Impact of Oncotype DX Recurrence Score on Treatment Decisions: Results of a Prospective Multicenter Study in Turkey

Vahit Ozmen ¹, Ajlan Atasoy ², Erhan Gokmen ³, Mustafa Ozdogan ⁴, Nilufer Guler ⁵, Cihan Uras ⁶, Engin Ok ⁷, Orhan Demircan ⁸, Abdurrahman Isikdogan ⁹, Pinar Saip ¹⁰

Affiliations

¹ Department of Surgery, Istanbul University.
² Medical Department, EORTC.
³ Department of Internal Medicine, Division of Medical Oncology, Ege University.
⁴ Department of Internal Medicine, Division of Medical Oncology, Akdeniz University / Memorial Hospital Antalya.
⁵ Department of Internal Medicine, Division of Medical Oncology, Hacettepe University Institute of Oncology.
⁶ Department of General Surgery, Acibadem University Maslak.
⁷ Department of General Surgery, Erciyes University.
⁸ Department of General Surgery, Cukurova University / Acibadem University Adana.
⁹ Department of Internal Medicine, Division of Medical Oncology, Dicle University.
¹⁰ Department of Medicine, Division of Medical Oncology, Istanbul University.

PMID: 27081583
19 References
9 citations

Abstract

Introduction: Breast cancer is the most common malignancy among Turkish women and the rate of early stage disease is increasing. The Oncotype DX(®) 21-gene assay is predictive of distant recurrence in ER-positive, HER2-negative early breast cancer. We aimed to evaluate the impact of the Recurrence Score(®) (RS) on treatment decisions and physician perceptions in Turkey. We also studied correlations between RS and routine risk factors.

Patients And Methods: Ten academic centers across Turkey participated in this prospective trial. Consecutive breast cancer patients with pT1-3, pN0-N1mic, ER-positive, and HER2-negative tumors were identified at multidisciplinary tumor conferences. The initial treatment decision was recorded before tumor blocks were sent to the central laboratory. Each case was brought back to tumor conference after receiving the RS result. Both pre- and post-RS treatment decisions and physician perceptions were recorded on questionnaire forms. Correlations between RS and classical risk factors were evaluated using univariate and multivariate analyses.

Results: Ten centers enrolled a total of 165 patients. The median tumor size was 2 cm. Of 165 patients, 57% had low RS, 35% had intermediate RS, and 8% had high RS, respectively. The overall rate of change in treatment decision was 33%. Initially, chemotherapy followed by hormonal therapy (CT+HT) was recommended to 92 (56%) of all patients, which decreased to 61 (37%) patients post-RS assay (p<0.001). Multivariate analysis indicated that progesterone receptor (PR) and Ki-67 scores were significantly related to RS.

Conclusion: Oncotype DX testing may provide meaningful additional information in carefully selected patients.

Keywords: adjuvant treatment; breast cancer; decision impact; genomic testing; oncotype dx.

