Rationale and Objectives
This study aims to evaluate the screening performance of digital breast tomosynthesis (DBT) combined with synthesized mammography (SM) vs combined with full-field digital mammography (FFDM).
Materials and Methods
We retrospectively reviewed all screening studies utilizing FFDM + DBT ( n = 7845) and SM + DBT ( n = 14,776) between April 1, 2013, and February 15, 2016. Recall rate, biopsy rate, positive predictive value 1 (PPV1), positive predictive value 3 (PPV3), and cancer detection rate (CDR) were compared between the two groups. A generalized linear mixed model specifying the reading radiologist as the random effect and controlling for age was used to compare clinical outcomes between the two groups.
Results
The overall recall rate was significantly lower in the SM + DBT cohort compared to the FFDM + DBT cohort (7.06% vs 7.63%, P = .04). There was no difference in biopsy rate, PPV1, PPV3, or CDR between the two groups.
Conclusions
When DBT is performed for screening, the use of SM rather than acquiring an additional FFDM has no significant effect on biopsy rate, PPV1, PPV3, or CDR. We found a decrease in recall rate in the SM + DBT group, which may be related to the learning curve of interpreting DBT. These findings support the use of SM for patients undergoing screening with DBT.
Introduction
Digital breast tomosynthesis (DBT) is a relatively recent advancement in breast imaging that decreases recall rate and improves invasive cancer detection rate (CDR) . The US Food and Drug Administration (FDA) initially approved DBT as a screening adjunct to be used in combination with standard full-field digital mammography (FFDM). The primary reasons that DBT was only approved in combination with FFDM were that some findings, such as microcalcifications, are thought to not be well visualized on DBT , and the standard FFDM examination allows easier comparison to previous examinations.
The disadvantage of combination FFDM and DBT is an approximate twofold increase in radiation dose , although the total dose still falls within radiation dose limits set forth by the Mammographic Quality and Standards Act (3 mGy). Concerns regarding increased radiation dose led to the advancement of synthesized two-dimensional mammography (SM). SM is a technique that generates two-dimensional images from the DBT dataset, eliminating the need for a separately acquired FFDM examination and thereby decreasing the radiation dose to the patient . The FDA approved replacing FFDM with a specific SM technique (Selenia Dimensions 3D System with C-View Software Module, sponsored by Hologic, Inc., Marlborough, MA) for screening mammography in May 2013.
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Materials and Methods
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Results
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TABLE 1
Clinical Performance Measures of Digital Breast Tomosynthesis (DBT) When Combined with Full-field Digital Mammogram (FFDM) vs Synthesized Mammogram (SM)
Measure FFDM + DBT ( N = 7,813) SM + DBT ( N = 14,722) GLM P Value \* Recall rate (No. of patients recalled) 7.63 (596) 7.06 (1039).04 95% CI 7.04–8.21 6.64–7.47 Biopsy rate (No. of biopsies) 17.3 (135) 14.5 (213) .11 95% CI 14.4–20.2 12.5–16.4 CDR (No. of cancers) 5.25 (41) 5.57 (82) .75 95% CI 3.65–6.85 4.37–6.77 PPV1 6.90 8.03 .33 95% CI 4.86–8.94 6.36–9.70 PPV3 29.2 36.7 .16 95% CI 20.8–37.6 30.0–43.5 CDR for DCIS (No. of cases) 1.28 (10) 0.88 (13) .38 95% CI 0.49–2.07 0.40–1.36 CDR for invasive cancers (No. of cases) 3.84 (30) 4.69 (69) 3.58–5.79 .41 95% CI 2.47–5.21
CDR, cancer detection rate; CI, confidence interval; PPV1, positive predictive value for abnormal findings at screening, excluding patients lost to follow-up; PPV3, positive predictive value for biopsies performed, excluding patients lost to follow-up.
This boldface item is statistically significant.
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TABLE 2
Recall Rate of Specific Findings for Digital Breast Tomosynthesis (DBT) When Combined with Full-field Digital Mammogram (FFDM) vs Synthesized Mammogram (SM)
Measure FFDM + DBT ( n = 7,849 \* ) SM + DBT ( n = 14,782 \* )P Value † Asymmetries (Number, recall rate) 237 (3.02) 359 (2.43) Calcifications (Number, recall rate) 111 (1.41) 197 (1.33) .09 Distortions (Number, recall rate) 58 (0.74) 126 (0.85) Masses (Number, recall rate) 226 (2.88) 417 (2.92)
Recall rate, number of patients recalled per 100 patients screened.
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TABLE 3
Characteristics for Cancers Diagnosed by Digital Breast Tomosynthesis (DBT) Combined with Full Field Digital Mammogram (FFDM) vs Synthesized Mammogram (SM)
Characteristic FFDM + DBT SM + DBT_P_ Value † No. of patients with cancers detected 41 82 Type of cancer, No. (%) of cancers DCIS 10 (24.4) 13 (15.8) 0.35 Invasive 30 (73.2) 69 (84.1) Other \* 1 (2.4) 0 (0) Invasive cancer type, No. (%) of invasive cancer types Ductal 25 (83.3) 47 (69.1) 0.27 Lobular 4 (13.3) 8 (11.8) Mixed 1 (3.3) 11 (16.2) Colloid 0 (0.0) 2 (2.9)
DCIS, ductal carcinoma in situ.
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Discussion
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Acknowledgments
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