Journal Article
. 2011 Oct;16(11).
doi: 10.1634/theoncologist.2011-0045.

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 1 Nicole N Esposito  John V Kiluk  Christine Laronga  M Catherine Lee  Loretta Loftus  Hatem Soliman  Judy C Boughey  Carol Reynolds  Thomas J Lawton  Peter I Acs  Lucio Gordan  Geza Acs  
Affiliations
  • PMID: 22016474
  •     25 References
  •     37 citations

Abstract

Purpose: The Oncotype DX assay predicts likelihood of distant recurrence and improves patient selection for adjuvant chemotherapy in estrogen receptor-positive (ER-positive) early stage breast cancer. This study has two primary endpoints: to evaluate the impact of Oncotype DX recurrence scores (RS) on chemotherapy recommendations and to compare the estimated recurrence risk predicted by breast oncology specialists to RS.

Methods: One hundred fifty-four patients with ER-positive early stage breast cancer and available RS results were selected. Clinicopathologic data were provided to four surgeons, four medical oncologists, and four pathologists. Participants were asked to estimate recurrence risk category and offer their chemotherapy recommendations initially without and later with knowledge of RS results. The three most important clinicopathologic features guiding their recommendations were requested.

Results: Ninety-five (61.7%), 45 (29.2%), and 14 (9.1%) tumors were low, intermediate, and high risk by RS, respectively. RS significantly correlated with tumor grade, mitotic activity, lymphovascular invasion, hormone receptor, and HER2/neu status. Estimated recurrence risk by participants agreed with RS in 54.2% ± 2.3% of cases. Without and with knowledge of RS, 82.3% ± 1.3% and 69.0% ± 6.9% of patients may be overtreated, respectively (p = 0.0322). Inclusion of RS data resulted in a 24.9% change in treatment recommendations. There was no significant difference in recommendations between groups of participants.

Conclusions: Breast oncology specialists tended to overestimate the risk of tumor recurrence compared with RS. RS provides useful information that improves patient selection for chemotherapy and changes treatment recommendations in approximately 25% of cases.

