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RATIONALE AND OBJECTIVES: Our multicentric study analysed clinical, radiologic and pathologic features in patients with atypical ductal hyperplasia (ADH) diagnosed with vacuum-assisted biopsy (VAB), to identify factors associated with the risk of upgrade, to develop a scoring system to support decision making. MATERIALS AND METHODS: Patients with ADH on VAB under stereotactic/tomosynthesis guidance (2012-2022) were eligible. Inclusion criteria were availability of surgical histopathological examination of the entire lesion or radiologic follow-up (FUP) ≥ 24 months. VAB results were compared with surgical pathological results or with imaging FUP evolution to assess upgrade. A backward stepwise linear regression was used to identify predictors of upgrade. The discriminatory power of the model was calculated through the area under the receiver operating curve (ROC-AUC); the Hosmer-Lemeshow test was used to assess model calibration. The points system was developed based on the selected risk factors, and the probability of upgrade associated with each point total was determined. RESULTS: 112 ADH lesions were included: 91 (91/112, 81.3%) underwent surgical excision with 20 diagnosis of malignancy, while 21 (21/112, 18.7%) underwent imaging FUP with one interval change (mean FUP time 48 months). Overall upgrade rate was 18.7% (21/112). Age, menopausal status, concurrent breast cancer, BIRADS classification and number of foci of ADH were identified as risk factors for upgrade. Our model showed an AUC = 0.85 (95% CI 0.76-0.94). The points system showed that the risk of upgrade is < 2% when the total score is ≤ 1. CONCLUSION: Our scoring system seemed a promising easy-to-use decision support tool for management of ADH, decreasing unnecessary surgeries, reducing patients' overtreatment and healthcare costs.
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Neoplasias da Mama , Carcinoma Intraductal não Infiltrante , Humanos , Feminino , Carcinoma Intraductal não Infiltrante/diagnóstico , Carcinoma Intraductal não Infiltrante/patologia , Carcinoma Intraductal não Infiltrante/cirurgia , Mama/patologia , Neoplasias da Mama/patologia , Biópsia por Agulha , Diagnóstico por Imagem , Estudos RetrospectivosRESUMO
PURPOSE: This study quantifies the impact on budget and cost per health benefit of implementing digital breast tomosynthesis (DBT) in place of digital mammography (DM) for breast cancer screening among asymptomatic women in Italy. METHODS: A budget impact analysis and a cost consequence analysis were conducted using parameters from the MAITA project and literature. The study considered four scenarios for DBT implementation, i.e., DBT for all women, DBT for women aged 45-49 years, DBT based on breast density (BI-RADS C + D or D only), and compared these to the current DM screening. Healthcare provider's perspective was adopted, including screening, diagnosis, and cancer treatment costs. RESULTS: Introducing DBT for all women would increase overall screening costs by 20%. Targeting DBT to women aged 45-49 years or with dense breasts would result in smaller cost increases (3.2% for age-based and 1.4-10.7% for density-based scenarios). The cost per avoided interval cancer was significantly higher when DBT was applied to all women compared to targeted approaches. The cost per gained early-detected cancer slightly increases in targeted approaches, while the assumptions on the clinical significance and overdiagnosis of cancers detected by DBT and not by DM have a strong impact. CONCLUSIONS: Implementing DBT as a primary breast cancer test in screening programs in Italy would lead to a substantial increase in costs. Tailoring DBT use to women aged 45-49 or with dense breasts could enhance the feasibility and sustainability of the intervention. Further research is needed to clarify the impact of DBT on overdiagnosis and the long-term outcomes.
