| 1. Broeders M, Moss S, Nystrom L, et al. The impact of mammographic screening on breast cancer mortality in Europe: a review of observational studies. [Review]. J Med Screen. 19 Suppl 1:14-25, 2012. |
Review/Other-Dx |
20 studies |
To assess the impact of population-based mammographic screening on breast cancer mortality in Europe, considering different methodologies and limitations of the data. |
Twelve of the 17 trend studies quantified the impact of population-based screening on breast cancer mortality. The estimated breast cancer mortality reductions ranged from 1% to 9% per year in studies reporting an annual percentage change, and from 28% to 36% in those comparing post- and prescreening periods. In the IBM studies, the pooled mortality reduction was 25% (relative risk [RR] 0.75, 95% confidence interval [CI] 0.69-0.81) among invited women and 38% (RR 0.62, 95% CI 0.56-0.69) among those actually screened. The corresponding pooled estimates from the CC studies were 31% (odds ratio [OR] 0.69, 95% CI 0.57-0.83), and 48% (OR 0.52, 95% CI 0.42-0.65) adjusted for self-selection. |
4 |
| 2. Nickson C, Mason KE, English DR, Kavanagh AM. Mammographic screening and breast cancer mortality: a case-control study and meta-analysis. Cancer Epidemiol Biomarkers Prev. 21(9):1479-88, 2012 Sep. |
Meta-analysis |
9 studies |
To evaluate the effect of participation in the BreastScreen Australia program, we conducted a case–control study of deaths from breast cancer in Western Australia. To evaluate the potential effect of biases discussed in the literature on case–control studies of screening, we conducted several sensitivity analyses. We also conducted a meta-analysis of case–control studies evaluating mammographic screening. |
The OR for participation in the Western Australian BreastScreen program in relation to death from breast cancer was 0.48 [95% confidence interval (CI), 0.38-0.59; P < 0.001]. We were unable to identify biases that could negate this finding: sensitivity analyses generated ORs from 0.45 to 0.52. Our meta-analysis yielded an OR of 0.51 (95% CI, 0.46-0.55). |
Good |
| 3. Tabar L, Vitak B, Chen TH, et al. Swedish two-county trial: impact of mammographic screening on breast cancer mortality during 3 decades. Radiology 2011;260:658-63. |
Observational-Dx |
133,065 women |
To estimate the long-term (29-year) effect of mammographic screening on breast cancer mortality in terms of both relative and absolute effects. |
There was a highly significant reduction in breast cancer mortality in women invited to screening according to both local end point committee data (relative risk [RR] = 0.69; 95% confidence interval: 0.56, 0.84; P < .0001) and consensus data (RR = 0.73; 95% confidence interval: 0.59, 0.89; P = .002). At 29 years of follow-up, the number of women needed to undergo screening for 7 years to prevent one breast cancer death was 414 according to local data and 519 according to consensus data. Most prevented breast cancer deaths would have occurred (in the absence of screening) after the first 10 years of follow-up. |
1 |
| 4. D'Orsi CJ, Sickles EA, Mendelson EB, et al. ACR BI-RADS® Atlas, Breast Imaging Reporting and Data System. Reston, VA: American College of Radiology; 2013. |
Review/Other-Dx |
N/A |
To provide standardized breast imaging findings terminology, report organization, assessment structure and a classification system for mammography, ultrasound and MRI of the breast. |
No abstract available. |
4 |
| 5. Kolb TM, Lichy J, Newhouse JH. Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology. 225(1):165-75, 2002 Oct. |
Observational-Dx |
221 women |
To (a) determine the performance of screening mammography, ultrasonography (US), and physical examination (PE); (b) analyze the influence of age, hormonal status, and breast density; (c) compare the size and stage of tumors detected with each modality; and (d) determine which modality or combination of modalities optimize cancer detection. |
In 221 women, 246 cancers were found. Sensitivity, specificity, negative and positive predictive values, and accuracy of mammography were 77.6%, 98.8%, 99.8%, 35.8%, and 98.6%, respectively; those of PE, 27.6%, 99.4%, 99.4%, 28.9%, and 98.8%, respectively; and those of US, 75.3%, 96.8%, 99.7%, 20.5%, and 96.6%, respectively. Screening breast US increased the number of women diagnosed with nonpalpable invasive cancers by 42% (30 of 71). Mammographic sensitivity declined significantly with increasing breast density (P <.01) (48% for the densest breasts) and in younger women with dense breasts (P =.02); the effects were independent. Mammography and US together had significantly higher sensitivity (97%) than did mammography and PE together (74%) (P <.001). Tumors detected at mammography and/or US were significantly smaller (P =.01) and of lower stage (P =.01) than those detected at PE. |
4 |
| 6. Mandelson MT, Oestreicher N, Porter PL, et al. Breast density as a predictor of mammographic detection: comparison of interval- and screen-detected cancers. J Natl Cancer Inst. 92(13):1081-7, 2000 Jul 05. |
Observational-Dx |
537 women |
To investigate whether mammographic breast density is related to the risk of interval cancer. |
Mammographic sensitivity (i.e., the ability of mammography to detect a cancer) was 80% among women with predominantly fatty breasts but just 30% in women with extremely dense breasts. The odds ratio (OR) for interval cancer among women with extremely dense breasts was 6.14 (95% confidence interval [CI] = 1.95-19.4), compared with women with extremely fatty breasts, after adjustment for age at index mammogram, menopausal status, use of hormone replacement therapy, and body mass index. When only those interval cancer cases confirmed by retrospective review of index mammograms were considered, the OR increased to 9.47 (95% CI = 2.78-32.3). |
3 |
| 7. van der Waal D, Ripping TM, Verbeek AL, Broeders MJ. Breast cancer screening effect across breast density strata: A case-control study. International Journal of Cancer. 140(1):41-49, 2017 Jan 01. |
Observational-Dx |
1998 subjects |
To address screening performance and the effect of screening on breast cancer mortality in different breast density strata, while dealing with incomplete risk factor information in the control group. |
Screening performance was better in the fatty than in the dense group (sensitivity 75.7% vs 57.8%). The mortality reduction appeared to be smaller for women with dense breasts, with an odds ratio (OR) of 0.87 (95% CI 0.52-1.45) in the dense and 0.59 (95% CI 0.44-0.79) in the fatty group. |
3 |
| 8. Pisano ED, Gatsonis C, Hendrick E, et al. Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med. 353(17):1773-83, 2005 Oct 27. |
Experimental-Dx |
42,760 women |
To assess whether the use of digital mammography would avoid some limitations in which film mammography has limited sensitivity for the detection of breast cancer in women with radiographically dense breasts. |
In the entire population, the diagnostic accuracy of digital and film mammography was similar (difference between methods in the area under the ROC curve, 0.03; 95 percent confidence interval, -0.02 to 0.08; P=0.18). However, the accuracy of digital mammography was significantly higher than that of film mammography among women under the age of 50 years (difference in the area under the curve, 0.15; 95 percent confidence interval, 0.05 to 0.25; P=0.002), women with heterogeneously dense or extremely dense breasts on mammography (difference, 0.11; 95 percent confidence interval, 0.04 to 0.18; P=0.003), and premenopausal or perimenopausal women (difference, 0.15; 95 percent confidence interval, 0.05 to 0.24; P=0.002). |
2 |
| 9. Kerlikowske K, Hubbard RA, Miglioretti DL, et al. Comparative effectiveness of digital versus film-screen mammography in community practice in the United States: a cohort study. Ann Intern Med. 155(8):493-502, 2011 Oct 18. |
Observational-Dx |
329,261 women |
To determine whether the interpretive performance of digital and film-screen mammography differs. |
Overall, cancer detection rates and tumor characteristics were similar for digital and film-screen mammography, but the sensitivity and specificity of each modality varied by age, tumor characteristics, breast density, and menopausal status. Compared with film-screen mammography, the sensitivity of digital mammography was significantly higher for women aged 60 to 69 years (89.9% vs. 83.0%; P = 0.014) and those with estrogen receptor-negative cancer (78.5% vs. 65.8%; P = 0.016); borderline significantly higher for women aged 40 to 49 years (82.4% vs. 75.6%; P = 0.071), those with extremely dense breasts (83.6% vs. 68.1%; P = 0.051), and pre- or perimenopausal women (87.1% vs. 81.7%; P = 0.057); and borderline significantly lower for women aged 50 to 59 years (80.5% vs. 85.1%; P = 0.097). The specificity of digital and film-screen mammography was similar by decade of age, except for women aged 40 to 49 years (88.0% vs. 89.7%; P < 0.001). |
3 |
| 10. Bennett RL, Sellars SJ, Moss SM. Interval cancers in the NHS breast cancer screening programme in England, Wales and Northern Ireland. Br J Cancer. 104(4):571-7, 2011 Feb 15. |
Review/Other-Dx |
25657 cases |
To report the initial results from an on-going project to collate individual-based interval cancer data at a national level. |
In the periods >0-<12 months, 12-<24 months and 24-<36 months after a negative screen, we found overall interval cancer rates and regional ranges of 0.55 (0.43-0.76), 1.13 (0.92-1.47) and 1.22 (0.93-1.57) per 1000 women screened, respectively. Rates in the period 33-<36 months showed a decline, possibly associated with early re-screening or delayed presentation. |
4 |
| 11. Gilliland FD, Joste N, Stauber PM, et al. Biologic characteristics of interval and screen-detected breast cancers. J Natl Cancer Inst. 92(9):743-9, 2000 May 03. |
Review/Other-Dx |
127 patients |
