Mammographic Screening For Breast Cancer Research Articles

Artificial Intelligence Improves Detection of Supplemental Screening Ultrasound-detected Breast Cancers in Mammography.

Despite recent advances in artificial intelligence (AI) software with improved performance in mammography screening for breast cancer, insufficient data are available on its performance in detecting cancers that were initially missed on mammography. In this study, we aimed to determine whether AI software-aided mammography could provide additional value in identifying cancers detected through supplemental screening ultrasound. We searched our database from 2017 to 2018 and included 238 asymptomatic patients (median age, 50 years; interquartile range, 45-57 years) diagnosed with breast cancer using supplemental ultrasound. Two unblinded radiologists retrospectively reviewed the mammograms using commercially available AI software and identified the reasons for missed detection. Clinicopathological characteristics of AI-detected and AI-undetected cancers were compared using univariate and multivariate logistic regression analyses. A total of 253 cancers were detected in 238 patients using ultrasound. In an unblinded review, the AI software failed to detect 187 of the 253 (73.9%) mammography cases with negative findings in retrospective observations. The AI software detected 66 cancers (26.1%), of which 42 (63.6%) exhibited indiscernible findings obscured by overlapping dense breast tissues, even with the knowledge of magnetic resonance imaging and post-wire localization mammography. The remaining 24 cases (36.4%) were considered interpretive errors by the radiologists. Invasive tumor size was associated with AI detection after multivariable analysis (odds ratio, 2.2; 95% confidence intervals, 1.5-3.3; p < 0.001). In the control group of 160 women without cancer, the AI software identified 19 false positives (11.9%, 19/160). Although most ultrasound-detected cancers were not detected on mammography with the use of AI, the software proved valuable in identifying breast cancers with indiscernible abnormalities or those that clinicians may have overlooked.

Australian women's judgements about using artificial intelligence to read mammograms in breast cancer screening.

Mammographic screening for breast cancer is an early use case for artificial intelligence (AI) in healthcare. This is an active area of research, mostly focused on the development and evaluation of individual algorithms. A growing normative literature argues that AI systems should reflect human values, but it is unclear what this requires in specific AI implementation scenarios. Our objective was to understand women's values regarding the use of AI to read mammograms in breast cancer screening. We ran eight online discussion groups with a total of 50 women, focused on their expectations and normative judgements regarding the use of AI in breast screening. Although women were positive about the potential of breast screening AI, they argued strongly that humans must remain as central actors in breast screening systems and consistently expressed high expectations of the performance of breast screening AI. Women expected clear lines of responsibility for decision-making, to be able to contest decisions, and for AI to perform equally well for all programme participants. Women often imagined both that AI might replace radiographers and that AI implementation might allow more women to be screened: screening programmes will need to communicate carefully about these issues. To meet women's expectations, screening programmes should delay implementation until there is strong evidence that the use of AI systems improves screening performance, should ensure that human expertise and responsibility remain central in screening programmes, and should avoid using AI in ways that exacerbate inequities.

Clinicopathological characteristics and recurrence risk in patients with ductal carcinoma in situ of the breast

Introduction: With the widespread adoption of mammographic screening for breast cancer, ductal carcinoma in situ (DCIS) has been detected more frequently. In developing countries, the prevalence of ductal carcinoma in situ is low due to the opportunistic nature of breast cancer screening. The aim of this study was to evaluate the clinicopathological characteristics and recurrence rate in a cohort of patients with ductal carcinoma in situ in Brazil. Methods: This study was an retrospective analysis of all 1,736 patients with non-metastatic breast cancer treated at a reference public hospital between 1999 and 2013. All data were collected from medical records and the descriptive statistics were performed to characterize the clinical and pathological features. Results: In the present cohort, we identified 102 (5.2%) patients with non-invasive breast neoplasms. Mean age at diagnosis was 54±12.7 years and most patients were treated with breast conserving surgery. There is a strong association between nuclear grade and the expression of estrogen and progesterone receptors in ductal carcinoma in situ. Ipsilateral and contralateral recurrence rates in 10 years were 7.2% and 2%, respectively. Conclusion: The pathological features of ductal carcinoma in situ diagnosed in Brazil are similar to those observed in patients diagnosed in countries following a systematic screening program, and the treatment in our patients achieves similar success compared with published data in high-income countries.

