Digital Breast Tomosynthesis Group Research Articles

Digital breast tomosynthesis versus X-ray of the breast specimen for intraoperative margin assessment: A randomized trial

BackgroundInvolved resection margins after breast conserving surgery (BCS) often require a re-operation with increased patient anxiety and risk of impaired cosmesis.We investigated the number of re-operations due to involved resection margins after BCS comparing digital breast tomosynthesis(DBT) with X-ray for intraoperative margin evaluation.Furthermore, we assessed the diagnostic accuracy of these methods to predict histopathological margin status. Finally, we evaluated risk factors for re-operation. MethodsIn this randomized, non-blinded study, 250 invasive breast cancer patients were randomized (1:1), whereof 241 were analyzed intraoperatively with either DBT (intervention, n = 119) or X-ray (standard, n = 122). Pearson's chi-squared test, Fisher's exact test, t-test, logistic and ordinal regression analysis was used as appropriate. ResultsNo difference was found in the number of re-operations between the DBT and X-ray group (16.8 % vs 19.7 %, p = 0.57), or in diagnostic accuracy to predict histopathological margin status (77.5 %, CI: 68.6–84.9 %) and (67.3 %, CI: 57.7–75.9 %), respectively. We evaluated 5 potential risk factors for re-operation: Ductal carcinoma in situ (DCIS) outside tumor, OR = 9.4 (CI: 4.3–20.6, p < 0.001); high mammographic breast density, OR = 6.1 (CI: 1.0–38.1, p = 0.047); non-evaluable margins on imaging, OR = 3.8 (CI: 1.3–10.8, p = 0.016); neoadjuvant chemotherapy, OR = 3.0 (CI: 1.0–8.8, p = 0.048); and T2 tumor-size, OR = 2.6 (CI: 1.0–6.4, p = 0.045). ConclusionsNo difference was found in the number of re-operations or in diagnostic accuracy to predict histopathological margin status between DBT and X-ray groups. DCIS outside the tumor showed the highest risk of re-operation. Intraoperative methods with improved visualization of DCIS are needed to obtain tumor free margins in BCS.

Frequency and Outcomes of BI-RADS Category 3 Assessments in Patients With a Personal History of Breast Cancer: Full-Field Digital Mammography Versus Digital Breast Tomosynthesis.

Background: Studies establishing the validity of BI-RADS category 3 excluded patients with personal history of breast cancer (PHBC). Utilization of category 3 in patients with PHBC may be impacted not only by this population's increased breast cancer risk, but also by adoption of digital breast tomosynthesis (DBT) over full-field digital mammography (FFDM). Objective: To compare the frequency, outcomes, and additional characteristics of BI-RADS category 3 assessments between FFDM and DBT in patients with PHBC. Methods: This retrospective study included 14,845 mammograms in 10,118 patients (mean age, 61.8 years) with PHBC, who had undergone mastectomy and/or lumpectomy. Of these, 8,422 examinations were performed by FFDM from October 2014 to September 2016, and 6423 examinations by FFDM with DBT from February 2017 to December 2018, following interval conversion of the center's mammography units. Information was extracted from the EHR and radiology reports. FFDM and DBT groups were compared in the entire sample and among index category 3 lesions (i.e., earliest category 3 assessment per lesion). Results: Frequency of category 3 assessment was lower for DBT than FFDM (5.6% vs 6.4%; p=.05). DBT, compared with FFDM, showed lower malignancy rate for category 3 lesions (1.8% vs 5.0%; p=.04), higher malignancy rate for category 4 lesions (32.0% vs 23.2%; p=.03), and no difference in malignancy rate for category 5 lesions (100.0% vs 75.0%; p=.02). Analysis of index category 3 lesions included 438 and 274 lesions for FFDM and DBT, respectively. For category 3 lesions, DBT, compared with FFDM, showed lower PPV3 (13.9% vs 36.1%; p=.02), and more frequent mammographic finding type of mass (33.2% vs 23.1%, p=.003). Conclusion: Malignancy rate for category 3 lesions in patients with PHBC was less than the accepted limit (2%) for DBT (1.8%), but not FFDM (5.0%). Lower malignancy rate for category 3 lesions but higher malignancy rate for category 4 lesions for DBT supports more appropriate application of category 3 assessment in patients with PHBC through use of DBT. Clinical Impact: These insights may help establish whether category 3 assessments in patients with PHBC are within benchmarks for early detection of second cancers and reduction of benign biopsies.

