Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening.

Importance: Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography. Objective: To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts. Design, Setting, and Participants: Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019. Exposures: All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias. Main Outcomes and Measures: The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity. Results: Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15). Conclusions and Relevance: Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT02933489.

Upstaging of atypical ductal hyperplasia after vacuum-assisted 11-gauge stereotactic core needle biopsy.

BACKGROUND: Nonpalpable mammographic abnormalities are frequently evaluated by means of a stereotactic core needle biopsy. This technique is a very sensitive indicator of invasive cancer, but is less reliable to discriminate between ductal carcinoma in situ and atypical ductal hyperplasia (ADH). The objective of this study was to determine the correlation of the 11-gauge vacuum-assisted core needle biopsy to open biopsy when a diagnosis of ADH is obtained. HYPOTHESIS: The use of 11-gauge vacuum-assisted stereotactic core needle biopsy does not conclusively diagnose ADH. DESIGN: Retrospective analysis. SETTING: University-affiliated teaching hospital. PATIENTS: Mammographic findings were evaluated with an 11-gauge vacuum-assisted stereotactic core biopsy in 1750 patients. Seventy-seven patients were diagnosed as having ADH; of these, 65 underwent excisional biopsy. MAIN OUTCOME MEASURES: Pathological upstaging rate. RESULTS: Of the 65 patients who underwent excisional breast biopsy, 11 (17%) had their condition upstaged to a breast cancer diagnosis. These patients had presented at a later age than those who retained a benign diagnosis after excisional biopsy. The number of cores taken did not correlate with diagnostic accuracy. CONCLUSIONS: Of the 65 patients who underwent open biopsy for ADH in this series, only 83% had an accurate diagnosis. A diagnosis of ADH by stereotactic core needle biopsy should be followed by an open excisional biopsy.