Women with low-risk breast cancer recurrence were treated with hormone therapy alone, those at intermediate risk received hormone therapy with or without chemotherapy, while women at high risk for recurrence received hormone therapy and chemotherapy. Dr. Clifford Hudis from The Memorial Sloan Kettering Cancer Center, New York, offered a statement of his own agreeing with Dr. Sparano. This trial continues to evaluate the effect of chemotherapy only for those with a mid-range Recurrence Score, as previous Oncotype DX studies have already confirmed the benefit of adjuvant chemotherapy for those in the high Recurrence Score range. Using the gene test lets us focus our chemotherapy more on the higher risk patients who do benefit.
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The study was sponsored by the National Cancer Institute.
The findings were published earlier today, September 28, 2015, in the New England Journal of Medicine.
Genomic Health Inc.GHDX recently announced the initial results of a multi-center trial named T rial A ssigning I ndividua L ized O ptions for Treatment (Rx), or TAILORx, which validated the clinical utility of Genomic’s Oncotype DX test to risk-classify patients suffering from early stage breast cancer. According to the NCI over 100,000 women in Researchers have found that many women diagnosed with early-stage breast cancer may be the U.S. alone are diagnosed with this annually.
The usual treatment is surgery followed by years of a hormone-blocking drug. The findings provide the highest level of evidence supporting expert-derived clinical practice guidelines which have recommended Oncotype DX in patients with early stage ER-positive breast cancer. Not only were the trial subjects who skipped the chemo based on test results able to avoid other health risks often caused by the chemical cocktails, they also had less than 1% chance of their cancer popping up in other organs such as their liver and/or lungs 5-years after treatment.
Oncotype DX works by measuring the activity of the genes responsible for cell growth, as well as the activity of the genes responsible for indicating how likely the patient is to respond to hormone therapy. The new study is the first to assign women treatments based on their scores and track recurrence rates.
The researchers looked at a total of 10,253 women.
The study is ongoing, however the results for the low risk group have been made available at the recommendation of independent monitors. The five-year overall patient survival was 98 percent.
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“These patients who had low risk scores by Oncotype did extraordinarily well at five years”, said Dr. Hope Rugo, a breast cancer specialist at the University of California, San Francisco, with no role in the study. Together, these groups enrolled 10,273 patients across 1,182 sites in the United States and five additional countries (Australia, Canada, Ireland, New Zealand, and Peru). The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient’s journey, from diagnosis to treatment selection and monitoring. Instead, hormonal therapy can lower the risk of cancer recurrence and increase survival chances, if the recurrence score is low. “I was thrilled not to have to have it”, and has been fine since then, she said.
