Clinical Performance Metrics of 3D Digital Breast Tomosynthesis Compared With 2D Digital Mammography for Breast Cancer Screening in Community Practice
TL;DR: In community-based radiology practice, mammography screening with 3D DBT yielded lower recall rates, an increasedCDR for cancer overall, and an increased CDR for invasive cancer compared with 2D DM.
Abstract: OBJECTIVE. The objective of our study was to assess the clinical performance of combined 2D-3D digital breast tomosynthesis (DBT), referred to as “3D DBT,” compared with 2D digital mammography (DM) alone for screening mammography in a community-based radiology practice. MATERIALS AND METHODS. Performance outcomes measures were assessed for 14 radiologists who interpreted more than 500 screening mammography 3D DBT studies after the initiation of tomosynthesis. Outcomes from screening mammography during the study period between August 9, 2011, and November 30, 2012, using 3D DBT (n = 23,149 patients) versus 2D DM (n = 54,684 patients) were compared. RESULTS. For patients screened with 3D DBT, the relative change in recall rate was 16.1% lower than for patients screened with 2D DM (p > 0.0001). The overall cancer detection rate (CDR), expressed as number of cancers per 1000 patients screened, was 28.6% greater (p = 0.035) for 3D DBT (6.3/1000) compared with 2D DM (4.9/1000). The CDR for invasive cancers with...
Citations
More filters
Rhode Island Hospital1, University of Cincinnati2, Emory University Hospital3, American College of Surgeons4, University of Virginia5, Memorial Hospital of South Bend6, St Lukes Episcopal Hospital7, University of Washington8, Society of Nuclear Medicine and Molecular Imaging9, University of Medicine and Dentistry of New Jersey10
TL;DR: The ACR Appropriateness Criteria as mentioned in this paper are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel and used to recommend imaging and treatment procedures.
Abstract: Mammography is the recommended method for breast cancer screening of women in the general population. However, mammography alone does not perform as well as mammography plus supplemental screening in high-risk women. Therefore, supplemental screening with MRI or ultrasound is recommended in selected high-risk populations. Screening breast MRI is recommended in women at high risk for breast cancer on the basis of family history or genetic predisposition. Ultrasound is an option for those high-risk women who cannot undergo MRI. Recent literature also supports the use of breast MRI in some women of intermediate risk, and ultrasound may be an option for intermediate-risk women with dense breasts. There is insufficient evidence to support the use of other imaging modalities, such as thermography, breast-specific gamma imaging, positron emission mammography, and optical imaging, for breast cancer screening. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review includes an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.
273 citations
TL;DR: Integration of 3D mammography (2D-3D or 2D synthetic-3d) detected more cases of breast cancer than 2D Mammography alone, but increased the percentage of false-positive recalls.
Abstract: Summary Background Breast tomosynthesis (pseudo-3D mammography) improves breast cancer detection when added to 2D mammography. In this study, we examined whether integrating 3D mammography with either standard 2D mammography acquisitions or with synthetic 2D images (reconstructed from 3D mammography) would detect more cases of breast cancer than 2D mammography alone, to potentially reduce the radiation burden from the combination of 2D plus 3D acquisitions. Methods The Screening with Tomosynthesis Or standard Mammography-2 (STORM-2) study was a prospective population-based screening study comparing integrated 3D mammography (dual-acquisition 2D–3D mammography or 2D synthetic–3D mammography) with 2D mammography alone. Asymptomatic women aged 49 years or older who attended population-based screening in Trento, Italy were recruited for the study. All participants underwent digital mammography with 2D and 3D mammography acquisitions, with the use of software that allowed synthetic 2D mammographic images to be reconstructed from 3D acquisitions. Mammography screen-reading was done in two parallel double-readings conducted sequentially for 2D acquisitions followed by integrated acquisitions. Recall based on a positive mammography result was defined as recall at any screen read. Primary outcome measures were a comparison between integrated (2D–3D or 2D synthetic–3D) mammography and 2D mammography alone of the number of cases of screen-detected breast cancer, the cancer detection rate per 1000 screens, the incremental cancer detection rate, and the number and percentage of false-positive recalls. Findings Between May 31, 2013, and May 29, 2015, 10 255 women were invited to participate, of whom 9672 agreed to participate and were screened. In these 9672 participants (median age 58 years [IQR 53–63]), screening detected 90 cases of breast cancer, including 74 invasive breast cancers, in 85 women (five women had bilateral breast cancer). To account for these bilateral cancers in cancer detection rate estimates, the number of screens used for analysis was 9677. Both 2D–3D mammography (cancer detection rate 8·5 per 1000 screens [82 cancers detected in 9677 screens]; 95% CI 6·7–10·5) and 2D synthetic–3D mammography (8·8 per 1000 [85 in 9677]; 7·0–10·8) had significantly higher rates of breast cancer detection than 2D mammography alone (6·3 per 1000 [61 in 9677], 4·8–8·1; p Interpretation Integration of 3D mammography (2D–3D or 2D synthetic–3D) detected more cases of breast cancer than 2D mammography alone, but increased the percentage of false-positive recalls in sequential screen-reading. These results should be considered in the context of the trade-off between benefits and harms inherent in population breast cancer screening, including that significantly increased breast cancer detection from integrating 3D mammography into screening has the potential to augment screening benefit and also possibly contribute to overdiagnosis. Funding None.
