Journal Article
. 2019 Jun; 37(22):1956-1964.
doi: 10.1200/JCO.19.00945.

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update-Integration of Results From TAILORx

Fabrice Andre 1 Nofisat Ismaila 2 N Lynn Henry 3 Mark R Somerfield 2 Robert C Bast 4 William Barlow 5 Deborah E Collyar 6 M Elizabeth Hammond 7 Nicole M Kuderer 8 Minetta C Liu 9 Catherine Van Poznak 10 Antonio C Wolff 11 Vered Stearns 11 
  • PMID: 31150316
  •     39 citations


Purpose: This focused update addresses the use of Oncotype DX in guiding decisions on the use of adjuvant systemic therapy.

Methods: ASCO uses a signals approach to facilitate guideline updating. For this focused update, the publication of the Trial Assigning Individualized Options for Treatment (TAILORx) evaluating noninferiority of endocrine therapy alone versus chemoendocrine therapy for invasive disease-free survival in women with Oncotype DX scores provided a signal. An expert panel reviewed the results of TAILORx along with other published literature on the Oncotype DX assay to assess for evidence of clinical utility.

Updated Recommendations: For patients with hormone receptor-positive, axillary node-negative breast cancer whose tumors have Oncotype DX recurrence scores of less than 26, there is little to no benefit from chemotherapy, especially for patients older than age 50 years. Clinicians may recommend endocrine therapy alone for women older than age 50 years. For patients 50 years of age or younger with recurrence scores of 16 to 25, clinicians may offer chemoendocrine therapy. Patients with recurrence scores greater than 30 should be considered candidates for chemoendocrine therapy. Based on informal consensus, the panel recommends that oncologists may offer chemoendocrine therapy to these patients with recurrence scores of 26 to 30. Additional information can be found at

