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News
May 19, 2002 - NEW STUDY SHOWS VALUE OF MONITORING WITH HER-2/NEU BLOOD TEST; Findings Define HER-2/neu Target in Metastatic Breast Cancer
Women with metastatic breast cancer (MBC) whose serum HER-2/neu levels periodically fall below 15 ng/ml, have a significantly better prognosis and longer overall survival than those with continuously elevated levels of HER-2/neu in the blood (>15 ng/ml), according to a new study presented today at the 38th Annual American Society of Clinical Oncology (ASCO) meeting. The study concluded that monitoring levels of HER-2/neu in the blood may aid in determining the prognosis of metastatic breast cancer (MBC) patients. “This study supports previous data showing that high levels of serum HER-2/neu correlate with poor prognosis in patients with breast cancer. A significant finding of our study was a correlation between prognosis and changing levels of serum HER-2/neu in the course of metastatic disease,” said Walter Schippinger, M.D., Division of Clinical Oncology, Graz, Austria and lead investigator of the study.
This new study using the serum HER-2/neu oncoprotein test suggests the decrease of elevated serum HER-2/neu values has an impact on prognosis of patients with MBC.
Previous studies have demonstrated that decreasing serum values of HER-2/neu are reflective of response to therapy, while increasing serum levels may indicate progressive disease, poor prognosis and shorter overall survival. HER-2/neu is overexpressed in aggressive forms of breast cancer.
The objective of this retrospective study was to determine if elevated serum HER-2/neu levels affect overall survival and survival after recurrence, in MBC patients. Researchers collected 2,964 blood samples from 313 patients. The serum samples were evaluated using the serum HER-2/neu oncoprotein test, and patients were separated into two groups: those with levels above 15 ng/ml and those with levels below 15 ng/ml. Patients were treated using standard hormone and chemotherapy regimens.
About Breast Cancer
The worldwide prevalence of breast cancer approaches 4 million. In the United States alone, approximately 192,000 new cases of invasive breast cancer, including MBC, will be diagnosed this year. Approximately 50 percent of women with breast cancer develop distant metastases within five years of primary detection. It is estimated that 50 to 70 percent of MBC patients have elevated levels of the HER-2/neu oncoprotein in the blood.
About the Serum HER-2/neu Oncoprotein Test
The U.S. Food and Drug Administration (FDA) cleared the serum HER-2/neu test in 2000. The serum HER-2/neu test is an in vitro, diagnostic device intended for use in the quantitative determination of serum HER-2/neu in women with MBC who have an initial value of 15 ng/ml or greater. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with MBC. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the serum management of HER-2/neu as a prognostic indicator for early recurrence and in the management of patients on immunotherapy regimens has not been fully established. The Bayer Diagnostics serum HER-2/neu oncoprotein test is available on the Bayer Immuno1TM Immunoassay System and the ELISA (available from Oncogene Science).
About Oncogene Science
Today, Bayer Diagnostics' Oncogene Science Group (www.oncogene.com) functions as a specialized center of excellence focused on clinical research and development of cancer diagnostic tests based on oncogenes, tumor suppressor genes and other gene targets whose proteins are directly involved in tumor growth or metastasis. These tests are designed to aid oncologists in the confirmation, monitoring, staging, screening or prognosis of human cancer.