To determine whether markers of tumor growth rate are associated with risk of an interval cancer, we conducted a population-based study with the use of data collected statewide by the New Mexico Mammography Project. |
It is more likely that mammography did not detect tumors with a high proportion of proliferating cells (>20%) than tumors with a low proportion of proliferating cells (<5%) (odds ratio [OR] = 4.09; 95% confidence interval [CI] = 1.14-14.65). The OR for mammographic failure was 2.96 (95% CI = 1.07-8.20) among cancers that expressed p53 compared with cancers that did not. Interval cancers also had fewer apoptotic cells. Approximately 75% of interval cancers appear to have tumors with 5% proliferating cells or more. Younger women had a higher proportion of rapidly proliferating and aggressive cancers. |
4 |
| 12. Houssami N, Hunter K. The epidemiology, radiology and biological characteristics of interval breast cancers in population mammography screening. NPJ Breast Cancer. 3:12, 2017. |
Review/Other-Dx |
N/A |
To describe the epidemiology, and the radiological and biological characteristics of interval breast cancers in population mammography screening. |
No results stated in abstract. |
4 |
| 13. Porter PL, El-Bastawissi AY, Mandelson MT, et al. Breast tumor characteristics as predictors of mammographic detection: comparison of interval- and screen-detected cancers. J Natl Cancer Inst 1999;91:2020-8. |
Observational-Dx |
576 women |
To identify tumor and patient characteristics associated with increased risk of interval-detected cancer among screened women with breast cancer or, equivalently, characteristics associated with reduced likelihood of screen detection (reduced sensitivity of mammography). |
Interval-detected cancers occurred more in younger women and were of larger tumor size than screen-detected cancers. In unconditional logistic regression models adjusted for age and tumor size, tumors with lobular (odds ratio [OR] = 1.9; 95% confidence interval [CI] = 0.9-4.2) or mucinous (OR = 5.5; 95% CI = 1.5-19.4) histology, high proliferation (by either mitotic count [OR = 2.9; 95% CI = 1.5-5.7] or Ki-67 antigen expression [OR = 2.3; 95% CI = 1.3-4.1]), high histologic grade (OR = 2.1; 95% CI = 1.2-4.0), high nuclear grade (OR = 2.0; 95% CI = 1.0-3.7), or negative estrogen receptor status (OR = 1.8; 95% CI = 1.0-3.1) were more likely to surface in the interval between screening examinations. Tumors with tubular histology (OR = 0.2; 95% CI = 0.0-0.8) or with a high percentage of in situ components (50%) (OR = 0.5; 95% CI = 0.2-1.2) were associated with an increased likelihood of screen detection. |
3 |
| 14. Mainiero MB, Moy L, Baron P, et al. ACR Appropriateness Criteria® Breast Cancer Screening. J Am Coll Radiol 2017;14:S383-S90. |
Review/Other-Dx |
N/A |
To provide evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for breast cancer screening. |
No results stated in abstract. |
4 |
| 15. Saslow D, Boetes C, Burke W, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007;57(2):75-89. |
Review/Other-Dx |
N/A |
To provide new evidence on breast MRI screening guidelines for the early detection of breast cancer in women. |
A guideline panel has reviewed this evidence and developed new recommendations for women at different defined levels of risk. Screening MRI is recommended for women with an approximately 20%–25% or greater lifetime risk of breast cancer, including women with a strong family history of breast or ovarian cancer and women who were treated for Hodgkin disease. There are several risk subgroups for which the available data are insufficient to recommend for or against screening, including women with a personal history of breast cancer, carcinoma in situ, atypical hyperplasia, and extremely dense breasts on mammography. |
4 |
| 16. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 311(24):2499-507, 2014 Jun 25. |
Observational-Dx |
454,850 examinations |
To determine if mammography combined with tomosynthesis is associated with better performance of breast screening programs in the United States. |
A total of 454,850 examinations (n=281,187 digital mammography; n=173,663 digital mammography + tomosynthesis) were evaluated. With digital mammography, 29,726 patients were recalled and 5056 biopsies resulted in cancer diagnosis in 1207 patients (n=815 invasive; n=392 in situ). With digital mammography + tomosynthesis, 15,541 patients were recalled and 3285 biopsies resulted in cancer diagnosis in 950 patients (n=707 invasive; n=243 in situ). Model-adjusted rates per 1000 screens were as follows: for recall rate, 107 (95% CI, 89-124) with digital mammography vs 91 (95% CI, 73-108) with digital mammography + tomosynthesis; difference, -16 (95% CI, -18 to -14; P < .001); for biopsies, 18.1 (95% CI, 15.4-20.8) with digital mammography vs 19.3 (95% CI, 16.6-22.1) with digital mammography + tomosynthesis; difference, 1.3 (95% CI, 0.4-2.1; P = .004); for cancer detection, 4.2 (95% CI, 3.8-4.7) with digital mammography vs 5.4 (95% CI, 4.9-6.0) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001); and for invasive cancer detection, 2.9 (95% CI, 2.5-3.2) with digital mammography vs 4.1 (95% CI, 3.7-4.5) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001). The in situ cancer detection rate was 1.4 (95% CI, 1.2-1.6) per 1000 screens with both methods. Adding tomosynthesis was associated with an increase in the positive predictive value for recall from 4.3% to 6.4% (difference, 2.1%; 95% CI, 1.7%-2.5%; P < .001) and for biopsy from 24.2% to 29.2% (difference, 5.0%; 95% CI, 3.0%-7.0%; P < .001). |
3 |
| 17. McDonald ES, Oustimov A, Weinstein SP, Synnestvedt MB, Schnall M, Conant EF. Effectiveness of Digital Breast Tomosynthesis Compared With Digital Mammography: Outcomes Analysis From 3 Years of Breast Cancer Screening. JAMA Oncology. 2(6):737-43, 2016 Jun 01. |
Observational-Dx |
23958 women |
To determine whether the improved outcomes observed after initial implementation of digital breast tomosynthesis (DBT) screening are sustainable over time at a population level and to evaluate the effect of more than 1 DBT screening at the individual level. |
Screening outcome metrics were evaluated for a total of 44,468 examinations attributable to 23,958 unique women (mean [SD] age, 56.8 [11.0] years) over a 4-year period: year 0 cohort (DM0), 10,728 women; year 1 cohort (DBT1), 11,007; year 2 cohort (DBT2), 11,157; and year 3 cohort (DBT3), 11,576. Recall rates rose slightly for years 1 to 3 of DBT (88, 90, and 92 per 1000 screened, respectively) but remained significantly reduced compared with the DM0 rate of 104 per 1000 screened. Reported as odds ratios (95% CIs), the findings were DM vs DBT1, 0.83 (0.76-0.91, P<.001); DM vs DBT2, 0.85 (0.78-0.93, P<.001); and DM vs DBT3, 0.87 (0.80-0.95, P=.003). The cancer cases per recalled patients continued to rise from DM0 rate of 4.4% to 6.2% (P=.06), 6.5% (P=.03), and 6.7% (P=.02) for years 1 to 3 of DBT, respectively. Outcomes assessed for the most recent screening for individual women undergoing only 1, 2, or 3 DBT screenings during the study period demonstrated decreasing recall rates of 130, 78, and 59 per 1000 screened, respectively (P<.001). Interval cancer rates, determined using available follow-up data, decreased from 0.7 per 1000 women screened with the use of DM to 0.5 per 1000 screened with the use of DBT1. |
4 |
| 18. Sharpe RE Jr, Venkataraman S, Phillips J, et al. Increased Cancer Detection Rate and Variations in the Recall Rate Resulting from Implementation of 3D Digital Breast Tomosynthesis into a Population-based Screening Program. Radiology. 278(3):698-706, 2016 Mar. |
Observational-Dx |
85,852 women |
To compare the recall and cancer detection rates (CDRs) at screening with digital breast tomosynthesis (DBT) with those at screening with two-dimensional (2D) mammography and to evaluate variations in the recall rate (RR) according to patient age, risk factors, and breast density and among individual radiologists at a single U.S. academic medical center. |
The study included 5703 (6.6%) DBT examinations and 80 149 (93.4%) 2D mammography examinations. The DBT subgroup contained a higher proportion of patients with risk factors for breast cancer and baseline examinations. DBT was used to detect 54.3% more carcinomas (+1.9 per 1000, P < .0018) than 2D mammography. The RR was 7.51% for 2D mammography and 6.10% for DBT (absolute change, 1.41%; relative change, -18.8%; P < .0001). The DBT subgroup demonstrated a significantly lower RR for patients with extremely or heterogeneously dense breasts and for patients in their 5th and 7th decades. |
3 |
| 19. Skaane P, Sebuodegard S, Bandos AI, et al. Performance of breast cancer screening using digital breast tomosynthesis: results from the prospective population-based Oslo Tomosynthesis Screening Trial. Breast Cancer Research & Treatment. 169(3):489-496, 2018 Jun. |
Observational-Dx |
24,301 women |
To investigate the effects of addition of DBT on interval and detected cancers in population-based screening. |
24,301 consenting women underwent FFDM + DBT screening over a 2-year period. Results were compared with 59,877 FFDM examinations during prior rounds. Addition of DBT resulted in a non-significant increase in sensitivity (76.2%, 378/496, vs. 80.8%, 227/281, p = 0.151) and a significant increase in specificity (96.4%, 57229/59381 vs. 97.5%, 23427/24020, p < .001). Number of recalls per screen-detected cancer decreased from 6.7 (2530/378) to 3.6 (820/227) with DBT (p < .001). Cancer detection per 1000 women screened increased (6.3, 378/59877, vs. 9.3, 227/24301, p < .001). Interval cancer rate per 1000 screens for FFDM + DBT remained similar to previous FFDM rounds (2.1, 51/24301 vs. 2.0, 118/59877, p = 0.734). Interval cancers post-DBT were comparable to prior rounds but significantly different in size, grade, and node status from cancers detected only using DBT. 39.6% (19/48) of interval cancers had positive nodes compared with only 3.9% (2/51) of additional DBT-only-detected cancers. |
