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Performance of Screening Ultrasonography as an Adjunct to Screening Mammography in Women Across the Spectrum of Breast Cancer Risk.

ABSTRACT: Importance:Whole-breast ultrasonography has been advocated to supplement screening mammography to improve outcomes in women with dense breasts. Objective:To determine the performance of screening mammography plus screening ultrasonography compared with screening mammography alone in community practice. Design, Setting, and Participants:Observational cohort study. Two Breast Cancer Surveillance Consortium registries provided prospectively collected data on screening mammography with vs without same-day breast ultrasonography from January 1, 2000, to December 31, 2013. The dates of analysis were March 2014 to December 2018. A total of 6081 screening mammography plus same-day screening ultrasonography examinations in 3386 women were propensity score matched 1:5 to 30 062 screening mammograms without screening ultrasonography in 15 176 women from a sample of 113 293 mammograms. Exclusion criteria included a personal history of breast cancer and self-reported breast symptoms. Exposures:Screening mammography with vs without screening ultrasonography. Main Outcomes and Measures:Cancer detection rate and rates of interval cancer, false-positive biopsy recommendation, short-interval follow-up, and positive predictive value of biopsy recommendation were estimated and compared using log binomial regression. Results:Screening mammography with vs without ultrasonography examinations was performed more often in women with dense breasts (74.3% [n = 4317 of 5810] vs 35.9% [n = 39 928 of 111 306] in the overall sample), in women who were younger than 50 years (49.7% [n = 3022 of 6081] vs 31.7% [n = 16 897 of 112 462]), and in women with a family history of breast cancer (42.9% [n = 2595 of 6055] vs 15.0% [n = 16 897 of 112 462]). While 21.4% (n = 1154 of 5392) of screening ultrasonography examinations were performed in women with high or very high (≥2.50%) Breast Cancer Surveillance Consortium 5-year risk scores, 53.6% (n = 2889 of 5392) had low or average (<1.67%) risk. Comparing mammography plus ultrasonography with mammography alone, the cancer detection rate was similar at 5.4 vs 5.5 per 1000 screens (adjusted relative risk [RR], 1.14; 95% CI, 0.76-1.68), as were interval cancer rates at 1.5 vs 1.9 per 1000 screens (RR, 0.67; 95% CI, 0.33-1.37). The false-positive biopsy rates were significantly higher at 52.0 vs 22.2 per 1000 screens (RR, 2.23; 95% CI, 1.93-2.58), as was short-interval follow-up at 3.9% vs 1.1% (RR, 3.10; 95% CI, 2.60-3.70). The positive predictive value of biopsy recommendation was significantly lower at 9.5% vs 21.4% (RR, 0.50; 95% CI, 0.35-0.71). Conclusions and Relevance:In a relatively young population of women at low, intermediate, and high breast cancer risk, these results suggest that the benefits of supplemental ultrasonography screening may not outweigh associated harms.

SUBMITTER: Lee JM

PROVIDER: S-EPMC6503561 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ContextScreening ultrasound may depict small, node-negative breast cancers not seen on mammography.ObjectiveTo compare the diagnostic yield, defined as the proportion of women with positive screen test results and positive reference standard, and performance of screening with ultrasound plus mammography vs mammography alone in women at elevated risk of breast cancer.Design, setting, and participantsFrom April 2004 to February 2006, 2809 women, with at least heterogeneously dense breast tissue in at least 1 quadrant, were recruited from 21 sites to undergo mammographic and physician-performed ultrasonographic examinations in randomized order by a radiologist masked to the other examination results. Reference standard was defined as a combination of pathology and 12-month follow-up and was available for 2637 (96.8%) of the 2725 eligible participants.Main outcome measuresDiagnostic yield, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) of combined mammography plus ultrasound vs mammography alone and the positive predictive value of biopsy recommendations for mammography plus ultrasound vs mammography alone.ResultsForty participants (41 breasts) were diagnosed with cancer: 8 suspicious on both ultrasound and mammography, 12 on ultrasound alone, 12 on mammography alone, and 8 participants (9 breasts) on neither. The diagnostic yield for mammography was 7.6 per 1000 women screened (20 of 2637) and increased to 11.8 per 1000 (31 of 2637) for combined mammography plus ultrasound; the supplemental yield was 4.2 per 1000 women screened (95% confidence interval [CI], 1.1-7.2 per 1000; P = .003 that supplemental yield is 0). The diagnostic accuracy for mammography was 0.78 (95% CI, 0.67-0.87) and increased to 0.91 (95% CI, 0.84-0.96) for mammography plus ultrasound (P = .003 that difference is 0). Of 12 supplemental cancers detected by ultrasound alone, 11 (92%) were invasive with a median size of 10 mm (range, 5-40 mm; mean [SE], 12.6 [3.0] mm) and 8 of the 9 lesions (89%) reported had negative nodes. The positive predictive value of biopsy recommendation after full diagnostic workup was 19 of 84 for mammography (22.6%; 95% CI, 14.2%-33%), 21 of 235 for ultrasound (8.9%, 95% CI, 5.6%-13.3%), and 31 of 276 for combined mammography plus ultrasound (11.2%; 95% CI. 7.8%-15.6%).ConclusionsAdding a single screening ultrasound to mammography will yield an additional 1.1 to 7.2 cancers per 1000 high-risk women, but it will also substantially increase the number of false positives.Trial registrationclinicaltrials.gov Identifier: NCT00072501.

