Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations.

PURPOSE: To (a) determine the performance of screening mammography, ultrasonography (US), and physical examination (PE); (b) analyze the influence of age, hormonal status, and breast density; (c) compare the size and stage of tumors detected with each modality; and (d) determine which modality or combination of modalities optimize cancer detection.

MATERIALS AND METHODS: A total of 11,130 asymptomatic women underwent 27,825 screening sessions, (mammography and subsequent PE). Women with dense breasts subsequently underwent screening US. Abnormalities were deemed positive if biopsy findings revealed malignancy and negative if findings from biopsy or all screening examinations were negative.

RESULTS: In 221 women, 246 cancers were found. Sensitivity, specificity, negative and positive predictive values, and accuracy of mammography were 77.6%, 98.8%, 99.8%, 35.8%, and 98.6%, respectively; those of PE, 27.6%, 99.4%, 99.4%, 28.9%, and 98.8%, respectively; and those of US, 75.3%, 96.8%, 99.7%, 20.5%, and 96.6%, respectively. Screening breast US increased the number of women diagnosed with nonpalpable invasive cancers by 42% (30 of 71). Mammographic sensitivity declined significantly with increasing breast density (P <.01) (48% for the densest breasts) and in younger women with dense breasts (P =.02); the effects were independent. Mammography and US together had significantly higher sensitivity (97%) than did mammography and PE together (74%) (P <.001). Tumors detected at mammography and/or US were significantly smaller (P =.01) and of lower stage (P =.01) than those detected at PE.

CONCLUSION: Mammographic sensitivity for breast cancer declines significantly with increasing breast density and is independently higher in older women with dense breasts. Addition of screening US significantly increases detection of small cancers and depicts significantly more cancers and at smaller size and lower stage than does PE, which detects independently extremely few cancers. Hormonal status has no significant effect on effectiveness of screening independent of breast density.