Abstract P019: Continued depression of breast and lung cancer screening among Medicare enrollees during the COVID-19 pandemic

Abstract Background: Several studies reported sharp decreases in screening mammography for breast cancer and low-dose computerized tomographic screening for lung cancer in the early months of the COVID-19 pandemic, followed by a return to normal or near-normal levels in the summer of 2020. Objective: To determine the observed vs. expected mammography and low dose computed tomography rates from the beginning of the pandemic through April 2022. Methods: Retrospective cohort study assessing mammography and low dose computed tomography rates from January 2017 through April 2022. Data for January 2016 to February 2020 were used to generate expected rates for the period March 2020 to April 2022.Setting: United States Medicare population. Participants: A 20% national sample of Medicare fee-for-service enrollees among women aged 50-74 for mammography, and men and women aged 55-79 for low dose computerized tomography. Main outcome: Receipt of screening mammography or low dose computed tomography. Results: From January 2017 through February 2020, monthly mammography rates were flat, while there was a monotonic increase in low dose computed tomography rates, from approximately 500 per million per month in early 2017 to 1100 per million per month by January 2020. Over the period from March 2020 to April 2022, there were episodic drops in both mammography and low dose computed tomography rates, coincident with increases in national COVID-19 infection rates. For the periods from March 2020 to February 2020 and March 2021 to February 2022, the observed low dose computed tomography rates were 24% (95% Confidence Interval: 23%, 24%) and 14% (95% Confidence Interval: 13%, 15%) below expected rates, while mammography rates were 17% (95% Confidence Interval: 17%, 18%) and 4% (95% Confidence Interval: 4%, 3%) below expected. Conclusions and Relevance: The negative impact of the COVID-19 pandemic on lung cancer screening and breast cancer screening did not resolve after the initial pandemic surges. Successful interventions to improve screening rates should address pandemic-specific reasons for low screening participation. Citation Format: Christopher Huy D. Doan, Shuang Li, James Goodwin. Continued depression of breast and lung cancer screening among Medicare enrollees during the COVID-19 pandemic. [abstract]. In: Proceedings of the AACR Special Conference: Precision Prevention, Early Detection, and Interception of Cancer; 2022 Nov 17-19; Austin, TX. Philadelphia (PA): AACR; Can Prev Res 2023;16(1 Suppl): Abstract nr P019.

Breast cancer mammographic screening by different guidelines among women of different races/ethnicities

Mammographic screening is a common diagnostic tool for breast cancer among average-risk women. However, breast cancer screening guidelines differ between societies and organizations. Appropriate adherence to screening guidelines helps early diagnosis and treatment of breast cancer, which subsequently improves breast cancer survival. We used three national guidelines to define adherence recommended by US Preventive Services Task Force (USPSTF), American Cancer Society (ACS), and American College of Radiology (ACR), which included different criteria for age and frequency. (USPSTF: 50–74, biennial; ACS: 45–54, yearly, 55+ biennial; ACR: 40+, yearly) We hypothesized that adherence rates for mammographic screening may be lower among minorities (non-Hispanic black (NHB) and Hispanic/Latino) than among non-Hispanic whites (NHW) regardless of the guideline applied. We conducted a cross-sectional study using nationally representative survey data from the 2020 Health Information National Trends Survey (HINTS). Adherence to mammographic screening among NHW, NHB, and Hispanic/Latino populations were calculated. A total of 1,751 survey samples were used in the final analysis. Adherence rates of each guideline for average-risk woman in this study were as follows: USPSTF - 77.37%, ACS - 68.41%, and ACR - 57.71%. Additionally, our results demonstrated that the adherence rate was higher among NHB when compared with NHW women regardless of which guideline was applied. Multivariate logistic regression analysis indicated that both NHB ethnicity and insurance coverage exhibited strong positive associations with adherence to breast cancer screening. Our findings support other studies’ results that different racial/ethnic and socio-demographic factors can affect screening adherence. Therefore, healthcare providers should promote breast cancer screening especially among NHW/Hispanic women and women lacking insurance coverage.

Radar reflector guidance system in breast surgery: A single-institution feasibility study.

Mammography breast cancer screening programs and continuing improvements in early diagnosis of the disease have led to more frequent detection of nonpalpable breast lesions. The commonly used technique in guiding the surgical removal of these lesions is hook wire-guided localization (WGL). However, the WGL procedure has been criticized for the last years. Key disadvantages of WGL are possible wire transection, wire migration before or during surgery, patient discomfort and pneumothorax. Over the last decade, alternatives to wire localization have emerged. In this study the authors present their initial experience with a wireless, nonradioactive, wave reflection implant system that enables surgeons to safely and accurately remove breast lesions (Tab. 2, Fig. 4, Ref. 20). Keywords: breast cancer, breast surgery, nonpalpable lesions, preoperative localization.