2 |
| 20. Yun SJ, Ryu CW, Rhee SJ, Ryu JK, Oh JY. Benefit of adding digital breast tomosynthesis to digital mammography for breast cancer screening focused on cancer characteristics: a meta-analysis. [Review]. Breast Cancer Research & Treatment. 164(3):557-569, 2017 Aug. |
Meta-analysis |
11 studies |
To evaluate the benefit of adding digital breast tomosynthesis (DBT) to full-field digital mammography (FFDM) compared to FFDM alone for breast cancer detection, focusing on cancer characteristics. |
Eleven eligible studies were included. Pooled RRs showed a greater cancer detection for DBT plus FFDM than for FFDM alone for invasive cancer (1.327; 95% CI, 1.168-1.508), stage T1 (1.388; 95% CI, 1.137-1.695), nodal-negative (1.451; 95% CI, 1.209-1.742), all histologic grades (grade I, 1.812; grade II/III, 1.403), and histologic types of invasive cancer (ductal, 1.437; lobular, 1.901). However, adding DBT did not increase for detection of carcinoma in situ (1.198; 95% CI, 0.942-1.524), stage =T2 (1.391; 95% CI, 0.895-2.163), or nodal-positive cancer (1.336; 95% CI, 0.921-1.938). Heterogeneity among studies was not significant in any subset analysis. |
Good |
| 21. Gilbert FJ, Tucker L, Gillan MG, et al. The TOMMY trial: a comparison of TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme--a multicentre retrospective reading study comparing the diagnostic performance of digital breast tomosynthesis and digital mammography with digital mammography alone. Health Technology Assessment (Winchester, England). 19(4):i-xxv, 1-136, 2015 Jan. |
Observational-Dx |
7060 women |
To compare the diagnostic accuracy of digital breast tomosynthesis (DBT) in conjunction with two-dimensional (2D) mammography or synthetic 2D mammography, against standard 2D mammography and to determine if DBT improves the accuracy of detection of different types of lesions. |
Data were available for 7060 subjects comprising 6020 (1158 cancers) assessment cases and 1040 (two cancers) family history screening cases. Overall sensitivity was 87% [95% confidence interval (CI) 85% to 89%] for 2D only, 89% (95% CI 87% to 91%) for 2D?+?DBT and 88% (95% CI 86% to 90%) for synthetic 2D?+?DBT. The difference in sensitivity between 2D and 2D?+?DBT was of borderline significance (p?=?0.07) and for synthetic 2D?+?DBT there was no significant difference (p?=?0.6). Specificity was 58% (95% CI 56% to 60%) for 2D, 69% (95% CI 67% to 71%) for 2D?+?DBT and 71% (95% CI 69% to 73%) for synthetic 2D?+?DBT. Specificity was significantly higher in both DBT reading arms for all subgroups of age, density and dominant radiological feature (p?<?0.001 all cases). In all reading arms, specificity tended to be lower for microcalcifications and higher for distortion/asymmetry. Comparing 2D?+?DBT to 2D alone, sensitivity was significantly higher: 93% versus 86% (p?<?0.001) for invasive tumours of size 11-20?mm. Similarly, for breast density 50% or more, sensitivities were 93% versus 86% (p?=?0.03); for grade 2 invasive tumours, sensitivities were 91% versus 87% (p?=?0.01); where the dominant radiological feature was a mass, sensitivities were 92% and 89% (p?=?0.04) For synthetic 2D?+?DBT, there was significantly (p?=?0.006) higher sensitivity than 2D alone in invasive cancers of size 11-20?mm, with a sensitivity of 91%. |
2 |
| 22. Gilbert FJ, Tucker L, Gillan MG, et al. Accuracy of Digital Breast Tomosynthesis for Depicting Breast Cancer Subgroups in a UK Retrospective Reading Study (TOMMY Trial). Radiology. 277(3):697-706, 2015 Dec. |
Observational-Dx |
8869 women |
To compare the diagnostic performance of two-dimensional (2D) mammography, 2D mammography plus digital breast tomosynthesis (DBT), and synthetic 2D mammography plus Digital Breast Tomosynthesis (DBT) in depicting malignant radiographic features. |
Overall sensitivity was 87% for 2D mammography, 89% for 2D mammography plus DBT, and 88% for synthetic 2D mammography plus DBT. The addition of DBT was associated with a 34% increase in the odds of depicting cancer (odds ratio [OR] = 1.34, P = .06); however, this level did not achieve significance. For patients aged 50-59 years old, sensitivity was significantly higher (P = .01) for 2D mammography plus DBT than it was for 2D mammography. For those with breast density of 50% or more, sensitivity was 86% for 2D mammography compared with 93% for 2D mammography plus DBT (P = .03). Specificity was 57% for 2D mammography, 70% for 2D mammography plus DBT, and 72% for synthetic 2D mammography plusmDBT. Specificity was significantly higher than 2D mammography (P < .001in both cases) and was observed for all subgroups (P < .001 for all cases). |
2 |
| 23. Powell JL, Hawley JR, Lipari AM, Yildiz VO, Erdal BS, Carkaci S. 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. Acad Radiol. 24(3):302-307, 2017 03. |
Observational-Dx |
12,781 patients |
To compare recall, short-term follow-up, and biopsy rates, as well as positive predictive values (PPVs) for women screened with two-dimensional (2D) mammogram with or without the addition of Digital Breast Tomosynthesis (DBT). We also sought to determine which patients, if any, will experience the greatest benefit from DBT. |
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). |
3 |
| 24. Haberle L, Fasching PA, Brehm B, et al. Mammographic density is the main correlate of tumors detected on ultrasound but not on mammography. International Journal of Cancer. 139(9):1967-74, 2016 11 01. |
Observational-Dx |
1,399 women |
To estimate the risk of a breast cancer patient diagnosed in a hospital-based mammography unit having a tumor that is visible on ultrasound but not on mammography. |
Tumors were only visible on ultrasound in 107 cases (7.6%). Percentage mammographic density (PMD) was the strongest predictor for mammography failure, but age, body mass index and previous breast surgery also influenced the risk, independently of the PMD. Risk probabilities ranged from 1% for a defined low-risk group up to 40% for a high-risk group. |
4 |
| 25. Chang JM, Koo HR, Moon WK. Radiologist-performed hand-held ultrasound screening at average risk of breast cancer: results from a single health screening center. Acta Radiologica. 56(6):652-8, 2015 Jun. |
Observational-Dx |
1526 women |
To determine the performance of screening breast US in women at an average risk for breast cancer undergoing breast screening by experienced radiologists. |
The average time to perform a screening US examination was 15-20 min. Of 1526 women, 1095 (71.8%) were classified as BI-RADS category 1 or 2; 340 (22.3%) were classified as category 3; and 91 (6.0%) were classified as category 4. Five malignant lesions were found in women with dense breasts. The overall cancer detection rate was 3.3, and the cancer detection rate for dense breasts was 5.1 per 1000 screens (4.1 per 1000 screens [heterogeneously dense breast], 7.7 per 1000 screens [extremely dense breast]). The PPV2 for biopsies was 5.3%. |
3 |
| 26. Sorin V, Yagil Y, Yosepovich A, et al. Contrast-Enhanced Spectral Mammography in Women With Intermediate Breast Cancer Risk and Dense Breasts. AJR. American Journal of Roentgenology. 211(5):W267-W274, 2018 11. |
Observational-Dx |
611 women |
To compare the diagnostic performance of contrast-enhanced spectral mammography (CESM) and ultrasound with that of standard digital mammography for breast cancer screening of women at intermediate risk who have dense breasts. |
Among the 611 women included, 48.3% (295/611) had family or personal history of breast cancer, the BI-RADS breast density score was C or D in 93.1% (569/611). The mean follow-up period was 20 months. Mammography depicted 11 of 21 malignancies, sensitivity of 52.4%, specificity of 90.5% (534/590), positive predictive value of 16.4% (11/67), and negative predictive value of 98.2% (534/544). CESM depicted 19 of 21 malignancies, sensitivity of 90.5%, specificity of 76.1% (449/590), positive predictive value of 11.9% (19/160), and negative predictive value of 99.6% (449/451). Differences in sensitivity (p = 0.008) and specificity (p < 0.001) were statistically significant. Adjunct ultrasound revealed 73 additional suspicious findings; all were false-positive. In 39 women MRI was needed to assess screening abnormalities; two MRI-guided biopsies were performed and yielded one cancer. The incremental cancer detection rate of CESM was 13.1/1000 women (95% CI, 6.1-20.1). Of eight cancers seen only with CESM, seven were invasive (mean size, 9 mm; two of four cancers lymph-node positive). |
2 |
| 27. Sung JS, Lebron L, Keating D, et al. Performance of Dual-Energy Contrast-enhanced Digital Mammography for Screening Women at Increased Risk of Breast Cancer. Radiology. 293(1):81-88, 2019 10. |
Observational-Dx |
904 women |
To evaluate the performance of contrast agent–enhanced digital mammography (CEDM) for breast cancer screening. |
In the study period 904 baseline CEDMs were performed. Mean age was 51.8 years ± 9.4 (standard deviation). Of 904 patients, 700 (77.4%) had dense breasts, 247 (27.3%) had a family history of breast cancer in a first-degree relative age 50 years or younger, and 363 (40.2%) a personal history of breast cancer. The final Breast Imaging Reporting and Data System score was 1 or 2 in 832 of 904 (92.0%) patients, score of 3 in 25 of 904 (2.8%) patients, and score of 4 or 5 in 47 of 904 (5.2%) patients. By using CEDM, 15 cancers were diagnosed in 14 of 904 women (cancer detection rate, 15.5 of 1000). PPV3 was 29.4% (15 of 51). At least 1-year follow up was available in 858 women. There were two interval cancers. Sensitivity was 50.0% (eight of 16; 95% confidence interval [CI]: 24.7%, 75.3%) on the low-energy images compared with 87.5% (14 of 16; 95% CI: 61.7%, 98.4%) for the entire study (low-energy and iodine images; P = .03). Specificity was 93.7% (789 of 842; 95% CI: 91.8%, 95.2%); PPV1 was 20.9% (14 of 67; 95% CI: 11.9%, 32.6%), and negative predictive value was 99.7% (789 of 791; 95% CI: 99.09%, 99.97%). |
