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In the mid-1990s, the identification of BRCA1/2 genes for breast cancer susceptibility led to testing breast MRI accuracy in screening women at increased risk. From 2000 onwards, ten intraindividual comparative studies showed the marked superiority of MRI: the sensitivity ranged 25−58% for mammography, 33−52% for ultrasound, 48−67% for mammography plus ultrasound, and 71−100% for MRI; specificity 93–100%, 91–98%, 89–98%, and 81–98%, respectively. Based on the available evidence, in 2006–2007, the UK National Institute for Clinical Excellence and the American Cancer Society recommended MRI screening of high-risk women, followed by other international guidelines. Despite evidence-based medicine ideally requiring randomised controlled trials (RCTs) for policy changes regarding screening procedures, breast MRI for high-risk screening was adopted in many countries worldwide. In 2019, the results of the "DENSE" RCT were published in favour of breast MRI screening of women with extremely dense breasts compared to mammography alone, showing a reduction of more than 80% of the interval cancer rate in women who attended MRI screening. Even though international recommendations in favour of this practice were issued, substantial obstacles still prevent health systems from adopting breast MRI for screening women with extremely dense breasts. A paradox is evident: we adopted a screening procedure without evidence from RCTs, and now that we have this level-1 evidence for the same procedure, we fail to do so. This critical review tries to explain the differences between the two cases, as examples of the complex pathways of translating radiological research into everyday practice. Critical relevance statement The high-level evidence in favour of breast MRI screening of women with extremely dense breasts is failing to persuade policy makers to translate this into clinical practice. Key points • Breast MRI screening of high-risk women was adopted on basis of the evidence provided by test accuracy comparative studies showing an MRI performance greatly superior to that of mammography. • Breast MRI screening of women with extremely dense breasts has not been adopted although the evidence of a large reduction in interval cancer rate from a RCT. • We illustrate the differences between the two cases, as an example of the complex ways of translation of radiological research in clinical practice according to the EBM theory. [ABSTRACT FROM AUTHOR]

Simple Summary: Contrast-enhanced mammography (CEM) is a dual-energy technique where low- and high-energy images are acquired for each mammographic view after contrast agent administration, and are then recombined to enhance potential contrast uptake. As CEM is increasingly used for both screening and diagnostic applications in breast imaging, but its associated radiation dose has been investigated only by single-center studies, we aimed to evaluate the CEM per-patient radiation dose on a large population in a bicentric setting, pooling data from two prospective studies employing the same model of mammography units. The CEM radiation dose showed a 6.2% difference between the two centers, mainly attributable to the study populations' characteristics and to manufacturing differences between the two systems. The CEM dose was about 30% higher than that of standard digital mammography. Such an increment was close to the dose increase reported for digital breast tomosynthesis, which is already used in both screening and clinical settings. Thus, considering the extensively demonstrated diagnostic gain granted by CEM over these non-contrast-enhanced techniques, radiation dose concerns should not hinder ever-wider clinical implementations of CEM. The radiation dose associated with contrast-enhanced mammography (CEM) has been investigated only by single-center studies. In this retrospective study, we aimed to compare the radiation dose between two centers performing CEM within two prospective studies, using the same type of equipment. The CEM mean glandular dose (MGD) was computed for low energy (LE) and high energy (HE) images and their sum was calculated for each view. MGD and related parameters (entrance dose, breast thickness, compression, and density) were compared between the two centers using the Mann–Whitney test. Finally, per-patient MGD was calculated by pooling the two datasets and determining the contribution of LE and HE images. A total of 348 CEM examinations were analyzed (228 from Center 1 and 120 from Center 2). The median total MGD per view was 2.33 mGy (interquartile range 2.19–2.51 mGy) at Center 1 and 2.46 mGy (interquartile range 2.32–2.70 mGy) at Center 2, with a 0.15 mGy median difference (p < 0.001) equal to 6.2%. LE-images contributed between 64% and 77% to the total patient dose in CEM, with the remaining 23–36% being associated with HE images. The mean radiation dose for a two-view bilateral CEM exam was 4.90 mGy, about 30% higher than for digital mammography. [ABSTRACT FROM AUTHOR]

Background: We investigated the radiodensity of epicardial (EAT), subcutaneous (SAT), and visceral adipose tissue (VAT) before and after treatment with anthracyclines in a population of breast cancer (BC) patients, and in controls not treated with anthracyclines, to detect a potential role of EAT density as a biomarker of changes related to chemotherapy cardiotoxicity. Methods: We reviewed BC patients treated with anthracyclines who underwent CT before (CT-t0) and after (CT-t1) chemotherapy, and age- and sex-matched controls who underwent two CT examinations at comparable intervals. On non-contrast scans, EAT was segmented contouring the pericardium and thresholding between -190 and -30 Hounsfield units (HU), and SAT and VAT were segmented with two 15-mm diameter regions of interest thresholded between -195 and -45 HU. Results: Thirty-two female patients and 32 controls were included. There were no differences in age (p = 0.439) and follow-up duration (p = 0.162) between patients and controls. Between CT-t0 and CT-t1, EAT density decreased in BC patients (-66 HU, interquartile range [IQR] -71 to -63 HU, to -71 HU, IQR -75 to -66 HU, p = 0.003), while it did not vary in controls (p = 0.955). SAT density increased from CT-t0 to CT-t1 in BC patients (-107 HU, IQR -111 to -105 HU, to -105 HU, IQR -110 to -100 HU, p = 0.014), whereas it did not change in controls (p = 0.477). VAT density did not vary in either BC patients (p = 0.911) or controls (p = 0.627). Conclusions: EAT density appears to be influenced by anthracycline treatment for BC, well known for its cardiotoxicity, shifting towards lower values indicative of a less active metabolism. [ABSTRACT FROM AUTHOR]

