An exploratory clinical trial of preoperative non-invasive localization before breast-conserving surgery using augmented reality technology.

PURPOSE: This single-center, randomized, prospective, exploratory clinical trial was conducted to assess the clinical efficacy of an augmented reality (AR)-based breast cancer localization imaging solution for patients with breast cancer. METHODS: This clinical trial enrolled 20 women who were diagnosed with invasive breast cancer between the ages of 19 and 80, had a single lesion with a diameter ≥ 5 mm but ≤ 30 mm, had no metastases to other organs, and had not received prior chemotherapy. All patients underwent mammography, ultrasound, computed tomography, and magnetic resonance imaging for preoperative assessment. Patients were randomly assigned to ultrasound-guided skin marking localization (USL) and AR-based localization (ARL) groups (n = 10 in each group). Statistical comparisons between USL and ARL groups were made based on demographics, radiologic features, pathological outcomes, and surgical outcomes using chi-square and Student t-tests. RESULTS: Two surgeons performed breast-conserving surgery on 20 patients. Histopathologic evaluation of all patients confirmed negative margins. Two independent pathologists evaluated the marginal distances, and there were no intergroup differences in the readers' estimates (R1, 6.20 ± 4.37 vs. 5.04 ± 3.47, P = 0.519; R2, 5.10 ± 4.31 vs. 4.10 ± 2.38, P = 0.970) or the readers' average values (5.65 ± 4.19 vs. 4.57 ± 2.84, P = 0.509). In comparing the tumor plane area ratio, there was no statistically significant difference between the two groups in terms of either reader's mean values (R1, 15.90 ± 9.52 vs. 19.38 ± 14.05, P = 0.525; R2, 15.32 ± 9.48 vs. 20.83 ± 12.85, P = 0.290) or the overall mean values of two readers combined (15.56 ± 9.11 vs. 20.09 ± 13.38, P = 0.388). Convenience, safety, satisfaction, and reusability were all superior in the AR localization group (P < 0.001) based on the two surgeons' responses. CONCLUSION: AR localization is an acceptable alternative to ultrasound-guided skin marking with no significant differences in surgical outcomes.

Intrinsically disordered region-mediated condensation of IFN-inducible SCOTIN/SHISA-5 inhibits ER-to-Golgi vesicle transport.

Newly synthesized proteins in the endoplasmic reticulum (ER) are sorted by coat protein complex II (COPII) at the ER exit site en route to the Golgi. Under cellular stresses, COPII proteins become targets of regulation to control the transport. Here, we show that the COPII outer coat proteins Sec31 and Sec13 are selectively sequestered into the biomolecular condensate of SCOTIN/SHISA-5, which interferes with COPII vesicle formation and inhibits ER-to-Golgi transport. SCOTIN is an ER transmembrane protein with a cytosolic intrinsically disordered region (IDR), which is required and essential for the formation of condensates. Upon IFN-γ stimulation, which is a cellular condition that induces SCOTIN expression and condensation, ER-to-Golgi transport was inhibited in a SCOTIN-dependent manner. Furthermore, cancer-associated mutations of SCOTIN perturb its ability to form condensates and control transport. Together, we propose that SCOTIN impedes the ER-to-Golgi transport through its ability to form biomolecular condensates at the ER membrane.

Estimating exposures from spray products using robotic simulations.

There is an increasing need for exposure data to enable more precise information for risk estimates and improved public health protection. While personal monitoring data are preferred, it is often difficult to collect due to the resources needed to complete a human research study. In this study, we successfully programmed a robotic arm to mimic human use (spraying) of a fabric crafts protector (FCP) and human cleaning (spraying and wiping) of a glass pane with glass cleaner (GC). The robot was then used in place of human subjects to assess inhalation exposures to volatile organic compounds (VOCs) during the use of the FCP and GC. Air sampling data were collected while the robot used the products to estimate personal exposures to VOCs. Average VOC concentrations were 1.57 ppm for FCP spraying and 0.17 ppm for GC spraying and wiping. During FCP spraying, average acetone concentrations were 0.88 ppm and average isopropyl alcohol concentrations were 0.26 ppm. During GC spraying and wiping, average 2-butoxyethanol concentrations were 0.15 ppm. Air sampling data were found to be within the range of data reported in the literature during human use of similar glass cleaning products. No data was found in the literature during use of fabric protector spray products. This study contributes exposure measurement data with detailed contextual information to help characterize inhalation exposures during the use of 2 spray products. In addition, the study offers a systematic, efficient method for generating exposure data which can be used to improve health and safety risk assessments used for public health protection.