Association of Screening With Digital Breast Tomosynthesis vs Digital Mammography With Risk of Interval Invasive and Advanced Breast Cancer

Digital breast tomosynthesis (DBT) was developed with the expectation of improving cancer detection in women with dense breasts. Studies are needed to evaluate interval invasive and advanced breast cancer rates, intermediary outcomes related to breast cancer mortality, by breast density and breast cancer risk. To evaluate whether DBT screening is associated with a lower likelihood of interval invasive cancer and advanced breast cancer compared with digital mammography by extent of breast density and breast cancer risk. Cohort study of 504 427 women aged 40 to 79 years who underwent 1 003 900 screening digital mammography and 375 189 screening DBT examinations from 2011 through 2018 at 44 US Breast Cancer Surveillance Consortium (BCSC) facilities with follow-up for cancer diagnoses through 2019 by linkage to state or regional cancer registries. Breast Imaging Reporting and Data System (BI-RADS) breast density; BCSC 5-year breast cancer risk. Rates per 1000 examinations of interval invasive cancer within 12 months of screening mammography and advanced breast cancer (prognostic pathologic stage II or higher) within 12 months of screening mammography, both estimated with inverse probability weighting. Among 504 427 women in the study population, the median age at time of mammography was 58 years (IQR, 50-65 years). Interval invasive cancer rates per 1000 examinations were not significantly different for DBT vs digital mammography (overall, 0.57 vs 0.61, respectively; difference, -0.04; 95% CI, -0.14 to 0.06; P = .43) or among all the 836 250 examinations with BCSC 5-year risk less than 1.67% (low to average-risk) or all the 413 061 examinations with BCSC 5-year risk of 1.67% or higher (high risk) across breast density categories. Advanced cancer rates were not significantly different for DBT vs digital mammography among women at low to average risk or at high risk with almost entirely fatty, scattered fibroglandular densities, or heterogeneously dense breasts. Advanced cancer rates per 1000 examinations were significantly lower for DBT vs digital mammography for the 3.6% of women with extremely dense breasts and at high risk of breast cancer (13 291 examinations in the DBT group and 31 300 in the digital mammography group; 0.27 vs 0.80 per 1000 examinations; difference, -0.53; 95% CI, -0.97 to -0.10) but not for women at low to average risk (10 611 examinations in the DBT group and 37 796 in the digital mammography group; 0.54 vs 0.42 per 1000 examinations; difference, 0.12; 95% CI, -0.09 to 0.32). Screening with DBT vs digital mammography was not associated with a significant difference in risk of interval invasive cancer and was associated with a significantly lower risk of advanced breast cancer among the 3.6% of women with extremely dense breasts and at high risk of breast cancer. No significant difference was observed in the 96.4% of women with nondense breasts, heterogeneously dense breasts, or with extremely dense breasts not at high risk.

Abstract P3-04-02: Real world evidence demonstrates replacement of 2D mammography with 3D mammography among insured women