In Europe, inappropriate reimbursement and funding rules and regulations act as disincentives to best breast cancer care or, at worst, hinder best care. This problem was the focus of the 12th European Breast Cancer Conference (EBCC) manifesto, discussed during the virtual conference. As patient involvement is indispensable in driving changes to clinical practice, Europa Donna the European patient advocacy group was closely involved in the 12th manifesto. Reimbursement policies have rarely evolved with advances in breast cancer care such as outpatient (ambulatory) care rather than inpatient admission, use of oral or subcutaneous anti-cancer drugs rather than day-hospital intravenous administration, oncoplastic surgery techniques to minimize mastectomy rates, breast reconstructive surgery, risk-reducing surgery for BRCA mutation carriers, or use of hypo-fractionated breast radiation therapy. Although each European country, region and centre will have to understand how their reimbursement policies may hinder best care and find their own solutions, the problems are similar throughout Europe and some solutions can be broadly applied. This manifesto is not calling for more funding or demanding changes that will result in more expensive care. Reimbursement, if better aligned with guidelines and optimal clinical practice, will deliver more cost-effective healthcare. This will release resources, support more equitable use of finite funding and resources, so allowing more European breast cancer patients to benefit from evidence-based treatment recommended by national and international guidelines. • Reimbursement rules for breast cancer care are not in line with evidence-based medicine and clinical practice guidelines. • Reimbursement rules hamper access to best practice treatments such as: outpatient (ambulatory) care rather than inpatient or day-hospital admission,oncoplastic breast surgery to limit need for mastectomy risk-reducing surgery for BRCA mutation carriers,or moderately hypofractionated post-operative radiation therapy. • Reimbursements aligned with optimal clinical practice guidelines can drive more cost-effective care. • This will lead to more equitable use of finite healthcare resources and improve cancer outcomes for more European patients. • Direct involvement of patients through education will allow them to understand and demand optimal guideline-driven care. • Patient understanding, support and engagement is vital to improve reimbursement rules and optimise care. [ABSTRACT FROM AUTHOR]

Despite its high diagnostic performance, the use of breast MRI in the preoperative setting is controversial. It has the potential for personalized surgical management in breast cancer patients, but two of three randomized controlled trials did not show results in favor of its introduction for assessing the disease extent before surgery. Meta-analyses showed a higher mastectomy rate in women undergoing preoperative MRI compared to those who do not. Nevertheless, preoperative breast MRI is increasingly used and a survey from the American Society of Breast Surgeons showed that 41% of respondents ask for it in daily practice. In this context, a large-scale observational multicenter international prospective analysis (MIPA study) was proposed under the guidance of the European Network for the Assessment of Imaging in Medicine (EuroAIM). The aims were (1) to prospectively and systematically collect data on consecutive women with a newly diagnosed breast cancer, not candidates for neoadjuvant therapy, who are offered or not offered breast MRI before surgery according to local practice; (2) to compare these two groups in terms of surgical and clinical endpoints, adjusting for covariates. The underlying hypotheses are that MRI does not cause additional mastectomies compared to conventional imaging, while reducing the reoperation rate in all or in subgroups of patients. Ninety-six centers applied to a web-based call; 36 were initially selected based on volume and quality standards; 27 were active for enrollment. On November 2018, the target of 7000 enrolled patients was reached. The MIPA study is presently at the analytic phase. Key Points • Breast MRI has a high diagnostic performance but its utility in the preoperative setting is controversial. • A large-scale observational multicenter prospective study was launched to compare women receiving with those not receiving preoperative MRI. • Twenty-seven centers enrolled more than 7000 patients. The study is presently at the analytic phase. [ABSTRACT FROM AUTHOR]

The Italian College of Breast Radiologists by the Italian Society of Medical Radiology (SIRM) provides recommendations for breast care provision and procedural prioritization during COVID-19 pandemic, being aware that medical decisions must be currently taken balancing patient's individual and community safety: (1) patients having a scheduled or to-be-scheduled appointment for in-depth diagnostic breast imaging or needle biopsy should confirm the appointment or obtain a new one; (2) patients who have suspicious symptoms of breast cancer (in particular: new onset palpable nodule; skin or nipple retraction; orange peel skin; unilateral secretion from the nipple) should request non-deferrable tests at radiology services; (3) asymptomatic women performing annual mammographic follow-up after breast cancer treatment should preferably schedule the appointment within 1 year and 3 months from the previous check, compatibly with the local organizational conditions; (4) asymptomatic women who have not responded to the invitation for screening mammography after the onset of the pandemic or have been informed of the suspension of the screening activity should schedule the check preferably within 3 months from the date of the not performed check, compatibly with local organizational conditions. The Italian College of Breast Radiologists by SIRM recommends precautions to protect both patients and healthcare workers (radiologists, radiographers, nurses, and reception staff) from infection or disease spread on the occasion of breast imaging procedures, particularly mammography, breast ultrasound, breast magnetic resonance imaging, and breast intervention procedures. [ABSTRACT FROM AUTHOR]

