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Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer: TBCRC 013.

Publication ,  Journal Article
King, TA; Lyman, JP; Gonen, M; Voci, A; De Brot, M; Boafo, C; Sing, AP; Hwang, ES; Alvarado, MD; Liu, MC; Boughey, JC; McGuire, KP; Norton, L ...
Published in: J Clin Oncol
July 10, 2016

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%) low risk (< 18), 29 (28%) intermediate risk (18 to 30); and 50 (49%) high risk (≥ 31). For all patients, RS was 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.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

July 10, 2016

Volume

34

Issue

20

Start / End Page

2359 / 2365

Location

United States

Related Subject Headings

  • Receptors, Estrogen
  • Receptor, erbB-2
  • Receptor, ErbB-2
  • Prospective Studies
  • Proportional Hazards Models
  • Prognosis
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Neoplasm Recurrence, Local
  • Middle Aged
 

Citation

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Chicago
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MLA
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King, T. A., Lyman, J. P., Gonen, M., Voci, A., De Brot, M., Boafo, C., … Hudis, C. A. (2016). Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer: TBCRC 013. J Clin Oncol, 34(20), 2359–2365. https://doi.org/10.1200/JCO.2015.63.1960
King, Tari A., Jaclyn P. Lyman, Mithat Gonen, Amy Voci, Marina De Brot, Camilla Boafo, Amy Pratt Sing, et al. “Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer: TBCRC 013.J Clin Oncol 34, no. 20 (July 10, 2016): 2359–65. https://doi.org/10.1200/JCO.2015.63.1960.
King TA, Lyman JP, Gonen M, Voci A, De Brot M, Boafo C, et al. Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer: TBCRC 013. J Clin Oncol. 2016 Jul 10;34(20):2359–65.
King, Tari A., et al. “Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer: TBCRC 013.J Clin Oncol, vol. 34, no. 20, July 2016, pp. 2359–65. Pubmed, doi:10.1200/JCO.2015.63.1960.
King TA, Lyman JP, Gonen M, Voci A, De Brot M, Boafo C, Sing AP, Hwang ES, Alvarado MD, Liu MC, Boughey JC, McGuire KP, Van Poznak CH, Jacobs LK, Meszoely IM, Krontiras H, Babiera GV, Norton L, Morrow M, Hudis CA. Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer: TBCRC 013. J Clin Oncol. 2016 Jul 10;34(20):2359–2365.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

July 10, 2016

Volume

34

Issue

20

Start / End Page

2359 / 2365

Location

United States

Related Subject Headings

  • Receptors, Estrogen
  • Receptor, erbB-2
  • Receptor, ErbB-2
  • Prospective Studies
  • Proportional Hazards Models
  • Prognosis
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Neoplasm Recurrence, Local
  • Middle Aged