Bladder Cancer Metastasis to the Breast in a Male Patient: Imaging Findings on Mammography and Ultrasonography.

Male breast cancer is rare, accounting for approximately 1% of breast cancers. Metastasis from extra-mammary malignancy to the breast in men is extremely rare. The most common primary tumors that metastasize to the breast in male are prostate, lung, stomach, colorectal cancer, melanoma, and sarcoma. To our knowledge, only a few cases of bladder cancer presenting with metastasis to the male breast have been reported, and metastasis with infiltration rather than mass is extremely rare. We report imaging findings on mammography and ultrasonography in a 59-year-old male with bladder cancer metastatic to the breast.

Breast Cancer after Radiation Therapy in a Patient with Li-Fraumeni Syndrome: A Case Report.

Li-Fraumeni syndrome (LFS) is an inherited autosomal-dominant tumor-predisposition disorder caused by germline mutations in the TP53 tumor suppressor gene. Since patients with LFS are likely to develop therapy-related cancers, radiation therapy should be avoided if breast cancer is found in these individuals. Herein, we present a case of secondary breast cancer in an LFS patient after radiation and chemotherapy for the first diagnosed breast sarcoma.

Differing benefits of artificial intelligence-based computer-aided diagnosis for breast US according to workflow and experience level.

PURPOSE: This study evaluated how artificial intelligence-based computer-assisted diagnosis (AICAD) for breast ultrasonography (US) influences diagnostic performance and agreement between radiologists with varying experience levels in different workflows. METHODS: Images of 492 breast lesions (200 malignant and 292 benign masses) in 472 women taken from April 2017 to June 2018 were included. Six radiologists (three inexperienced [<1 year of experience] and three experienced [10-15 years of experience]) individually reviewed US images with and without the aid of AI-CAD, first sequentially and then simultaneously. Diagnostic performance and interobserver agreement were calculated and compared between radiologists and AI-CAD. RESULTS: After implementing AI-CAD, the specificity, positive predictive value (PPV), and accuracy significantly improved, regardless of experience and workflow (all P<0.001, respectively). The overall area under the receiver operating characteristic curve significantly increased in simultaneous reading, but only for inexperienced radiologists. The agreement for Breast Imaging Reporting and Database System (BI-RADS) descriptors generally increased when AI-CAD was used (κ=0.29-0.63 to 0.35-0.73). Inexperienced radiologists tended to concede to AI-CAD results more easily than experienced radiologists, especially in simultaneous reading (P<0.001). The conversion rates for final assessment changes from BI-RADS 2 or 3 to BI-RADS higher than 4a or vice versa were also significantly higher in simultaneous reading than sequential reading (overall, 15.8% and 6.2%, respectively; P<0.001) for both inexperienced and experienced radiologists. CONCLUSION: Using AI-CAD to interpret breast US improved the specificity, PPV, and accuracy of radiologists regardless of experience level. AI-CAD may work better in simultaneous reading to improve diagnostic performance and agreement between radiologists, especially for inexperienced radiologists.

Feasibility study of portable multi-energy computed tomography with photon-counting detector for preclinical and clinical applications.