Factors Associated with Breast Cancer Mammographic Screening Behavior among Iranian Women

This study was conducted on 458 female teachers aged 40 years and older of Hamadan city, in western part of Iran, during October to December of 2019. The participants were asked about the factors affecting mammography based on the health belief model. Questionnaires were completed by self-reported method and analyzed by SPSS software at 95% confidence interval. The average age of the study participants was 46±4.1 years. Among the participants, about 41.5% had performed mammography at least once. In univariate analysis, the constructs of the health belief model generally predicts performing mammography between 35 and 49 percent. In multivariate analysis, age 46 to 50 years, having supplementary insurance, history of breast disease, perceived barriers with odds ratio of 3.4, 3.4, 10.6 and .89, respectively, were significantly related to mammography. Female teachers over 45 years of age with a history of breast disease, if they do not have financial or other barriers to do mammography, perform breast cancer screening.

Trends in breast cancer screening rates among Korean women: results from the Korean National Cancer Screening Survey, 2005-2020.

Since 2002, the Korean government has provided breast cancer screening as part of the National Cancer Screening Program. This study reported trends in the screening rate among Korean women from 2005 to 2020, including organized and opportunistic screening for breast cancer. Data from the Korean National Cancer Screening Survey, an annual cross-sectional nationwide survey, were collected using a structured questionnaire between 2005 and 2020. The study population included 23,702 women aged 40-74 years with no history of cancer. We estimated the screening rate based on the current recommendation of biennial mammographic screening for breast cancer. In addition, a joinpoint trend analysis was performed for breast cancer screening rates among various subgroups. In 2020, the breast cancer screening rate was 63.5%, reflecting an annual increase of 7.72% (95% confidence interval 5.53 to 9.95) between 2005 and 2012, followed by non-significant trends thereafter. In particular, a significant decrease in the breast cancer screening rate was observed in the subgroups aged 50-59 years old, with 12-15 years of education, and living in rural areas. Although there has been substantial improvement in breast cancer screening rates in Korean women, the trend has flattened in recent years. Therefore, continual efforts are required to identify subgroups with unmet needs and solve barriers to the uptake of breast cancer screening.

Factors associated with breast cancer mammography screening and breast self-examination in Irish women: results from the Irish Longitudinal Study on Ageing (TILDA)

Background BreastCheck is Ireland’s breast screening service which offers biennial mammograms to women aged 50–69. Practicing regular breast self-examination (BSE) enhances women’s awareness and increases their perception of their susceptibility to the risk of breast cancer, possibly increasing their likelihood of attending a screening programme which reduces breast cancer mortality. Research is needed to identify the promotors and barriers to both attending breast cancer screening and practicing BSE. Purpose The aim of this study was to determine the promotors and barriers associated with attending breast cancer screening and practicing BSE in Irish women. Materials and Methods Data from the participants of TILDA wave 3 (2014–2015) was used, the participant population included females only (≥50 years old), a total of 3575 women. Bivariate analysis was used to identify variables that were significantly associated with having had a mammogram since the last interview (wave 2) or regularly checking their breasts for lumps (BSE). Regression analysis was then used to determine the effect the significant variables had on predicting the likelihood of participants attending breast screening or practicing BSE. Results Over half (55%) of all women over the age of 50 had a mammogram since wave 2 was completed (2012) and two thirds reported practicing regular BSE. The factors associated with having attended for breast cancer screening were: having private health insurance (OR = 1.86, 95%CI = 1.45–2.380), and practicing BSE (OR = 1.683, 95%CI = 1.344–2.107). The factors found to be associated with practicing regular BSE were: higher quality of life (OR = 1.035, 95%CI = 1.015–1.057), higher BMI (OR = 1.118, 95%CI = 1.020–1.226), being married (OR = 1.436, 95%CI = 1.190–1.732) and attending mammogram screening (OR = 1.691, 95%CI = 1.353–2.114). Conclusion Regular participation in mammography screening reduces breast cancer mortality. Women eligible for BreastCheck were significantly more likely to attend screening. BSE is associated with increased attendance at screening. Health-care professionals should encourage BSE in order to increase screening uptake.

