Journal Article
. 2020 Jul;12(7).
doi: 10.3390/cancers12071829.

The 21-Gene Recurrence Score Assay and Prediction of Chemotherapy Benefit: A Propensity Score-Matched Analysis of the SEER Database

In Sil Choi 1 Jiwoong Jung 2 Byoung Hyuck Kim 3 Sohee Oh 4 Jongjin Kim 5 Jin Hyun Park 1 Jeong Hwan Park 6 Ki-Tae Hwang 5 
Affiliations
  • PMID: 32650374
  •     28 References

Abstract

Background: To evaluate the performance of the 21-gene recurrence score (RS) assay in predicting chemotherapy benefit in the Surveillance, Epidemiology, and End Results population, we aimed to assess breast cancer-specific mortality (BCSM) by chemotherapy use within each of the RS categories.

Methods: Data on breast cancer (BC) cases diagnosed between 2004 and 2015 with available RS results were released. Our analysis included patients with hormone receptor-positive, node-negative early-stage BC (n = 89,402), and three RS groups were defined; RS < 11, low; RS 11-25, intermediate; RS > 25, high. A propensity score matched-analysis was performed to assess and compare BCSM.

Results: Chemotherapy was significantly associated with a reduced risk of BC death among patients in the high RS group (hazard ratio = 0.782; 95% CI, 0.618-0.990; p = 0.041). However, in the low and intermediate RS groups, there were no significant differences in BCSM between patients who received chemotherapy and those who did not. Among those with RS 11-25, chemotherapy benefit varied with tumor size (p = 0.001).

Conclusions: Our findings provide real-world evidence that the 21-gene RS assay is predictive of chemotherapy benefit among patients in clinical practice. More refined risk estimates would be needed for patients with an intermediate RS.

Keywords: breast cancer; chemotherapy; genomic assay; mortality; observational study.

Association Between Use of the 21-Gene Recurrence Score Assay and Receipt of Chemotherapy Among Medicare Beneficiaries With Early-Stage Breast Cancer, 2005-2009.
Michaela A Dinan, Xiaojuan Mi, +2 authors, Lesley H Curtis.
JAMA Oncol, 2015 Aug 28; 1(8). PMID: 26313372
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.
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.
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.
Oleg Gluz, Ulrike A Nitz, +18 authors, Nadia Harbeck.
J Clin Oncol, 2016 Mar 02; 34(20). PMID: 26926676
Highly Cited.
21-Gene assay as predictor of chemotherapy benefit in HER2-negative breast cancer.
Charles E Geyer, Gong Tang, +8 authors, Norman Wolmark.
NPJ Breast Cancer, 2018 Nov 21; 4. PMID: 30456299    Free PMC article.
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.
Comparison of SEER Treatment Data With Medicare Claims.
Anne-Michelle Noone, Jennifer L Lund, +4 authors, Joan L Warren.
Med Care, 2014 Mar 19; 54(9). PMID: 24638121    Free PMC article.
Highly Cited.
70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer.
Fatima Cardoso, Laura J van't Veer, +32 authors, MINDACT Investigators.
N Engl J Med, 2016 Aug 25; 375(8). PMID: 27557300
Highly Cited.
Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer.
Joseph A Sparano, Robert J Gray, +27 authors, George W Sledge.
N Engl J Med, 2018 Jun 05; 379(2). PMID: 29860917    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.
N Engl J Med, 2015 Sep 29; 373(21). PMID: 26412349    Free PMC article.
Highly Cited.
Pooled analysis of prospective European studies assessing the impact of using the 21-gene Recurrence Score assay on clinical decision making in women with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative early-stage breast cancer.
Joan Albanell, Christer Svedman, +6 authors, Wolfgang Eiermann.
Eur J Cancer, 2016 Aug 22; 66. PMID: 27544930
Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry.
Salomon M Stemmer, Mariana Steiner, +21 authors, Nicky Liebermann.
NPJ Breast Cancer, 2017 Sep 14; 3. PMID: 28900633    Free PMC article.
21-Gene recurrence score decreases receipt of chemotherapy in ER+ early-stage breast cancer: an analysis of the NCDB 2010-2013.
Benjamin M Parsons, Jeffrey Landercasper, +3 authors, Leah L Dietrich.
Breast Cancer Res Treat, 2016 Aug 11; 159(2). PMID: 27507245    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.
Recent Trends in Chemotherapy Use and Oncologists' Treatment Recommendations for Early-Stage Breast Cancer.
Allison W Kurian, Irina Bondarenko, +7 authors, Steven J Katz.
J Natl Cancer Inst, 2017 Dec 14; 110(5). PMID: 29237009    Free PMC article.
Trend and survival benefit of Oncotype DX use among female hormone receptor-positive breast cancer patients in 17 SEER registries, 2004-2015.
Lu Zhang, Mei-Chin Hsieh, +3 authors, Xiao-Cheng Wu.
Breast Cancer Res Treat, 2020 Feb 16; 180(2). PMID: 32060781
Breast cancer-specific survival in patients with lymph node-positive hormone receptor-positive invasive breast cancer and Oncotype DX Recurrence Score results in the SEER database.
Megan C Roberts, Dave P Miller, Steven Shak, Valentina I Petkov.
Breast Cancer Res Treat, 2017 Mar 01; 163(2). PMID: 28243896
A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent information to conventional clinical risk factors.
Martin Filipits, Margaretha Rudas, +25 authors, EP Investigators.
Clin Cancer Res, 2011 Aug 03; 17(18). PMID: 21807638
Highly Cited.
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, Nofisat Ismaila, +10 authors, Vered Stearns.
J Clin Oncol, 2019 Jun 01; 37(22). PMID: 31150316
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 Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy: A Secondary Analysis of the TAILORx Randomized Clinical Trial.
Joseph A Sparano, Robert J Gray, +26 authors, George W Sledge.
JAMA Oncol, 2019 Oct 01; 6(3). PMID: 31566680    Free PMC article.
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.
Supervised risk predictor of breast cancer based on intrinsic subtypes.
Joel S Parker, Michael Mullins, +17 authors, Philip S Bernard.
J Clin Oncol, 2009 Feb 11; 27(8). PMID: 19204204    Free PMC article.
Highly Cited.
The impact of the 21-gene assay on adjuvant treatment decisions in oestrogen receptor-positive early breast cancer: a prospective study.
Anna Kuchel, Tim Robinson, +8 authors, Jeremy P Braybrooke.
Br J Cancer, 2016 Mar 10; 114(7). PMID: 26954715    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.
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.
Risk of recurrence and chemotherapy benefit for patients with node-negative, estrogen receptor-positive breast cancer: recurrence score alone and integrated with pathologic and clinical factors.
Gong Tang, Jack Cuzick, +6 authors, Norman Wolmark.
J Clin Oncol, 2011 Oct 20; 29(33). PMID: 22010013    Free PMC article.
Development of the 21-gene assay and its application in clinical practice and clinical trials.
Joseph A Sparano, Soonmyung Paik.
J Clin Oncol, 2008 Feb 09; 26(5). PMID: 18258979
Highly Cited. Review.