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Medline ® Abstract for Reference 28

of 'Prognostic and predictive factors in metastatic breast cancer'

Prognostic Impact of 21-Gene Recurrence Score in Patients With Stage IV Breast Cancer: TBCRC 013.
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
J Clin Oncol. 2016;34(20):2359. Epub 2016 Mar 21.
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.
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@p