Results of Two-Years Mammographic Screening in the Kaluga Region

Objective: approbation of the project of mass breast cancer mammographic screening in the Kaluga Region.Material and methods. From April 2018 to December 2019, screening mammography was performed in 35,439 women aged from 38 to 93 years (mean age 57.33 ± 8.07 years). The study was carried out on mobile mammography complexes assembled on Russian KamAZ vehicles with Russian-made equipment from Amiko company. Mammography was performed in frontal and oblique projections. BI-RADS ACR international classification was used to standardize the identified changes and assess the sensitivity and specificity of the study method.Results. Out of the total number of women examined, pathological changes (BI-RADS IV–V) were assumed according to mammography data in 778 (2.2%) cases, of which 700 (1.98%) patients appealed to an oncological institution. Benign processes were found in 394 (1.11%) patients, breast cancer in 164 (0.46%). Without verification of the diagnosis, 137 (0.39%) patients remained under the supervision of oncologists. Distribution of detected tumors by stages for 2 years of observation: stage 0 – 7, stage 1 – 73, stage 2 – 56, stage 3 – 13, stage 4 – 3. The stage was not set in 4 cases. The total number of those examined with verification of the diagnosis in the oncological institution was 596. The proportion of correct diagnoses was 94%. The total number of diagnostic errors that would occur in the absence of a true double scan accounted for 36 (6%) cases.Conclusion. The proposed screening method makes it possible to increase the breast cancer detection in the early preclinical stages of the disease, to provide the available diagnostics for the population due to mobile mammography complexes, and to speed up the process of diagnostics and further hospitalization for examination and necessary treatment according to the disease stage in a specialized oncological institution.

Breast Cancer Risk and Screening Mammography Frequency Among Multiethnic Women

In 2009, the U.S. Preventive Services Task Force updated recommended mammography screening frequency from annual to biennial for average-risk women aged 50-74 years. The association between estimated breast cancer risk and mammography screening frequency was evaluated. A single-center retrospective cohort study was conducted among racially/ethnically diverse women, aged 50-74 years, who underwent screening mammography from 2014 to 2018. Data on age, race/ethnicity, first-degree family history of breast cancer, previous benign breast biopsies, and mammographic density were extracted from the electronic health record to calculate Breast Cancer Surveillance Consortium 5-year risk of invasive breast cancer, with a 5-year risk ≥1.67% defined as high risk. Multivariable analyses were conducted to determine the association between breast cancer risk factors and mammography screening frequency (annual versus biennial). Data were analyzed from 2020 to 2022. Among 12,929 women with a mean age of 61±6.9 years, 82.7% underwent annual screening mammography, and 30.7% met high-risk criteria for breast cancer. Hispanic women were more likely to screen annually than non-Hispanic Whites (85.0% vs 79.8%, respectively), despite fewer meeting high-risk criteria. In multivariable analyses adjusting for breast cancer risk factors, high- versus low/average-risk women (OR=1.17; 95% CI=1.04, 1.32) and Hispanic versus non-Hispanic White women (OR=1.46; 95% CI=1.29, 1.65) were more likely to undergo annual mammography. A majority of women continue to undergo annual screening mammography despite only a minority meeting high-risk criteria, and Hispanic women were more likely to screen annually despite lower overall breast cancer risk. Future studies should focus on the implementation of risk-stratified breast cancer screening strategies.

Mammography and Decision Aid Use for Breast Cancer Screening in Older Women

Decision aids for breast cancer screening are increasingly being used by physicians, but the association between physician practice decision-aid use and mammography rates remains uncertain. Using national data, this study examines the association between practice-level decision-aid use and mammography use among older women. Physician practice responses to the 2017/2018 National Survey of Healthcare Organizations and Systems (n=1,236) were linked to 2016 and 2017 Medicare fee-for-service beneficiary data from eligible beneficiaries (n=439,684) aged 65-74 years. In 2021, multivariable generalized linear models estimated the association of practice decision-aid use for breast cancer screening and advanced health information technology functions with mammography use, controlling for practice and beneficiary characteristics. Overall, 60.1% of eligible beneficiaries had a screening mammogram, and 37.3% of physician practices routinely used decision aids for breast cancer screening. In adjusted analyses, advanced health information technology functions (OR=1.19, p=0.04) were associated with mammography use, but practice use of decision aids was not (OR=0.95, p=0.21). Beneficiary clinical and socioeconomic characteristics, including race, comorbidities, Medicare and Medicaid eligibility, and median household income were more strongly associated with mammography use than practice-level decision-aid use or advanced health information technology functions. Health information technology‒enabled automation of mammography reminders and other advanced health information technology functions may support mammography, whereas breast cancer decision aids may reduce patients' propensities to be screened through the alignment of their preferences and screening decision. More resources may be needed for decision aids to be routinely implemented to improve solicitation of patient preferences and targeting of mammography services.

