Journal Article
. 2020 Mar;11(9).
doi: 10.7150/jca.38976.

Decision-making of Adjuvant Chemotherapy for Breast Cancer Patients with Discordant Risk Classifications between Clinical-Pathological Factors and 21-gene Recurrence Score

Weiqi Gao 1 Lin Lin 2 Xiaochun Fei 3 Xiaosong Chen 1 Kunwei Shen 1 
  • PMID: 32201521
  •     16 References


Background: Clinical-pathological factors and 21-gene recurrence score (RS) influence adjuvant chemotherapy (ACT) decision for early breast cancer patients. We investigated the decision-making of ACT in patients with discordant risk classifications of clinical-pathological factors and RS. Methods: Patients with hormonal receptor (HR)+/ human epidermal growth factor receptor 2 (HER2)-, early breast cancer, who underwent 21-gene RS testing were identified from Ruijin Hospital (RJBC) and the Surveillance, Epidemiology, and End Results (SEER) database. According to Adjuvant! Online and RS (≤25 or >25), discordant risk classifications were defined as: clinical low-risk/ RS high-risk (C-low/ RS-high) and clinical high-risk/ RS low-risk (C-high/RS-low). McNemar's test was used to assess the changes between pre- and post-RS recommendations. Breast cancer-specific survival (BCSS) was estimated using the Kaplan-Meier methods. Results: Among 727 RJBC patients, the C-low/RS-high group and the C-high/RS-low group represented 19.7% and 21.3% of the cohort. After receiving 21-gene RS results, treatment recommendations were changed for 22.1% patients with discordant risk classifications: ACT rate increased from 41.9% to 75.5% in the C-low/RS-high group and decreased from 63.9% to 60.0% in the C-high/RS-low group. Among 2958 patients from the SEER cohort, 18.4% of the C-high/RS-low group and 59.2% of the C-low/RS-high group received ACT. There was no significant difference in the estimated 3-year BCSS between ACT or not among the C-low/RS-high group (p=0.708) and the C-high/RS-low groups (p=0.391). Conclusion: For patients with discordant risk classifications, physicians were apt to adopt the 21-gene RS rather than routine clinical-pathological factors to guide ACT selection.

Keywords: 21-gene recurrence score; Adjuvant! Online; adjuvant chemotherapy; breast cancer; discordant risk.

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.
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.
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.
Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.
Lyndsay N Harris, Nofisat Ismaila, +11 authors, American Society of Clinical Oncology.
J Clin Oncol, 2016 Feb 10; 34(10). PMID: 26858339    Free PMC article.
Highly Cited. Review.
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.
Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer.
Marc Buyse, Sherene Loi, +18 authors, TRANSBIG Consortium.
J Natl Cancer Inst, 2006 Sep 07; 98(17). PMID: 16954471
Highly Cited.
US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status.
Nadia Howlader, Sean F Altekruse, +4 authors, Kathleen A Cronin.
J Natl Cancer Inst, 2014 Apr 30; 106(5). PMID: 24777111    Free PMC article.
Highly Cited.
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.
Validation of 70-gene prognosis signature in node-negative breast cancer.
J M Bueno-de-Mesquita, S C Linn, +16 authors, M J van de Vijver.
Breast Cancer Res Treat, 2008 Sep 27; 117(3). PMID: 18819002
De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017.
G Curigliano, H J Burstein, +52 authors, B Xu.
Ann Oncol, 2017 Aug 26; 28(8). PMID: 28838210    Free PMC article.
Highly Cited.
Breast Cancer Treatment: A Review.
Adrienne G Waks, Eric P Winer.
JAMA, 2019 Jan 23; 321(3). PMID: 30667505
Highly Cited. Review.
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.
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.
Results of PONDx, a prospective multicenter study of the Oncotype DX® breast cancer assay: Real-life utilization and decision impact in French clinical practice.
Elsa Curtit, Jean-Michel Vannetzel, +10 authors, Xavier Pivot.
Breast, 2019 Jan 12; 44. PMID: 30634106