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4.
NPJ Breast Cancer ; 2: 16017, 2016.
Article in English | MEDLINE | ID: mdl-28721379

ABSTRACT

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.

5.
Cancer ; 120 Suppl 16: 2566-74, 2014 Aug 15.
Article in English | MEDLINE | ID: mdl-25099899

ABSTRACT

BACKGROUND: Little empirical evidence exists about the effectiveness of performance management systems in government. This study assessed the effectiveness of the performance management system of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) and explored why it works. METHODS: Generalized estimating equation models were used to assess change in program performance after the implementation of a performance management system. In addition, qualitative case study data including observations, interviews, and document review were analyzed using inductive methods. RESULTS: Five of the 7 indicators tested had statistically significant increases in performance postimplementation. Case study results suggest that the system is characterized by high-quality data, measures viewed by grantees as meaningful and fair, and institutionalized data use. CONCLUSIONS: Several factors help to explain the system's effectiveness including characteristics of the NBCCEDP program (eg, service delivery program), qualities of the indicators (eg, process level), financial investment in the system, and a culture of data use.


Subject(s)
Breast Neoplasms/diagnosis , Early Detection of Cancer/methods , Mass Screening/organization & administration , Uterine Cervical Neoplasms/diagnosis , Early Detection of Cancer/standards , Female , Humans , Mass Screening/methods , Mass Screening/standards , Quality Indicators, Health Care , United States
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