2 |
| 28. Cheung YC, Lin YC, Wan YL, et al. Diagnostic performance of dual-energy contrast-enhanced subtracted mammography in dense breasts compared to mammography alone: interobserver blind-reading analysis. Eur Radiol. 24(10):2394-403, 2014 Oct. |
Observational-Dx |
89 females |
To analyse the accuracy of dual-energy contrast-enhanced spectral mammography in dense breasts in comparison with contrast-enhanced subtracted mammography (CESM) and conventional mammography (Mx). |
One hundred lesions (28 benign and 72 breast malignancies) in 89 females were analysed. Use of CESM improved the cancer diagnosis by 21.2 % in sensitivity (71.5 % to 92.7 %), by 16.1 % in specificity (51.8 % to 67.9 %) and by 19.8 % in accuracy (65.9 % to 85.8 %) compared with Mx. The interobserver diagnostic consistency was markedly higher using CESM than using Mx alone (0.6235 vs. 0.3869 using the kappa ratio). The probability of a correct prediction was elevated from 80 % to 90 % after 75 consecutive case readings. |
3 |
| 29. Fallenberg EM, Dromain C, Diekmann F, et al. Contrast-enhanced spectral mammography: Does mammography provide additional clinical benefits or can some radiation exposure be avoided?. Breast Cancer Res Treat. 146(2):371-81, 2014 Jul. |
Observational-Dx |
118 patients |
To compare contrast-enhanced spectral mammography (CESM) with mammography (MG) and combined CESM + MG in terms of detection and size estimation of histologically proven breast cancers in order to assess the potential to reduce radiation exposure. |
A total of 107 imaging pairs were available for analysis. Densities were ACR1: 2, ACR2: 45, ACR3: 42, and ACR4: 18. Mean AGD was 1.89 mGy for CESM alone, 1.78 mGy for MG, and 3.67 mGy for the combination. In very dense breasts, AGD of CESM was significantly lower than MG. Sensitivity across readers was 77.9 % for MG alone, 94.7 % for CESM, and 95 % for CESM + MG. Average tumor size measurement error compared to postsurgical pathology was -0.6 mm for MG, +0.6 mm for CESM, and +4.5 mm for CESM + MG (p < 0.001 for CESM + MG vs. both modalities). CESM alone has the same sensitivity and better size assessment as CESM + MG and was significantly better than MG with only 6.2 % increase in AGD. The combination of CESM + MG led to systematic size overestimation. |
3 |
| 30. Lalji UC, Houben IP, Prevos R, et al. Contrast-enhanced spectral mammography in recalls from the Dutch breast cancer screening program: validation of results in a large multireader, multicase study. European Radiology. 26(12):4371-4379, 2016 Dec. |
Observational-Dx |
199 cases |
To study the validity of preliminary results of contrast-enhanced spectral mammography (CESM) using a larger panel of radiologists with different levels of CESM experience. |
CESM increased diagnostic accuracy in all readers. The performance for all readers using CESM was: sensitivity 96.9 % (+3.9 %), specificity 69.7 % (+33.8 %) and area under the ROC curve 0.833 (+0.188). |
3 |
| 31. Lobbes MB, Lalji U, Houwers J, et al. Contrast-enhanced spectral mammography in patients referred from the breast cancer screening programme. European Radiology. 24(7):1668-76, 2014 Jul. |
Observational-Dx |
113 women |
To evaluate the diagnostic performance of contrast-enhanced spectral mammography (CESM) as compared to conventional mammography in a true clinical population with the lowest disease prevalence reported thus far. |
Of the 116 eligible women, 113 underwent CESM. CESM increased sensitivity to 100.0% (+3.1%), specificity to 87.7% (+45.7%), PPV to 76.2% (+36.5%) and NPV to 100.0% (+2.9%) as compared to mammography. Differences between conventional mammography and CESM were statistically significant (p<0.0001). A similar trend was observed in the ROC curve. For conventional mammography, AUC was 0.779. With CESM, AUC increased to 0.976 (p<0.0001). In addition, good agreement between tumour diameters measured using CESM, breast MRI and histopathology was observed. |
2 |
| 32. Strahle DA, Pathak DR, Sierra A, Saha S, Strahle C, Devisetty K. Systematic development of an abbreviated protocol for screening breast magnetic resonance imaging. Breast Cancer Res Treat. 162(2):283-295, 2017 04. |
Observational-Dx |
671 women |
To develop an abbreviated protocol (AP) for breast MRI that maximizes lesion detection by assessing each lesion not seen on mammography by each acquisition from a full diagnostic protocol (FDP). |
FDP breast MRI detected 452 findings not visible on mammography, including 17 suspicious lesions recommended for biopsy of which seven (PPV 41.2%) were malignant in six women. Mean size of the four invasive malignancies was 1.9 cm (range 0.7-4.1), all node negative; three lesions in two women were ductal carcinoma in situ. Nine biopsied lesions were benign, mean size 1.2 cm (range 0.6-2.0). All biopsied lesions were in women with dense breasts (heterogeneously or extremely dense on mammography, n = 367), for a cancer detection rate of 16.3/1000 examinations in this subpopulation. These data were used to identify four high-yield acquisitions: T2, T1-pre-contrast, T11.5, and T16 to create the AP with a scan time of 7.5 min compared to 24 min for the FDP. |
3 |
| 33. Kuhl CK, Strobel K, Bieling H, Leutner C, Schild HH, Schrading S. Supplemental Breast MR Imaging Screening of Women with Average Risk of Breast Cancer. Radiology. 283(2):361-370, 2017 May. |
Observational-Dx |
2120 women |
To investigate the utility and accuracy of breast magnetic resonance (MR) imaging as a supplemental screening tool in women at average risk for breast cancer and to investigate the types of cancer detected with MR imaging screening. |
A total of 2120 women were recruited and underwent 3861 screening MR imaging studies, covering an observation period of 7007 women-years. Breast MR imaging depicted 60 additional breast cancers (ductal carcinoma in situ, n = 20; invasive carcinoma, n = 40) for an overall supplemental cancer detection rate of 15.5 per 1000 cases (95% confidence interval [CI]: 11.9, 20.0). Forty-eight additional cancers were detected with MR imaging at initial screening (supplemental cancer detection rate, 22.6 per 1000 cases). During the 1741 subsequent screening rounds, 12 of 13 incident cancers were found with MR imaging alone (supplemental cancer detection rate, 6.9 per 1000 cases). One cancer was diagnosed with all three methods (mammography, US, and MR imaging), and none were diagnosed with mammography only or US only. Cancers diagnosed with MR imaging were small (median, 8 mm), node negative in 93.4% of cases, and dedifferentiated (high-grade cancer) in 41.7% of cases at prevalence screening and 46.0% of cases at incidence screening. No interval cancers were observed. MR imaging screening offered high specificity (97.1%; 95% CI: 96.5, 97.6) and high PPV (35.7%; 95% CI: 28.9, 43.1). |
1 |
| 34. Song SE, Cho N, Chang JM, Chu AJ, Yi A, Moon WK. Diagnostic performances of supplemental breast ultrasound screening in women with personal history of breast cancer. Acta Radiol. 59(5):533-539, 2018 May. |
Observational-Dx |
12,230 women |
To evaluate diagnostic performances of supplemental breast US screening for women with personal history of breast cancer (PHBC) and to compare with those for women without PHBC. |
Overall cancer detection rate and first-year interval cancer rate were 1.80/1000 exams and 0.91/1000 negative exams, both of which were higher in women with PHBC than in women without PHBC (2.88 vs. 0.53 per 1000, P = 0.003; 1.50 vs. 0.20 per 1000, P = 0.027). Abnormal interpretation rate was lower in the women with PHBC than in women without PHBC (9.1% vs. 12.1%, P < 0.001). Sensitivity was not different (67.9% vs. 75.0%, P = 1.000), whereas specificity and PPV3 were higher in women with PHBC than in women without PHBC (91.2% vs. 88.0%, P < 0.001; 22.6% vs. 3.1%, P < 0.001). The majority of detected cancers in women with PHBC (78.9%, 15/19) were stage 0 or 1. |
4 |
| 35. Cortesi L, Canossi B, Battista R, et al. Breast ultrasonography (BU) in the screening protocol for women at hereditary-familial risk of breast cancer: has the time come to rethink the role of BU according to different risk categories?. International Journal of Cancer. 144(5):1001-1009, 2019 03 01. |
Observational-Dx |
2,313 women |
To evaluate the breast cancer (BC) screening efficacy of biannual ultrasound (US) in three different risk categories. |
Among 2,313 asymptomatic women at different risk (136 mutation carriers, 1,749 at HR and 428 at IR) 211 developed a BC, of which 193 (91.5%) were screen detected BC (SDBC) and 18 (8.5%) were interval BC (IBC). The SDBC detection rate (DR) was 11.2 per 1.000 person-years (37.9, 8.5 and 16.1 for BRCA, HR and IR, respectively); 116 BC were detected by MMG (DR = 6.6 × 1,000 persons-years), 62 by US (DR = 3.6 × 1,000 persons-years) and 15 by MRI, that was applied only in 60 BRCA women (DR = 37 × 1,000 persons-years). At the six-monthly US, 52 BC were detected (DR = 3.0 × 1,000 persons/years), of which 8 were BRCA-related. The most sensitive technique was MRI (93.7%) followed by MMG (55%) and US (29.4%). Combined sensitivity for MMG plus US was 100% in HR and 80.4% for IR women (p < 0.01). |
3 |
| 36. Heacock L, Melsaether AN, Heller SL, et al. Evaluation of a known breast cancer using an abbreviated breast MRI protocol: Correlation of imaging characteristics and pathology with lesion detection and conspicuity. Eur J Radiol. 85(4):815-23, 2016 Apr. |
Observational-Dx |
107 women |
To evaluate use of an abbreviated magnetic resonance imaging protocol with T2-weighted imaging in detecting biopsy-proven unifocal breast cancer. |
