Mammography Screening Program Research Articles

Effectiveness of Mammography Screening on Breast Cancer Mortality - A Study Protocol for Emulation of Target Trials Using German Health Claims Data.

The efficacy of mammography screening in reducing breast cancer mortality has been demonstrated in randomized trials. However, treatment options - and hence prognosis - for advanced tumor stages as well as mammography techniques have considerably improved since completion of these trials. Consequently, the effectiveness of mammography screening under current conditions is unclear and controversial. The German mammography screening program (MSP), an organized population-based screening program, was gradually introduced between 2005 and 2008 and achieved nation-wide coverage in 2009. We describe in detail a study protocol for investigating the effectiveness of the German MSP in reducing breast cancer mortality in women aged 50 to 69 years based on health claims data. Specifically, the proposed study aims at estimating per-protocol effects of several screening strategies on cumulative breast cancer mortality. The first analysis will be conducted once 10-year follow-up data are available. We will use claims data from five statutory health insurance providers in Germany, covering approximately 37.6 million individuals. To estimate the effectiveness of the MSP, hypothetical target trials will be emulated across time, an approach that has been demonstrated to minimize design-related biases. Specifically, the primary contrast will be in terms of the cumulative breast cancer mortality comparing the screening strategies of "never screen" versus "regular screening as intended by the MSP". In Germany, the utilization of data from health insurances for scientific research is regulated by the Code of Social Law. All involved health insurance providers as well as the responsible authorities approved the use of the health claims data for this study. The Ethics Committee of the University of Bremen determined that studies based on claims data are exempt from institutional review. The findings of the proposed study will be published in peer-reviewed journals.

21 (PB-021) Poster Spotlight - Breast Cancer Whole Blood Screening: Analytical and Clinical Performance from Early Analysis of the International Identify Breast Cancer (IDBC) Study

Background: Breast cancer is detected after stage I for many women, particularly women with dense breast tissue and those under 50, due to screening mammography performance and program participation. This report provides data for a new CE-marked blood test currently available in Canada. The test uses a non-fractionated blood sample and involves analysis of a gene expression panel (12 targets) using custom reagents and machine-learning informed software for identification of an active breast cancer signature that has been validated through a retrospective clinical study.

140 (PB-053) Poster - Contribution and performance of subsidized mammography and breast cancer detection rate in underserved populations of rural and urban areas of Sindh, Pakistan

Background: In Pakistan, breast cancer is an enormous public health concern as its mortality is the highest in any Asian population. It can be effectively detected in its early stage with screening mammography, offered to all eligible asymptomatic women. However, in Pakistan, there is no organized screening mammography program at the national level & screening practices are very low. That is why advanced-stage presentation is common in our population. It is important to assess the utility of subsidized screening mammography services in the early detection of breast cancer and reduction of mortality rates in Pakistan.

The Norwegian Breast Cancer Registry (NBCR): A clinical register that monitors surgical care with the intention to increase the quality of treatment given to breast cancer patients in Norway

Increased focus on quality indicators and the use of clinical registries for breast cancer has shown higher compliance with recommended treatment in several studies. Norwegian Breast Cancer Registry (NBCR) has presented data on quality indicators since 2015. The registry is 95% complete for surgical treatment during 2015-2021. Over time, increased compliance to recommended surgical therapy has been observed. The completeness of data is, unfortunately, a problem, particularly for breast radiology outside the Norwegian mammography screening program, and for data on oncological treatment. Automation of data capture is a priority at the Cancer Registry of Norway (CRN), with the ongoing INSPIRE (INcreaSe PharmaceutIcal REporting) and SNOMED CT (Systematized Nomenclature of Medicine – Clinical Terms) projects. These projects may add important data and improve the completeness and quality of the NBCR, which is useful for improving the quality of care given to Norwegian breast cancer patients.

Determinants of mammography screening participation-a cross-sectional analysis of the German population-based Gutenberg Health Study (GHS).

