| 1. 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 |
| 2. Plecha D, Salem N, Kremer M, et al. Neglecting to screen women between 40 and 49 years old with mammography: what is the impact on treatment morbidity and potential risk reduction?. AJR Am J Roentgenol. 202(2):282-8, 2014 Feb. |
Observational-Dx |
149 screened breast cancers, 81 nonscreened breast cancers |
To determine whether there were significant differences with respect to treatment recommendations, stage at diagnosis, and identification of high-risk lesions for women 40-49 years old undergoing screening mammography (screened) compared to women with a symptom needing a diagnostic evaluation (nonscreened). |
Of 230 primary breast cancers, 149 were in the screened group and 81 were considered nonscreened. Nonscreened patients were more likely to undergo chemotherapy (p = 0.042). Eighty-one percent of the high-risk lesions were diagnosed in the screened patients. Screened patients with cancer were significantly more likely to receive a diagnosis at earlier stages (p = 0.001), to have negative axillary lymph nodes (p = 0.005), and to have smaller tumors (p < 0.001). |
3 |
| 3. Monticciolo DL, Newell MS, Moy L, Lee CS, Destounis SV. Breast Cancer Screening for Women at Higher-Than-Average Risk: Updated Recommendations From the ACR. J Am Coll Radiol 2023:[Epub ahead of print]. |
Review/Other-Dx |
N/A |
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4 |
| 4. 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 |
| 5. Oeffinger KC, Fontham ET, Etzioni R, et al. Breast Cancer Screening for Women at Average Risk: 2015 Guideline Update From the American Cancer Society. JAMA. 314(15):1599-614, 2015 Oct 20. |
Review/Other-Dx |
N/A |
To update the American Cancer Society (ACS) 2003 breast cancer screening guideline for women at average risk for breast cancer. |
The ACS recommends that women with an average risk of breast cancer should undergo regular screening mammography starting at age 45 years (strong recommendation). Women aged 45 to 54 years should be screened annually (qualified recommendation). Women 55 years and older should transition to biennial screening or have the opportunity to continue screening annually (qualified recommendation). Women should have the opportunity to begin annual screening between the ages of 40 and 44 years (qualified recommendation). Women should continue screening mammography as long as their overall health is good and they have a life expectancy of 10 years or longer (qualified recommendation). The ACS does not recommend clinical breast examination for breast cancer screening among average-risk women at any age (qualified recommendation). |
4 |
| 6. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer Screening and Diagnosis. Version 1.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf. |
Review/Other-Dx |
N/A |
To facilitate clinical decision making.To discuss the diagnostic evaluation of individuals with suspected breast cancer. |
No abstract available. |
4 |
| 7. Siu AL, U.S. Preventive Services Task Force. Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine. 164(4):279-96, 2016 Feb 16. |
Review/Other-Dx |
N/A |
To update the 2009 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for breast cancer. |
The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. (B recommendation) The decision to start screening mammography in women prior to age 50 years should be an individual one. Women who place a higher value on the potential benefit than the potential harms may choose to begin biennial screening between the ages of 40 and 49 years. (C recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening mammography in women aged 75 years or older. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the benefits and harms of digital breast tomosynthesis (DBT) as a primary screening method for breast cancer. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of adjunctive screening for breast cancer using breast ultrasonography, magnetic resonance imaging (MRI), DBT, or other methods in women identified to have dense breasts on an otherwise negative screening mammogram. (I statement). |
4 |
| 8. Monticciolo DL, Malak SF, Friedewald SM, et al. Breast Cancer Screening Recommendations Inclusive of All Women at Average Risk: Update from the ACR and Society of Breast Imaging. Journal of the American College of Radiology. 18(9):1280-1288, 2021 09. |
Review/Other-Dx |
N/A |
To offer recommendations more inclusive of all women of average risk for breast cancer. |
Screening should continue past age 74 years, without an upper age limit unless severe comorbidities limit life expectancy. Benefits of screening should be considered along with the possibilities of recall for additional imaging and benign biopsy and the less tangible risks of anxiety and overdiagnosis. Although recall and biopsy recommendations are higher with more frequent screening, so are life-years gained and breast cancer deaths averted. Women who wish to maximize benefit will choose annual screening starting at age 40 years and will not stop screening prematurely. |
4 |
| 9. Brown A, Lourenco AP, Niell BL, et al. ACR Appropriateness Criteria® Transgender Breast Cancer Screening. J Am Coll Radiol 2021;18:S502-S15. |
Review/Other-Dx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for transgender breast cancer screening. |
No results stated in abstract. |
4 |
| 10. Weinstein SP, Slanetz PJ, Lewin AA, et al. ACR Appropriateness Criteria® Supplemental Breast Cancer Screening Based on Breast Density. J Am Coll Radiol 2021;18:S456-S73. |
Review/Other-Dx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for supplemental breast cancer screening based on breast density |
No results stated in abstract. |
4 |
| 11. Heller SL, Lourenco AP, Niell BL, et al. ACR Appropriateness Criteria® Imaging After Mastectomy and Breast Reconstruction. J Am Coll Radiol 2020;17:S403-S14. |
Review/Other-Dx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for imaging after mastectomy and breast reconstruction |
No results stated in abstract. |
4 |
| 12. Mehta TS, Lourenco AP, Niell BL, et al. ACR Appropriateness Criteria® Imaging After Breast Surgery. J Am Coll Radiol 2022;19:S341-S56. |
Review/Other-Dx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for imaging after breast surgery. |
No results stated in abstract. |
4 |
| 13. diFlorio-Alexander RM, Slanetz PJ, Moy L, et al. ACR Appropriateness Criteria® Breast Imaging of Pregnant and Lactating Women. J Am Coll Radiol 2018;15:S263-S75. |
Review/Other-Dx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for breast imaging of pregnant and lactating women. |
No results stated in abstract. |
4 |
| 14. 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 |
| 15. Greenberg JS, Javitt MC, Katzen J, Michael S, Holland AE. Clinical performance metrics of 3D digital breast tomosynthesis compared with 2D digital mammography for breast cancer screening in community practice. AJR. American Journal of Roentgenology. 203(3):687-93, 2014 Sep. |
Observational-Dx |
3D DBT (n = 23,149 patients) versus 2D DM (n = 54,684 patients) |
To assess the clinical performance of combined 2D-3D digital breast tomosynthesis (DBT), referred to as "3D DBT," compared with 2D digital mammography (DM) alone for screening mammography in a community-based radiology practice. |
For patients screened with 3D DBT, the relative change in recall rate was 16.1% lower than for patients screened with 2D DM (p > 0.0001). The overall cancer detection rate (CDR), expressed as number of cancers per 1000 patients screened, was 28.6% greater (p = 0.035) for 3D DBT (6.3/1000) compared with 2D DM (4.9/1000). The CDR for invasive cancers with 3D DBT (4.6/1000) was 43.8% higher (p = 0.0056) than with 2D DM (3.2/1000). The positive predictive value for recalls from screening (PPV1) was 53.3% greater (p = 0.0003) for 3D DBT (4.6%) compared with 2D DM (3.0%). No significant difference in the positive predictive value for biopsy (PPV3) was found for 3D DBT versus 2D DM (22.8% and 23.8%, respectively) (p = 0.696). |
3 |
| 16. Haas BM, Kalra V, Geisel J, Raghu M, Durand M, Philpotts LE. Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening. Radiology. 2013;269(3):694-700. |
Observational-Dx |
13,158 patients (screening mammography) and 6,100 patients (tomosynthesis) |
To compare screening recall rates and cancer detection rates of tomosynthesis plus conventional digital mammography to those of conventional digital mammography alone. |