Abstract Background Digital breast tomosynthesis (DBT), also called 3D mammography, was first approved by the Federal Drug Administration in 2011. The goal of 3D mammography is to improve accuracy compared to 2D digital mammography (DM), by increasing sensitivity and decreasing recall rates. To capture the broad utilization of DBT in populations receiving both screening and diagnostic imaging, this analysis investigates DBT usage over time in a longitudinal sample from 2016 through 2020 for adult women ranging from 18-74 years of age. Methods Retrospective analyses were conducted using de-identified administrative claims data from a large national U.S. health insurer. The study cohort consisted of women who were continuously enrolled in a commercial or Medicare Advantage plan from 1/2016 to 12/2020 and aged 18 to 74 years old as of 2016. All procedures were identified based on Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes. For each study year, receipt of breast cancer screening with DM (S-DM) or including DBT (S-DBT) were captured. Receipt of DM and DBT not specified for screening based on CPT code descriptions were categorized as diagnostic, D-DM and D-DBT respectively. Women that received both DBT and DM in the same year were included in the DBT group. In addition, women who received MRI and ultrasound were also captured. Rates of each procedure by study year, insurance type, and age categories that align with recommended screening guidelines (&amp;lt;40 years old, 40-49 years old and 50-74 years old) were examined. Results Approximately 3.8 million women met study criteria; 85% were commercially insured and 15% were Medicare Advantage. Table 1 shows rates of adult women who received mammography, MRI and ultrasound over the study period. About 74% of study subjects receiving screening were 50-74 years old at the start of the study period, 25% were 40-49 years and 1% were under 40 years old. In 2020, there were fewer women (3%-13%) receiving imaging procedures compared to counts in 2019. During the 5-year study period, there was a 3.5-fold increase in the number of women who received S-DBT. In 2016, 23% of women who received a screening mammogram received S-DBT and by 2020, this percent increased to 82%. The percent of women who received a diagnostic mammogram using D-DBT compared to D-DM also increased overtime; 29% of women received a D-DBT in 2016 and this increased to 77% in 2020. The number of women with receipt of ultrasound and MRI were similar in each study year. The percent diagnostic/screening tests (including DBT and DM) were in the range of 18.5%-20.2% each year. Conclusion Among this cohort of women who were continuously enrolled in the health plan throughout the 5-year study period, this analysis shows that screening and diagnostic DBT utilization rates increased from 2016 to 2020 while DM screening and diagnostic imaging utilization concomitantly decreased. The percentages of women that received S-DBT and D-DBT were highest in 2020, even though 8%-13% fewer women had evidence of mammography than in 2019, which is largely due to COVID-19 related healthcare service disruptions. The rate of diagnostic tests as a percent of screening tests did not decrease with the adoption of DBT. Further analyses investigating rates of follow-up procedures and downstream costs are warranted. Table. Rates of adult women who received digital breast tomosynthesis, digital mammography, MRI and ultrasound by age group and year from 2016-2020.Calendar YearAge Group categoryTotal women with ≥1 Screening Mammography, N% with S-DBT% with S-DMTotal women with ≥1 Diagnostic Mammography Procedure, N% with D-DBT% with D-DMWomen with at least ≥1 MRI procedureWomen with ≥1 Ultrasound procedure2016Total100175523%77%20237129%71%20786227790&amp;lt;401269724%76%1360831%69%16582428240-4925258521%79%5682729%71%55106767550-7473647323%77%13193629%71%136181358332017Total106871644%56%20791143%57%23153243413&amp;lt;401211451%49%1364146%54%17652405940-4925583346%54%5589544%56%60366963550-7480076944%56%13837543%57%153521497192018Total108956461%39%20584657%43%24901251678&amp;lt;401111869%31%1265262%38%18512256440-4925074764%36%5429058%42%64877061450-7482769960%40%13890456%44%165631585002019Total112823673%27%20895169%31%28394264503&amp;lt;401039081%19%1258674%26%19392202440-4925084376%24%5364069%31%71877230650-7486700372%28%14272568%32%192681701732020Total98572982%18%19229677%23%27580245350&amp;lt;40827988%12%1096381%19%18281850440-4920904185%15%4725377%23%67776438850-7476840982%18%13408076%24%18975162458 Citation Format: Stacey DaCosta Byfield, Kenneth Wimmer, Beatrice Amara Adajar, Peter Onglao, Annika Fredrickson, Maria Eloisa Ventura, James Staib, Kierstin Catlett, Rashna Soonavala, Mi-Ok Kim, Allison Fiscalini, Laura Esserman. Real world evidence demonstrates replacement of 2D mammography with 3D mammography among insured women [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-04-02.

Disparities in the uptake of digital breast tomosynthesis for breast cancer screening: A retrospective cohort study.

We present a retrospective cohort study evaluating the utilization and effectiveness of digital breast tomosynthesis (DBT) for breast cancer screening with a focus on racial differences. 46,236 females underwent screening mammography between 4/1/2013 and 3/30/2020, during which there was an increase in DBT utilization from 18.8% in year 1 to 89.6% in year 7. Black and Asian women were significantly less likely to have a screening study with DBT compared to White women. Overall, the DBT group had a lower recall rate (9.1% versus 11.2%, p < 0.001) and higher cancer detection rate (6.0 vs 4.1, p < 0.001) compared to the FFDM group.

Design, implementation, and pitfalls of TMIST

The early detection of breast cancer has been shown to reduce deaths through randomized, controlled trials. Numerous observational studies, failure analyses, and “incidence of death” studies have confirmed that screening reduces deaths in the general population. Digital Breast Tomosynthesis (DBT) which collects mammographic images from different angles and uses them to synthesize planes through the breast is simply another advance in mammography among others that have been made over the years. DBT “absolutely” detects more cancers at a time when cure is more likely while also having the advantage of reducing recall rates. The Tomosynthesis Mammographic Imaging Screening Trial (TMIST) has been designed to compare DBT with 2-Dimensional Full Field Digital Mammography (FFDM), but it's major design issues may provide misleading results. Instead of using a reduction in deaths as the endpoint, benefit in TMIST is predicated on a reduction in advanced cancers in the DBT group. This is a questionable “endpoint” (a reduction in advanced cancers is not necessary as proof of benefit). In addition, the trial may be underpowered so that even if DBT shows a benefit it may not be able to achieve “statistical significance”. The six CISNET models of the National Cancer Institute have shown that annual mammography beginning at the age of 40 will save the most lives. Yet TMIST will only include women ages 45 and over and will screen postmenopausal women every two years instead of annually. Consequently, TMIST results may be used, inappropriately, to limit access to breast cancer screening starting at the age of 45, and only offer biennial screening for post-menopausal women.