To compare the sensitivity for breast cancer (BC) and BC size estimation of preoperative contrast-enhanced magnetic resonance imaging (CEMRI) versus combined unenhanced magnetic resonance imaging (UMRI) and digital breast tomosynthesis (DBT). We retrospectively included 56 women who underwent DBT and preoperative 1.5 T CEMRI between January 2016–February 2017. Three readers with 2–10 years of experience in CEMRI and DBT, blinded to pathology, independently reviewed CEMRI (diffusion-weighted imaging [DWI], T2-weighted imaging, pre- and post-contrast T1-weighted imaging) and a combination of UMRI (DWI and pre-contrast T1-weighted imaging) and DBT. We calculated per-lesion sensitivity of CEMRI and UMRI + DBT, and the agreement between CEMRI, UMRI and DBT versus pathology in assessing cancer size (Bland-Altman analysis). Logistic regression was performed to assess features predictive of cancer missing. We included 70 lesions (64% invasive BC, 36% ductal carcinoma in situ or invasive BC with in situ component). UMRI + DBT showed lower sensitivity (86–89%) than CEMRI (94–100%), with a significant difference for the most experienced reader only (p = 0.008). False-positives were fewer with UMRI + DBT (4–5) than with CEMRI (18–25), regardless of the reader (p = 0.001–0.005). For lesion size, UMRI showed closer limits of agreement with pathology than CEMRI or DBT. Cancer size ≤1 cm was the only independent predictor for cancer missing for both imaging strategies (Odds ratio 8.62 for CEMRI and 19.16 for UMRI + DBT). UMRI + DBT showed comparable sensitivity and less false-positives than CEMRI in the preoperative assessment of BC. UMRI was the most accurate tool to assess cancer size. • Combined UMRI + DBT shows high sensitivity in the preoperative assessment of breast cancer. • UMRI + DBT avoids most false-positives induced by CEMRI. • In combined imaging, UMRI is the better predictor of cancer size at pathology. • UMRI + DBT is a potential alternative to CEMRI in the preoperative assessment of breast cancer. [ABSTRACT FROM AUTHOR]

Neither breast cancer prevention and early-detection programs, nor their outcomes, are uniform across Europe. This article describes the rationale, methods, and process for development of the European Commission (EC) Initiative on Breast Cancer Screening and Diagnosis Guidelines. To be consistent with standards set by the Institute of Medicine and others, the EC followed 6 general principles. First, the EC selected, via an open call, a panel with broad representation of areas of expertise. Second, it ensured that all recommendations were supported by systematic reviews. Third, the EC separately considered important subgroups of women, included patient advocates in the guidelines development group, and focused on good communication to inform women's decisions. Fourth, EC rules on conflicts of interest were followed and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests. Fifth, it focused its recommendations on outcomes that matter to women, and certainty of the evidence is rated for each. Sixth, the EC elicited stakeholder feedback to ensure that the recommendations remain up to date and relevant to practice. This article describes the approach and highlights ways of disseminating and adapting the recommendations both within and outside Europe, using innovative information technology tools. [ABSTRACT FROM AUTHOR]

Objectives: To test 3T proton magnetic resonance spectroscopy (H-MRS) for breast mass lesions. Methods: Patients with BI-RADS 4-5 lesions at mammography/ultrasound were prospectively enrolled. After contrast-enhanced breast MRI, single-voxel MRS (point-resolved volume selection, PRESS); pencil-beam shimming; volume of interest 1 cm; TR/TE = 3000/135 ms) was performed. Spectra were considered reliable if the full width at half maximum (FWHM) of the water peak was ≤45 Hz. A signal-to-noise ratio of the total choline (tCho) peak at 3.21 ppm ≥2 was used as cutoff for malignancy. All lesions underwent needle sampling. Final pathology was available for all malignant lesions; for benign lesions the reference standard was final pathology or at least 1-year negative follow-up. Results: Reliable spectra were obtained in 115/127 lesions (91%), with a mean FWHM of 32.4 Hz (range 8-45 Hz). A tCho peak SNR ≥2 was detected in 66 malignant lesions (62 invasive cancers; 4 ductal carcinoma in situ) and in 3 benign lesions. Excluding lesions located ≤1 cm from the skin ( n = 3) or pectoral muscle ( n = 11), sensitivity was 65/73 [89%, 95% confidence interval (CI): 80-95%], and specificity 25/28 (89%) (95% CI: 72-98%). Considering only invasive cancers, sensitivity reached 61/68 (90%, 95% CI: 81-96%). MRS additional time was 8 min. Conclusions: When lesions close to the skin or pectoral muscle are excluded, 3T H-MRS of mass lesions ≥1 cm showed a high diagnostic performance, however, insufficient to avoid needle biopsy. [ABSTRACT FROM AUTHOR]