We investigated the association between social inequality and participation in a mammography screening program (MSP). Since the German government offers mammography screening free of charge, any effect of social inequality on participation should be due to educational status and not due to the financial burden. The 'Gutenberg Health Study' is a cohort study in the Rhine-Main-region, Germany. A health check-up was performed, and questions about medical history, health behavior, including secondary prevention such as use of mammography, and social status are included. Two indicators of social inequality (equivalence income and educational status), an interaction term of these two, and different covariables were used to explore an association in different logistic regression models. A total of 4,681 women meeting the inclusion criteria were included. Only 6.2% never participated in the MSP. A higher income was associated with higher chances of ever participating in a mammography screening (odds ratios (OR): 1.67 per €1000; 95%CI:1.26-2.25, model 3, adjusted for age, education and an interaction term of income and education). Compared to women with a low educational status, the odds ratios for ever participating in the MSP was lower for the intermediate educational status group (OR = 0.64, 95%CI:0.45-0.91) and for the high educational status group (0.53, 95%CI:0.37-0.76). Results persisted also after controlling for relevant confounders. Despite the absence of financial barriers for participation in the MSP, socioeconomic inequalities still influence participation. It would be interesting to examine whether the educational effect is due to an informed decision.

Breast Density and Breast Cancer Screening with Digital Breast Tomosynthesis: A TOSYMA Trial Subanalysis.

Background Digital breast tomosynthesis (DBT) plus synthesized mammography (SM) reduces the diagnostic pitfalls of tissue superimposition, which is a limitation of digital mammography (DM). Purpose To compare the invasive breast cancer detection rate (iCDR) of DBT plus SM versus DM screening for different breast density categories. Materials and Methods An exploratory subanalysis of the TOmosynthesis plus SYnthesized MAmmography (TOSYMA) study, a randomized, controlled, multicenter, parallel-group trial recruited within the German mammography screening program from July 2018 to December 2020. Women aged 50-69 years were randomly assigned (1:1) to DBT plus SM or DM screening examination. Breast density categories A-D were visually assessed according to the Breast Imaging Reporting and Data System Atlas. Exploratory analyses were performed of the iCDR in both study arms and stratified by breast density, and odds ratios and 95% CIs were determined. Results A total of 49 762 women allocated to DBT plus SM and 49 796 allocated to DM (median age, 57 years [IQR, 53-62 years]) were included. In the DM arm, the iCDR was 3.6 per 1000 screening examinations in category A (almost entirely fatty) (16 of 4475 screenings), 4.3 in category B (102 of 23 534 screenings), 6.1 in category C (116 of 19 051 screenings), and 2.3 in category D (extremely dense breasts) (six of 2629 screenings). The iCDR in the DBT plus SM arm was 2.7 per 1000 screening examinations in category A (12 of 4439 screenings), 6.9 in category B (154 of 22 328 screenings), 8.3 in category C (156 of 18 772 screenings), and 8.1 in category D (32 of 3940 screenings). The odds ratio for DM versus DBT plus SM in category D was 3.8 (95% CI: 1.5, 11.1). The invasive cancers detected with DBT plus SM were most often grade 2 tumors; in category C, it was 58% (91 of 156 invasive cancers), and in category D, it was 47% (15 of 32 invasive cancers). Conclusion The TOmosynthesis plus SYnthesized MAmmography trial revealed higher invasive cancer detection rates with digital breast tomosynthesis plus synthesized mammography than digital mammography in dense breasts, relatively and absolutely most marked among women with extremely dense breasts. ClinicalTrials.gov registration no.: NCT03377036 © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Lee and Moy in this issue.

Effectiveness of Organized Mammography Screening for Different Breast Cancer Molecular Subtypes.