Abstract SS1-02: Racial disparities persist despite with uptake of digital breast tomosynthesis (DBT) for breast cancer screening

Abstract Background: Breast cancer screening with digital breast tomosynthesis (DBT) has been shown to improve recall rates and detection of invasive cancer compared to 2D full field digital mammography (FFDM). The Federal Drug Administration (FDA) approved the use of DBT in 2011, and the Centers for Medicare and Medicaid Services (CMS) approved coverage in 2015. We report a single institution’s longitudinal experience of the utilization and effectiveness of DBT for breast cancer screening over time with a focus on racial differences. Materials and Methods: The analytic population (n = 140,346) included females &amp;gt;18 years who underwent one or more breast cancer screening examinations performed at Johns Hopkins (a tertiary care institution) and affiliated sites between 4/1/2013 and 3/30/2020. Females were categorized as having only FFDM for screening (n = 43,323) or including DBT views (n = 97,023). Recall rate and cancer detection rate were compared between the two groups overall and stratified by race using the Chi-squared test and Fishers Exact test. Univariate and multivariate logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (CIs) of having a DBT screening mammogram compared to an FFDM mammogram adjusted for year, race, and an interaction term between year and race. Results: The mean age was 58.9 +/- 10.8 years for the FFDM group and 60.3 +/- 11.1 years for the DBT group. A larger percentage of White patients (62% FFDM vs 71.1% DBT) than Black patients (30.4% FFDM vs 22.6% DBT) or Asian patients (3.8% FFDM vs 3.0% DBT) were in the DBT group (p&amp;lt;0.001). During the study period, there was rapid increased in utilization of DBT. In year 1 (4/1/2013-3/30/2014), 2791/14841 (18.8%) of patients had a screening mammogram with DBT. By year 3, during which CMS approved coverage of DBT, this increased to 15069/21304 (70.7%). By year 6, 18759/20929 (90.0%) included DBT views. All women irrespective of race had similar increases in utilization rates\ of DBT during the study period (effect modifier term OR 0.99, 95% CI 0.98-1.00). However, Black women and Asian women were significantly less likely to have a screening study with DBT compared to White women (Black women: OR 0.51, 95% CI 0.48-0.70; Asian women: OR 0.59, 95% CI 0.57-0.80). Overall the DBT group had lower recall rate compared to the FFDM group (9.1% versus 11.2%, p&amp;lt;0.001). This was observed for White women (8.6% vs 10.7, p&amp;lt;0.001), Black women: 10.4% vs 11.9% p=0.001) but not Asian women (11.5% vs 11.6%, p=0.97). The DBT group also had higher cancer detection rate overall compared to the FFDM group (6.0 vs 4.1, p&amp;lt;0.001). This was observed for White women (7.3 vs 4.5, p&amp;lt;0.0001); Black women (7.1 vs 4.3, p=0.001), and Asian women (10.4 vs 2.6, p=0.01). Conclusions: We observed racial differences in the utilization of DBT for screening mammography, which could have significant clinical implications given the improved recall rate and cancer detection of DBT over the study period. Longer follow up is needed to understand the impact of these racial differences. Studies are also needed to understand and address existing obstacles such as socioeconomic level, insurance status, and education to reduce the disparity preventing all patients equitable access to DBT. Citation Format: Emily B Ambinder, Eniola Oluyemi, Kala Visvanathan. Racial disparities persist despite with uptake of digital breast tomosynthesis (DBT) for breast cancer screening [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr SS1-02.

Breast cancer screening using digital breast tomosynthesis compared to digital mammography alone for Japanese women.

The purpose of this study is to confirm the position of DBT in breast cancer screening in Japan, to assess cancer detection rates, recall rates, positive predictive value (PPV), and to evaluate the type of mammographic findings of cancer with the use of digital mammography alone (2DDM) and combined with digital breast tomosynthesis (DBT). 11,894 examinations of the opportunistic breast cancer screening using only 2DDM and 2DDM plus DBT were performed from May 1, 2017 to March 31, 2019. The 11,894 women [3535 women who received DBT in addition to 2DDM (3D group) and 8359 who received 2DDM only (2D group)] participated in this study. The study was approved by the Institute's Ethics Committee and all participants provided written informed consent. The recall rate was 2.6% for the 3D group and 3.6% for the 2D group (p < 0.01). The cancer detection rate was 0.17% in both 3D and 2D groups (p = 0.978). The positive predictive value (PPV) was 6.5% for the 3D group and 4.7% for the 2D group (p = 0.484). The cause of the decrease in recall rate was due to a decrease in the finding of focal asymmetric density (FAD). The recall rate was improved by using DBT for breast cancer screening in Japanese women. Cancer detection rates were exactly the same in DBT and 2DDM groups, so only DBT non-inferiority could be verified. We have verified that breast cancer screening combined with DBT is useful even for Japanese women to reduce unnecessary further examination.