Magnetic resonance imaging (MRI) of the breast gained a role in clinical practice thanks to the optimal sensitivity of contrast-enhanced (CE) protocols. This approach, first proposed 30 years ago and further developed as bilateral highly spatially resolved dynamic study, is currently considered superior for cancer detection to any other technique. However, other directions than CE imaging have been explored. Apart from morphologic features on unenhanced T2-weighted images, two different non-contrast molecular approaches were mainly run in vivo: proton MR spectroscopy (1H-MRS) and diffusion-weighted imaging (DWI). Both approaches have shown aspects of breast cancer (BC) hidden to CE-MRI: 1H-MRS allowed for evaluating the total choline peak (tCho) as a biomarker of malignancy; DWI showed that restricted diffusivity is correlated with high cellularity and tumor aggressiveness. Secondary evidence on the two approaches is now available from systematic reviews and meta-analyses, mainly considered in this article: pooled sensitivity ranged 71-74% for 1H-MRS and 84-91% for DWI; specificity 78-88% and 75-84%, respectively. Interesting research perspectives are opened for both techniques, including multivoxel MRS and statistical strategies for classification of MR spectra as well as diffusion tensor imaging and intravoxel incoherent motion for DWI. However, when looking at a clinical perspective, while MRS remained a research tool with important limitations, such as relatively long acquisition times, frequent low quality spectra, difficult standardization, and quantification of tCho tissue concentration, DWI has been integrated in the standard clinical protocols of breast MRI and several studies showed its potential value as a stand-alone approach for BC detection. [ABSTRACT FROM AUTHOR]

Elucidation of molecular mechanisms underlying the aberrant phosphatidylcholine cycle in cancer cells plays in favor of the use of metabolic imaging in oncology and opens the way for designing new targeted therapies. The anomalous choline metabolic profile detected in cancer by magnetic resonance spectroscopy and spectroscopic imaging provides molecular signatures of tumor progression and response to therapy. The increased level of intracellular phosphocholine (PCho) typically detected in cancer cells is mainly attributed to upregulation of choline kinase, responsible for choline phosphorylation in the biosynthetic Kennedy pathway, but can also be partly produced by activation of phosphatidylcholine-specific phospholipase C (PC-PLC). This hydrolytic enzyme, known for implications in bacterial infection and in plant survival to hostile environmental conditions, is reported to be activated in mitogen- and oncogene-induced phosphatidylcholine cycles in mammalian cells, with effects on cell signaling, cell cycle regulation, and cell proliferation. Recent investigations showed that PC-PLC activation could account for 20-50% of the intracellular PCho production in ovarian and breast cancer cells of different subtypes. Enzyme activation was associated with PC-PLC protein overexpression and subcellular redistribution in these cancer cells compared with non-tumoral counterparts. Moreover, PC-PLC coimmunoprecipitated with the human epidermal growth factor receptor-2 (HER2) and EGFR in HER2-overexpressing breast and ovarian cancer cells, while pharmacological PC-PLC inhibition resulted into long-lasting HER2 downregulation, retarded receptor re-expression on plasma membrane and antiproliferative effects. This body of evidence points to PC-PLC as a potential target for newly designed therapies, whose effects can be preclinically and clinically monitored by metabolic imaging methods. [ABSTRACT FROM AUTHOR]

Background: Magnetic resonance imaging (MRI) may guide breast cancer surgery by measuring residual tumor size post-neoadjuvant chemotherapy (NAC). Accurate measurement may avoid overly radical surgery or reduce the need for repeat surgery. This individual patient data (IPD) meta-analysis examines MRI's agreement with pathology in measuring the longest tumor diameter and compares MRI with alternative tests.Methods: A systematic review of MEDLINE, EMBASE, PREMEDLINE, Database of Abstracts of Reviews of Effects, Heath Technology Assessment, and Cochrane databases identified eligible studies. Primary study authors supplied IPD in a template format constructed a priori. Mean differences (MDs) between tests and pathology (i.e. systematic bias) were calculated and pooled by the inverse variance method; limits of agreement (LOA) were estimated. Test measurements of 0.0 cm in the presence of pathologic residual tumor, and measurements >0.0 cm despite pathologic complete response (pCR) were described for MRI and alternative tests.Results: Eight studies contributed IPD (N = 300). The pooled MD for MRI was 0.0 cm (LOA: +/-3.8 cm). Ultrasound underestimated pathologic size (MD: -0.3 cm) relative to MRI (MD: 0.1 cm), with comparable LOA. MDs were similar for MRI (0.1 cm) and mammography (0.0 cm), with wider LOA for mammography. Clinical examination underestimated size (MD: -0.8 cm) relative to MRI (MD: 0.0 cm), with wider LOA. Tumors "missed" by MRI typically measured 2.0 cm or less at pathology; tumors >2.0 cm were more commonly "missed" by clinical examination (9.3 %). MRI measurements >5.0 cm occurred in 5.3 % of patients with pCR, but were more frequent for mammography (46.2 %).Conclusions: There was no systematic bias in MRI tumor measurement, but LOA are large enough to be clinically important. MRI's performance was generally superior to ultrasound, mammography, and clinical examination, and it may be considered the most appropriate test in this setting. Test combinations should be explored in future studies. [ABSTRACT FROM AUTHOR]

