Project description:BackgroundMammography is not effective in detecting breast cancer in dense breasts.MethodsA search in Medline, Cochrane, EMBASE and Google Scholar databases was conducted from January 1, 1980 to April 10, 2019 to identify women with dense breasts screened by mammography (M) and/or ultrasound (US). Meta-analysis was performed using the random-effect model.ResultsA total of 21 studies were included. The pooled sensitivity values of M alone and M + US in patients were 74% and 96%, while specificity of the two methods were 93% and 87%, respectively. Screening sensitivity was significantly higher in M + US than M alone (risk ratio: M alone vs. M + US = 0.699, P < 0.001), but the slight difference in specificity was statistically significant (risk ratio = 1.060, P = 0.001). Pooled diagnostic performance of follow-up US after initial negative mammography demonstrated a high pooled sensitivity (96%) and specificity (88%). The findings were supported by subgroup analysis stratified by study country, US method and timing of US.ConclusionsBreast cancer screening by supplemental US among women with dense breasts shows added detection sensitivity compared with M alone. However, US slightly decreased the diagnostic specificity for breast cancer. The cost-effectiveness of supplemental US in detecting malignancy in dense breasts should be considered additionally.
Project description:ImportanceImproved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.ObjectiveTo compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.Design, setting, and participantsCross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.ExposuresAll women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.Main outcomes and measuresThe primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.ResultsAmong 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).Conclusions and relevanceAmong women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.Trial registrationClinicalTrials.gov Identifier: NCT02933489.
Project description:ObjectiveTo compare the outcomes of digital breast tomosynthesis (DBT) screening combined with ultrasound (US) with those of digital mammography (DM) combined with US in women with dense breasts.Materials and methodsA retrospective database search identified consecutive asymptomatic women with dense breasts who underwent breast cancer screening with DBT or DM and whole-breast US simultaneously between June 2016 and July 2019. Women who underwent DBT + US (DBT cohort) and DM + US (DM cohort) were matched using 1:2 ratio according to mammographic density, age, menopausal status, hormone replacement therapy, and a family history of breast cancer. The cancer detection rate (CDR) per 1000 screening examinations, abnormal interpretation rate (AIR), sensitivity, and specificity were compared.ResultsA total of 863 women in the DBT cohort were matched with 1726 women in the DM cohort (median age, 53 years; interquartile range, 40-78 years) and 26 breast cancers (9 in the DBT cohort and 17 in the DM cohort) were identified. The DBT and DM cohorts showed comparable CDR (10.4 [9 of 863; 95% confidence interval {CI}: 4.8-19.7] vs. 9.8 [17 of 1726; 95% CI: 5.7-15.7] per 1000 examinations, respectively; P = 0.889). DBT cohort showed a higher AIR than the DM cohort (31.6% [273 of 863; 95% CI: 28.5%-34.9%] vs. 22.4% [387 of 1726; 95% CI: 20.5%-24.5%]; P < 0.001). The sensitivity for both cohorts was 100%. In women with negative findings on DBT or DM, supplemental US yielded similar CDRs in both DBT and DM cohorts (4.0 vs. 3.3 per 1000 examinations, respectively; P = 0.803) and higher AIR in the DBT cohort (24.8% [188 of 758; 95% CI: 21.8%-28.0%] vs. 16.9% [257 of 1516; 95% CI: 15.1%-18.9%; P < 0.001).ConclusionDBT screening combined with US showed comparable CDR but lower specificity than DM screening combined with US in women with dense breasts.
Project description:IntroductionMagnetic resonance imaging (MRI) has shown the potential to improve the screening effectiveness among women with dense breasts. The introduction of fast abbreviated protocols (AP) makes MRI more feasible to be used in a general population. We aimed to investigate the cost-effectiveness of AP-MRI in women with dense breasts (heterogeneously/extremely dense) in a population-based screening program.MethodsA previously validated model (SiMRiSc) was applied, with parameters updated for women with dense breasts. Breast density was assumed to decrease with increased age. The base scenarios included six biennial AP-MRI strategies, with biennial mammography from age 50-74 as reference. Fourteen alternative scenarios were performed by varying screening interval (triennial and quadrennial) and by applying a combined strategy of mammography and AP-MRI. A 3% discount rate for both costs and life years gained (LYG) was applied. Model robustness was evaluated using univariate and probabilistic sensitivity analyses.ResultsThe six biennial AP-MRI strategies ranged from 132 to 562 LYG per 10,000 women, where more frequent application of AP-MRI was related to higher LYG. The optimal strategy was biennial AP-MRI screening from age 50-65 for only women with extremely dense breasts, producing an incremental cost-effectiveness ratio of € 18,201/LYG. At a threshold of € 20,000/LYG, the probability that the optimal strategy was cost-effective was 79%.ConclusionPopulation-based biennial breast cancer screening with AP-MRI from age 50-65 for women with extremely dense breasts might be a cost-effective alternative to mammography, but is not an option for women with heterogeneously dense breasts.
