Prognostic impact of 21-gene Recurrence Score in patients with stage IV breast cancer: TBCRC 013 Journal Article


Authors: King, T. A.; Lyman, J. P.; Gonen, M.; Voci, A.; De Brot, M.; Boafo, C.; Sing, A. P.; Hwang, E. S.; Alvarado, M. D.; Liu, M. C.; Boughey, J. C.; McGuire, K. P.; Van Poznak, C. H.; Jacobs, L. K.; Meszoely, I. M.; Krontiras, H.; Babiera, G. V.; Norton, L.; Morrow, M.; Hudis, C. A.
Article Title: Prognostic impact of 21-gene Recurrence Score in patients with stage IV breast cancer: TBCRC 013
Abstract: Purpose: The objective of this study was to determine whether the 21-gene Recurrence Score (RS) provides clinically meaningful information in patients with de novo stage IV breast cancer enrolled in the Translational Breast Cancer Research Consortium (TBCRC) 013. Patients and Methods: TBCRC 013 was a multicenter prospective registry that evaluated the role of surgery of the primary tumor in patients with de novo stage IV breast cancer. From July 2009 to April 2012, 127 patients from 14 sites were enrolled; 109 (86%) patients had pretreatment primary tumor samples suitable for 21-gene RS analysis. Clinical variables, time to first progression (TTP), and 2-year overall survival (OS) were correlated with the 21-gene RS by using log-rank, Kaplan-Meier, and Cox regression. Results: Median patient age was 52 years (21 to 79 years); the majority had hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative (72 [66%]) or hormone receptor-positive/HER2-positive (20 [18%]) breast cancer. At a median follow-up of 29 months, median TTP was 20 months (95% CI, 16 to 26 months), and median survival was 49 months (95% CI, 40 months to not reached). An RS was generated for 101 (93%) primary tumor samples: 22 (23%) lowrisk (< 18), 29 (28%) intermediate risk (18 to 30); and 50 (49%) high risk (≥31). For all patients, RSwas associated with TTP (P = .01) and 2-year OS (P = .04). In multivariable Cox regression models among 69 patients with estrogen receptor (ER)-positive/HER2-negative cancer, RS was independently prognostic for TTP (hazard ratio, 1.40; 95% CI, 1.05 to 1.86; P = .02) and 2-year OS (hazard ratio, 1.83; 95% CI, 1.14 to 2.95; P = .013). Conclusion: The 21-gene RS is independently prognostic for both TTP and 2-year OS in ER-positive/HER2-negative de novo stage IV breast cancer. Prospective validation is needed to determine the potential role for this assay in the clinical management of this patient subset. © 2016 by American Society of Clinical Oncology.
Journal Title: Journal of Clinical Oncology
Volume: 34
Issue: 20
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2016-07-10
Start Page: 2359
End Page: 2365
Language: English
DOI: 10.1200/jco.2015.63.1960
PROVIDER: scopus
PUBMED: 27001590
PMCID: PMC4981976
DOI/URL:
Notes: Article -- Export Date: 2 August 2016 -- Source: Scopus
Altmetric Score
MSK Authors
  1. Monica Morrow
    434 Morrow
  2. Clifford Hudis
    818 Hudis
  3. Larry Norton
    543 Norton
  4. Mithat Gonen
    687 Gonen
  5. Tari King
    161 King
  6. Amy Elaine Voci
    3 Voci
  7. Jaclyn   Lyman
    4 Lyman