Impact of the 21-Gene Recurrence Score (Oncotype DX®) on adjuvant therapy decision-making

a collaborative multicenter cohort study from Argentina

Authors

Keywords:

breast neoplasms, genomics, chemotherapy, adjuvant, medication therapy management

Abstract

Introduction: At present, more than half of patients diagnosed with early-stage breast cancer (BC) and express hormonal receptors will receive some adjuvant chemotherapy scheme, but only a few of them would benefit in terms of survival. Genomic platforms allow a better understanding of the heterogeneity of different types of hormonal receptor-positive and HER2-negative BC. They have proven their validity as tools to identify those patients who will obtain a clear benefit with the indication of chemotherapy treatment. The aim of this study is to analyze the use of the genomic platform, namely, Oncotype Dx® and its impact on the indication of adjuvant treatment, evaluated mainly as the change in treatment indication. Methods: Multicenter observational cohort study was performed in different Mastology units in Argentina. Patients underwent the Oncotype Dx to clarify the adjuvant treatment. Treatment decisions were settled before and after performing Oncotype Dx. Results: From January 2013 to December 2018, 211 patients with luminal A or B and HER2-negative breast carcinomas, who underwent the Oncotype Dx, were included. Based on our records, 40% of the patients change the indication of adjuvant treatment after the performance of the Oncotype Dx. Of these, 24% of patients who underwent initial endocrine therapy only adjusted their treatment with the addition of chemotherapy. Among patients with an initial CTH recommendation, 49% were able to receive endocrine therapy only when, due to traditional prognostic factors, they would have received chemotherapy. Conclusions: In our population, the use of the Recurrence Score was clinically significant in relation to the change of the established treatments. Consequently, it is a very important tool and a decisive factor in the adjuvant indication in patients with positive hormonal receptors and HER2neu-negative early BC.

Downloads

Download data is not yet available.

References

Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials. Obstetr Gynecol. 2005;106(2):407. http://dx.doi.org/10.1097/01.aog.0000173956.06308.f7

Ribnikar D, Cardoso F. Tailoring chemotherapy in early-stage breast cancer: based on tumor biology or tumor burden?Am Soc Clin Oncol Educ Book. 2016;35:e31-8. https://doi.org/10.1200/edbk_159077

Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351(27):2817-26. https://doi.org/10.1056/nejmoa041588

Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med. 2015;373(21):2005-14. https://doi.org/10.1056/nejmoa1510764

Senkus E, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rutgers E, et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(Suppl. 5):v8-30. https://doi.org/10.1093/annonc/mdv298

Gradishar WJ, Anderson BO, Abraham J, Aft R, Agnese D, Allison KH, et al. Breast Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2020;18(4):452-78. https://doi.org/10.6004/jnccn.2020.0016

Markopoulos C, van de Velde C, Zarca D, Ozmen V, Masetti

R. Clinical evidence supporting genomic tests in early breast cancer: Do all genomic tests provide the same information?Eur J Surg Oncol. 2017;43(5):909-20. https://doi.org/10.1016/j.ejso.2016.08.012

Mamounas EP, Tang G, Fisher B, Paik S, Shak S, Costantino JP, et al. 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. J Clin Oncol. 2010;28(10):1677-83. https://doi.org/10.1200/jco.2009.23.7610

Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med. 2018;379(2):111-21. https://doi.org/10.1056/nejmoa1804710

Lo SS, Mumby PB, Norton J, Rychlik K, Smerage J, Kash J, et al. Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J Clin Oncol. 2010;28(10):1671-6. https://doi.org/10.1200/jco.2008.20.2119

Partin JF, Mamounas EP. Impact of the 21-gene recurrence score assay compared with standard clinicopathologic guidelines in adjuvant therapy selection for node-negative, estrogen receptor-positive breast cancer. Ann Surg Oncol. 2011;18(12):3399-406. https://doi.org/10.1245/s10434-011-1698-z

Gluz O, Nitz UA, Christgen M, Kates RE, Shak S, Clemens M, et al. West German Study Group Phase III PlanB Trial: first prospective outcome data for the 21-gene recurrence score assay and concordance of prognostic markers by central and local pathology assessment. J Clin Oncol. 2016;34(20):2341-9. https://doi.org/10.1200/jco.2015.63.5383

Pelorosso F, Mosto J, Morris B, Montoya D, Beccar Varela E, Elías AS, et al. Comparación de la estratificación de riesgo de recurrencia de cáncer de mama con score IHC4+C y Score de Recurrencia de 21 genes. Estudio retrospectivo de evaluación de impacto teórico en toma de decisión. Rev Arg Mastología. 2015;34(125):41-51.

Petracci F, Loza J, Coló F, Chacón R. Evaluación prospectiva de pacientes testeadas con Oncotype Dx® en Cáncer de Mama Temprano RE+/RP+/her2- en el Instituto Alexander Fleming. Rev Arg Mastología. 2016;36(127):90-102.

Enewold L, Geiger AM, Zujewski J, Harlan LC. Oncotype Dx assay and breast cancer in the United States: usage and concordance with chemotherapy. Breast Cancer Res Treat. 2015;151(1):149-56. https://doi.org/10.1007/s10549-015-3366-7

Albanell J, González A, Ruiz-Borrego M, Alba E, García-Saenz JA, Corominas JM, et al. Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER) node-negative breast cancer. Ann Oncol. 2012;23(3):625-31. http://dx.doi.org/10.1093/annonc/mdr278

Oratz R, Kim B, Chao C, Skrzypczak S, Ory C, Bugarini R, et al. Physician survey of the effect of the 21-gene recurrence score assay results on treatment recommendations for patients with lymph node-positive, estrogen receptor-positive breast cancer. J Oncol Pract. 2011;7(2):94-9. https://dx.doi.org/10.1200%2FJOP.2010.000046

Downloads

Published

2021-04-05

How to Cite

Allemand, C., Valerio, A. C., Calvo, M. F., Izbizky, G., Lean, I. M., Terrier, F., … Gil, L. B. (2021). Impact of the 21-Gene Recurrence Score (Oncotype DX®) on adjuvant therapy decision-making: a collaborative multicenter cohort study from Argentina. Mastology, 31, 1–7. Retrieved from https://revistamastology.emnuvens.com.br/revista/article/view/312

Issue

Section

Original Articles