Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue

The somoinsight study

Rachel F. Brem, László Tabár, Stephen W. Duffy, Marc F. Inciardi, Jessica A. Guingrich, Beverly E. Hashimoto, Marla R. Lander, Robert L. Lapidus, Mary Kay Peterson, Jocelyn A. Rapelyea, Susan Roux, Kathy J. Schilling, Biren A. Shah, Jessica Torrente, Ralph T. Wynn, Dave P. Miller

Research output: Contribution to journalArticle

Abstract

Purpose: To determine improvement in breast cancer detection by using supplemental three-dimensional (3D) automated breast (AB) ultrasonography (US) with screening mammography versus screening mammography alone in asymptomatic women with dense breasts. Materials and Methods: Institutional review board approval and written informed consent were obtained for this HIPAA-compliant study. The SomoInsight Study was an observational, multicenter study conducted between 2009 and 2011. A total of 15 318 women (mean age, 53.3 years ± 10 [standard deviation]; range, 25-94 years) presenting for screening mammography alone with heterogeneously (50%-75%) or extremely (>75%) dense breasts were included, regardless of further risk characterization, and were followed up for 1 year. Participants underwent screening mammography alone followed by an AB US examination; results were interpreted sequentially. McNemar test was used to assess differences in cancer detection. Results: Breast cancer was diagnosed at screening in 112 women: 82 with screening mammography and an additional 30 with AB US. Addition of AB US to screening mammography yielded an additional 1.9 detected cancers per 1000 women screened (95% confidence interval [CI]: 1.2, 2.7; P , .001). Of cancers detected with screening mammography, 62.2% (51 of 82) were invasive versus 93.3% (28 of 30) of additional cancers detected with AB US (P <.001). Of the 82 cancers detected with either screening mammography alone or the combined read, 17 were detected with screening mammography alone. Of these, 64.7% (11 of 17) were ductal carcinoma in situ versus 6.7% (two of 30) of cancers detected with AB US alone. Sensitivity for the combined read increased by 26.7% (95% CI: 18.3%, 35.1%); the increase in the recall rate per 1000 women screened was 284.9 (95% CI: 278.0, 292.2; P <.001). Conclusion: Addition of AB US to screening mammography in a generalizable cohort of women with dense breasts increased the cancer detection yield of clinically important cancers, but it also increased the number of false-positive results.

Original languageEnglish (US)
Pages (from-to)663-673
Number of pages11
JournalRadiology
Volume274
Issue number3
DOIs
StatePublished - Mar 1 2015
Externally publishedYes

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Mammary Ultrasonography
Mammography
Breast
Breast Neoplasms
Neoplasms
Confidence Intervals
Health Insurance Portability and Accountability Act
Carcinoma, Intraductal, Noninfiltrating
Research Ethics Committees
Informed Consent
Multicenter Studies
Observational Studies

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

Brem, R. F., Tabár, L., Duffy, S. W., Inciardi, M. F., Guingrich, J. A., Hashimoto, B. E., ... Miller, D. P. (2015). Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: The somoinsight study. Radiology, 274(3), 663-673. https://doi.org/10.1148/radiol.14132832

Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue : The somoinsight study. / Brem, Rachel F.; Tabár, László; Duffy, Stephen W.; Inciardi, Marc F.; Guingrich, Jessica A.; Hashimoto, Beverly E.; Lander, Marla R.; Lapidus, Robert L.; Peterson, Mary Kay; Rapelyea, Jocelyn A.; Roux, Susan; Schilling, Kathy J.; Shah, Biren A.; Torrente, Jessica; Wynn, Ralph T.; Miller, Dave P.

In: Radiology, Vol. 274, No. 3, 01.03.2015, p. 663-673.

Research output: Contribution to journalArticle

Brem, RF, Tabár, L, Duffy, SW, Inciardi, MF, Guingrich, JA, Hashimoto, BE, Lander, MR, Lapidus, RL, Peterson, MK, Rapelyea, JA, Roux, S, Schilling, KJ, Shah, BA, Torrente, J, Wynn, RT & Miller, DP 2015, 'Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: The somoinsight study', Radiology, vol. 274, no. 3, pp. 663-673. https://doi.org/10.1148/radiol.14132832
Brem, Rachel F. ; Tabár, László ; Duffy, Stephen W. ; Inciardi, Marc F. ; Guingrich, Jessica A. ; Hashimoto, Beverly E. ; Lander, Marla R. ; Lapidus, Robert L. ; Peterson, Mary Kay ; Rapelyea, Jocelyn A. ; Roux, Susan ; Schilling, Kathy J. ; Shah, Biren A. ; Torrente, Jessica ; Wynn, Ralph T. ; Miller, Dave P. / Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue : The somoinsight study. In: Radiology. 2015 ; Vol. 274, No. 3. pp. 663-673.
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abstract = "Purpose: To determine improvement in breast cancer detection by using supplemental three-dimensional (3D) automated breast (AB) ultrasonography (US) with screening mammography versus screening mammography alone in asymptomatic women with dense breasts. Materials and Methods: Institutional review board approval and written informed consent were obtained for this HIPAA-compliant study. The SomoInsight Study was an observational, multicenter study conducted between 2009 and 2011. A total of 15 318 women (mean age, 53.3 years ± 10 [standard deviation]; range, 25-94 years) presenting for screening mammography alone with heterogeneously (50{\%}-75{\%}) or extremely (>75{\%}) dense breasts were included, regardless of further risk characterization, and were followed up for 1 year. Participants underwent screening mammography alone followed by an AB US examination; results were interpreted sequentially. McNemar test was used to assess differences in cancer detection. Results: Breast cancer was diagnosed at screening in 112 women: 82 with screening mammography and an additional 30 with AB US. Addition of AB US to screening mammography yielded an additional 1.9 detected cancers per 1000 women screened (95{\%} confidence interval [CI]: 1.2, 2.7; P , .001). Of cancers detected with screening mammography, 62.2{\%} (51 of 82) were invasive versus 93.3{\%} (28 of 30) of additional cancers detected with AB US (P <.001). Of the 82 cancers detected with either screening mammography alone or the combined read, 17 were detected with screening mammography alone. Of these, 64.7{\%} (11 of 17) were ductal carcinoma in situ versus 6.7{\%} (two of 30) of cancers detected with AB US alone. Sensitivity for the combined read increased by 26.7{\%} (95{\%} CI: 18.3{\%}, 35.1{\%}); the increase in the recall rate per 1000 women screened was 284.9 (95{\%} CI: 278.0, 292.2; P <.001). Conclusion: Addition of AB US to screening mammography in a generalizable cohort of women with dense breasts increased the cancer detection yield of clinically important cancers, but it also increased the number of false-positive results.",
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AU - Brem, Rachel F.