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PURPOSE: We present a comprehensive investigation into the organizational, social, and ethical impact of implementing digital breast tomosynthesis (DBT) as a primary test for breast cancer screening in Italy. The analyses aimed to assess the feasibility of DBT specifically for all women aged 45-74, women aged 45-49 only, or those with dense breasts only. METHODS: Questions were framed according to the European Network of Health Technology Assessment (EuNetHTA) Screening Core Model to produce evidence for the resources, equity, acceptability, and feasibility domains of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) decision framework. The study integrated evidence from the literature, the MAITA DBT trials, and Italian pilot programs. Structured interviews, surveys, and systematic reviews were conducted to gather data on organizational impact, acceptability among women, reading and acquisition times, and the technical requirements of DBT in screening. RESULTS: Implementing DBT could significantly affect the screening program, primarily due to increased reading times and the need for additional human resources (radiologists and radiographers). Participation rates in DBT screening were similar, if not better, to those observed with standard digital mammography, indicating good acceptability among women. The study also highlighted the necessity for specific training for radiographers. The interviewed key persons unanimously considered feasible tailored screening strategies based on breast density or age, but they require effective communication with the target population. CONCLUSIONS: An increase in radiologists' and radiographers' workload limits the feasibility of DBT screening. Tailored screening strategies may maximize the benefits of DBT while mitigating potential challenges.
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Neoplasias da Mama , Detecção Precoce de Câncer , Mamografia , Humanos , Feminino , Neoplasias da Mama/diagnóstico por imagem , Itália , Mamografia/métodos , Pessoa de Meia-Idade , Idoso , Detecção Precoce de Câncer/métodos , Estudos de ViabilidadeRESUMO
Background Few results are available about subsequent outcomes after screening with digital breast tomosynthesis (DBT). Purpose To compare the diagnostic accuracy of a screening round with DBT plus synthetic mammography (SM) (hereafter, DBT+SM) and the repeat screening round with DBT with SM (hereafter, DBT+SM) or full-field digital mammography (FFDM) with FFDM screening. Materials and Methods This prospective study (Verona Pilot Study, clinical trial identification: 2015/1238) included women screened with DBT+SM between April 2015 and March 2017 and rescreened with DBT+SM or FFDM between April 2017 and March 2019. Screening performance (recall rate, cancer detection rate [CDR], and positive predictive value of recall [PPV1]) was compared with that obtained from 28 680 women screened with FFDM between 2013 and 2014 (control group). Cancer stages were compared between modalities and screening rounds. A χ2 test was used to evaluate differences. P < .05 was indicative of a statistically significant difference. Results Of 34 638 women enrolled, 32 870 (median age, 58 years; age range, 52-71 years) underwent repeat screening-16 198 with DBT+SM and 16 672 with FFDM. The CDR was higher for repeat screening with DBT+SM than for the control group with FFDM (8.1 per 1000 women screened vs 4.5 per 1000 women screened, respectively; P < .01) and was not significantly lower for repeat screening with FFDM (3.5 per 1000 women screened vs 4.5 per 1000 women screened, respectively; P = .11). Compared with the control group, there was no difference in the recall rate at repeat screening with both DBT+SM (3.71% vs 3.40%, respectively; P = .10) and FFDM (3.71% vs 3.69%, P = .92), whereas PPV1 was higher only when repeat screening was performed with DBT+SM (23.8% vs 12.0%, P < .01). At repeat screening, the proportion of cancers stage II or higher was 14.5% (19 of 131 cancers) with DBT+SM and 8.5% (five of 59 cancers) with FFDM, both of which were lower than the proportion in the control group with FFDM (30 of 110 cancers, 27.3%) (P ≤ .01). Conclusion At repeat screening, digital breast tomosynthesis plus synthetic mammography depicted more cancers than full-field digital mammography (FFDM) and found a lower number of stage II cancers compared with FFDM. © RSNA, 2020 See also the editorial by Bae in this issue.
