scholarly journals Prediction of Low versus High Recurrence Scores in Estrogen Receptor–Positive, Lymph Node–Negative Invasive Breast Cancer on the Basis of Radiologic-Pathologic Features: Comparison with Oncotype DX Test Recurrence Scores

Radiology ◽  
2016 ◽  
Vol 280 (2) ◽  
pp. 370-378 ◽  
Author(s):  
Vandana Dialani ◽  
Shantanu Gaur ◽  
Tejas S. Mehta ◽  
Shambhavi Venkataraman ◽  
Valerie Fein-Zachary ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Lymph Node ◽  
Invasive Breast Cancer ◽  
Positive Lymph Node ◽  
Oncotype Dx ◽  
Node Negative ◽  
Pathologic Features ◽  
Estrogen Receptor Positive

Can Features Evaluated in the Routine Pathologic Assessment of Lymph Node–Negative Estrogen Receptor–Positive Stage I or II Invasive Breast Cancer Be Used to Predict the Oncotype DX Recurrence Score?

2010 ◽  
Vol 134 (11) ◽  
pp. 1697-1701
Author(s):  
Jena Auerbach ◽  
Mimi Kim ◽  
Susan Fineberg
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Lymph Node ◽  
Invasive Breast Cancer ◽  
Recurrence Score ◽  
Mitotic Count ◽  
Oncotype Dx ◽  
Node Negative ◽  
Estrogen Receptor Positive ◽  
Pathologic Assessment

Abstract Context.—Oncotype DX is a multigene reverse transcription–polymerase chain reaction assay used to quantify recurrence risk in patients with stage I or II estrogen receptor–positive, lymph node–negative invasive breast cancer. The results are reported as a Recurrence Score (RS). The 16 cancer genes evaluated include a proliferation set, hormone receptor set, and HER2 set. The activity of these genes is addressed by pathologic assessment of breast cancers. Objective.—To determine if factors evaluated in pathologic evaluation of breast cancer could be used to predict Oncotype DX results. Design.—We studied 138 cases of invasive breast cancer for which Oncotype DX results and pathology data were available. Grading was performed by using Nottingham grading system. For hormone receptor immunostaining, 10% nuclear staining was considered a positive result. Results.—Oncotype DX RS was low in 81 cases, intermediate in 44 cases, and high in 13 cases. All 6 cases with both a negative progesterone receptor (PR) and a mitotic count score of 3 had a high RS. All 12 cases with both a negative PR and a mitotic count score greater than 1 had either an intermediate or high RS. Although Nottingham grade, PR status, mitotic count score, tumor size, and nuclear grade were each significantly associated with RS, in bivariate analyses the only variables that remained independently predictive of an intermediate or high RS score in a multivariate logistic regression model were negative PR and mitotic count score greater than 1. Conclusions.—Our study suggests that a mitotic count score greater than 1 combined with a negative PR result, as determined by pathologic assessment, could serve as a marker for an intermediate or high Oncotype DX RS.

Recurrence Score across the age spectrum: Is there an age discrimination?

2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 27-27
Author(s):  
Franz Omar Smith ◽  
Marie Catherine Lee ◽  
Geza Acs ◽  
William J. Fulp ◽  
Ji-Hyun Lee ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Lymph Node ◽  
Treatment Planning ◽  
Tumor Size ◽  
Predictive Power ◽  
Early Stage ◽  
Recurrence Score ◽  
Positive Lymph Node ◽  
Node Negative

27 Background: Treatment planning for early-stage estrogen receptor (ER) positive, lymph node negative breast cancer was based on prognostic factors with limited predictive power such as age. The Recurrence Score (RS) from the Oncotype DX assay (ODX) provides predictive power transcending age but is rarely applied to the elderly or young patients (pts). We examined our experience with RS along the age continuum. Methods: Retrospective review was conducted of prospectively gathered breast cancer pts having a RS obtained as part of their cancer care. Eligibility for performance of the ODX was based on NCCN guidelines or physician discretion. Comparisons on RS were made by age groups (young: <45yrs; middle: >45yrs -<70yrs: elderly: >70yrs) using general linear regression model and the exact Wilcoxon Rank Sum Test. Results: 677pts had 681 tumors with RS available (89 young, 476 middle and 112 elderly pts). Median RS for the study pts was 17 (range 0-85) and 16, 17, and 15 for the young, middle, and elderly respectively. Median age was 58yrs (range: 27-95); young, middle, and elderly was 42, 58, and 74yrs respectively. Age as a continuous or categorical variable was not predictive of RS (p value = 0.38, 0.58 respectively). No significant differences were seen between age cohorts for histology, mitotic rate, lymphovascular invasion (LVI), grade, nodal status, stage, or strength of ER positivity. Mastectomy rates were higher in the young (57.5%), compared to the middle (42.5%) and elderly (39.6%) (p=0.02). Median invasive tumor size was 1.6, 1.5, and 1.5cm for young, middle, and elderly. Larger tumor size, as a continuous variable, equaled higher RS (p=0.046). Other significant factors predicting higher RS were increased mitosis (p<0.001), LVI (p=0.013), high grade (p<0.001), and weak (<10%) ER positivity (p<0.001). Nodal status, stage, and histology did not affect RS. Conclusions: Age has limited predictive power for treatment planning for breast cancer. Age alone should not preclude recommendations for performance of ODX in estrogen receptor positive lymph node negative early stage breast cancer as the RS distribution across the spectrum of age is well matched.

scholarly journals Analytical Validation of the Oncotype DX Genomic Diagnostic Test for Recurrence Prognosis and Therapeutic Response Prediction in Node-Negative, Estrogen Receptor–Positive Breast Cancer

2007 ◽  
Vol 53 (6) ◽  
pp. 1084-1091 ◽  
Author(s):  
Maureen Cronin ◽  
Chithra Sangli ◽  
Mei-Lan Liu ◽  
Mylan Pho ◽  
Debjani Dutta ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Oncotype Dx ◽  
Analytical Performance ◽  
Performance Criteria ◽  
Operational Performance ◽  
Node Negative ◽  
Unit Scale ◽  
Estrogen Receptor Positive ◽  
Positive Breast Cancer

Abstract Background: Oncotype DX™ is a clinically validated, high-complexity, multianalyte reverse transcription–PCR genomic test that predicts the likelihood of breast cancer recurrence in early-stage, node-negative, estrogen receptor–positive breast cancer. The Recurrence Score™ (RS) provides a more accurate, reproducible measure of breast cancer aggressiveness and therapeutic responsiveness than standard measures. Individualized patient management requires strict performance criteria for clinical laboratory tests. We therefore investigated the analytical performance of the assay. Methods: Assays used a pooled RNA sample from fixed paraffin-embedded tissues to evaluate the analytical performance of a 21-gene panel with respect to amplification efficiency, precision, linearity, and dynamic range, as well as limits of detection and quantification. Performance variables were estimated from assays carried out with sample dilutions. In addition, individual patient samples were used to test the optimized assay for reproducibility and sources of imprecision. Results: Assay results defined acceptable operational performance ranges, including an estimated maximum deviation from linearity of &lt;1 cycle threshold (CT) units over a ≥2000-fold range of RNA concentrations, with a mean quantification bias of 0.3% and CVs of 3.2%–5.7%. An analysis of study design showed that assay imprecision contributed by instrument, operator, reagent, and day-to-day baseline variation was low, with SDs of &lt;0.5 CT. Conclusion: The analytical and operational performance specifications defined for the Oncotype DX assay allow the reporting of quantitative RS values for individual patients with an SD within 2 RS units on a 100-unit scale.

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