Breast Cancer Progression Test: Oncotype DNA DX Test (DXT) by Tailorx Study
Cancer is a generic term for a group of more than 100 diseases that can affect any part of the body. Other terms used are malignant tumours and neoplasms. One defining feature of cancer is the rapid creation of abnormal cells which grow beyond their usual boundaries, and which can invade adjoining parts of the body and spread to other organs, a process referred to as metastasis. Metastases are the major cause of death from cancer.
But if a cell changes into an abnormal, sometimes harmful form, it can divide quickly without dying, making many, many copies of itself. When this happens, a tumor, abnormal body cells grouped together in the form of a mass or lump, can start to form and grow.Breast cancer often starts as a small lump in the breast and is one of the most common cancers in women. With time, the cancer may grow and spread to other organs, such as skin, lymph nodes, the liver, brain, lungs, and spine.
Breast cancer is the third leading cause of death for women in the U.S. Breast cancer is newly diagnosed in more than 1.1 million women annually; these cases represent 10% of all new cancer cases. Breast cancer deaths, at more than 410,000 annually, represent about 1.6% of all female deaths worldwide. "Breast cancer is an urgent public-health problem in high-resource regions and is becoming an increasingly urgent problem in low-resource regions, where incidence rates have been increasing by up to 5%.
The Breast Health Global Initiative (BHGI) Guidelines outline recommendations in four areas for breast health and cancer control in limited resource countries:
*Early Detection and Access to Care;
*Diagnosis and Pathology;
*Treatment and Allocation of Resources; and
*Health-Care Systems and Public Policy.
The Guidelines recommend, based on the country's resource level, what level of care and/or service to provide and evaluation goals. Four panels of BHGI experts developed the Guideline recommendations using an evidence-based consensus approach.
In most cases, it isn't clear what triggers abnormal cell growth in breast tissue, but doctors do know that between 5 percent and 10 percent of breast cancers are inherited. Defects in one of two genes, breast cancer gene 1 (BRCA1) or breast cancer gene 2 (BRCA2), put you at greater risk of developing both breast and ovarian cancer. Inherited mutations in the ataxia-telangiectasia mutation gene, the cell-cycle checkpoint kinase 2 (CHEK-2) gene and the p53 tumor suppressor gene also make it more likely that you'll develop breast cancer.
Using Oncotype DX™, a modern diagnostic test developed by Genomic Health, Inc., Redwood City, Calif., in collaboration with the National Surgical Adjuvant Breast and Bowel Project (NSABP), a network of cancer research professionals, The study, called the Trial Assigning Individualized Options for Treatment (Rx), or TAILORx, TAILORx will determine the most effective cancer treatment, with the fewest side effects, for women with early-stage breast cancer. TAILORx is the first trial to be launched as part of a new NCI program -- the Program for the Assessment of Clinical Cancer Tests (PACCT) -- which seeks to individualize cancer treatment by using, evaluating and improving the latest diagnostic tests.
Up to 90 percent of women with early-stage breast cancer are advised to receive chemotherapy in addition to radiation and hormone therapy, yet research has not demonstrated that chemotherapy benefits all of them. TAILORx seeks to identify women who would not benefit from chemotherapy in order to spare them unnecessary treatment. TAILORx study designed to examine whether women with early-stage lymph node-negative breast cancer can be assigned to individualized treatment plans based on certain genes that may predict whether their cancer will return.
Most recently,researchers will study a new test that analyzes a breast tumor's DNA in order to determine its aggressiveness and to identify which patients need chemotherapy.
The trial will involve more than 10,000 breast cancer patients across the United States.
The majority of postmenopausal women with small breast tumors don't need chemotherapy in order to reduce their risk of cancer recurrence after they've had a lumpectomy, experts explained.
"The dilemma physicians have with these patients is, because they have such small tumors, it's hard to tell who needs chemotherapy," study principal investigator Dr. Thomas A. Samuel, a Medical College of Georgia hematologist/oncologist who specializes in breast cancer, said in a prepared statement.
Of every 100 postmenopausal women who have a small tumor that has estrogen receptors and who have no sign of cancer spread to the lymph nodes, only about 12 to 15 require chemotherapy to reduce the risk of cancer recurrence, Samuel said.
But right now, all 100 women would likely receive chemotherapy because of a lack of tests to definitively identify who needs it and who doesn't, he said.
This study will investigate the Oncotype DX test (DXT), which looks at the DNA of the breast cancer to determine whether it's likely to spread and grow. The test looks at 16 tumor genes and uses five reference genes as controls.
The test, which costs several thousand dollars, has been on the market for more than a year but is not widely used. Participants in this U.S. government-funded Trial Assigning Individualized Options for Treatment (TAILORx) study will be assessed using the DXT.
Those with the lowest recurrence risk scores will receive radiation and hormonal treatment following lumpectomy, while those with the highest scores will also undergo chemotherapy. The patients will be followed for a minimum of five years after treatment.
Efforts have focused on early detection since breast cancer is more easily treated and often curable if it is found early. Breast self-examination (BSE), clinical breast examination (CBE) by a medical professional, and screening mammography are the three tools of early detection. Women who carry the BRCA mutations have several effective options for screening and prevention.
Most recommend breast self-examinations (BSE) once a month -- the week following your menstrual period if you are age 20 or older