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Neoplasias da Mama/diagnóstico por imagem , Mamografia/métodos , Idoso , Mama/diagnóstico por imagem , Feminino , Humanos , Pessoa de Meia-Idade , Projetos Piloto , Estudos Prospectivos , Reprodutibilidade dos TestesRESUMO
OBJECTIVE: We investigated the accuracy of digital breast tomosynthesis compared to full-field digital mammography for evaluating tumor-free resection margins in the intraoperative specimen during breast-conserving surgery, reducing re-excision rates. MATERIALS AND METHODS: In total, 170 patients, with proven breast cancer and eligible for breast-conserving surgery, were enrolled. Intraoperative specimens underwent digital mammography and digital breast tomosynthesis. Two breast radiologists, with ten years of experience in breast imaging, in batch mode, evaluated tumor-free resection margins and the distance between the margins and lesion. Histopathological findings were considered the standard of reference. RESULTS: We used the correlation analysis to evaluate the agreement between measures of tumor-free resection margins obtained with digital mammography and the true value (histopathological findings), and between digital breast tomosynthesis and histopathological findings. The size evaluation determined by digital breast tomosynthesis was more accurately correlated with that found by pathology; the calculated Pearson's correlation coefficient of digital breast tomosynthesis and digital mammography to the pathologically determined tumor-free resection margins were 0.92 and 0.79 in CC view and 0.92 and 0.72 in LL view, respectively. Compared with the pathologically determined tumor-free resection margins, the size determined by both imaging modalities was, on average, overestimated. Bland-Altman analysis showed an excellent inter readers agreement. CONCLUSIONS: Digital breast tomosynthesis is more accurate in assessment of margin status than digital mammography; it could be a more accurate technique than full-field digital mammography for the intraoperative delineating of tumor resection margins.
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Neoplasias da Mama/diagnóstico , Mamografia/métodos , Margens de Excisão , Mastectomia Segmentar/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/cirurgia , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos TestesRESUMO
BACKGROUND: The Verona population-based breast cancer (BC) screening program provides biennial mammography to women aged 50-69 years. Based on emerging evidence of enhanced detection, the program transitioned to digital breast tomosynthesis (DBT) screening. METHODS: This is a prospective pilot evaluation of DBT with synthesised 2D mammography screening implemented during April 2015-March 2017; the rate and characteristics of cancers detected at DBT screening were compared with those detected at the preceding digital mammography (DM) screening round (April 2013-March 2015) in the same screening program. Distribution of imaging and tumour characteristics were compared. RESULTS: Amongst 34,071 women screened in the Verona DBT pilot, 315 BCs were detected; 153 BCs were detected amongst 29,360 women in the DM screening round. Estimated CDRs were 9.2/1000 (95% CI 8.3-10.3) DBT screens versus 5.2/1000 (95% CI 4.4-6.1) DM screens, P < 0.001. Statistically significant differences were found in the distribution of whether recall by one/both screen readers (more BCs recalled by both readers at DBT than DM); whether detected on one/two views (higher proportion detected on only one view at DBT than DM); type of radiological lesions; tumour stage, pT and histological categories (lower proportion of DCIS/pTis, higher proportions of pT1a and pT1b, and higher proportion of invasive cancers of special types, at DBT than DM); and tumour grade (higher proportion of grade I at DBT than DM). There were no differences in distributions of nodal and hormone receptor (ER/PR) status. CONCLUSIONS: Our findings provide early insights into the extent that transitioning to DBT screening may modify the characteristics of screen-detected breast cancer to inform discussion regarding pros and cons of DBT screening; although our data provide some reassurance that DBT does not increase the proportion of screen-detected DCIS, they highlight mixed findings on comparative tumour characteristics, suggesting a potential for enhancing screening benefit and possibly also over-diagnosis from DBT screening.