A total of 13 158 patients presented for screening mammography; 6100 received tomosynthesis. The overall recall rate was 8.4% for patients in the tomosynthesis group and 12.0% for those in the conventional mammography group (P < .01). The addition of tomosynthesis reduced recall rates for all breast density and patient age groups, with significant differences (P < .05) found for scattered fibroglandular, heterogeneously dense, and extremely dense breasts and for patients younger than 40 years, those aged 40-49 years, those aged 50-59 years, and those aged 60-69 years. These findings persisted when multivariate logistic regression was used to control for differences in age, breast density, and elevated risk of breast cancer. The cancer detection rate was 5.7 per 1000 in patients receiving tomosynthesis versus 5.2 per 1000 in patients receiving conventional mammography alone (P = .70). |
3 |
| 17. Hofvind S, Holen AS, Aase HS, et al. Two-view digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening programme (To-Be): a randomised, controlled trial. Lancet Oncology. 20(6):795-805, 2019 06. |
Experimental-Dx |
14,734 women (digital breast tomosynthesis) and 14,719 women (digital mammography) |
To compare first-generation digital breast tomo-synthesis including two-dimensional (2D) synthetic mammograms versus digital mammography in a population-based screening programme. |
Between, Jan 14, 2016, and Dec 31, 2017, 44 266 women were invited to the screening programme in Bergen, and 32 976 (74·5%) attended. After excluding women with breast implants and women who did not consent to participate, 29 453 (89·3%) were eligible for electronic randomisation. 14 734 women were allocated to digital breast tomosynthesis and 14 719 to digital mammography. After randomisation, women with a previous breast cancer were excluded (digital breast tomosynthesis group n=314, digital mammography group n=316), women with metastases from melanoma (digital breast tomosynthesis group n=1), and women who informed the radiographer about breast symptoms after providing consent (digital breast tomosynthesis group n=39, digital mammography group n=34). After exclusions, information from 28 749 women were included in the analyses (digital breast tomosynthesis group n=14 380, digital mammography group n=14 369). The proportion of screen-detected breast cancer among the screened women did not differ between the two groups (95 [0·66%, 0·53-0·79] of 14 380 vs 87 [0·61%, 0·48-0·73] of 14 369; RR 1·09, 95% CI 0·82-1·46; p=0·56). |
1 |
| 18. Marinovich ML, Hunter KE, Macaskill P, Houssami N. Breast Cancer Screening Using Tomosynthesis or Mammography: A Meta-analysis of Cancer Detection and Recall. Journal of the National Cancer Institute. 110(9):942-949, 2018 09 01. |
Meta-analysis |
17 studies (1 009 790 participants) |
To compare breast cancer screening detection and recall in asymptomatic women for tomosynthesis vs 2D mammography. |
Seventeen studies (1 009 790 participants) were included from 413 citations. The pooled incremental CDR fortomosynthesis was 1.6 cancers per 1000 screens (95% confidence interval [CI] ¼ 1.1 to 2.0, P<.001, I2 ¼ 36.9%). IncrementalCDR was statistically significantly higher for European/Scandinavian studies, all using a “paired” design where women hadboth tests (2.4 per 1000 screens, 95% CI ¼ 1.9 to 2.9, P<.001, I2 ¼ 0.0%) compared with US (“unpaired”) studies (1.1 per 1000screens, 95% CI ¼ 0.8 to 1.5, P<.001, I2 ¼ 0.0%; P<.001 between strata). The recall rate for tomosynthesis was statisticallysignificantly lower than for 2D mammography (pooled absolute reduction ¼ –2.2%, 95% CI ¼ –3.0 to –1.4, P<.001, I2 ¼ 98.2%).Stratified analyses showed a decrease in US studies (pooled difference in recall rate ¼ –2.9%, 95% CI ¼ –3.5 to –2.4, P<.001,I2 ¼ 92.9%) but not European/Scandinavian studies (0.5% increase in recall, 95% CI ¼ –0.1 to 1.2, P¼.12, I2 ¼ 93.5%; P<.001between strata). Results were similar in sensitivity analyses excluding studies with overlapping cohorts. |
Good |
| 19. McCarthy AM, Kontos D, Synnestvedt M, et al. Screening outcomes following implementation of digital breast tomosynthesis in a general-population screening program. J Natl Cancer Inst. 106(11), 2014 Nov. |
Observational-Dx |
15,571 women screened with DBT and 10,728 screened with DM alone |
To report the impact on screening outcomes for DBT screening implemented in an entire clinic population. |
DBT screening showed a statistically significant reduction in recalls compared to DM alone. For the entire population, there were 16 fewer recalls (8.8% vs 10.4%, P <.001, adjusted OR = 0.80, 95% confidence interval [CI] = 0.74 to 0.88, P < .001) and 0.9 additional cancers detected per 1000 screened with DBT compared to DM alone. There was a statistically significant increase in PPV1 (6.2% vs 4.4%, P = .047). In women younger than age 50 years screened with DBT, there were 17 fewer recalls (12.3% vs 14.0%, P = .02) and 3.6 additional cancer detected per 1000 screened (5.7 vs 2.2 per 1000, P = .02). |
2 |
| 20. Pattacini P, Nitrosi A, Giorgi Rossi P, et al. Digital Mammography versus Digital Mammography Plus Tomosynthesis for Breast Cancer Screening: The Reggio Emilia Tomosynthesis Randomized Trial. Radiology. 288(2):375-385, 2018 08. |
Experimental-Dx |
9777 women (DM+DBT) and 9783 women (DM) |
To compare digital mammography (DM) plus digital breast tomosynthesis (DBT) versus DM alone for breast cancer screening in the Reggio Emilia Tomosynthesis trial, a two-arm test-and-treat randomized controlled trial. |
From March 2014 to March 2016, 9777 women were recruited to the DM+DBT arm of the study, and 9783 women were recruited to the DM arm (mean age, 56.2 vs 56.3 years). Recall was 3.5% in both arms; detection was 4.5 per 1000 (44 of 9783) and 8.6 per 1000 (83 of 9777), respectively (+89%; 95% confidence interval [CI]: 31, 72). PPV of the recall was 13.0% and 24.1%, respectively (P = .0002); 72 of 80 cancers found in the DBT+DM arm and with complete DBT imaging were positive at least at one DBT-alone reading. The greater detection rate for DM+DBT was stronger for ductal carcinoma in situ (+180%, 95% CI: 1, 665); it was notable for small and medium invasive cancers, but not for large ones (+94 [95% CI: 6, 254]; +122 [95% CI: 18, 316]; -12 [95% CI: -68, 141]; for invasive cancers < 10 mm, 10-19 mm, and = 20 mm, respectively). |
1 |
| 21. Skaane P, Bandos AI, Gullien R, et al. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013;267(1):47-56. |
Experimental-Tx |
12,621 cases |
To assess cancer detection rates, false-positive rates before arbitration, positive predictive values for women recalled after arbitration, and the type of cancers detected with use of digital mammography alone and combined with tomosynthesis in a large prospective screening trial. |
Detection rates, including those for invasive and in situ cancers, were 6.1 per 1000 examinations for mammography alone and 8.0 per 1000 examinations for mammography plus tomosynthesis (27% increase, adjusted for reader; P = .001). False-positive rates before arbitration were 61.1 per 1000 examinations with mammography alone and 53.1 per 1000 examinations with mammography plus tomosynthesis (15% decrease, adjusted for reader; P < .001). After arbitration, positive predictive values for recalled patients with cancers verified later were comparable (29.1% and 28.5%, respectively, with mammography alone and mammography plus tomosynthesis; P = .72). Twenty-five additional invasive cancers were detected with mammography plus tomosynthesis (40% increase, adjusted for reader; P < .001). The mean interpretation time was 45 seconds for mammography alone and 91 seconds for mammography plus tomosynthesis (P < .001). |
1 |
| 22. Skaane P, Bandos AI, Niklason LT, et al. Digital Mammography versus Digital Mammography Plus Tomosynthesis in Breast Cancer Screening: The Oslo Tomosynthesis Screening Trial. Radiology. 291(1):23-30, 2019 04. |
Observational-Dx |
24,301 women |
To compare the accuracy of DM versus DM + DBT in population-based breast cancer screening. |
Sensitivity was 54.1% (152 of 281) for DM and 70.5% (198 of 281) for DM + DBT. Reader-adjusted difference was 12.6% (95% confidence interval [CI]: 5.2%, 19.7%; P = .001). Specificity was 94.2% (false-positive fraction [FPF], 5.8%; 1388 of 24 020) for DM and 95.0% (FPF, 5.0%; 1209/24 020) for DM + DBT, with a reader-adjusted difference in FPF of -1.2% (95% CI: -1.7%, -0.7%; P < .001). Sensitivity was 69.0% (194 of 281) for SM + DBT and 70.5% (198 of 281) for DM + DBT, with a reader-adjusted difference of 1.0% (95% CI: -6.2%, 8.5%; P = .77). Specificity was 95.4% (FPF, 4.6%; 1111 of 24 020) for SM + DBT and 95.0% (FPF, 5.0%;1209 of 24 020) for DM + DBT, with reader-adjusted 95% CIs for FPF of 4.7%, 5.4% and 5.0%, 5.7%, respectively, and a difference of -0.3% (95% CI: -0.8%, 0.2%; P = .23). Differences in sensitivity and specificity with the addition of CAD were small and not significant (P > .2). |