214 citations
TL;DR: Tomosynthesis improves CDR and reduces recall; however, effects are dependent on screening setting, with greater improvement in CDR in European/Scandinavian studies (biennial screening) and reduction in recall in US studies with high baseline recall.
Abstract: Background Tomosynthesis approximates a 3D mammogram of the breast, reducing parenchymal overlap that masks cancers or creates false "lesions" on 2D mammography, and potentially enabling more accurate detection of breast cancer. We compared breast cancer screening detection and recall in asymptomatic women for tomosynthesis vs 2D mammography. Methods A systematic review and random effects meta-analysis were undertaken. Electronic databases (2009-July 2017) were searched for studies comparing tomosynthesis and 2D mammography in asymptomatic women who attended population breast cancer screening and reporting cancer detection rate (CDR) and recall rate. All statistical tests were two-sided. Results Seventeen studies (1 009 790 participants) were included from 413 citations. The pooled incremental CDR for tomosynthesis was 1.6 cancers per 1000 screens (95% confidence interval [CI] = 1.1 to 2.0, P < .001, I2 = 36.9%). Incremental CDR was statistically significantly higher for European/Scandinavian studies, all using a "paired" design where women had both tests (2.4 per 1000 screens, 95% CI = 1.9 to 2.9, P < .001, I2 = 0.0%) compared with US ("unpaired") studies (1.1 per 1000 screens, 95% CI = 0.8 to 1.5, P < .001, I2 = 0.0%; P < .001 between strata). The recall rate for tomosynthesis was statistically significantly lower than for 2D mammography (pooled absolute reduction = -2.2%, 95% CI = -3.0 to -1.4, P < .001, I2 = 98.2%). Stratified analyses showed a decrease in US studies (pooled difference in recall rate = -2.9%, 95% CI = -3.5 to -2.4, P < .001, I2 = 92.9%) but not European/Scandinavian studies (0.5% increase in recall, 95% CI = -0.1 to 1.2, P = .12, I2 = 93.5%; P < .001 between strata). Results were similar in sensitivity analyses excluding studies with overlapping cohorts. Conclusions Tomosynthesis improves CDR and reduces recall; however, effects are dependent on screening setting, with greater improvement in CDR in European/Scandinavian studies (biennial screening) and reduction in recall in US studies with high baseline recall.
159 citations
TL;DR: Implementing DBT into a U.S. breast cancer screening program significantly decreased the screening RR overall and for certain patient subgroups, while significantly increasing the CDR.
Abstract: This prospective internally funded investigation demonstrates that the addition of digital breast tomosynthesis to a two-dimensional mammography screening program in a U.S. academic medical center resulted in a significant increase in the cancer detection rate, as well as a decrease in the screening recall rate overall and for patients with heterogeneous or extremely dense breasts and for patients in their 5th or 7th decades.
116 citations
TL;DR: Abbreviated magnetic resonance imaging has high rate of detection for known breast cancer and short interpretation time and initial enhancement ratio correlated with invasive disease and tumor grade.
108 citations
References
More filters
TL;DR: The use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers.
Abstract: We found a significant increase in cancer detection rates, particularly for invasive cancers, and a simultaneous decrease in false-positive rates with use of mammography plus tomosynthesis compared with mammography alone.
890 citations
"Clinical Performance Metrics of 3D ..." refers background or result in this paper
...Initial European population-based screening programs documented improvements in clinical outcomes for 3D DBT [8, 9]....
[...]
...[8] but differ from the lesser, nonsignificant increase in CDR of 9....
[...]
...[8] in the Oslo population-based screening program....
[...]
TL;DR: Integrated 2D and 3D mammography improves breast-cancer detection and has the potential to reduce false positive recalls.
