Abstract
Purpose
To compare the diagnostic performances of tomosynthesis and ultrasonography as adjunctives to digital mammography in women with dense breasts.
Methods
A total of 778 women with dense breasts underwent digital mammography with tomosynthesis and ultrasonography for screening and diagnostic purposes. The findings of tomosynthesis and ultrasonography were evaluated independently. The primary endpoint was overall diagnostic accuracy determined by area under the receiver operating characteristic curve (AUC). Secondary endpoints included sensitivity, specificity, and predictive values.
Results
Of the 778 participants, 698 women (140 breast cancers) were included in the analysis. Based on the AUC findings, the non-inferiority of tomosynthesis to ultrasonography was established in the overall group as well as in all subgroups except for that comprising women with extremely dense breast composition. There were no significant differences in AUC between tomosynthesis and ultrasonography among asymptomatic participants and participants who underwent imaging for screening (0.912 vs. 0.934 [P = 0.403] and 0.987 vs. 0.950 [P = 0.270], respectively). Tomosynthesis exhibited lower sensitivity (91.4 vs. 96.4%; P = 0.039), and higher specificity (83.9 vs. 70.4%; P < 0.001) and positive predictive value (58.7 vs. 45.0%; P < 0.001) than ultrasonography.
Conclusions
Tomosynthesis exhibits comparable performance to ultrasonography as an adjunct to mammography for diagnosis of breast cancer, except among women with extremely dense breasts.
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Abbreviations
- 2D:
-
Two-dimensional
- AUC:
-
Area under the ROC curve
- BI-RADS:
-
Breast imaging reporting and data system
- CI:
-
Confidence interval
- DCIS:
-
Ductal carcinoma in situ
- IDC:
-
Invasive ductal carcinomas
- NPV:
-
Negative predictive value
- PPV:
-
Positive predictive value
- ROC:
-
Receiver operating characteristic
- SD:
-
Standard deviation
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Funding
This research was supported by a grant (number 05-2014-0040) from the Seoul National University Hospital Research Fund, and the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (Grant Number: HI14C1234).
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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An erratum to this article is available at http://dx.doi.org/10.1007/s10549-017-4172-1.
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Kim, W.H., Chang, J.M., Lee, J. et al. Diagnostic performance of tomosynthesis and breast ultrasonography in women with dense breasts: a prospective comparison study. Breast Cancer Res Treat 162, 85–94 (2017). https://doi.org/10.1007/s10549-017-4105-z
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DOI: https://doi.org/10.1007/s10549-017-4105-z