Molecular profiling for precision cancer therapies.
Eoghan R Malone, Marc Oliva, +2 authors, Lillian L Siu.
Genome Med, 2020 Jan 16; 12(1). PMID: 31937368    Free PMC article.
Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer.
Philip D Poorvu, Shari I Gelber, +12 authors, Ann H Partridge.
J Clin Oncol, 2019 Dec 07; 38(7). PMID: 31809240    Free PMC article.
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.
Curr Oncol, 2020 Jun 04; 27(2). PMID: 32489257    Free PMC article.
EndoPredict® in early hormone receptor-positive, HER2-negative breast cancer.
K Almstedt, S Mendoza, +9 authors, M Schmidt.
Breast Cancer Res Treat, 2020 May 22; 182(1). PMID: 32436145    Free PMC article.
Sex Disparity Observed for Oncotype DX Breast Recurrence Score in Predicting Mortality Among Patients with Early Stage ER-Positive Breast Cancer.
Fei Wang, Sonya Reid, +6 authors, Xiao-Ou Shu.
Clin Cancer Res, 2019 Nov 22; 26(1). PMID: 31748278    Free PMC article.
Should women with early breast cancer under 40 years of age have a routine 21-gene recurrence score testing: A SEER database study.
Kai-Hua Liu, Lei Zhang, +4 authors, San-Gang Wu.
Breast, 2020 Jan 10; 49. PMID: 31918322    Free PMC article.
Artificial intelligence in digital breast pathology: Techniques and applications.
Asmaa Ibrahim, Paul Gamble, +4 authors, Emad A Rakha.
Breast, 2020 Jan 15; 49. PMID: 31935669    Free PMC article.
Prospective observational study on the impact of the 21-gene assay on treatment decisions and resources optimization in breast cancer patients in Lombardy: The BONDX study.
Alberto Zambelli, Edda Simoncini, +11 authors, Carlo Tondini.
Breast, 2020 Apr 24; 52. PMID: 32325372    Free PMC article.
High Levels of Chromosomal Copy Number Alterations and TP53 Mutations Correlate with Poor Outcome in Younger Breast Cancer Patients.
Ayla Koçak, Kerstin Heselmeyer-Haddad, +13 authors, Thomas Ried.
Am J Pathol, 2020 May 18; 190(8). PMID: 32416097    Free PMC article.
Propensity score analysis of the prognostic value of genomic assays for breast cancer in diverse populations using the National Cancer Data Base.
Abiola Ibraheem, Olufunmilayo I Olopade, Dezheng Huo.
Cancer, 2020 Jun 11; 126(17). PMID: 32521056    Free PMC article.
The 21-Gene Recurrence Score Assay and Prediction of Chemotherapy Benefit: A Propensity Score-Matched Analysis of the SEER Database.
In Sil Choi, Jiwoong Jung, +5 authors, Ki-Tae Hwang.
Cancers (Basel), 2020 Jul 12; 12(7). PMID: 32650374    Free PMC article.
Personalised medicine and the decision to withhold chemotherapy in early breast cancer with intermediate risk of recurrence - a systematic review and meta-analysis.
Susanna M Wallerstedt, Astrid Nilsson Ek, +3 authors, Barbro Linderholm.
Eur J Clin Pharmacol, 2020 Jun 07; 76(9). PMID: 32504183    Free PMC article.
Systematic Review.
The Potential Use of Tumour-Based Prognostic and Predictive Tools in Older Women with Primary Breast Cancer: A Narrative Review.
Sophie Gordon-Craig, Ruth M Parks, Kwok-Leung Cheung.
Oncol Ther, 2020 Jul 24; 8(2). PMID: 32700048    Free PMC article.
Future perspectives of surgical treatment of breast cancer.
Margit Riis.
Ann Med Surg (Lond), 2020 Oct 03; 59. PMID: 33005399    Free PMC article.
Clinical utility of genomic signatures in young breast cancer patients: a systematic review.
Cynthia Villarreal-Garza, Ana S Ferrigno, +3 authors, Hatem A Azim.
NPJ Breast Cancer, 2020 Oct 17; 6. PMID: 33062888    Free PMC article.
Question Prompt List to Support Patient-Provider Communication in the Use of the 21-Gene Recurrence Test: Feasibility, Acceptability, and Outcomes.
Jinani Jayasekera, Susan T Vadaparampil, +8 authors, Suzanne C O'Neill.
JCO Oncol Pract, 2020 May 29; 16(10). PMID: 32463763    Free PMC article.
Management of Breast Cancer During the COVID-19 Pandemic: A Stage- and Subtype-Specific Approach.
Jennifer Y Sheng, Cesar A Santa-Maria, +18 authors, Karen L Smith.
JCO Oncol Pract, 2020 Jul 01; 16(10). PMID: 32603252    Free PMC article.
Patterns of Biomarker Use in Cancer Treatment Among Medical Oncologists in the Philippines.
Lance Isidore Catedral, Harold Nathan Tan, +2 authors, Dennis L Sacdalan.
JCO Glob Oncol, 2020 Oct 21; 6. PMID: 33079606    Free PMC article.
How to Predict Metastasis in Luminal Breast Cancer? Current Solutions and Future Prospects.
Sylwia Tabor, Małgorzata Szostakowska-Rodzos, Anna Fabisiewicz, Ewa A Grzybowska.