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Neoplasias da Mama/diagnóstico , Neoplasias da Mama/epidemiologia , Detecção Precoce de Câncer , Mamografia , Idoso , Neoplasias da Mama/mortalidade , Detecção Precoce de Câncer/métodos , Feminino , Humanos , Processamento de Imagem Assistida por Computador , Mamografia/métodos , Pessoa de Meia-Idade , Gradação de Tumores , Estadiamento de Neoplasias , Vigilância da População , PrognósticoRESUMO
Purpose To examine the outcomes of a breast cancer screening program based on digital breast tomosynthesis (DBT) plus synthesized two-dimensional (2D) mammography compared with those after full-field digital mammography (FFDM). Materials and Methods This prospective study included 16 666 asymptomatic women aged 50-69 years who were recruited in April 2015 through March 2016 for DBT plus synthetic 2D screening in the Verona screening program. A comparison cohort of women screened with FFDM (n = 14 423) in the previous year was included. Screening detection measures for the two groups were compared by calculating the proportions associated with each outcome, and the relative rates (RRs) were estimated with multivariate logistic regression. Results Cancer detection rate (CDR) for DBT plus synthetic 2D imaging was 9.30 per 1000 screening examinations versus 5.41 per 1000 screening examinations with FFDM (RR, 1.72; 95% confidence interval [CI]: 1.30, 2.29). CDR was significantly higher in patients screened with DBT plus synthetic 2D imaging than in those screened with FFDM among women classified as having low breast density (RR, 1.53; 95% CI: 1.13, 2.10) or high breast density (RR, 2.86; 95% CI: 1.42, 6.25). The positive predictive value (PPV) for recall was almost doubled with DBT plus synthetic 2D imaging: 23.3% versus 12.9% of recalled patients who were screened with FFDM (RR, 1.81; 95% CI: 1.34, 2.47). The recall rate was similar between groups (RR, 0.95; 95% CI: 0.84, 1.06), whereas the recall rate with invasive assessment was higher for DBT plus synthetic 2D imaging than for FFDM (RR, 1.93; 95% CI: 1.31, 2.03). The mean number of screening studies interpreted per hour was significantly lower for screening examinations performed with DBT plus synthetic 2D imaging (38.5 screens per hour) than with FFDM (60 screens per hour) (P < .001). Conclusion DBT plus synthetic 2D imaging increases CDRs with recall rates comparable to those of FFDM. DBT plus synthetic 2D imaging increased image reading time and the time needed for invasive assessments. © RSNA, 2017.
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Neoplasias da Mama/diagnóstico por imagem , Mamografia/métodos , Programas de Rastreamento/métodos , Idoso , Mama/diagnóstico por imagem , Feminino , Humanos , Itália , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos TestesRESUMO
BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is considered safe and effective even as conversion procedure after primary bariatric operations. The correlation between gastric pouch volumes and patients weight loss remains unclear. METHODS: To assess a correlation between the gastric remnant size and the weight loss, we reviewed 49 consecutive barium swallow UGS performed at our institute from August 2012 through May 2014 in LSG patients with symptoms and/or unsatisfactory weight loss. The anteroposterior (AP), laterolateral (LL) and vertical (CC) diameters of the gastric pouch were measured to calculate the volume by the formula of the ellipsoid (AP × LL × CC × 0.5). Patients were divided in two groups: group 1 without gastric pouch (n = 36) and group 2 with gastric pouch (n = 13). Correlation between pouch volume and weight loss data was calculated with t Student's and Fisher tests to compare the percent excess body mass index (BMI) and percent excess body mass loss (EBL) between two groups, and P < 0.05 was considered statistically significant. RESULTS: The mean percent EBL was 26.54 ± 11.02 and 27.12 ± 12.35 kg/m(2) in groups with and without pouch, respectively. The mean volume of the pouch after LSG was 17.13 ± 21.56 mm(3). Pouch volume, when present, was not significantly correlated to weight loss (P = 0.88 95% CI, CL 19.88-33.20 group 2; CL 22.94-31.30 group 1). CONCLUSIONS: No statistical correlation was found between the volume of the gastric pouch and weight loss (percent EBL) after LSG in symptomatic or with unsatisfactory weight loss patients.