Abstract 1019: Address breast cancer equity through virtual community oncology navigation and engagement (vCONET)

Abstract The objective of this study is to develop and test a culturally sensitive, inclusive, and accessible virtual navigation model for Black women to promote and improve breast cancer screening behaviors. Breast cancer is among the leading causes of cancer morbidity and mortality globally, and there is a wide range of racial and ethnic disparities across the cancer continuum. Black women continue to have disproportionately high mortality rates compared to Whites, and are more impacted by triple-negative breast cancer and inflammatory breast cancer earlier in their lives and at more advanced stages. Patient navigation, particularly when culturally tailored to the intended population, is highly effective in reducing the complexity of access to care for cancer prevention and treatment. The growing momentum and usage of telehealth and virtual care has significant potential to reach Black women, to promote higher mammography screening and early detection of breast cancer. Virtual patient navigation can provide a safe, engaging, and accessible space to accelerate the application of practical approaches to address health disparities and increase preventive behaviors in underrepresented community. However, limited information exists on specific factors which impact the design, implementation, and receptivity of virtual navigation in Black communities. This study aims to: 2) Develop and test a culturally-adapted prototype of a virtual patient navigation intervention tool for increasing access to breast cancer screening education and promotion for Black women. 1) Use qualitative focus group methodology to explore the beliefs, attitudes, perceptions, and receptivity of community members of program usability and breast cancer awareness, prevention and screening behaviors among Black women. The study will examine social determinants of health that impact potential challenges to access utilization of mammography screening services. Qualitative focus group discussions will be conducted to guide the details of the virtual patient navigation, such as communication channels, specific messaging approaches, and sociocultural factors to integrate, as well as addressing current challenges and needs faced by the community. The results of this study can provide valuable insight to specific needs regarding outreach and access to screening mammography services to underrepresented communities of color to ultimately reduce breast cancer rates. Data collection is ongoing and preliminary results will be presented. Citation Format: Manisha Salinas. Address breast cancer equity through virtual community oncology navigation and engagement (vCONET) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 1019.

Strengthening Breast Cancer Screening Mammography Services in Pakistan Using Islamabad Capital Territory as a Pilot Public Health Intervention.

Late diagnosis of treatable breast cancer is the reason for higher breast cancer mortality. Until now, no public breast cancer facility has been established in the Islamabad Capital Territory. First, a Federal Breast Screening Center (FBSC) was established. Afterward, awareness campaigns about breast cancer were organized among the public. Subsequently, women above 40 years of age were provided with mammography screenings. Data were analyzed in SPSS version 22.0. An intervention was performed using a six tier approach to strengthening the health system. Utilizing the offices of the FBSC and the national breast cancer screening campaign, breast cancer awareness has become a national cause and is being advocated by the highest offices of the country. The number of females undergoing mammography has increased each year, starting from 39 in 2015 to 1403 in 2019. Most of the cases were BI-RAD I (n = 2201, 50.74%) followed by BI-RAD II (n = 864, 19.92%), BI-RAD III (n = 516, 11.89%), BI-RAD IV (n = 384, 8.85%), BI-RAD V (n = 161, 3.71%), and BI-RVAD VI (n = 60, 1.38%). The current study has theoretical and practical implications for the contemplation of policymakers. The FBSC can serve as a model center for the establishment of centers in other parts of the country, thereby promoting nationwide screening coverage.

The Effects of Prior Mammography Screening on the Performance of Breast Cancer Detection in Taiwan.

