Percutaneous vacuum-assisted excision (VAE) of breast lesions of uncertain malignant potential (B3 lesions): a preliminary single-centre Italian experience.

PURPOSE: In recent years vacuum-assisted excision (VAE) has been described as an alternative treatment for some B3 lesions. This study aims to assess the effectiveness of using VAE to manage selected B3 lesions by quantifying the number of B3 lesions undergoing VAE, the malignant upgrade rate, and the complications encountered. MATERIALS AND METHODS: Our department evaluated all B3 lesions diagnosed between January 2019 and October 2021 and treated them with VAE. The data were collected during the initial biopsy and final histology based on VAE image guidance, also considering initial lesions and complications. The exclusion criteria were: B3 lesion of size > 20 mm, presence of a concomitant malignant lesion, lesion < 5.0 mm distant from the skin, nipple or pectoral muscle, phyllodes tumours or indeterminate B3 lesions. Lesions that upgraded to malignancy underwent surgical excision, while benign lesions performed radiological follow-ups. RESULTS: From 416 B3 lesions diagnosed, 67 (16.1%) underwent VAE. VAE was performed under X-ray (50/67) or ultrasound guidance (17/67). Five cases (7.5%) upgraded to a malignant lesion, 2 ADH, 2 LIN and one papillary lesion that underwent surgery. No malignancy or new lesions has occurred at the site of the VAE, with an average radiological follow-up of 14.9 months. CONCLUSIONS: VAE could be a safe and effective pathway for managing selected B3 lesions. Lesions initially subjected to CNB with ADH and LN outcome, before undergoing VAE, should perform a VAB for better tissue characterization and management.

Reducing the Use of Frozen Section for Sentinel Node Biopsy in Breast Carcinoma: Feasibility and Outcome.

BACKGROUND/AIM: Sentinel lymph node biopsy (SLNB) is a standard practice for staging the axilla in breast cancer. Initially, intraoperative frozen section (FS) examination was used but was time-consuming and often provided false-negative results. Delayed permanent section (PS) analysis is currently performed; FS-SLNB is maintained for selected high-risk cases. The aim of this study was to evaluate the feasibility of this approach. PATIENTS AND METHODS: All patients with breast cancer with clinically negative lymph nodes undergoing SLNB at our institution from 2004 to 2020 were analyzed, comparing operative time, re-operation rate and clinical outcome in terms of regional lymphatic recurrence-free and overall survival by type of SLNB (FS vs. PS). RESULTS: FS-SLNB comprised 100% of the procedures in 2004 and 18.2% at the end of the study period. The use of PS-SLNB instead of FS-SLNB was associated with a significantly reduced rate of axillary dissection (AD): 4.4% vs. 27.2, respectively (p<0.001). There was no significant difference in re-operation rate for AD: 3.9% vs. 6.9%, respectively (p=0.20). The use of PS-SLNB significantly reduced the operative time (mean=51 minutes) (p<0.001). After a mean follow-up of 70.9 months (range=16-180 months) there were no differences in regional lymphatic recurrence free or overall survival. CONCLUSION: The reduced use of FS-SLNB resulted in a significantly lower rate of AD, and significant operative time and costs savings, without any increase in the reoperation rate and lymphatic recurrences. Therefore, this approach is feasible, safe and beneficial, both for patients and healthcare services.

Contrast Enhanced Mammography (CEM) Enhancing Asymmetry: Single-Center First Case Analysis.

