The results of a study presented at the European Cancer Congress demonstrate that early-stage breast cancer patients with a low Oncotype DX® Recurrence Score® result of 10 or less who received hormonal therapy alone without chemotherapy had less than a one percent chance of distant recurrence at five years.
The results are the first to be reported from the Trial Assigning Individualized Options for Treatment (Rx), or TAILORx clinic trial which was designed to evaluate the clinical utility of Oncotype DX and provide physicians and patients with greater confidence in using this test to make chemotherapy treatment decisions.
The trial enrolled 10,273 patients across 1,182 sites and major cancer centers in six countries, including Canada. TAILORx used the Oncotype DX test on every patient to quantify individual risk of recurrence in order to assign the appropriate treatment. This study is evaluating the effect of chemotherapy only for those with a mid-range Recurrence Score result, as previous Oncotype DX studies have already confirmed the benefit of adjuvant chemotherapy for those in the high Recurrence Score range and minimal, if any, benefit for those in the low Recurrence Score range.
The results from a group of 1,626 patients with a Recurrence Score between 0 and 10 demonstrated that 99.3 percent of node-negative, estrogen receptor-positive, HER2-negative patients who met accepted guidelines for recommending chemotherapy in addition to hormonal therapy had no distant recurrence at five years after treatment with hormonal therapy alone. Outcomes were excellent irrespective of patient age, tumor size, and tumor grade.
The evidence supports Oncotype DX as the only multi-gene expression assay that can identify patients who can effectively forego chemotherapy.
Reference: Genomic Health, Inc.; ECOG-ACRIN Cancer Research Group Press Release
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