3 |
| 23. 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 |
| 24. Kim WH, Chang JM, Lee J, et al. Diagnostic performance of tomosynthesis and breast ultrasonography in women with dense breasts: a prospective comparison study. Breast Cancer Research & Treatment. 162(1):85-94, 2017 02. |
Observational-Dx |
698 women with dense breasts (140 breast cancers) |
To compare the diagnostic performances of tomosynthesis and ultrasonography as adjunctives to digital mammography in women with dense breasts. |
Of the 778 participants, 698 women (140 breast cancers) were included in the analysis. Based on the AUC findings, the non-inferiority of tomosynthesis to ultrasonography was established in the overall group as well as in all subgroups except for that comprising women with extremely dense breast composition. There were no significant differences in AUC between tomosynthesis and ultrasonography among asymptomatic participants and participants who underwent imaging for screening (0.912 vs. 0.934 [P = 0.403] and 0.987 vs. 0.950 [P = 0.270], respectively). Tomosynthesis exhibited lower sensitivity (91.4 vs. 96.4%; P = 0.039), and higher specificity (83.9 vs. 70.4%; P < 0.001) and positive predictive value (58.7 vs. 45.0%; P < 0.001) than ultrasonography. |
1 |
| 25. Lowry KP, Coley RY, Miglioretti DL, et al. Screening Performance of Digital Breast Tomosynthesis vs Digital Mammography in Community Practice by Patient Age, Screening Round, and Breast Density. JAMA Network Open. 3(7):e2011792, 2020 07 01. |
Observational-Dx |
1,584,079 screening exams of women aged 40-79 |
To compare DM vs DBT performance by age, baseline vs subsequent screening round, and breast density category. |
Of 1 273 492 DM and 310 587 DBT examinations analyzed, 1 028 891 examinations (65.0%) were of white non-Hispanic women; 399 952 women (25.2%) were younger than 50 years; and 671 136 women (42.4%) had heterogeneously dense or extremely dense breasts. Adjusted differences in DM vs DBT performance were largest on baseline examinations: for example, per 1000 baseline examinations in women ages 50 to 59, recall rates decreased from 241 examinations for DM to 204 examinations for DBT (RR, 0.84; 95% CI, 0.73-0.98), and cancer detection rates increased from 5.9 with DM to 8.8 with DBT (RR, 1.50; 95% CI, 1.10-2.08). On subsequent examinations, women aged 40 to 79 years with heterogeneously dense breasts had improved recall rates and improved cancer detection with DBT. For example, per 1000 examinations in women aged 50 to 59 years, the number of recall examinations decreased from 102 with DM to 93 with DBT (RR, 0.91; 95% CI, 0.84-0.98), and cancer detection increased from 3.7 with DM to 5.3 with DBT (RR, 1.42; 95% CI, 1.23-1.64). Women aged 50 to 79 years with scattered fibroglandular density also had improved recall and cancer detection rates with DBT. Women aged 40 to 49 years with scattered fibroglandular density and women aged 50 to 79 years with almost entirely fatty breasts benefited from improved recall rates without change in cancer detection rates. No improvements in recall or cancer detection rates were observed in women with extremely dense breasts on subsequent examinations for any age group. |
3 |
| 26. 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 |
| 27. McCormack VA, dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev 2006;15:1159-69. |
Meta-analysis |
42 studies |
To conduct a systematic review and meta-analysis of published studies on the association between both quantitative and qualitative measures of mammographic features with the aim of exploring reasons for differences in RR estimates and, where appropriate, estimating pooled effects. |
Aggregate data for > 14,000 cases and 226,000 noncases from 42 studies were included. Associations were consistent in studies conducted in the general population but were highly heterogeneous in symptomatic populations. They were much stronger for percentage density than for Wolfe grade or Breast Imaging Reporting and Data System classification and were 20% to 30% stronger in studies of incident than of prevalent cancer. No differences were observed by age/menopausal status at mammography or by ethnicity. For percentage density measured using prediagnostic mammograms, combined relative risks of incident breast cancer in the general population were 1.79 (95% confidence interval, 1.48-2.16), 2.11 (1.70-2.63), 2.92 (2.49-3.42), and 4.64 (3.64-5.91) for categories 5% to 24%, 25% to 49%, 50% to 74%, and > or = 75% relative to < 5%. This association remained strong after excluding cancers diagnosed in the first-year postmammography. |
Good |
| 28. Sickles EA. The use of breast imaging to screen women at high risk for cancer. Radiol Clin North Am 2010;48:859-78. |
Review/Other-Dx |
N/A |
|
|
4 |
| 29. 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 |
| 30. Houssami N, Zackrisson S, Blazek K, et al. Meta-analysis of prospective studies evaluating breast cancer detection and interval cancer rates for digital breast tomosynthesis versus mammography population screening. Eur J Cancer 2021;148:14-23. |
Meta-analysis |
5 studies (129,969 DBT-screened participants and 227,882 mammography-only screens) |
To examine the effect of DBT versus mammography screening on ICR, based on prospective DBT studies that report outcomes for both screen-detected and interval cancers in population BC screening. |
Five eligible prospective (non-randomised) studies of DBT population screening reported on 129,969 DBT-screened participants and 227,882 mammography-only screens, including follow-up publications reporting interval BC data. Pooled CDR was 9.03/1000 (95% confidence interval [CI] 8.53-9.56) for DBT, and 5.95/1000 (95% CI 5.65-6.28) for mammography: the pooled difference in CDR was 3.15/1000 (95% CI 2.53-3.77), and was evident for the detection of invasive and in-situ malignancy. Pooled ICR was 1.56/1000 DBT screens (95% CI 1.22-2.00), and 1.75/1000 mammography screens (95% CI 1.46-2.11): the estimated pooled difference in ICR was -0.15/1000 (95% CI -0.59 to 0.29) and was not substantially altered in several sensitivity analyses. |
Good |
| 31. Hendrick RE, Helvie MA, Hardesty LA. Implications of CISNET modeling on number needed to screen and mortality reduction with digital mammography in women 40-49 years old. AJR Am J Roentgenol. 203(6):1379-81, 2014 Dec. |
Review/Other-Dx |
1904 women 40–49 years |
To evaluate the implications of recent Cancer Intervention and Surveillance Modeling Network (CISNET) modeling of benefits and harms of screening to women 40-49 years old using annual digital mammography. |
We show that adding annual digital mammography of women 40-49 years old to biennial screening of women 50-74 years old increases lives saved by 27% and life-years gained by 47%. Annual digital mammography in women 40-49 years old saves 42% more lives and life-years than biennial digital mammography. The number needed to screen to save one life (NNS) with annual digital mammography in women 40-49 years old is 588. |
4 |
| 32. Hendrick RE, Helvie MA. United States Preventive Services Task Force screening mammography recommendations: science ignored. AJR Am J Roentgenol. 196(2):W112-6, 2011 Feb. |
Review/Other-Dx |
N/A |
To examine the scientific evidence considered by the United States Preventive Services Task Force (USPSTF) in recommending against screening mammography in women 40-49 years old and against annual screening mammography in women 50 and older. |
Averaged over the six Cancer Intervention and Surveillance Modeling Network models of benefit, screening mammography shows greatest benefit--a 39.6% mortality reduction--from annual screening of women 40-84 years old. This screening regimen saves 71% more lives than the USPSTF-recommended regimen of biennial screening of women 50-74 years old, which had a 23.2% mortality reduction. For U.S. women currently 30-39 years old, annual screening mammography from ages 40-84 years would save 99,829 more lives than USPSTF recommendations if all women comply, and 64,889 more lives with the current 65% compliance rate. The potential harms of a screening examination in women 40-49 years old, on average, consist of the risk of a recall for diagnostic workup every 12 years, a negative biopsy every 149 years, a missed breast cancer every 1,000 years, and a fatal radiation-induced breast cancer every 76,000-97,000 years. Evidence made available to the USPSTF strongly supports the mortality benefit of annual screening mammography beginning at age 40 years, whereas potential harms of screening with this regimen are minor. |
