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Purpose: The use of tissue adhesive instead of a drain following mastectomy was a point of interest for many breast surgeons. Postoperative formation of multiple unusual sonographic lesions was observed in patients that underwent mastectomy with TissuGlu. The aim of this study was to describe the sonographic features of these lesions and, when possible, to examine them histologically., Materials and Methods: This study includes 98 patients, 49 underwent mastectomy with the application of TissuGlu and 49 with drain insertion. Unusual postoperative sonographic findings were thoroughly described. A histological examination was carried out according to the guideline recommendations., Results: Unusual sonographic findings were detected in 87.8% of patients in the TissuGlu group and in only 4% of the patients in the drain group. These lesions were detectable between 6 and 59 months postoperatively. 47 breasts of the TissuGlu group were classified as category 3, while only 2 breasts as category 4. Lesions were on average 7.5 mm in diameter, echogenic or isoechoic with posterior shadowing, an irregular and ill circumscribed marginal contour, and a horizontal axis. All histologically examined lesions (n=29) were benign. Granulomatous tissue was histologically proven in 63% of those lesions (n=17), while residual adhesive material could be detected in 18.5% of lesions (n=5)., Conclusion: The use of TissuGlu adhesive after mastectomy may cause the formation of unusual palpable granulomas, with or without residual adhesive materials. Sonographic description of lesions will help physicians to differentiate between granulomas and local relapse., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Objectives: We evaluated whether lesion-to-fat ratio measured by shear wave elastography in patients with Breast Imaging Reporting and Data System (BI-RADS) 3 or 4 lesions has the potential to further refine the assessment of B-mode ultrasound alone in breast cancer diagnostics., Methods: This was a secondary analysis of an international diagnostic multicenter trial (NCT02638935). Data from 1288 women with breast lesions categorized as BI-RADS 3 and 4a-c by conventional B-mode ultrasound were analyzed, whereby the focus was placed on differentiating lesions categorized as BI-RADS 3 and BI-RADS 4a. All women underwent shear wave elastography and histopathologic evaluation functioning as reference standard. Reduction of benign biopsies as well as the number of missed malignancies after reclassification using lesion-to-fat ratio measured by shear wave elastography were evaluated., Results: Breast cancer was diagnosed in 368 (28.6%) of 1288 lesions. The assessment with conventional B-mode ultrasound resulted in 53.8% (495 of 1288) pathologically benign lesions categorized as BI-RADS 4 and therefore false positives as well as in 1.39% (6 of 431) undetected malignancies categorized as BI-RADS 3. Additional lesion-to-fat ratio in BI-RADS 4a lesions with a cutoff value of 1.85 resulted in 30.11% biopsies of benign lesions which correspond to a reduction of 44.04% of false positives., Conclusions: Adding lesion-to-fat ratio measured by shear wave elastography to conventional B-mode ultrasound in BI-RADS 4a breast lesions could help reduce the number of benign biopsies by 44.04%. At the same time, however, 1.98% of malignancies were missed, which would still be in line with American College of Radiology BI-RADS 3 definition of <2% of undetected malignancies., (© 2023 The Authors. Journal of Ultrasound in Medicine published by Wiley Periodicals LLC on behalf of American Institute of Ultrasound in Medicine.)

Purpose:  In this prospective, multicenter trial we evaluated whether additional shear wave elastography (SWE) for patients with BI-RADS 3 or 4 lesions on breast ultrasound could further refine the assessment with B-mode breast ultrasound for breast cancer diagnosis., Materials and Methods:  We analyzed prospective, multicenter, international data from 1288 women with breast lesions rated by conventional 2 D B-mode ultrasound as BI-RADS 3 to 4c and undergoing 2D-SWE. After reclassification with SWE the proportion of undetected malignancies should be < 2 %. All patients underwent histopathologic evaluation (reference standard)., Results:  Histopathologic evaluation showed malignancy in 368 of 1288 lesions (28.6 %). The assessment with B-mode breast ultrasound resulted in 1.39 % (6 of 431) undetected malignancies (malignant lesions in BI-RADS 3) and 53.80 % (495 of 920) unnecessary biopsies (biopsies in benign lesions). Re-classifying BI-RADS 4a patients with a SWE cutoff of 2.55 m/s resulted in 1.98 % (11 of 556) undetected malignancies and a reduction of 24.24 % (375 vs. 495) of unnecessary biopsies., Conclusion:  A SWE value below 2.55 m/s for BI-RADS 4a lesions could be used to downstage these lesions to follow-up, and therefore reduce the number of unnecessary biopsies by 24.24 %. However, this would come at the expense of some additionally missed cancers compared to B-mode breast ultrasound (rate of undetected malignancies 1.98 %, 11 of 556, versus 1.39 %, 6 of 431) which would, however, still be in line with the ACR BI-RADS 3 definition (< 2 % of undetected malignancies)., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Background: Breast ultrasound identifies additional carcinomas not detected in mammography but has a higher rate of false-positive findings. We evaluated whether use of intelligent multi-modal shear wave elastography (SWE) can reduce the number of unnecessary biopsies without impairing the breast cancer detection rate., Methods: We trained, tested, and validated machine learning algorithms using SWE, clinical, and patient information to classify breast masses. We used data from 857 women who underwent B-mode breast ultrasound, SWE, and subsequent histopathologic evaluation at 12 study sites in seven countries from 2016 to 2019. Algorithms were trained and tested on data from 11 of the 12 sites and externally validated using the additional site's data. We compared findings to the histopathologic evaluation and compared the diagnostic performance between B-mode breast ultrasound, traditional SWE, and intelligent multi-modal SWE., Results: In the external validation set (n = 285), intelligent multi-modal SWE showed a sensitivity of 100% (95% CI, 97.1-100%, 126 of 126), a specificity of 50.3% (95% CI, 42.3-58.3%, 80 of 159), and an area under the curve of 0.93 (95% CI, 0.90-0.96). Diagnostic performance was significantly higher compared to traditional SWE and B-mode breast ultrasound (P < 0.001). Unlike traditional SWE, positive-predictive values of intelligent multi-modal SWE were significantly higher compared to B-mode breast ultrasound. Unnecessary biopsies were reduced by 50.3% (79 versus 159, P < 0.001) without missing cancer compared to B-mode ultrasound., Conclusion: The majority of unnecessary breast biopsies might be safely avoided by using intelligent multi-modal SWE. These results may be helpful to reduce diagnostic burden for patients, providers, and healthcare systems., Competing Interests: Conflict of interest statement The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

