Journal Article
. 2008 Aug;26(25).
doi: 10.1200/JCO.2007.14.4501.

Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast cancer compared with classical clinicopathologic features

Lori J Goldstein 1 Robert Gray  Sunil Badve  Barrett H Childs  Carl Yoshizawa  Steve Rowley  Steven Shak  Frederick L Baehner  Peter M Ravdin  Nancy E Davidson  George W Sledge  Edith A Perez  Lawrence N Shulman  Silvana Martino  Joseph A Sparano  
Affiliations
  • PMID: 18678838
  •     29 References
  •     109 citations

Abstract

Purpose: Adjuvant! is a standardized validated decision aid that projects outcomes in operable breast cancer based on classical clinicopathologic features and therapy. Genomic classifiers offer the potential to more accurately identify individuals who benefit from chemotherapy than clinicopathologic features.

Patients And Methods: A sample of 465 patients with hormone receptor (HR) -positive breast cancer with zero to three positive axillary nodes who did (n = 99) or did not have recurrence after chemohormonal therapy had tumor tissue evaluated using a 21-gene assay. Histologic grade and HR expression were evaluated locally and in a central laboratory.

Results: Recurrence Score (RS) was a highly significant predictor of recurrence, including node-negative and node-positive disease (P < .001 for both) and when adjusted for other clinical variables. RS also predicted recurrence more accurately than clinical variables when integrated by an algorithm modeled after Adjuvant! that was adjusted to 5-year outcomes. The 5-year recurrence rate was only 5% or less for the estimated 46% of patients who have a low RS (< 18).

Conclusion: The 21-gene assay was a more accurate predictor of relapse than standard clinical features for individual patients with HR-positive operable breast cancer treated with chemohormonal therapy and provides information that is complementary to features typically used in anatomic staging, such as tumor size and lymph node involvement. The 21-gene assay may be used to select low-risk patients for abbreviated chemotherapy regimens similar to those used in our study or high-risk patients for more aggressive regimens or clinical trials evaluating novel treatments.