4 |
| 33. Duffy S, Vulkan D, Cuckle H, et al. Annual mammographic screening to reduce breast cancer mortality in women from age 40 years: long-term follow-up of the UK Age RCT. Health Technology Assessment (Winchester, England). 24(55):1-24, 2020 10. |
Experimental-Dx |
53,883 women (the intervention group) and 106,953 women (the control group) |
To determine the effect of annual mammographic screening on breast cancer mortality for those aged 40–49 years.To estimate the effect on other-cause and all-cause mortality, and the effect on breast cancer incidence.To assess the implications for overdiagnosis of breast cancer. |
There was a statistically significant 25% reduction in mortality from breast cancers diagnosed during the intervention phase at 10 years' follow-up (relative rate 0.75, 95% confidence interval 0.58 to 0.97; p = 0.03). No reduction was observed thereafter (relative rate 0.98, 95% confidence interval 0.79 to 1.22). Overall, there was a statistically non-significant 12% reduction (relative rate 0.88, 95% confidence interval 0.74 to 1.03; p = 0.1). The absolute benefit remained approximately constant over time, at one death prevented per 1000 women screened. There was no effect of intervention on other-cause mortality (relative rate 1.02, 95% confidence interval 0.97 to 1.07; p = 0.4). The intervention group had a higher incidence of breast cancer than the control group during the intervention phase of the trial, but incidence equalised immediately on the first National Programme screen at the age of 50-52 years. |
3 |
| 34. Duffy SW, Tabar L, Yen AM, et al. Beneficial Effect of Consecutive Screening Mammography Examinations on Mortality from Breast Cancer: A Prospective Study. Radiology. 299(3):541-547, 2021 06. |
Observational-Dx |
549,091 women |
To estimate the effect of participation in successive mammographic screening examinations on breast cancer mortality. |
Data were available for a total average population of 549 091 women (average age, 58.9 years ± 6.7 [standard deviation]). The numbers of participants in the four groups were as follows: serial participants, 392 135; intermittent participants, 41 746; lapsed participants, 30 945; and serial nonparticipants, 84 265. Serial participants had a 49% lower risk of breast cancer mortality (relative risk [RR], 0.51; 95% CI: 0.48, 0.55; P < .001) and a 50% lower risk of death from breast cancer within 10 years of diagnosis (RR, 0.50; 95% CI: 0.46, 0.55; P < .001) than serial nonparticipants. Lapsed and intermittent participants had a smaller reduction. Serial participants had significantly lower risk of both outcomes than lapsed or intermittent participants. Analyses correcting for potential biases made little difference to the results. |
3 |
| 35. Tabar L, Yen AM, Wu WY, et al. Insights from the breast cancer screening trials: how screening affects the natural history of breast cancer and implications for evaluating service screening programs. Breast Journal. 21(1):13-20, 2015 Jan-Feb. |
Meta-analysis |
9 studies |
To review in detail the individual breast screening trial results with respect to advanced stage disease, breast cancer mortality, and the association between the two. |
The overall reduction in Stage II or more advanced breast cancers for all trials was 18% (RR = 0.82, 95% CI: 0.77–0.88, p < 0.001). The combined log relative risk pertaining to breast cancer mortality for all the trials was -0.25 unadjusted and -0.08 after adjustment for the rate of advanced disease, giving a Freedman statistic of 67% (95% CI: 43–89%) for the percentage of the mortality effect attributable to the effect on advanced stage breast cancer. There was excess mortality for the trial with negative effect on the advanced breast cancer rate (RR = 1.06, 95% CI: 0.85–1.29, p = 0.4), a 24% reduction in the trials with medium effect on the advanced breast cancer rate (RR = 0.76, 95% CI: 0.69–0.85, p < 0.001), and a 28% reduction in the high effect group (RR = 0.72, 95% CI: 0.63–0.82, p < 0.001). For all trials combined, the mortality reduction was 22% (RR = 0.78, 95% CI: 0.72–0.84, p < 0.001). In the medium and high effect groups, the cumulative mortality rates for the invited and control groups begin to diverge at 4– 5 years after randomization. |
Inadequate |
| 36. Hendrick RE. Obligate Overdiagnosis Due to Mammographic Screening: A Direct Estimate for U.S. Women. Radiology. 287(2):391-397, 2018 May. |
Review/Other-Dx |
N/A |
To determine obligate overdiagnosis rates, defined as the percentage of women diagnosed with screen-detected breast cancer who die of causes other than breast cancer prior to clinical presentation of that cancer, for ductal carcinoma in situ (DCIS), invasive breast cancer, and all breast cancers. |
Obligate overdiagnosis rates depend strongly on the age at which a woman is screened, ranging from less than 1% at age 40 years to 30%, 21%, and 22.5% at age 80 years for DCIS, invasive breast cancer, and all breast cancers, respectively. Type 1 overdiagnosis rates among screened women in the United States are estimated to be 9% for DCIS and approximately 7% for both invasive breast cancer and all breast cancers. Screening of women ages 40-49 years (or premenopausal women, as determined from patient history, starting at age 40 years) adds little to obligate overdiagnosis rates (0.15% for DCIS and less than 0.1% for invasive breast cancer and all breast cancers). |
4 |
| 37. van Luijt PA, Heijnsdijk EA, van Ravesteyn NT, Hofvind S, de Koning HJ. Breast cancer incidence trends in Norway and estimates of overdiagnosis. Journal of Medical Screening. 24(2):83-91, 2017 06. |
Review/Other-Dx |
N/A |
To assess the trends in breast cancer incidence and overdiagnosis in Norway by evaluating trends in the overall breast cancer incidence rate, and ductal carcinoma in situ (DCIS) incidence rate, obtained from the Norwegian Cancer Registry, with joinpoint analysis. |
We estimated a 2% overdiagnosis rate as a fraction of all cancers diagnosed in women aged 50-100, and a 3% overdiagnosis rate as a fraction of all cancers diagnosed in women aged 50-70 (i.e. screening age). If all of the increased incidence would be the result of the detection of slow growing tumours, these estimates were 7% and 11%, respectively. |
4 |
| 38. Monticciolo DL, Newell MS, Hendrick RE, et al. Breast Cancer Screening for Average-Risk Women: Recommendations From the ACR Commission on Breast Imaging. Journal of the American College of Radiology. 14(9):1137-1143, 2017 Sep. |
Review/Other-Dx |
N/A |
To provide recommendations from the ACR Commission on Breast Imaging on breast cancer screening for average-risk women. |
The ACR recommends annual mammography screening starting at age 40 for women of average risk of developing breast cancer. |
4 |
| 39. Ray KM, Price ER, Joe BN. Evidence to Support Screening Women in Their 40s. [Review]. Radiologic Clinics of North America. 55(3):429-439, 2017 May. |
Review/Other-Dx |
N/A |
To describe evidence that presents the efficacy and effectiveness of screening mammography in women ages 40 to 49. |
A large body of evidence demonstrates a 30% to 50% mortality benefit of screening mammography for women aged 40 to 49. Because of more rapid cancer growth rates in younger women, annual screening is more effective than biennial. Studies indicate that selective screening of women aged 40 to 49 would miss the majority of breast cancers. If implemented, recent US Preventive Services Task Force breast cancer screening guidelines, which recommend against routine screening of women in their 40s, could result in thousands of preventable breast cancer deaths per year. Vigilance is needed to safeguard younger women's access to screening mammography. |
4 |
| 40. Wang L, Strigel RM. Supplemental Screening for Patients at Intermediate and High Risk for Breast Cancer. [Review]. Radiologic Clinics of North America. 59(1):67-83, 2021 Jan. |
Review/Other-Dx |
N/A |
To review of risk profiles that may be considered for supplemental screening, breast density, types of supplemental screening modalities, and current national guidelines. |
No results in abstract. |
4 |
| 41. Price ER, Keedy AW, Gidwaney R, Sickles EA, Joe BN. The Potential Impact of Risk-Based Screening Mammography in Women 40-49 Years Old. AJR Am J Roentgenol. 205(6):1360-4, 2015 Dec. |
Review/Other-Dx |
136 cases |
To determine the prevalence of very strong family history and extremely dense tissue in women 40-49 years old with breast cancer detected on screening mammography. |
