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- Title
Ultrasound as the Primary Screening Test for Breast Cancer: Analysis From ACRIN 6666.
- Authors
Berg, Wendie A.; Bandos, Andriy I.; Mendelson, Ellen B.; Lehrer, Daniel; Jong, Roberta A.; Pisano, Etta D.
- Abstract
<bold>Background: </bold>Mammography is not widely available in all countries, and breast cancer incidence is increasing. We considered performance characteristics using ultrasound (US) instead of mammography to screen for breast cancer.<bold>Methods: </bold>Two thousand eight hundred nine participants were enrolled at 20 sites in the United States, Canada, and Argentina in American College of Radiology Imaging 6666. Two thousand six hundred sixty-two participants completed three annual screens (7473 examinations) with US and film-screen (n = 4351) or digital (n = 3122) mammography and had biopsy or 12-month follow-up. Cancer detection, recall, and positive predictive values were determined. All statistical tests were two-sided.<bold>Results: </bold>One hundred ten women had 111 breast cancer events: 89 (80.2%) invasive cancers, median size 12 mm. The number of US screens to detect one cancer was 129 (95% bootstrap confidence interval [CI] = 110 to 156), and for mammography 127 (95% CI = 109 to 152). Cancer detection was comparable for each of US and mammography at 58 of 111 (52.3%) vs 59 of 111 (53.2%, P = .90), with US-detected cancers more likely invasive (53/58, 91.4%, median size 12 mm, range = 2-40 mm), vs mammography at 41 of 59 (69.5%, median size 13 mm, range = 1-55 mm, P < .001). Invasive cancers detected by US were more frequently node-negative, 34 of 53 (64.2%) vs 18 of 41 (43.9%) by mammography (P = .003). For 4814 incidence screens (years 2 and 3), US had higher recall and biopsy rates and lower PPV of biopsy (PPV3) than mammography: The recall rate was 10.7% (n = 515) vs 9.4% (n = 453, P = .03), the biopsy rate was 5.5% (n = 266) vs 2.0% (n = 97, P < .001), and PPV3 was 11.7% (31/266) vs 38.1% (37/97, P < .001).<bold>Conclusions: </bold>Cancer detection rate with US is comparable with mammography, with a greater proportion of invasive and node-negative cancers among US detections. False positives are more common with US screening.
- Subjects
ARGENTINA; CANADA; UNITED States; MAMMOGRAMS; BREAST cancer diagnosis; ULTRASONIC imaging; EARLY detection of cancer; BREAST exams; BIOPSY; BREAST tumors; CLINICAL trials; COMPARATIVE studies; DIAGNOSTIC errors; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; MEDICAL screening; RESEARCH; RESEARCH funding; EVALUATION research; PREDICTIVE tests; DISEASE incidence
- Publication
JNCI: Journal of the National Cancer Institute, 2016, Vol 108, Issue 4, p1
- ISSN
0027-8874
- Publication type
clinical trial
- DOI
10.1093/jnci/djv367