Simple SummaryWe evaluated the short-term effectiveness of a mammography screening program in all women who participated in the screening program and were diagnosed with screen-detected or interval breast cancer (BC) in Flanders (2008–2018). The evaluation was performed for the major molecular subtypes of invasive BC separately and considering the regularity of participation. We found that screen-detected BC was more likely to be diagnosed at early stages than interval BC of luminal, luminal-HER2-positive, and triple-negative BC (TNBC) type, but not for the human epidermal growth factor receptor 2-positive (HER2 positive) subtype. In addition, regular participation was related to a higher likelihood of screening detection than irregular participation for luminal, luminal-HER2-positive, and TNBC, but not for the HER2 positive subtype, either. Our results indicate that regular screening as compared to irregular screening is effective for all breast cancers except for the HER2 subtype.Background: Screening program effectiveness is generally evaluated for breast cancer (BC) as one disease and without considering the regularity of participation, while this might have an impact on detection rate. Objectives: To evaluate the short-term effectiveness of a mammography screening program for the major molecular subtypes of invasive BC. Methods: All women who participated in the screening program and were diagnosed with screen-detected or interval BC in Flanders were included in the study (2008–2018). Molecular subtypes considered were luminal and luminal-HER2-positive, human epidermal growth factor receptor 2-positive, and triple-negative BC (TNBC). The relationship between the BC stage at diagnosis (early (I–II) versus advanced (III–IV)) and the method of detection (screen-detected or interval) and the relationship between the method of detection and participation regularity (regular versus irregular) were evaluated by multi-variable logistic regression models. All models were performed for each molecular subtype and adjusted for age. Results: Among the 12,318 included women, BC of luminal and luminal-HER2-positive subtypes accounted for 70.9% and 11.3%, respectively. Screen-detected BC was more likely to be diagnosed at early stages than interval BC with varied effect sizes for luminal, luminal-HER2-positive, and TNBC with OR:2.82 (95% CI: 2.45–3.25), OR:2.39 (95% CI: 1.77–3.24), and OR:2.29 (95% CI: 1.34–4.05), respectively. Regular participation was related to a higher likelihood of screening detection than irregular participation for luminal, luminal-HER2-positive, and TNBC with OR:1.21 (95% CI: 1.09–1.34), OR: 1.79 (95% CI: 1.38–2.33), and OR: 1.62 (95% CI: 1.10–2.41), respectively. Conclusions: Regular screening as compared to irregular screening is effective for all breast cancers except for the HER2 subtype.

Breast cancer screening in low and middle-income countries.

Breast cancer incidence rates are rising in low and middle-income countries (LMIC), and these populations have reduced access to advanced multidisciplinary treatment. Screening and early detection are therefore critical in these regions but must be affordable and sustainable. Mammography screening programs are well established in more affluent countries, but alternative strategies to reduce the breast cancer burden of LMIC (such as clinical breast examination, general breast health awareness, and addressing modifiable lifestyle factors including obesity) are likely to be more realistic at the present time.

An Integrated Machine Learning Scheme for Predicting Mammographic Anomalies in High-Risk Individuals Using Questionnaire-Based Predictors.

This study aimed to investigate the important predictors related to predicting positive mammographic findings based on questionnaire-based demographic and obstetric/gynecological parameters using the proposed integrated machine learning (ML) scheme. The scheme combines the benefits of two well-known ML algorithms, namely, least absolute shrinkage and selection operator (Lasso) logistic regression and extreme gradient boosting (XGB), to provide adequate prediction for mammographic anomalies in high-risk individuals and the identification of significant risk factors. We collected questionnaire data on 18 breast-cancer-related risk factors from women who participated in a national mammographic screening program between January 2017 and December 2020 at a single tertiary referral hospital to correlate with their mammographic findings. The acquired data were retrospectively analyzed using the proposed integrated ML scheme. Based on the data from 21,107 valid questionnaires, the results showed that the Lasso logistic regression models with variable combinations generated by XGB could provide more effective prediction results. The top five significant predictors for positive mammography results were younger age, breast self-examination, older age at first childbirth, nulliparity, and history of mammography within 2 years, suggesting a need for timely mammographic screening for women with these risk factors.

The Role of Surgical Axillary Staging Prior to Immediate Breast Reconstruction in the Era of De-Escalation of Axillary Management in Early Breast Cancer.

Postmastectomy radiotherapy (PMRT) following immediate breast reconstruction (IBR) is associated with postoperative complications. Although the incidence of node-positive breast cancer is declining, a separate sentinel lymph node biopsy (SLNB) is still performed before mastectomy when IBR is planned, in order to evaluate nodal status and the need for PMRT. This study assessed the impact of staged SLNB on the breast reconstructive planning, and presents common clinicopathological characteristics of breast cancer with macrometastatic nodal spread where staged SLNB would be beneficial to indicate PMRT. Medical records of breast cancer patients scheduled for mastectomy and IBR at Skåne University Hospital, Sweden, from November 2014 to February 2020, were reviewed. Of 92 patients, node-positive disease was present in 15 (16%). Fifty-three patients underwent staged SLNB before mastectomy and IBR, and 10 (19%) presented with nodal metastasis. All patients with macrometastatic sentinel nodes were presented with palpable, multifocal, ER+ breast carcinoma of no special type with tumor size > 17.0 mm. Overall, four women received PMRT after verified metastasis by staged SLNB, and IBR was cancelled for three patients. These findings question the benefit of routine staged SLNB before mastectomy and IBR in breast cancer populations within established mammography screening programs with low risk of nodal metastasis.