One hundred thirty-six cases of breast cancer were identified on screening mammography in 40- to 49-year-old women; 50% were invasive cancers, and 50%, ductal carcinoma in situ. Very strong family history was absent in 88%, and extremely dense breast tissue was absent in 86%. Seventy-six percent of patients had neither very strong family history nor extremely dense breasts, including 79% of the cases of invasive cancers, of which 25% had axillary nodal involvement and 89% were estrogen receptor positive. |
4 |
| 42. 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 |
| 43. Bakker MF, de Lange SV, Pijnappel RM, et al. Supplemental MRI Screening for Women with Extremely Dense Breast Tissue. New England Journal of Medicine. 381(22):2091-2102, 2019 11 28. |
Meta-analysis |
29 studies |
To review the published literature on the use of ultrasound in addition to mammography in screening women with dense breast tissue.To summarise in quantitative terms the likely benefit in terms of increased breast cancer detection, and the effect on the increased diagnostic activity, specifically in terms of recall rates for assessment. |
Twenty-nine studies satisfied our inclusion criteria. The proportion of total cancers detected only by ultrasound was 0.29 (95% CI: 0.27-0.31), consistent with an approximately 40% increase in the detection of cancers compared to mammography. In the studied populations, this translated into an additional 3.8 (95% CI: 3.4-4.2) screen-detected cases per 1000 mammography-negative women. About 13% (32/248) of cancers were in situ from 17 studies with information on this subgroup. Ultrasound approximately doubled the referral for assessment in three studies with these data. |
Good |
| 44. Mann RM, Athanasiou A, Baltzer PAT, et al. Breast cancer screening in women with extremely dense breasts recommendations of the European Society of Breast Imaging (EUSOBI). Eur Radiol 2022;32:4036-45. |
Review/Other-Dx |
N/A |
To provide guidance on breast cancer screening in women with extremely dense breasts. |
Because there is now a valid option to improve breast cancer screening, the European Society of Breast Imaging (EUSOBI) recommends that women should be informed about their breast density. EUSOBI thus calls on all providers of mammography screening to share density information with the women being screened. In light of the available evidence, in women aged 50 to 70 years with extremely dense breasts, the EUSOBI now recommends offering screening breast MRI every 2 to 4 years. The EUSOBI acknowledges that it may currently not be possible to offer breast MRI immediately and everywhere and underscores that quality assurance procedures need to be established, but urges radiological societies and policymakers to act on this now. Since the wishes and values of individual women differ, in screening the principles of shared decision-making should be embraced. In particular, women should be counselled on the benefits and risks of mammography and MRI-based screening, so that they are capable of making an informed choice about their preferred screening method. |
4 |
| 45. 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 |
| 46. 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 |
| 47. Rhodes DJ. Supplemental screening in the dense breast: does molecular breast imaging have a role?. Menopause. 27(1):110-112, 2020 01. |
Review/Other-Dx |
N/A |
To discuss whether other supplemental screening modalities should be performed despite the lack of evidence. |
Numerous studies have elucidated the extent of masking that occurs with mammography screening in dense breasts when mammography is compared with other supplemental screening modalities. Despite this evidence, there is currently no consensus among experts or imaging societies as to whether or with what supplemental screening should be performed, leaving providers to counsel patients regarding the balance of benefits and harms |
4 |
| 48. Zhang Z, Wang W, Wang X, et al. Breast-specific gamma imaging or ultrasonography as adjunct imaging diagnostics in women with mammographically dense breasts. European Radiology. 30(11):6062-6071, 2020 Nov. |
Observational-Dx |
364 women with mammographically dense breasts |
To investigate the adjunctive efficacy of ultrasonography (US) and breast-specific gamma imaging (BSGI) in mammographically dense breasts. |
From April 2013 to April 2016, 364 women with mammographically dense breasts and a final surgical or biopsy pathological diagnosis were recruited, comprising 218 cases of malignant disease (59.9%) and 146 cases of benign disease (40.1%). There was no difference between BSGI and US in enhancing the sensitivity of MMG diagnosis (Se-Difference 3.2%, p = 0.23), but the diagnostic specificity of MMG plus BSGI was superior to that of MMG plus US (Sp-Difference 10.3%, p = 0.003). The area under the ROC curve showed that MMG plus BSGI had better diagnostic accuracy than MMG plus US (0.90 vs. 0.83, p = 0.0019). |
2 |
| 49. Hooley RJ, Greenberg KL, Stackhouse RM, Geisel JL, Butler RS, Philpotts LE. Screening US in patients with mammographically dense breasts: initial experience with Connecticut Public Act 09-41. Radiology 2012;265:59-69. |
Observational-Dx |
935 women |
To determine performance and utilization of screening breast ultrasonography (US) in women with dense breast tissue who underwent additional screening breast US in the 1st year since implementation of Connecticut Public Act 09-41 requiring radiologists to inform patients with heterogeneous or extremely dense breasts at mammography that they may benefit from such examination. |
Of 935 women, 614 (65.7%) were at low risk, 149 (15.9%) were at intermediate risk, and 87 (9.3%) were at high risk for breast cancer. Of the screening breast US examinations, in 701 (75.0%), results were classified as Breast Imaging Reporting and Data System (BI-RADS) category 1 or 2; in 187 (20.0%), results were classified as BI-RADS category 3; and in 47 (5.0%), results were classified as BI-RADS category 4. Of 63 aspirations or biopsies recommended and performed in 53 patients, in nine, lesions were BI-RADS category 3, and in 54, lesions were BI-RADS category 4. Among 63 biopsies and aspirations, three lesions were malignant (all BI-RADS category 4, diagnosed with biopsy). All three cancers were smaller than 1 cm, were found in postmenopausal patients, and were solid masses. One cancer was found in each risk group. In 44 of 935 (4.7%) patients, examination results were false-positive. Overall positive predictive value (PPV) for biopsy or aspirations performed in patients with BI-RADS category 4 masses was 6.5% (three of 46; 95% confidence interval [CI]: 1.7%, 19%). Overall cancer detection rate was 3.2 cancers per 1000 women screened (three of 935; 95% CI: 0.8 cancers per 1000 women screened, 10 cancers per 1000 women screened). |
2 |
| 50. Tagliafico AS, Mariscotti G, Valdora F, et al. A prospective comparative trial of adjunct screening with tomosynthesis or ultrasound in women with mammography-negative dense breasts (ASTOUND-2). Eur J Cancer. 104:39-46, 2018 11. |
Observational-Dx |
5300 screening participants with negative 2D mammography or synthetic 2D mammography and dense breasts with a median age of 50 |
To estimate the incremental cancer detection rate (CDR) and false-positive recall for each of tomosynthesis and ultrasound, as adjunct screening modalities in women with mammography-negative dense breasts. |
We recruited 5300 screening participants with median age of 50 (interquartile range 43-79) years who had negative mammography and dense breasts (April 2015-September 2017). Adjunct screening detected 29 additional BCs (27 invasive, 2 in situ): 12 detected on both tomosynthesis and ultrasound, 3 detected only on tomosynthesis, 14 detected only on ultrasound. Incremental CDR for tomosynthesis (+15 cancers) was 2.83/1000 screens (95% confidence interval [CI]: 1.58-4.67) versus ultrasound (+26 cancers) with an incremental CDR of 4.90/1000 screens (95% CI: 3.21-7.19), P = 0.015. Mean size of these cancers was 14.2 mm (standard deviation: 7.8 mm), and six had nodal metastases. Incremental false-positive recall was 1.22% (95% CI: 0.91%-1.49%) and differed significantly between tomosynthesis (0.30%) and ultrasound (1.0%), P < 0.001. |
1 |
| 51. 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 |
| 52. Wu T, Warren LJ. The Added Value of Supplemental Breast Ultrasound Screening for Women With Dense Breasts: A Single Center Canadian Experience. Canadian Association of Radiologists Journal. 73(1):101-106, 2022 Feb. |