Project description:Importance:Younger women (aged ?50 years) who underwent breast conservation therapy may benefit from breast magnetic resonance imaging (MRI) screening as an adjunct to mammography. Objective: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. Design, Setting, and Participants:This multicenter, prospective, nonrandomized study was conducted from December 1, 2010, to January 31, 2016, at 6 academic institutions. Seven hundred fifty-four women who were 50 years or younger at initial diagnosis and who had undergone breast conservation therapy for breast cancer were recruited to participate in the study. Reference standard was defined as a combination of pathology and 12-month follow-up. Interventions:Participants underwent 3 annual MRI screenings of the conserved and contralateral breasts in addition to mammography and ultrasonography, with independent readings. Main Outcomes and Measures:Cancer detection rate, sensitivity, specificity, interval cancer rate, and characteristics of detected cancers. Results: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. Conclusions and Relevance:After breast conservation therapy in women 50 years or younger, the addition of MRI to annual mammography screening improves detection of early-stage but biologically aggressive breast cancers at acceptable specificity. Results from this study can inform patient decision making on screening methods after breast conservation therapy.

Project description:Annual ultrasound screening may detect small, node-negative breast cancers that are not seen on mammography. Magnetic resonance imaging (MRI) may reveal additional breast cancers missed by both mammography and ultrasound screening.To determine supplemental cancer detection yield of ultrasound and MRI in women at elevated risk for breast cancer.From April 2004-February 2006, 2809 women at 21 sites with elevated cancer risk and dense breasts consented to 3 annual independent screens with mammography and ultrasound in randomized order. After 3 rounds of both screenings, 612 of 703 women who chose to undergo an MRI had complete data. The reference standard was defined as a combination of pathology (biopsy results that showed in situ or infiltrating ductal carcinoma or infiltrating lobular carcinoma in the breast or axillary lymph nodes) and 12-month follow-up.Cancer detection rate (yield), sensitivity, specificity, positive predictive value (PPV3) of biopsies performed and interval cancer rate.A total of 2662 women underwent 7473 mammogram and ultrasound screenings, 110 of whom had 111 breast cancer events: 33 detected by mammography only, 32 by ultrasound only, 26 by both, and 9 by MRI after mammography plus ultrasound; 11 were not detected by any imaging screen. Among 4814 incidence screens in the second and third years combined, 75 women were diagnosed with cancer. Supplemental incidence-screening ultrasound identified 3.7 cancers per 1000 screens (95% CI, 2.1-5.8; P < .001). Sensitivity for mammography plus ultrasound was 0.76 (95% CI, 0.65-0.85); specificity, 0.84 (95% CI, 0.83-0.85); and PPV3, 0.16 (95% CI, 0.12-0.21). For mammography alone, sensitivity was 0.52 (95% CI, 0.40-0.64); specificity, 0.91 (95% CI, 0.90-0.92); and PPV3, 0.38 (95% CI, 0.28-0.49; P < .001 all comparisons). Of the MRI participants, 16 women (2.6%) had breast cancer diagnosed. The supplemental yield of MRI was 14.7 per 1000 (95% CI, 3.5-25.9; P = .004). Sensitivity for MRI and mammography plus ultrasound was 1.00 (95% CI, 0.79-1.00); specificity, 0.65 (95% CI, 0.61-0.69); and PPV3, 0.19 (95% CI, 0.11-0.29). For mammography and ultrasound, sensitivity was 0.44 (95% CI, 0.20-0.70, P = .004); specificity 0.84 (95% CI, 0.81-0.87; P < .001); and PPV3, 0.18 (95% CI, 0.08 to 0.34; P = .98). The number of screens needed to detect 1 cancer was 127 (95% CI, 99-167) for mammography; 234 (95% CI, 173-345) for supplemental ultrasound; and 68 (95% CI, 39-286) for MRI after negative mammography and ultrasound results.The addition of screening ultrasound or MRI to mammography in women at increased risk of breast cancer resulted in not only a higher cancer detection yield but also an increase in false-positive findings.clinicaltrials.gov Identifier: NCT00072501.