Comparison of BIRADS lexicon to breast biopsy findings in low resource countries

Breast cancer is the most common malignancy in women worldwide and early detection is of utmost importance. In developed countries, mandatory mammographic screening programs help in early detection, whereas, in developing countries cancer is often detected at an advanced stage. The BIRADS guidelines permit a standard approach and follow up for breast lesions. Many newer imaging modalities are being available for better diagnosis. Breast lesions have a varied spectrum and the gold standard for diagnosis of breast cancer is based on histopathological examination of tissue. At times, even on trucut biopsy, it is difficult to categorize the lesion as the tissue studied is limited and some evolving lesions may have overlapping features. As there are limitations to both radiologic and pathologic approaches, the general and accepted way is to combine both modalities to arrive at a diagnosis. The aim: The aim of the study was to find out how well the BIRADS radiological findings correlate with histopathological findings on breast biopsies. Materials and methods: A MEDLINE search for articles published in English language, with key words as breast biopsy histopathology and BIRADS was done for the years between 1985 and 2021. In addition, other cross-referenced articles were also searched for relevant data. Results: There is good correlation between BIRADS category 1, 2 and 5 with the findings on core needle biopsy in breast lumps i.e., good correlation is seen at the end of spectrum of breast lesions in totally benign and unequivocally malignant lesions. But this correlation is lacking in the middle of the spectrum i.e., in borderline/intermediate category of BIRADS. Conclusion: The non-suspicious (BIRADS 1/ 2) and highly suspicious (BIRADS 4C/5) compare very well with the histopathologic findings. It is the grey zone i.e., BIRADS 3/4A which has a wide and variable predictive value for breast cancer when compared with histopathology and imaging study alone is insufficient and mandates histopathology in all such cases

Comparison of female breast cancer between Russia and Germany: A population-based study on time trends and stage at diagnosis

ObjectivesWhile a mammography-screening program (MSP) is being offered systematically in Germany since 2009, the dispanserizatsiya has been implemented in Russia since 2013. This study examined trends of stage at breast cancer diagnosis in two Russian regions and compared the results with the development in Germany. In addition, we aimed to gain further insights into the early detection of breast cancer in Russia. MethodsIncidence data from two cancer registries in Russia and 12 population-based cancer registries in Germany were used to analyse breast cancer incidence rates among women above age 30 over time. Further, we calculated rate ratios to compare the age group-specific incidence rates after the implementation of MSP in Germany (2010–2014) with the period before implementation (2003–2005) separately for each tumour stage and all stages combined. ResultsDuring the study period from 2003 to 2014, age-standardised rates for breast cancer were 54.6 and 116.7 per 100,000 for Russia and Germany, respectively. The proportion of the T1 stage at diagnosis among Russian women aged 50 + is half than that in Germany. Nevertheless, we observed an increasing trend of early-stage alongside the reduction of advanced-stage incidence rates of breast cancer in Russia. ConclusionsThe observed trend in Russia may reflect overall positive changes in early detection of breast cancer, with actual proportion of T1 stage still far behind Germany. Advances in breast cancer screening efforts through the dispanserizatsiya may help to further reduce the breast cancer burden.

Breast cancer risk predictions by birth cohort and ethnicity in a population-based screening mammography program.

To examine whether birth cohorts affect the risk of breast cancer for East Asian, First Nations, African, South Asian and Caucasian ethnicities in British Columbia (BC). We used Cox PH models adjusted for well-known risk factors, such as age, breast density, mammographic features on false positives, and family history, to examine risk of breast cancer among East Asian, First Nations, African and South Asian ethnicities, relative to Caucasian, across three birth cohorts. There were 813,280 participants and 11,166 in situ and invasive breast cancer diagnoses. East Asians screened in BC were found to have a lower risk of breast cancer in the birth cohort born pre-1946 compared to Caucasian, but there was no statistically significant decrease for East Asians born after 1946. First Nations had an increased risk of breast cancer compared with Caucasian for all birth cohorts ranging from 1.1 to 2.0x the risk, which was statistically significant for those born after 1965. South Asians showed a statistically significant decrease in risk ranging from 0.58 to 0.81x lower compared with Caucasians for all birth cohorts. Risk of breast cancer for South Asians living in BC was found to be lower than Caucasians for each birth cohort examined, while East Asians had a comparable risk of breast cancer, First Nations had a consistently higher risk than Caucasians. When accounting for birth cohort, compared to Caucasians, South Asians have a decreased risk, First Nations have an increased risk, and East Asians have a similar risk of breast cancer.

