Journal Article
. 2019 Nov;5().
doi: 10.1038/s41523-019-0137-3.

Ten-year clinical outcomes in N0 ER+ breast cancer patients with Recurrence Score-guided therapy

Salomon M Stemmer 1 Mariana Steiner 2 Shulamith Rizel 1 Noa Ben-Baruch 3 Beatrice Uziely 4 Debbie M Jakubowski 5 Julie Baron 5 Steven Shak 5 Lior Soussan-Gutman 6 Avital Bareket-Samish 7 Georgeta Fried 8 Ora Rosengarten 9 Amit Itay 10 Bella Nisenbaum 11 Daniela Katz 12 Michelle Leviov 2 Margarita Tokar 13 Nicky Liebermann 14 David B Geffen 13 
Affiliations
  • PMID: 31728408
  •     14 References
  •     2 citations

Abstract

The 21-gene Recurrence Score (RS) assay is a validated prognosticator/predictor of chemotherapy (CT) benefit in early-stage estrogen receptor (ER)-positive breast cancer (BC). Long-term data from real-life clinical practice where treatment was guided by the RS result are lacking. We performed exploratory analysis of the Clalit Health Services (CHS) registry, which included all CHS patients with node-negative ER+ HER2-negative BC who underwent RS testing between 1/2006 and 12/2009 to determine 10-year Kaplan-Meier estimates for distant recurrence/BC-specific mortality (BCSM) in this cohort. The analysis included 1365 patients. Distribution of RS results: RS 0-10, 17.8%; RS 11-25, 62.5%; RS 26-100, 19.7%. Corresponding CT use: 0, 9.4, and 69.9%. Ten-year distant recurrence rates in patients with RS 0-10, 11-25, and 26-100: 2.6% (95% confidence interval [CI], 1.1-6.2%), 6.1% (95% CI, 4.4-8.6%), and 13.1% (95% CI, 9.4-18.3%), respectively (P < 0.001); corresponding BCSM rates: 0.7% (95% CI 0.1-5.1%), 2.2% (95% CI, 1.3-3.7%), and 9.5% (95% CI, 6.0-14.9%) (P < 0.001). When the analysis included patients treated with endocrine therapy alone (95.5/87.5% of patients with RS 0-10/11-25), 10-year distant recurrence and BCSM rates for RS 0-10 patients were 2.7% (95% CI, 1.1-6.5%) and 0.8% (95% CI, 0.1-5.3%), respectively, and for RS 11-25 patients, 5.7% (95% CI, 3.9-8.3%) and 2.0% (95% CI, 1.1-3.7%), respectively. For RS 11-25 patients, no statistically significant differences were observed in 10-year distant recurrence/BCSM rates between CT-treated and untreated patients; however, this should be interpreted cautiously since the number of events was low and patients were not randomized. In conclusion, in node-negative ER+ HER2-negative BC patients, where treatment decisions in real-life clinical practice incorporated the RS, patients with RS 0-25 (~80% of patients, <10% CT use) had excellent outcomes at 10 years. Patients with RS 26-100 had high distant recurrence risk despite CT use and are candidates for new treatment approaches.

Keywords: Breast cancer; Cancer therapy.

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.
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.
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.
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.
20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years.
Hongchao Pan, Richard Gray, +9 authors, EBCTCG.
N Engl J Med, 2017 Nov 09; 377(19). PMID: 29117498    Free PMC article.
Highly Cited.
Interobserver agreement and reproducibility in classification of invasive breast carcinoma: an NCI breast cancer family registry study.
Teri A Longacre, Marguerite Ennis, +10 authors, Frances P O'malley.
Mod Pathol, 2005 Dec 13; 19(2). PMID: 16341153
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.
Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial.
Ulrike Nitz, Oleg Gluz, +18 authors, Nadia Harbeck.
Breast Cancer Res Treat, 2017 Jul 01; 165(3). PMID: 28664507    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.
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.
Prognostic Impact of the Combination of Recurrence Score and Quantitative Estrogen Receptor Expression (ESR1) on Predicting Late Distant Recurrence Risk in Estrogen Receptor-Positive Breast Cancer After 5 Years of Tamoxifen: Results From NRG Oncology/National Surgical Adjuvant Breast and Bowel Project B-28 and B-14.
Norman Wolmark, Eleftherios P Mamounas, +6 authors, Soonmyung Paik.
J Clin Oncol, 2016 May 25; 34(20). PMID: 27217450    Free PMC article.
Breast cancer in the elderly-Should it be treated differently?
Petra Tesarova.
Rep Pract Oncol Radiother, 2012 Jan 01; 18(1). PMID: 24381744    Free PMC article.
Review.
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.
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.
Review.