(1) Purpose: The latest Breast Imaging Reporting and Data System (BI-RADS) lexicon for CEM introduced a new descriptor, enhancing asymmetries (EAs). The purpose of this study was to determine which types of lesions were correlated with EAs. (2) Methods: A total of 3359 CEM exams, executed at AOUC Careggi in Florence, Italy between 2019 and 2021 were retrospectively assessed by two radiologists. For each of the EAs found, the size, the enhancing conspicuity (degree of enhancement relative to background described as low, moderate, or high), whether there was a corresponding finding in the traditional radiology images (US or mammography), the biopsy results when performed including any follow-up exams, and the presence of background parenchymal enhancement (BPE) of the normal breast tissue (minimal, mild, moderate, marked) were described. (3) Results: A total of 64 women were included, 36 of them underwent CEM for a preoperative staging assessment, and 28 for a problem-solving examination. Among the 64 EAs, 19/64 (29.69%) resulted in being category B5 (B5) lesions, 5/64 (7.81%) as category B3 (B3) lesions, and 40/64(62.50%) were negative or benign either after biopsy or second-look exams or follow-up. We assessed that EAs with higher enhancing conspicuity correlated significantly with a higher risk of B5 lesions (p: 0.0071), especially bigger ones (p: 0.0274). Conclusions: EAs can relate both with benign and tumoral lesions, and they need to be assessed as the other CEM descriptors, with re-evaluation of low-energy images and second-look exams, particularly larger EAs with higher enhancing conspicuity.

Safety of CDK4/6 inhibitors and concomitant radiation therapy in patients affected by metastatic breast cancer.

PURPOSE: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) currently represent the standard of care for the initial treatment of patients with metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. The aim of our study is to evaluate the safety of the use of concomitant radiation therapy (RT) in a consecutive series of HR+/HER2- patients treated in two academic institutions with CDK4/6i in the metastatic setting. METHODS AND MATERIALS: From September 2017 to February 2020, we retrospectively collected and analysed data on a sequential series of patients treated with CDK4/6i, receiving RT or not, at two European institutions. Primary outcome of the study was the association between RT and any adverse events (AEs) ≥ G3. Secondary outcomes were the association between RT and any AEs (any grade), CDK4/6i dose reduction rate, and CDK4/6i treatment discontinuation rate. RESULTS: We analysed a total of 132 consecutive women; RT was prescribed in 57 (43.2%) patients (70 irradiated lesions). The median age of the series was 52.1 years (range 32.3-78.2). Concomitant RT administration was not significantly related to higher AEs ≥ G3 (p = 0.19) and any grade AEs (p = 1.0); there was no association with RT and CDK4/6i dose reduction (p = 0.49) and discontinuation rates (p = 0.14). At a median follow-up of 18.8 months, the progression-free survival (PFS) rate was 35% and the overall survival (OS) rate was 38.7% in the whole group. The use of concomitant RT did not affect both PFS (p = 0.71) and OS rates (p = 0.55). CONCLUSIONS: Our data are encouraging regarding the safety of this combination, showing that concurrent RT did not increase severe toxicity and did not have an impact on systemic treatment conduction.

Preoperative robotic radiosurgery for early breast cancer: Results of the phase II ROCK trial (NCT03520894).

Background and purpose: Preoperative partial breast irradiation (PBI) has got the advantage of treating a well-defined target. We report the results of the phase II ROCK trial (NCT03520894), enrolling early breast cancer (BC) patients treated with preoperative robotic radiosurgery (prRS), in terms of acute and early late toxicity, disease control, and cosmesis. Material and methods: The study recruited between 2018 and 2021 at our Radiation Oncology Unit. Eligible patients were 50 + years old BC, hormonal receptors positive/human epidermal growth factor receptor 2 negative (HR+/HER2-), sized up to 25 mm. The study aimed to prospectively assess the toxicity and feasibility of a robotic single 21 Gy-fraction prRS in preoperative setting. Results: A total of 70 patients were recruited and 22 patients were successfully treated with pRS. Overall, three G1 adverse events (13.6 %) were recorded within 7 days from prRS. Three events (13.6 %) were recorded between 7 and 30 days, one G2 breast oedema and two G1 breast pain. No acute toxicity greater than G2 was recorded. Five patients experienced early late G1 toxicity. One patient reported G2 breast induration. No early late toxicity greater than G2 was observed. At a median follow up of 18 months (range 6-29.8), cosmetic results were scored excellent/good and fair in 14 and 5 patients, respectively, while 3 patients experienced a poor cosmetic outcome. Conclusions: ROCK trial showed that a single 21 Gy dose prRS represents a feasible technique for selected patients affected by early BC, showing an acceptable preliminary toxicity profile.

Comparison between second-look ultrasound and second-look digital breast tomosynthesis in the detection of additional lesions with presurgical CESM.