The aim of this study was to investigate the influence of previous mammography screening on the performance of breast cancer detection. The screened women were divided into first-visit and follow-up groups for breast cancer screening. The positive predictive value (PPV), cancer detection rate (CDR), and recall rate were used to evaluate and analyze the overall screening performance among the two groups. Among them, 10,040 screenings (67.2%) were first visits and 4895 screenings (32.8%) were follow-up visits. The proportion of positive screening results for first-visit participants was higher than that for their follow-up counterparts (9.3% vs. 4.0%). A total of 98 participants (74 first-visit and 24 follow-up visit) were confirmed to have breast cancer. The PPV for positive mammography for women who underwent biopsy confirmation was 28.7% overall, reaching 35.8% for the follow-up visit group and 27.0% for the first-visit group. The CDR was 6.6 per 1000 overall, reaching 7.4 per 1000 for first-visit group and 4.9 per 1000 for the follow-up group. The overall recall rate was 7.9%, reaching 9.7% for the first-visit group and 4.2% for the follow-up group. The PPV is improved and the recall rate is decreased if prior mammography images are available for comparison when conducting mammography screening for breast cancer. By this study, we concluded that prior mammography plays an important role for breast cancer screening, while follow-up mammography may increase the diagnostic rate when compared to the prior mammography. We suggest that the public health authority can encourage subjects to undergo screenings in the same health institute where they regularly visit.

Interest of individual breast cancer screening by mammography in women aged over 75 years

Retrospective study of a continuous monocentric series of women over 75 having undergone surgery for breast cancer. The following variables were studied: addressing after screening or not, age at diagnosis, UICC stage and therapeutic measures (surgery by lumpectomy or mastectomy, lymph node dissection, adjuvant treatment with chemotherapy, radiotherapy or hormone therapy). 185 women aged 82.8 ± 5.2 years [extreme ages 75 to 95] were included in the study. 136 (73.5%) breast cancers were discovered after palpation and 49 (26.5%) after screening mammography. The distribution by stage was: I - 38.8%, II - 39.5%, III - 15.1% and stage IV - 7%. 164 (87.7%), patients received surgical treatment: 115 lumpectomies (61.2%) and 49 mastectomies (26.5%). 51 (27.6%) patients underwent lymph node dissection. The distribution of adjuvant treatments was: chemotherapy 21.1%, radiotherapy 68.6%, or hormone therapy (79.5%), sometimes combined. Women not screened are older than women screened (84 ± 5.3 versus 79.5 ± 3.6 years; p < 0.0001). Cancers are diagnosed at a more advanced stage in non-screened patients compared to screened patients (p < 0.0001). While there is a higher proportion of stage I among screened patients (75.5%), stage II is the most frequent in women not screened (47%). Stage I and II are the majority in the latter (72%). In multivariate analysis with adjustment for age, screening made it possible to make a diagnosis at a less advanced stage (stage I-II vs II-IV: OR = 5.593; 95% CI [1.575–19.866]; p = 0.0078) and to have conservative surgery more often (lumpectomy vs mastectomy: OR = 2.645; 95% CI [1.079–6.493]; p = 0.0333) without more recourse to surgery (OR = 1.856 95% CI [0.207–16.612]; p = 0.58). After adjusting for age and stage, screening was no longer a determining factor in the choice of type of surgery (OR = 1.934; 95% CI [0.753–4.975]; p = 0.170). At the age when organized breast cancer screening in France stopped, there was a decrease in survival, a diagnosis at a higher stage and an increase in co-morbidities. Our study shows a change in management with heavier treatment, more complications and a greater loss of autonomy without screening. This pleads for a continuation beyond 75 years of the practice of mammography screening for breast cancer in elderly women.

Contrast-enhanced mammography for the assessment of screening recalls: a two-centre study

