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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The Surveillance, Epidemiology and End Results (SEER) Program is funded by the National Cancer Institute (NCI). SEER registries were supported as follows: California—the collection of cancer incidence data used in this study was supported by: the California Department of Public Health pursuant to California Health and Safety Code Section 103885; the Centers for Disease Control and Prevention (CDC) National Program of Cancer Registries (NPCR), under cooperative agreement 5NU58DP003862-04/DP003862; the NCI SEER Program, under contract HHSN261201000140C awarded to the Cancer Prevention Institute of California, contract HHSN261201000035C awarded to the University of Southern California, and contract HHSN261201000034C awarded to the Public Health Institute.
Due to the large number of funding sources, only the first few are listed in this section. For the complete list of funding sources, please download this article.
Supplementary Information accompanies the paper on the npj Breast Cancer website (http://www.nature.com/npjbcancer).
Petkov, Valentina I.; Miller, Dave P.; Howlader, Nadia; Gliner, Nathan; Howe, Will; Schussler, Nicola; Cronin, Kathleen; Baehner, Frederick L.; Cress, Rosemary; Deapen, Dennis; Glaser, Sally L.; Hernandez, Brenda Y.; Lynch, Charles F.; Mueller, Lloyd; Schwartz, Ann G.; Schwartz, Stephen M.; Stroup, Antoinette; Sweeney, Carol; Tucker, Thomas C.; Ward, Kevin C.; Wiggins, Charles; Wu, Xiao-Cheng; Penberthy, Lynne; and Shak, Steven, "Breast-Cancer-Specific Mortality in Patients Treated Based on the 21-Gene Assay: A SEER Population-Based Study" (2016). Markey Cancer Center Faculty Publications. 91.