Project description:BackgroundOur objective was to perform a systematic review and meta-analysis comparing the breast cancer detection rate (CDR), invasive CDR, recall rate, and positive predictive value 1 (PPV1) of digital mammography (DM) alone, combined digital breast tomosynthesis (DBT) and DM, combined DBT and synthetic 2-dimensional mammography (S2D), and DBT alone.MethodsMEDLINE and Embase were searched until April 2020 to identify comparative design studies reporting on patients undergoing routine breast cancer screening. Random effects model proportional meta-analyses estimated CDR, invasive CDR, recall rate, and PPV1. Meta-regression modeling was used to compare imaging modalities. All statistical tests were 2-sided.ResultsForty-two studies reporting on 2 606 296 patients (13 003 breast cancer cases) were included. CDR was highest in combined DBT and DM (6.36 per 1000 screened, 95% confidence interval [CI] = 5.62 to 7.14, P < .001), and combined DBT and S2D (7.40 per 1000 screened, 95% CI = 6.49 to 8.37, P < .001) compared with DM alone (4.68 per 1000 screened, 95% CI = 4.28 to 5.11). Invasive CDR was highest in combined DBT and DM (4.53 per 1000 screened, 95% CI = 3.97 to 5.12, P = .003) and combined DBT and S2D (5.68 per 1000 screened, 95% CI = 4.43 to 7.09, P < .001) compared with DM alone (3.42 per 1000 screened, 95% CI = 3.02 to 3.83). Recall rate was lowest in combined DBT and S2D (42.3 per 1000 screened, 95% CI = 37.4 to 60.4, P<.001). PPV1 was highest in combined DBT and DM (10.0%, 95% CI = 8.0% to 12.0%, P = .004), and combined DBT and S2D (16.0%, 95% CI = 10.0% to 23.0%, P < .001), whereas no difference was detected for DBT alone (7.0%, 95% CI = 6.0% to 8.0%, P = .75) compared with DM alone (7.0%, 95.0% CI = 5.0% to 8.0%).ConclusionsOur findings provide evidence on key performance metrics for DM, DBT alone, combined DBT and DM, and combined DBT and S2D, which may inform optimal application of these modalities for breast cancer screening.

