Search

Background & Aims: Colorectal cancer (CRC) screening guidelines include screening colonoscopy and sequential high-sensitivity fecal occult blood testing (HSgFOBT), with expectation of similar effectiveness based on the assumption of similar high adherence. However, adherence to screening colonoscopy compared with sequential HSgFOBT has not been reported. In this randomized clinical trial, we assessed adherence and pathology findings for a single screening colonoscopy vs sequential and nonsequential HSgFOBTs. Methods: Participants aged 40–69 years were enrolled at 3 centers representing different clinical settings. Participants were randomized into a single screening colonoscopy arm vs sequential HSgFOBT arm composed of 4–7 rounds. Initial adherence to screening colonoscopy and sequential adherence to HSgFOBT, follow-up colonoscopy for positive HSgFOBT tests, crossover to colonoscopy, and detection of advanced neoplasia or large serrated lesions (ADN-SERs) were measured. Results: There were 3523 participants included in the trial; 1761 and 1762 participants were randomized to the screening colonoscopy and HSgFOBT arms, respectively. Adherence was 1473 (83.6%) for the screening colonoscopy arm vs 1288 (73.1%) for the HSgFOBT arm after 1 round (relative risk [RR], 1.14; 95% CI, 1.10–1.19; P ≤.001), but only 674 (38.3%) over 4 sequential HSgFOBT rounds (RR, 2.19; 95% CI, 2.05–2.33). Overall adherence to any screening increased to 1558 (88.5%) in the screening colonoscopy arm during the entire study period and 1493 (84.7%) in the HSgFOBT arm (RR, 1.04; 95% CI, 1.02–1.07). Four hundred thirty-six participants (24.7%) crossed over to screening colonoscopy during the first 4 rounds. ADN-SERs were detected in 121 of the 1473 participants (8.2%) in the colonoscopy arm who were adherent to protocol in the first 12 months of the study, whereas detection of ADN-SERs among those who were not sequentially adherent (n = 709) to HSgFOBT was subpar (0.6%) (RR, 14.72; 95% CI, 5.46–39.67) compared with those who were sequentially adherent (3.3%) (n = 647) (RR, 2.52; 95% CI, 1.61–3.98) to HSgFOBT in the first 4 rounds. When including colonoscopies from HSgFOBT patients who were never positive yet crossed over (n = 1483), 5.5% of ADN-SERs were detected (RR, 1.50; 95% CI, 1.15–1.96) in the first 4 rounds. Conclusions: Observed adherence to sequential rounds of HSgFOBT was suboptimal compared with a single screening colonoscopy. Detection of ADN-SERs was inferior when nonsequential HSgFOBT adherence was compared with sequential adherence. However, the greatest number of ADN-SERs was detected among those who crossed over to colonoscopy and opted to receive a colonoscopy. The effectiveness of an HSgFOBT screening program may be enhanced if crossover to screening colonoscopy is permitted. ClinicalTrials.gov, Number: NCT00102011.

A history of benign breast disease (BBD) is associated with an approximate two-fold increase in risk of breast cancer, however, the risk differs according to the histological characteristics of the benign lesion and other factors. Although histopathology identifies women with BBD with increased risk of breast cancer, such as women with atypical hyperplasia, few women with BBD fall into these high-risk categories and most will not go on to develop breast cancer. In contrast, many women with "low risk" benign lesions are subsequently diagnosed with breast cancer and for these women, the histopathology of their BBD is not a useful predictor of risk. The purpose of this research was to investigate the relation between prior BBD and subsequent breast cancer in a cohort of women who underwent mammography in a defined population at Group Health Cooperative, a large health maintenance organization in western Washington state. Using a nested case-control design, the project examined the relation between histologic type of BBD and other established risk factors (e.g., age at diagnosis or mammogram, race, family history of breast cancer, menopausal status, use of hormone replacement therapy, and mammographic breast density) with risk of breast cancer. Women were eligible for the study if they underwent mammography at GHC, reported a history of prior breast biopsy at least 1 year prior to their mammogram, and had no history of prior breast cancer. A total of 17,714 women met the study criteria. Of these women, 521 were diagnosed with breast cancer subsequent to their benign biopsy and comprised the "case" group for the present study. These cases were matched to the pool of the remaining 17,193 women with prior breast biopsy and no subsequent breast cancer on the basis of date of mammogram at Group Health Cooperative using a 1:4 ratio, and compared on the basis of key characteristics.