Breast Cancer Priorities in Limited-Resource Environments: The Price-Efficacy Dilemma in Cancer Care.

Breast cancer has become one of the leading causes of morbidity and mortality in low- and middle-income countries, where 62% of the world's total new cases are diagnosed. Therefore, the productivity loss because of premature death resulting from female breast cancer is also on the rise. The major challenge in low- and middle-income countries is to reduce the proportion of women presenting with advanced-stage disease, a challenge unlikely to be overcome by adoption of expensive national mammography screening programs. Awareness and education campaigns should focus not only on patients and societies but also on policy makers to address and optimize breast cancer care. Adaptation of existing guidelines and prioritization according to local resources are essential to address the unique needs and overcome the unique barriers of each society to facilitate practical implementation and improve outcomes. Emphasis on the principle of a cancer groundshot in addressing value in cancer care is vital to improving access to therapies that are proven to work rather than chasing after new drugs or innovations of doubtful or marginal clinical benefit. Until we have drug-pricing interventions that take into account the local income of each society, we must acknowledge the fact that the delivery of cancer care will never be the same all around the world.

Immunohistochemical Tumor Characteristics of Breast Cancer according to Participation in the Mammography Screening Program

Abstract Background Breast cancer detected in participants of the German Mammography Screening Program (MSP) shows a favorable distribution of prognostic parameters and hormone receptor status compared to cancer in non-participants, even including interval cancers. The aim of our study is to examine the distribution of intrinsic breast cancer subtypes considering the proliferation marker Ki-67 in participants and non-participants in a population-based setting and to evaluate the association between Ki-67 and tumour characteristics. Methods Population based data from the Epidemiological Cancer Registry Lower Saxony is analysed in this retrospectiv observational study. 1115 cases of breast cancer (in situ and invasive, year of diagnosis 2014) among women aged 50–69 years and residing in the regions of two screening units of Lower Saxony are included (n = 285 634 biennially entitled women). The group of the participants containes cancers that are detected by screening or in the interval of 24 month after a negative screening. The group of non-participants includes all breast cancers without match with screening data. Results Considering cases with invasive breast cancer (n = 953) tumours detected in screening participants are more often diagnosed in early T stage (T1, p < 0,0001), HER2 negativ (p = 0,0336), with lower Ki-67 percentage scores (p < 0,0003) and without loco-regional lymph node involvement (p < 0,0001), compared to tumours in non-participants – even including interval cancers. Regarding grading both groups show less differences (p = 0,1718), because interval cancer are more comparable with cancers in non-participants. We find distinct differences in distribution of the intrinsic suptypes between both groups (p < 0,0003): especially in category Luminal A (38,4 % vs. 26,7 %), but also in the categories Luminal A or B (26,7 vs. 22,1 %), Luminal B (21,1 vs. 30,6 %), HER2 enriched (5,1 vs. 7,8 %) und triple-negative (8,8 vs. 12,8 %). Ki-67 is associated with all analysed prognostic factors, first of all with grading (p < 0,0001). Discussion According to the S3-Guidelines an adjuvant chemotherapy can be avoided in the majority of Luminal A type breast cancers. Assuming that both groups received a guideline-based therapy MSP participants (including interval cancers) could be treated with less aggressive systemic therapy compared with cancers in non-participants. Our results indicate for both groups that Ki-67 is a prognostic marker, which is not independent of other histopathological factors.

Time to biopsy of screening mammography-detected abnormalities: Evaluating the impact of same-day services implemented during the COVID-19 pandemic.

