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Breast Imaging

Original Research

Outcomes of Return to Routine Screening for BI-RADS 3 Lesions Detected at Supplemental Automated Whole-Breast Ultrasound in Women With Dense Breasts: A Prospective Study

+ Affiliations:
1Department of Radiology, Northeastern Ohio Medical University, Rootstown, OH

2Southwoods Imaging, 7623 Market St, Youngstown, OH, 44512

3Clinical Epidemiology and Biometeric Unit, Fondazione IRCCS Policlinico, San Matteo Pavia, Italy

4Department of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany

Citation: American Journal of Roentgenology: 1-9. 10.2214/AJR.21.26180

ABSTRACT :

BACKGROUND. Supplemental screening breast ultrasound (US) detects additional cancers in women with dense breasts but identifies many BI-RADS 3 lesions that result in short-term follow-up and biopsies.

OBJECTIVE. The purpose of this study was to evaluate outcomes in patients recommended for return to routine screening for lesions assessed as BI-RADS 3 on supplemental automated whole-breast US.

METHODS. This prospective study invited patients with BI-RADS 1 or 2 on screening mammography and breast density C or D to undergo supplemental automated breast US (ABUS). ABUS was interpreted as BI-RADS 1, 2, 3, or 0. Return to routine screening was recommended for ABUS BI-RADS 1, 2, or 3. ABUS BI-RADS 0 lesions underwent targeted handheld US. Remaining patients were followed for 2 years. Malignancy rates were compared using Fisher exact tests.

RESULTS. A total of 2257 women (mean age, 58.0 ± 11.2 [SD] years) were included. Supplemental ABUS was scored as BI-RADS 1 in 1186 (52.5%) women, BI-RADS 2 in 591 (26.2%), BI-RADS 3 in 395 (17.5%), and BI-RADS 0 in 85 (3.8%). A total of 394 patients with ABUS BI-RADS 3 had 2-year follow-up, during which no cancer (0%; 95% CI, 0.0–0.9%) was diagnosed in the quadrant of the lesion. Among patients with 2-year follow-up, breast cancer was diagnosed in 4/1117 (0.4%) with ABUS BI-RADS 1, 2/556 (0.4%) with ABUS BI-RADS 2, and 2/394 (0.5%) with ABUS BI-RADS 3 (cancer in other quadrant than the lesion). Malignancy rates were not different between ABUS BI-RADS 1, 2, and 3 (p = .28). The ABUS recall rate was 3.8% (85/2257; 95% CI, 3.6–4.0%). If short-term follow-up had been recommended for ABUS BI-RADS 3, the ABUS recall rate would have been 21.3% (480/2257, 95% CI 19.6–23.0%). The biopsy rate was 0.5% (12/2257; 95% CI, 0.3–0.9%); the positive biopsy rate was 58.3% (7/12). One of seven cancers diagnosed by initial supplemental ABUS and none of eight cancers diagnosed during subsequent follow-up were node-positive cancer.

CONCLUSION. Return to routine screening for ABUS BI-RADS 3 lesions results in a substantial decrease in recall rate and is unlikely to result in an adverse outcome.

CLINICAL IMPACT. This prospective study supports a recommendation for routine annual follow-up for BI-RADS 3 lesions at supplemental ABUS.

TRIAL REGISTRATION. ClinicalTrials.gov NCT02650778

Keywords: automated breast ultrasound, breast screening, dense breasts, supplemental breast ultrasound

Based on a presentation at the Radiological Society of North America 2020 virtual annual meeting.

Supported by an equipment grant from Siemens Healthineers.

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Address correspondence to R. G. Barr ().

The authors declare that they have no disclosures relevant to the subject matter of this article.

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