OBJECTIVES: To compare second-look ultrasound (SL-ultrasound) with second-look digital breast tomosynthesis (SL-DBT) in the detection of additional lesions (ALs) with presurgical contrast-enhanced spectral mammography (CESM). METHODS: We retrospectively included 121 women with 128 ALs from patients who underwent CESM for presurgical staging at our centre from September 2016 to December 2018. These ALs underwent SL-ultrasound and a retrospective review of DBT (SL-DBT) performed 1-3 weeks prior to CESM to evaluate the performance of each technique individually and in combination. ALs in CESM images were evaluated according to enhancement type (focus, mass, or non-mass), size (<10 mm or >10 mm) and level of suspicion (BI-RADS 2, 3, 4 or 5). Our gold-standard was post-biopsy histology, post-surgical specimen or >24 month negative follow-up. McNemar's test was used for the statistical analysis. RESULTS: Out of the 128 ALs, an imaging correlate was found for 71 (55.5 %) with ultrasound, 79 (61.7%) with DBT, 53 (41.4 %) with DBT and ultrasound, and 97 (75.8%) with ultrasound and/or DBT. SL-DBT demonstrated a higher detection rate vs SL-ultrasound in non-mass enhancement (NME) pattern (p: 0.0325) and ductal carcinoma in situ histological type (p: 0.0081). Adding SL-DBT improved the performance vs SL-ultrasound alone in the overall sample (p: <0.0001) and in every subcategory identified; adding SL-ultrasound to SL-DBT improved the detectability of ALs in the overall sample and in every category except for NME (p: 0.0833), foci (p: 0.0833) and B3 lesions (p: 0.3173). CONCLUSION: Combined second-look imaging (SL-DBT+ SL-ultrasound) for CESM ALs is superior to SL-DBT alone and SL-ultrasound alone. In B3 lesions, NME, and foci, the analysis of a larger sample could determine whether adding SL-ultrasound to SL-DBT is necessary or not. ADVANCES IN KNOWLEDGE: Thanks to its high sensitivity, CESM is a useful tool in presurgical staging to detect the extent of the disease burden and identify ALs not detected with conventional imaging. Since CESM-guided biopsy systems are still scarcely available in clinical practice, it is necessary to look for other approaches to histologically characterize ALs detected with CESM. In our study, combined second-look imaging (SL-DBT + SL-ultrasound) showed better performance in terms of detectability of ALs, than either SL-DBT or SL-ultrasound alone, and allowed us to identify 91.2% of ALs that turned out to be malignant at final histology; for the remaining 8.8% it was still necessary to perform MRI or MRI-guided biopsy. However, this issue could be solved once CESM-guided biopsies spread in clinical practice. SL-DBT demonstrated a higher detection rate than SL-ultrasound in NME and ductal carcinoma in situ histology.

Structured reporting of x-ray mammography in the first diagnosis of breast cancer: a Delphi consensus proposal.

BACKGROUND: Radiology is an essential tool in the management of a patient. The aim of this manuscript was to build structured report (SR) Mammography based in Breast Cancer. METHODS: A working team of 16 experts (group A) was composed to create a SR for Mammography Breast Cancer. A further working group of 4 experts (group B), blinded to the activities of the group A, was composed to assess the quality and clinical usefulness of the SR final draft. Modified Delphi process was used to assess level of agreement for all report sections. Cronbach's alpha (Cα) correlation coefficient was used to assess internal consistency and to measure quality analysis according to the average inter-item correlation. RESULTS: The final SR version was built by including n = 2 items in Personal Data, n = 4 items in Setting, n = 2 items in Comparison with previous breast examination, n = 19 items in Anamnesis and clinical context; n = 10 items in Technique; n = 1 item in Radiation dose; n = 5 items Parenchymal pattern; n = 28 items in Description of the finding; n = 12 items in Diagnostic categories and Report and n = 1 item in Conclusions. The overall mean score of the experts and the sum of score for structured report were 4.9 and 807 in the second round. The Cronbach's alpha (Cα) correlation coefficient was 0.82 in the second round. About the quality evaluation, the overall mean score of the experts was 3.3. The Cronbach's alpha (Cα) correlation coefficient was 0.90. CONCLUSIONS: Structured reporting improves the quality, clarity and reproducibility of reports across departments, cities, countries and internationally and will assist patient management and improve breast health care and facilitate research.