All 107 cancers were identified at first protocol by at least one reader; five cancers were missed by either one or two readers. One cancer was missed by one reader at protocols two and three. Mean percentage detection for protocol one was 97.8%; protocol two, 99.4%, protocol three, 99.4%. T2-weighted images did not alter cancer detection but increased lesion conspicuity for 2/3 readers. 3/5 missed lesions were low grade cancers. Initial enhancement ratio was positively associated with increasing tumor grade (p=0.031) and pathology (p=0.002). Reader interpretation time decreased and lesion conspicuity increased as initial enhancement ratio increased. |
2 |
| 37. Mango VL, Morris EA, David Dershaw D, et al. Abbreviated protocol for breast MRI: are multiple sequences needed for cancer detection?. European Journal of Radiology. 84(1):65-70, 2015 Jan. |
Observational-Dx |
100 breast MRI examinations |
To evaluate the ability of an abbreviated breast magnetic resonance imaging (MRI) protocol, consisting of a precontrast T1 weighted (T1W) image and single early post-contrast T1W image, to detect breast carcinoma. |
All 100 cancers were visualized on initial reading of the abbreviated protocol by at least one reader. The mean sensitivity for each sequence was 96% for the first post-contrast sequence, 96% for the first post-contrast subtraction sequence and 93% for the subtraction MIP sequence. Within each sequence, there was no significant difference between the sensitivities among the 4 readers (p=0.471, p=0.656, p=0.139). Mean interpretation time was 44s (range 11-167s). The abbreviated imaging protocol could be performed in approximately 10-15 min, compared to 30-40 min for the standard protocol. |
2 |
| 38. Choi BH, Choi N, Kim MY, Yang JH, Yoo YB, Jung HK. Usefulness of abbreviated breast MRI screening for women with a history of breast cancer surgery. Breast Cancer Research & Treatment. 167(2):495-502, 2018 01. |
Observational-Dx |
725 women |
To investigate the usefulness of abbreviated breast MRI (AB-MRI), including fat-suppressed T2-weighted imaging, pre- and postcontrast image acquisition, and subtracted maximum-intensity projection imaging, for the screening of women with a history of breast cancer surgery. |
AB-MRI detected 12 malignancies in 12 women (15.0 cancers per 1000 cases). Seven of these 12 malignancies were initially invisible on ultrasound and mammography, although subsequent targeted ultrasound revealed lesions corresponding to the MRI-detected lesions. The positive predictive values for recall and biopsy and sensitivity and specificity values for screening MRI were 12.4, 61.5, 100, and 89.2%, respectively. The rates of malignancies belonging to categories 1, 2, 3, and 4 of the BI-RADS were 0, 0, 4.8, and 57.1%, respectively. |
4 |
| 39. Kuhl CK, Schrading S, Strobel K, Schild HH, Hilgers RD, Bieling HB. Abbreviated breast magnetic resonance imaging (MRI): first postcontrast subtracted images and maximum-intensity projection-a novel approach to breast cancer screening with MRI. Journal of Clinical Oncology. 32(22):2304-10, 2014 Aug 01. |
Observational-Dx |
443 women |
To investigate whether an abbreviated protocol (AP), consisting of only one pre- and one postcontrast acquisition and their derived images (first postcontrast subtracted [FAST] and maximum-intensity projection [MIP] images), was suitable for breast magnetic resonance imaging (MRI) screening. |
MRI acquisition time for FDP was 17 minutes, versus 3 minutes for the AP. Average time to read the single MIP and complete AP was 2.8 and 28 seconds, respectively. Eleven breast cancers (four ductal carcinomas in situ and seven invasive cancers; all T1N0 intermediate or high grade) were diagnosed, for an additional cancer yield of 18.2 per 1,000. MIP readings were positive in 10 (90.9%) of 11 cancers and allowed establishment of the absence of breast cancer, with a negative predictive value (NPV) of 99.8% (418 of 419). Interpretation of the complete AP, as with the FDP, allowed diagnosis of all cancers (11 [100%] of 11). Specificity and positive predictive value (PPV) of AP versus FDP were equivalent (94.3% v 93.9% and 24.4% v 23.4%, respectively). |
2 |
| 40. Brennan S, Liberman L, Dershaw DD, Morris E. Breast MRI screening of women with a personal history of breast cancer. AJR Am J Roentgenol. 2010;195(2):510-516. |
Observational-Dx |
144 women |
To determine the cancer detection and biopsy rate among women who have breast MRI screening solely on the basis of a personal history of breast cancer. |
Of 144 women, 44 (31% [95% CI, 15%–29%]) underwent biopsies prompted by MRI examination. Biopsies revealed malignancies in 17 women (12% [95% CI, 7%–18%]) and benign findings only in 27 women (19% [95% CI, 13%–26%]). Of the 17 women in whom cancer was detected, 7 also had benign biopsy results. In total, 18 malignancies were found. One woman had 2 metachronous cancers. MRI screening resulted in a total of 61 biopsies, with a positive predictive value of 39% (95% CI, 27%–53%). The malignancies found included 17 carcinomas and 1 myxoid liposarcoma. Of the 17 cancers, 12 (71%) were invasive, 5 (29%) were DCIS, and 10 (59%) were minimal breast cancers. Of 17 cancers, 10 were detected by MRI only. The 10 cancers detected by MRI only, vs 7 cancers later found by other means, were more likely to be DCIS (4/10 [40%] vs 1/7 [14%]; P=0.25) or minimal breast cancers (7/10 [70%] vs 3/7 [43%]; P=0.26). |
3 |
| 41. Lehman CD, Lee JM, DeMartini WB, et al. Screening MRI in Women With a Personal History of Breast Cancer. Journal of the National Cancer Institute. 108(3), 2016 Mar. |
Observational-Dx |
1521 women |
To compare screening MRI performance in women with personal history versus genetic risk or family history of breast cancer. |
Of 1521 women who underwent screening MRI from July 2004 to November 2011, 915 had PH and 606 had GFH of breast cancer. Overall, MRI sensitivity was 79.4% for all cancers and 88.5% for invasive cancers. False-positive exams were lower in the PH vs GFH groups (12.3% vs 21.6%, P < .001), specificity was higher (94.0% vs 86.0%, P < .001), and sensitivity and cancer detection rate were not statistically different (P > .99). Age (P < .001), prior MRI (P < .001), and clinical indication (P < .001) were individually associated with initial false-positive rate; age and prior MRI remained statistically significant in multivariable modeling (P = .001 and P < .001, respectively). |
3 |
| 42. Sung JS, Malak SF, Bajaj P, Alis R, Dershaw DD, Morris EA. Screening breast MR imaging in women with a history of lobular carcinoma in situ. Radiology. 261(2):414-20, 2011 Nov. |
Observational-Dx |
220 women |
To assess the utility of screening MR imaging in the detection of otherwise occult breast cancers in women with a history of lobular carcinoma in situ (LCIS). |
Biopsy was recommended in 63 lesions seen in 58 (9%) of 670 screening MR studies. Eight additional lesions were identified at short-term follow-up MR imaging for a total of 71 lesions in 59 patients. Twelve cancers (20%) were identified in 60 lesions sampled. Biopsy was recommended in 26 additional lesions identified at mammography; biopsy was performed in 25 of these lesions and revealed malignancy in five (20%). Overall, 17 cancers were detected in 14 patients during the study period. Of these, 12 were detected with MR imaging alone, and five were detected with mammography alone. Of the 12 cancers detected at MR imaging, there were nine invasive cancers and three cases of ductal carcinoma in situ (DCIS). Of the five cancers detected at mammography, two were invasive and three were DCIS. MR imaging is a useful adjunct modality with which to screen women with a history of LCIS at high-risk of developing breast cancer, resulting in a 4.5% incremental cancer detection rate. Sensitivity in the detection of breast cancers with a combination of MR imaging and mammography was higher than sensitivity of either modality alone. |
4 |
| 43. Monticciolo DL, Newell MS, Moy L, Niell B, Monsees B, Sickles EA. Breast Cancer Screening in Women at Higher-Than-Average Risk: Recommendations From the ACR. Journal of the American College of Radiology. 15(3 Pt A):408-414, 2018 03. |
Review/Other-Dx |
N/A |
To provide recommendations for breast cancer screening in women at higher-than-average-risk. |
No results stated in abstract. |
4 |
| 44. Kuhl CK, Schrading S, Leutner CC, et al. Mammography, breast ultrasound, and magnetic resonance imaging for surveillance of women at high familial risk for breast cancer. J Clin Oncol. 2005;23(33):8469-8476. |
Observational-Dx |
529 asymptomatic women |
To compare the effectiveness of mammography, breast US, and MRI for surveillance of women at increased familial risk for breast cancer (lifetime risk of 20% or more). |
43 breast cancers were identified in the total cohort (34 invasive, nine ductal carcinoma-in-situ). Overall sensitivity of diagnostic imaging was 93% (40 of 43 breast cancers); overall node-positive rate was 16%, and one interval cancer occurred (one of 43 cancers, or 2%). In the analysis by modality, sensitivity was low for mammography (33%) and US(40%) or the combination of both (49%). MRI offered a significantly higher sensitivity (91%). The sensitivity of mammography in the higher risk groups was 25%, compared with 100% for MRI. Specificity of MRI (97.2%) was equivalent to that of mammography (96.8%). Mammography alone, and also mammography combined with breast US, seems insufficient for early diagnosis of breast cancer in women who are at increased familial risk with or without documented BRCA mutation. If MRI is used for surveillance, diagnosis of intraductal and invasive familial or hereditary cancer is achieved with a significantly higher sensitivity and at a more favorable stage. |
2 |
| 45. Berg WA, Zhang Z, Lehrer D, et al. Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk. JAMA. 307(13):1394-404, 2012 Apr 04. |
Observational-Dx |
2,662 women |
To determine supplemental cancer detection yield of ultrasound and MRI in women at elevated risk for breast cancer. |