For many years, breast ultrasound has been used in addition to mammography as an important method for clarifying breast findings. However, differences in the interpretation of findings continue to be problematic 1 2. These differences decrease the diagnostic accuracy of ultrasound after detection of a finding and complicate interdisciplinary communication and the comparison of scientific studies 3. In 1999, the American College of Radiology (ACR) created a working group (International Expert Working Group) that developed a classification system for ultrasound examinations based on the established BI-RADS classification of mammographic findings under consideration of literature data 4. Due to differences in content, the German Society for Ultrasound in Medicine (DEGUM) published its own BI-RADS-analogue criteria catalog in 2006 3. In addition to the persistence of differences in content, there is also an issue with formal licensing with the current 5th edition of the ACR BI-RADS catalog, even though the content is recognized by the DEGUM as another system for describing and documenting findings. The goal of the Best Practice Guideline of the Breast Ultrasound Working Group of the DEGUM is to provide colleagues specialized in senology with a current catalog of ultrasound criteria and assessment categories as well as best practice recommendations for the various ultrasound modalities., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Objectives: AI-based algorithms for medical image analysis showed comparable performance to human image readers. However, in practice, diagnoses are made using multiple imaging modalities alongside other data sources. We determined the importance of this multi-modal information and compared the diagnostic performance of routine breast cancer diagnosis to breast ultrasound interpretations by humans or AI-based algorithms., Methods: Patients were recruited as part of a multicenter trial (NCT02638935). The trial enrolled 1288 women undergoing routine breast cancer diagnosis (multi-modal imaging, demographic, and clinical information). Three physicians specialized in ultrasound diagnosis performed a second read of all ultrasound images. We used data from 11 of 12 study sites to develop two machine learning (ML) algorithms using unimodal information (ultrasound features generated by the ultrasound experts) to classify breast masses which were validated on the remaining study site. The same ML algorithms were subsequently developed and validated on multi-modal information (clinical and demographic information plus ultrasound features). We assessed performance using area under the curve (AUC)., Results: Of 1288 breast masses, 368 (28.6%) were histopathologically malignant. In the external validation set (n = 373), the performance of the two unimodal ultrasound ML algorithms (AUC 0.83 and 0.82) was commensurate with performance of the human ultrasound experts (AUC 0.82 to 0.84; p for all comparisons > 0.05). The multi-modal ultrasound ML algorithms performed significantly better (AUC 0.90 and 0.89) but were statistically inferior to routine breast cancer diagnosis (AUC 0.95, p for all comparisons ≤ 0.05)., Conclusions: The performance of humans and AI-based algorithms improves with multi-modal information., Key Points: • The performance of humans and AI-based algorithms improves with multi-modal information. • Multimodal AI-based algorithms do not necessarily outperform expert humans. • Unimodal AI-based algorithms do not represent optimal performance to classify breast masses., (© 2022. The Author(s).)

Background: Shear wave elastography (SWE) and strain elastography (SE) have shown promising potential in breast cancer diagnostics by evaluating the stiffness of a lesion. Combining these two techniques could further improve the diagnostic performance. We aimed to exploratorily define the cut-offs at which adding combined SWE and SE to B-mode breast ultrasound could help reclassify Breast Imaging Reporting and Data System (BI-RADS) 3-4 lesions to reduce the number of unnecessary breast biopsies., Methods: We report the secondary results of a prospective, multicentre, international trial (NCT02638935). The trial enrolled 1288 women with BI-RADS 3 to 4c breast masses on conventional B-mode breast ultrasound. All patients underwent SWE and SE (index test) and histopathologic evaluation (reference standard). Reduction of unnecessary biopsies (biopsies in benign lesions) and missed malignancies after recategorising with SWE and SE were the outcome measures., Results: On performing histopathologic evaluation, 368 of 1288 breast masses were malignant. Following the routine B-mode breast ultrasound assessment, 53.80% (495 of 920 patients) underwent an unnecessary biopsy. After recategorising BI-RADS 4a lesions (SWE cut-off ≥3.70 m/s, SE cut-off ≥1.0), 34.78% (320 of 920 patients) underwent an unnecessary biopsy corresponding to a 35.35% (320 versus 495) reduction of unnecessary biopsies. Malignancies in the new BI-RADS 3 cohort were missed in 1.96% (12 of 612 patients)., Conclusion: Adding combined SWE and SE to routine B-mode breast ultrasound to recategorise BI-RADS 4a patients could help reduce the number of unnecessary biopsies in breast diagnostics by about 35% while keeping the rate of undetected malignancies below the 2% ACR BI-RADS 3 definition., Competing Interests: Conflict of interest statement The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Aim: This research compares postoperative complication rates with Strattice™, SERAGYN ® BR, and TiLOOP ® Bra interposition devices for subpectoral implant placement after skin or nipple sparing mastectomy., Patients and Methods: 188 breast reconstructions in 157 patients after primary (n=96), secondary (n=71), or prophylactic (n=21) surgery were analyzed regarding major and minor complications., Results: With acellular dermal matrix (ADM) Strattice™, 27.5% major and 27.5% minor complications occurred. Implant loss rates were 27.3% in primary and 30.8% in secondary reconstructions. With SERAGYN ® BR, 11.1% major and 13,0% minor complications occurred. Implant losses (6.1%) occurred exclusively in primary reconstructions. With TiLOOP ® Bra, 14.9% major and 9.6% minor complications occurred. Implant loss rates were 7.7% in primary and 7.1% in secondary reconstructions., Conclusion: ADM was associated with high complication rates in primary and secondary reconstructions. Low complication rates were seen with mesh interposition devices in primary, secondary, and prophylactic reconstructions., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Synthetic meshes (SMs) and acellular dermal matrices (ADMs) are used in reconstructive breast surgery. In the absence of prospective comparative studies, the identification of differences relies on retrospective analyses., Patients and Methods: Our analysis focused on the impact of pre- and postoperative radiotherapy (RTX) and material-related differences. The analysis included 281 breast cancer patients (362 breasts) after nipple- and skin-sparing mastectomy with subpectoral implant insertion., Results: Overall, the implant loss rate was 23.1% using porcine ADM, 7% using partially resorbable SM (prSM), and 5.6% using non-resorbable SM (nrSM). After RTX, the implant loss rate was 56.3% with ADM, 13% with prSM and 13.2% with nrSM. The ADM group showed a significant effect of RTX on the postoperative seroma rate, wound infections, and implant loss rate. When prSM was used, RTX showed no significant effect. When using the nrSM, RTX significantly influenced complication rates regarding wound infections and implant loss., Conclusion: In material-assisted breast reconstructions with pre- or post-operative RTX, there is a significantly higher implant loss rate when using porcine ADM compared to SM., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: This trial intended to identify patient- and therapy-specific risk factors influencing the genesis of seroma and the extent of its formation., Patients and Methods: Within a prospective randomized controlled trial, 70 patients (n=35 TissuGlu ® ; n=35 drain) underwent a mastectomy with or without sentinel lymphonodectomy. Specific seroma-associated risk factors were recorded. Regular outpatient aftercare was performed during a 90-day postoperative follow-up., Results: A statistically significant increase in the postoperative seroma rate was demonstrated for those with pre-adiposity compared to normal body weight (p=0.016), as well as for the state of health evaluated by the score of American Society of Anesthesiologists (ASA) (ASA III compared to I; p=0.046), the presence of diabetes mellitus (p<0.001) and the reduction of the length of the surgical procedure (p=0.044)., Conclusion: A high body mass index, a poor state of health (ASA score), and diabetes mellitus, as well as a shorter duration of surgery, favor the incidence of postoperative seroma., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Purpose: Postoperative seromas are a problem in the surgical treatment of breast cancer. The aim of the study was to evaluate whether the lysine-urethane-based tissue adhesive TissuGlu ® without drainage is equal/ non-inferior to standard mastecomy with drainage., Methods: The study was designed as a prospective, randomized, multicentre non-inferiority study comparing the use of TissuGlu ® without drainage with standard wound care with a drain insertion in ablative breast procedures. The number of clinical interventions, quality of life and wound complications were followed-up for 90 days in both groups., Results: Although the statistical power was not reached, twice as many clinical interventions were performed in the TissuGlu ® group than in the drainage group, especially aspirations of clinically relevant seromas (p = 0.014). The TissuGlu ® group produced overall less wound fluid, but developed a clinically relevant seroma (100% vs. 63%) which made an intervention necessary. Less hospitalisation time was observed in the TissuGlu ® group, but the complication rate was higher. There was no significant difference in regards to postoperative pain. In summary the non-inferiority of TissuGlu ® compared to standard drainage couldn't be reached., Discussion: The present evaluation shows no advantage of the tissue adhesive TissuGlu ® in terms of seroma formation and frequency of intervention compared to a standard drainage for mastectomies, but the shorter inpatient stay certainly has a positive effect on the quality of life.