Single Center Evaluation of Comparative Breast Radiation dose of Contrast Enhanced Digital Mammography (CEDM), Digital Mammography (DM) and Digital Breast Tomosynthesis (DBT).

RATIONALE AND OBJECTIVES: The aim of this retrospective study is to compare the radiation dose received during CEDM, short and long protocol (CEDM SP and CEDM LP), with dose received during DM and DBT on patients with varying breast thickness, age and density. MATERIALS AND METHODS: Between January 2019 and December 2019, patients having 6214 DM, 3662 DBT and 173 CEDM examinations in our department were analyzed. Protocol total single breast AGD has been evaluated for all clinical imaging protocols, extracting AGD values and exposure data from the dose DICOM Structured Report (SR) information stored in the hospital PACS system. Protocol AGD was calculated as the sum of single projection AGDs carried out in every exam for each clinical protocol. A total amount of 23,383 exams for each breast were analyzed. Protocol AGDs, stratified as a function of patient breast compression thickness, age, and breast density were assessed. RESULTS: The total protocol AGD median values for each protocol are: 2.8 mGy for DM, 3.2 mGy for DBT, 6.0 mGy for DM+DBT, 4.5 mGy for CEDM SP, 7.4 mGy for CEDM SP_DBT (CEDM SP protocol with DBT), 8.4 mGy for CEDM LP and 11.6 mGy for CEDM LP_DBT (CEDM LP protocol with DBT). CEDM SP AGD median value is 59% higher than DM AGD median value and 40% lesser than DM+DBT AGD median; this last difference was statistically confirmed with a p-value <0.001. AGD value for each standard breast CEDM SP projection results to be below 3-mGy limit. AGD value for each standard breast CEDM SP projection results to be below 3 mGy, as required by international legislation. For dense breasts, the AGD median value is 4.2 mGy, with the first and third quartile of 3.3 mGy and 6.0 mGy respectively; for non-dense breasts, the AGD median value is 4.7 mGy, with first and third quartile of 3.5 mGy and 6.3 mGy respectively. The difference between the two groups was statistically tested and confirmed, with a p-value of 0.039. CONCLUSION: CEDM SP results in higher radiation exposure compared with conventional DM and DBT but lower than the Combo mode. The dose administered during the CEDM SP is lower in patients with dense breasts regardless of their size. An interesting outcome, considering the ongoing studies on CEDM screening in patients with dense breasts.

Pre-pectoral breast reconstruction: early and long-term safety evaluation of 146 unselected cases of the early pre-pectoral era of a single-institution, including cases with previous breast irradiation and post-mastectomy radiation therapy.

We re-evaluated acute and early-late toxicity-related factors among pre-pectoral immediate tissue expander/implant (TE/I) breast reconstruction (BR) unselected, first-era, cases, including previous breast radiation treatment and post-mastectomy radiation therapy (PMRT). A retrospective analysis of 146 (117 therapeutic and 29 prophylactic) pre-pectoral reconstructions, between 2012 and 2016, considered patient-related (age, body mass index [BMI], smoke-history, comorbidity, BRCA mutation), and treatment-related characteristics (previous irradiation, axillary surgery, PMRT, pre- and postoperative chemotherapy, endocrine therapy, and target-therapy). Safety was evaluated as acute and early-late complications, and TE/I failures. At multivariate analysis of the 146 cases (117 patients submitted to BR) a significant factor related to acute toxicity was: BMI ≥ 25 (31.3% [≥ 25] vs 8.8% [< 25]; OR 4.44, 95% CI 1.56-12.6; p = 0.003), while previous breast surgery on ipsilateral side presented a borderline significance (31.6% [previous surgery] vs 7.4% [no previous surgery]; OR 3.74, 95% CI 0.97-14.40; p = 0.055). Factors significantly related to TE/I failure were: current or previous smoking exposition (13.8% [smokers] vs 2.6% [non-smokers]; OR 7.32, 95% CI 1.37-39.08; p = 0.02) and preoperative chemotherapy (18.8% [yes] vs 3.5% [no]; OR 8.16, 95% CI 1.29-51.63; p = 0.026). At 4-year median follow-up, 3 deaths, 5 locoregional recurrences, and 14 distant metastases occurred. Immediate pre-pectoral BR is safe and effective, with low rates of acute and early-late complications. BMI and previous breast surgery were related to higher complications but not failure; smoking and preoperative chemotherapy were related to TE/I explant. Previous RT and PMRT were related neither to early-late toxicity nor failure.

