title: Ultrasound as the Primary Screening Test for Breast Cancer: Analysis From ACRIN 6666.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Magee-Womens Hospital of UPMC (WAB) and Department of Biostatistics (AIB), University of Pittsburgh School of Medicine, Pittsburgh, PA; Department of Radiology, Feinberg School of Medicine, Northwestern University, Chicago, IL (EBM); CERIM, Buenos Aires, Argentina (DL); Department of Medical Imaging, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada (RAJ); Department of Radiology, Medical University of South Carolina, Charleston, SC (EDP). wendieberg@gmail.com.
authors.forename: Wendie A
authors.initials: WA
authors.lastname: Berg
authors.affiliation: Magee-Womens Hospital of UPMC (WAB) and Department of Biostatistics (AIB), University of Pittsburgh School of Medicine, Pittsburgh, PA; Department of Radiology, Feinberg School of Medicine, Northwestern University, Chicago, IL (EBM); CERIM, Buenos Aires, Argentina (DL); Department of Medical Imaging, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada (RAJ); Department of Radiology, Medical University of South Carolina, Charleston, SC (EDP).
authors.forename: Andriy I
authors.initials: AI
authors.lastname: Bandos
authors.affiliation: Magee-Womens Hospital of UPMC (WAB) and Department of Biostatistics (AIB), University of Pittsburgh School of Medicine, Pittsburgh, PA; Department of Radiology, Feinberg School of Medicine, Northwestern University, Chicago, IL (EBM); CERIM, Buenos Aires, Argentina (DL); Department of Medical Imaging, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada (RAJ); Department of Radiology, Medical University of South Carolina, Charleston, SC (EDP).
authors.forename: Ellen B
authors.initials: EB
authors.lastname: Mendelson
authors.affiliation: Magee-Womens Hospital of UPMC (WAB) and Department of Biostatistics (AIB), University of Pittsburgh School of Medicine, Pittsburgh, PA; Department of Radiology, Feinberg School of Medicine, Northwestern University, Chicago, IL (EBM); CERIM, Buenos Aires, Argentina (DL); Department of Medical Imaging, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada (RAJ); Department of Radiology, Medical University of South Carolina, Charleston, SC (EDP).
authors.forename: Daniel
authors.initials: D
authors.lastname: Lehrer
authors.affiliation: Magee-Womens Hospital of UPMC (WAB) and Department of Biostatistics (AIB), University of Pittsburgh School of Medicine, Pittsburgh, PA; Department of Radiology, Feinberg School of Medicine, Northwestern University, Chicago, IL (EBM); CERIM, Buenos Aires, Argentina (DL); Department of Medical Imaging, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada (RAJ); Department of Radiology, Medical University of South Carolina, Charleston, SC (EDP).
authors.forename: Roberta A
authors.initials: RA
authors.lastname: Jong
authors.affiliation: Magee-Womens Hospital of UPMC (WAB) and Department of Biostatistics (AIB), University of Pittsburgh School of Medicine, Pittsburgh, PA; Department of Radiology, Feinberg School of Medicine, Northwestern University, Chicago, IL (EBM); CERIM, Buenos Aires, Argentina (DL); Department of Medical Imaging, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada (RAJ); Department of Radiology, Medical University of South Carolina, Charleston, SC (EDP).
authors.forename: Etta D
authors.initials: ED
authors.lastname: Pisano
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008875:Middle Aged; D001118:Argentina / Q000453:epidemiology; D001706:Biopsy; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000453:epidemiology; D002170:Canada / Q000453:epidemiology; D055088:Early Detection of Cancer / Q000379:methods; D005189:False Positive Reactions; D015994:Incidence; D008327:Mammography; D008403:Mass Screening / Q000379:methods; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012307:Risk Factors; D016217:Ultrasonography, Mammary / Q000592:standards / Q000706:statistics & numerical data / Q000639:trends; D014481:United States / Q000453:epidemiology