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Medical Community Recognise Significance of Herceptin Results in Early HER2-Positive Breast Cancer

Landmark adjuvant breast cancer trial published in New England Journal of Medicine

BRUSSELS, BELGIUM -- October 20, 2005 -- The New England Journal of Medicine (NEJM) today reports that the administration of Herceptin(R) (trastuzumab) following standard chemotherapy significantly reduces the risk of disease recurrence for women with early-stage HER2-positive breast cancer by 46%.

The interim results from the international HERA (HERceptin Adjuvant) study provide new hope in the fight against HER2-positive breast cancer, a more aggressive form of the disease affecting approximately 20% to 30% of women with breast cancer. The HERA study is one of the largest breast cancer trials ever carried out, with more than 5,000 patients in 39 countries.

The study allowed the use of a wide range of chemotherapy regimens before treatment with Herceptin, making the results relevant to many parts of the world.

Dr. Martine Piccart, lead investigator of the HERA study and Chair of the Breast International Group (BIG), commented, "Breast cancer is a serious and sometimes life-threatening disease, but with appropriate and timely treatment in the early stages, many women can improve their chances of long-term survival. For women with early-stage HER2-positive breast cancer, results from the HERA study provide some much needed optimism. The study showed that Herceptin, a drug designed specifically for HER2-positive breast cancer, can remarkably reduce the risk of cancer returning." Dr. Piccart added, "I can't stress enough how crucial it is that all patients' breast tumours are tested appropriately at initial diagnosis, and if patients are HER2-positive, that they have access to Herceptin."

Results from a joint interim analysis of over 3,000 patients from two North American trials provided similar remarkable results for Herceptin in early-stage HER2-positive breast cancer, and were also published in the NEJM today. These data, at a median follow-up of 2 years, show that Herceptin in combination with a specific chemotherapy regimen provided a 52% reduction in risk of cancer coming back as well as a 33% reduction in risk of death.

The strength of the results from the HERA study has influenced medical and regulatory organizations around the world to act urgently to ensure access to Herceptin for early-stage HER2-positive breast cancer patients. Several countries are already developing clinical guidelines and committing funding to allow eligible patients faster access, prior to license.

About the HERA study
HERA, conducted by the Breast International Group (BIG) and Roche, is one of the largest adjuvant studies ever carried out among breast cancer patients; enrolment to the trial began in December 2001, and nearly 5,100 HER2-positive patients were enrolled at 480 sites in 39 countries across the world. HERA is a randomised trial, which, following standard adjuvant systemic chemotherapy and radiotherapy (if applicable), evaluates observation versus Herceptin every 3 weeks for 12 months or 24 months in women with early-stage HER2-positive breast cancer. The HERA study allowed for the use of a wide range of chemotherapy regimens, and both lymph node-positive and lymph node-negative patients were eligible for entry into the trial.

According to the interim analysis, the primary efficacy endpoint was met, showing that in both 12- and 24-month arms, patients who received Herceptin had a statistically significant improvement in disease-free survival (the length of time after treatment during which no disease is found). At a median follow-up of 1 year, the secondary endpoint of overall survival had not reached statistical significance, but an improvement in overall survival is also possible as the data mature.

The NEJM article provides the results of the comparison between 12 months of Herceptin versus observation, but not a comparison of 12 months versus 24 months treatment duration. The trial will continue to assess this comparison and data are expected in 2008.

All study data are managed by a Brussels-based BIG member group, the Breast European Adjuvant Studies Team (BrEAST), with independent statistical analysis carried out in Boston and Scotland by the non-profit research organization, Frontier Science. The HERA study also has an external Independent Data Monitoring Committee (IDMC) that regularly reviews safety data. No safety concerns were raised by the IDMC, and the incidence of congestive heart failure was very low (0.5% in the Herceptin arm vs. 0% in the observation arm). Patients in this study will continue to be followed for any side effects for up to 10 years.

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. 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. Research shows that HER2-positivity affects approximately 20-30% 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. Herceptin 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.

Herceptin received approval in the European Union in 2000 for use in patients with metastatic breast cancer, whose tumours overexpress the HER2 protein, as first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, and as a single agent in third-line therapy. In 2004, it also received approval for use in combination with docetaxel as a first-line therapy in HER2-positive patients who have not received chemotherapy for their metastatic disease. 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 BIG
The Breast International Group (BIG) was founded in 1996 by a group of leading European breast cancer specialists. BIG enables its members – academic co-operative groups based in Europe, Latin America, Canada, Australia / New Zealand and Asia that have affiliated centres around the world - to get together regularly to develop collaborations in clinical and translational research in order to reduce wasteful duplication of efforts and to achieve results more quickly. By accelerating the process that informs both clinicians and patients about their treatment choices, and by guarding the highest standards and principles of research, BIG hopes ultimately that this model of international collaboration in breast cancer research will better serve the women whose lives are affected by this disease.

All trademarks used or mentioned in this release are legally protected.

REFERENCES:
1. -Gebhart M, Procter M, Leyland-Jones B, et al. A Randomized Trial of Trastuzumab Following Adjuvant Chemotherapy in Women with HER2 Positive Breast cancer. New England Journal of Medicine 353:16 2005.
2. Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.
3. Romond, E., Perez, E. et al. Trastuzumab plus Adjuvant Chemotherapy for Operable HER2 Positive Breast Cancer. New England Journal of Medicine 353:16 2005.
4. World Health Organization, Globocan 2000: Cancer Incidence, Mortality and Prevalence Worldwide. 2000.


SOURCE: Roche

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