Cardioprotective Strategy for Patients With Nonmetastatic Breast Cancer Who Are Receiving an Anthracycline-Based Chemotherapy: A Randomized Clinical Trial.

IMPORTANCE: Several studies have evaluated cardioprotective strategies to prevent myocardial dysfunction in patients who are receiving cardiotoxic therapies. However, the optimal approach still represents a controversial issue. OBJECTIVE: To determine whether pharmacological cardioprevention could reduce subclinical heart damage in patients with breast cancer who are being treated with anthracycline-based chemotherapy. DESIGN, SETTING, AND PARTICIPANTS: The SAFE trial was a 4-arm, randomized, phase 3, double-blind, placebo-controlled, national multicentric study conducted at 8 oncology departments in Italy. It was a prespecified interim analysis on the first 174 patients who had completed cardiac assessment at 12 months. The study recruitment was conducted between July 2015 and June 2020. The interim analysis was performed in 2020. Patients were eligible for trial inclusion if they had indication to receive primary or postoperative systemic therapy using an anthracycline-based regimen. Patients with a prior diagnosis of cardiovascular disease were excluded. INTERVENTIONS: Cardioprotective therapy (bisoprolol, ramipril, or both drugs compared with placebo) was administered for 1 year from the initiation of chemotherapy or until the end of trastuzumab therapy in case of ERBB2-positive patients. Doses for all groups were systematically up-titrated up to the daily target dose of bisoprolol (5 mg, once daily), ramipril (5 mg, once daily), and placebo, if tolerated. MAIN OUTCOMES AND MEASURES: The primary end point was defined as detection of any subclinical impairment (worsening ≥10%) in myocardial function and deformation measured with standard and 3-dimensional (3D) echocardiography, left ventricular ejection fraction (LVEF), and global longitudinal strain (GLS). RESULTS: The analysis was performed on 174 women (median age, 48 years; range, 24-75 years) who had completed a cardiological assessment at 12 months and reached the end of treatment. At 12 months, 3D-LVEF worsened by 4.4% in placebo arm and 3.0%, 1.9%, 1.3% in the ramipril, bisoprolol, ramipril plus bisoprolol arms, respectively (P = .01). Global longitudinal strain worsened by 6.0% in placebo arm and 1.5% and 0.6% in the ramipril and bisoprolol arms, respectively, whereas it was unchanged (0.1% improvement) in the ramipril plus bisoprolol arm (P < .001). The number of patients showing a reduction of 10% or greater in 3D-LVEF was 8 (19%) in the placebo arm, 5 (11.5%) in the ramipril arm, 5 (11.4%) in the bisoprolol, arm and 3 (6.8%) in the ramipril plus bisoprolol arm; 15 patients (35.7%) who received placebo showed a 10% or greater worsening of GLS compared with 7 (15.9; ramipril), 6 (13.6%; bisoprolol), and 6 (13.6%; ramipril plus bisoprolol) (P = .03). CONCLUSIONS AND RELEVANCE: The interim analysis of this randomized clinical trials suggested that cardioprotective pharmacological strategies in patients who were affected by breast cancer and were receiving an anthracycline-based chemotherapy are well tolerated and seem to protect against cancer therapy-related LVEF decline and heart remodeling. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT2236806.

Immunohistochemical Evaluation of FGD3 Expression: A New Strong Prognostic Factor in Invasive Breast Cancer.