Observational-Dx |
695 screening breast ultrasounds |
To evaluate the contribution to cancer detection of supplemental breast ultrasound screening in women with dense breasts based on a single center experience by comparing our results with similar programs elsewhere. |
695 screening breast ultrasounds for women with dense breasts and negative mammograms were performed in 2019. The biopsy rate was 1.3%, breast cancer detection rate was 7 in 1000, PPV3 was 42%, and the average tumor size was 9.0 ± 1.4 mm. |
4 |
| 53. Yi A, Jang MJ, Yim D, Kwon BR, Shin SU, Chang JM. Addition of Screening Breast US to Digital Mammography and Digital Breast Tomosynthesis for Breast Cancer Screening in Women at Average Risk. Radiology. 298(3):568-575, 2021 03. |
Observational-Dx |
1,003 women who had undergone whole-breast US after DM/DBT screening |
To evaluate the added value of supplemental US screening following combined DM/DBT. |
A total of 1003 women (mean age, 56 years 6 8.6 [standard deviation]) were included. Among them, 12 cancers (mean invasive tumor size, 14 mm; range, 6–33 mm) were diagnosed. With DM/DBT and DM/DBT combined with US, the CDRs were 9.0 per 1000 screening examinations (nine of 1003 women; 95% CI: 4.1, 17) and 12 per 1000 screening examinations (12 of 1003 women; 95% CI: 6.2, 21), respectively, and the abnormal interpretation rates were 7.8% (78 of 1003 women; 95% CI: 6.2, 9.6) and 24% (243 of 1003 women; 95% CI: 22, 27). In women with negative findings at DM/DBT, supplementary US yielded a CDR of 3.2 per 1000 examinations (three of 925 women; 95% CI: 0.7, 9.4), sensitivity of 100% (three of three women; 95% CI: 29, 100), specificity of 82% (760 of 922 women; 95% CI: 80, 85), and abnormal interpretation rate of 18% (165 of 925 women; 95% CI: 15, 21). The three additional US-detected cancers were identified in women with dense breasts; no benefit was observed in women with nondense breasts. |
3 |
| 54. Rebolj M, Assi V, Brentnall A, Parmar D, Duffy SW. Addition of ultrasound to mammography in the case of dense breast tissue: systematic review and meta-analysis. British Journal of Cancer. 118(12):1559-1570, 2018 06. |
Meta-analysis |
29 studies |
To review the published literature on the use of ultrasound in addition to mammography in screening women with dense breast tissue.To summarise in quantitative terms the likely benefit in terms of increased breast cancer detection, and the effect on the increased diagnostic activity, specifically in terms of recall rates for assessment. To further discuss the benefit and the required diagnostic activity in the context of a routine mammography screening service such as the one implemented by the NHS Breast Screening Programme. |
Twenty-nine studies satisfied our inclusion criteria. The proportion of total cancers detected only by ultrasound was 0.29 (95% CI: 0.27-0.31), consistent with an approximately 40% increase in the detection of cancers compared to mammography. In the studied populations, this translated into an additional 3.8 (95% CI: 3.4-4.2) screen-detected cases per 1000 mammography-negative women. About 13% (32/248) of cancers were in situ from 17 studies with information on this subgroup. Ultrasound approximately doubled the referral for assessment in three studies with these data. |
Good |
| 55. Harada-Shoji N, Suzuki A, Ishida T, et al. Evaluation of Adjunctive Ultrasonography for Breast Cancer Detection Among Women Aged 40-49 Years With Varying Breast Density Undergoing Screening Mammography: A Secondary Analysis of a Randomized Clinical Trial. JAMA Network Open. 4(8):e2121505, 2021 08 02. |
Experimental-Dx |
9705 in the intervention group and 9508 in the control group (72,998 asymptomatic women aged 40 to 49 years) |
To evaluate the performance of adjunctive ultrasonography with mammography for breast cancer screening, according to differences in breast density. |
A total of 76 119 women were enrolled, and data for 19 213 women (mean [SD] age, 44.5 [2.8] years) from the Miyagi prefecture were analyzed; 9705 were randomized to the intervention group and 9508 were randomized to the control group. A total of 11 390 women (59.3%) had heterogeneously or extremely dense breasts. Among the overall group, 130 cancers were found. Sensitivity was significantly higher in the intervention group than the control group (93.2% [95% CI, 87.4%-99.0%] vs 66.7% [95% CI, 54.4%-78.9%]; P < .001). Similar trends were observed in women with dense breasts (sensitivity in intervention vs control groups, 93.2% [95% CI, 85.7%-100.0%] vs 70.6% [95% CI, 55.3%-85.9%]; P < .001) and nondense breasts (sensitivity in intervention vs control groups, 93.1% [95% CI, 83.9%-102.3%] vs 60.9% [95% CI, 40.9%-80.8%]; P < .001). The rate of interval cancers per 1000 screenings was lower in the intervention group compared with the control group (0.5 cancers [95% CI, 0.1-1.0 cancers] vs 2.0 cancers [95% CI, 1.1-2.9 cancers]; P = .004). Within the intervention group, the rate of invasive cancers detected by ultrasonography alone was significantly higher than that for mammography alone in both dense (82.4% [95% CI, 56.6%-96.2%] vs 41.7% [95% CI, 15.2%-72.3%]; P = .02) and nondense (85.7% [95% CI, 42.1%-99.6%] vs 25.0% [95% CI, 5.5%-57.2%]; P = .02) breasts. However, sensitivity of mammography or ultrasonography alone did not exceed 80% across all breast densities in the 2 groups. Compared with the control group, specificity was significantly lower in the intervention group (91.8% [95% CI, 91.2%-92.3%] vs 86.8% [95% CI, 86.2%-87.5%]; P < .001). Recall rates (13.8% [95% CI, 13.1%-14.5%] vs 8.6% [95% CI, 8.0%-9.1%]; P < .001) and biopsy rates (5.5% [95% CI, 5.1%-6.0%] vs 2.1% [95% CI, 1.8%-2.4%]; P < .001) were significantly higher in the intervention group than the control group. |
2 |
| 56. 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 |
| 57. Hogan MP, Amir T, Sevilimedu V, Sung J, Morris EA, Jochelson MS. Contrast-Enhanced Digital Mammography Screening for Intermediate-Risk Women With a History of Lobular Neoplasia. AJR. American Journal of Roentgenology. 216(6):1486-1491, 2021 06. |
Observational-Dx |
132 women who underwent 306 CEDM examinations |
To assess to the role of contrast-enhanced digital mammography (CEDM) as a screening tool in women at intermediate risk for developing breast cancer due to a personal history of lobular neoplasia without additional risk factors. |
CEDM detected cancer in six patients and showed an overall sensitivity of 100%, specificity of 88% (95% CI, 84-92%), NPV of 100%, and accuracy of 88% (95% CI, 84-92%). The positive likelihood ratio of 8.33 suggested that CEDM findings are 8.3 times more likely to be positive in an individual with breast cancer when compared with an individual without the disease. |
3 |
| 58. Kim G, Phillips J, Cole E, et al. Comparison of Contrast-Enhanced Mammography With Conventional Digital Mammography in Breast Cancer Screening: A Pilot Study. Journal of the American College of Radiology. 16(10):1456-1463, 2019 Oct. |
Observational-Dx |
64 de-identified CEM cases |
To perform a pilot evaluation of contrast-enhanced mammography (CEM) for screening to determine whether it can improve accuracy and reader confidence in diagnosis |
There were 635 out a total possible 640 complete reader interpretations included in this analysis. The remaining five incomplete interpretations were excluded. Median sensitivity and specificity improved with the addition of CEM (sensitivity: 0.86 [95% confidence interval {CI}: 0.74-0.95] versus 1 [95% CI: 0.83-1.00], specificity: 0.85 [95% CI: 0.64-0.94] versus 0.88 [95% CI: 0.80-0.92]). Individual receiver operating characteristic curves showed significant improvement with CEM (mean area under the curve increase = 0.056 [95% CI: 0.015-0.097], P = .002). The addition of CEM significantly improved average confidence in 5 of 10 readers when compared with LE (P < .0001) and improved pooled confidence across all tissue density categories, except the almost entirely fatty category. There was a trend toward improved confidence with increasing tissue density with CEM. Degree of background parenchymal enhancement did not affect readers' level of improvement in confidence when interpreting CEM. |
2 |
| 59. 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 |
| 60. 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 |
| 61. 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 |
| 62. 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 |
| 63. Raikhlin A, Curpen B, Warner E, Betel C, Wright B, Jong R. Breast MRI as an adjunct to mammography for breast cancer screening in high-risk patients: retrospective review. AJR. American Journal of Roentgenology. 204(4):889-97, 2015 Apr. |