AU - Tabár, László

AU - Duffy, Stephen W.

AU - Inciardi, Marc F.

AU - Guingrich, Jessica A.

AU - Hashimoto, Beverly E.

AU - Lander, Marla R.

AU - Lapidus, Robert L.

AU - Peterson, Mary Kay

AU - Rapelyea, Jocelyn A.

AU - Roux, Susan

AU - Schilling, Kathy J.

AU - Shah, Biren A.

AU - Torrente, Jessica

AU - Wynn, Ralph T.

AU - Miller, Dave P.

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N2 - Purpose: To determine improvement in breast cancer detection by using supplemental three-dimensional (3D) automated breast (AB) ultrasonography (US) with screening mammography versus screening mammography alone in asymptomatic women with dense breasts. Materials and Methods: Institutional review board approval and written informed consent were obtained for this HIPAA-compliant study. The SomoInsight Study was an observational, multicenter study conducted between 2009 and 2011. A total of 15 318 women (mean age, 53.3 years ± 10 [standard deviation]; range, 25-94 years) presenting for screening mammography alone with heterogeneously (50%-75%) or extremely (>75%) dense breasts were included, regardless of further risk characterization, and were followed up for 1 year. Participants underwent screening mammography alone followed by an AB US examination; results were interpreted sequentially. McNemar test was used to assess differences in cancer detection. Results: Breast cancer was diagnosed at screening in 112 women: 82 with screening mammography and an additional 30 with AB US. Addition of AB US to screening mammography yielded an additional 1.9 detected cancers per 1000 women screened (95% confidence interval [CI]: 1.2, 2.7; P , .001). Of cancers detected with screening mammography, 62.2% (51 of 82) were invasive versus 93.3% (28 of 30) of additional cancers detected with AB US (P <.001). Of the 82 cancers detected with either screening mammography alone or the combined read, 17 were detected with screening mammography alone. Of these, 64.7% (11 of 17) were ductal carcinoma in situ versus 6.7% (two of 30) of cancers detected with AB US alone. Sensitivity for the combined read increased by 26.7% (95% CI: 18.3%, 35.1%); the increase in the recall rate per 1000 women screened was 284.9 (95% CI: 278.0, 292.2; P <.001). Conclusion: Addition of AB US to screening mammography in a generalizable cohort of women with dense breasts increased the cancer detection yield of clinically important cancers, but it also increased the number of false-positive results.

AB - Purpose: To determine improvement in breast cancer detection by using supplemental three-dimensional (3D) automated breast (AB) ultrasonography (US) with screening mammography versus screening mammography alone in asymptomatic women with dense breasts. Materials and Methods: Institutional review board approval and written informed consent were obtained for this HIPAA-compliant study. The SomoInsight Study was an observational, multicenter study conducted between 2009 and 2011. A total of 15 318 women (mean age, 53.3 years ± 10 [standard deviation]; range, 25-94 years) presenting for screening mammography alone with heterogeneously (50%-75%) or extremely (>75%) dense breasts were included, regardless of further risk characterization, and were followed up for 1 year. Participants underwent screening mammography alone followed by an AB US examination; results were interpreted sequentially. McNemar test was used to assess differences in cancer detection. Results: Breast cancer was diagnosed at screening in 112 women: 82 with screening mammography and an additional 30 with AB US. Addition of AB US to screening mammography yielded an additional 1.9 detected cancers per 1000 women screened (95% confidence interval [CI]: 1.2, 2.7; P , .001). Of cancers detected with screening mammography, 62.2% (51 of 82) were invasive versus 93.3% (28 of 30) of additional cancers detected with AB US (P <.001). Of the 82 cancers detected with either screening mammography alone or the combined read, 17 were detected with screening mammography alone. Of these, 64.7% (11 of 17) were ductal carcinoma in situ versus 6.7% (two of 30) of cancers detected with AB US alone. Sensitivity for the combined read increased by 26.7% (95% CI: 18.3%, 35.1%); the increase in the recall rate per 1000 women screened was 284.9 (95% CI: 278.0, 292.2; P <.001). Conclusion: Addition of AB US to screening mammography in a generalizable cohort of women with dense breasts increased the cancer detection yield of clinically important cancers, but it also increased the number of false-positive results.

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