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June 10, 2014
05:54 EDTGHDXGenomic Health announces results of three studies with Oncotype DX test
Genomic Health announced results of three studies with the Oncotype DX breast cancer test at the recent 2014 American Society of Clinical Oncology Annual Meeting. The PACS01 trial was a large study conducted in France which compared six cycles of fluorouracil, epirubicin, and cyclophosphamide with three cycles of FEC followed by three cycles of docetaxel in 1,999 node positive breast cancer patients. The study presented at ASCO2 included 530 patients from the original PACS01 trial and assessed the association of the Oncotype DX Recurrence Score results with distant recurrence in hormone-receptor-positive, node positive patients treated with either FEC or FEC-D. Results were consistent with those of a similar study3 conducted previously, and showed that the Recurrence Score was a significant predictor of distant recurrence and disease free survival in both treatment arms. Importantly, there was no indication that patients with low Recurrence Score results benefited from the addition of docetaxel to their treatment regimen. A comparison study evaluated if the information provided by Oncotype DX and the Risk of Recurrence scores are equivalent. Specifically, results in 52 node negative, estrogen receptor-positive, post-menopausal, tamoxifen-treated invasive breast cancer patients revealed a very low concordance between Oncotype DX and ROR results. Results of a large, positive study6 confirm that the Oncotype DX Recurrence Score results and quantitative ER expression predict late distant recurrence risk in certain early-stage invasive breast cancer patients after initial tamoxifen therapy. These results suggest that the Oncotype DX test may help identify which patients have greater potential to benefit from extended hormonal treatment beyond five years. The results suggest that extending tamoxifen beyond five years may be most beneficial in patients with high and intermediate Recurrence Score results with higher quantitative ER expression. Conversely, patients with low Recurrence Score results would be expected to have limited benefit from extended tamoxifen beyond five years due to much lower risk for late distant recurrence.
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