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Gastrectomia/métodos , Laparoscopia , Redução de Peso , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade Mórbida/cirurgia , Estudos Retrospectivos , Adulto JovemRESUMO
AIM: The analyses here reported aim to compare the screening performance of digital tomosynthesis (DBT) versus mammography (DM). METHODS: MAITA is a consortium of four Italian trials, REtomo, Proteus, Impeto, and MAITA trial. The trials adopted a two-arm randomised design comparing DBT plus DM (REtomo and Proteus) or synthetic-2D (Impeto and MAITA trial) versus DM; multiple vendors were included. Women aged 45 to 69 years were individually randomised to one round of DBT or DM. FINDINGS: From March 2014 to February 2022, 50,856 and 63,295 women were randomised to the DBT and DM arm, respectively. In the DBT arm, 6656 women were screened with DBT plus synthetic-2D. Recall was higher in the DBT arm (5·84% versus 4·96%), with differences between centres. With DBT, 0·8/1000 (95% CI 0·3 to 1·3) more women received surgical treatment for a benign lesion. The detection rate was 51% higher with DBT, ie. 2·6/1000 (95% CI 1·7 to 3·6) more cancers detected, with a similar relative increase for invasive cancers and ductal carcinoma in situ. The results were similar below and over the age of 50, at first and subsequent rounds, and with DBT plus DM and DBT plus synthetic-2D. No learning curve was appreciable. Detection of cancers >= 20 mm, with 2 or more positive lymph nodes, grade III, HER2-positive, or triple-negative was similar in the two arms. INTERPRETATION: Results from MAITA confirm that DBT is superior to DM for the detection of cancers, with a possible increase in recall rate. DBT performance in screening should be assessed locally while waiting for long-term follow-up results on the impact of advanced cancer incidence.
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Neoplasias da Mama , Carcinoma Intraductal não Infiltrante , Feminino , Humanos , Mama/diagnóstico por imagem , Mama/patologia , Neoplasias da Mama/diagnóstico , Detecção Precoce de Câncer/métodos , Incidência , Mamografia/métodos , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Idoso , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Angiosarcoma of the breast is a rare breast cancer, which can arise de novo (primary breast angiosarcoma, PBA) or as a secondary malignancy (secondary breast angiosarcoma, SBA) as a result of a biological insult. In the latter case, it is usually diagnosed in patients with a previous history of radiation therapy following a conserving treatment for breast cancer. Over the years, the advances in early diagnosis and treatment of breast cancer, with increasing use of breast-conserving surgery and radiation therapy (instead of radical mastectomy), brought about an increased incidence of the secondary type. PBA and SBA have different clinical presentations and often represent a diagnostic challenge due to the nonspecific imaging findings. The purpose of this paper is to review and describe the radiological features of breast angiosarcoma, both in conventional and advanced imaging to guide radiologists in the diagnosis and management of this rare tumor.
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OBJECTIVE: to determine the positive predictive value (PPV) of tomosynthesis (DBT)-detected architectural distortions (ADs) and evaluate correlations between AD's imaging characteristics and histopathologic outcomes. METHODS: biopsies performed between 2019 and 2021 on ADs were included. Images were interpreted by dedicated breast imaging radiologists. Pathologic results after DBT-vacuum assisted biopsy (DBT-VAB) and core needle biopsy were compared with AD detected by DBT, synthetic2D (synt2D) and ultrasound (US). RESULTS: US was performed to assess a correlation for ADs in all 123 cases and a US correlation was identified in 12/123 (9.7%) cases, which underwent US-guided core needle biopsy (CNB). The remaining 111/123 (90.2%) ADs were biopsied under DBT guidance. Among the 123 ADs included, 33/123 (26.8%) yielded malignant results. The overall PPV for malignancy was 30.1% (37/123). The imaging-specific PPV for malignancy was 19.2% (5/26) for DBT-only ADs, 28.2% (24/85) for ADs visible on DBT and synth2D mammography and 66.7% (8/12) for ADs with a US correlation with a statistically significant difference among the three groups (p = 0.01). CONCLUSIONS: DBT-only ADs demonstrated a lower PPV of malignancy when compared with syntD mammography, and DBT detected ADs but not low enough to avoid biopsy. As the presence of a US correlate was found to be related with malignancy, it should increase the radiologist's level of suspicion, even when CNB returned a B3 result.