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.
Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer?
Juhi Asad, Allyson F Jacobson, +7 authors, Paul I Tartter.
Am J Surg, 2008 Sep 24; 196(4). PMID: 18809056
Histopathologic variables predict Oncotype DX recurrence score.
Melina B Flanagan, David J Dabbs, +2 authors, Rohit Bhargava.
Mod Pathol, 2008 Mar 25; 21(10). PMID: 18360352
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.
The influence of a gene expression profile on breast cancer decisions.
Leonard R Henry, Alexander Stojadinovic, +3 authors, Peter W Soballe.
J Surg Oncol, 2009 Feb 11; 99(6). PMID: 19204954
Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection.
Shelly S Lo, Patricia B Mumby, +8 authors, Kathy S Albain.
J Clin Oncol, 2010 Jan 13; 28(10). PMID: 20065191
Highly Cited.
Changing paradigms in breast cancer management: introducing molecular genetics into the treatment algorithm.
Jessica A Rayhanabad, L Andrew Difronzo, Phillip I Haigh, Lina Romero.
Am Surg, 2008 Oct 24; 74(10). PMID: 18942607
TAILORx: trial assigning individualized options for treatment (Rx).
Joseph A Sparano.
Clin Breast Cancer, 2006 Nov 10; 7(4). PMID: 17092406
Gene expression profiling in breast cancer.
Kiran Turaga, Geza Acs, Christine Laronga.
Cancer Control, 2010 Jul 29; 17(3). PMID: 20664515
Review.
Cancer of the breast: size of neoplasm and prognosis.
B Fisher, N H Slack, I D Bross.
Cancer, 1969 Nov 01; 24(5). PMID: 5353940
Highly Cited.
Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.
Soonmyung Paik, Gong Tang, +11 authors, Norman Wolmark.
J Clin Oncol, 2006 May 25; 24(23). PMID: 16720680
Highly Cited.
A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.
Soonmyung Paik, Steven Shak, +12 authors, Norman Wolmark.
N Engl J Med, 2004 Dec 14; 351(27). PMID: 15591335
Highly Cited.
Time-dependence of hazard ratios for prognostic factors in primary breast cancer.
S G Hilsenbeck, P M Ravdin, +3 authors, G M Clark.
Breast Cancer Res Treat, 1999 Mar 05; 52(1-3). PMID: 10066085
Relation of tumor size, lymph node status, and survival in 24,740 breast cancer cases.
C L Carter, C Allen, D E Henson.
Cancer, 1989 Jan 01; 63(1). PMID: 2910416
Highly Cited.
Impact of a 21-gene RT-PCR assay on treatment decisions in early-stage breast cancer: an economic analysis based on prognostic and predictive validation studies.
Gary H Lyman, Leon E Cosler, Nicole M Kuderer, John Hornberger.
Cancer, 2007 Feb 22; 109(6). PMID: 17311307
Impact of a commercial reference laboratory test recurrence score on decision making in early-stage breast cancer.
Ruth Oratz, Dev Paul, Allen L Cohn, Scot M Sedlacek.
J Oncol Pract, 2007 Jul 01; 3(4). PMID: 20859407    Free PMC article.
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
The oncotype DX recurrence score is correlated with a composite index including routinely reported pathobiologic features.
Joseph Geradts, Sarah M Bean, Rex C Bentley, William T Barry.
Cancer Invest, 2010 Sep 30; 28(9). PMID: 20873988
Long-term followup of breast cancer patients: the 30-year report.
F Adair, J Berg, L Joubert, G F Robbins.
Cancer, 1974 Apr 01; 33(4). PMID: 4819216
Highly Cited.
Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20.
Eleftherios P Mamounas, Gong Tang, +7 authors, Norman Wolmark.
J Clin Oncol, 2010 Jan 13; 28(10). PMID: 20065188    Free PMC article.
Highly Cited.
Breast cancer: relationship between the size of the primary tumour and the probability of metastatic dissemination.
S Koscielny, M Tubiana, +4 authors, D Sarrazin.
Br J Cancer, 1984 Jun 01; 49(6). PMID: 6733019    Free PMC article.
Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial.
Kathy S Albain, William E Barlow, +20 authors, Breast Cancer Intergroup of North America.
Lancet Oncol, 2009 Dec 17; 11(1). PMID: 20005174    Free PMC article.
Highly Cited.
Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG).
Lancet, 2005 May 17; 365(9472). PMID: 15894097
Highly Cited.
Impact of multigene assays in early stage breast cancer.
Shelly S Lo, Kathy S Albain.
Oncologist, 2011 Oct 22; 16(11). PMID: 22016475    Free PMC article.
Expert opinion: future frontiers and challenges in cancer medicine.
Patrick G Johnston, Mark Lawler.
Oncologist, 2012 May 29; 17(5). PMID: 22639114    Free PMC article.