Observational-Dx |
650 high-risk women who underwent screening breast MRI and mammography |
To evaluate the diagnostic performance of screening breast MRI as compared with mammography in a population-based high-risk screening program. |
Malignancy was diagnosed in 13 patients (invasive cancer in nine, ductal carcinoma in situ in three [one with microinvasion], and chest wall metastasis in one). Of the 13 cancers, 12 (92.3%) were detected by MRI and four (30.8%) by mammography. In nine of these patients, the cancer was diagnosed by MRI only, resulting in an incremental cancer detection rate of 10 cancers per 1000 women screened. MRI screening had significantly higher sensitivity than mammography (92.3% vs 30.8%) but lower specificity (85.9% vs 96.8%). MRI also resulted in a higher callback rate for a 6-month follow-up study (BI-RADS category 3 assessment) than mammography (119 [14.8%] vs 13 [1.6%]) and more image-guided biopsies than mammography (95 [11.8%] vs 19 [2.4%]). |
4 |
| 64. 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 |
| 65. Sippo DA, Burk KS, Mercaldo SF, et al. Performance of Screening Breast MRI across Women with Different Elevated Breast Cancer Risk Indications. Radiology. 292(1):51-59, 2019 07. |
Observational-Dx |
5,170 screening MRI examinations from 2637 patients |
To evaluate screening breast MRI performance across women with different elevated breast cancer risk indications. |
There were 5170 screening examinations in 2637 women (mean age, 52 years; range, 23-86 years); 67 breast cancers were detected. The cancer detection rate (CDR) was highest in the BRCA/RT group (26 per 1000 examinations; 95% confidence interval [CI]: 16, 43 per 1000 examinations), intermediate for those in the PH and HRL groups (12 per 1000 examinations [95% CI: 9, 17 per 1000 examinations] and 15 per 1000 examinations [95% CI: 7, 32 per 1000 examinations], respectively), and lowest for those in the FH group (8 per 1000 examinations; 95% CI: 4, 14 per 1000 examinations). No difference in CDR was evident for the PH or HRL group compared with the BRCA/RT group (P = .14 and .18, respectively). The CDR was lower for the FH group compared with the BRCA/RT group (P = .02). No difference was evident in positive predictive value for biopsies performed (PPV3) for the BRCA/RT group (41%; 95% CI: 26%, 56%) compared with the PH (41%; 95% CI: 31%, 52%; P = .63) or HRL (36%, 95% CI: 17%, 60%; P = .37) groups. PPV3 was lower for the FH group (14%; 95% CI: 8%, 25%; P = .048). |
3 |
| 66. Cho N, Han W, Han BK, et al. Breast Cancer Screening With Mammography Plus Ultrasonography or Magnetic Resonance Imaging in Women 50 Years or Younger at Diagnosis and Treated With Breast Conservation Therapy. JAMA Oncol. 3(11):1495-1502, 2017 Nov 01. |
Observational-Dx |
754 women 50 years or younger at initial diagnosis and who had undergone breast conservation therapy for breast cancer |
To prospectively determine the cancer yield and tumor characteristics of combined mammography with MRI or ultrasonography screening in women who underwent breast conservation therapy for breast cancers and who were 50 years or younger at initial diagnosis. |
A total of 754 women underwent 2065 mammograms, ultrasonography, and MRI screenings. Seventeen cancers were diagnosed, and most of the detected cancers (13 of 17 [76%]) were stage 0 or stage 1. Overall cancer detection rate (8.2 vs 4.4 per 1000; P = .003) or sensitivity (100% vs 53%; P = .01) of mammography with MRI was higher than that of mammography alone. After the addition of ultrasonography, the cancer detection rate was higher than that by mammography alone (6.8 vs 4.4 per 1000; P = .03). The specificity of mammography with MRI or ultrasonography was lower than that by mammography alone (87% or 88% vs 96%; P < .001). No interval cancer was found. |
3 |
| 67. Haas CB, Nekhlyudov L, Lee JM, et al. Surveillance for second breast cancer events in women with a personal history of breast cancer using breast MRI: a systematic review and meta-analysis. Breast Cancer Res Treat 2020;181:255-68. |
Meta-analysis |
11 articles (8338 women with PHBC and 12,335 breast MRIs) |
To compile and compare existing studies that describe the test performance of surveillance breast MRI among women with personal history of breast cancer (PHBC). |
Our review included 11 articles in which unique cohorts were studied, comprised of a total of 8338 women with PHBC and 12,335 breast MRI done for the purpose of surveillance. We predict intervals (PI) for cancer detection rate per 1000 examinations (PI 9-15; I2 = 10%), recall rate (PI 5-31%; I2 = 97%), sensitivity (PI 58-95%; I2 = 47%), specificity (PI 76-97%; I2 = 97%), and PPV3 (PI 16-40%; I2 = 44%). |
Inadequate |
| 68. Saadatmand S, Geuzinge HA, Rutgers EJT, et al. MRI versus mammography for breast cancer screening in women with familial risk (FaMRIsc): a multicentre, randomised, controlled trial. Lancet Oncology. 20(8):1136-1147, 2019 08. |
Experimental-Dx |
1355 women (675 in MRI group and 680 in mammography group) |
To compare MRI screening with mammography in women with familial risk. |
Between Jan 1, 2011, and Dec 31, 2017, 1355 women provided consent for randomisation and 231 for registration. 675 of 1355 women were randomly allocated to the MRI group and 680 to the mammography group. 218 of 231 women opting to be in a registration group were in the mammography registration group and 13 were in the MRI registration group. The mean number of screening rounds per woman was 4·3 (SD 1·76). More breast cancers were detected in the MRI group than in the mammography group (40 vs 15; p=0·0017). Invasive cancers (24 in the MRI group and eight in the mammography group) were smaller in the MRI group than in the mammography group (median size 9 mm [5-14] vs 17 mm [13-22]; p=0·010) and less frequently node positive (four [17%] of 24 vs five [63%] of eight; p=0·023). Tumour stages of the cancers detected at incident rounds were significantly earlier in the MRI group (12 [48%] of 25 in the MRI group vs one [7%] of 15 in the mammography group were stage T1a and T1b cancers; one (4%) of 25 in the MRI group and two (13%) of 15 in the mammography group were stage T2 or higher; p=0·035) and node-positive tumours were less frequent (two [11%] of 18 in the MRI group vs five [63%] of eight in the mammography group; p=0·014). All seven tumours stage T2 or higher were in the two highest breast density categories (breast imaging reporting and data system categories C and D; p=0·0077) One patient died from breast cancer during follow-up (mammography registration group). |
3 |
| 69. 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 |
| 70. Chiarelli AM, Prummel MV, Muradali D, et al. Effectiveness of screening with annual magnetic resonance imaging and mammography: results of the initial screen from the ontario high risk breast screening program. Journal of Clinical Oncology. 32(21):2224-30, 2014 Jul 20. |
Observational-Dx |
2,207 women with initial screening examinations |
To evaluate screening performance measures among women screened in the first year of the OBSP High Risk Screening Program. |
The recall rate was significantly higher among women who had abnormal MRI alone (15.1%; 95% CI, 13.8% to 16.4%) compared with mammogram alone (6.4%; 95% CI, 5.5% to 7.3%). Of the 35 breast cancers detected (16.3 per 1,000; 95% CI, 11.2 to 22.2), none were detected by mammogram alone, 23 (65.7%) were detected by MRI alone (10.7 per 1,000; 95% CI, 6.7 to 15.8), and 25 (71%) were detected among women who were known gene mutation carriers (30.8 per 1,000, 95% CI, 19.4 to 43.7). The positive predictive value was highest for detection based on mammogram and MRI (12.4%; 95% CI, 7.3% to 19.3%). |
3 |
| 71. 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 |
| 72. Kwon MR, Choi JS, Won H, et al. Breast Cancer Screening with Abbreviated Breast MRI: 3-year Outcome Analysis. Radiology. 299(1):73-83, 2021 04. |
Observational-Dx |
1,975 consecutive women who underwent abbreviated screening MRI |
To assess the longitudinal diagnostic performance of abbreviated screening MRI and to determine whether the screening outcomes of abbreviated MRI differed between yearly time periods for 3 consecutive years. |
