On June 3, 2018 researchers published findings from a study to assess the effect of chemotherapy in women with early-stage breast cancer. TAILORx, the largest prospective study on adjuvant treatment in breast cancer worldwide, included 10,273 patients with early-stage breast cancer who had positive hormone receptors, negative axillary lymph nodes, HER2 negative and tumor dimension between 1.1-5.0 cm. The study concluded that for 70% of women with the most common type of breast cancer, adding chemotherapy provided no benefit versus treatment with hormone therapy alone.
During the trial, the Oncotype DX test was used, which examines 21 genes in the tumor tissue. The results obtained establish a score that indicates the risk of cancer breast recurrence (<11 pts = low risk, 11-25 pts = intermediate risk,> 25 pts = high risk).
“We are proud that the Oncotype DX breast recurrence scoring test played a pivotal role in the allocation of treatment for this pioneering precision medicine trial. These TAILORx results will more accurately inform physicians and their patients with results of recurrence of 11 to 25 over who will benefit or not from the addition of chemotherapy, “said Steven Shak, MD, Scientific Director of Genomic Health.
Of the 10,273 patients studied, 1626 presented a low risk of recurrence. These patients were prescribed endocrine therapy without chemotherapy, and after 5 years of treatment the overall survival rate was of 98.0%.
In order to clarify the benefits that chemotherapy would have in patients with an intermediate risk of recurrence (6700 patients within this study), these patients were divided into 2 groups. One group received endocrine therapy plus chemotherapy, while the other group only received endocrine therapy.
After 9 years of follow-up, the data obtained showed that the majority of patients who did not receive chemotherapy obtained the same results as those who received chemotherapy. However, women 50 years of age or younger were the exception. According to Joseph Sparano, the main author of the study and Director for Clinical Research at the Albert Einstein Cancer Center, those patients with a recurrence score greater than 16 on the Oncotype DX test had a substantial benefit from chemotherapy treatment.
The American Cancer Society estimates that, excluding skin cancer, breast cancer represents the most commonly diagnosed cancer in women in the US, with 112,350 new cases of breast cancer and over 40,000 deaths in 2018 alone.
Research like this helps oncologists to come up with an effective treatment plan that cures the disease without the known side-effects associated with chemotherapy.
“The impact is tremendous. Most women in this situation don’t need treatment beyond surgery and hormone therapy,” said lead researcher, Dr. Joseph Sparano of Montefiore Medical Center in New York.
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