Introduction: Implant-based or expander-supported breast reconstruction is an established surgical method after mastectomies due to cancer or to prophylactic reasons. Patient reported outcome (PRO) and cosmetic outcome after breast reconstruction with a synthetic surgical mesh was investigated in a prospective, single-arm, multi-center study., Material and Methods: Primary or secondary implant-based breast reconstruction with support of TiLOOP® Bra was performed in 269 patients during the PRO-BRA study. PRO 12 months after breast reconstruction was evaluated using Breast-Q questionnaire. Cosmetic outcome was evaluated by two independent experts by means of pictures taken preoperatively and at the follow-up visits., Results: Breast-Q and 12 months FU were completed by 210 women. Patients without adverse event had a significantly higher Breast-Q score for "sexual well-being" (p = 0.001); "psychosocial well-being" was negatively influenced by prior therapies (p < 0.01), and older patients had significantly lower scores at 12 months FU compared to pre-OP for "satisfaction with breasts" (p < 0.01) while the opposite was true for younger patients. Unilateral surgery resulted in reduced "satisfaction with breast" at 12 months FU (p < 0.01). Radiotherapy negatively influenced "satisfaction with breast", "sexual well-being" and "physical well-being chest". The cosmetic evaluation showed a significant difference (p < 0.001) in the evaluation by the patients and experts with the patients' assessment being worse compared to experts' assessment., Conclusion: Our study showed that two years after implant-based breast reconstruction with support of TiLOOP® Bra PRO is influenced by different factors. This information can be used to improve the decision-making process for women who chose implant-based breast reconstruction., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background/aim: The study aimed at investigating the correlation between ductoscopic and histopathological findings and clarify whether the former allow for accurate prediction of malignancy., Patients and Methods: The prospective national multi-center study covered a sample of 224 patients with pathologic nipple discharge. A total of 214 patients underwent ductoscopy with subsequent extirpation of the mammary duct. The ductoscopic findings were categorized according to shape, number, color and surface structure of lesions and vascularity and compared to the histological results and analyses., Results: Ductoscopy revealed lesions in 134 of 214 patients (62.2%). The criteria "multiple versus solitary lesion" differed significantly between malignant and benign lesions. All other criteria were not statistically significant. Malignant tumors were more frequently presented as multiple lesions, benign lesions or masses as solitary lesions (80% vs. 24.8%; p=0.018)., Conclusion: The ductoscopic criterion "solitary vs. multiple lesion" appears to have a low diagnostic prediction of malignancy or benignity., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Purpose:  The aim of the present study was to determine the accuracy of breast cancer measurement with 2 D shear wave elastography (2 D SWE), B-mode ultrasound, and mammography by comparing these methods with the actual histopathological tumor size., Materials and Methods:  135 patients with proven malignant breast lesions at two centers were included in a prospective study. The maximum lesion diameter was measured by 2 D SWE, B-mode ultrasound, and mammography. After surgery, the histopathological tumor size was measured by a pathologist., Results:  The mean difference in tumor size on 2 D SWE, B-mode ultrasound, and mammography on the one hand, and the actual tumor size on the other, was -0.03 cm, 0.16 cm and 0.10 cm, respectively. Lesion size on histopathological investigation was overestimated by 2 D SWE (p = 0.004) and underestimated by B-mode imaging (p < 0.001). All three imaging methods underestimated the size of invasive lobular cancers and lesions > 15 mm; 2 D SWE was most accurate in this regard., Conclusion:  2 D SWE predicted lesion size more precisely than B-mode ultrasound or mammography. In cases of invasive lobular carcinoma, all three imaging methods underestimated lesion size, with 2 D SWE coming closest to the actual tumor size., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (© Georg Thieme Verlag KG Stuttgart · New York.)

Objective: Synthetic meshes and acellular dermal matrices are increasingly used in implant-based breast reconstruction. The objective of this study was to determine the incidence and severity of complications following the implantation of the partially absorbable bi-component soft mesh SERAGYN® BR and assess risk factors for adverse operative outcomes., Methods: A retrospective clinical study was performed: The SERAGYN® BR soft mesh was utilized in 148 operations (skin-sparing mastectomy, nipple-sparing mastectomy, breast-conserving surgery, and secondary reconstruction after mastectomy) in four different institutions in Germany from June 2012 to February 2014. We analyzed whether the results were affected by tumor morphology (e.g., grading), patient characteristics and comorbidities, previous surgery or therapies, and use of alloplastic materials., Results: The SERAGYN® BR soft mesh was successfully implanted in 131 of 148 operations. The rate of reconstructive failure was 11.5%. The most common complication was seroma (25.7%), followed by hematoma and skin infection (each 14.2%). Wound-healing issues were detected in 13.5% cases, secondary wound infections in 10.8%. 83.8% of operations had no severe complications. Independent predictors for reconstructive failure were wound-healing issues, nipple- or skin necrosis, wound- or skin infections, a high volume of excised tissue, hematomas, seromas, and sentinel lymph node excisions. A higher body mass index was correlated with a higher rate of infection., Conclusion: SERAGYN® BR mesh can be used successfully in breast reconstructive surgery. Rates of major complications or reconstructive failure are comparable to the use of other synthetic or biological meshes.

