Journal Article
. 2016 Dec;161(3).
doi: 10.1007/s10549-016-4069-4.

Estimating the OncotypeDX score: validation of an inexpensive estimation tool

Anne A Eaton 1 Catherine E Pesce 2 James O Murphy 3 Michelle M Stempel 4 Sujata M Patil 1 Edi Brogi 5 Clifford A Hudis 6 Mahmoud El-Tamer 7 
Affiliations
  • PMID: 27928699
  •     19 References
  •     8 citations

Abstract

Background: OncotypeDX, a multi-gene expression assay, has been incorporated into clinical practice as a prognostic and predictive tool. However, its use in resource-constrained international healthcare systems is limited. Here we develop and validate a simplified model using clinicopathologic criteria to predict OncotypeDX score.

Methods: Patients with estrogen receptor (ER) and/or progesterone receptor (PR)-positive and HER2-negative invasive ductal carcinoma for whom the OncotypeDX test was successfully performed between 09/2008 and 12/2011 were retrospectively identified. Tumor size, nuclear and histologic grade, lymphovascular invasion, and ER and PR status were extracted from pathology reports. Data were split into a training dataset comprising women tested 09/2008-04/2011, and a validation dataset comprising women tested 04/2011-12/2011. Using the training dataset, linear regression analysis was used to identify factors associated with OncotypeDX score, and to create a simplified risk score and identify risk cutoffs.

Results: Estrogen and progesterone receptors, tumor size, nuclear and histologic grades, and lymphovascular involvement were independently associated with OncotypeDX. The full model explained 39% of the variation in the test data, and the simplified risk score and cutoffs assigned 57% of patients in the test data to the correct risk category (OncotypeDX score <18, 18-30, >30). 41% of patients were predicted to have OncotypeDX score <18, of these 83, 16, and 2% had true scores of <18, 18-30, and >30, respectively.

Conclusions: Awaiting an inexpensive test that is prognostic and predictive, our simplified tool allows clinicians to identify a fairly large group of patients (41%) with very low chance of having high-risk disease (2%).

Keywords: Breast cancer; OncotypeDX; Risk prediction.