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OBJECTIVES: To conduct a review of evidence about papillomatosis/multiple papillomas (MP), its clinical and imaging presentation, the association between MP and malignancy and the management strategies that follow. METHODS: A computerized literature search using PubMed and Google Scholar was performed up to January 2021 with the following search strategy: "papilloma" OR "intraductal papilloma" OR "intraductal papillary neoplasms" OR "papillomatosis" OR "papillary lesion" AND "breast". Two authors independently conducted a search, screening and extraction of data from the eligible studies. RESULTS: Of the 1881 articles identified, 29 articles met the inclusion criteria. The most common breast imaging methods (mammography, ultrasound) showed few specific signs of MP, and evidence about magnetic resonance imaging were weak. Regarding the association between MP and malignancy, the risk of underestimation to biopsy methods and the frequent coexistence of MP and other high-risk lesions needs to be taken into consideration. Results about the risk of developing breast carcinoma of patients affected by MP were inconsistent. CONCLUSIONS: MP is a challenge for all breast specialists, and familiarity with its features is required to make the correct diagnosis. Further studies are needed to evaluate the factors to take into account to plan management, time of follow-up and imaging methods.
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Low-grade adenosquamous carcinoma is a less frequent variant of metaplastic breast carcinoma, incidentally detected during screening and has an age distribution similar to other breast carcinomas. It shares characteristics with both benign and malignant carcinomas: its mammographic and sonographic features are therefore nonspecific. Breast conserving surgery with adjuvant radiation therapy is currently the preferred therapeutic approach. The aim of this review is to describe the imaging and clinical features of low-grade adenosquamous carcinoma for appropriate identification and diagnosis. The associated pitfalls, histopathologic and epidemiologic factors, natural course, and management of low-grade adenosquamous carcinoma are also discussed.
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OBJECTIVES: To compare the conspicuity of lobular breast cancers at digital breast tomosynthesis (DBT) versus synthesized 2D mammography (synt2D). MATERIALS AND METHODS: Seventy-six women (mean age 61.2 years, range 50-74 years) submitted to biopsy in our institution, from 2019 to 2021, with proven invasive lobular breast cancer (ILC) were enrolled in this retrospective study. The participants underwent DBT and synt2D. Five breast radiologists, with different years of experience in breast imaging, independently assigned a conspicuity score (ordinal 6-point scale) to DBT and synt2D. Lesion conspicuity was compared, for each reader, between the synt2D overall conspicuity interpretation and DBT overall conspicuity interpretation using a Wilcoxon matched pairs test. RESULTS: A total of 50/78 (64%) cancers were detected on both synt2D and DBT by all the readers, while 28/78 (26%) cancers where not recognized by at least one reader on synt2D. For each reader, in comparison with synt2D, DBT increased significantly the conspicuity of ILC (p < 0.0001). The raw proportion of high versus low conspicuity by modality confirmed that cancers were more likely to have high conspicuity at DBT than synt2D. CONCLUSIONS: ILCs were more likely to have high conspicuity at DBT than at synt2D, increasing the chances of the detection of ILC breast cancer.