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References
A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. Soonmyung Paik, Steven Shak, +12 authors, Norman Wolmark. less N Engl J Med, 2004 Dec 14; 351(27). PMID: 15591335 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. less J Clin Oncol, 2006 May 25; 24(23). PMID: 16720680 Highly Cited.
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. less J Clin Oncol, 2007 Oct 24; 25(33). PMID: 17954709 Highly Cited. Review.
Histopathologic variables predict Oncotype DX recurrence score. Melina B Flanagan, David J Dabbs, +2 authors, Adam M Brufsky, Sushil Beriwal, Rohit Bhargava. less Mod Pathol, 2008 Mar 25; 21(10). PMID: 18360352
Cancer trends and incidence and mortality patterns in Turkey. Hakki Hakan Yılmaz, Nuray Yazıhan, +4 authors, Murat Tuncer. less Jpn J Clin Oncol, 2010 Jun 19; 41(1). PMID: 20558464
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
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, C M Sitlani, S M Dintzis, A M Gown. less Breast Cancer Res Treat, 2011 Mar 04; 131(2). PMID: 21369717
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. less Oncologist, 2011 Oct 22; 16(11). PMID: 22016474 Free PMC article.
How reliable is Ki-67 immunohistochemistry in grade 2 breast carcinomas? A QA study of the Swiss Working Group of Breast- and Gynecopathologists. Zsuzsanna Varga, Joachim Diebold, +16 authors, Hans-Anton Lehr. less PLoS One, 2012 Jun 05; 7(5). PMID: 22662150 Free PMC article.
Impact of progesterone receptor semiquantitative immunohistochemical result on Oncotype DX recurrence score: a quality assurance study of 1074 cases. Beth Z Clark, David J Dabbs, Kristine L Cooper, Rohit Bhargava. Appl Immunohistochem Mol Morphol, 2012 Oct 13; 21(4). PMID: 23060300
The 21-gene recurrence score assay impacts adjuvant therapy recommendations for ER-positive, node-negative and node-positive early breast cancer resulting in a risk-adapted change in chemotherapy use. W Eiermann, M Rezai, +13 authors, J Blohmer. less Ann Oncol, 2012 Nov 09; 24(3). PMID: 23136233 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. less Mod Pathol, 2013 Mar 19; 26(5). PMID: 23503643 Free PMC article.
A decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the U.K. S Holt, G Bertelli, +12 authors, C J Phillips. less Br J Cancer, 2013 May 23; 108(11). PMID: 23695023 Free PMC article.
Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. A Goldhirsch, E P Winer, +5 authors, Panel members. less Ann Oncol, 2013 Aug 07; 24(9). PMID: 23917950 Free PMC article. Highly Cited.
Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. E Senkus, S Kyriakides, +5 authors, ESMO Guidelines Working Group. less Ann Oncol, 2013 Aug 24; 24 Suppl 6. PMID: 23970019 Highly Cited.
The impact of Oncotype DX testing on breast cancer management and chemotherapy prescribing patterns in a tertiary referral centre. Terri Patricia McVeigh, Lauren M Hughes, +4 authors, Michael J Kerin. less Eur J Cancer, 2014 Sep 23; 50(16). PMID: 25240289 Free PMC article.
Tailoring therapies--improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. A S Coates, E P Winer, +6 authors, Panel Members. less Ann Oncol, 2015 May 06; 26(8). PMID: 25939896 Free PMC article. Highly Cited.
Prospective Validation of a 21-Gene Expression Assay in Breast Cancer. Joseph A Sparano, Robert J Gray, +28 authors, George W Sledge. less N Engl J Med, 2015 Sep 29; 373(21). PMID: 26412349 Free PMC article. Highly Cited.
Breast Cancer in Turkey: Clinical and Histopathological Characteristics (Analysis of 13.240 Patients). Vahit Özmen. J Breast Health, 2014 Jan 01; 10(2). PMID: 28331652 Free PMC article.

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Gene Expression Profiling in Breast Cancer and Its Effect on Therapy Selection in Early-Stage Breast Cancer. E Nilüfer Güler. Eur J Breast Health, 2017 Oct 31; 13(4). PMID: 29082373 Free PMC article. Review.
Spotlight on the utility of the Oncotype DX® breast cancer assay. Zhen Rong Siow, Richard H De Boer, Geoffrey J Lindeman, G Bruce Mann. Int J Womens Health, 2018 Mar 06; 10. PMID: 29503586 Free PMC article. Review.
The Warwick Experience of the Oncotype DX® Breast Recurrence Score® Assay as a Predictor of Chemotherapy Administration. Mashuk Alam Khan, Laura Henderson, +2 authors, Dayalan Clarke, Simon Harries, Lucie Jones. less Breast Care (Basel), 2018 Dec 01; 13(5). PMID: 30498424 Free PMC article.
Multidisciplinary care of breast cancer patients: a scoping review of multidisciplinary styles, processes, and outcomes. J Shao, M Rodrigues, A L Corter, N N Baxter. Curr Oncol, 2019 Jul 10; 26(3). PMID: 31285683 Free PMC article. Review.
Gene Expression Profiling Tests for Early-Stage Invasive Breast Cancer: A Health Technology Assessment. Ontario Health (Quality). Ont Health Technol Assess Ser, 2020 Apr 15; 20(10). PMID: 32284770 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. less Curr Oncol, 2020 Jun 04; 27(2). PMID: 32489257 Free PMC article.
Cost effectiveness of Gene Expression Profiling in Patients with Early-Stage Breast Cancer in a Middle-Income Country, Turkey: Results of a Prospective Multicenter Study. Vahit Özmen, Burcu Çakar, +7 authors, Pınar Saip. less Eur J Breast Health, 2019 Jul 18; 15(3). PMID: 31312795 Free PMC article.
Adjuvant Chemotherapy for Patients with Breast Cancer Based on Clinical and Evolving Oncotype DX Criteria. Jamal Zekri, Meteb Al-Foheidi, +2 authors, Maaz Alata, Reem Zabani, Ayman Rasmy. less Breast Care (Basel), 2021 Jan 16; 15(6). PMID: 33447239 Free PMC article.

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