Background/aim: Using drains after breast surgery is a preventive, but invasive measure to reduce seroma formation. A polyurethane-based tissue adhesive (TissuGlu®) might facilitate drainage-free wound healing after mastectomy in a non-invasive manner., Patients and Methods: Retrospectively, data from 84 patients (42 receiving TissuGlu®, 42 receiving a drainage) who underwent mastectomy, were collected (90 days postoperative follow-up). Study endpoints were defined as the number of fluid-related postoperative clinical interventions, cumulative volume of postoperative wound fluid, duration of hospitalization and postoperative complications., Results: In the entirety of postoperative interventions, no significant difference could be demonstrated (p=0.298). The drainage arm showed significantly less seroma aspirations (p=0.024) and complications (p=0.012). A significantly reduced length of hospitalization (p<0.001) and less cumulative wound secretion volume (p<0.001) appeared in the TissuGlu® group., Conclusion: The polyurethane-based tissue adhesive is a less invasive alternative to drain use in mastectomy., (Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: Retrospective analysis of breast cancer imaging methods is a common tool for evaluating the effectiveness of ultrasound and mammography regarding ductal carcinoma in situ (DCIS). No large number subpopulation of pure DCIS has been reported. It is however known that mammography and ultrasound underestimate tumor dimension with increasing tumor size. We aimed to quantify this discrepancy., Materials and Methods: This retrospective analysis reviewed the ultrasound and mammography data from 173 patients with DCIS at the University of Cologne - Department of Gynecology and Obstetrics between the years 2007 and 2010. Of these 173 patients, 34 fulfilled the DCIS analysis requirements and were evaluated in this study., Results: Overall, ultrasound underestimated tumor size 79.4% of the time, while overestimating only 20.6% of the time. Mammography underestimated tumor size in 50%, overestimated in 38.2%, correctly estimating in 11.8%. Over and underestimation distributions differed drastically above and a cut-off point of ≤2 cm actual tumor size, with a significant shift toward severe underestimation by both methods above a tumor size of 2 cm. DCIS misestimation was defined as the absolute value of the difference between actual tumor size and pre-surgical measurement by an imaging method. Mean DCIS size misestimation (actual tumor size ≤2 cm) was 3 mm for ultrasound and 6.2 mm for mammography., Conclusion: We support previous findings that ultrasound and mammography lose accuracy with increasing tumor size. Nonetheless, ultrasound may be more useful in estimation of DCIS size for tumors ≤2 cm than previously expected., (Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: Acellular dermal matrix is increasingly used as caudolateral coverage for breast implants in immediate breast reconstruction after skin-sparing mastectomy or in the correction of implant-associated breast deformities. Matrices of human, bovine, and porcine origin are available. The purpose of this retrospective multicenter study was to report experiences with porcine acellular dermal matrices, as only limited data can be found in the literature., Methods: In the hospital databases of five institutions, 127 patients were identified who underwent breast reconstructions in 156 breasts using an acellular porcine dermal matrix. Medical records were reviewed. Patients were divided into three groups: immediate expander-implant or direct to implant reconstructions (n = 98), delayed expander-implant reconstructions (n = 14), and revision surgery for implant-associated breast deformities (n = 44)., Results: With a mean follow-up of 19.6 months, total major complication rate was 7.1 %: implant loss (3.2 %), skin flap necrosis (2.6 %), delayed skin healing (2.6 %), hematoma (1.9 %), seroma (1.3 %), infection (0.6 %), and capsular contracture (0.6 %). Total minor complication rate was 22.9 %, with seroma being the most frequent complication (19.2 %). In the group of immediate breast reconstructions, 20.4 % of the breasts had received radiotherapy in the past. These patients exhibited a significantly higher rate of seroma than patients without prior radiotherapy (35.0 vs. 14.9 %, p = 0.031)., Conclusions: Complication rates using porcine acellular dermal matrix in breast reconstruction are comparable to complication rates reported in studies using human acellular dermal matrices. Thus, porcine acellular dermal matrices can safely be applied in breast reconstructive surgery.

Background: According to the literature, ductoscopy is gaining increasing importance in the diagnosis of intraductal anomalies in cases of pathologic nipple discharge. In a multicenter study, the impact of this method was assessed in comparison with that of standard diagnostics., Patients and Methods: Between 09/2006 and 05/2009, a total of 214 patients from 7 German breast centers were included. All patients underwent elective ductoscopy and subsequent ductal excision because of pathologic nipple discharge. Ductoscopy was compared with the following standard diagnostics: breast sonography, mammography, magnetic resonance imaging (MRI), galactography, cytologic nipple swab, and ductal lavage cytology. The histological and imaging results were compared and contrasted to the results obtained from the nipple swab and cytologic assessment., Results: Sonography had the highest (82.9%) sensitivity, followed by MRI (82.5%), galactography (81.3%), ductoscopy (71.2%), lavage cytology (57.8%), mammography (57.1%), and nipple swab (22.8%). Nipple swabs had the highest (85.5%) specificity, followed by lavage cytology (85.2%), ductoscopy (49.4%), galactography (44.4%), mammography (33.3%), sonography (17.9%), and MRI (11.8%)., Conclusion: Currently, ductoscopy provides a direct intraoperative visualization of intraductal lesions. Sensitivity and specificity are similar to those of standard diagnostics. The technique supports selective duct excision, in contrast to the unselective technique according to Urban. Therefore, ductoscopy extends the interventional/diagnostic armamentarium., (© 2014 S. Karger GmbH, Freiburg.)

Purpose: To determine the benefit of ShearWave™ Elastography (SWE™) in the ultrasound characterization of BI-RADS® 3 breast lesions in a diagnostic population., Materials and Methods: 303 BI-RADS® 3 lesions (mean size: 13.2 mm, SD: 7.5 mm) from the multicenter BE1 prospective study population were analyzed: 201 (66%) had cytology or core biopsy, and the remaining 102 had a minimum follow-up of one year; 8 (2.6%) were malignant. 7 SWE features were evaluated with regard to their ability to downgrade benign BI-RADS® 3 masses. The performance of each SWE feature was assessed by evaluating the number of lesions correctly reclassified and the impact on cancer rates within the new BI-RADS® 3' lesion group., Results: No malignancies were found with an E-color "black to dark blue", which allowed the downgrading of 110/303 benign masses (p < 0.0001), with a non-significant increase in BI-RADS® 3' malignancy rate from 2.6% to 4.1%. E-max ≤ 20 kPa (2.6 m/s) was able to downgrade 48/303 (p < 0.0001) lesions with a lower increase in BI-RADS® 3' malignancy rate (3.1%). No other SWE features were useful for reclassifying benign BI-RADS® 3 lesions., Conclusion: Applying simple reclassification rules, SWE assessment of the maximum stiffness of lesions allowed the downgrading of a sub-group of benign BI-RADS® 3 lesions. This was accompanied by a non-significant increase in the malignancy rate in the new BI-RADS® 3 class., (© Georg Thieme Verlag KG Stuttgart · New York.)

Objectives: To investigate effects of menopausal status, oral contraceptives (OC), and postmenopausal hormone therapy (HT) on normal breast parenchymal contrast enhancement (CE) and non-mass-like enhancing areas in magnetic resonance mammography (MRM)., Methods: A total of 459 female volunteers (mean age 49.1 ± 12.5 years) underwent T1-weighted 3D MRM 1-5 min after bolus injection of gadobutrol. Quantitative analysis was performed in normal breast parenchyma by manually tracing regions of interest and calculating percentage CE. Semiquantitative analysis was performed in non-mass-like enhancing areas, and signal intensity changes were characterised by five predefined kinetic curve types. The influence of OC (n = 69) and HT (n = 24) on CE was studied using random effects models., Results: Breast parenchymal enhancement was significantly higher in premenopausal than in postmenopausal women (P < 0.001). CE decreased significantly with the use of OC (P = 0.01), while HT had negligible effects (P = 0.52). Prevalence of kinetic curve types of non-mass-like enhancement differed strongly between pre- and postmenopausal women (P < 0.0001), but was similar in OC users and non-OC users (P = 0.61) as well as HT users and non-HT users (P = 0.77)., Conclusions: Normal breast parenchymal enhancement and non-mass-like enhancing areas were strongly affected by menopausal status, while they were not affected by HT use and only moderately by OC use., Key Points: Breast parenchymal enhancement at MR mammography is stronger in premenopausal than postmenopausal women. The prevalence of strong enhancing non-mass-like areas is greater before menopause. Such enhancing non-mass-like areas may impair lesion detection in premenopausal women. Breast parenchymal enhancement is only marginally affected by hormone use. Discontinuation of hormone use before MR mammography may be unnecessary.

Background: The objective was the investigation of a possible predictive quantitative impact of initial tumor sphericity, measured by 3D sonography, on response to pre-operative chemotherapy., Patients and Methods: This 3D ultrasound study was conducted on 41 consecutive primary breast cancer patients who received pre-operative epirubicin and paclitaxel chemotherapy; the tumors were measured by 3D sonography and by pathology after chemotherapy. Sphericity was defined as the ratio of the smallest to the largest extent by 3D sonography., Results: A predictive impact of initial tumor sphericity on response to pre-operative chemotherapy was quantitatively identified for the first time. Sphericity was a significant predictor of pathological complete remission with a rank difference of 0.34 or about 1/3 i.e., spherical tumors were more likely to show successful remission., Conclusion: Tumor sphericity as defined from 3D sonography could be predictive of response to pre-operative chemotherapy regimens; prospective investigation is suggested.