The 2662 patients underwent 7473 mammograms and US, with 110 women having 111 breast cancers detected, of which 33 were detected on mammography only, 32 on US only, 26 on both mammography and US, and 9 on MRI after mammography and US. Eleven were not detected by any imaging modality. Supplemental incidence-screening US identified 3.7 cancers per 1000 women-screens (95% CI 2.1 to 5.8, p<.001). Sensitivity, specificity, and PPV3 for M +US were 57/75 (0.76, 95% CI 0.65 to 0.85), 3987/4739 (0.84, 95% CI 0.83 to 0.85), and 55/339 (0.16, 95% CI 0.12 to 0.21); and for mammography alone 39/75 (0.52, 95% CI 0.40 to 0.64), 4325/4739 (0.91,95% 0.90 to 0.92), and 37/97 (0.38, 95% CI 0.28 to 0.49) (p<.001 all comparisons). Of 612 analyzable MRI participants, 16 (2.6%) had breast cancer diagnosed. Supplemental yield of MRI was 14.7 per 1000 (95% CI 3.5 to 25.9, p=.004). Sensitivity, specificity, and PPV3 for MRI+M+US were 16/16 (1.00, 95% CI 0.79 to 1.00), 390/596 (0.65, 95% CI 0.61 to 0.69), and 15/81 (0.19, 95% CI 0.11 to 0.29); and for M+US 7/16 (0.44, 95% CI 0.20 to 0.70, p=.004), 503/596 (0.84, 95% CI 0.81 to 0.87, p <.001), and 7/38 (0.18, 95% CI 0.08 to 0.34, p= .98) for M+US. Number of screens needed to detect one cancer was 127(95%CI 99 to 167) for mammography; 234(95%CI 173 to 345) for supplemental ultrasound, and 68 (95%CI 39 to 286) for MRI after negative M+US. |
1 |
| 46. Kuhl C, Weigel S, Schrading S, Arand B, Bieling H, König R, Tombach B, Leutner C, Rieber-Brambs A, Nordhoff D, Heindel W, Reiser M, Schild HH. Prospective multicenter cohort study to refine management recommendations for women at elevated familial risk of breast cancer: the EVA trial. J Clin Oncol. 2010 Mar 20;28(9):1450-7. |
Observational-Dx |
687 women |
To investigate the respective contribution (in terms of cancer yield and stage at diagnosis) of clinical breast examination (CBE), mammography, ultrasound, and quality-assured breast magnetic resonance imaging (MRI), used alone or in different combination, for screening women at elevated risk for breast cancer. |
Twenty-seven women were diagnosed with breast cancer: 11 ductal carcinoma in situ (41%) and 16 invasive cancers (59%). Three (11%) of 27 were node positive. All cancers were detected during annual screening; no interval cancer occurred; no cancer was identified during half-yearly ultrasound. The cancer yield of ultrasound (6.0 of 1,000) and mammography (5.4 of 1,000) was equivalent; it increased nonsignificantly (7.7 of 1,000) if both methods were combined. Cancer yield achieved by MRI alone (14.9 of 1,000) was significantly higher; it was not significantly improved by adding mammography (MRI plus mammography: 16.0 of 1,000) and did not change by adding ultrasound (MRI plus ultrasound: 14.9 of 1,000). Positive predictive value was 39% for mammography, 36% for ultrasound, and 48% for MRI. |
1 |
| 47. Jochelson MS, Pinker K, Dershaw DD, et al. Comparison of screening CEDM and MRI for women at increased risk for breast cancer: A pilot study. Eur J Radiol. 97:37-43, 2017 Dec. |
Observational-Dx |
318 women |
To prospectively compare screening contrast enhanced digital mammography (CEDM) to breast MRI in women with an increased risk for breast cancer. |
Data from 307/318 patients were evaluable. Three cancers (two invasive cancers, one ductal carcinoma in situ) were detected at first round screening: MRI detected all three and CEDM detected the two invasive cancers. None of the three cancers was seen on the low energy mammograms which are comparable to conventional mammography. At 2-year imaging follow up, there were 5 additional screen detected cancers and no palpable cancers. The positive predictive value 3 (PPV3) for CEDM was 15% (2/13, 95% CI: 2-45%) and 14% for MRI (3/21, 95% CI: 3-36%). The specificity of CEDM and MRI were 94.7% and 94.1% respectively. |
2 |
| 48. Harvey SC, Di Carlo PA, Lee B, Obadina E, Sippo D, Mullen L. An Abbreviated Protocol for High-Risk Screening Breast MRI Saves Time and Resources. Journal of the American College of Radiology. 13(4):374-80, 2016 Apr. |
Review/Other-Dx |
1,052 women |
To review the ability of an abbreviated, high-risk, screening, breast MRI protocol to detect cancer and save resources. |
A total of 568 MRI cases were reviewed, with the abbreviated and full protocols. No difference was found in the number of cancers detected. Scan times were decreased by 18.8 minutes per case, for a total of 10,678 minutes (178 hours). Interpretation time, on average, was 1.55 minutes for the abbreviated protocol, compared with 6.43 minutes for the full protocol. Review of the full protocol led to a significant change in the final BI-RADS(®) assessment in 12 of 568 (2.1%) cases. |
4 |
| 49. Panigrahi B, Mullen L, Falomo E, Panigrahi B, Harvey S. An Abbreviated Protocol for High-risk Screening Breast Magnetic Resonance Imaging: Impact on Performance Metrics and BI-RADS Assessment. Academic Radiology. 24(9):1132-1138, 2017 09. |
Observational-Dx |
746 women |
To assess the performance of an abbreviated MRI protocol as a resource-efficient approach for screening patients at high-risk of breast cancer, and assesses whether the abbreviated protocol alters the assigned Breast Imaging Reporting and Data System (BI-RADS) category. |
A total of 1052 MRI cases were reviewed. The cancer detection rate was 13.3 per 1000 with a PPV3 of 30.4% based on the full protocol. Review of sequences included in the full protocol resulted in a change in the final BI-RADS assessments in 3.4% of the cases, the majority of which did not change clinical management with respect to biopsy. The sensitivity and specificity of the abbreviated and full protocols were not significantly different. |
4 |
| 50. Kriege M, Brekelmans CT, Boetes C, et al. Efficacy of MRI and mammography for breast-cancer screening in women with a familial or genetic predisposition. N Engl J Med. 351(5):427-37, 2004 Jul 29. |
Observational-Dx |
1909 women |
To prospectively compare MRI with mammography for screening women with a familial or genetic predisposition to breast cancer predisposition in order to determine whether screening with MRI facilitated the early diagnosis of hereditary breast cancer. |
We screened 1909 eligible women, including 358 carriers of germ-line mutations. Within a median follow-up period of 2.9 years, 51 tumors (44 invasive cancers, 6 ductal carcinomas in situ, and 1 lymphoma) and 1 lobular carcinoma in situ were detected. The sensitivity of clinical breast examination, mammography, and MRI for detecting invasive breast cancer was 17.9 percent, 33.3 percent, and 79.5 percent, respectively, and the specificity was 98.1 percent, 95.0 percent, and 89.8 percent, respectively. The overall discriminating capacity of MRI was significantly better than that of mammography (P<0.05). The proportion of invasive tumors that were 10 mm or less in diameter was significantly greater in our surveillance group (43.2 percent) than in either control group (14.0 percent [P<0.001] and 12.5 percent [P=0.04], respectively). The combined incidence of positive axillary nodes and micrometastases in invasive cancers in our study was 21.4 percent, as compared with 52.4 percent (P<0.001) and 56.4 percent (P=0.001) in the two control groups. |
2 |
| 51. Leach MO, Boggis CR, Dixon AK, et al. Screening with magnetic resonance imaging and mammography of a UK population at high familial risk of breast cancer: a prospective multicentre cohort study (MARIBS). Lancet. 2005;365(9473):1769-1778. |
Observational-Dx |
649 women |
To compare contrast enhanced MRI (CE MRI) with mammography for screening. |
35 cancers were diagnosed in 649 women screened with both mammography and CE MRI (1881 screens): 19 by CE MRI only, six by mammography only, and eight by both, with two interval cases. Sensitivity was significantly higher for CE MRI (77%, 95% CI 60-90) than for mammography (40%, 24-58; p=0.01), and was 94% (81-99) when both methods were used. Specificity was 93% (92-95) for mammography, 81% (80-83) for CE MRI (p<0.0001), and 77% (75-79) with both methods. The difference between CE MRI and mammography sensitivities was particularly pronounced in BRCA1 carriers (13 cancers; 92%vs 23%, p=0.004). Findings indicate that CE MRI is more sensitive than mammography for cancer detection. Specificity for both procedures was acceptable. Despite a high proportion of grade 3 cancers, tumours were small and few women were node positive. Annual screening, combining CE MRI and mammography, would detect most tumours in this risk group. |
2 |
| 52. Phi XA, Houssami N, Obdeijn IM, et al. Magnetic resonance imaging improves breast screening sensitivity in BRCA mutation carriers age >= 50 years: evidence from an individual patient data meta-analysis. Journal of Clinical Oncology. 33(4):349-56, 2015 Feb 01. |
Meta-analysis |
6 Studies |
To investigate the evidence on age-related screening accuracy in women with BRCA1/2 mutations using individual patient data (IPD) meta-analysis. |
Pooled analysis showed that in women age = 50 years, screening sensitivity was not different from that in women age < 50 years, whereas screening specificity was. In women age = 50 years, combining MRI and mammography significantly increased screening sensitivity compared with mammography alone (94.1%; 95% CI, 77.7% to 98.7% v 38.1%; 95% CI, 22.4% to 56.7%; P < .001). The combination was not significantly more sensitive than MRI alone (94.1%; 95% CI, 77.7% to 98.7% v 84.4%; 95% CI, 61.8% to 94.8%; P = .28). Combining MRI and mammography in women age = 50 years resulted in sensitivity similar to that in women age < 50 years (94.1%; 95% CI, 77.7% to 98.7% v 93.2%; 95% CI, 79.3% to 98%; P = .79). |
Good |
| 53. Sardanelli F, Podo F, D'Agnolo G, et al. Multicenter comparative multimodality surveillance of women at genetic-familial high risk for breast cancer (HIBCRIT study): interim results. Radiology. 242(3):698-715, 2007 Mar. |
