18.04.2008 – 12:09
Herceptin(R) Helps Eradicate HER2-Positive Breast Tumours When Given Before Surgery
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- Herceptin Offers Women With HER2-Positive Breast Cancer the Best Chance of a Cure
New data presented today as part of a late breaking plenary session at EBCC in Berlin showed that Herceptin (trastuzumab) in combination with standard chemotherapy prior to breast cancer surgery (neoadjuvant therapy) completely eradicates the tumours in 45.5% of women with HER2-positive early breast cancer. This is an impressive finding since the proportion of women achieving total tumor eradication with standard chemotherapy alone is less than 30%.(1) These important results from the GeparQuattro study highlight the efficacy of early treatment of HER2-positive breast cancer, raising the prospect of cure.
"Herceptin delivered on its promise of high tumour eradication when given to women with this aggressive form of breast cancer before their surgery", said investigator Prof. Dr. von Minckwitz, University Women's Hospital, Frankfurt, Germany and Managing Director of the German Breast Group. "The GeparQuattro study is the largest neoadjuvant clinical trial in women with HER2-positive breast cancer and shows that Herceptin offers real hope for women with early breast cancer."
The GeparQuattro results are consistent with other Herceptin neoadjuvant studies, such as NOAH (NeOAdjuvant Herceptin, including 228 evaluable HER2-positive patients)(2) and TECHNO (Taxol-Epirubicin-Cyclophosphamid-Herceptin Neoadjuvant), reinforcing the strong evidence for the benefits associated with Herceptin in the early stages of HER2-positive breast cancer.
"It is very reassuring to see that the GeparQuattro study confirmed the significant benefits observed with Herceptin in other neoadjuvant studies in HER2-positive breast cancer", commented Prof. Dr. Untch, Helios Clinics, Berlin, Germany, who presented the study findings. "Herceptin makes women with this aggressive type of breast cancer feel more confident about their future."
GeparQuattro and NOAH studied Herceptin in combination with different chemotherapy regimens and showed equally good efficacy results, indicating that Herceptin can be combined successfully with different chemotherapies. Measuring the efficacy of Herceptin in these studies was based on the disappearance of tumour cells in the breast and in the lymph nodes - a therapeutic success measure known as complete pathological response, which is a strong predictor for long-term survival.(3),(4)
HER2-positive breast cancer is diagnosed in approximately 20-30% of all breast cancer cases.(5) It demands special attention because the tumours are typically fast-growing, and there is a high likelihood of the cancer coming back. Pre-surgery therapy is administered to women to help make large (>2cm) tumours shrink enabling them to become operable and improve treatment outcomes.
Notes to Editors:
About the GeparQuattro study
GeparQuattro is a study conducted by the AGO and GBG study groups. It is a randomized phase III study that enrolled 1510 patients - 453 of the patients had HER2-positive disease. Patients with HER2-positive breast cancer received four cycles of epirubicin plus cyclophosphamide plus Herceptin. Patients then received one of three treatment options: either four cycles of docetaxel plus Herceptin, docetaxel plus Xeloda plus Herceptin concomitantly, or docetaxel plus Herceptin followed by Xeloda plus Herceptin. HER2-negative patients received the same chemotherapy regimen without adding Herceptin. The primary objective of the study was to assess the efficacy of different chemotherapy regimens. One of the study endpoints of GeparQuattro was pathological complete response rate (pCR) including in situ pathological response rate in patients with HER2-negative and HER2-positive disease. There were no significant cardiac events observed in the study.
About breast cancer
Breast cancer is the most common cancer among women worldwide.(6) 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.(7)
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 more than 450,000 HER2-positive breast cancer patients worldwide.
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, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at http://www.roche.com.
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(1) Sachelarie I, et al. Primary systemic therapy of breast cancer. The Oncologist. 2006;11:574-589
(2) Gianni L, et al., Neoadjuvant trastuzumab in locally advanced breast cancer (NOAH):antitumor and safety analysis. Abstract # 532. American Society of Clinical Oncology Annual Meeting 2007
(3) Rastogi et al. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85
(4) Kaufmann, von Minckwitz. Preoperative (neoadjuvant) systemic treatment of breast cancer. Breast. 2005 Dec;14(6):576-81
(5) Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002
(6) World Health Organization, http://www.who.int/cancer/detection/breastcancer/en/
(7) Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004
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