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PLoS One, 2017 May 10; 12(5). PMID: 28486497    Free PMC article.
Systematic Review.
Clinical utility of gene-expression signatures in early stage breast cancer.
Maryann Kwa, Andreas Makris, Francisco J Esteva.
Nat Rev Clin Oncol, 2017 Jun 01; 14(10). PMID: 28561071
Highly Cited. Review.
Clinical use of the Oncotype DX genomic test to guide treatment decisions for patients with invasive breast cancer.
Terri P McVeigh, Michael J Kerin.
Breast Cancer (Dove Med Press), 2017 Jun 16; 9. PMID: 28615971    Free PMC article.
Review.
Comparison of Oncotype DX® Recurrence Score® with other risk assessment tools including the Nottingham Prognostic Index in the identification of patients with low-risk invasive breast cancer.
Maura Bríd Cotter, Alex Dakin, +5 authors, Cecily M Quinn.
Virchows Arch, 2017 Jul 15; 471(3). PMID: 28707056
Learning from big data: are we undertreating older women with high-risk breast cancer?
Joseph A Sparano, Hyman Muss.
NPJ Breast Cancer, 2017 Jul 20; 2. PMID: 28721380    Free PMC article.
Exploitation of Gene Expression and Cancer Biomarkers in Paving the Path to Era of Personalized Medicine.
Hala Fawzy Mohamed Kamel, Hiba Saeed A Bagader Al-Amodi.
Genomics Proteomics Bioinformatics, 2017 Aug 17; 15(4). PMID: 28813639    Free PMC article.
Review.
21-Gene Recurrence Score for prognosis and prediction of taxane benefit after adjuvant chemotherapy plus endocrine therapy: results from NSABP B-28/NRG Oncology.
Eleftherios P Mamounas, Gong Tang, +14 authors, Norman Wolmark.
Breast Cancer Res Treat, 2017 Nov 13; 168(1). PMID: 29128898    Free PMC article.
A metastasis biomarker (MetaSite Breast™ Score) is associated with distant recurrence in hormone receptor-positive, HER2-negative early-stage breast cancer.
Joseph A Sparano, Robert Gray, +13 authors, Joan Jones.
NPJ Breast Cancer, 2017 Nov 16; 3. PMID: 29138761    Free PMC article.
The Era of Multigene Panels Comes? The Clinical Utility of Oncotype DX and MammaPrint.
Ling Xin, Yin-Hua Liu, Tracey A Martin, Wen G Jiang.
World J Oncol, 2017 Nov 18; 8(2). PMID: 29147432    Free PMC article.
Review.
Germline variation in ADAMTSL1 is associated with prognosis following breast cancer treatment in young women.
Latha Kadalayil, Sofia Khan, +13 authors, William Tapper.
Nat Commun, 2017 Nov 22; 8(1). PMID: 29158497    Free PMC article.
Prospective Evaluation of the Impact of the 21-Gene Recurrence Score Assay on Adjuvant Treatment Decisions for Women with Node-Positive Breast Cancer in Ontario, Canada.
Sofia Torres, Maureen Trudeau, +7 authors, Andrea Eisen.
Oncologist, 2018 Jan 27; 23(7). PMID: 29371476    Free PMC article.
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.
Prognostic & predictive factors for planning adjuvant chemotherapy of early-stage breast cancer.
Onur Esbah, Berna Oksuzoglu.
Indian J Med Res, 2018 Mar 08; 146(5). PMID: 29512598    Free PMC article.
Review.
A 35-gene signature discriminates between rapidly- and slowly-progressing glioblastoma multiforme and predicts survival in known subtypes of the cancer.
Azeez A Fatai, Junaid Gamieldien.
BMC Cancer, 2018 Apr 05; 18(1). PMID: 29614978    Free PMC article.
The 21-gene Recurrence Score® assay predicts distant recurrence in lymph node-positive, hormone receptor-positive, breast cancer patients treated with adjuvant sequential epirubicin- and docetaxel-based or epirubicin-based chemotherapy (PACS-01 trial).
Frédérique Penault-Llorca, Thomas Filleron, +12 authors, Henri Roché.
BMC Cancer, 2018 May 08; 18(1). PMID: 29728098    Free PMC article.
Integrating Radiosensitivity and Immune Gene Signatures for Predicting Benefit of Radiotherapy in Breast Cancer.
Yi Cui, Bailiang Li, +2 authors, Ruijiang Li.
Clin Cancer Res, 2018 Jun 21; 24(19). PMID: 29921729    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.
Levels of uPA and PAI-1 in breast cancer and its correlation to Ki67-index and results of a 21-multigene-array.
Hans-Ullrich Völker, Michael Weigel, Annette Strehl, Lea Frey.
Diagn Pathol, 2018 Sep 02; 13(1). PMID: 30170623    Free PMC article.