In this study, preclinical experiments were performed with an in-house developed prototypal photon-counting detector computed tomography (PCD CT) system. The performance of the system was compared with the conventional energy-integrating detector (EID)-based CT, concerning the basic image quality biomarkers and the respective capacities for material separation. The pre- and the post-contrast axial images of a canine brain captured by the PCD CT and EID CT systems were found to be visually similar. Multi-energy images were acquired using the PCD CT system, and machine learning-based material decomposition was performed to segment the white and gray matters for the first time in soft tissue segmentation. Furthermore, to accommodate clinical applications that require high resolution acquisitions, a small, native, high-resolution (HR) detector was implemented on the PCD CT system, and its performance was evaluated based on animal experiments. The HR acquisition mode improved the spatial resolution and delineation of the fine structures in the canine's nasal turbinates compared to the standard mode. Clinical applications that rely on high-spatial resolution expectedly will also benefit from this resolution-enhancing function. The results demonstrate the potential impact on the brain tissue segmentation, improved detection of the liver tumors, and capacity to reconstruct high-resolution images both preclinically and clinically.

Digital Breast Tomosynthesis as a Breast Cancer Screening Tool for Women with Gynecologic Cancer.

Purpose: The purpose of our study was to evaluate digital breast tomosynthesis as a breast cancer screening modality for women with gynecologic cancer. Materials and Methods: This retrospective study included patients with underlying gynecologic malignancies who underwent screening digital breast tomosynthesis for breast cancer. The cancer detection rate, recall rate, sensitivity, specificity, and positive predictive value (PPV) were calculated. PPV1 was defined as the percentage of all positive screening exams that have a tissue diagnosis of cancer within a year. PPV2 was defined as the percentage of all diagnostic exams (and Breast Imaging Reporting and Data System category 4, 5 from screening setting) with a recommendation for tissue diagnosis that have cancer within a year. PPV3 was defined as the percentage of all known biopsies actually performed that resulted in a tissue diagnosis of cancer within the year. For each case of screen-detected cancer, we analyzed the age, type of underlying gynecologic malignancy, breast density, imaging features, final Breast Imaging Reporting and Data System assessment, histologic type, T and N stages, molecular subtype, and Ki-67 index. Results: Among 508 patients, 7 with breast cancer were identified after a positive result. The cancer detection rate was 13.8 per 1000 screening exams, and the recall rate was 17.9%. The sensitivity was 100%, and the specificity was 83.2%. The false negative rate was 0 per 1000 exams. The PPV1, PPV2, and PPV3 were 7.7, 31.8, and 31.8, respectively. Conclusion: Digital breast tomosynthesis may be a promising breast cancer screening modality for women with gynecologic cancer, based on the high cancer detection rate, high sensitivity, high PPV, and high detection rate of early-stage cancer observed in our study.

Oxaliplatin-loaded chemically cross-linked hydrogels for prevention of postoperative abdominal adhesion and colorectal cancer therapy.

Colorectal cancer (CRC) is the third most commonly diagnosed cancer among both men and women worldwide. New therapeutic strategies involving cytoreductive surgery and intra-peritoneal chemotherapy could lead to a definitive cure in some cases. However, postoperative intra-abdominal adhesion can cause further complications. In this study, hyaluronic acid (HA)- and carboxymethyl cellulose sodium (CMCNa)-based novel cross-linked hydrogels (HC hydrogels) were synthesized and fully characterized. We demonstrated that varied compositions of HA and CMCNa altered the microstructure, rheology, and degradation behavior of hydrogels. Pre-constructed hydrogels were further loaded with oxaliplatin to prevent intra-abdominal adhesion following chemotherapy. Sustained release of oxaliplatin was observed from hydrogels compared that from solutions, which release drugs through diffusion, following the Higuchi and Korsmeyer-Peppas models. Moreover, low adhesion scores in an in vivo SD rat model demonstrated inhibition of intra-peritoneal adhesion in response to HC hydrogels. Therefore, HC hydrogels offer a novel formulation strategy for providing an intra-abdominal anti-adhesion barrier after cytoreductive surgery and intra-peritoneal chemotherapy for CRC treatment.