ObjectivesTo evaluate the potential of contrast-enhanced mammography (CEM) for reducing the biopsy rate of screening recalls.MethodsRecalled women were prospectively enrolled to undergo CEM alongside standard assessment (SA) through additional views, tomosynthesis, and/or ultrasound. Exclusion criteria were symptoms, implants, allergy to contrast agents, renal failure, and pregnancy. SA and CEM were independently evaluated by one of six radiologists, who recommended biopsy or 2-year follow-up. Biopsy rates according to SA or recombined CEM (rCEM) were compared with the McNemar’s test. Diagnostic performance was calculated considering lesions with available final histopathology.ResultsBetween January 2019 and July 2021, 220 women were enrolled, 207 of them (median age 56.6 years) with 225 suspicious findings analysed. Three of 207 patients (1.4%) developed mild self-limiting adverse reactions to iodinated contrast agent. Overall, 135/225 findings were referred for biopsy, 90/225 by both SA and rCEM, 41/225 by SA alone and 4/225 by rCEM alone (2/4 being one DCIS and one invasive carcinoma). The rCEM biopsy rate (94/225, 41.8%, 95% CI 35.5–48.3%) was 16.4% lower (p < 0.001) than the SA biopsy rate (131/225, 58.2%, 95% CI 51.7–64.5%). Considering the 124/135 biopsies with final histopathology (44 benign, 80 malignant), rCEM showed a 93.8% sensitivity (95% CI 86.2–97.3%) and a 65.9% specificity (95% CI 51.1–78.1%), all 5 false negatives being ductal carcinoma in situ detectable as suspicious calcifications on low-energy images.ConclusionsCompared to SA, the rCEM-based work-up would have avoided biopsy for 37/225 (16.4%) suspicious findings. Including low-energy images in interpretation provided optimal overall CEM sensitivity.Key Points• The work-up of suspicious findings detected at mammographic breast cancer screening still leads to a high rate of unnecessary biopsies, involving between 2 and 6% of screened women.• In 207 recalled women with 225 suspicious findings, recombined images of contrast-enhanced mammography (CEM) showed a 93.8% sensitivity and a 65.9% specificity, all 5 false negatives being ductal carcinoma in situ detectable on low-energy images as suspicious calcifications.• CEM could represent an easily available one-stop shop option for the morphofunctional assessment of screening recalls, potentially reducing the biopsy rate by 16.4%.

Diagnostic accuracy of the CxPREVENTIVE breast model for early detection of breast cancer.

e13578 Background: Despite different available methods for breast cancer (BC) screening (mainly mammographies for ages between 50 and 65 yr.), and their proven benefits, morbidity, and mortality of this malignancy are still high, partly due to technical limitations and low compliance with screening. The aim of the present study was to assess the diagnostic accuracy for early detection of BC using a modeling algorithm based on multiple blood and urine biomarkers. Methods: In this retrospective cohort study, clinical and blood and urine markers-based algorithms with predefined cutoff values were applied to a generally healthy asymptomatic outpatient cohort of women aged 23 years or older undergoing mammography and histopathology for routine breast cancer screening. We used a modeling algorithm based on two different frameworks (Multiple Biomarkers Disease Activity Algorithm MBDAA [Bioprognos], and Artificial Intelligence Recursive Algorithm AIRA [Mintlot] both in Barcelona, Spain). Both algorithms compute information from a wide number of analytes, tumor markers (CA 15.3, CEA, EGFR, NGAL, NSE and 8-OHdG), and additional clinical data (age, weight, height, and BMI). MBDAA includes Barcelona Criteria (four criteria to correctly interpret the cause of the increase in tumor markers, benign or malignant, defined by the Spanish Society of Clinical Biochemistry and Molecular Pathology, Commission of Biological Markers of Cancer). To assess the association between the modelling algorithm and downstream diagnosis we used logistic regression to compute receiver operating characteristic curves (ROC). Exact binomial confidence limits were calculated to test accuracy, sensitivity, and specificity. Results: 123 women (median age 48 yr. [IQR 40-63]) who underwent mammography at the Juan Ramón Jiménez Hospital (Huelva, Spain), were included in this analysis. Based on mammography and histopathologic findings, BC was diagnosed in 61 (49.5%) women, and absence of pathological findings (control group) was seen in 62 (51.5%). The diagnostic intervention for BC yielded an area under the curve (AUC) of 1 among the entire specimen set, accuracy 1 (95% CI 0.990,1), Se 1 (0.991, 1) and Sp 1 (0.991, 1). Conclusions: Using mammography as a gold standard, our data suggest that an innovative newly designed non-invasive blood and urine-based biomarker algorithm CxPREVENTIVE Breast may provide a timely diagnosis of BC with very high accuracy, especially for those women under 50 and over 65yr., where up to 60% of all BC are concentrated. Our findings warrant further investigation, and we are planning large-scale (n 10,000), fully powered study to inform clinical practice.

Adjusting the TMIST study design to accommodate slower than expected accrual: ECOG-ACRIN EA1151.

