Tari A King1, Jaclyn P Lyman2, Mithat Gonen2, Amy Voci2, Marina De Brot2, Camilla Boafo2, Amy Pratt Sing2, E Shelley Hwang2, Michael D Alvarado2, Minetta C Liu2, Judy C Boughey2, Kandace P McGuire2, Catherine H Van Poznak2, Lisa K Jacobs2, Ingrid M Meszoely2, Helen Krontiras2, Gildy V Babiera2, Larry Norton2, Monica Morrow2, Clifford A Hudis2. 1. Tari A. King, Jaclyn P. Lyman, Mithat Gonen, Amy Voci, Marina De Brot, Camilla Boafo, Larry Norton, Monica Morrow, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Amy Pratt Sing, Genomic Health, Redwood City; Michael D. Alvarado, University of California San Francisco Comprehensive Cancer Center, San Francisco, CA; E. Shelley Hwang, Duke University School of Medicine, Durham, NC; Minetta C. Liu, Georgetown University Medical Center, Washington, DC; Judy C. Boughey, Mayo Clinic, Rochester, MN; Kandace P. McGuire, University of Pittsburgh, Pittsburgh, PA; Catherine H. Van Poznak, University of Michigan Medical School, Ann Arbor, MI; Lisa K. Jacobs, Johns Hopkins University School of Medicine, Baltimore, MD; Ingrid M. Meszoely, Vanderbilt University Medical Center, Nashville, TN; Helen Krontiras, University of Alabama at Birmingham School of Medicine, Birmingham, AL; and Gildy V. Babiera, The University of Texas MD Anderson Cancer Center, Houston, TX. tking7@partners.org. 2. Tari A. King, Jaclyn P. Lyman, Mithat Gonen, Amy Voci, Marina De Brot, Camilla Boafo, Larry Norton, Monica Morrow, and Clifford A. Hudis, Memorial Sloan Kettering Cancer Center, New York, NY; Amy Pratt Sing, Genomic Health, Redwood City; Michael D. Alvarado, University of California San Francisco Comprehensive Cancer Center, San Francisco, CA; E. Shelley Hwang, Duke University School of Medicine, Durham, NC; Minetta C. Liu, Georgetown University Medical Center, Washington, DC; Judy C. Boughey, Mayo Clinic, Rochester, MN; Kandace P. McGuire, University of Pittsburgh, Pittsburgh, PA; Catherine H. Van Poznak, University of Michigan Medical School, Ann Arbor, MI; Lisa K. Jacobs, Johns Hopkins University School of Medicine, Baltimore, MD; Ingrid M. Meszoely, Vanderbilt University Medical Center, Nashville, TN; Helen Krontiras, University of Alabama at Birmingham School of Medicine, Birmingham, AL; and Gildy V. Babiera, The University of Texas MD Anderson Cancer Center, Houston, TX.
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%) 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.
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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