Among new prognostic factors for breast cancer, the most promising one seems to be FGD3 (Facio-Genital Dysplasia 3) gene, whose expression improves outcome by inhibiting cell migration. The aim of the study was to evaluate the prognostic role of FGD3 in invasive breast cancer in a series of 401 women, treated at our unit, by evaluating the expression of this gene by immunohistochemistry. Patients with high FGD3 expression showed a significantly better disease-free survival (DFS) (p < 0.001) and overall survival (OS) (p < 0.001). The prognostic value of FGD3 expression was stronger than that of classical pathologic parameters such as histological grade of differentiation, Ki-67 index and molecular subtype. By multivariate Cox analysis, FGD3 expression was confirmed as significant and independent prognostic factor, ranking second after age at diagnosis (≤40 years) for DFS (p = 0.003) and the second strongest predictor of OS, after AJCC Stage (p < 0.001). Our data suggest that inclusion of FGD3 evaluation in the routine workup of breast cancer patients may result in a more accurate stratification of the individual risk. The possibility to assess FGD3 expression by a simple and cheap technique such as immunohistochemistry may enhance the spread of its use in the clinical practice.

A Review of Breast Imaging for Timely Diagnosis of Disease.

Breast cancer (BC) is the cancer with the highest incidence in women in the world. In this last period, the COVID-19 pandemic has caused in many cases a drastic reduction of routine breast imaging activity due to the combination of various factors. The survival of BC is directly proportional to the earliness of diagnosis, and especially during this period, it is at least fundamental to remember that a diagnostic delay of even just three months could affect BC outcomes. In this article we will review the state of the art of breast imaging, starting from morphological imaging, i.e., mammography, tomosynthesis, ultrasound and magnetic resonance imaging and contrast-enhanced mammography, and their most recent evolutions; and ending with functional images, i.e., magnetic resonance imaging and contrast enhanced mammography.

A new technique for the histological diagnosis of Paget's disease of the breast using a semiautomated core needle biopsy with a 14-gauge needle.

PURPOSE: The aim of our work is to illustrate a new technique for the histological diagnosis of Paget's disease (PD) using a core needle biopsy with a semiautomated 14-gauge needle called nipple-core needle biopsy (N-CNB). We report 3 years' experience in our senology unit. MATERIALS AND METHODS: Twenty-six women with 26 clinical of nipple-areola complex (NAC) changes with suspected PD and subjected to core needle biopsy using our new 14G semiautomated needle technique were included in our study group. Institutional review board approval was obtained for this retrospective analysis. A semiautomated biopsy gun with a 14-gauge, 15-cm-long needle was used for this new procedure. After a subcutaneous injection of anesthetic and spray-ice application to the NAC, the 14G needle was opened with the cradle exposed and positioned on the NAC with considerable pressure exerted on the same. The cradle was then closed by triggering the needle spring, and 2-4 core samples were withdrawn by moving the needle position each time. Clinical, instrumental and histological differences between the lesions that gave benign results after N-CNB and those that resulted PD were analyzed by applying the Fisher's exact test. RESULTS: After N-CNB, 13/26 lesions were found to be PD (50%) while 13/26 alterations were benign (50%). No malignant lesions were detected during the follow-up in patients with benign N-CNB results. The diagnosis of PD obtained with N-CNB was confirmed in all 13 cases by means of a histological analysis of the surgical specimens. No significant post-biopsy complications were recorded. Patients with PD more frequently presented nipple retraction (ρ = 0.0407) and associated suspicious (i.e., BI-RADS 4 and 5) mammographic (ρ = 0.0006) findings compared to patients whose N-CNB had given benign results and the difference was statistically significant. CONCLUSIONS: In conclusion, with this novel technique, we were able to obtain an easy, painless, major complication-free and accurate diagnosis of PD of the NAC using a semiautomated core needle biopsy with a 14-gauge needle.

Which clinical, radiological, histological, and molecular parameters are associated with the absence of enhancement of known breast cancers with Contrast Enhanced Digital Mammography (CEDM)?

