Why Oncotype DX Was Chosen For The Trial
Oncotype DX® is being used by the NCI in the TAILORx trial because:
- It is a standardized, multi-gene RT-PCR-based molecular diagnostic assay performed in a single laboratory.
- The Genomic Health® laboratory that performs the Oncotype DX test is certified under the federal Clinical Laboratory Improvement Amendments (CLIA), accredited by the College of American Pathologists and licensed by state agencies in the United States.
- It may be performed on formalin-fixed, paraffin-embedded tissue specimens routinely processed in clinical pathology laboratories.
- It has been validated to assess the likelihood that breast cancer will recur in a woman diagnosed with Stage I or II, ER-positive, node-negative disease.
- The Recurrence Score® has been validated as quantifying the likelihood of distant recurrence in tamoxifen-treated patients with node-negative, estrogen receptor-positive breast cancer. Recurrence Score performance is superior to that of patient age, tumor size or tumor grade in either predictive power or reproducibility.
- The major validation study was performed on samples from the NSABP Study B-14. This validation study was published in The New England Journal of Medicine.
- The assay was further validated in a large, population-based study conducted by Kaiser Permanente.
- Another study, published in the Journal of Clinical Oncology, was based on samples from the NSABP Study B-20, and indicated that Oncotype DX can predict which patients benefit from adjuvant chemotherapy and which may not.
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