Malignancy Risk and Related Factors of Atypia of Undetermined Significance/Follicular Lesion of Undetermined Significance in Thyroid Fine Needle Aspiration.

Atypia of undetermined significance/follicular lesion of undetermined significance (AUS/FLUS) in thyroid fine needle aspiration (FNA) is a challenging category. The malignancy risk is different by multiple factors and subsequent management strategy is inconclusive. Therefore, we analyzed the malignancy risk of AUS/FLUS according to radiological and clinical features. A total of 687 nodules that had been initially diagnosed as AUS/FLUS were retrospectively reviewed from 6365 thyroid FNAs between 2011 and 2014. The ultrasonographic (US) features were categorized using the Korean Thyroid Imaging Reporting and Data System. Radiological and clinical features were compared according to the second FNA results or histologically confirmed results from surgery. Repeat FNA was performed on 248 (36%) nodules, and 49 (7%) nodules underwent immediate surgery. Among the 248 nodules subjected to repeated FNA, 49 (20%) nodules were diagnosed again as AUS/FLUS, 123 (50%) were found to be benign, and 47 (19%) were diagnosed as follicular neoplasm, suspicious for malignancy or malignant. Among histologically confirmed nodules, the US features were more unfavorable in malignant nodules, and hypo- or anechogenicity was associated with a higher risk of malignancy after adjusting for age, size, and other US features (P < 0.01). In conclusion, we observed that malignant nodules tended to show unfavorable US features, especially hypo- or anechogenicity. Age, sex, and thyroid function were not significantly associated with malignancy risk. We also found out that malignancy risk was not different between the group which underwent immediate operation following the AUS/FLUS diagnosis and the group which underwent repeated FNA after the initial diagnosis.

Dystrophic Calcifications in the Breast from Secondary Hyperparathyroidism.

BACKGROUND: Soft tissue calcification is common in patients with secondary hyperparathyroidism who have received long-term treatment with hemodialysis. However, calcifications in the breast parenchyma are not common. We report a case of a woman with dystrophic breast calcifications from secondary hyperparathyroidism. CASE REPORT: A 65-year-old woman presented with a palpable mass in her right breast which she had discovered 1 month ago. She had a medical history of end-stage renal disease. Mammography and ultrasound revealed large dystrophic calcifications in both breasts. Core needle biopsy was performed for calcifications in the right breast, and the pathologic diagnosis was dystrophic calcification in the stroma from secondary hyperparathyroidism. CONCLUSION: Reviewing our case will contribute to a fast and correct diagnosis in patients with dystrophic breast calcifications and lab results indicating secondary hyperparathyroidism, and will help discriminate these benign lesions from malignancies.

FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia.

On September 2, 2017, the U.S. Food and Drug Administration approved gemtuzumab ozogamicin (GO; Mylotarg; Pfizer, New York City, NY) for treatment of relapsed or refractory (R/R) CD33-positive acute myeloid leukemia (AML) in patients 2 years of age and older. GO is a CD33-directed antibody drug conjugate linked to the cytotoxic antibiotic calicheamicin. It originally received accelerated approval for treatment of older patients with relapsed CD33-positive AML in 2000, but it was withdrawn from the market in 2010 when the confirmatory trial failed to demonstrate clinical benefit among safety concerns, such as a higher rate of induction fatalities on the GO combination arm compared with chemotherapy alone. In addition, GO was associated with hepatic veno-occlusive disease (VOD), which has substantial morbidity and mortality. Pharmacokinetic analyses suggested a lower maximum concentration of GO would result in less VOD without affecting target saturation or efficacy. A meta-analysis across dose schedules of GO in patients with R/R AML showed that a lower-dose "fractionated" schedule of 3 mg/m2 days 1, 4, and 7 was associated with less early mortality, hemorrhage, and VOD, without an apparent decrease in complete remission (CR) rate. MyloFrance 1 was a single-arm study evaluating response rates in patients with relapsed CD33-positive AML treated with the lower-dose fractionated GO regimen. The CR rate was 26% (95% confidence interval 16%-40%). Common adverse reactions were fever, infections, nausea, vomiting, constipation, bleeding, increased liver enzymes, and mucositis. There were no cases of VOD. These results supported the approval of GO as monotherapy for R/R CD33-positive AML using the lower-dose fractionated regimen. IMPLICATIONS FOR PRACTICE: Gemtuzumab ozogamicin (GO) 3 mg/m2 days 1, 4, and 7 is an active regimen for induction of remission when used to treat patients with relapsed or refractory CD33-positive acute myeloid leukemia without curative intent. The risks of hepatic veno-occlusive disease and early mortality with this regimen appear to be lower than reported previously for GO 9 mg/m2 days 1 and 15. The data were not sufficient to enable conclusions about the safety of GO in children younger than 2 years of age.

FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia.

On September 1, 2017, the FDA granted approval for gemtuzumab ozogamicin (Mylotarg; Pfizer Inc.) in combination with daunorubicin and cytarabine and as a monotherapy for the treatment of adult patients with newly diagnosed CD33-positive acute myeloid leukemia (AML). Gemtuzumab ozogamicin is a CD33-targeted antibody-drug conjugate joined to calicheamicin. Approval of gemtuzumab ozogamicin combination treatment was based on a randomized trial of 271 patients with newly diagnosed AML treated with daunorubicin and cytarabine with or without 3 mg/m2 fractionated gemtuzumab ozogamicin, which resulted in an event-free survival (EFS) of 13.6 months for gemtuzumab ozogamicin + daunorubicin and cytarabine and 8.8 months for daunorubicin and cytarabine alone [HR = 0.68 (95% confidence interval (CI), 0.51-0.91)]. Hemorrhage, prolonged thrombocytopenia, and veno-occlusive disease were serious toxicities that were more common in patients treated with gemtuzumab ozogamicin + daunorubicin and cytarabine. Approval of gemtuzumab ozogamicin monotherapy was based on a randomized trial of 237 patients with newly diagnosed AML treated without curative intent. Median overall survival (OS) was 4.9 months with gemtuzumab ozogamicin versus 3.6 months on best supportive care [HR = 0.69 (95% CI, 0.53-0.90)]. Adverse events were similar on both arms. Postapproval, several studies are required including evaluation of fractionated gemtuzumab ozogamicin pharmacokinetics, safety of combination gemtuzumab ozogamicin in the pediatric population, immunogenicity, and the effects of gemtuzumab ozogamicin on platelet function. Clin Cancer Res; 24(14); 3242-6. ©2018 AACR.

Visualization of Breast Microcalcifications on Digital Breast Tomosynthesis and 2-Dimensional Digital Mammography Using Specimens.

PURPOSE: The purpose of this study is to compare the visibility of microcalcifications of digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) using breast specimens. MATERIALS AND METHODS: Thirty-one specimens' DBT and FFDM were retrospectively reviewed by four readers. RESULTS: The image quality of microcalcifications of DBT was rated as superior or equivalent in 71.0% by reader 1, 67.8% by reader 2, 64.5% by reader 3, and 80.6% by reader 4. The Fleiss kappa statistic for agreement among readers was 0.31. CONCLUSIONS: We suggest that image quality of DBT appears to be comparable with or better than FFDM in terms of revealing microcalcifications.

Shear-Wave Elastography for the Differential Diagnosis of Breast Papillary Lesions.