Comparison of interval breast cancers with 2D digital mammography versus 3D digital breast tomosynthesis in a large community-based practice.

Incidence of interval cancers is an important outcome in assessing efficacy of screening. Our primary objective was to compare the incidence of interval cancers detected with two-dimensional digital mammography (DM) versus digital breast tomosynthesis (DBT) in a large community health system. Our secondary objectives were to compare the patient and tumor characteristics of interval cancers, cancer detection rate, and recall rate. Interval cancers before and after implementation of DBT (2012-2014 DM group; 2016-2018 DBT group) were reviewed. Patient factors (age, race, breast density, personal history of breast cancer, family history of breast cancer, known BRCA-1 or BRCA-2 genetic mutation, baseline mammogram, and presentation) and tumor characteristics (in situ versus invasive, grade, size, hormone receptor status, and nodal status) were compared with the chi-squared test or the MidP exact test. Rates (detection and recall) were compared using a z-score. The rates of interval cancers with DM (0.30 per 1000 [35/117099]) and DBT (0.33 per 1000 [40/119746]) were similar (P=.3). Proportion of node-positive interval cancers was lower in the DBT group (22.9% [8/35] vs 48% [15/31], p.01). Otherwise, the patient and tumor characteristics were similar. The cancer detection rate increased (5.9 per 1000 [709/119746] vs 3.5 per 1000 [411/117099], P=.0001), and the recall rate decreased with DBT (8.6% [10347/119746] versus 10.7% [12508/117099], (P<.0001). Although the cancer detection rate was higher with DBT, the rate of interval breast cancers was similar in both groups. Node-positive invasive interval cancers were decreased with DBT.

Breast Cancer Screening with Digital Breast Tomosynthesis: Are Initial Benefits Sustained?

Background Performance metrics with digital breast tomosynthesis (DBT) are based on early experiences. There is limited research on whether the benefits of DBT are sustained. Purpose To determine whether improved screening performance metrics with DBT are sustained over time at the population level and after the first screening round at the individual level. Materials and Methods A retrospective review was conducted of screening mammograms that had been obtained before DBT implementation (March 2008 to February 2011, two-dimensional digital mammography [DM] group) and for 5 years after implementation (January 2013 to December 2017, DBT1-DBT5 groups, respectively). Patients who underwent DBT were also categorized according to the number of previous DBT examinations they had undergone. Performance metrics were compared between DM and DBT groups and between patients with no previous DBT examinations and those with at least one prior DBT examination by using multivariable logistic regression models. Results The DM group consisted of 99 582 DM examinations in 55 086 women (mean age, 57.3 years ± 11.6 [standard deviation]). The DBT group consisted of 205 048 examinations in 76 276 women (mean age, 58.2 years ± 11.2). There were no differences in the cancer detection rate (CDR) between DM and DBT groups (4.6-5.8 per 1000 examinations, P = .08 to P = .95). The highest CDR was observed with a woman's first DBT examination (6.1 per 1000 examinations vs 4.4-5.7 per 1000 examinations with at least one prior DBT examination, P = .001 to P = .054). Compared with the DM group, the DBT1 group had a lower abnormal interpretation rate (AIR) (adjusted odds ratio [AOR], 0.85; P < .001), which remained reduced in the DBT2, DBT3, and DBT5 groups (P < .001 to P = .02). The reduction in AIR was also sustained after the first examination (P < .001 to P = .002). Compared with the DM group, the DBT1 group had a higher specificity (AOR, 1.20; P < .001), which remained increased in DBT2, DBT3, and DBT5 groups (P < .001 to P = .004). The increase in specificity was also sustained after the first examination (P < .001 to P = .01). Conclusion The benefits of reduced false-positive examinations and higher specificity with screening tomosynthesis were sustained after the first screening round at the individual level. © RSNA, 2020 See also the editorial by Taourel in this issue.