Abstract: Summary Background Digital breast tomosynthesis with 3D images might overcome some of the limitations of conventional 2D mammography for detection of breast cancer. We investigated the effect of integrated 2D and 3D mammography in population breast-cancer screening. Methods Screening with Tomosynthesis OR standard Mammography (STORM) was a prospective comparative study. We recruited asymptomatic women aged 48 years or older who attended population-based breast-cancer screening through the Trento and Verona screening services (Italy) from August, 2011, to June, 2012. We did screen-reading in two sequential phases—2D only and integrated 2D and 3D mammography—yielding paired data for each screen. Standard double-reading by breast radiologists determined whether to recall the participant based on positive mammography at either screen read. Outcomes were measured from final assessment or excision histology. Primary outcome measures were the number of detected cancers, the number of detected cancers per 1000 screens, the number and proportion of false positive recalls, and incremental cancer detection attributable to integrated 2D and 3D mammography. We compared paired binary data with McNemar's test. Findings 7292 women were screened (median age 58 years [IQR 54–63]). We detected 59 breast cancers (including 52 invasive cancers) in 57 women. Both 2D and integrated 2D and 3D screening detected 39 cancers. We detected 20 cancers with integrated 2D and 3D only versus none with 2D screening only (p Interpretation Integrated 2D and 3D mammography improves breast-cancer detection and has the potential to reduce false positive recalls. Randomised controlled trials are needed to compare integrated 2D and 3D mammography with 2D mammography for breast cancer screening. Funding National Breast Cancer Foundation, Australia; National Health and Medical Research Council, Australia; Hologic, USA; Technologic, Italy.
713 citations
"Clinical Performance Metrics of 3D ..." refers background in this paper
...Initial European population-based screening programs documented improvements in clinical outcomes for 3D DBT [8, 9]....
[...]
TL;DR: In this article, the authors compared the image quality of tomosynthesis with that of conventional mammography and estimated the recall rate of screening when Tomosynthesis is used in addition to mammography.
Abstract: OBJECTIVE. The purpose of our study was to compare the image quality of tomosynthesis with that of conventional mammography and to estimate the recall rate of screening when tomosynthesis is used in addition to mammography.MATERIALS AND METHODS. Women with an abnormal screening mammography were recruited sequentially. Consenting women underwent tomosynthesis of the affected breast corresponding to the views obtained with diagnostic mammography. The study radiologist compared the image quality, including lesion conspicuity and feature analysis, of tomosynthesis with diagnostic film-screen mammography and assessed the need for recall when tomosynthesis was added to digital screening mammography. Screening recalls were considered unnecessary when tomosynthesis did not show a corresponding abnormality or allowed definitely benign lesion characterization. Fisher's exact test was used to determine the association of equivalence and recall status with mammographic finding type.RESULTS. There were 99 digital scre...
465 citations
"Clinical Performance Metrics of 3D ..." refers background in this paper
...Prior observer performance studies [4, 7, 13] reported 30–40% potential reductions in recall rate....
[...]
TL;DR: Addition of tomosynthesis to digital mammography offers the dual benefit of significantly increased diagnostic accuracy and significantly reduced recall rates for noncancer cases.
Abstract: The addition of tomosynthesis to digital mammography offers the dual benefit of improved diagnostic accuracy and significant reduction in false-positive recall rate, thereby avoiding unnecessary additional testing and decreasing attendant anxiety, inconvenience, and cost for women.
408 citations
"Clinical Performance Metrics of 3D ..." refers background in this paper
...Prior observer performance studies [4, 7, 13] reported 30–40% potential reductions in recall rate....
[...]
TL;DR: Age is a minor determinant of mammographic sensitivity in women aged 40 years or older and sensitivity is substantially decreased with the combination of higher breast density and estrogen replacement therapy use, and there was not a notable shift in cancer outcomes in the groups with lower mammography sensitivity.
Abstract: PURPOSE: To examine how common patient factors affect screening mammographic sensitivity and cancer stage at diagnosis. MATERIALS AND METHODS: The authors used a population-based database of 183,134 screening mammograms and a statewide tumor registry to identify 807 breast cancers detected at screening mammography. RESULTS: Sensitivity varied significantly with ethnicity, use of estrogen replacement therapy, mammographic breast density, and age. Sensitivity was 54% (13 of 24) in women younger than 40 years, 77% (121 of 157) in women aged 40-49 years, 78% (224 of 286) in women aged 50-64 years, and 81% (277 of 340) in women older than 64 years. Sensitivity was 68% (162 of 237) for dense breasts and 85% (302 of 356) for nondense breasts and 74% (180 of 244) in estrogen replacement therapy users and 81% (417 of 513) in nonusers. Sensitivity was most markedly reduced with the combination of dense breasts and estrogen replacement therapy use; there was little difference when only one factor was present. Median...
387 citations