Global microRNA profiling in favorable prognosis subgroups of cancer of unknown primary (CUP) demonstrates no significant expression differences with metastases of matched known primary tumors.
George Pentheroudakis, Yael Spector, +8 authors, Ranit Aharonov.
Clin Exp Metastasis, 2012 Nov 06; 30(4). PMID: 23124598
Biomarkers and sustainable innovation in cardiovascular drug development: lessons from near and far afield.
Russell M Medford, T Forcht Dagi, Robert S Rosenson, Margaret K Offermann.
Curr Atheroscler Rep, 2013 Mar 21; 15(5). PMID: 23512605
Review.
Breast cancer genomics: challenges in interpretation and application.
Cathy M Kelly, W Fraser Symmans, Eleni Andreopoulou, Giampaolo Bianchini.
Oncologist, 2013 May 02; 18(4). PMID: 23633449    Free PMC article.
The impact of the 21-gene Recurrence Score assay on clinical decision-making in node-positive (up to 3 positive nodes) estrogen receptor-positive breast cancer patients.
Salomon M Stemmer, Shmuel H Klang, +7 authors, Nicky Lieberman.
Breast Cancer Res Treat, 2013 Jun 27; 140(1). PMID: 23801158    Free PMC article.
The impact of the Oncotype Dx breast cancer assay in clinical practice: a systematic review and meta-analysis.
Josh J Carlson, Joshua A Roth.
Breast Cancer Res Treat, 2013 Aug 27; 141(1). PMID: 23974828    Free PMC article.
Highly Cited. Systematic Review.
The clinical impact of 21-gene recurrence score on treatment decisions for patients with hormone receptor-positive early breast cancer in Korea.
Moo Hyun Lee, Wonshik Han, +7 authors, Eun Sook Lee.
Cancer Res Treat, 2014 Nov 11; 47(2). PMID: 25381828    Free PMC article.
Clinical utility of gene-expression profiling in women with early breast cancer: an overview of systematic reviews.
Michael Marrone, Alison Stewart, W David Dotson.
Genet Med, 2014 Dec 05; 17(7). PMID: 25474343    Free PMC article.
Review.
The value of multigene predictors of clinical outcome in breast cancer: an analysis of the evidence.
Amalia M Issa, Vivek S Chaudhari, Gary E Marchant.
Expert Rev Mol Diagn, 2014 Dec 06; 15(2). PMID: 25479414    Free PMC article.
Review.
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
Comparative Effectiveness of Biomarkers to Target Cancer Treatment: Modeling Implications for Survival and Costs.
Jeanette K Birnbaum, Foluso O Ademuyiwa, +3 authors, Ruth Etzioni.
Med Decis Making, 2015 Aug 26; 36(5). PMID: 26304062    Free PMC article.
Impact of Oncotype DX Recurrence Score on Treatment Decisions: Results of a Prospective Multicenter Study in Turkey.
Vahit Ozmen, Ajlan Atasoy, +7 authors, Pinar Saip.
Cureus, 2016 Apr 16; 8(3). PMID: 27081583    Free PMC article.
The effects of lymph node status on predicting outcome in ER+ /HER2- tamoxifen treated breast cancer patients using gene signatures.
Jessica G Cockburn, Robin M Hallett, +5 authors, Anita Bane.
BMC Cancer, 2016 Jul 30; 16. PMID: 27469239    Free PMC article.
Breast carcinoma with an Oncotype Dx recurrence score <18: Rate of distant metastases in a large series with clinical follow-up.
Hannah Y Wen, Melissa Krystel-Whittemore, +7 authors, Edi Brogi.
Cancer, 2016 Aug 16; 123(1). PMID: 27526056    Free PMC article.
Clinicopathological and Functional Significance of RECQL1 Helicase in Sporadic Breast Cancers.
Arvind Arora, Swetha Parvathaneni, +9 authors, Srinivasan Madhusudan.
Mol Cancer Ther, 2016 Nov 12; 16(1). PMID: 27837030    Free PMC article.
Estimating the OncotypeDX score: validation of an inexpensive estimation tool.
Anne A Eaton, Catherine E Pesce, +5 authors, Mahmoud El-Tamer.
Breast Cancer Res Treat, 2016 Dec 09; 161(3). PMID: 27928699    Free PMC article.
Integrated precision medicine: the role of electronic health records in delivering personalized treatment.
Amy Sitapati, Hyeoneui Kim, +5 authors, Lucila Ohno-Machado.
Wiley Interdiscip Rev Syst Biol Med, 2017 Feb 17; 9(3). PMID: 28207198    Free PMC article.
Review.
Correlations Between Oncotype DX Recurrence Score and Classic Risk Factors in Early Breast Cancer: Results of A Prospective Multicenter Study in Turkey.
Vahit Özmen, Ajlan Atasoy, +9 authors, Pınar Saip.
J Breast Health, 2016 Jan 01; 12(3). PMID: 28331745    Free PMC article.
Using the 21-gene assay from core needle biopsies to choose neoadjuvant therapy for breast cancer: A multicenter trial.