Surveillance Mammography After Breast Conservation Therapy

We investigated the downstream workup and costs associated with digital breast tomosynthesis (DBT) compared with 2-dimensional full field digital mammogram (FFDM) when employed as initial follow-up imaging in breast conservation therapy. Between the years 2015 and 2017, 450 consecutive breast conservation therapy patients, ages 32 to 89, with a follow-up DBT (n=162) or FFDM (n=288) were retrospectively reviewed. The primary endpoints were further workup after follow-up mammogram and associated health care costs at 1 year. A single DBT costs an estimated $149 compared with $111 for FFDM, based on Centers for Medicare claims data from the Oncology Care Model. The first posttreatment mammogram was received within 3 (20%), 3 to 6 (32%), or after 6 months (48%) following radiation. Younger patients and those undergoing hypofractionated radiation were more likely to get DBT. There were no differences in stage, receptor status, or mammogram timing between those in the FFDM and DBT groups.The following downstream workup ensued for DBT compared with FFDM imaging: 18% versus 29% short-interval (6-mo) mammogram (odds ratio=1.83, P=0.01), 6% versus 11% breast magnetic resonance imaging (odds ratio=1.90, P=0.08), 4% ultrasound for each, and 3% biopsy for each (1 positive in the FFDM group). Including downstream workup, the estimated cost per patient in the DBT group was $216.14 compared with $237.83 in the FFDM group. Independent predictors for reduced downstream workup per multivariable analysis were the use of DBT and first follow-up mammogram at least 6 months after radiation (P<0.05). Excess workup was reduced with DBT compared with FFDM in the posttreatment setting, which translated to an improvement in cost efficiency in this study.

Comparison of Call-Back Rates between Digital Mammography and Digital Breast Tomosynthesis

The effect of mammographic screening on the natural history and evolution of breast cancer treatment cannot be overstated; however, despite intensive and resource consuming screening, advanced breast cancer is still diagnosed frequently. The development of three-dimensional mammography or digital breast tomosynthesis (DBT) has already demonstrated greater sensitivity in the diagnosis of breast pathology and effectiveness in identifying early breast cancers. In addition to being a more sensitive screening tool, other studies indicate DBT has a lower call-back rate when compared with traditional DM. This study compares call-back rates between these two screening tools. A single institution, retrospective review was conducted of almost 20,000 patient records who underwent digital mammography or DBT in the years 2016 to 2018. These charts were analyzed for documentation of imaging type, Breast Imaging Reporting and Data System 0 status, call-back status, and type of further imaging that was required. Charts for 19,863 patients were reviewed, 17,899 digital mammography examinations were conducted compared with 11,331 DBT examinations resulting in 1,066 and 689 Breast Imaging Reporting and Data System 0 studies, respectively. Of the DM call-backs, 82.08 per cent were recommended for additional radiographic imaging and 17.82 per cent for ultrasound imaging. In the DBT group, only 39.77 per cent of call-backs were recommended for additional radiographic imaging and 60.09 per cent for ultrasound imaging. Our data suggest that DBT results in less call-back for additional mammographic images as compared with digital mammography. DBT may offer benefits over DM, including less imaging before biopsy, less time before biopsy, quicker diagnosis, and improved patient satisfaction.

Digital 2D versus Tomosynthesis Screening Mammography among Women Aged 65 and Older in the United States.

Background Although breast cancer incidence and mortality rates increase with advancing age, there are limited data on the benefits and risks of screening mammography in older women and on the performance of two-dimensional digital mammography (DM) and digital breast tomosynthesis (DBT) in older women. Purpose To compare performance metrics of DM and DBT among women aged 65 years and older. Materials and Methods For this retrospective study, consecutive screening mammograms in patients aged 65 years and older from March 2008 to February 2011 (DM group) and from January 2013 to December 2015 (DBT group) were reviewed. Cancer detection rate, abnormal interpretation rate, positive predictive values, sensitivity, and specificity were calculated. Multivariable logistic regression models were fit to compare performance metrics in the DM versus DBT groups. Results The DM group had 15 019 women (mean age ± standard deviation, 72.7 years ± 6.3), and the DBT group had 20 646 women (mean age, 72.1 years ± 5.9). After adjusting for multiple variables, there was no difference in cancer detection rate between the DM and DBT groups (6.9 vs 8.2 per 1000 examinations; adjusted odds ratio [AOR], 1.13; P = .23). Compared with the DM group, the DBT group had a lower abnormal interpretation rate (5.7% vs 5.8%; AOR, 0.88; P < .001), higher positive predictive value 1 (14.5% vs 11.9%; AOR, 1.26; P = .03), and higher specificity (95.1% vs 94.8%; AOR, 1.18; P < .001). The DBT group had a higher proportion of invasive cancers relative to in situ cancers (81.1% vs 74.4%; P = .06) and fewer node-positive cancers (10.2% vs 16.6%; P = .054) than did the DM group. Conclusion In women aged 65 years and older, integration of digital breast tomosynthesis led to improved performance metrics, with a lower abnormal interpretation rate, higher positive predictive value 1, and higher specificity. © RSNA, 2019 See also the editorial by Philpotts and Durand in this issue.