Purpose To compare gadobenate dimeglumine-enhanced magnetic resonance imaging (MRI) with gadopentetate dimeglumine-enhanced MRI, mammography, and ultrasound for breast cancer detection across different malignant lesion types and across different densities of breast tissue. Materials and Methods In all, 153 women with Breast Imaging Reporting and Data System (BI-RADS) 3-5 findings on mammography and/or ultrasound underwent identical breast MRI exams at 1.5T with gadobenate dimeglumine and gadopentetate dimeglumine. Images were evaluated by three independent blinded radiologists. Mammography, ultrasound, and combined mammography and/or ultrasound findings were available for 108, 109, and 131 women. Imaging findings were matched with histology data by a fourth, independent, blinded radiologist. Malignant lesion detection rates and diagnostic performance were compared. Results In all, 120, 120, and 140 confirmed malignant lesions were present in patients undergoing MRI+mammography, MRI+ultrasound, and MRI+mammography and/or ultrasound, respectively. Significantly greater cancer detection rates were noted by all three readers for comparisons of gadobenate dimeglumine-enhanced MRI with mammography (Δ15.8-17.5%; P < 0.0001), ultrasound (Δ18.3-20.0%; P < 0.0001), and mammography and/or ultrasound (Δ8.6-10.7%; P ≤ 0.0105) but not for comparisons of gadopentetate dimeglumine-enhanced MRI with conventional techniques ( P > 0.05). The false-positive detection rates were lower on gadobenate dimeglumine-enhanced MRI than on conventional imaging (4.0-5.5% vs. 11.1% at mammography; 6.3-8.4% vs. 15.5% at ultrasound). Significantly improved cancer detection on MRI was noted in heterogeneously dense breast (91.2-97.3% on gadobenate dimeglumine-enhanced MRI vs. 77.2-84.9% on gadopentetate dimeglumine-enhanced MRI vs. 71.9-84.9% with conventional techniques) and for invasive cancers (93.2-96.2% for invasive ductal carcinoma [IDC] on gadobenate dimeglumine-enhanced MRI vs. 79.7-88.5% on gadopentetate dimeglumine-enhanced MRI vs. 77.0-84.4% with conventional techniques). Overall diagnostic performance for the detection of cancer was superior on gadobenate dimeglumine-enhanced MRI than on conventional imaging or gadopentetate dimeglumine-enhanced MRI. Conclusion Gadobenate dimeglumine-enhanced MRI significantly improves cancer detection compared to gadopentetate dimeglumine-enhanced MRI, mammography, and ultrasound in a selected group of patients undergoing breast MRI for preoperative staging or because of inconclusive findings at conventional imaging. J. Magn. Reson. Imaging 2014;39:1272-1286. © 2013 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

The use of breast magnetic resonance imaging (MRI) is rapidly increasing. EUSOMA organised a workshop in Milan on 20–21st October 2008 to evaluate the evidence currently available on clinical value and indications for breast MRI. Twenty-three experts from the disciplines involved in breast disease management – including epidemiologists, geneticists, oncologists, radiologists, radiation oncologists, and surgeons – discussed the evidence for the use of this technology in plenary and focused sessions. This paper presents the consensus reached by this working group. General recommendations, technical requirements, methodology, and interpretation were firstly considered. For the following ten indications, an overview of the evidence, a list of recommendations, and a number of research issues were defined: staging before treatment planning; screening of high-risk women; evaluation of response to neoadjuvant chemotherapy; patients with breast augmentation or reconstruction; occult primary breast cancer; breast cancer recurrence; nipple discharge; characterisation of equivocal findings at conventional imaging; inflammatory breast cancer; and male breast. The working group strongly suggests that all breast cancer specialists cooperate for an optimal clinical use of this emerging technology and for future research, focusing on patient outcome as primary end-point. [Copyright &y& Elsevier]

Abstract: The role of pre-operative breast MRI is outlined on the basis of the existing evidence in favor of a superior capability in comparison with mammography and sonography to detect ipsilateral and contralateral malignant lesions and to evaluate the disease extent, including the extensive intraductal component associated with invasive cancers. Patients with a potential higher anticipated benefit from pre-operative MRI can be identified as those: with mammographically dense breasts; with a unilateral multifocal/multicentric cancer or a synchronous bilateral cancer already diagnosed at mammography and sonography; with a lobular invasive cancer; at high-risk for breast cancer; with a cancer which shows a discrepancy in size of >1 cm between mammography and sonography; or under consideration for partial breast irradiation. More limited evidence exists in favor of MRI for evaluating candidates for total skin sparing mastectomy or for patients with Paget''s disease. Irrespective of whether the clinical team routinely uses preoperative MRI or not: women newly diagnosed with breast cancer should always be informed of the potential risks and benefits of pre-operative MRI; results of pre-operative MRI should be interpreted taking into account clinical breast examination, mammography, sonography and verified by percutaneous biopsy; MRI-only detected lesions require MR-guidance for needle biopsy and pre-surgical localization, and these should be available or potentially accessible if pre-operative MRI is to be implemented; total therapy delay due to pre-operative MRI (including MRI-induced work-up) should not exceed one month; changes in therapy planning resulting from pre-operative MRI should be decided by a multidisciplinary team. [Copyright &y& Elsevier]

