Use of Mammostrat Bioassay Predicts Early Relapse Risk in ER-Positive Postmenopausal Breast Cancer Patients
Results from TEAM Trial presented at 2012 Annual Meeting of American Society of Clinical Oncology
CHICAGO--(BUSINESS WIRE)-- GE Healthcare today announced results from the Tamoxifen and Exemestane Adjuvant Multinational (TEAM) Trial at the 2012 Annual Meeting of the American Society of Clinical Oncology. Results from this study, presented by John M.S. Bartlett, PhD of the Ontario Institute for Cancer Research demonstrated the ability of Mammostrat to predict distant relapse - free survival and disease- free survival for both exemestane and tamoxifen-exemestane treated estrogen receptor-positive (ER+) patients, irrespective of nodal status and chemotherapy.
For many postmenopausal patients with hormone sensitive early breast cancer the dilemma is whether or not to opt for adjuvant chemotherapy as well as endocrine therapy to reduce their risk of disease recurrence. We are actively pursuing novel diagnostic tests which can inform patients of their risks of disease recurrence following adjuvant endocrine therapy. said John M.S. Bartlett, PhD, Director, Transformative Pathology, Ontario Institute for Cancer Research and lead investigator for this trial. Our study suggests that the Mammostrat test may provide additional information following endocrine treatment and provides further evidence for its utility in risk stratification of ER-positive postmenopausal breast cancer patients.
For this study, pathology blocks from 4598 patients were collected and tissue microarrays (TMAs) were constructed. All TMA cores were stained, and, utilizing Mammostrat, positivity for five biomarkers were assessed and assigned Mammostrat scores. In multivariate regression analyses, corrected for conventional clinicopathological markers, Mammostrat provided significant additional information on distant relapse-free survival (DRFS) after endocrine therapy in ER+ node negative patients (n=1226) patients not receiving chemotherapy (p=0.004). Further analyses in all patients not exposed to chemotherapy, irrespective of nodal status (n=2559) and in the entire cohort (n=3837) showed Mammostrat scores provide additional information on DRFS (p=0.001 and p<0.0001 respectively.
"This study shows the valuable role of Mammostrat for clinicians who are assessing the aggressiveness of their patient's breast cancer," said Kenneth J. Bloom, Chief Medical Officer, Clarient Diagnostic Services, Inc. "Mammostrat scores can provide clinicians important information to help select the appropriate therapeutic management for each individual patient. For patients, Mammostrat offers the confidence that the decisions being made to manage their breast cancer are based on the clinical characteristics of their specific disease using the most current validated technology available."
Mammostrat employs a well-validated, novel, and proprietary set of five biomarkers that are able to be identified visually on a patient's tumor specimen by using a well-established technology called immunohistochemistry. Those biomarkers are then analyzed using a mathematical algorithm to generate an assessment of risk for cancer recurrence. By using Mammostrat pathologists and oncologists can gain greater understanding of the aggressiveness of a patient's disease and guide clinical management. Mammostrat provides additional clinical information that cannot be obtained from routinely used prognostic factors. Mammostrat can be performed accurately on small biopsy samples and results are typically delivered in as little as 48-72 hours, thereby allowing more rapid treatment decisions.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.
Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality and efficiency around the world. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our web site at www.gehealthcare.com.
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About Clarient Diagnostic Services, Inc.
Clarient Diagnostic Services, Inc. - a GE Healthcare Company - is a leading provider of comprehensive, cancerdiagnostic laboratory services. With its advanced technologies, Clarient is able to provide pathologists and oncologist with more accurate and detailed information to better characterize and assess cancer which can lead to more accurate diagnoses and more effective treatment. In addition, Clarients services are finding more efficient ways to reduce the cost as well as accelerating the drug development process to identify and develop treating pharmaceuticals that can result in better outcomes for patients.
From its state-of-the-art diagnostic laboratory to its Internet-based PATHSiTE®, Clarient delivers advanced oncology diagnostic services to pathologists, oncologists, hospitals and biopharmaceutical companies throughout the U.S. Clarient also is developing proprietary companion diagnostic tests for therapeutics in breast, prostate, lung and colon cancers, as well as leukemia/lymphoma.
Clarient is improving the lives of those affected by cancer by bringing clarity to a complex disease. For more information visit www.clarientinc.com.
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Scott Lerman, 609-514-6346 (office)
Source: GE HealthcareCopyright Business Wire 2012