Performance of Screening Breast MRI After Negative Full-Field Digital Mammography Versus After Negative Digital Breast Tomosynthesis in Women at Higher Than Average Risk for Breast Cancer

The objective of our study was to compare the supplemental cancer yield and performance of breast MRI in women at higher-than-average risk for breast cancer after negative 2D full-field digital mammography (FFDM) or negative digital breast tomosynthesis (DBT). Retrospective review identified 4418 screening breast MRI examinations: 2291 were performed from January 2010 through January 2012 of patients with a negative FFDM examination in the 12 months before MRI (FFDM group), and 2127 were performed from January 2013 through January 2015 of patients with a negative DBT examination in the 12 months before MRI (DBT group). Screening indications included genetic predisposition, personal history of breast cancer or high-risk lesion, prior chest irradiation, family history, or other risk factors conferring a lifetime risk of greater than 20%. Supplemental cancer detection rate (CDR), abnormal interpretation rate (AIR), and positive predictive values (PPVs) were estimated with 95% exact CIs. Logistic regression analysis, adjusting for differences in patient demographics, was used to compare metrics. There was no significant difference in the CDR of MRI in the FFDM group versus the DBT group (11 vs 16 cancers per 1000 examinations, respectively; odds ratio, 1.4; 95% CI, 0.4-1.2; p = 0.23). The AIR, PPV1, PPV2, and PPV3 were 7.4%, 15%, 23%, and 28% for the FFDM group and 7.3%, 22%, 33%, and 35% for the DBT group, with no statistical differences. Of the cancers detected in both groups, the majority were invasive, less than 1 cm, and node-negative. In women at higher-than-average risk of breast cancer screened with DBT, the supplemental CDR of MRI is similar to that of MRI after FFDM screening, with most cancers being invasive, subcentimeter, and node-negative.

Pathologic Upgrade Rates of High-Risk Breast Lesions on Digital Two-Dimensional vs Tomosynthesis Mammography

Our aim was to compare the pathologic upgrade rates of high-risk breast lesions (HRLs) on digital two-dimensional mammography (DM) vs digital breast tomosynthesis (DBT). The study cohort was composed of patients with HRLs diagnosed by image-guided core needle biopsy from December 2007 to February 2011 (DM group, before DBT integration) and from January 2013 to March 2016 (DBT group, after complete DBT integration). Medical records were reviewed for surgical outcomes and follow-up imaging. Eight hundred and ninety-three patients with 900 biopsy-proven HRLs underwent surgical excision (97.0% [873 of 900]) or had at least 2 years of imaging follow-up (3.0% [27 of 900]). The most common HRL was atypical ductal hyperplasia in the DM and DBT groups (37.4% [337 of 900]). The overall upgrade rate of HRLs to malignancy was 11.3% (102 of 900). There were no statistically significant differences in overall upgrades rates of HRLs on DM vs DBT (11.4% [54 of 475] vs 11.3% [48 of 425]; p= 0.97) or in upgrade rates of HRL subtypes. However, HRLs that upgraded on DBT were more likely to be invasive rather than in situ carcinoma compared with HRLs that upgraded on DM (39.6% [19 of 48] vs 20.4% [11 of 54]; p= 0.03). Overall, the most common HRL to upgrade was atypical ductal hyperplasia (18.4% [62 of 337]). The least common HRLs to upgrade in the DBT group were biphasic neoplasms (0% [0 of 22]), flat epithelial atypia (1.6% [1 of 62]), and papillomas without atypia (4.5% [2of44]). There is no difference in the upgrade rates of HRLs on DM vs DBT, but the proportion of HRL upgrades that are invasive rather than in situ carcinoma is higher with DBT.

Synthesized Mammography: The New Standard of Care When Screening for Breast Cancer with Digital Breast Tomosynthesis?

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). 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. 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. 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.

Digital Breast Tomosynthesis: Cost-Effectiveness of Using Private and Medicare Insurance in Community-Based Health Care Facilities.