1511 Background: Screening mammography programs often require patients undergo multiple visits (screening exam, diagnostic exam, and biopsy) before tissue diagnoisis of screen-detected abnormalities. During the COVID-19 pandemic, same-day breast imaging services were leveraged to decrease the number of visits following abnormal screening exams. Specifically, in May 2020, we implemented an immediate-read screening mammography program to synergize with our pre-existing same-day breast biopsy program, such that every effort was made to perform diagnostic imaging during the same visit after an abnormal screening mammogram. This study aims to evaluate the impact of these same-day breast imaging services on time and number of patient visits to undergo breast biopsy after an abnormal screening mammogram. Methods: Consecutive screening mammograms performed during normal business hours pre- (6/1/16 to 5/30/17) and post-implementation (6/1/20 to 5/30/21) of same-day services were identified. Patient demographics, imaging and biopsy results, and visit dates were extracted from the medical record. Multivariable logistic, linear, and ordinal regression models estimated with generalized estimating equations were fit to assess the association of period (pre- versus post-implementation), patient age, and race and ethnicity (White versus races other than White) with having a same-day biopsy (biopsy on the same day as the abnormal screening exam), number of days to biopsy, and number of visits. Adjusted odds ratios (aOR) and beta estimates (aBeta) of each covariate and corresponding 95% confidence intervals (CI) were estimated. Results: A total of 409/25,922 (1.6%) of patients (median age 61, IQR 50-70) pre-implementation and 221/20,452 (1.1%) patients (median age 62, IQR 49-71) post-implementation had screen-detected abnormalities leading to diagnostic breast imaging and biopsy. Median number of days from screening to biopsy decreased from 16 days pre-implementation to 5 days post-implementation (p < 0.001). Pre-implementation, 86.8% of patients required 3 visits between screening and biopsy, while post-implementation only 23.1% required 3 visits (p < 0.001). Compared to pre-implementation, the post-implementation period was associated with increased odds of undergoing same-day biopsy (aOR 20.7, 95% CI 8.3-51.7), p < 0.001), fewer days from abnormal screening mammogram to biopsy (aBeta -13.3, 95% CI -15.7 to -10.9, p < 0.001), and fewer visits (aOR 0.05, 95% CI 0.02-0.09), p < 0.001), controlling for age and race and ethnicity. Conclusions: Same-day breast imaging services decreased time and patient visits between abnormal screening mammogram and breast biopsy. Same-day services implemented out of necessity during the COVID-19 pandemic should be continued after the pandemic has subsided to improve timeliness of care.

SMALL: Open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancers.

TPS614 Background: Mammographic screening programmes reduce breast cancer mortality but detect many small tumours with favourable biology which may not progress. These are treated with surgery and adjuvant therapies, but associated morbidities mean there is a need to reduce overtreatment. Minimally invasive treatments such as vacuum-assisted excision (VAE) have been described but there is no prospective randomised evidence to support their routine use. SMALL (ISRCTN 12240119) is designed to establish the feasibility of using VAE to treat small tumours detected within the UK NHS Breast Screening Programme (BSP). Methods: Phase III multicenter randomized trial comparing surgery with VAE for screen-detected good prognosis cancers. Eligibility criteria are age ≥47 years, unifocal grade 1 tumors (maximum diameter 15mm), strongly ER/PR+ve and HER2-ve, with negative axillary staging. Patients are randomized 2:1 to VAE or surgery, with no axillary surgery in the VAE arm. Excision is assessed radiologically, and if incomplete, patients undergo surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm. Coprimary end-points are: (1) Non-inferiority comparison of the requirement for a second procedure. (2) Single-arm analysis of local recurrence (LR) at 5 years after VAE. Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure, ensuring sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. The DMC will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimize recruitment and informed consent. Recruitment challenges are identified by analyzing recruiter/patient interviews, audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions are developed collaboratively, including recruiter feedback and recruitment tips documents. Results: SMALL opened in December 2019, but recruitment halted for 5 months due to COVID-19. At 11th February 2022, 91 patients had been recruited from 22 centers, with an approached/consented ration of 50%. Drawing from preliminary QRI findings, a recruitment tips document has been circulated (on discussing SMALL, providing balanced information on treatment options and explaining randomization). Individual recruiter feedback has commenced, with wider feedback planned shortly. Conclusion: Despite pandemic-related challenges, SMALL has excellent recruitment to date and is expected to have a global impact on treatment of screen-detected breast cancer. Clinical trial information: 12240119.