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PURPOSE: To investigate clinical, radiologic and pathologic features of B3 lesions diagnosed on VABB targeting microcalcifications, for identifying predictors of malignancy. METHOD: This retrospective multi-centre study included consecutive VABBs performed over a 10-year period on suspicious microcalcifications not associated with other radiological signs diagnosed as B3 on histology from VABB, with outcomes ascertained by surgical excision. Clinical, demographic, radiological and histological (B3 subcategory) data were collected. For statistical analysis (univariate and binary logistic regression), the primary outcome variable was the upgrade rate to malignancy after surgery. Predictors of upgrade to malignancy were identified from clinical, demographic, radiological and pathological variables (including B3 subcategory). RESULTS: Amongst 447 VABBs, there were 57(12.7 %) upgrades to malignancy at surgical histology (36 DCIS and 21 invasive cancer). At univariate analysis, variables significantly associated with increased risk of upgrade to malignancy were age>55 years (pâ¯=â¯0.01), lesion size>10â¯mm (pâ¯<â¯0.0001), BI-RADS 4b-c and 5 (pâ¯=â¯0.0001), and fine pleomorphic morphology (pâ¯=â¯0.002) of microcalcifications. Binary logistic regression confirmed as significant independent risk factors age, lesion size and BI-RADS category (pâ¯=â¯0.02, 0.02 and 0.0006 respectively). Amongst subcategories of B3 lesions, lobular neoplasia was significantly(pâ¯=â¯0.04) associated with upgrade, confirmed as an independent risk factor [pâ¯=â¯0.03, ORâ¯=â¯2.3(1.1-4.7)]. Flat epithelial atypia was significantly(pâ¯=â¯0.004) associated with reduced odds of upgrade, but binary logistic regression showed only borderline association [pâ¯=â¯0.052, ORâ¯=â¯0.4(0.2-1.01)]. CONCLUSIONS: Across B3 lesions diagnosed on histology from VABB of suspicious microcalcifications, older age, size>10â¯mm, BI-RADS category≥ 4b on imaging, and lobular neoplasia were risk factors for upgrade to malignancy. This information can be used to discuss patients' tailored management options.
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Neoplasias da Mama/patologia , Calcinose/patologia , Adulto , Idoso , Biópsia por Agulha/métodos , Mama/patologia , Neoplasias da Mama/cirurgia , Calcinose/cirurgia , Carcinoma in Situ/patologia , Carcinoma Intraductal não Infiltrante/patologia , Carcinoma Intraductal não Infiltrante/cirurgia , Diagnóstico Diferencial , Feminino , Humanos , Biópsia Guiada por Imagem , Modelos Logísticos , Mamografia , Mastectomia , Pessoa de Meia-Idade , Lesões Pré-Cancerosas/patologia , Estudos RetrospectivosRESUMO
BACKGROUND & METHODS: The prospective 'screening with tomosynthesis or standard mammography' (STORM) trial recruited women participating in biennial breast screening in Italy (2011-2012), and compared sequential screen-readings based on 2D-mammography alone or based on tomosynthesis (integrated 2D/3D-mammography). The STORM trial showed that tomosynthesis screen-reading significantly increased breast cancer detection compared to 2D-mammography alone. The present study completes reporting of the trial by examining interval breast cancers ascertained at two year follow-up. RESULTS: 9 interval breast cancers were identified; the estimated interval cancer rate was 1.23/1000 screens [9/7292] (95%CI 0.56 to 2.34) or 1.24/1000 negative screens [9/7235] (95%CI 0.57 to 2.36). In concurrently screened women who attended the same screening services and received 2D-mammography, interval cancer rate was 1.60/1000 screens [40/25,058] (95% CI 1.14 to 2.17) or 1.61/1000 negative screens [40/24,922] (95% CI 1.15 to 2.18). Estimated screening sensitivity for the STORM trial was 85.5% [59/69] (95%CI 75.0%-92.8%), and that for 2D-mammography screening was 77.3% [136/176] (95%CI 70.4%-83.2%). CONCLUSION: Interval breast cancer rate amongst screening participants in the STORM trial was marginally lower (and screening sensitivity higher) than estimates amongst 2D-screened women; these findings should be interpreted with caution given the small number of interval cases and the sample size of the trial. Much larger screening studies, or pooled analyses, are required to examine interval cancer rates arising after breast tomosynthesis screening versus digital mammography screening.