Web-Based Tool to Facilitate Shared Decision Making With Regard to Neoadjuvant Chemotherapy Use in Muscle-Invasive Bladder Cancer.
Matthew D Galsky, Michael Diefenbach, +12 authors, Bart S Ferket.
JCO Clin Cancer Inform, 2017 Nov 01; 1. PMID: 30657403    Free PMC article.
Evaluation of the Incorporation of Recurrence Score into the American Joint Committee on Cancer Eighth Edition Staging System in Patients with T1-2N0M0, Estrogen Receptor-Positive, Human Epidermal Growth Receptor 2-Negative Invasive Breast Cancer: A Population-Based Analysis.
Shuning Ding, Jiayi Wu, +6 authors, Li Zhu.
Oncologist, 2019 Apr 26; 24(11). PMID: 31019021    Free PMC article.
TAILORx: Questions Answered, Lessons Learned, and Remaining Knowledge Gaps.
Joseph A Sparano, Robert Gray.
J Clin Oncol, 2019 Jun 08; 37(21). PMID: 31173552    Free PMC article.
Decision of Adjuvant Systemic Treatment in HR+ HER2- Early Invasive Breast Cancer: Which Biomarkers Could Help?
Marie Alexandre, Aurélie Maran-Gonzalez, +6 authors, Séverine Guiu.
Cancer Manag Res, 2019 Dec 19; 11. PMID: 31849525    Free PMC article.
Review.
Prediction and clinical utility of a contralateral breast cancer risk model.
Daniele Giardiello, Ewout W Steyerberg, +52 authors, Marjanka K Schmidt.
Breast Cancer Res, 2019 Dec 19; 21(1). PMID: 31847907    Free PMC article.
Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer.
Joseph A Sparano, Robert J Gray, +27 authors, George W Sledge.
N Engl J Med, 2019 Jun 04; 380(25). PMID: 31157962    Free PMC article.
Highly Cited.
21-Gene Recurrence Score and Adjuvant Chemotherapy Decision for Breast Cancer Patients with Positive Lymph Nodes.
Yiwei Tong, Jiayi Wu, +6 authors, Kunwei Shen.
Sci Rep, 2019 Sep 13; 9(1). PMID: 31511599    Free PMC article.
Community clinical practice patterns and mortality in patients with intermediate oncotype DX recurrence scores: Who benefits from chemotherapy?
Abiola F Ibraheem, David J Press, Olufunmilayo I Olopade, Dezheng Huo.
Cancer, 2018 Nov 06; 125(2). PMID: 30387876    Free PMC article.
The Utility of Oncotype DX for Adjuvant Chemotherapy Treatment Decisions in Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative, Node-negative Breast Cancer.
Hirah Rizki, Christopher Hillyar, Omar Abbassi, Sascha Miles-Dua.
Cureus, 2020 Mar 21; 12(3). PMID: 32195072    Free PMC article.
Correlation Between Oncotype DX, PREDICT and the Nottingham Prognostic Index: Implications for the Management of Early Breast Cancer.
Christopher Hillyar, Hirah Rizki, +4 authors, Simon Smith.
Cureus, 2020 May 10; 12(4). PMID: 32382456    Free PMC article.
Glycosylation and its implications in breast cancer.
Danielle A Scott, Richard R Drake.
Expert Rev Proteomics, 2019 Jul 18; 16(8). PMID: 31314995    Free PMC article.
Review.
Clinicopathological characteristics, adjuvant chemotherapy decision and disease outcome in patients with breast cancer with a 21-gene recurrence score of 26-30.
Jing Yu, Jiayi Wu, +6 authors, Kunwei Shen.
Oncol Lett, 2020 Jul 30; 20(2). PMID: 32724396    Free PMC article.
MicroRNAs, Hypoxia and the Stem-Like State as Contributors to Cancer Aggressiveness.
Lucy Wanjiku Macharia, Caroline Muriithi Wanjiru, +3 authors, Vivaldo Moura-Neto.
Front Genet, 2019 Mar 08; 10. PMID: 30842790    Free PMC article.
Review.
Gene Expression Assays for Early-Stage Hormone Receptor-Positive Breast Cancer: Understanding the Differences.
Ana Tablante Nunes, Deborah E Collyar, Lyndsay N Harris.
JNCI Cancer Spectr, 2017 Dec 11; 1(1). PMID: 31360834    Free PMC article.
Review.
Factors That Predict Biological Aggressiveness in Estrogen Receptor-Positive / Human Epidermal Growth Factor Receptor 2-Negative / Lymph Node-Negative Breast Cancer.
Lauren E Arthur, Ashley H McMann, +4 authors, Ralph L Corsetti.
Ochsner J, 2021 Jan 08; 20(4). PMID: 33408575    Free PMC article.
A Phenomic Perspective on Factors Influencing Breast Cancer Treatment: Integrating Aging and Lifestyle in Blood and Tissue Biomarker Profiling.
Ainhoa Arana Echarri, Mark Beresford, +6 authors, James E Turner.
Front Immunol, 2021 Feb 19; 11. PMID: 33597950    Free PMC article.
Review.