Purpose: Rational therapy planning should aim to minimize the rate of axillary lymph node dissection (ALND) in patients without metastatic disease. By the same token, the frequency of sentinel lymph node biopsies (SLNB) should not be unnecessarily high in patients with axillary node disease. Preoperative axillary ultrasonography is a generally available noninvasive technique for assessing nodal status., Materials and Methods: Based on retrospective data, we analyzed the sensitivity, specificity, positive and negative predictive value, and efficiency of preoperative ultrasonography US. A total of 429 axillary ultrasonographic examinations were included, and the management decisions were based on the ultrasonographic findings. Patients with suspicious US results were scheduled for ALND, while patients with unremarkable findings underwent SLNB., Results: Axillary metastases were found in 146 of 429 (34 %) cases. In 75 of 429 (17 %) axillary examinations, ultrasonography revealed suspicious findings. In these cases, we proceeded with ALND, thereby reducing the number of SLNB by 17 %. 219 of 429 cases were classified correctly as not having metastasis, thus lowering the rate of ALND, which is associated with higher postoperative morbidity, by 51 %. Preoperative ultrasonography had a sensitivity of 53.6 %, specificity of 75.5 %, and a positive predictive value of 77.3 %. The negative predictive value was 51.3 % and the efficiency was 68.5 %., Conclusion: Ultrasonography is a moderately sensitive, but quite specific, preoperative method for assessing the axillary lymph nodes., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: This prospective study evaluates whether sonoelastography can improve B-mode ultrasonographic sizing of breast tumors. Precise measuring is important for effective therapy planning for breast cancer patients., Materials and Methods: The size of 100 surgically excised breast lesions (92 patients: 77 malignant, 23 benign) was compared to preoperative measurements. Lesions were imaged with both ultrasonographic techniques in identical planes. The largest sizes measured with each modality were compared to the largest histopathological measurements. The interobserver variability was also computed from measurements made by two examiners assessing identical planes., Results: Both ultrasonographic measuring techniques underestimate lesion size. The sonoelastography measurements were within ± 5 mm of the histological size in 70.1 % of malignant lesions, and the B-mode measurements in 57.1 % of cases. Sonoelastography leads to more accurate measurements of 13.0 % of cases (statistically not significant). A total of 22 lesions were also imaged by a second examiner. Sonoelastography had 27.3 % less interobserver variability (examiners agreed in 36.4 % of sonoelastography and in 9.1 % of B-mode results)., Conclusion: In this study there is no significant advantage of sonoelastography, although a tendency is apparent. The low interobserver variability also favors sonoelastography for preoperative diagnostics, since it may be less dependent on the observer than conventional B-mode imaging. The results of this prospective study require validation in a prospective multicenter study with larger case numbers., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: This prospective study aimed to compare sonoelastography, B-mode ultrasonography, and mammography in terms of their ability to distinguish benign from malignant breast lesions. We also assessed how the diagnostic value of sonoelastography differs between palpable and clinically occult lesions., Materials and Methods: Evaluation revealed a total of 97 lesions (66 benign; 31 malignant) without histological confirmation at the time of the initial examination. The sensitivity, specificity, positive (PPV) and negative predictive value (NPV) as well as efficiency were calculated. These parameters were separately assessed for palpable lesions and for non-palpable lesions. We subsequently compared these results., Results: Sonography had a sensitivity of 97% and a specificity of 82% (PPV: 71 %, NPV: 98%, efficiency: 87%). For mammography, the respective figures were 84% and 89% (PPV: 79%, NPV: 92%, efficiency: 88%). Sonoelastography had a sensitivity of 71% and a specificity of 48% (PPV: 39%, NPV: 78%, efficiency: 56%). The combination of sonography and sonoelastography yielded a sensitivity of 100% and a specificity of 38% (PPV: 43%, NPV: 100%, efficiency: 58%). The sensitivity and specificity were not statistically different between the groups of palpable and non-palpable lesions., Conclusion: Sonoelastography is easily performed and not very time-consuming. Used by itself, the method is not more efficacious than alternative techniques. When used in conjunction with B-mode ultrasonography, the latter's sensitivity was increased, albeit at the expense of specificity., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: In order to elucidate criteria for distinguishing benign from malignant lesions, this study correlated the ductoscopy-based macroscopic description of intraductal lesions with histopathologic results., Materials and Methods: Aiming to use diagnostic criteria consistent with previous publications, we analyzed the literature and established a uniform set of diagnostic descriptors. Based on these criteria, we subsequently analyzed and catalogued video and photographic material from 68 patients with nipple discharge, who had undergone ductoscopy followed by open surgery. For all breast lesions, the factors lesion type, number of lesions, lesion color, surface characteristics, and presence of blood or atypical vessels were reported. Based on the frequency distribution and the odds ratio, we were able to evaluate the differential diagnostic value of ductoscopic criteria in comparison with the respective histopathologic results., Results: Among the ductoscopic criteria, a fissured surface, hemorrhage or atypical vessels, and a polypoid appearance were important predictors for malignant lesions. In contrast, a smooth surface, the absence of hemorrhage and atypical vessels and a level appearance of the lesions predicted benign lesions., Conclusions: For predicting the benign versus malignant character of ductoscopic lesions, the following criteria should be used: presence or absence of blood and atypical vessels, surface type, and level versus polypoid appearance.

Purpose: According to the current interdisciplinary S 3 guideline for breast cancer diagnostics, treatment, and follow-up (1st update 2008), palpation is one of the diagnostic mainstays for follow-up examinations after mastectomy. Although recommended in the manuscript, regular ultrasonographic examinations are neither explicitly mentioned in the statement nor in the follow-up plan. In ambiguous cases, MRI can serve as a supplementary diagnostic method. In order to evaluate the value of palpation and ultrasonography for diagnosing recurrent disease after mastectomy, we analyzed the sensitivity of each method individually and the sensitivity of both methods combined., Materials and Methods: Over a 12-year time span, histological data from 57 patients suspected to have recurrent disease after mastectomy (benign lesions: n = 15, 26.3% malignant lesions: n = 42, 73.7%) were collected. Prior to biopsy, the benign versus malignant character of all lesions was assessed by palpation and ultrasonography (BI-RADS). Sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv), and efficacy were calculated using a contingency table., Results: Palpation had a sensitivity of 85.7 % and a specificity of 6.7% the respective figures for ultrasonography were 90.5% and 46.7%. The sensitivity of palpation and ultrasonography combined was 100%, i. e. 14.3% higher than the sensitivity of palpation alone. Five cases of recurrent disease which remained undetected by palpation were only recognized by ultrasonography., Conclusion: In agreement with several other studies, the results of our retrospective study show that ultrasonography is superior to palpation for diagnosing recurrent disease after mastectomy. Prospective multicenter studies are needed to evaluate ultrasonographic follow-up before an amendment of the current S 3 guidelines can be recommended with a high degree of evidence., (Georg Thieme Verlag KG Stuttgart, New York.)

Background: In consideration of increasing incidence by introduction of screening mammography, the prevalence of distant metastases and necessity of staging procedures in early breast cancer should be proved., Patients and Methods: A retrospective review was undertaken of 466 patients with newly diagnosed breast cancer in the period from 2003 to 2006., Results: Distant metastases were found in 22 (4.8%) patients at the time of primary diagnosis of breast cancer. None of these patients had a tumour < or =1 cm and the percentage of metastatic disease increased with local extension (pT1 1.4%; pT2 7.9%; pT3 14.3%; pT4 23.1%; p<0.001) and nodal status (pN0 1.7%; pN1 3.8%; pN2 21.7%; pN3 17.6%; p<0.001), Conclusion: Indication for bone scan, liver ultrasound and chest x-ray should be limited to patients with tumours >2 cm, or tumours >1 cm with lymph node involvement (N1-3).

