Study suggests Siemens non-invasive blood test may have a role in monitoring breast cancer patients' response to Herceptin

Siemens Healthcare announced that data from a new study published in the American Cancer Society journal Cancer, supports using the Siemens Serum HER-2/neu test to monitor patients with an aggressive type of metastatic breast cancer.

This non-invasive blood test can be used to help monitor the widely-used Herceptin(R) therapy.

Metastatic cancer is an advanced stage of cancer that has spread to one or more sites throughout the body. As recommended by the National Comprehensive Cancer Network (NCCN), clinicians should determine if a metastatic breast cancer (MBC) patient carries a protein called HER-2/neu, which is associated with an aggressive type of cancer that responds less favorably to treatment. Studies now document that greater than 50% of metastatic breast cancer patients can have HER-2/neu positive tumors. It is important to identify these patients because they may benefit from Herceptin therapy, which specifically targets this aggressive type of cancer.

Historically, there have been few tools available to monitor the effectiveness of Herceptin therapy, making it difficult to determine if a patient's therapy should be altered. In addition to the new study published in Cancer, there are other published studies(1-2) supporting the use of Siemens' Serum HER-2/neu test for monitoring MBC patients and their response to therapy.

"This particular study is important because it offers additional evidence of the importance of monitoring therapy for an aggressive type of breast cancer," noted Chief Executive Officer of Siemens Healthcare Diagnostics, Donal Quinn. "Breast cancer is the most frequent type of cancer diagnosed in women, causing over 548,000 deaths worldwide each year. It is a priority to our company to help clinicians understand their options to monitor and treat breast cancer patients, with the goal to increase survival rates of the thousands of women fighting this battle."

About the Serum HER-2/neu test and the study published in Cancer

The Siemens Serum HER-2/neu blood test was used in the study and was cleared by the U.S. Food and Drug Administration (FDA) in September 2000. It is intended to quantitatively measure the HER-2/neu protein in serum of women with metastatic breast cancer. The use of the Serum HER-2/neu test is indicated for follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu value is greater than 15 ng/mL. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of metastatic breast cancer. The clinical utility of the serum measurement 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. Please visit www.siemens.com/herstory for more information about the Serum HER-2/neu test.

The study referenced in this news release was published in Cancer; volume 113 issue 6; pages 1294-1301 (October 2008). Cancer is the premier interdisciplinary, international journal of oncology, published by the American Cancer Society. The article is titled: "Serum Human Epidermal Growth Factor Receptor 2 Proto-oncogene and Relative Resistance to Trastuzumab-based Therapy in Patients with Metastatic Breast Cancer"; authors Suhail M. Ali, M.D., Walter P. Carney, Ph.D., Francisco J. Esteva, M.D., Ph.D., Monica Fornier, M.D., Lyndsay Harris, M.D., Wolfgang. J. Kostler, M.D., Jean-Pierre Lotz, M.D., Diana Luftner, M.D., Marie-France Pichon, PharmD, DSc, Allan Lipton, M.D., the Serum HER-2/neu Study Group. An abstract of the article may be viewed online.

As stated in the study, out of the 307 patients with MBC monitored, 191 patients (62%) had a significant decline (>20%) in Serum HER-2/neu and 116 patients (38%) did not. The response to therapy was 57% for patients who achieved this decline in Serum HER-2/neu (>20%) compared with 28% for patients who did not. Patients who achieved this decline in Serum HER-2/neu also had a significantly longer time to disease progression (a longer period of response to therapy) and longer overall survival. These results support the use of Siemens' Serum HER-2/neu test while monitoring Herceptin therapy.