TPS10614 Background: The ECOG-ACRIN Tomosynthesis Mammographic Imaging Screening Trial (TMIST), which opened in 2017, is a randomized trial designed to assess whether Tomosynthesis Mammography (TM) should replace Digital Mammography (DM) for breast cancer screening. It is hypothesized that women assigned to TM for 3-5 screening rounds will have fewer advanced breast cancers than the women assigned to DM. Advanced cancers are those that have distant metastases or positive nodes, are invasive tumors greater than or equal to 2.0 cm in size, or are invasive tumors greater than 1.0 cm in size that are triple negative or HER 2+. The initially planned enrollment of 164,946 women was due to be completed by the end of 2020, with follow-up concluded by 2025. There were substantial challenges in meeting this timeline, including the organizational and funding structure of the NCI National Clinical Trials Network which is dependent upon sites using their existing staffing resources (not always readily available at the time of study activation). This led to longer than anticipated start of enrollment for most interested sites and lower than anticipated annual enrollment per participating site based ultimately on the staffing support that could be allocated to manage TMIST. In addition, research staffing shortages and periodic research operations closures due to COVID-19 have also impacted enrolling TMIST sites, though unevenly, since the start of the pandemic. Enrollment plateaued at approximately 2,100 subjects per month by the end of 2020. With that accrual rate expected, the trial design was modified to reduce the sample size so that the study could be completed by 2027. Methods: With the approval of the NCI CIRB, we changed how the primary endpoint measure for TMIST is assessed from the number of advanced cancers that occur by 4.5 years after randomization to the time from randomization to occurrence of advanced cancers. All advanced cancers occurring within 7 years of randomization are now included and all participants followed for at least three years. In addition, the power of the study of the study was modified from 0.9 to 0.85, while the originally assumed effect size at 4.5 years was retained These changes allowed a reduction of sample size to 128,905, with subject recruitment projected to end in 2024. As of February 14, 2022, there are 125 sites open, 114 in the U.S. and 11 in other countries, with an additional 31 sites planning to open. As of February 14, 2022, a total of 63,845 women have been enrolled in the trial worldwide at 115 sites, with 20% of US participants self-identifying as belonging to minority racial and ethnic groups and 70% consenting to optional blood and/or buccal cell collection. Clinical trial information: NCT03233191.

Breast cancer screening in persons experiencing homelessness.

6515 Background: Persons experiencing homelessness (PEH) suffer from poor health outcomes, including worse cancer mortality, compared to persons not experiencing homelessness. A portion of the disparity in cancer outcomes is attributable to reduced access to cancer screening, leading to more advanced-stage disease and a higher risk of death compared to the general population. Data regarding cancer screening rates in PEH are scarce. We therefore sought to evaluate baseline rates of breast cancer screening in PEH. Methods: All patients presenting for care from January 1, 2014 onward at a hospital system spanning five counties in a populous Midwestern state were screened for homelessness. Homelessness was identified by two criteria: presence of the Z-code for homelessness (Z59) in the patient’s electronic medical record, and/or patient’s address on record listed as an address matching that of a regional homeless shelter, transitional housing, or “homeless.” Identified PEH were maintained in a prospective registry. For each female PEH in the screening age range, billing data for completed breast cancer screening mammography performed in the previous five years (1/1/17-12/31/21) were extracted (CPT codes 77063, 77067). Data were also extracted for a cohort of non-PEH patients eligible for screening. Demographic and clinical data were extracted for all patients. This study was approved by the hospital system’s IRB. Results: A total of 3,474 female (biological sex) PEH were identified, with 1,320 eligible for screening mammography (alive and between the ages of 40 and 79) in the study timeframe. The median age was 53.5 years old; 44% were Black, 48% White, 8.5% unknown/other race, and 3% Hispanic ethnicity. 28% of PEH were uninsured, and 67% had government insurance; 66% had an assigned primary care physician (PCP). Of PEH eligible for screening mammography, 237 (18%) had at least one screening mammogram during this five-year interval (2017, 2.2%; 2018, 4.3%; 2019, 3.6%; 2020, 3.7%; 2021, 4.3%). In a cohort of 6,240 non-PEH eligible for screening over the same timeframe, the screening mammography rate was 32%, which was significantly higher than the screening rate for PEH (p &lt; 0.00001). Compared to PEH who did not undergo screening mammography, PEH who underwent screening mammography were more likely to have an assigned PCP (90% vs 38%, p &lt; 0.00001), to be a non-current tobacco user (56% vs 35%, p &lt; 0.00001), and to be a non-current illicit drug user (84 % vs 68%, p = 0.0015). PEH who underwent screening mammography were significantly less likely to be uninsured (12% vs 31%, p &lt; 0.00001). Conclusions: In the largest study of its kind to date, we identified low rates of breast cancer screening in female PEH. Interventions to increase breast cancer screening in this vulnerable population are urgently needed and may include increased access to PCPs, tobacco and drug cessation programs, and provision of health insurance.