Ultrasound as the Primary Screening Test for Breast Cancer: Analysis From ACRIN 6666

J Natl Cancer Inst. 2015 Dec 28;108(4):djv367. doi: 10.1093/jnci/djv367. Print 2016 Apr.

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.

Trial registration: ClinicalTrials.gov NCT00072501.

Publication types

  • Clinical Trial
  • Editorial
  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Argentina / epidemiology
  • Biopsy
  • Breast Neoplasms / diagnostic imaging*
  • Breast Neoplasms / epidemiology
  • Canada / epidemiology
  • Early Detection of Cancer / methods*
  • False Positive Reactions
  • Female
  • Humans
  • Incidence
  • Mammography
  • Mass Screening / methods*
  • Middle Aged
  • Predictive Value of Tests
  • Prospective Studies
  • Risk Factors
  • Ultrasonography, Mammary* / standards
  • Ultrasonography, Mammary* / statistics & numerical data
  • Ultrasonography, Mammary* / trends
  • United States / epidemiology

Associated data

  • ClinicalTrials.gov/NCT00072501