Mammography and ultrasound indicated a cancer of the right breast in a 77-year-old woman with a dual-chamber demand pacemaker. The patient was not pacemaker-dependent. She underwent breast 1.5T magnetic resonance imaging (MRI) (dynamic gradient echo sequence with Gd-DOTA 0.1 mmol/kg). Before the patient entered the MR room, the configuration of the device was changed (the response to magnet was switched from asynchronous to off and the rate-responsive algorithm was disabled). No relevant modifications of heart rhythm or rate were observed during the MR examination. No symptom was reported. Immediately after the examination, the pacemaker interrogation showed neither program changes nor alert warnings. MRI detected a bifocal cancer in the right breast which allowed tailored breast-conserving treatment to be initiated. Histopathology confirmed a bifocal invasive ductal carcinoma. [ABSTRACT FROM AUTHOR]

We developed a machine learning model based on radiomics to predict the BI-RADS category of ultrasound-detected suspicious breast lesions and support medical decision-making towards short-interval follow-up versus tissue sampling. From a retrospective 2015–2019 series of ultrasound-guided core needle biopsies performed by four board-certified breast radiologists using six ultrasound systems from three vendors, we collected 821 images of 834 suspicious breast masses from 819 patients, 404 malignant and 430 benign according to histopathology. A balanced image set of biopsy-proven benign (n = 299) and malignant (n = 299) lesions was used for training and cross-validation of ensembles of machine learning algorithms supervised during learning by histopathological diagnosis as a reference standard. Based on a majority vote (over 80% of the votes to have a valid prediction of benign lesion), an ensemble of support vector machines showed an ability to reduce the biopsy rate of benign lesions by 15% to 18%, always keeping a sensitivity over 94%, when externally tested on 236 images from two image sets: (1) 123 lesions (51 malignant and 72 benign) obtained from two ultrasound systems used for training and from a different one, resulting in a positive predictive value (PPV) of 45.9% (95% confidence interval 36.3–55.7%) versus a radiologists' PPV of 41.5% (p < 0.005), combined with a 98.0% sensitivity (89.6–99.9%); (2) 113 lesions (54 malignant and 59 benign) obtained from two ultrasound systems from vendors different from those used for training, resulting into a 50.5% PPV (40.4–60.6%) versus a radiologists' PPV of 47.8% (p < 0.005), combined with a 94.4% sensitivity (84.6–98.8%). Errors in BI-RADS 3 category (i.e., assigned by the model as BI-RADS 4) were 0.8% and 2.7% in the Testing set I and II, respectively. The board-certified breast radiologist accepted the BI-RADS classes assigned by the model in 114 masses (92.7%) and modified the BI-RADS classes of 9 breast masses (7.3%). In six of nine cases, the model performed better than the radiologist did, since it assigned a BI-RADS 3 classification to histopathology-confirmed benign masses that were classified as BI-RADS 4 by the radiologist. [ABSTRACT FROM AUTHOR]

Simple Summary: Image-guided biopsy of suspicious findings at mammography or breast ultrasonography can result in the diagnosis of lesions with uncertain malignant potential (B3 lesions). These, in turn, can turn out to be cancer (i.e., they are upgraded) when larger specimens of tissue are examined after breast surgery, especially if these lesions belong to the B3b subcategory, characterized by a higher probability of malignancy than the B3a subcategory. This uncertain nature makes their management highly controversial. We aimed to report a particularly large series of B3 lesions—coming from an internationally certified Breast Unit—since such series are seldom available. In this series of 3634 consecutive biopsies, we found 604 B3 lesions, of which 17 (2.8%) were upgraded to malignancy after surgery. B3b lesions had an almost 12-fold higher upgrade rate (4.7%) than B3a lesions (0.4%), reinforcing the evidence that recommends surgery for B3b lesions and acknowledges the possibility of active surveillance of B3a lesions. The rate of upgrade to cancer for breast lesions with uncertain malignant potential (B3 lesions) diagnosed at needle biopsy is highly influenced by several factors, but large series are seldom available. We retrospectively assessed the upgrade rates of a consecutive series of B3 lesions diagnosed at ultrasound- or mammography-guided vacuum-assisted biopsy (VAB) at an EUSOMA-certified Breast Unit over a 7-year timeframe. The upgrade rate was defined as the number of ductal carcinoma in situ (DCIS) or invasive cancer at pathology after excision or during follow-up divided by the total number of B3 lesions. All lesions were reviewed by one of four pathologists with a second opinion for discordant assessments of borderline cases. Excision or surveillance were defined by the multidisciplinary tumor board, with 6- and 12-month follow-up. Out of 3634 VABs (63% ultrasound-guided), 604 (17%) yielded a B3 lesion. After excision, 17/604 B3 lesions were finally upgraded to malignancy (2.8%, 95% confidence interval [CI] 1.8–4.5%), 10/17 (59%) being upgraded to DCIS and 7/17 (41%) to invasive carcinoma. No cases were upgraded during follow-up. B3a lesions showed a significantly lower upgrade rate (0.4%, 95% CI 0.1–2.1%) than B3b lesions (4.7%, 95% CI 2.9–7.5%, p = 0.001), that had a 22.0 adjusted odds ratio for upgrade (95% CI 2.1–232.3). No significant difference was found in upgrade rates according to imaging guidance or needle caliper. Surveillance-oriented management can be considered for B3a lesions, while surgical excision should be pursued for B3b lesions. [ABSTRACT FROM AUTHOR]