Observational-Dx |
278 women |
Prospective, multicenter trial to compare clinical breast examination (CBE), mammography, US, and contrast material-enhanced MR imaging for screening women at genetic-familial high risk for breast cancer and report interim results, with pathologic findings as standard. |
Breast cancer was found in 11 of 278 women at first round and seven of 99 at second round (14 invasive, four intraductal; eight were |
2 |
| 54. Weinstein SP, Localio AR, Conant EF, Rosen M, Thomas KM, Schnall MD. Multimodality screening of high-risk women: a prospective cohort study. J Clin Oncol. 2009 Dec 20;27(36):6124-8. |
Observational-Dx |
609 women |
To prospectively compare cancer detection of digital mammography (DM), whole-breast ultrasound (WBUS), and contrast-enhanced MRI in a high-risk screening population previously screened negative by film screen mammogram (FSM). |
Twenty cancers were diagnosed in 18 patients (nine ductal carcinomas in situ and 11 invasive breast cancers). The overall cancer yield on a per-patient basis was 3.0% (18 of 609 patients). The cancer yield by modality was 1.0% for FSM (six of 597 women), 1.2% for DM (seven of 569 women), 0.53% for WBUS (three of 567 women), and 2.1% for MRI (12 of 571 women). Of the 20 cancers detected, some were only detected on one imaging modality (FSM, n = 1; DM, n = 3; WBUS, n = 1; and MRI, n = 8). |
1 |
| 55. Lo G, Scaranelo AM, Aboras H, et al. Evaluation of the Utility of Screening Mammography for High-Risk Women Undergoing Screening Breast MR Imaging. Radiology. 285(1):36-43, 2017 10. |
Observational-Dx |
1249 women |
To evaluate the value of mammography in detecting breast cancer in high-risk women undergoing screening breast magnetic resonance (MR) imaging. |
A total of 45 cancers (33 invasive and 12 ductal carcinomas in situ) were diagnosed, 43 were seen with MR imaging and 14 with both mammography and MR imaging. Additional tests (further imaging and/or biopsy) were recommended in 461 screening MR imaging studies (recall rate, 23.3%; 95% confidence interval [CI]: 21.5%, 25.2%), and mammography recalled 217 (recall rate, 11.1%; 95% CI: 9.7%, 12.6%). The cancer detection rate for MR imaging was 21.8 cancers per 1000 examinations (95% CI: 15.78, 29.19) and that for mammography was 7.2 cancers per 1000 examinations (95% CI: 3.92, 11.97; P < .001). Sensitivity and specificity of MR imaging were 96% and 78% respectively, and those of mammography were 31% and 89%, respectively (P < .001). Positive predictive value for MR imaging recalls was 9.3% (95% CI: 6.83%, 12.36%) and that for mammography recalls was 6.5% (95% CI: 3.57%, 10.59%). |
3 |
| 56. Sung JS, Stamler S, Brooks J, et al. Breast Cancers Detected at Screening MR Imaging and Mammography in Patients at High Risk: Method of Detection Reflects Tumor Histopathologic Results. Radiology. 280(3):716-22, 2016 09. |
Observational-Dx |
7519 women |
To compare the clinical, imaging, and histopathologic features of breast cancers detected at screening magnetic resonance (MR) imaging, screening mammography, and those detected between screening examinations (interval cancers) in women at high risk. |
A total of 18064 screening MR imaging examinations and 26 866 screening mammographic examinations were performed. Two hundred twenty-two cancers were diagnosed in 219 women, 167 (75%) at MR imaging, 43 (19%) at mammography, and 12 (5%) interval cancers. Median age at diagnosis was 52 years. No risk factors were associated with screening MR imaging, screening mammography, or interval cancer (P > .06). Cancers found at screening MR imaging were more likely to be invasive cancer (118 of 167 [71%]; P < .0001). Of the 43 cancers found at screening mammography, 38 (88%) manifested as calcifications and 28 (65%) were ductal carcinoma in situ. Interval cancers were associated with nodal involvement (P = .005) and the triple-negative subtype (P = .03). |
4 |
| 57. Houssami N, Turner RM. Rapid review: Estimates of incremental breast cancer detection from tomosynthesis (3D-mammography) screening in women with dense breasts. [Review]. Breast. 30:141-145, 2016 Dec. |
Review/Other-Dx |
8 studies |
To perform a rapid review (a streamlined evidence synthesis) to summarize data on tomosynthesis screening in women with heterogeneously dense or extremely dense breasts, with the aim of estimating incremental (additional) breast cancer (BC) detection attributed to tomosynthesis in comparison with standard 2D-mammography. |
Meta-analysed data from prospective trials comparing these mammography modalities in the same women (N = 10,188) in predominantly biennial screening showed significant incremental BC detection of 3.9/1000 screens attributable to tomosynthesis (P < 0.001). Studies comparing different groups of women screened with tomosynthesis (N = 103,230) or with 2D-mammography (N = 177,814) yielded a pooled difference in BC detection of 1.4/1000 screens representing significantly higher BC detection in tomosynthesis-screened women (P < 0.001), and a pooled difference for recall of -23.3/1000 screens representing significantly lower recall in tomosynthesis-screened groups (P < 0.001), than for 2D-mammography. |
4 |
| 58. Phi XA, Tagliafico A, Houssami N, Greuter MJW, de Bock GH. Digital breast tomosynthesis for breast cancer screening and diagnosis in women with dense breasts - a systematic review and meta-analysis. [Review]. BMC Cancer. 18(1):380, 2018 04 03. |
Meta-analysis |
16 studies |
To systematically review and to meta-analyse the accuracy of digital breast tomosynthesis (DBT) versus digital mammography (DM) in women with mammographically dense breasts in screening and diagnosis. |
Sixteen studies were included (five diagnostic; eleven screening). In diagnosis, DBT increased sensitivity (84%-90%) versus DM alone (69%-86%) but not specificity. DBT improved CDR versus DM alone (RR: 1.16, 95% CI 1.02-1.31). In screening, DBT + DM increased CDR versus DM alone (RR: 1.33, 95% CI 1.20-1.47 for retrospective studies; RR: 1.52, 95% CI 1.08-2.11 for prospective studies). Recall rate was significantly reduced by DBT + DM in retrospective studies (RR: 0.72, 95% CI 0.64-0.80) but not in two prospective studies (RR: 1.12, 95% CI 0.76-1.63). |
Good |
| 59. Wilczek B, Wilczek HE, Rasouliyan L, Leifland K. Adding 3D automated breast ultrasound to mammography screening in women with heterogeneously and extremely dense breasts: Report from a hospital-based, high-volume, single-center breast cancer screening program. European Journal of Radiology. 85(9):1554-63, 2016 Sep. |
Observational-Dx |
1,668 women |
To evaluate the impact of the 3D automated breast ultrasound (3D ABUS) when added to full field digital screening mammography (FFDSM), on breast cancer detection and recall rates in asymptomatic women with dense breasts examined in a high-volume breast cancer screening mammography center. |
The combined FFDSM and 3D ABUS generated a total of 6.6 cancers per 1000 women screened (95% CI: 3.0, 10.2; p<0.001) compared with 4.2 cancers per 1000 women screened (95% CI) for FFDSM alone. The difference in yield was an additional 2.4 detected cancers per 1000 women screened (95% CI: 0.6, 4.8; p<0.001). The corresponding recall rate per 1000 women screened was 13.8 (95% CI: 9.0, 19.8) for FFDSM alone and 22.8 for combined FFDSM and ABUS (95% CI: 16.2, 30.0), yielding a difference of an additional 9.0 recalls per 1000 women screened (95% CI: 3.0, 15.0; p=0.004). |
1 |
| 60. Buchberger W, Geiger-Gritsch S, Knapp R, Gautsch K, Oberaigner W. Combined screening with mammography and ultrasound in a population-based screening program. European Journal of Radiology. 101:24-29, 2018 Apr. |
Observational-Dx |
66,680 women |
To compare the performance of screening with mammography combined with ultrasound versus mammography alone in women at average risk for breast cancer. |
The overall sensitivity of mammography only was 61.5% in women with dense breasts and 86.6% in women with non-dense breasts. The sensitivity of mammography plus ultrasound combined was 81.3% in women with dense breasts and 95.0% in women with non-dense breasts. Adjunctive ultrasound increased the recall rate from 10.5 to 16.5 per 1000 women screened, and increased the biopsy rate from 6.3 to 9.3 per 1000 women screened. The positive predictive value of biopsy was 55.5% (95% CI 50.6%-60.3%) for mammography alone and 43.3 (95% CI 39.4%-47.3%) for combined mammography plus ultrasound. |
2 |
| 61. Ohuchi N, Suzuki A, Sobue T, et al. Sensitivity and specificity of mammography and adjunctive ultrasonography to screen for breast cancer in the Japan Strategic Anti-cancer Randomized Trial (J-START): a randomised controlled trial. Lancet. 387(10016):341-348, 2016 Jan 23. |
Observational-Tx |
72,998 women |
To investigate the efficacy of adjunctive ultrasonography for breast cancer screening. |
Of 72,998 women enrolled, 36,859 were assigned to the intervention group and 36,139 to the control group. Sensitivity was significantly higher in the intervention group than in the control group (91·1%, 95% CI 87·2-95·0 vs 77·0%, 70·3-83·7; p=0·0004), whereas specificity was significantly lower (87·7%, 87·3-88·0 vs 91·4%, 91·1-91·7; p<0·0001). More cancers were detected in the intervention group than in the control group (184 [0·50%] vs 117 [0·32%], p=0·0003) and were more frequently stage 0 and I (144 [71·3%] vs 79 [52·0%], p=0·0194). 18 (0·05%) interval cancers were detected in the intervention group compared with 35 (0·10%) in the control group (p=0·034). |
2 |
| 62. Lee JM, Arao RF, Sprague BL, et al. Performance of Screening Ultrasonography as an Adjunct to Screening Mammography in Women Across the Spectrum of Breast Cancer Risk. JAMA Intern Med. 179(5):658-667, 2019 05 01. |
Observational-Dx |
3386 women |
To determine the performance of screening mammography plus screening ultrasonography compared with screening mammography alone in community practice. |