Utilization of Oncotype DX in an Inner City Population: Race or Place?
Amber A Guth, Susan Fineberg, +2 authors, Nina A Bickell.
Int J Breast Cancer, 2014 Jan 24; 2013. PMID: 24455283    Free PMC article.
Prediction of the Oncotype DX recurrence score: use of pathology-generated equations derived by linear regression analysis.
Molly E Klein, David J Dabbs, +4 authors, Rohit Bhargava.
Mod Pathol, 2013 Mar 19; 26(5). PMID: 23503643    Free PMC article.
Commercialized multigene predictors of clinical outcome for breast cancer.
Jeffrey S Ross, Christos Hatzis, +2 authors, Gabriel N Hortobágyi.
Oncologist, 2008 Jun 03; 13(5). PMID: 18515733
Review.
The effect of Oncotype DX recurrence score on treatment recommendations for patients with estrogen receptor-positive early stage breast cancer and correlation with estimation of recurrence risk by breast cancer specialists.
Jennifer E Joh, Nicole N Esposito, +10 authors, Geza Acs.
Oncologist, 2011 Oct 22; 16(11). PMID: 22016474    Free PMC article.
Estrogen receptor analyses. Correlation of biochemical and immunohistochemical methods using monoclonal antireceptor antibodies.
K S McCarty, L S Miller, +2 authors, K S McCarty.
Arch Pathol Lab Med, 1985 Aug 01; 109(8). PMID: 3893381
Highly Cited.
A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients.
Laurel A Habel, Steven Shak, +12 authors, Charles P Quesenberry.
Breast Cancer Res, 2006 Jun 02; 8(3). PMID: 16737553    Free PMC article.
Highly Cited.
Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study.
Mitch Dowsett, Jack Cuzick, +11 authors, Steven Shak.
J Clin Oncol, 2010 Mar 10; 28(11). PMID: 20212256
Highly Cited.
Prognostic value of a combined estrogen receptor, progesterone receptor, Ki-67, and human epidermal growth factor receptor 2 immunohistochemical score and comparison with the Genomic Health recurrence score in early breast cancer.
Jack Cuzick, Mitch Dowsett, +10 authors, John F Forbes.
J Clin Oncol, 2011 Oct 13; 29(32). PMID: 21990413
Highly Cited.
Breast medical oncologists' use of standard prognostic factors to predict a 21-gene recurrence score.
Arif H Kamal, Charles L Loprinzi, +7 authors, Matthew P Goetz.
Oncologist, 2011 Sep 22; 16(10). PMID: 21934103    Free PMC article.
American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer.
Lyndsay Harris, Herbert Fritsche, +7 authors, American Society of Clinical Oncology.
J Clin Oncol, 2007 Oct 24; 25(33). PMID: 17954709
Highly Cited. Review.
Gene expression profiling in breast cancer.
Kiran Turaga, Geza Acs, Christine Laronga.
Cancer Control, 2010 Jul 29; 17(3). PMID: 20664515
Review.
The value of personalizing medicine: medical oncologists' views on gene expression profiling in breast cancer treatment.
Yvonne Bombard, Linda Rozmovits, +3 authors, Deborah A Marshall.
Oncologist, 2015 Mar 10; 20(4). PMID: 25746345    Free PMC article.
Use of modified Magee equations and histologic criteria to predict the Oncotype DX recurrence score.
Bradley M Turner, Kristin A Skinner, +6 authors, David G Hicks.
Mod Pathol, 2015 May 02; 28(7). PMID: 25932962
Gene expression profiling of breast cancer.
Ting Bao, Nancy E Davidson.
Adv Surg, 2008 Oct 29; 42. PMID: 18953822    Free PMC article.
Review.
Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population.
Masakazu Toi, Hiroji Iwata, +8 authors, Japan Breast Cancer Research Group-Translational Research Group.
Cancer, 2010 Jun 22; 116(13). PMID: 20564629
Routine pathologic parameters can predict Oncotype DX recurrence scores in subsets of ER positive patients: who does not always need testing?
K H Allison, P L Kandalaft, +2 authors, A M Gown.
Breast Cancer Res Treat, 2011 Mar 04; 131(2). PMID: 21369717
Evaluating use characteristics for the oncotype dx 21-gene recurrence score and concordance with chemotherapy use in early-stage breast cancer.
Clara Chen, Rahul Dhanda, +2 authors, Debra A Patt.
J Oncol Pract, 2013 Aug 15; 9(4). PMID: 23942918    Free PMC article.
Economic evaluation of the 21-gene signature (Oncotype DX) in lymph node-negative/positive, hormone receptor-positive early-stage breast cancer based on Japanese validation study (JBCRG-TR03).
Masahide Kondo, Shu-Ling Hoshi, +2 authors, Masakazu Toi.
Breast Cancer Res Treat, 2010 Nov 18; 127(3). PMID: 21082239
Prospective Validation of a 21-Gene Expression Assay in Breast Cancer.
Joseph A Sparano, Robert J Gray, +28 authors, George W Sledge.
N Engl J Med, 2015 Sep 29; 373(21). PMID: 26412349    Free PMC article.
Highly Cited.
Will oncotype DX DCIS testing guide therapy? A single-institution correlation of oncotype DX DCIS results with histopathologic findings and clinical management decisions.
Chieh-Yu Lin, Kelly Mooney, +5 authors, Kimberly Allison.
Mod Pathol, 2017 Dec 16; 31(4). PMID: 29243740
Prognostic Value of the Progesterone Receptor by Subtype in Patients with Estrogen Receptor-Positive, HER-2 Negative Breast Cancer.
Kathleen Van Asten, Laurence Slembrouck, +16 authors, Patrick Neven.
Oncologist, 2018 Sep 02; 24(2). PMID: 30171067    Free PMC article.
Breast Cancers With Magee Equation Score of Less Than 18, or 18-25 and Mitosis Score of 1, Do Not Require Oncotype DX Testing: A Value Study.
Rohit Bhargava, Beth Z Clark, David J Dabbs.
Am J Clin Pathol, 2018 Nov 06; 151(3). PMID: 30395177    Free PMC article.
The healthcare value of the Magee Decision Algorithm™: use of Magee Equations™ and mitosis score to safely forgo molecular testing in breast cancer.
Rohit Bhargava, Beth Z Clark, +2 authors, David J Dabbs.
Mod Pathol, 2020 Mar 24; 33(8). PMID: 32203092    Free PMC article.
BCL-2 expression aids in the immunohistochemical prediction of the Oncotype DX breast cancer recurrence score.
Mark D Zarella, Rebecca C Heintzelman, Nikolay K Popnikolov, Fernando U Garcia.
BMC Clin Pathol, 2018 Dec 24; 18. PMID: 30574014    Free PMC article.
Racial differences in estrogen receptor staining levels and implications for treatment and survival among estrogen receptor positive, HER2-negative invasive breast cancers.
Kristen S Purrington, David Gorski, +5 authors, Manohar Ratnam.
Breast Cancer Res Treat, 2020 Apr 03; 181(1). PMID: 32236827
Variation in breast cancer grading in 1,636 resections assessed using control charts and in silico kappa.
Jinesa Moodley, Phillip Williams, +2 authors, Michael Bonert.
PLoS One, 2020 Dec 29; 15(12). PMID: 33370310    Free PMC article.
Concordance between results of inexpensive statistical models and multigene signatures in patients with ER+/HER2- early breast cancer.
Laurence Slembrouck, Isabelle Vanden Bempt, +12 authors, Giuseppe Floris.
Mod Pathol, 2021 Feb 10;. PMID: 33558657