Breast cancer (BC) is the most common female cancer and the second cause of death among women worldwide. The 5-year relative survival rate recently improved up to 90% due to increased population coverage and women's attendance to organised mammography screening as well as to advances in therapies, especially systemic treatments. Screening attendance is associated with a mortality reduction of at least 30% and a 40% lower risk of advanced disease. The stage at diagnosis remains the strongest predictor of recurrences. Systemic treatments evolved dramatically over the last 20 years: aromatase inhibitors improved the treatment of early-stage luminal BC; targeted monoclonal antibodies changed the natural history of anti-human epidermal growth factor receptor 2-positive (HER2) disease; immunotherapy is currently investigated in patients with triple-negative BC; gene expression profiling is now used with the aim of personalising systemic treatments. In the era of precision medicine, it is a challenging task to define the relative contribution of early diagnosis by screening mammography and systemic treatments in determining BC survival. Estimated contributions before 2000 were 46% for screening and 54% for treatment advances and after 2000, 37% and 63%, respectively. A model showed that the 10-year recurrence rate would be 30% and 25% using respectively chemotherapy or novel treatments in the absence of screening, but would drop to 19% and 15% respectively if associated with mammography screening. Early detection per se has not a curative intent and systemic treatment has limited benefit on advanced stages. Both screening mammography and systemic therapies continue to positively contribute to BC prognosis. [ABSTRACT FROM AUTHOR]

Evidence on gadolinium brain accumulation after contrast-enhanced MRI prompted research in dose reduction. To estimate accuracy and inter-reader reproducibility of tumor size measurement in breast MRI using 0.08 mmol/kg of gadobutrol. We retrospectively analyzed all women who underwent 1.5-T breast MRI for cancer staging at our department with 0.08 mmol/kg of gadobutrol. Two readers (R1 and R2, 12 and 3 years-experience) measured the largest lesion diameter. Accuracy was estimated both as correlation with pathology and rate of absolute (>5 mm) overestimation and underestimation, inter-reader reproducibility using the Bland–Altman method. Data are given as median and interquartile range. Thirty-six patients were analyzed (median age 56 years, 49–66) for a total of 38 lesions, 24 (63%) mass enhancement, 14 (37%) non-mass enhancement. Histopathological median size (mm) of all lesions was 15 (9–25): 13 (9–19) for mass lesions, 19 (11–39) for non-mass lesions. On MRI, R1 measured (mm) 14 (10−22) for all lesions, 13 (10–19) for mass lesions, 19 (11–49) for non-mass lesions. MRI-pathology correlation was very high for all lesion categories (ρ ≥ 0.766). On MRI, R1 overestimated lesion size in 6 cases (16%), and underestimated in 3 (8%); R2, overestimated 7 cases (18%) and underestimated 3 cases (8%). At inter-reader reproducibility analysis (mm): bias 0.9, coefficient of reproducibility 13 for all lesions; −0.1 and 6 for mass lesions; 2.5 and 20 for non-mass lesions. Breast MRI may be performed using 0.08 mmol/kg of gadobutrol with high accuracy and acceptable inter-reader agreement. • Concerns on gadolinium brain deposition/retention prompted dose reduction research. • Preoperative breast MRI must allow for accurate tumor sizing. • No study evaluated MRI tumor sizing accuracy at 1.5-T with a reduced gadobutrol dose. • 1.5-T breast MRI with a 0.08 mmol/kg gadobutrol dose maintains high sizing accuracy. • Tumor sizing with 0.08 mmol/kg gadobutrol retains acceptable interreader agreement. [ABSTRACT FROM AUTHOR]

The present study was designed to describe tumour features and treatments for patients with breast cancer. It also aimed at assessing the risk of distant metastases in relation to biological profiles, disease stages and treatment. Data were analysed from 81,882 patients in the EUSOMA database (disease stages at diagnosis 0-IV; median age 61 years; range 20–100 years). All patients were treated between January 2016 and December 2021 in 53 Breast Centres within the EUSOMA certification process in 13 European countries. Cases were classified as HR+ /HER2-, HR+ /HER2 + , HR-/HER2 + or HR-/HER2- and data were analysed accordingly. Univariable and multivariable analyses for distant metastases were conducted on a subset of 38,119 cases with information on whether or not they had developed them. Potential determinants included sub-group type, Ki67 value, disease stage, adjuvant systemic therapies and post-operative radiation therapy. In multivariable analysis, the HR-/HER2 + and HR-/HER2- sub-groups were associated with a higher risk of distant metastases than HR+ /HER2–. Ki67 > 20 % and advanced stage disease also carried a high risk. Radiation therapy emerged as a protective factor against distant metastases. Present results show a large patient database offers an information stream that can be applied to reduce uncertainties in clinical practice. Database parameters need to be updated dynamically for outcome monitoring. Molecular prognostic factors, gene-expression signatures, tumour-infiltrating lymphocytes and circulating tumoral DNA should be added. • European multi-centre data analysis of breast cancer, describing tumour features and treatments. • HR-/HER2 + and HR-/HER2- sub-types were linked with a high risk of distant metastases. • Ki67 > 20% and advanced stage disease carried a high risk. • Radiation therapy emerged as a protective factor against distant metastases. [ABSTRACT FROM AUTHOR]