Integrating mammography screening programmes into specialist breast centres in Italy: insights from a national survey of Senonetwork breast centres

BackgroundDespite recommendations, mammography screening is often insufficiently integrated into specialist breast centres. A national, cross-sectional, voluntary, online survey on this issue was carried out among the Italian breast centres associated with Senonetwork, the Italian network of breast cancer services.MethodsA 73-item questionnaire was created, pre-tested and piloted. Centres integrating and not integrating a screening programme were compared using the unified theory of acceptance and use of technology (UTAUT) model. Centres’ clustering was performed using the Gower’s distance metric. Groups and clusters were compared with the equality-of-means test.ResultsThe response rate was 82/128 (65%). Overall, 84% (69/82) breast centres reported a collaboration with a screening programme in performing and/or reading mammograms and in the diagnostic work-up of women with abnormal screening results. The same proportion was observed among those centres responding to all questions (62/74). Performance expectancies (or the perceived usefulness of integration in terms of clinical quality, patient convenience, ease of job, and professional growth), satisfaction and motivation were higher in those centres collaborating with the screening programme. Effort expectancy indicators (or the degree to which the respondents believe that the integration is easy to implement) and those concerning the existence of facilitating conditions were lower both in centres collaborating and not collaborating with the screening programme. Among the former, six clusters of centres, distributed from ‘no integration’ to ‘high’, were identified. In cluster analysis, the highest level of integration was associated with higher agreement that integration eases the job, offers better opportunities for professional growth, and makes the working environment more satisfactory. The least integrated cluster assigned the lowest score to the statement that local health authority made available the resources needed.ConclusionsWhile confirming the positive effects of integrating screening programmes into breast centres, this survey has brought to light specific difficulties that must be faced. The results provide insights into the importance of integration focusing on the perspectives of professional career and motivation. The deficiency of facilitating conditions to integration is modifiable. Screening professionals’ societies may have a role as initiators of the integration. Other supporting actions may be included in health laws at the national and regional level.

Is mammography screening an effective public health intervention? Evidence from a natural experiment

Population-based breast screening programmes aim to improve clinical outcomes, alleviate health inequalities, and reduce healthcare costs. However, while screening can bring about immediate changes in mode of presentation and stage at diagnosis of breast cancer cases, the benefits and harms of these programmes can only be observed at a population level, and only over a long enough timeframe for the cascade of events triggered by screening to culminate in disease-specific mortality reductions. In this paper we exploit a natural experiment resulting from the phased geographic rollout of a national mammography screening programme to examine the impact of screening on breast cancer outcomes from both a patient cohort and a population perspective. Using data on 33,722 breast cancer cases over the period 1994–2011, we employ a difference-in-differences research design using ten-year follow-up data for cases diagnosed before and after the introduction of the programme in screened and unscreened regions. We conclude that although the programme produced the intended intermediate effects on breast cancer presentation and incidence, these failed to translate into significant decreases in overall population-level mortality, though screening may have helped to reduce socioeconomic disparities in late stage breast cancer incidence.

Field cancerization in breast cancer.

Breast cancer affects one in seven women worldwide during their lifetime. Widespread mammographic screening programs and education campaigns allow for early detection of the disease, often during its asymptomatic phase. Current practice in treatment and recurrence monitoring is based primarily on pathological evaluations but can also encompass genomic evaluations, both of which focus on the primary tumor. Although breast cancer is one of the most studied cancers, patients still recur at a rate of up to 15% within the first 10 years post‐surgery. Local recurrence was originally attributed to tumor cells contaminating histologically normal (HN) tissues beyond the surgical margin, but advances in technology have allowed for the identification of distinct aberrations that exist in the peri‐tumoral tissues themselves. One leading theory to explain this phenomenon is the field cancerization theory. Under this hypothesis, tumors arise from a field of molecularly altered cells that create a permissive environment for malignant evolution, which can occur with or without morphological changes. The traditional histopathology paradigm dictates that molecular alterations are reflected in the tissue phenotype. However, the spectrum of inter‐patient variability of normal breast tissue may obfuscate recognition of a cancerized field during routine diagnostics. In this review, we explore the concept of field cancerization focusing on HN peri‐tumoral tissues: we present the pathological and molecular features of field cancerization within these tissues and discuss how the use of peri‐tumoral tissues can affect research. Our observations suggest that pathological and molecular evaluations could be used synergistically to assess risk and guide the therapeutic management of patients. © 2022 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland.