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Overview
This guide will explain the most relevant sections of your Mammostrat report. The Mammostrat pathology report is provided to your oncologist by the pathologist responsible for characterizing or analyzing your tumor. Questions related to your report should be addressed to your physicians. The Breast Profile Summary is an optional section that may or may not be included in your report and thus is described at the end of this document.
Should you have any questions regarding this report or your treatment decisions, please contact your physician.
Risk Category and Risk Index
Mammostrat consists of five proteins called monoclonal antibodies. Each antibody, or test, can detect a separate target protein in your tumor. A “result” for each antibody is determined by detecting the presence or absence of that target protein in the cells that make up your tumor. A pathologist decides the result of these tests and enters them into an equation to calculate a Risk Index. The higher your Risk Index, the more likely you are to have a recurrence of your cancer. Patients are assigned to a Risk Category (High, Moderate, or Low) based upon their Risk Index. Both your Risk Index and Risk Category are reported on the Mammostrat pathology report. The table to the right of your Risk Index is the reference range which determined your Risk Category.
Mammostrat Result
This section reports your Risk Category again. In addition, the results of a large, independent study (Edinburgh, Scotland) are reported both in this section and the Clinical Data section. This Results section reports the probability of a tumor recurrence over ten years for patients with a similar Mammostrat Risk Category to yours, i.e. high, moderate, or low. It is important to remember that this study was performed on patients treated with tamoxifen only (i.e. no additional chemotherapy) with estrogen receptor-positive (ER+), lymph node negative tumors. No comparisons should be made for patients whose tumor characteristics do not match the characteristics of patients from this study.
Clinical Data
This section gives more details about the 568 patients treated in Edinburgh, Scotland (from the Results section above). The graph with colored lines shows the recurrence rate over time for patients categorized in each of the three Mammostrat risk categories (green line is High risk, orange line is Moderate risk and dotted blue line is Low risk). The table contains the percent recurrence rates for each Risk Category translated from the graph. For example, a patient categorized as low risk in the Edinburgh study would have a 7.6% likelihood of having a recurrence at 10 years. Again, this study was conducted on estrogen-receptor positive, lymph node negative patients and conclusions about recurrence risk should only be applied to patients whose cancer has the same characteristics.
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Mammostrat Markers
Mammostrat is a test that detects the presence of five proteins (SLC7A5, p53, NDRG1, TRMT2A (HTF9C), and CEACAM5). In the purple box labeled “Clarient Insight Dx Mammostrat Markers,” images show the presence or absence of each protein (presence is indicated by brown color). An additional test is performed called a hemotoxylin and eosin stain (H&E) which allows the pathologist to locate your tumor for analysis (first picture in the box). The scores for each of the five Mammostrat proteins are shown just following the name of the protein. Some proteins are scored as positive or negative (presence or absence of protein). Other proteins are scored more quantitatively (amount of protein present). All of these scores are entered into the Mammostrat equation to calculate the Mammostrat Risk Index and determine Risk Category.
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Methodology and Intended Use
Methodology: Following antigen retrieval, slides were incubated with primary antibody for 30 minutes (clone, dilution and buffer used listed in table below) along with appropriate positive controls. Visualization was achieved with a biotin-free, polymer-based detection system (Vision Biosystems Refine Polymer-HRP) using DAB as chromagen and haematoxylin as counterstain. A review type of MANUAL indicates the immunostained slide was reviewed by the pathologist with a standard light microscope. A review type of IMAGE indicates that the pathologist reviewed the immunostained slide with the aid of image analysis. All controls were reviewed and showed appropriate positive and negative immunoreactivity.
Intended Use: Mammostrat is a tool designed to assess the biologic aggressiveness of a breast cancer specimen. Based upon testing results patients are classified as having a relatively high, moderate, or low risk of breast cancer recurrence. The assay is intended as an aid for the treating physician in the selection of the appropriate therapeutic approach for the patient. The results of Mammostrat should be interpreted in the context of other clinical findings.
These sections contain brief descriptions of how each antibody (protein) is tested on your tumor. The intended use defines how the assay is to be used, i.e. as an aid for your physician to make recommendations to you about treatment decisions.
Breast Profile Summary
This is an optional cover page that will not be included on all reports. Further, some results may not be able to be calculated on the Breast Profile Summary if all data is not obtained. In addition to your Mammostrat result, the cover page may include a Predictive Marker section that summarizes the results of certain traditional tests (ER, PR, HER2) performed on your tumor where a particular result means the patient may want to discuss with her physician a particular therapy. Finally, there is a place for the pathologist to provide overall comments about the biology of your tumor.
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