BACKGROUND: CEDM has demonstrated a diagnostic performance similar to MRI and could have similar limitations in breast cancer (BC) detection. PURPOSE: The aim of our study was to systematically analyze the characteristics of the lesions with the absence of enhancement with CEDMs, called false-negatives (FNs), in order to identify which clinical, radiological, histological and molecular parameters are associated with the absence of enhancement of known BCs with CEDMs, and which types of BC are most likely to cause FNs in CEDMs. We also tried to evaluate which parameters instead increased the probability of showing enhancement in the same context. MATERIALS AND METHODS: Included in our study group were 348 women with 348 diagnosed BCs performing CEDM as preoperative staging. Two breast-imaging radiologists reviewed the CEDM exams. The absence of perceptible contrast enhancement at the index cancer site was indicative of an FN CEDM, whereas cases with appreciable enhancement were considered true positives (TPs). Dichotomic variables were analyzed with Fisher's exact probability test or, when applicable, the chi-square test. Binary logistic regression was performed on variables shown to be significant by the univariate analysis in order to assess the relationship between predictors (independent variables) and TFNs (outcome). RESULTS: Enhancement was observed in 317 (91.1%) of the 348 BCs. From the 31 (8.9%) lesions which were FNs, we excluded 12 (38.7%) which showed an artifact generated by the post biopsy hematoma and 6 (19.4%) which were outside the CEDM field of vision. We thus obtained 13 (41.9%) BCs considered "True False Negatives" (TFNs), i.e. BCs which showed no enhancement despite being within the CEDM field of vision and failed to show post biopsy hematoma artifacts. We found that the TFNs frequently have a unifocal disease extension, diameter <10 mm, a lower number of luminal B HER2-subtypes, a higher number of DCIS, and an index lesion with microcalcifications. CONCLUSIONS: The parameters we found to be associated with no enhancement of known BCs with CEDMs were: unifocal disease extension, DCIS histotype, lesion dimensions <10 mm, and index lesion with microcalcifications. The characteristics that instead increase the probability of showing enhancement were US mass, Luminal B HER2 negative molecular subtype, the presence of an invasive ductal component, and lesion dimensions ≥10 mm.

Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial.

PURPOSE: To report the long-term results of external-beam accelerated partial-breast irradiation (APBI) intensity-modulated radiation therapy (IMRT) Florence phase III trial comparing whole-breast irradiation (WBI) to APBI in early-stage breast cancer. PATIENTS AND METHODS: The primary end point was to determine the 5-year difference in ipsilateral breast tumor recurrence (IBTR) between 30 Gy in 5 once-daily fractions (APBI arm) and 50 Gy in 25 fractions with a tumor bed boost (WBI arm) after breast-conserving surgery. RESULTS: Five hundred twenty patients, more than 90% of whom had characteristics associated with low recurrence risk, were randomly assigned (WBI, n = 260; APBI, n = 260) between 2005 and 2013. Median follow-up was 10.7 years. The 10-year cumulative incidence of IBTR was 2.5% (n = 6) in the WBI and 3.7% (n = 9) in the APBI arm (hazard ratio [HR], 1.56; 95% CI, 0.55 to 4.37; P = .40). Overall survival at 10 years was 91.9% in both arms (HR, 0.95; 95% CI, 0.50 to 1.79; P = .86). Breast cancer-specific survival at 10 years was 96.7% in the WBI and 97.8% in the APBI arm (HR, 0.65; 95% CI, 0.21 to 1.99; P = .45). The APBI arm showed significantly less acute toxicity (P = .0001) and late toxicity (P = .0001) and improved cosmetic outcome as evaluated by both physician (P = .0001) and patient (P = .0001). CONCLUSION: The 10-year cumulative IBTR incidence in early breast cancer treated with external APBI using IMRT technique in 5 once-daily fractions is low and not different from that after WBI. Acute and late treatment-related toxicity and cosmesis outcomes were significantly in favor of APBI.

Lesions of uncertain malignant potential of the breast (B3) on vacuum-assisted biopsy for microcalcifications: Predictors of malignancy.