A total of 1975 women (median age, 49 years; interquartile range, 44-56 years) underwent 3037 abbreviated MRI examinations over 3 years. CDR (year 1 to year 3, 6.9-10.7 per 1000 examinations), positive predictive value for recall (9.7% [six of 62] to 15.6% [12 of 77]), positive predictive value for biopsy (31.6% [six of 19] to 63.2% [12 of 19]), sensitivity (75.0% [six of eight] to 80.0% [12 of 15]), and specificity (93.5% [807 of 863] to 94.1% [1041 of 1106]) were highest in year 3, and AIR (7.1% [62 of 871] to 6.9% [77 of 1121]) was lowest in year 3. However, all outcome measures did not differ statistically between years 1, 2, and 3 (all P > .05). The interval cancer rate was 0.66 per 1000 examinations (two of 3037). Thirty-eight breast cancers were identified in 36 women; 29 were detected with abbreviated MRI, but nine were missed. Of these, seven were detected with other imaging modalities after negative results at the last screening MRI examination, and two were interval cancers. All missed cancers were node-negative early-stage invasive cancers and were smaller (median size, 0.8 cm vs 1.2 cm; P = .01) than detected cancers. |
3 |
| 73. Dialani V, Tseng I, Slanetz PJ, et al. Potential role of abbreviated MRI for breast cancer screening in an academic medical center. Breast Journal. 25(4):604-611, 2019 07. |
Observational-Dx |
259 patients with breast MRIs |
To further explore the abbreviated breast MRI protocol (ABMR) and its impact on cancer detection rates, abnormal interpretation rates (AIR), sensitivity and specificity as compared to the full protocol.To assess interpretation time per study/per radiologist, as these factors together will assess possibility of incorporating ABMR in practice. |
Of the 259 patients (avg. age-52 years; range 26-78), there were seven cancers (three invasive, three DCIS and one breast lymphoma). Acquisition time for ABMR was 3 minutes, ABMR + T2-8 minutes, and original full protocol 16 minutes. Average MIP was positive or indeterminate in 86% (6/7) and negative in 14% (1/7) cancers. The average AIR for MIP only was 20.8% (sens-77.1%; spec-80.8%. The AIR w/o comparisons was 25.6% (sens-91.4%; spec- 76.2%); however the average AIR decreased in phase 2 with comparisons to 13.7% (sens-91.4%; spec-88.5%). The AIR of the original full protocol read was 16.2% (sens-100%; spec-85.7%). Addition of T2 changed assessment in only 3% (1.2%-6.5%). Avg. read time for ABMR including T2 was 2.5 minutes (1.6-4.0 minutes). |
3 |
| 74. 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 |
| 75. 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 |
| 76. 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 |
| 77. Lowry KP, Geuzinge HA, Stout NK, et al. Breast Cancer Screening Strategies for Women With ATM, CHEK2, and PALB2 Pathogenic Variants: A Comparative Modeling Analysis. JAMA Oncol 2022;8:587-96. |
Observational-Dx |
32,247 cases and 32,544 controls |
To estimate the benefits and harms of breast cancer screening strategies using mammography and MRI at various start ages for women with ATM, CHEK2, and PALB2 pathogenic variants. |
The mean model-estimated lifetime breast cancer risk was 20.9% (18.1%-23.7%) for women with ATM pathogenic variants, 27.6% (23.4%-31.7%) for women with CHEK2 pathogenic variants, and 39.5% (35.6%-43.3%) for women with PALB2 pathogenic variants. Across pathogenic variants, annual mammography alone from 40 to 74 years was estimated to reduce breast cancer mortality by 36.4% (34.6%-38.2%) to 38.5% (37.8%-39.2%) compared with no screening. Screening with annual MRI starting at 35 years followed by annual mammography and MRI at 40 years was estimated to reduce breast cancer mortality by 54.4% (54.2%-54.7%) to 57.6% (57.2%-58.0%), with 4661 (4635-4688) to 5001 (4979-5023) false-positive screenings and 1280 (1272-1287) to 1368 (1362-1374) benign biopsies per 1000 women. Annual MRI starting at 30 years followed by mammography and MRI at 40 years was estimated to reduce mortality by 55.4% (55.3%-55.4%) to 59.5% (58.5%-60.4%), with 5075 (5057-5093) to 5415 (5393-5437) false-positive screenings and 1439 (1429-1449) to 1528 (1517-1538) benign biopsies per 1000 women. When starting MRI at 30 years, initiating annual mammography starting at 30 vs 40 years did not meaningfully reduce mean mortality rates (0.1% [0.1%-0.2%] to 0.3% [0.2%-0.3%]) but was estimated to add 649 (602-695) to 650 (603-696) false-positive screenings and 58 (41-76) to 59 (41-76) benign biopsies per 1000 women. |
4 |
| 78. Hermann N, Klil-Drori A, Angarita FA, et al. Screening women at high risk for breast cancer: one program fits all? : Subgroup analysis of a large population high risk breast screening program. Breast Cancer Research & Treatment. 184(3):763-770, 2020 Dec. |
Observational-Dx |
2081 participants |
To examine the differences in incidence and outcome of BC diagnosis between different cohorts within a large institutional high-risk breast screening program. |
673 women carried PVs in hereditary breast cancer genes, 159 had a history of chest radiotherapy, and 1249 had an ELR = 25%. The total cohort of screening years was 8126. Median age at BC diagnosis was 41 for the first group, 47 for the second group and 51 for the third. BC incidence rate was 18.2 for PV mutation carriers, 17.9 for the chest radiotherapy group and 6.2 for ELR = 25%. Hazard ratio was similar for the first two groups, but significantly lower for the ELR = 25% group. When stratifying by age, the incidence rate in the ELR = 25% increased over time, until it became similar to that of the other subgroups after age 50. |
4 |
| 79. Phi XA, Saadatmand S, De Bock GH, et al. Contribution of mammography to MRI screening in BRCA mutation carriers by BRCA status and age: individual patient data meta-analysis. Br J Cancer 2016;114:631-7. |
Meta-analysis |
6 studies (2,226 women) |
To assess the accuracy of screening women at familial risk of BC without a known gene mutation, adding MRI to mammography and stratifying outcomes by age. |
There were 2226 women (median age: 41 years, interquartile range 35-47) with 7478 woman-years of follow-up, with a BC rate of 12 (95% confidence interval 9.3-14) in 1000 woman-years. Mammography screening had a sensitivity of 55% (standard error of mean [SE] 7.0) and a specificity of 94% (SE 1.3). Screening with MRI alone had a sensitivity of 89% (SE 4.6) and a specificity of 83% (SE 2.8). Adding MRI to mammography increased sensitivity to 98% (SE 1.8, P < 0.01 compared to mammography alone) but lowered specificity to 79% (SE 2.7, P < 0.01 compared with mammography alone). |
Inadequate |
| 80. Narayan AK, Visvanathan K, Harvey SC. Comparative effectiveness of breast MRI and mammography in screening young women with elevated risk of developing breast cancer: a retrospective cohort study. Breast Cancer Res Treat 2016;158:583-9. |
Observational-Dx |
342 breast MRI exams |
To test whether adding mammography to breast MRI screening compared to breast MRI screening alone in women below 40 increases cancer detection rates. |
342 breast MRI exams were identified (average age was 33, 37 % were nulliparous, and 64 % had prior benign biopsy), 226 (66 %) of which underwent concurrent mammography. Risk factors included 64 % with breast cancer in first-degree relative(s), 90 % had heterogeneous or extremely dense breast tissue on mammography, and 16 % were BRCA carriers. Four invasive cancers were detected by MRI (11.7 cancers/1000 examinations, 95 % CI 8.3, 15.1). None of these was detected by mammography, and no cancers were independently identified by mammography. Breast MRI screening in high-risk women under 40 yielded elevated cancer detection rates (11.7/1000). The cancer detection rate for mammography was 0 %, suggesting that MRI alone may be useful in screening high-risk women under 40. |
4 |
| 81. Phi XA, Houssami N, Hooning MJ, et al. Accuracy of screening women at familial risk of breast cancer without a known gene mutation: Individual patient data meta-analysis. [Review]. Eur J Cancer. 85:31-38, 2017 11. |
Meta-analysis |
6studies (1,951 patients) |
To investigate the additional contribution of mammography to screening accuracy in BRCA1/2 mutation carriers screened with MRI at different ages using individual patient data from six high-risk screening trials. |
In BRCA1/2 mutation carriers of all ages (BRCA1 = 1,219 and BRCA2 = 732), adding mammography to MRI did not significantly increase screening sensitivity (increased by 3.9% in BRCA1 and 12.6% in BRCA2 mutation carriers, P > 0.05). However, in women with BRCA2 mutation younger than 40 years, one-third of breast cancers were detected by mammography only. Number of screens needed for mammography to detect one breast cancer not detected by MRI was much higher for BRCA1 compared with BRCA2 mutation carriers at initial and repeat screening. |
Inadequate |
| 82. 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 |
| 83. 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 |