Screening mammography with vs without ultrasonography examinations was performed more often in women with dense breasts (74.3% [n=4317 of 5810] vs 35.9% [n=39,928 of 111,306] in the overall sample), in women who were younger than 50 years (49.7% [n=3022 of 6081] vs 31.7% [n=16,897 of 112,462]), and in women with a family history of breast cancer (42.9% [n=2595 of 6055] vs 15.0% [n=16,897 of 112,462]). While 21.4% (n=1154 of 5392) of screening ultrasonography examinations were performed in women with high or very high (=2.50%) Breast Cancer Surveillance Consortium 5-year risk scores, 53.6% (n=2889 of 5392) had low or average (<1.67%) risk. Comparing mammography plus ultrasonography with mammography alone, the cancer detection rate was similar at 5.4 vs 5.5 per 1000 screens (adjusted relative risk [RR], 1.14; 95% CI, 0.76-1.68), as were interval cancer rates at 1.5 vs 1.9 per 1000 screens (RR, 0.67; 95% CI, 0.33-1.37). The false-positive biopsy rates were significantly higher at 52.0 vs 22.2 per 1000 screens (RR, 2.23; 95% CI, 1.93-2.58), as was short-interval follow-up at 3.9% vs 1.1% (RR, 3.10; 95% CI, 2.60-3.70). The positive predictive value of biopsy recommendation was significantly lower at 9.5% vs 21.4% (RR, 0.50; 95% CI, 0.35-0.71). |
4 |
| 63. Sprague BL, Stout NK, Schechter C, et al. Benefits, harms, and cost-effectiveness of supplemental ultrasonography screening for women with dense breasts. Ann Intern Med. 162(3):157-66, 2015 Feb 03. |
Review/Other-Dx |
N/A |
To evaluate the benefits, harms, and cost-effectiveness of supplemental ultrasonography screening for women with dense breasts. |
Supplemental ultrasonography screening after a negative mammography result for women aged 50 to 74 years with heterogeneously or extremely dense breasts averted 0.36 additional breast cancer deaths (range across models, 0.14 to 0.75), gained 1.7 QALYs (range, 0.9 to 4.7), and resulted in 354 biopsy recommendations after a false-positive ultrasonography result (range, 345 to 421) per 1000 women with dense breasts compared with biennial screening by mammography alone. The cost-effectiveness ratio was $325,000 per QALY gained (range, $112,000 to $766,000). Supplemental ultrasonography screening for only women with extremely dense breasts cost $246,000 per QALY gained (range, $74,000 to $535,000). |
4 |
| 64. Kerlikowske K, Zhu W, Tosteson AN, et al. Identifying women with dense breasts at high risk for interval cancer: a cohort study. Ann Intern Med. 162(10):673-81, 2015 May 19. |
Observational-Dx |
365,426 women |
To better direct discussions of supplemental imaging by determining which combinations of breast cancer risk and Breast Imaging Reporting and Data System (BI-RADS) breast density categories are associated with high interval cancer rates. |
High interval cancer rates were observed for women with 5-year risk of 1.67% or greater and extremely dense breasts or 5-year risk of 2.50% or greater and heterogeneously dense breasts (24% of all women with dense breasts). The interval rate of advanced-stage disease was highest (>0.4 case per 1000 examinations) among women with 5-year risk of 2.50% or greater and heterogeneously or extremely dense breasts (21% of all women with dense breasts). Five-year risk was low to average (0% to 1.66%) for 51.0% of women with heterogeneously dense breasts and 52.5% with extremely dense breasts, with interval cancer rates of 0.58 to 0.63 and 0.72 to 0.89 case per 1000 examinations, respectively. |
4 |
| 65. Chen SQ, Huang M, Shen YY, Liu CL, Xu CX. Application of Abbreviated Protocol of Magnetic Resonance Imaging for Breast Cancer Screening in Dense Breast Tissue. Acad Radiol. 24(3):316-320, 2017 03. |
Observational-Dx |
478 patients |
To evaluate the usefulness of an abbreviated protocol (AP) of magnetic resonance imaging (MRI) in comparison to a full diagnostic protocol (FDP) of MRI in the breast cancer screening with dense breast tissue. |
Sixteen cases of breast cancer from 478 patients with dense breasts were detected using the FDP method, with pathologic confirmation of nine cases of ductal carcinoma in situ, six cases of invasive ductal carcinoma, and one case of mucinous carcinoma. Fifteen cases of breast cancer were successfully screened using the AP method. The sensitivity showed no obvious significant difference between AP and FDP (?2?=?0.592, P?=?0.623), but the specificity showed a statistically significant difference (?2?=?4.619, P?=?0.036). The receiver operating characteristics curves showed high efficacy of both methods in the detection of breast cancer in dense breast tissue (the areas under the curve were 0.931?±?0.025 and 0.947?±?0.024, respectively), and the ability to diagnose breast cancer was not statistically significantly different between the two methods. |
3 |
| 66. Comstock CE, Gatsonis C, Newstead GM, et al. Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening. JAMA. 323(8):746-756, 2020 02 25. |
Experimental-Dx |
1444 women |
To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts. |
Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P?=?.002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P?=?.001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P?<?.001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P?=?.02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P?=?.15). |
1 |
| 67. Minamimoto R, Senda M, Jinnouchi S, Terauchi T, Yoshida T, Inoue T. Detection of breast cancer in an FDG-PET cancer screening program: results of a nationwide Japanese survey. Clinical Breast Cancer. 15(2):e139-46, 2015 Apr. |
Observational-Dx |
62,054 females |
To analyze the detection rate and effectiveness of the FDG-PET cancer screening program for breast cancer between 2006 and 2009 in Japan. |
Among 473 possible cases, 161 were verified as breast cancer. The relative sensitivity and positive predictive value (PPV) of FDG-PET for breast cancer were 83.9% and 41.7%, respectively. The relative sensitivity and PPV of mammography (MMG) for breast cancer was less than for FDG-PET; results for breast ultrasonography (US) were close to FDG-PET. The combination of FDG-PET with MMG and US might contribute to increased sensitivity but does not improve PPV. Most breast cancer cases (83.0%) detected using the FDG-PET cancer screening program were stage 0 or I based on the Union for International Cancer Control criteria. |
4 |
| 68. Holbrook A, Newel MS. Alternative screening for women with dense breasts: breast-specific gamma imaging (molecular breast imaging). [Review]. AJR. American Journal of Roentgenology. 204(2):252-6, 2015 Feb. |
Review/Other-Dx |
N/A |
To review the literature pertinent to the performance of breast-specific gamma imaging (BSGI) in patients with dense breasts. |
Many studies have reported the sensitivity of BSGI in finding cancers even in dense breasts. However, BSGI has not yet been validated as an effective screening tool in large prospective studies. In addition, whole-body dose remains a significant concern. |
4 |
| 69. Rhodes DJ, Hruska CB, Conners AL, et al. Journal club: molecular breast imaging at reduced radiation dose for supplemental screening in mammographically dense breasts. AJR. American Journal of Roentgenology. 204(2):241-51, 2015 Feb. |
Observational-Dx |
1585 patients |
To assess the diagnostic performance of supplemental screening molecular breast imaging (MBI) in women with mammographically dense breasts after system modifications to permit radiation dose reduction. |
In 1585 participants with a complete reference standard, 21 were diagnosed with cancer: two detected by mammography only, 14 by MBI only, three by both modalities, and two by neither. Of 14 participants with cancers detected only by MBI, 11 had invasive disease (median size, 0.9 cm; range, 0.5-4.1 cm). Nine of 11 (82%) were node negative, and two had bilateral cancers. With the addition of MBI to mammography, the overall cancer detection rate (per 1000 screened) increased from 3.2 to 12.0 (p < 0.001) (supplemental yield 8.8). The invasive cancer detection rate increased from 1.9 to 8.8 (p < 0.001) (supplemental yield 6.9), a relative increase of 363%, while the change in DCIS detection was not statistically significant (from 1.3 to 3.2, p =0.250). For mammography alone, sensitivity was 24%; specificity, 89%; and PPV3, 25%. For the combination, sensitivity was 91% (p < 0.001); specificity, 83% (p < 0.001); and PPV3, 28% (p = 0.70). The recall rate increased from 11.0% with mammography alone to 17.6% (p < 0.001) for the combination; the biopsy rate increased from 1.3% for mammography alone to 4.2% (p < 0.001). |
1 |
| 70. Shermis RB, Wilson KD, Doyle MT, et al. Supplemental Breast Cancer Screening With Molecular Breast Imaging for Women With Dense Breast Tissue. AJR. American Journal of Roentgenology. 207(2):450-7, 2016 Aug. |
Observational-Dx |
1696 women |
To retrospectively assess the clinical performance of molecular breast imaging as a supplementary screening tool for women with dense breast tissue. |
Molecular breast imaging screening of 1696 women in this study resulted in the detection of 13 mammographically occult malignancies, of which 11 were invasive, one was node positive, and one had unknown node positivity. The lesion size ranged from 0.6 to 2.4 cm, with a mean of 1.1 cm. The incremental cancer detection rate was 7.7‰ (95% CI, 4.5-13.1‰), the recall rate was 8.4% (95% CI, 7.2-9.8%), and the biopsy rate was 3.7% (95% CI, 2.9%-4.7%). The PPV for recall (PPV 1) was 9.1% (95% CI, 5.4-15.0%), and the PPV for biopsy (PPV 3) was 19.4% (95% CI, 11.4-30.9%). |
3 |
| 71. American College of Radiology. ACR Appropriateness Criteria® Radiation Dose Assessment Introduction. Available at: https://www.acr.org/-/media/ACR/Files/Appropriateness-Criteria/RadiationDoseAssessmentIntro.pdf. |
Review/Other-Dx |
N/A |
To provide evidence-based guidelines on exposure of patients to ionizing radiation. |
No abstract available. |
4 |
