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.
Women screened by the NBCCEDP received diagnostic follow-up and initiated treatment within preestablished program guidelines.
BACKGROUND: Colorectal cancer remains the second leading cause of cancer-related deaths among US men and women. Screening rates have been slow to increase, and disparities in screening remain. METHODS: To address the disparity in screening for this high burden but largely preventable disease, the Centers for Disease Control and Prevention (CDC) designed and established a 4-year Colorectal Cancer Screening Demonstration Program (CRCSDP) in 2005 for low-income, under-insured or uninsured men and women aged 50 to 64 years in 5 participating US program sites. In this report, the authors describe the design of the CRCSDP and the overall clinical findings and screening test performance characteristics, including the positive fecal occult blood testing (FOBT) rate; the rates of polyp, adenoma, and cancer detection with FOBTs and colonoscopies; and the positive predicative value for polyps, adenomas, and cancers. RESULTS: In total, 5233 individuals at average risk and increased risk were screened for colorectal cancer across all 5 sites, including 44% who underwent screening FOBT and 56% who underwent screening colonoscopy. Overall, 77% of all individuals screened were women. The FOBT positivity rate was 10%. Results from all screening or diagnostic colonoscopies indicated that 75% had negative results and required a repeat screening colonoscopy in 10 years, 16% had low-risk adenomas and required surveillance colonoscopy in 5 to 10 years, 8% had high-risk adenomas and required surveillance colonoscopy in 3 years, and 0.6% had invasive cancers. CONCLUSIONS: This report documents the successes and challenges in implementing the CDC's CRCSDP and describes the clinical outcomes of this 4-year initiative, the patterns in program uptake and test choice, and the comparative test performance characteristics of FOBT versus colonoscopy. Patterns in final outcomes from the follow-up of positive screening tests were consistent with national registry data. KEYWORDS: colorectal cancer screening; colonoscopy; fecal occult blood testing; cancer screening programs; colorectal cancer prevention. INTRODUCTIONThe Centers for Disease Control and Prevention (CDC) designed and established a 4-year Colorectal Cancer Screening Demonstration Program (CRCSDP) in 2005 for low-income, under-insured or uninsured men and women ages 50 to 64 years in 5 participating US program sites. This report documents the successful implementation of the CRCSDP and describes the clinical outcomes of this 4-year initiative, the patterns of program uptake and test choice, the challenges of implementing fecal occult blood testing (FOBT) screening programs, and the comparative test performance characteristics of FOBT versus colonoscopy.Cancer is the second leading cause of death among US adults, and colorectal cancer is the second leading cause of US cancer-related deaths among cancers that affect both men and women. In 2007, 142,672 new cases and 53,219 deaths
Objectives-To examine time intervals from cervical cancer screening to diagnosis and treatment initiation among low-income and uninsured women in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) during two consecutive time periods.Methods-We analyzed NBCCEDP data for women with abnormal Pap tests (n = 100,167), from which 1,417 invasive cervical cancers were diagnosed. We examined two time intervals for this study: diagnostic interval (time from abnormal Pap test to the date of definitive diagnosis) and treatment initiation interval (time from definitive diagnosis to treatment initiation) for two time periods : 1996-2002 and 2003-2009. We compared median time intervals for diagnostic and treatment initiation using the Kruskal-Wallis test. Adjusted proportions (predicted marginals) were calculated using logistic regression to examine diagnosis and treatment within program benchmarks (≤ 60 days).Results-Median diagnostic intervals decreased overall by 6 days (54 vs. 48 days, p < 0.001). This decrease in the median diagnostic interval was noted for all variables examined. The median treatment initiation intervals remained stable over the two time periods.Conclusions-Women screened by the NBCCEDP receive diagnostic follow-up and initiate treatment within preestablished program guidelines.
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