Abbott Molecular Inc.: Breast Cancer Stages

The purpose of the breast cancer staging system is to help organize the different factors and personality features of the cancer into categories, in order to:

Best understand your prognosis (the most likely outcome of the disease)

Guide your treatment decisions

provide a common way to describe the extent of breast cancer for doctors and nurses all over the world, so that results of your treatment can be compared and understood.

The system most often used to describe the growth and spread of breast cancer is the TNM staging system, also known as the American Joint Committee on Cancer (AJCC) system. In TNM staging, information about the tumor, nearby lymph nodes, and distant organ metastases is combined and a stage is assigned to specific TNM groupings. T stands for the size of the cancer (measured in centimeters; 2.54 centimeters = 1 inch). N stands for spread to lymph nodes in the area of the breast, and M is for metastasis (spread to distant organs of the body).

The stages are described using Roman numerals from I to IV. The clinical stage is determined by what the doctor learns from the physical examination and tests. The pathologic stage includes the findings of the pathologist after surgery. Most of the time, pathologic stage is the most important stage because usually the cancer isn't known to have spread to lymph nodes until the pathologist examines them under the microscope.

Each woman's outlook with breast cancer differs, depending on the cancer's stage and other factors such as hormone receptors, HER-2 status, her general state of health, and her treatment. If you have questions about breast cancer staging, ask your doctor.

For more information about breast cancer staging, visit these organizations' web sites at www.cancer.org (ACS) and www.nccn.org (NCCN).

For In Vitro Diagnostic Use.

Intended Use
The PathVysion HER-2 DNA Probe Kit (PathVysion Kit) is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the PathVysion Kit are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients. The PathVysion Kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin and 5-fluorouracil (CAF) chemotherapy.

The PathVysion Kit is indicated as an aid in the assessment of patients for whom HERCEPTIN (Trastuzumab) treatment is being considered (see HERCEPTIN package insert).

Warning:
Note: All of the patients in the Herceptin^® clinical trials were selected using an investigational immunohistochemical assay. The PathVysion assay was compared to the CTA on a subset of clinical trial samples and found to provide acceptably concordant results. The actual correlation of the PathVysion assay to Herceptin clinical outcomes in prospective clinical trials has not been established.

The Vysis PathVysion Kit is not intended for use to screen for or diagnose breast cancer. It is intended to be used as an adjunct to other prognostic factors currently used to predict disease-free and overall survival in stage II, node-positive breast cancer patients. In making decisions regarding adjuvant CAF treatment, all other available clinical information should also be taken into consideration, such as tumor size, number of involved lymph nodes, and steroid receptor status. No treatment decision for stage II, node-positive breast cancer patients should be based on HER-2/neu gene amplification status alone. The potential risks associated with misuse of the assay, or misinterpretation of the test results would be to assign patients to receive an adjuvant therapy regimen which is either too low for optimum effectiveness, or higher than necessary, potentially exposing the patient to serious side effects and, in rare cases, death. Selected patients with breast cancers shown to lack amplification of HER-2/neu, may still benefit from CAF adjuvant therapy on the basis of other prognostic factors which predict poor outcome. Conversely, selected patients with breast cancers shown to contain gene amplification may not be candidates for CAF therapy because of pre-existing or intercurrent medical illnesses. The dose and schedule of cyclophosphamide, doxorubicin, and 5-fluorouracil in the CAF regimen have not been standardized. Vysis will provide training in specimen preparation, assay procedure, and interpretation of FISH testing of the Her-2 gene for inexperienced users.