About Bayer Diagnostics
With approximately 7,000 employees worldwide and 2001 sales of $1.8 billion, Bayer Diagnostics (www.bayerdiag.com), based in Tarrytown, New York, U.S.A., is one of the largest diagnostic businesses in the world. The organization supports customers in 100 countries through an extensive portfolio of central laboratory, self-testing, nucleic acid and near patient care diagnostics systems and services for use in the assessment and management of health, including the areas of cardiovascular and kidney disease, oncology, virology, women's health and diabetes. Bayer Diagnostics is a part of the worldwide Bayer Group, a $29 billion international health care and chemicals group based in Leverkusen, Germany. Bayer Diagnostics’ global headquarters in the United States operates as part of Bayer Corporation of Pittsburgh, a research-based company with major businesses in health care, life sciences and chemicals.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Contact:
Amy Samaha
Bayer Diagnostics
Office: (914) 524-2962
Jen Acer
Ketchum
Office: (646) 935-4038
Mobile: (732) 266-4450
Women with metastatic breast cancer (MBC) whose serum HER-2/neu levels periodically fall below 15 ng/ml, have a significantly better prognosis and longer overall survival than those with continuously elevated levels of HER-2/neu in the blood (>15 ng/ml), according to a new study presented today at the 38th Annual American Society of Clinical Oncology (ASCO) meeting. The study concluded that monitoring levels of HER-2/neu in the blood may aid in determining the prognosis of metastatic breast cancer (MBC) patients. “This study supports previous data showing that high levels of serum HER-2/neu correlate with poor prognosis in patients with breast cancer. A significant finding of our study was a correlation between prognosis and changing levels of serum HER-2/neu in the course of metastatic disease,” said Walter Schippinger, M.D., Division of Clinical Oncology, Graz, Austria and lead investigator of the study.
This new study using the serum HER-2/neu oncoprotein test suggests the decrease of elevated serum HER-2/neu values has an impact on prognosis of patients with MBC.
Previous studies have demonstrated that decreasing serum values of HER-2/neu are reflective of response to therapy, while increasing serum levels may indicate progressive disease, poor prognosis and shorter overall survival. HER-2/neu is overexpressed in aggressive forms of breast cancer.
The objective of this retrospective study was to determine if elevated serum HER-2/neu levels affect overall survival and survival after recurrence, in MBC patients. Researchers collected 2,964 blood samples from 313 patients. The serum samples were evaluated using the serum HER-2/neu oncoprotein test, and patients were separated into two groups: those with levels above 15 ng/ml and those with levels below 15 ng/ml. Patients were treated using standard hormone and chemotherapy regimens.
About Breast Cancer
The worldwide prevalence of breast cancer approaches 4 million. In the United States alone, approximately 192,000 new cases of invasive breast cancer, including MBC, will be diagnosed this year. Approximately 50 percent of women with breast cancer develop distant metastases within five years of primary detection. It is estimated that 50 to 70 percent of MBC patients have elevated levels of the HER-2/neu oncoprotein in the blood.
About the Serum HER-2/neu Oncoprotein Test
The U.S. Food and Drug Administration (FDA) cleared the serum HER-2/neu test in 2000. The serum HER-2/neu test is an in vitro, diagnostic device intended for use in the quantitative determination of serum HER-2/neu in women with MBC who have an initial value of 15 ng/ml or greater. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with MBC. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the serum management of HER-2/neu as a prognostic indicator for early recurrence and in the management of patients on immunotherapy regimens has not been fully established. The Bayer Diagnostics serum HER-2/neu oncoprotein test is available on the Bayer Immuno1TM Immunoassay System and the ELISA (available from Oncogene Science).
About Oncogene Science
Today, Bayer Diagnostics' Oncogene Science Group (www.oncogene.com) functions as a specialized center of excellence focused on clinical research and development of cancer diagnostic tests based on oncogenes, tumor suppressor genes and other gene targets whose proteins are directly involved in tumor growth or metastasis. These tests are designed to aid oncologists in the confirmation, monitoring, staging, screening or prognosis of human cancer.
About Bayer Diagnostics
With approximately 7,000 employees worldwide and 2001 sales of $1.8 billion, Bayer Diagnostics (www.bayerdiag.com), based in Tarrytown, New York, U.S.A., is one of the largest diagnostic businesses in the world. The organization supports customers in 100 countries through an extensive portfolio of central laboratory, self-testing, nucleic acid and near patient care diagnostics systems and services for use in the assessment and management of health, including the areas of cardiovascular and kidney disease, oncology, virology, women's health and diabetes. Bayer Diagnostics is a part of the worldwide Bayer Group, a $29 billion international health care and chemicals group based in Leverkusen, Germany. Bayer Diagnostics’ global headquarters in the United States operates as part of Bayer Corporation of Pittsburgh, a research-based company with major businesses in health care, life sciences and chemicals.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Contact:
Amy Samaha
Bayer Diagnostics
Office: (914) 524-2962
Jen Acer
Ketchum
Office: (646) 935-4038
Mobile: (732) 266-4450