The purpose of this study was to determine whether digital breast tomosynthesis (DBT) is a cost-effective alternative to full-field digital mammography (FFDM) for both Medicare and privately insured patients undergoing screening mammography. A retrospective data analysis was performed between July 15, 2013, and July 14, 2014, with data on women presenting for screening mammography that included any additional radiologic workup (n = 6319). Patients chose to undergo DBT or FFDM on the basis of personal preference, physician suggestion, and cost difference. The summation of findings over the 1-year period were used to calculate recall rates, cancer detection rates, and billing costs for a regional private insurer and Medicare. Data from the 6319 patients who participated were divided: 3655 patients underwent DBT, and 2664 underwent FFDM during the year of screening. Private insurance billing cost $2.9 million, and Medicare cost $1.2 million for screening, follow-up imaging, and radiologic procedures. Per-person costs were approximately $40 higher for the DBT group using both forms of insurance. However, cost per cancer detected was lower in the DBT group for both private and governmental insurance, leading to potentially $3.7 million and $899,000 saved per 100 cancers found. After standardization of the difference in cancer detection rates between the two groups, DBT was a cost-equivalent alternative to FFDM for private insurance billing but was a cost-inefficient alternative with respect to Medicare costs. In a community-based setting, DBT is a cost-equivalent or potentially cost-effective alternative to FFDM and has the capacity for improving cancer detection and recall rates.

Impact of the Addition of Digital Breast Tomosynthesis (DBT) to Standard 2D Digital Screening Mammography on the Rates of Patient Recall, Cancer Detection, and Recommendations for Short-term Follow-up

The addition of digital breast tomosynthesis (DBT) to digital screening mammography (DM) has been shown to decrease recall rates and improve cancer detection rates, but there is a lack of data regarding the impact of DBT on rates of short-term follow-up. We assessed possible changes in performance measures with the introduction of DBT at our facility. In our observational study, databases were used to compare rates of recall, short-term follow-up, biopsy, and cancer detection between women undergoing DM without (n = 10,477) and women undergoing DM with (n = 2304) the addition of DBT. Regression analysis was performed to determine associations with patient age, breast density, and availability of comparison examinations. The addition of DBT resulted in significantly lower recall rates (16%-14%, P = .017), higher rates of biopsy (12.7%-19.1%, P < .01), and increased detection of ductal carcinoma in situ, with a difference of 2.3 cases per 1000 screens (P = .044). A 33% increase in cancer detection rates was observed with DBT, which did not reach statistical significance. Short-term follow-up of probably benign findings was 80% higher in the DBT group (odds ratio = 1.80, 95% confidence interval = 1.38-2.36, P < .001). To our knowledge, we are the first to study the impact of DBT on rates of short-term follow-up, and observed an 80% increase over the DM group. Further research is needed to determine the malignancy rate of Breast Imaging Reporting and Data System 3 lesions detected with DBT, and establish appropriate follow-up to maximize cancer detection while minimizing expense and patient anxiety.

Initial experience with combination digital breast tomosynthesis plus full field digital mammography or full field digital mammography alone in the screening environment.

Objectives:Initial review of patients undergoing screening mammography imaged with a combination of digital breast tomosynthesis (DBT) plus full field digital mammography (FFDM) compared with FFDM alone.Materials and Methods:From June 2011 to December 2011, all patients presenting for routine screening mammography were offered a combination DBT plus FFDM exam. Under institutional review board approval, we reviewed 524 patients who opted for combination DBT plus FFDM and selected a sample group of 524 FFDM screening exams from the same time period for a comparative analysis. The χ2 (Chi-square) test was used to compare recall rates, breast density, personal history of breast cancer, and family history of breast cancer between the two groups.Results:Recall rate for FFDM, 11.45%, was significantly higher (P < 0001) than in the combination DBT plus FFDM group (4.20%). The biopsy rate in the FFDM group was 2.29% (12/524), with a cancer detection rate of 0.38% (2/524, or 3.8 per 1000) and positive predictive value (PPV) of 16.7% (2/12). The biopsy rate for the DBT plus FFDM group was 1.14% (n = 6/524), with a cancer detection rate 0.57% (n = 3/524, or 5.7 per 1000) and PPV of 50.0% (n = 3/6). Personal history of breast cancer in the FFDM group was significantly lower (P < 0.0001) than in the combination DBT plus FFDM group; 2.5% and 5.7%, respectively. A significant difference in family history of breast cancer (P < 0.0001) was found, with a higher rate in the combination DBT plus FFDM group (36.0% vs. 53.8%). There was a significant difference between the combination DBT plus FFDM group and FFDM alone group, when comparing breast density (P < 0.0147, 61.64% vs. 54.20% dense breasts, respectively) with a higher rate of dense breasts in the DBT plus FFDM group. In follow-up, one cancer was detected within one year of normal screening mammogram in the combination DBT plus FFDM group.Conclusion:Our initial experience found the recall rate in the combination DBT plus FFDM group was significantly lower than in the FFDM alone group, despite the fact that the combination DBT plus FFDM group had additional risk factors.