Project description:ImportanceMany US radiologists have screening mammography recall rates above the expert-recommended threshold of 12%. The influence of digital breast tomosynthesis (DBT) on the distribution of radiologist recall rates is uncertain.ObjectiveTo evaluate radiologists' recall and cancer detection rates before and after beginning interpretation of DBT examinations.Design, setting, and participantsThis cohort study included 198 radiologists from 104 radiology facilities in the Breast Cancer Surveillance Consortium who interpreted 251?384 DBT and 2?000?681 digital mammography (DM) screening examinations from 2009 to 2017, including 126 radiologists (63.6%) who interpreted DBT examinations during the study period and 72 (36.4%) who exclusively interpreted DM examinations (to adjust for secular trends). Data were analyzed from April 2018 to July 2019.ExposuresDigital breast tomosynthesis and DM screening examinations.Main outcomes and measuresRecall rate and cancer detection rate.ResultsA total of 198 radiologists interpreted 2?252?065 DM and DBT examinations (2?000?681 [88.8%] DM examinations; 251?384 [11.2%] DBT examinations; 710?934 patients [31.6%] aged 50-59 years; 1?448?981 [64.3%] non-Hispanic white). Among the 126 radiologists (63.6%) who interpreted DBT examinations, 83 (65.9%) had unadjusted DM recall rates of no more than 12% before using DBT, with a median (interquartile range) recall rate of 10.0% (7.5%-13.0%). On DBT examinations, 96 (76.2%) had an unadjusted recall rate of no more than 12%, with a median (interquartile range) recall rate of 8.8% (6.3%-11.3%). A secular trend in recall rate was observed, with the multivariable-adjusted risk of recall on screening examinations declining by 1.2% (95% CI, 0.9%-1.5%) per year. After adjusting for examination characteristics and secular trends, recall rates were 15% lower on DBT examinations compared with DM examinations interpreted before DBT use (relative risk, 0.85; 95% CI, 0.83-0.87). Adjusted recall rates were significantly lower on DBT examinations compared with DM examinations interpreted before DBT use for 45 radiologists (35.7%) and significantly higher for 18 (14.3%); 63 (50.0%) had no statistically significant change. The unadjusted cancer detection rate on DBT was 5.3 per 1000 examinations (95% CI, 5.0-5.7 per 1000 examinations) compared with 4.7 per 1000 examinations (95% CI, 4.6-4.8 per 1000 examinations) on DM examinations interpreted before DM use (multivariable-adjusted risk ratio, 1.21; 95% CI, 1.11-1.33).Conclusions and relevanceIn this study, DBT was associated with an overall decrease in recall rate and an increase in cancer detection rate. However, our results indicated that there is wide variability among radiologists, including a subset of radiologists who experienced increased recall rates on DBT examinations. Radiology practices should audit radiologist DBT screening performance and consider additional DBT training for radiologists whose performance does not improve as expected.

Project description:BACKGROUND:To investigate the performance of primary ultrasound (P-US) screening for breast cancer, and that of supplemental ultrasound (S-US) screening for breast cancer after negative mammography (MAM). METHODS:Electronic databases (PubMed, Scopus, Web of Science, and Embase) were systematically searched to identify relevant studies published between January 2003 and May 2018. Only high-quality or fair-quality studies reporting any of the following performance values for P-US or S-US screening were included: sensitivity, specificity, cancer detected rate (CDR), recall rate (RR), biopsy rate (BR), proportion of invasive cancers among screening-detected cancers (ProIC), and proportion of node-negative cancers among screening-detected invasive cancers (ProNNIC). RESULTS:Twenty-three studies were included, including 12 studies in which S-US screening was used after negative MAM and 11 joint screening studies in which both primary MAM (P-MAM) and P-US were used. Meta-analyses revealed that S-US screening could detect 96% [95% confidential intervals (CIs): 82 to 99%] of occult breast cancers missed by MAM and identify 93% (95% CIs: 89 to 96%) of healthy women, with a CDR of 3.0/1000 (95% CIs: 1.8/1000 to 4.6/1000), RR of 8.8% (95% CIs: 5.0 to 13.4%), BR of 3.9% (95% CIs: 2.7 to 5.4%), ProIC of 73.9% (95% CIs: 49.0 to 93.7%), and ProNNIC of 70.9% (95% CIs: 46.0 to 91.6%). Compared with P-MAM screening, P-US screening led to the recall of significantly more women with positive screening results [1.5% (95% CIs:0.6 to 2.3%), P?=?0.001] and detected significantly more invasive cancers [16.3% (95% CIs: 10.6 to 22.1%), P?<?0.001]. However, there were no significant differences for other performance measures between the two screening methods, including sensitivity, specificity, CDR, BR, and ProNNIC. CONCLUSIONS:Current evidence suggests that S-US screening could detect occult breast cancers missed by MAM. P-US screening has shown to be comparable to P-MAM screening in women with dense breasts in terms of sensitivity, specificity, cancer detection rate, and biopsy rate, but with higher recall rates and higher detection rates for invasive cancers.

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Performance of Screening Ultrasonography as an Adjunct to Screening Mammography in Women Across the Spectrum of Breast Cancer Risk.

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