Several large, well-controlled clinical trials have now established that the aromatase inhibitors (AIs), including letrozole, anastrozole, and exemestane, are more effective than tamoxifen when used as adjuvant endocrine therapy in postmenopausal women with breast cancer. Yet, it is an open question as to how these drugs should be best integrated into the adjuvant treatment regimen. Both letrozole and anastrozole have shown efficacy over tamoxifen when used as initial adjuvant therapy (initiated just following surgery for breast cancer), while exemestane and anastrozole have been used as switching adjuvant therapy, i.e., following 2-3 years of initial adjuvant tamoxifen therapy, with proven efficacy over continued tamoxifen. Studies demonstrate that recurrence risk peaks in the early period after surgery, and that distant metastases in particular, accounting for most of the early recurrences, have worse survival rates when compared with other types of recurrences. Treatments that reduce recurrences, especially distant metastases, in this early period are therefore likely to improve overall survival (OS) and reduce mortality from breast cancer. In this review, we discuss early recurrence risk among postmenopausal women with successfully treated early breast cancer, the efficacy of the different AIs in reducing early recurrences and distant metastases when incorporated into adjuvant therapy, and the evidence for increased OS when AIs are used as initial or switch adjuvant therapy.

Background: Endoscopy of the female breast, known as ductoscopy, is increasingly gaining acceptance as a diagnostic procedure worldwide. Recent technical development of ductoscopes and micro-instruments is shifting research interest from diagnostic to interventional ductoscopy. We describe novel technical aspects and the resulting possible future perspective of ductoscopy., Methods: This study comprised the analysis and review of new technical developments from research at the Technical University Munich, Germany, and others, as well as a review of the MEDLINE and COCHRANE databases for the keyword ductoscopy., Results: Diagnostic ductoscopy is performed by many breast physicians worldwide. Interventional ductoscopy, however, depends on an additional working channel and a variety of micro-instruments of 0.4-0.8 mm for procedures inside the breast duct. They are at present not available in the U.S. but are used in Germany and several other countries. Autofluorescence ductoscopy is a new imaging technique used on an experimental base for clinical evaluation to identify intraductal lesions. Laser ductoscopy for removal of intraductal papillomas and 3-dimensional intraductal tracking systems are future projects., Conclusion: Technical innovation and further miniaturization of instruments is supporting a change from diagnostic to interventional ductoscopy. A therapeutic intraductal approach as well as autofluorescence endoscopy could potentially eliminate unnecessary biopsies and offer better identification of intraductal lesions.

Background: This is a retrospective cohort study on the safety and efficacy profiles of weekly docetaxel at varying doses in patients with pretreated metastatic breast cancer., Patients and Methods: Twenty-five anthracycline-pretreated patients received docetaxel administered on a weekly basis, as a one-hour infusion, at various dosage levels (25, 30, 35, 40 mg/m2) depending on their baseline Karnofsky index. Each 8-week cycle consisted of 6 weeks of drug infusion, followed by a 2-week rest period., Results: Of the 25 patients investigated, none achieved complete response (CR), while 9 patients showed partial response (PR), which corresponds to an overall response rate of 36%. Five patients (20%) maintained stable disease (SD), whereas 11 patients (44%) suffered tumor progression (PD) during treatment. Clinical response (defined as PR+SD) was achieved in 14 patients (56%). Median time to progression was 231 days (95% CI, 187-275). The baseline Karnofsky index was 87% +/- 9% (range: 70-100). Patients pretreated with anthracyclines only tended to have a better response than anthracycline/paclitaxel-pretreated patients (n = 6, p = 0.054). Higher dosages were associated with neurotoxicity, skin/nail toxicity, leukopenia, nausea/vomiting, fatigue/asthenia, peripheral edema, but not with diarrhea and alopecia. The cumulative dose per patient was largest for a weekly docetaxel dosage of 35 mg/m2 and almost as large for 30 mg/m2., Conclusion: Balancing toxicity vs. efficacy/cumulative dosage delivered, our results support weekly administration of docetaxel at dosages of 30-35 mg/m2 in metastatic breast cancer. Response in patients pretreated with anthracyclines and taxanes may be poorer than in those pretreated with anthracyclines only.

Purpose: According to the S-3 guidelines for the diagnosis and treatment of breast cancer, only palpation and mammography are mandatory follow-up examinations. Ultrasonography is only mentioned as an optional technique. Aiming to elucidate the diagnostic yield for detecting recurrent disease after breast-preserving therapy (BPT) and radiation treatment, we analysed the sensitivity of palpation, mammography, ultrasonography, and combinations of these methods., Materials and Methods: Over a period of 12 years, 27 suspicious lesions in patients status post BPT and radiation therapy were biopsied (histologic results: 16 benign lesions: 59.3 %, 11 malignant lesions: 40.7 %). Prior to biopsy, the benign or malignant character of each lesion was predicted by palpation, mammography and ultrasonography (BIRADS). Sensitivity, specifity, positive predictive value (ppv), negative predictive value (npv), and efficiency were calculated from a contingency table., Results: For lesions status post BPT and radiation treatment, palpation had a sensitivity of 72.7 % and was 25 % specific. For mammography, the respective values were 36.4 % and 87.5 %, and for ultrasonography 90.9 % and 68.8 %. Palpation and mammography combined were 81.8 % sensitive and had a specificity of 6.2 %. The computed sensitivity for the 3 methods applied together was 100 %. Adding ultrasonography to palpation and mammography therefore increases sensitivity by 18.2 %., Conclusion: For diagnosing recurrent disease in patients status post BPT and radiation therapy, ultrasonography is superior to palpation and/or mammography and should become an obligatory follow-up tool. The role of mammographic follow-up appears overrated and the role of ultrasonographic assessment underrated. The S-3 guidelines will need to be changed accordingly.

Purpose: Aim of the study were to evaluate the success of ultrasound and mammography guided wire marking of non-palpable breast lesions and the results of specimen mammography/ultrasonography, completeness of resection, and number of secondary resections (during the initial surgical session and as a separate intervention) were analysed., Materials and Methods: Between May 1994 and December 2004, 668 women with 741 non-palpable breast lesions underwent surgery at the Greifswald University Department of Gynaecology and Obstetrics. Ultrasound directed wire marking was used in 418, mammography directed marking in 284 cases. In 39 lesions, both techniques were combined., Results: Out of all lesions approached with ultrasound directed wire marking, 88 (21.1 %) were malignant. Among lesions marked during mammography, 52 (19.3 %) were malignant. Specimen ultrasonography indicated that 90.9 % of lesions were resected completely. Specimen mammography demonstrated complete resection in 89.1 %. On histological examination, 19.5 % of the malignant lesions marked with sonographic guiding and 36.5 % of the malignant lesions marked with mammographic guiding did not have clear margins. Secondary resections (during the first procedure) for incomplete specimens were needed in 10 patients in whom sonographic localisation had been used, and in 25 patients in whom mammographic localisation had been employed. A second surgical session for secondary resection was required in 5.5 % of lesions marked with ultrasound and in 12.3 % of lesions marked with mammography guidance., Conclusion: Sonography directed wire localisation appears to be superior to the respective mammographic method. Ultrasound guided wire marking should be considered the preferred method for all mammographic lesions with an ultrasonographic equivalent and no micro-calcifications.