Objectives: To estimate the impact on recall rate (RR) of digital breast tomosynthesis (DBT) associated with digital mammography (DM+DBT), compared to DM alone, evaluate the impact of double reading (DR) and review the literature. Methods: Ethics committees approved this multicenter study. Patients gave informed consent. Women recalled from population-based screening reading were included. Reference standard was histology and/or ≥ 1 year follow up. Negative multiple assessment was considered for patients lost at follow up. Two blinded readers (R1, R2) evaluated first DM and subsequently DM+DBT. RR, sensitivity, specificity, accuracy, positive and negative predictive values (PPV, NPV), were calculated for R1, R2, and DR. Cohen κ and χ(2) were used for R1-R2 agreement and RR related to breast density. Results: We included 280 cases (41 malignancies, 66 benign lesions, and 173 negative examinations). The RR reduction was 43% (R1), 58% (R2), 43% (DR). Sensitivity, specificity, accuracy, PPV and NPV were: 93%, 67%, 71%, 33%, 98% for R1; 88%, 73%, 75%, 36%, 97% for R2; 98%, 55%, 61%, 27%, 99% for DR. The agreement was higher for DM+DBT (κ=0.459 versus κ=0.234). Reduction in RR was independent from breast density (p=0.992). Conclusion: DBT was confirmed to reduce RR, as shown by 13 of 15 previous studies (reported reduction 6-82%, median 31%). This reduction is confirmed when using DR. DBT allows an increased inter-reader agreement. [ABSTRACT FROM AUTHOR]

Purpose: To highlight the importance of quantitative breast arterial calcifications (BAC) assessment for an effective stratification of cardiovascular (CV) risk in women, for whom current preventive strategies are inadequate. BAC, easily detectable on mammograms, are associated with CV disease and represent a potential imaging biomarker for CV disease prevention in women.Method: We summarized the available evidence on this topic.Results: Age, parity, diabetes, and hyperlipidemia were found to positively correlate with BAC. Women with BAC have a higher CV risk than those without BAC: the relative risk was reported to be 1.4 for transient ischemic attack/stroke, 1.5 for thrombosis, 1.8 for myocardial infarction; the reported hazard ratio was 1.32 for coronary artery disease (CAD), 1.52 for heart failure, 1.29 for CV death, 1.44 for death from CAD. However, BAC do not alarm radiologists; when reported, they are commonly mentioned as "present", not impacting on CV decision-making. Of 18 published studies, 9 reported only presence/absence of BAC, 4 used a semi-quantitative scale, and 5 a continuous scale (with manual, automatic or semiautomatic segmentation). Various appearance, topological complexity, and vessels overlap make BAC quantification difficult to standardize. Nevertheless, machine learning approaches showed promising results in BAC quantification on mammograms.Conclusions: There is a strong rationale for mammography to become a dual test for breast cancer screening and CV disease prevention. However, robust and automated quantification methods are needed for a deeper insight on the association between BAC and CV disease, to stratifying CV risk and define personalized preventive actions. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: To evaluate the performance of the first years since the beginning of a mammographic population-based screening program. Materials and methods: Women aged 49–69 were invited biennially for two-view film-screen mammography and double reading without arbitration was performed. Interval cancers (ICs) from 2001 to 2006 were identified using screening archives, local pathology archives, and hospital discharge records. The proportional incidence of IC was determined considering breast cancers expected without screening. Three offsite radiologists experienced in breast cancer screening blindly evaluated mammograms prior to diagnosis, randomly mixed with negative mammograms (1:2 ratio). Cases unrecalled at review were considered as true ICs, those recalled by only one reviewer as minimal signs, and those recalled by two or three reviewers as missed cancers. T and N stage of the reviewed ICs were evaluated and compared. Results: A total of 86,276 first level mammograms were performed. Mean recall rate was 6.8% at first and 4.6% at repeat screening. We had 476 screen-detected cancers and 145 ICs (10 of them ductal carcinomas in situ). Absolute incidence was 17 per 10,000 screening examinations. Invasive proportional incidence was 19% (44/234) in the first year, 39% (91/234) in the second year, and 29% (135/468) in the two-year interval. Of 145 ICs, 130 (90%) were reviewed mixed with 287 negative controls: 55% (71/130) resulted to be true ICs, 24% (31/130) minimal signs, and 22% (28/130) missed cancers. The rate of ICs diagnosed in the first year interval was 21% (15/71) for true ICs, 46% (13/28) for missed cancers, and 39% (12/31) for minimal signs, with a significant difference of true ICs rate compared to missed cancers rate (p =0.012). A higher rate of T3 and T4 stages was found for missed cancers (18%, 5/28) compared to minimal signs (6%, 2/31) or true ICs (8%, 6/71), while the rate of N2 and N3 stage for both minimal signs (19%, 6/31) or missed cancers (25%, 7/28) was higher than that for true ICs (10%, 7/71), although all these differences were not significant (p ≥0.480). Conclusion: These results showed the possibility to comply with European Community standards in the first years of a screening program implementation. [Copyright &y& Elsevier]