A 21-gene test has shown that most patients with early stage breast cancer can forego chemotherapy, enabling 3000 patients per year in Italy to avoid it.
A revolution that has arrived from America
Oncologists today have an additional weapon- a gene test that can identify the best therapeutic strategy for breast cancer patients, as proven by the results of the TAILORx trial recently presented at the American Society of Clinical Oncology’s (Asco) Annual Meeting. TAILORx is the largest adjuvant breast cancer treatment trial ever conducted, enrolling 10,273 women with hormone receptor positive, HER2 negative, node-negative breast cancer- the most common type of early stage breast cancer. According to researchers, the findings “will have an immediate impact on clinical practice, sparing thousands of women the side effects of chemotherapy”. These findings have proven that about 70% of women with this specific type of breast cancer can avoid chemotherapy followed by hormonal therapy.
How does the test work?
The OncotypeDX is a genomic test that analyzes the activity of 21 genes within a sample of a cancer tumor and provides information on a patient’s breast cancer tumor biology. The test is performed on tissue removed from the breast during surgery or biopsy and is then given a score between 0 and 100, depending on how likely the cancer will recur ten years after diagnosis.
Women with a low score (0-10) have a low risk of recurrence and may only need hormonal therapy. Women with a high score (26-100) have a high risk of recurrence and will need chemotherapy and hormonal therapy. This data is not completely new, but mid-range scores in prior studies did not provide definite answers. For this reason, a new study was performed, the TAILORx trial. Joseph Sparano, from the Albert Einstein Cancer Center, the study chair for the TAILORx clinical trial, explains that “before TAILORx, there was uncertainty about the best treatment for women with a mid-range score of 11-25”. The new trial gives a definite answer. After a follow-up period of 7.5 years, it was noted that hormone therapy alone was no less effective than chemotherapy alongside hormone therapy in patients with a score of 11-25, in terms of duration and recurrence of the cancer. There is one exception in women with a score of 11-25 -chemotherapy and hormonal therapy combined are advised in women 50 years or younger.
A transformation in breast cancer therapy
The importance of the TAILORx trial can be better understood by analyzing the following data: one out of eight women have breast cancer; breast cancer is the most common cancer in women and represents 29% of cancer in women; breast cancer is the number one cause of cancer deaths in women with a mortality rate of 17%.
“This study will transform care immediately, and for the better”, said Expert Asco Harold Burstein. “Practically speaking, this means that thousands of women will be able to avoid chemotherapy, with all of its side effects, while still achieving excellent long-term outcomes”. This is why Dr. Sparano says “any woman with early-stage breast cancer 75 years or younger should have the test and discuss the results of TAILORx with her doctor”.
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