Background: Ductoscopy is gaining increased importance in the diagnosis of nipple discharge of unclear origin and intraductal proliferation. For this reason we compared its diagnostic value and feasibility to standard diagnostic methods., Material and Methods: Ductoscopy was compared to mammography, galactography, sonography, magnetic resonance imaging (MRI), nipple smear, fine needle aspiration cytology (FNAC), and high-speed core biopsy; feasibility, sensitivity, and specificity were investigated for each method., Results: 71 ductoscopies were evaluated, which were followed up by open biopsies. Here, 3 invasive and 8 ductal carcinomas in situ were found, as well as 3 atypical ductal hyperplasias, 44 papillomas/papillomatoses, and 13 benign findings. Feasibility of ductoscopy was in this series 100%. Duct sonography showed the highest sensitivity (67.3%), followed by MRI (65.2%), galactography (56.3%), ductoscopy (55.2%), and FNAC (51.9%). The highest specificity was shown by FNAC, core biopsy, and galactography (each 100.0%), followed by mammography (92.3%), nipple smear (77.8%), ductoscopy, and duct sonography (each 61.5%); the lowest specificity was displayed by MRI (25.0%)., Conclusion: The results confirm that ductoscopy can be performed within the same range of sensitivity and specificity as other techniques. In order to make conclusive statements about ductoscopy, especially in order to precisely define the indications for this method, a prospective multicenter study was initiated.

Aim: This prospective double-blind study was designed to assess (i) if primary breast screening by ultrasonography is capable of detecting breast cancer independent of tissue density and (ii) if the rate of unnecessary biopsies remains acceptable when diagnostics are based on ultrasonography., Patients and Methods: Bilateral breast ultrasonography was performed in 448 asymptomatic women as the initial diagnostic method. Sonograms were interpreted using a set of standardized diagnostic criteria. Subsequently, mammograms were obtained. The radiologists reading the mammograms were blinded to the sonographic results., Results: Overall, 3 non-palpable breast cancers were detected by ultrasound and mammography. All 3 ultrasonographically detected breast cancers were smaller than 1 cm (0.7, 0.7, 0.6 cm). All 3 carcinomas were correctly detected by both methods. For ultrasonography, the false positive rate was 1.1% (n=5) and for mammography 0.6% (n=3). When both methods were combined, the rate of unnecessary open biopsies was 1.6% (n=7). The ratio of benign to malignant lesions was 3.7/1., Conclusion: Without prior mammography, primary high-resolution breast ultrasonography is capable of detecting non-palpable breast carcinomas in asymptomatic women at an early stage. The rate of unnecessary open biopsies is low and the ratio of benign to malignant biopsies acceptable.

Objectives: To evaluate whether real-time elastography, a new, non-invasive method for the diagnosis of breast cancer, improves the differentiation and characterization of benign and malignant breast lesions., Methods: Real-time elastography was carried out in 108 potential breast tumor patients with cytologically or histologically confirmed focal breast lesions (59 benign, 49 malignant; median age, 53.9 years; range, 16-84 years). Tumor and healthy tissue were differentiated by measurement of elasticity based on the correlation between tissue properties and elasticity modulus. Evaluation was performed using the three-dimensional (3D) finite element method, in which the information is color-coded and superimposed on the B-mode ultrasound image. A second observer evaluated the elastography images, in order to improve the objectivity of the method. The results of B-mode scan and elastography were compared with those of histology and previous sonographic findings. Sensitivities and specificities were calculated, taking histology as the gold standard., Results: B-mode ultrasound had a sensitivity of 91.8% and a specificity of 78%, compared with sensitivities of 77.6% and 79.6% and specificities of 91.5% and 84.7%, respectively, for the two observers evaluating elastography. Agreement between B-mode ultrasound and elastography was good, yielding a weighted kappa of 0.67., Conclusions: Our initial clinical results suggest that real-time elastography improves the specificity of breast lesion diagnosis and is a promising new approach for the diagnosis of breast cancer. Elastography provides additional information for differentiating malignant BI-RADS (breast imaging reporting and data system) category IV lesions., (Copyright 2006 ISUOG. Published by John Wiley & Sons, Ltd.)

Even in elderly patients, greater consideration is now being given to tumor volume reduction in locally advanced breast cancer, with increased subsequent breast-conserving surgery. Neoadjuvant endocrine therapy offers the possibility of testing therapeutic efficacy in vivo, which is of great importance for optimal adjuvant treatment. Resulting therapy modifications can be expected to increase disease-free as well as overall survival. Recent results indicate that remission rates with primary chemotherapy are significantly lower in receptor-positive than in receptor-negative breast cancer and that efficacy parameters in receptor-positive tumors tend to favor primary endocrine therapy, highlighting the increased importance of this type of treatment. Aromatase inhibitors are superior to tamoxifen in terms of clinical response as well as breast conservation rate. Results from a small number of studies suggest that prolonged preoperative aromatase inhibitor therapy for up to 12 months can increase the rate of clinical and pathological complete remissions. In conclusion, primary endocrine therapy is a valid therapeutic option for postmenopausal patients with locally advanced hormone receptor-positive breast cancer and significant comorbidity, increased risk of complications with regard to anesthesia and surgery, desire for breast-conserving surgery and/or reduced suitability for chemotherapy, as well as in very old patients.

Background: The present investigation aimed at assessing the possibility of distinguishing between malignant and benign breast lesions by measuring the signal intensity in vessels of the suspect lesions over time after administration of the ultrasound contrast agent Levovist., Materials and Methods: Levovist was administered intravenously to 21 patients with breast cancer and 12 patients with a benign breast lesion. In the subsequent ultrasound investigation (Color Power Angiography) the resulting increase in brightness over time in the vessels of the lesions was measured using the videodensitometry method. From the calculated time-brightness curves, the time to maximum brightness (T(max)), time to 90% of maximum brightness (T(90%)), maximum brightness and other time and brightness parameters were determined. The data were analyzed by means of the Mann-Whitney-Wilcoxon test. Additionally, the sensitivity and specificity were calculated for a sequence of cut-off levels for T(90%), T(max) maximum brightness and wash-in wash-out parameters., Results: The differences between the benign and the malignant lesions for the parameters T(max) and T(90%) were statistically significant. The malignant foci showed a significantly more rapid in-flow of the contrast agent (p = 0.006) than the benign lesions. The wash-in wash-out time for Levovist was significantly shorter for the malignant lesions than for the benign lesions (p = 0.02). The time difference in attaining maximum brightness was not significant (p = 0.14). The specificity and sensitivity made a more precise differentiation between benign and malignant tumors possible., Conclusion: The use of a contrast agent in Doppler ultrasound enhances the diagnostic reliability in distinguishing between malignant and benign lesions, justifying the use of a contrast agent with a high specificity (92%) such as Levovist. However, invasive pre-operative methods such as punch biopsy are not, thereby, rendered unneccessary. It is possible that the combination of Levovist and videodensitometry will make it possible to increase the specificity of breast cancer diagnosis.

The primary administration of chemotherapy leads to a reduction in size of tumors, increasing the possibility of breast-conserving surgery in both locally advanced, inoperable and primary operable mamma carcinomas. This, however, increases the rate of local relapse and the rate of mastectomy over the course of the disease, even although the EUSOMA guidelines are not exceeded. Whether the pre-surgical administration of chemotherapy with pathological complete remission actually increases the disease-free rate and overall survival remains to be determined. Further clinical studies are required to establish the reliability of sentinel lymph-node biopsy; currently, axillary lymphadenectomy is still the standard therapy. The response of the tumor to therapy, in correlation with predictive factors and the molecular-genetic profile, could make more individualized treatment regimes possible in the future.

