Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer

TBCRC 013

Tari A. King, Jaclyn P. Lyman, Mithat Gonen, Amy Voci, Marina De Brot, Camilla Boafo, Amy Pratt Sing, E. Shelley Hwang, Michael D. Alvarado, Minetta C Liu, Judy C Boughey, Kandace P. McGuire, Catherine H. Van Poznak, Lisa K. Jacobs, Ingrid M. Meszoely, Helen Krontiras, Gildy V. Babiera, Larry Norton, Monica Morrow, Clifford A. Hudis

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)2359-2365
Number of pages7
JournalJournal of Clinical Oncology
Volume34
Issue number20
DOIs
StatePublished - Jul 10 2016

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Breast Neoplasms
Recurrence
Research
Genes
Survival
Estrogen Receptors
Neoplasms
Hormones
Proportional Hazards Models
Registries
human ERBB2 protein

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Cancer Research

Cite this

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. Journal of Clinical Oncology, 34(20), 2359-2365. https://doi.org/10.1200/JCO.2015.63.1960

Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer : TBCRC 013. / King, Tari A.; Lyman, Jaclyn P.; Gonen, Mithat; Voci, Amy; De Brot, Marina; Boafo, Camilla; Sing, Amy Pratt; Hwang, E. Shelley; Alvarado, Michael D.; Liu, Minetta C; Boughey, Judy C; McGuire, Kandace P.; Van Poznak, Catherine H.; Jacobs, Lisa K.; Meszoely, Ingrid M.; Krontiras, Helen; Babiera, Gildy V.; Norton, Larry; Morrow, Monica; Hudis, Clifford A.

In: Journal of Clinical Oncology, Vol. 34, No. 20, 10.07.2016, p. 2359-2365.

Research output: Contribution to journalArticle

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 2016, 'Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer: TBCRC 013', Journal of Clinical Oncology, vol. 34, no. 20, pp. 2359-2365. https://doi.org/10.1200/JCO.2015.63.1960
King, Tari A. ; Lyman, Jaclyn P. ; Gonen, Mithat ; Voci, Amy ; De Brot, Marina ; Boafo, Camilla ; Sing, Amy Pratt ; Hwang, E. Shelley ; Alvarado, Michael D. ; Liu, Minetta C ; Boughey, Judy C ; McGuire, Kandace P. ; Van Poznak, Catherine H. ; Jacobs, Lisa K. ; Meszoely, Ingrid M. ; Krontiras, Helen ; Babiera, Gildy V. ; Norton, Larry ; Morrow, Monica ; Hudis, Clifford A. / Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer : TBCRC 013. In: Journal of Clinical Oncology. 2016 ; Vol. 34, No. 20. pp. 2359-2365.
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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.",
author = "King, {Tari A.} and Lyman, {Jaclyn P.} and Mithat Gonen and Amy Voci and {De Brot}, Marina and Camilla Boafo and Sing, {Amy Pratt} and Hwang, {E. Shelley} and Alvarado, {Michael D.} and Liu, {Minetta C} and Boughey, {Judy C} and McGuire, {Kandace P.} and {Van Poznak}, {Catherine H.} and Jacobs, {Lisa K.} and Meszoely, {Ingrid M.} and Helen Krontiras and Babiera, {Gildy V.} and Larry Norton and Monica Morrow and Hudis, {Clifford A.}",
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T1 - Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer

T2 - TBCRC 013

AU - King, Tari A.

AU - Lyman, Jaclyn P.

AU - Gonen, Mithat

AU - Voci, Amy

AU - De Brot, Marina

AU - Boafo, Camilla

AU - Sing, Amy Pratt

AU - Hwang, E. Shelley

AU - Alvarado, Michael D.

AU - Liu, Minetta C

AU - Boughey, Judy C

AU - McGuire, Kandace P.

AU - Van Poznak, Catherine H.

AU - Jacobs, Lisa K.

AU - Meszoely, Ingrid M.

AU - Krontiras, Helen

AU - Babiera, Gildy V.

AU - Norton, Larry

AU - Morrow, Monica

AU - Hudis, Clifford A.

PY - 2016/7/10

Y1 - 2016/7/10

N2 - 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.

AB - 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.

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