Friday, October 31, 2014

Genomic Testing / Risk of Recurrence

I just finished reading the following article on Breastcancer.org.

On November 10th, I will see Dr. Gupta, an oncologist, to discuss my 'targeted therapy' which will include hormonal therapy treatment (Arimidex). I will ask him about my risk of recurrence (which is 4%) and whether taking Arimidex for 10 years will be beneficial.

The genetic testing being performed in the last 5 years is amazing. If there is no benefit to taking certain medication beyond the 5-year mark, why take it for 10 years?

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"Genomic Test Helps Estimate Risk of Recurrence More Than 5 Years After Diagnosis for Some Breast Cancers

Published on October 29, 2014 at 8:46 AM

TOPIC: Screening and Testing

A genomic test (also called a genomic assay) analyzes the activity of a group of genes linked to the risk of a particular disease. The tests are done on blood or tissue samples. For example, a genomic test may help figure out if a woman diagnosed with early-stage, hormone-receptor-positive breast cancer has a high, medium, or low risk of recurrence (the cancer coming back), as well as if she’s likely to benefit from chemotherapy to reduce that risk.

A study has found that the Prosigna Breast Cancer Prognostic Gene Signature Assay (formerly called the PAM50 test) can help predict the risk of distant recurrence (the cancer coming back in a part of the body away from the breast) for early-stage, hormone-receptor-positive breast cancer after 5 years of hormonal therapy treatment in postmenopausal women.

The study was published online on Oct. 20, 2014 by the Journal of Clinical Oncology. Read the abstract of “Prediction of Late Distant Recurrence After 5 Years of Endocrine Treatment: A Combined Analysis of Patients From the Austrian Breast and Colorectal Cancer Study Group 8 and Arimidex, Tamoxifen Alone or in Combination Randomized Trials Using the PAM50 Risk of Recurrence Score.”

The Prosigna test was approved by the U.S. Food and Drug Administration in September 2013. The test received the CE mark, which is Europe’s approval, in 2012.

The test looks at the activity of 58 genes (called the PAM50 gene signature) in early-stage, hormone-receptor-positive breast cancer. Based on these activity levels, Prosigna test results are reported as a risk of recurrence (ROR) score in two ways:

● node-negative cancers are classified as low (0-40), intermediate (41-60), or high (61-100) risk

● node-positive cancers are classified as low (0-40) or high (41-100) risk

In this study, the researchers wanted to see if the Prosigna test could accurately estimate the risk of distant recurrence for postmenopausal women diagnosed with early-stage, hormone-receptor-positive disease after they’d received 5 years of hormonal therapy. Knowing this could help doctors decide which women should stay on hormonal therapy for 10 years rather than stopping after 5 years.

The women in this study were all part of two studies that had already been done, so the researchers knew how many women had had a distant recurrence -- the point of the study was to see how accurate the Prosigna test’s predictions were.

The researchers looked at the records of more than 2,100 women in two studies:

● Austrian Breast and Colorectal Cancer Study Group 8 (ABCSG 8)

● Arimidex, Tamoxifen Alone or in Combination translational research cohort (TransATAC)

None of the women had had a recurrence in the 5 years after diagnosis while they were being treated with hormonal therapy. Also, none of the women had been treated with chemotherapy. The women had been followed for about 10 years after being diagnosed.

The ABCSG 8 study compared 5 years of tamoxifen to 2 years of tamoxifen followed by 3 years of Arimidex (chemical name: anastrozole) to treat early-stage, hormone-receptor positive disease in postmenopausal women.

The ATAC study compared 5 years of tamoxifen to 5 years of Arimidex to treat early-stage, hormone-receptor-positive disease in postmenopausal women. The TransATAC cohort was a subset of women from the ATAC study from whom breast cancer tissue samples were collected and stored.

The researchers tested cancer tissue samples from the women with the Prosigna test and recorded the risk of recurrence score for each breast cancer. They also looked at the clinical treatment score for each cancer. The clinical treatment score is based on:

cancer size

cancer grade

women’s age

how many, if any, lymph nodes are involved

cancer treatment

The researchers found that the clinical treatment score was the best predictor of distant recurrence up to 5 years after diagnosis. The Prosigna risk of recurrence score also helped estimate the risk of distant recurrence in the 5 years after diagnosis, but wasn’t as accurate as the clinical treatment score.

From 5 to 10 years after diagnosis:

● the clinical treatment score offered the most accurate estimate of distant recurrence overall and for women who had positive lymph nodes

● the Prosigna risk of recurrence score offered the most accurate estimate of distant recurrence for women with negative lymph nodes and women with negative lymph nodes and HER2-negative breast cancer

Knowing whether a woman has a high or low risk of breast cancer coming back in a part of the body away from the breast more than 5 years after diagnosis can help doctors decide how long hormonal therapy medicine should be taken. Research has shown that taking tamoxifen for 10 years instead of 5 years can better lower the risk of recurrence and improve overall survival for some women. If doctors knew that a woman had a low risk of distant recurrence, they could spare her the extra 5 years of hormonal therapy treatment. At the same time, women at high risk would benefit from the extra 5 years of treatment.

When making treatment decisions, you and your doctor will consider a number of factors, including:

your age

your menopausal status

the size of the cancer

hormone receptor status

cancer grade

the results of any genomic tests, if you’ve had them

Armed with the best information possible, you and your doctor can decide on a treatment plan that makes the most sense for your unique situation."

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