Background: Intraparenchymal leiomyomas of the breast are quite rare. Areolar lesions are distinguished from intraparenchymal leiomyomas, which are less frequent. Clinically, leiomyomas appear as nodules; mammographically, they show up as round lesions. Reports on sonographic criteria are rare, and the criteria are nonspecific. Based on our case of an intraparenchymal leiomyoma, we describe additional sonographic features. The clinical, mammographic and sonographic characteristics of an intraparenchymal leiomyoma of the breast were evaluated. After surgery, the diagnosis was confirmed histologically., Results: The clinical presentation of our patient with deep-seated leiomyoma of the breast included skin dimpling and a reduction in tissue mobility, differing from more commonly reported characteristics. Mammographically, the lesion was dense and only partly demarcated clearly, corresponding to other reports. On breast ultrasonography, the leiomyoma appeared as a hypodense, well demarcated, inhomogeneous lesion with posterior acoustic shadowing. A central tumour vessel was visible on Doppler imaging, and Cooper's ligaments were discontinuous. Acoustic shadowing, the hypodense character, hyperechoic border and the central tumour vessel are therefore additional ultrasonographic characteristics of an intraparenchymal leiomyoma of the breast. This type of lesion is usually described as isodense to hyperdense and homogeneous, possibly containing semicystic components. Previous reports have only described posterior acoustic enhancement, but not acoustic shadowing., Conclusion: On breast ultrasonography, an intraparenchymal leiomyoma of the breast can present with posterior acoustic shadowing, hypodense echogenicity, a hyperechoic border and a central tumour vessel. Neither imaging studies nor palpation allow distinction between benign and malignant lesions.

We report on a 76-year-old patient with papillary intracystic breast carcinoma. Papillary intracystic carcinomas represent a rare entity. Among all malignant breast tumors, this lesion has an incidence of 0.5-2%. Palpation is not sufficient to distinguish benign from malignant findings. The same applies to mammography, unless the tumor infiltrates the cyst wall. The method of pneumocystography has become obsolete. Sonography is the preferred diagnostic modality to distinguish cystic from solid lesions and to differentiate simple cysts from cysts with intracystic growth. In this respect, Doppler and power Doppler sonography can be instrumental. It is feasible to obtain preoperative ultrasound guided FNAC or core biopsies of the cystic and solid components for cytological or histological verification. Complete excision of the cyst which should include the intracystic growth is considered the treatment of choice.

This report summarises the imaging findings of juvenile papillomatosis (JP) in a 16-year-old woman. Sonographically, the lesion was oval, well defined, heterogeneous with multiple small, cystic spaces. Ultrasonography can be helpful in differentiating between JP and similar cystic lesions, fibroadenomas, phyllodes tumours, intracystic papillomas and carcinomas. A core needle biopsy is still needed to confirm the diagnosis. An open biopsy with excision of the lesion is mandatory, mere observation is inadequate because of insufficient knowledge about the direct relationship between JP and subsequent cancer.

Objective: The investigation of the value of sonographic criteria for the assessment of the character of solid breast lesions., Methods: 281 preoperative sonographic studies of breast lesions were analysed and classified according to the following features: characteristics of the contour, echodensity, echo pattern, posterior acoustic properties, mobility, compressibility, axis of the lesion, L/T ratio (longitudinal size divided by transverse size), and architecture of surrounding tissue. We assessed the differential diagnostic value of each feature based on frequency distribution and odds ratio (OR)., Results: 152 (54.1 %) benign and 129 (45.9 %) malignant breast lesions were evaluated by ultrasound. The following sonographic criteria were the most clear-cut signs for lesions to be malignant: ill-defined borders (OR: 19.8), incompressibility (OR: 9.7), and discontinuity of Cooper's ligaments (OR: 4.8). Benign lesions were characterised by compressibility (OR: 0.12), smooth borders (OR: 0.12), and displacement of Cooper's ligaments (OR: 0.24)., Conclusion: When distinguishing benign from malignant breast lesions, ultrasound examiners should be primarily guided by the lesion's contour and compressibility and the architecture of the surrounding tissue. Aiming for the widest possible consensus on terminology issues and standardised interpretation of the above criteria would help to advance breast sonography from its current status as a supplementary technique to the status of the modality of choice for the early diagnosis of breast cancer.

We report on a 45-year-old patient who presented with a 7 cm palpable right breast mass which had been classified as a cyst by ultrasonography. Multiple aspiration cytologies revealed no evidence of malignancy. Repeat sonography in our institution showed a lesion at 1 o'clock, 1 cm deep, and 3-8 cm from the nipple. The lesion contained a solitary cystic component measuring 3.9 x 4.1 x 4.4 cm. A 3.1 x 2.6 x 2.5 cm solid, inhomogeneous mass with irregular margins was found at the lateral border of the cyst. This mass raised suspicion of an intracystic carcinoma. Histopathologic analysis of 5 high-speed biopsy tissue cores demonstrated an invasive large-cell ductal carcinoma (G2-3). Final histopathologic assessment subsequent to breast-preserving resection and axillary node dissection confirmed the initial diagnosis: keratinizing intracystic squamous cell carcinoma (G2-3, pT2, pN0 (0/15)). The search for a remote primary squamous cell carcinoma included a chest X-ray, cystoscopy, colposcopy and PAP smear, esophago-gastroscopy, ENT consultation (laryngoscopy), and did not reveal any extramammary cancer. The postoperative management consisted of a total of 6 cycles of chemotherapy (Cisplatinum 75 mg/m (2) BSA and Paclitaxel 175 mg/m (2) BSA every 21 days) and subsequent percutaneous radiotherapy. In accordance with published reports, the diagnostic and therapeutic management was analogous to that of adenocarcinoma of the breast. However, some authors recommend the same chemotherapy as used for squamous cell carcinomas of other organs. It remains difficult to make any statements regarding the adjuvant therapy and prognosis, since this type of tumor is so infrequent, especially as an intracystic lesion.

Breast cancer is the most frequent gynecological tumor. The HER-2/neu oncogene may play a role in the prognosis and management of patients with breast cancer. In a retrospective study on 100 patients, we correlated the expression of this oncogene with the classic clinical and pathological factors. 32 % of patients exhibited overexpression of HER-2/neu. There was no significant correlation with classic parameters. This finding could indicate that HER-2/neu expression is a new independent prognostic factor. Prospective studies correlating HER-2/neu overexpression with prognosis might provide additional data.

Benign tumours in pregnancy are often "lactating adenomas". The differentiation against malignant processes is sometimes difficult. In this case report we demonstrate the diagnostic and therapeutic procedure in an 18-year old woman with multiple nodes in the right and left breast. Pregnancy makes it difficult to examine the breast with the usual methods. Because of suspect clinical and ultrasonic findings we made a core biopsy already during pregnancy. With nodes in the breast during pregnancy, ultrasound is the diagnostic method of choice. Histology by core biopsy must be made. As long as the histology corresponds with the ultrasound findings, controls are sufficient if the findings are benign. Otherwise, diagnostic exstirpation will be necessary even though the patient is pregnant. Ultrasound and biopsy are the only significant examinations in pregnancy and lactation. Mammography is contraindicated because of radiation. Assessment by palpation and NMR is problematic during pregnancy.