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NPJ Breast Cancer. 2016 Jun 8;2:16017. doi: 10.1038/npjbcancer.2016.17. eCollection 2016.

Breast-cancer-specific mortality in patients treated based on the 21-gene assay: a SEER population-based study.

Author information

National Cancer Institute, Bethesda, MD, USA.
Genomic Health, Inc., Redwood City, CA, USA.
IMS, Inc., Calverton, MD, USA.
University of California, San Francisco, CA, USA.
Public Health Institute, Cancer Registry of Greater California, Sacramento, CA, USA.
University of Southern California, Los Angeles, CA, USA.
Cancer Prevention Institute of California, Fremont, CA, USA.
Stanford Cancer Institute, Stanford, CA, USA.
University of Hawaii Cancer Center, Honolulu, HI, USA.
Department of Epidemiology, University of Iowa, Iowa City, IA, USA.
Connecticut Tumor Registry, Connecticut Department of Public Health, Hartford, CT, USA.
Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.
Cancer Surveillance System, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Rutgers School of Public Health, Piscataway, NJ, USA.
Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Utah Cancer Registry, Department of Internal Medicine, and Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
University of Kentucky, Markey Cancer Center, Lexington, KY, USA.
Emory University, Atlanta, GA, USA.
New Mexico Tumor Registry, University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.
Louisiana State University Health Sciences Center, New Orleans, LA, USA.


The 21-gene Recurrence Score assay is validated to predict recurrence risk and chemotherapy benefit in hormone-receptor-positive (HR+) invasive breast cancer. To determine prospective breast-cancer-specific mortality (BCSM) outcomes by baseline Recurrence Score results and clinical covariates, the National Cancer Institute collaborated with Genomic Health and 14 population-based registries in the the Surveillance, Epidemiology, and End Results (SEER) Program to electronically supplement cancer surveillance data with Recurrence Score results. The prespecified primary analysis cohort was 40-84 years of age, and had node-negative, HR+, HER2-negative, nonmetastatic disease diagnosed between January 2004 and December 2011 in the entire SEER population, and Recurrence Score results (N=38,568). Unadjusted 5-year BCSM were 0.4% (n=21,023; 95% confidence interval (CI), 0.3-0.6%), 1.4% (n=14,494; 95% CI, 1.1-1.7%), and 4.4% (n=3,051; 95% CI, 3.4-5.6%) for Recurrence Score <18, 18-30, and ⩾31 groups, respectively (P<0.001). In multivariable analysis adjusted for age, tumor size, grade, and race, the Recurrence Score result predicted BCSM (P<0.001). Among patients with node-positive disease (micrometastases and up to three positive nodes; N=4,691), 5-year BCSM (unadjusted) was 1.0% (n=2,694; 95% CI, 0.5-2.0%), 2.3% (n=1,669; 95% CI, 1.3-4.1%), and 14.3% (n=328; 95% CI, 8.4-23.8%) for Recurrence Score <18, 18-30, ⩾31 groups, respectively (P<0.001). Five-year BCSM by Recurrence Score group are reported for important patient subgroups, including age, race, tumor size, grade, and socioeconomic status. This SEER study represents the largest report of prospective BCSM outcomes based on Recurrence Score results for patients with HR+, HER2-negative, node-negative, or node-positive breast cancer, including subgroups often under-represented in clinical trials.

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