Combining breast cancer genetic and routine mammogram tests enhance patient survival

Breast cancer is a serious health-related concern in the Western Pennsylvania region. There is a high incidence of breast cancer in Pennsylvania, with more than 30 women diagnosed with this disease every day, and there are six breast cancer-related deaths every day. Moreover, Pennsylvania ranked eighth last year among states in the tally of breast cancer-related deaths.

This somber news calls for immediate and urgent action to prevent and efficiently treat breast cancer in Western Pennsylvania. Fortunately, Pittsburgh is one of the few cities in the United States that is leading the charge against cancer. As a testament of this distinction, the Comprehensive Breast Cancer Center at Magee Womens Hospital and the University of Pittsburgh Cancer Institute (UPIC) are ranked among the top ten in the nation for offering high quality breast cancer care and prevention programs. More importantly, Magee’s Women hospital is well equipped with a comprehensive digital mammography system and offer a variety of genetic breast cancer tests to accurately diagnose the type of breast cancer a patient harbors.

Moreover, UPMC’s Health Plan has been previously recognized for meeting the benchmarks for breast cancer screening rates, an important accomplishment given the serious health concern posed by a high incidence of breast cancer in Western Pennsylvanian. There are several breast cancer genetic tests which include Oncotype DX from GenomicHealth and Agendia’s MammaPrint which is briefly reviewed in this Examiner related Article below. Oncotype DX  is currently included in UPMC's Health plan but The article below highlights the importance of undergoing an FDA approved genetic test in order to better dictate the use of economic resources, time and treatments for early stage breast cacer patients.  MammaPrint is considered to be a competitive and robust genetic test for screening breast cancer offered at many hospitals in the nation. See below:

MammaPrint is currently the only robust and accurate genetic test available for predicting the survival rate and prognosis of early-stage breast cancer. The results provided by the MammaPrint test yield data which determine not only the type of cancer harbored by a specific patient, but also predicts the probability that the cancer may recur in the future (<10 years).

In February 2007, MammaPrint became the world’s first and only multi-gene expression test to acquire clearance from the U.S. FDA. In June 2007, MammaPrint received a second FDA clearance for its tissue sampling and shipping procedure at room temperature. According to Agendia, the FDA label on MammaPrint indicates that as a diagnostic tool, MammaPrint has a 98.9% degree of accuracy in classifying patients as ‘Low Risk’ or ‘High Risk’ and technical reproducibility of 98.5%.

In other words, the FDA-approved MammaPrint test equips doctors with an additional weapon for fighting breast cancer.

 As put in the words of Richard Bender, Chief Medical Officer of Agendia, "This new clearance (by the FDA) confirms the opinion of the international medical community that MammaPrint carries clinical utility and is safe and effective in breast cancer patients of all ages," Also adding that "Seeking clearance for all ages further demonstrates Agendia's commitment to provide patients and physicians with high quality FDA-cleared tests to help guide vital treatment decisions."

Brief overview of Breast cancer

  Breast cancer is the most common type of cancer among women in the United States, where it accounts for one in every three cancer diagnoses. The American Cancer Society estimates that in 2009, roughly 190,000 American women were be diagnosed with invasive breast cancer, and over 40,000 died of the disease. Breast cancer contributes to approximately 6.9% of all cancers cases in the world.

   Breast cancer originates from breast tissue, specifically originating in either the inner lining of milk ducts or the lobules supplying the ducts with milk. Breast cancer that can be classified by disease stage at diagnosis (I-V), the cancer’s ability to metastasize and the genetic makeup of the tumor. Depending on the genetic and pathological profiles exhibited by a particular breast tumor in a patient, the prognoses and survival rates vary greatly. According to the American Cancer Society, the five-year survival rate for breast cancer diagnosed in Stage I is nearly 100%. However, in Stage III the survival rate can be as low as 54%, and in Stage IV the survival rate is only 20%.

  Treatments available for breast cancer include: radiation therapy, cycles of chemotherapeutic drugs (such as cyclophosphamide and doxorubicin) combined with hormone therapies including estrogen and progesterone receptor antagonists (ie. Tamoxifen), and humanized antibodies against the Her-2 receptor (Traztuzumab), a biomarker associated with aggressive tumor progression.

The MammaPrint test

  The MammaPrint test is a robust and unique genetic test that examines the expression of 70 different genes or biomarkers that are involved in advanced breast cancer signaling. MammaPrint is only recommended to early stage breast cancer patients whose cancer has not spread to the lymph nodes, independent of any form of (neo-adjuvant) treatment.

  Unlike other tests in the market, the MammaPrint is very robust as it interrogates all of the known molecular signaling pathways that are involved in breast cancer metastasis. The developers of MammaPrint identified 231 key genes in the human genome that participate in advanced breast cancer signaling. The MammaPrint test ultimately came to rely on a 70-gene subset of these genes that has been scientifically and clinically shown to be high predictors for breast cancer metastasis.

  Some of the genes that are analyzed by MammaPrint include the estrogen, progesterone, Her-2, the newly identified metadherin gene (MTDH), BRCA-1 and BRCA-2 genes and many others.

   The results given by MammaPrint classify patients in only two categories: the ‘Low Risk’ patient and the ‘High Risk’ patient. The Low Risk patient has a high probability of having a 10-year disease free survival and may only require basic hormonal therapy such as Tamoxifen ,(estrogen antagonist) administration. On the other hand, a High Risk patient may require the co-administration of humanized anti-Her-2 (Traztuzamab) antibodies and higher, more frequent doses of chemotherapy. It is important to note that MammaPrint does not yield intermediate results; it always yields an actionable result, which is crucial for patients and their physicians when determining a therapeutic course of action.

   According to Agendia, the cost associated for performing the MammaPrint test is covered by CMS, and a range of health insurance providers (HMO or PPO),ensuring a total coverage of some 70 million lives.,(Pharmacogenomics Reporter, Dec. 23, 2009)

Final thoughts-

   The MammaPrint test will no doubt save more lives and extend the chances of survival for patients by personalizing breast cancer treatment. More importantly, many patients suffer collateral damage in normal tissue due to the fact that some forms of breast cancer (Her- 2 positive) do not respond well to traditional chemotherapeutic combo treatments (ie, cyclophosphamide and doxorubicin). The MammaPrint test gives the advantage to early stage breast cancer patients for tailoring their treatments and curtailing unnecessary chemotherapy treatments in non-responsive breast cancer patients.
 

Did you find this article interesting? Then please subscribe to my homepage in order to receive additional groundbreaking medical technology news or follow me on Twitter.