Project description:ObjectivesSupplemental MRI screening improves early breast cancer detection and reduces interval cancers in women with extremely dense breasts in a cost-effective way. Recently, the European Society of Breast Imaging recommended offering MRI screening to women with extremely dense breasts, but the debate on whether to implement it in breast cancer screening programs is ongoing. Insight into the participant experience and willingness to re-attend is important for this discussion.MethodsWe calculated the re-attendance rates of the second and third MRI screening rounds of the DENSE trial. Moreover, we calculated age-adjusted odds ratios (ORs) to study the association between characteristics and re-attendance. Women who discontinued MRI screening were asked to provide one or more reasons for this.ResultsThe re-attendance rates were 81.3% (3458/4252) and 85.2% (2693/3160) in the second and third MRI screening round, respectively. A high age (> 65 years), a very low BMI, lower education, not being employed, smoking, and no alcohol consumption were correlated with lower re-attendance rates. Moderate or high levels of pain, discomfort, or anxiety experienced during the previous MRI screening round were correlated with lower re-attendance rates. Finally, a plurality of women mentioned an examination-related inconvenience as a reason to discontinue screening (39.1% and 34.8% in the second and third screening round, respectively).ConclusionsThe willingness of women with dense breasts to re-attend an ongoing MRI screening study is high. However, emphasis should be placed on improving the MRI experience to increase the re-attendance rate if widespread supplemental MRI screening is implemented.Clinical relevance statementFor many women, MRI is an acceptable screening method, as re-attendance rates were high - even for screening in a clinical trial setting. To further enhance the (re-)attendance rate, one possible approach could be improving the overall MRI experience.Key points• The willingness to re-attend in an ongoing MRI screening study is high. • Pain, discomfort, and anxiety in the previous MRI screening round were related to lower re-attendance rates. • Emphasis should be placed on improving MRI experience to increase the re-attendance rate in supplemental MRI screening.
Project description:IntroductionDigital breast tomosynthesis (DBT) may improve sensitivity in population screening. However, evidence is currently limited on the performance of DBT in patients at a higher risk of breast cancer. This systematic review compares the clinical effectiveness and cost-effectiveness of DBT, digital mammography (DM), and ultrasound, for breast cancer detection in women with dense breasts and additional risk factors.MethodsMedline, Embase, and Evidence-Based Medicine Reviews via OvidSP were searched to identify literature from 2010 to August 21, 2023. Selection of studies, data extraction, and quality assessment (using QUADAS-2 and CHEERS) were completed in duplicate. Findings were summarised descriptively and narratively.ResultsTwenty-six studies met pre-specified inclusion criteria. In women with breast symptoms or recalled for investigation of screen-detected findings (19 studies), DBT may be more accurate than DM. For example, in symptomatic women, the sensitivity of DBT + DM ranged from 82.8 % to 92.5 % versus 56.8 %-81.3 % for mammography (DM/synthesised images). However, most studies had a high risk of bias due to participant selection. Evidence regarding DBT in women with a personal or family history of breast cancer, for DBT versus ultrasound alone, and cost-effectiveness of DBT was limited.ConclusionsIn women with dense breasts and additional risk factors for breast cancer, evidence is limited about the accuracy of DBT compared to other imaging modalities, particularly in those with personal or family history of breast cancer. Future research in this population should consider head-to-head comparisons of imaging modalities to determine the relative effectiveness of these imaging tests.Systematic review registrationPROSPERO registration number CRD42021236470.
Project description:BACKGROUND:This study aimed to systematically review and to meta-analyse the accuracy of digital breast tomosynthesis (DBT) versus digital mammography (DM) in women with mammographically dense breasts in screening and diagnosis. METHODS:Two independent reviewers identified screening or diagnostic studies reporting at least one of four outcomes (cancer detection rate-CDR, recall rate, sensitivity and specificity) for DBT and DM in women with mammographically dense breasts. Study quality was assessed using QUADAS-2. Meta-analysis of CDR and recall rate used a random effects model. Summary ROC curve summarized sensitivity and specificity. RESULTS:Sixteen studies were included (five diagnostic; eleven screening). In diagnosis, DBT increased sensitivity (84%-90%) versus DM alone (69%-86%) but not specificity. DBT improved CDR versus DM alone (RR: 1.16, 95% CI 1.02-1.31). In screening, DBT + DM increased CDR versus DM alone (RR: 1.33, 95% CI 1.20-1.47 for retrospective studies; RR: 1.52, 95% CI 1.08-2.11 for prospective studies). Recall rate was significantly reduced by DBT + DM in retrospective studies (RR: 0.72, 95% CI 0.64-0.80) but not in two prospective studies (RR: 1.12, 95% CI 0.76-1.63). CONCLUSION:In women with mammographically dense breasts, DBT+/-DM increased CDR significantly (versus DM) in screening and diagnosis. In diagnosis, DBT+/-DM increased sensitivity but not specificity. The effect of DBT + DM on recall rate in screening dense breasts varied between studies.
Project description:PurposeMammography, the standard method of breast cancer screening, misses many cancers, especially in dense-breasted women. We compared the performance and diagnostic yield of mammography alone versus an automated whole breast ultrasound (AWBU) plus mammography in women with dense breasts and/or at elevated risk of breast cancer.MethodsAWBU screening was tested in 4,419 women having routine mammography (Trial registrationClinicalTrials.gov Identifier: NCT00649337). Cancers occurring during the study and subsequent 1-year follow-up were evaluated. Sensitivity, specificity and positive predictive value (PPV) of biopsy recommendation for mammography alone, AWBU and mammography with AWBU were calculated.ResultsBreast cancer detection doubled from 23 to 46 in 6,425 studies using AWBU with mammography, resulting in an increase in diagnostic yield from 3.6 per 1,000 with mammography alone to 7.2 per 1,000 by adding AWBU. PPV for biopsy based on mammography findings was 39.0% and for AWBU 38.4%. The number of detected invasive cancers 10 mm or less in size tripled from 7 to 21 when AWBU findings were added to mammography.ConclusionAWBU resulted in significant cancer detection improvement compared with mammography alone. Additional detection and the smaller size of invasive cancers may justify this technology's expense for women with dense breasts and/or at high risk for breast cancer.