Harry D Bear, Wen Wan, +8 authors, Amy P Sing.
J Surg Oncol, 2017 Apr 14; 115(8). PMID: 28407247    Free PMC article.
Towards decision-making using individualized risk estimates for personalized medicine: A systematic review of genomic classifiers of solid tumors.
Daniel M Trifiletti, Vanessa N Sturz, Timothy N Showalter, Jennifer M Lobo.
PLoS One, 2017 May 10; 12(5). PMID: 28486497    Free PMC article.
Systematic Review.
The 21-gene recurrence score in special histologic subtypes of breast cancer with favorable prognosis.
Gulisa Turashvili, Edi Brogi, +4 authors, Hannah Y Wen.
Breast Cancer Res Treat, 2017 Jun 04; 165(1). PMID: 28577081    Free PMC article.
21-Gene recurrence score and locoregional recurrence in lymph node-negative, estrogen receptor-positive breast cancer.
Gulisa Turashvili, Joanne F Chou, +5 authors, Hannah Y Wen.
Breast Cancer Res Treat, 2017 Jul 14; 166(1). PMID: 28702894    Free PMC article.
Breast-cancer-specific mortality in patients treated based on the 21-gene assay: a SEER population-based study.
Valentina I Petkov, Dave P Miller, +21 authors, Steven Shak.
NPJ Breast Cancer, 2017 Jul 20; 2. PMID: 28721379    Free PMC article.
Highly Cited.
Clinical outcomes in ER+ HER2 -node-positive breast cancer patients who were treated according to the Recurrence Score results: evidence from a large prospectively designed registry.
Salomon M Stemmer, Mariana Steiner, +13 authors, Noa Ben-Baruch.
NPJ Breast Cancer, 2017 Sep 14; 3. PMID: 28900632    Free PMC article.
Use of 21-gene recurrence score assay to individualize adjuvant chemotherapy recommendations in ER+/HER2- node positive breast cancer-A National Cancer Database study.
Prema P Peethambaram, Tanya L Hoskin, +3 authors, Judy C Boughey.
NPJ Breast Cancer, 2017 Oct 27; 3. PMID: 29067357    Free PMC article.
Molecular Genomic Testing for Breast Cancer: Utility for Surgeons.
Oluwadamilola M Fayanju, Ko Un Park, Anthony Lucci.
Ann Surg Oncol, 2017 Nov 22; 25(2). PMID: 29159748    Free PMC article.
Review.
Breast carcinoma with 21-gene recurrence score lower than 18: rate of locoregional recurrence in a large series with clinical follow-up.
Gulisa Turashvili, Edi Brogi, +4 authors, Hannah Y Wen.
BMC Cancer, 2018 Jan 07; 18(1). PMID: 29304773    Free PMC article.
The 21-Gene Recurrence Score in Male Breast Cancer.
Gulisa Turashvili, Monica Gonzalez-Loperena, +4 authors, Hannah Y Wen.
Ann Surg Oncol, 2018 Mar 10; 25(6). PMID: 29520654    Free PMC article.
Practical Consequences Resulting from the Analysis of a 21-Multigene Array in the Interdisciplinary Conference of a Breast Cancer Center.
Hans-Ullrich Voelker, Lea Frey, Annette Strehl, Michael Weigel.
Int J Breast Cancer, 2018 Aug 17; 2018. PMID: 30112216    Free PMC article.
Distribution and Clinical Utility of the 21-gene Recurrence Score in Pure Mucinous Breast Cancer Patients: a case-control study.
Wei Wang, Xiaosong Chen, +12 authors, Kunwei Shen.
J Cancer, 2018 Oct 03; 9(18). PMID: 30271480    Free PMC article.
Expected Monetary Impact of Oncotype DX Score-Concordant Systemic Breast Cancer Therapy Based on the TAILORx Trial.
Angela Mariotto, Jinani Jayasekerea, +5 authors, Jeanne S Mandelblatt.
J Natl Cancer Inst, 2019 Jun 06; 112(2). PMID: 31165854    Free PMC article.
Impact of Recurrence Score on type and duration of chemotherapy in breast cancer.
K Willemsma, W Yip, +5 authors, C E Simmons.
Curr Oncol, 2020 Jun 04; 27(2). PMID: 32489257    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.
ONCOLOGISTS' BARRIERS AND FACILITATORS FOR ONCOTYPE DX USE: QUALITATIVE STUDY.
Megan C Roberts, Amy Bryson, +4 authors, Stephanie B Wheeler.
Int J Technol Assess Health Care, 2016 Dec 14; 32(5). PMID: 27958190    Free PMC article.
The impact of gene expression profile testing on confidence in chemotherapy decisions and prognostic expectations.
Laura Panattoni, Tracy A Lieu, +5 authors, Scott D Ramsey.
Breast Cancer Res Treat, 2018 Oct 12; 173(2). PMID: 30306429    Free PMC article.
A Nomogram for Predicting the Oncotype DX Recurrence Score in Women with T1-3N0-1miM0 Hormone Receptor‒Positive, Human Epidermal Growth Factor 2 (HER2)‒Negative Breast Cancer.
Sae Byul Lee, Junetae Kim, +8 authors, Kyung Hae Jung.
Cancer Res Treat, 2018 Nov 06; 51(3). PMID: 30384581    Free PMC article.