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 (p = 0.01), lesion size>10 mm (p < 0.0001), BI-RADS 4b-c and 5 (p = 0.0001), and fine pleomorphic morphology (p = 0.002) of microcalcifications. Binary logistic regression confirmed as significant independent risk factors age, lesion size and BI-RADS category (p = 0.02, 0.02 and 0.0006 respectively). Amongst subcategories of B3 lesions, lobular neoplasia was significantly(p = 0.04) associated with upgrade, confirmed as an independent risk factor [p = 0.03, OR = 2.3(1.1-4.7)]. Flat epithelial atypia was significantly(p = 0.004) associated with reduced odds of upgrade, but binary logistic regression showed only borderline association [p = 0.052, OR = 0.4(0.2-1.01)]. CONCLUSIONS: Across B3 lesions diagnosed on histology from VABB of suspicious microcalcifications, older age, size>10 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.

Long-term Results After Neoadjuvant Chemotherapy for Breast Cancer: A Single-center Experience.

BACKGROUND/AIM: We evaluated the efficacy of neoadjuvant chemotherapy (NACT) in reducing locally-advanced breast cancer (LABC) size, thus improving breast-conserving surgery (BCS) rates, as well as its long-term outcome. PATIENTS AND METHODS: We analyzed 59 patients treated between 1999-2017 with NACT and subsequent surgery for LABC. RESULTS: We observed a tumor size reduction in 95% of cases, resulting in downstaging in 62.7%. The average tumor shrinkage was 49%. Women with a reduction in tumor size >50% after NACT had better 10-year OS rates than women with a reduction ≤50% (p=0.025). NACT allowed to perform BCS in 44% cases, whereas the remaining 56% cases underwent mastectomy. Overall, we observed recurrences in 37.2% patients. Recurrence rates after BCS and mastectomy were 30.7% (6 loco-regional and 2 distant cases) and 42.4% (5 loco-regional and 9 distant cases), respectively (p=0.07). CONCLUSION: NACT confirmed its effectiveness in reducing mastectomy rates by approximately 50%, without increasing the risk of local or distant recurrences.

Artefacts in contrast enhanced digital mammography: how can they affect diagnostic image quality and confuse clinical diagnosis?

Contrast-enhanced digital mammography (CEDM) is a diagnostic tool for breast cancer detection. Artefacts are observed in about 10% of CEDM examinations. Understanding CEDM artefacts is important to prevent diagnostic misinterpretation. In this article, we have described the artefacts that we have commonly encountered in clinical practice; we hope to ease the recognition and help troubleshoot solutions to prevent or minimise them.

Evaluation of contrast-enhanced digital mammography (CEDM) in the preoperative staging of breast cancer: Large-scale single-center experience.

One of the most important indications for contrast-enhanced breast imaging is the presurgical breast cancer (BC) staging. This is a large-scale single-center experience which evaluates the role of CEDM in presurgical staging and its impact on surgical planning. The aims of this retrospective study were to define the diagnostic performance of CEDM in the presurgical setting and to identify which types of patients could benefit from having CEDM. We selected 326 patients with BC who underwent CEDM as preoperative staging and had breast cancer-related surgery at our institution. We analyzed those cases in which CEDM led to additional imaging or biopsy and those in which it changed the type of surgery that was planned according to conventional breast imaging (CI) techniques (digital mammography, tomosynthesis and bilateral handheld ultrasound). CEDM sensitivity in identifying the index lesion and sensitivity, specificity, positive (PPV) and negative (NPV) predictive values, and accuracy in the correct preoperative staging of BC of the whole population and in various subgroups were calculated. CEDM sensitivity for the index lesion was 98.8% (322/326), which led to additional breast imaging in 23.6% (77/326) of patients and additional biopsies in 17.5% (57/326). CEDM changed the type of surgery in 18.4% (60/326). In the preoperative breast cancer staging, CEDM sensitivity, specificity, PPV, NPV, and accuracy produced results of 93%, 98%, 90%, 98%, and 97%, respectively. CEDM performance was better in patients with palpable lesions. CEDM has an excellent diagnostic performance in the presurgical staging of BC. Symptomatic patients with palpable lesions benefitted most from preoperative CEDM, with a statistically significant difference compared with nonpalpable.