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Genomic Test May Be Able to Predict Outcomes in Breast Cancer Patients

Three new studies of Oncotype DX suggest efficacy

New studies provide evidence that information from the Oncotype DX genomic breast cancer test should be included in treatment decisions, according to test developer Genomic Health.

Positive five-year results from a group of patients with low Oncotype DX Recurrence Score results from the ECOG-ACRIN Cancer Research Group's TAILORx (Trial Assigning IndividuaLized Options for Treatment [Rx]) study, sponsored by the National Cancer Institute (NCI), were published online today in The New England Journal of Medicine. In addition, two other positive international Oncotype DX clinical outcomes studies were presented at the 2015 European Cancer Congress, being held September 25 through 29 in Vienna, Austria.

Together, these new studies establish Oncotype DX as the only genomic breast cancer test with prospective outcomes data in more than 5,700 patients, Genomic Health said.

Reinforcing the published findings from TAILORx, the two studies presented in Austria included positive results from a large, multicenter cohort in Israel with follow-up exceeding five years, and a separate study of prospective survival results in Germany.

In an analysis of medical records of 930 patients across four medical centers within Clalit Health Services, the largest health maintenance organization in Israel, Oncotype DX was used to identify patients for treatment with hormonal therapy alone or with hormonal therapy plus chemotherapy. Women with low recurrence-score results (less than 18) showed very low distant recurrence rates (0.5%) after five years of follow-up. Women with high recurrence-score results (greater than or equal to 31) and intermediate recurrence-score results (between 18 and 30) had a 4% and 2.3% risk of distant recurrence, respectively, after five years of follow-up. The selection of patients for chemotherapy treatment was consistent with the recurrence-score results as recommended in treatment guidelines.

An additional analysis from the prospective Plan B trial, Europe's largest contemporary adjuvant breast cancer trial, conducted by the Women's Healthcare Study Group in Germany, showed a high level of discordance in tumor grade assessment as performed by central and local pathologists. The investigators also reported that patients with a recurrence-score result between 0 and 11 who were treated by hormonal therapy alone had excellent three-year relapse-free survival.

Initial results have been announced from TAILORx, one of the largest-ever adjuvant breast cancer trials, designed and conducted by the ECOG-ACRIN Cancer Research Group and sponsored by NCI. The study demonstrated that a group of early-stage breast cancer patients with low Oncotype DX Recurrence Score results of 10 or less who received hormonal therapy alone without chemotherapy had less than a 1% chance of distant recurrence at five years. The data safety monitoring board of the trial, as mandated by the study protocol, continues to monitor outcomes in patients with a recurrence score of 11 to 25 randomized to chemo-endocrine therapy or endocrine therapy alone.

Source: Genomic Health; September 28, 2015.

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