Illuminating Breast Cancer Recurrence Risk  |   > Search     |   Take me to: Oncotype - Home Patients and Caregivers - Home Oncotype DX Logistics - Home About Oncotype DX The Role of Oncotype DX Oncotype DX Studies Oncotype DX Logistics Clinical Practice Guidelines Health Insurance Coverage The TAILORx Clinical Trial Frequently Asked Questions About Oncotype DX The Role of Oncotype DX Assessing Recurrence Chemotherapy Benefit Quantitative ER and PR Scores Oncotype DX Studies Oncotype DX Logistics Clinical Practice Guidelines Health Insurance Coverage The TAILORx Clinical Trial Frequently Asked Questions Quantitative ER and PR Scores Additional Insight into Tumor Biology Can Inform Treatment Planning For all reports generated as of February 1, 2008, Oncotype DX® reports now include quantitative estrogen receptor (ER) and progesterone receptor (PR) Scores. ER and PR are two of the genes measured in the determination of the Recurrence ScoreTM result. To view a Sample Node Negative Report, please click here. To view a Sample Node Positive Report, please click here. There is high concordance between ER and PR status (positive/negative) as determined by the Oncotype DX assay, measuring RNA, and by immunohistochemistry (IHC), measuring protein. Studies were performed with ECOG (E2197 study, 769 patient samples) and Northern California Kaiser Permanente (607 patient samples): Central IHC vs. Oncotype DX ECOG Study1 (n=769) Concordance (95% CI) Kaiser Study2 (n=607) Concordance (95% CI)    Estrogen Receptor (ER) Status      93% (91-94%)      96% (94-97%)    Progesterone Receptor (PR) Status      90% (88-92%)      90% (87-92%)    Hormone Receptor Status      93% (91-95%)      95% (93-97%) ER Score as measured by Oncotype DX is a strong predictor of tamoxifen benefit.3 For tumors with high ER Scores, tamoxifen benefit is substantial; for tumors with very low ER Scores but still in the ER-positive range, the likelihood of a large benefit from tamoxifen is low, but cannot be excluded. Please note that quantitative expression of ER and PR as measured by the Oncotype DX assay is used in the calculation of the Recurrence Score. Therefore, the magnitude of tamoxifen benefit indicated by the ER Score is reflected in the Recurrence Score result. Clinical Utility of ER and PR Scores While the Recurrence Score remains the strongest tool for assessing prognosis and predicting chemotherapy benefit, the quantitative ER and PR Scores may: Allow more informed treatment planning for some patients: The quantitative ER Score can help determine the likelihood that an individual patient will derive a substantial benefit from tamoxifen, allowing more informed adjuvant treatment planning. Clarify borderline/uncertain IHC results: The quantitative ER Score can provide additional information for clinical decision making for a patient whose ER protein expression is borderline positive by IHC, or reported as uncertain. Provide further insight into the Recurrence Score result: Patients with low Recurrence Scores have low recurrence risk because they have good prognosis tumors, because their likely benefit from tamoxifen is high, or both. The quantitative ER Score can help determine which of those reasons most likely drove the low risk assessment. Similarly, while patients in the high Recurrence Score group have a lower benefit from tamoxifen, the quantitative ER Score is the more specific indicator of an individual patient’s likely benefit from tamoxifen. References: Badve SS et al. ER and PR assessment in ECOG 2197: comparison of locally determined IHC with centrally determined IHC and quantitative RT-PCR. Presented at the ASCO Breast Cancer Symposium. September 7-8, 2007; San Francisco, CA. Abstract #87 Baehner FL et al. A Kaiser-Permanente population-based study of ER and PR expression by the standard method, immunohistochemistry (IHC), compared to a new method, quantitative reverse transcription polymerase chain reaction (RT-PCR). Presented at the ASCO Breast Cancer Symposium. September 7-8, 2007; San Francisco, CA. Abstract #88 Paik S et al. Expression of the 21 genes in the Recurrence Score assay and tamoxifen clinical benefit in the NSABP Study B-14 of node negative, estrogen receptor positive breast cancer. Presented at the 41st Annual Meeting of the American Society of Clinical Oncology. May 13-17, 2005; Orlando, FL. Abstract #510 What's New? June 2, 2008 Genomic Health Announces Expansion of Oncotype DX(R) Breast Cancer Test to Include Quantitative Estrogen Receptor (ER) and Progesterone Receptor (PR) Scores May 31, 2008 Genomic Health Announces Results of Initial Studies to Develop Predictive Tests for Targeted Therapies

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