cancer compared to chemotherapy alone. Inflammatory
breast cancer is a rare, but highly aggressive form of the disease - the
tumours spread quickly, often leading to the need for full mastectomies, and
it has a worse outlook than other breast cancers. These results, presented at
the European Cancer Conference (ECCO 14) in Barcelona, are particularly
significant as treatment with Herceptin in this setting may actually lead to
more breast conserving surgery and most importantly to potentially improved
survival.
"This Herceptin data is very important for women with inflammatory
HER2-positive breast cancer, an extremely aggressive cancer," said Prof. Dr.
med. Wolfgang Eiermann, Medical Director, Red-Cross-Clinik Munich. "Women
could have their tumours eradicated by treating with Herceptin and
chemotherapy prior to surgery which could lead to fewer mastectomies, and
more importantly, fewer deaths from this type of breast cancer".
HER2-positive disease is diagnosed in up to 30% of all breast cancer
cases.(1) It demands special attention because the tumours are typically
fast-growing and there is a high likelihood of relapse. Neoadjuvant therapy
is administered to patients to help make inoperable tumours shrink and become
removable, thus promoting breast conserving surgery.
The results from the NeOAdjuvant Herceptin (NOAH) study demonstrated that
Herceptin plus chemotherapy led to the complete disappearance of the tumour
in the breast (a pathological complete response to treatment) in nearly three
times as many patients with inflammatory breast cancer (55% vs. 19%, p=0.004)
compared to chemotherapy alone.(2) Furthermore, the combination led to
complete disappearance of the tumours from both the breast and the lymph
nodes (a total pathological complete response to treatment) in 48% of
patients, compared to only 13% of those who received chemotherapy alone
(p=0.002). The treatment was well tolerated with acceptable cardiac safety.
The trial is ongoing and event-free survival data are maturing.
Notes to editors:
About the NOAH study
NOAH is a phase III trial assessing neoadjuvant Herceptin in combination
with chemotherapy in patients with HER2-positive locally advanced breast
cancer (LABC). Patients were assigned to one of two cohorts depending on HER2
status. All patients received neoadjuvant chemotherapy before surgery
consisting of three cycles of doxorubicin-paclitaxel (AT), four cycles of
paclitaxel (T) and three cycles of cyclophosphamide / methotrexate /
5-fluorouracil (CMF). Patients with HER2-positive disease were randomised to
receive concomitant Herceptin for one year or chemotherapy only.
Out of 228 evaluable patients with HER2-positive breast cancer that were
included in the study, 61 had inflammatory breast cancer (IBC). Of the 99
evaluable patients with HER2-negative breast cancer, 14 had IBC. 31 patients
with HER2-positive IBC received Herceptin in addition to chemotherapy. The
analysis discussed in this news release involves this subset of patients with
inflammatory breast cancer.
The NOAH protocol is a joint effort of Fondazione Michelangelo, Grupo
SOLTI and Roche.
About breast cancer
Breast cancer is the most common cancer among women worldwide.(3) Each
year more than one million new cases of breast cancer are diagnosed
worldwide, and nearly 400,000 people will die of the disease annually.(4)
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 percent of
women with breast cancer.
About Herceptin (trastuzumab)
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. It has demonstrated efficacy in treating both early and advanced
(metastatic) breast cancer. Given on its own as monotherapy as well as in
combination with or following standard chemotherapy, Herceptin has been shown
to improve response rates, disease-free survival and overall survival while
maintaining quality of life in women with HER2-positive breast cancer.
Herceptin received approval for use in the European Union for advanced
(metastatic) HER2-positive breast cancer in 2000, and for early HER2-positive
breast cancer in 2006. In the advanced setting, Herceptin is now approved for
use as a first-line therapy in combination with paclitaxel where
anthracyclines are unsuitable, as first-line therapy in combination with
docetaxel, and as a single agent in third-line therapy. It is also approved
for use in combination with an aromatase inhibitor for the treatment of
post-menopausal patients with HER2 and hormone receptor co-positive
metastatic breast cancer. In the early setting, Herceptin is approved for use
following standard (adjuvant) 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 nearly 400,000 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 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, metabolism and 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 employs roughly 75,000 worldwide and has R? 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 at www.roche.com.
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(1) Harries M, Smith I. The development and clinical use of trastuzumab
(Herceptin). Endocr Relat Cancer 9: 75-85, 2002.
(2) Baselga J, et al., Efficacy of Neoadjuvant Trastuzumab in Patients
With Inflammatory Breast Cancer: Data From the NOAH (NEOADJUVANT HERCEPTIN)
Phase III Trial. Abstract #2030. ECCO Meeting 2007.
(3) World Health Organization,
http://www.who.int/cancer/detection/breastcancer/en/
(4) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and
Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon,
2004. 2004
For further information please contact: Nils Eckardt, F. Hoffmann-La Roche Ltd, Mobile: +41-(0)-79-593-4357, nils.eckardt@roche.com; Amanda Sefton, Ketchum, Mobile : +44-(0)-7707-812-968, amanda.sefton@ketchum.com