Int J Mol Sci, 2020 Nov 14; 21(21). PMID: 33182512    Free PMC article.
A Computational Statistics Approach to Evaluate Blood Biomarkers for Breast Cancer Risk Stratification.
Kaan Oktay, Ashlie Santaliz-Casiano, +5 authors, Zeynep Madak Erdogan.
Horm Cancer, 2019 Dec 21; 11(1). PMID: 31858384
Tumour-infiltrating lymphocytes as a prognostic and tamoxifen predictive marker in premenopausal breast cancer: data from a randomised trial with long-term follow-up.
Christine Lundgren, Pär-Ola Bendahl, +6 authors, Lisa Rydén.
Breast Cancer Res, 2020 Dec 29; 22(1). PMID: 33357231    Free PMC article.
High B3GALT5 expression confers poor clinical outcome and contributes to tumor progression and metastasis in breast cancer.
Yu-Mei Liao, Ya-Hui Wang, +6 authors, Alice L Yu.
Breast Cancer Res, 2021 Jan 09; 23(1). PMID: 33413566    Free PMC article.
Overdiagnosis in the Age of Digital Cancer Screening.
Otis W Brawley, Channing J Paller.
J Natl Cancer Inst, 2020 Jun 24; 113(1). PMID: 32572471    Free PMC article.
Concordance of the 21-gene assay between core needle biopsy and resection specimens in early breast cancer patients.
Peng Qi, Yu Yang, +5 authors, Xiao-Yan Zhou.
Breast Cancer Res Treat, 2021 Jan 14; 186(2). PMID: 33439420    Free PMC article.
Association of Race/Ethnicity and the 21-Gene Recurrence Score With Breast Cancer-Specific Mortality Among US Women.
Kent F Hoskins, Oana C Danciu, Naomi Y Ko, Gregory S Calip.
JAMA Oncol, 2021 Jan 22; 7(3). PMID: 33475714    Free PMC article.
Characterizing patient-oncologist communication in genomic tumor testing: The 21-gene recurrence score as an exemplar.
Suzanne C O'Neill, Susan T Vadaparampil, +9 authors, Susan Eggly.
Patient Educ Couns, 2020 Sep 10; 104(2). PMID: 32900604    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
Recommendations from the European Commission Initiative on Breast Cancer for multigene testing to guide the use of adjuvant chemotherapy in patients with early breast cancer, hormone receptor positive, HER-2 negative.
Paolo Giorgi Rossi, Annette Lebeau, +13 authors, ECIBC Contributor Group.
Br J Cancer, 2021 Feb 19; 124(9). PMID: 33597715    Free PMC article.
Selection of neoadjuvant treatment based on the 21-GENE test results in luminal breast cancer.
Serafin Morales Murillo, Ariadna Gasol Cudos, +6 authors, Antonieta Salud Salvia.
Breast, 2021 Feb 19; 56. PMID: 33601299    Free PMC article.
Neoadjuvant Endocrine Therapy in Breast Cancer Management: State of the Art.
Florence Lerebours, Luc Cabel, Jean-Yves Pierga.
Cancers (Basel), 2021 Mar 07; 13(4). PMID: 33670042    Free PMC article.
Invasive Ductal Breast Cancer with Osteoclast-Like Giant Cells: A Case Report Based on the Gene Expression Profile for Changes in Management.
Azzurra Irelli, Maria Maddalena Sirufo, +5 authors, Massimo De Martinis.
J Pers Med, 2021 Mar 07; 11(2). PMID: 33672165    Free PMC article.
Advanced Approaches to Breast Cancer Classification and Diagnosis.
M Zubair, S Wang, N Ali.
Front Pharmacol, 2021 Mar 16; 11. PMID: 33716731    Free PMC article.
Prognostic Cancer Gene Expression Signatures: Current Status and Challenges.
Yuquan Qian, Jimmy Daza, +4 authors, Andreas Teufel.
Cells, 2021 Apr 04; 10(3). PMID: 33804045    Free PMC article.
Photoacoustic Computed Tomography of Breast Cancer in Response to Neoadjuvant Chemotherapy.
Li Lin, Xin Tong, +3 authors, Lihong V Wang.
Adv Sci (Weinh), 2021 Apr 16; 8(7). PMID: 33854889    Free PMC article.
GATA3 as an Adjunct Prognostic Factor in Breast Cancer Patients with Less Aggressive Disease: A Study with a Review of the Literature.
Patrizia Querzoli, Massimo Pedriali, +3 authors, Elisabetta Kuhn.
Diagnostics (Basel), 2021 Apr 04; 11(4). PMID: 33800667    Free PMC article.
Multigene tests for breast cancer: the physician's perspective.
Francesco Cognetti, Laura Biganzoli, +9 authors, Sandro Barni.
Oncotarget, 2021 May 07; 12(9). PMID: 33953847    Free PMC article.
The impact of progesterone receptor negativity on oncological outcomes in oestrogen-receptor-positive breast cancer.
M G Davey, É J Ryan, +8 authors, A J Lowery.
BJS Open, 2021 May 21; 5(3). PMID: 34013318    Free PMC article.
Effects of supervised exercise during adjuvant endocrine therapy in overweight or obese patients with breast cancer: The I-MOVE study.
Harm L Ormel, Carolina P Schröder, +7 authors, Anna K L Reyners.
Breast, 2021 May 24; 58. PMID: 34023558    Free PMC article.