OBJECTIVE: To evaluate the diagnostic performance of shear-wave elastography (SWE) for the differential diagnosis of breast papillary lesions. METHODS: This study was an institutional review board-approved retrospective study, with a waiver of informed consent. A total of 79 breast papillary lesions in 71 consecutive women underwent ultrasound and SWE prior to biopsy. Ultrasound features and quantitative SWE parameters were recorded for each lesion. All lesions were surgically excised or excised using an ultrasound-guided vacuum-assisted method. The diagnostic performances of the quantitative SWE parameters were compared using the area under the receiver operating characteristic curve (AUC). RESULTS: Of the 79 lesions, six (7.6%) were malignant and 12 (15.2%) were atypical. Orientation, margin, and the final BI-RADS ultrasound assessments were significantly different for the papillary lesions (p < 0.05). All qualitative SWE parameters were significantly different (p < 0.05). The AUC values for SWE parameters of benign and atypical or malignant papillary lesions ranged from 0.707 to 0.757 (sensitivity, 44.4-94.4%; specificity, 42.6-88.5%). The maximum elasticity and the mean elasticity showed the highest AUC (0.757) to differentiate papillary lesions. CONCLUSION: SWE provides additional information for the differential diagnosis of breast papillary lesions. Quantitative SWE features were helpful to differentiate breast papillary lesions.

Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling.

Dose selection is one of the key decisions made during drug development in pediatrics. There are regulatory initiatives that promote the use of model-based drug development in pediatrics. Pharmacometrics or quantitative clinical pharmacology enables development of models that can describe factors affecting pharmacokinetics and/or pharmacodynamics in pediatric patients. This manuscript describes some examples in which pharmacometric analysis was used to support approval and labeling in pediatrics. In particular, the role of pharmacokinetic (PK) comparison of pediatric PK to adults and utilization of dose/exposure-response analysis for dose selection are highlighted. Dose selection for esomeprazole in pediatrics was based on PK matching to adults, whereas for adalimumab, exposure-response, PK, efficacy, and safety data together were useful to recommend doses for pediatric Crohn's disease. For vigabatrin, demonstration of similar dose-response between pediatrics and adults allowed for selection of a pediatric dose. Based on model-based pharmacokinetic simulations and safety data from darunavir pediatric clinical studies with a twice-daily regimen, different once-daily dosing regimens for treatment-naïve human immunodeficiency virus 1-infected pediatric subjects 3 to <12 years of age were evaluated. The role of physiologically based pharmacokinetic modeling (PBPK) in predicting pediatric PK is rapidly evolving. However, regulatory review experiences and an understanding of the state of science indicate that there is a lack of established predictive performance of PBPK in pediatric PK prediction. Moving forward, pharmacometrics will continue to play a key role in pediatric drug development contributing toward decisions pertaining to dose selection, trial designs, and assessing disease similarity to adults to support extrapolation of efficacy.

Can preoperative 3-T MRI predict nipple-areolar complex involvement in patients with breast cancer?

PURPOSE: To evaluate the diagnostic performances of preoperative 3-T breast MRI for predicting nipple-areolar complex (NAC) involvement. MATERIALS AND METHODS: We analyzed the predictors of NAC involvement in breast cancer, with diagnostic performances. RESULTS: Among the 403 patients, 43 cases were surgically confirmed for NAC involvement. For predicting NAC involvement, sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 60.5%, 87.5%, 36.6%, 94.9%, and 84.6%, respectively. Continuity to NAC, unilateral enhancement of NAC and thickening of NAC were significant magnetic resonance findings predictive of NAC involvement. CONCLUSIONS: Preoperative 3-T breast MRI is a useful method to predict NAC involvement in breast cancer patients.

Digital breast tomosynthesis and breast ultrasound: Additional roles in dense breasts with category 0 at conventional digital mammography.

PURPOSE: To compare the diagnostic performances of digital breast tomosynthesis (DBT) and ultrasound for the dense breasts with category 0 at conventional digital mammography. MATERIALS AND METHODS: This retrospective study was approved by the institutional review board, and informed consent was waived. Among the 1103 patients who underwent screening digital mammography at our institution, 769 (69.7%) patients had dense breasts. Of the 769 patients, 229 (29.8%) lesions were categorized as 0. DBT, breast ultrasound and digital mammography were performed in 108 (47.2%) patients. BI-RADS final assessments for DBT and ultrasound were recorded. Categories 1-3 were clinically considered as benign, and categories 4 and 5 were clinically considered as malignant. The diagnostic performances of breast ultrasound and DBT were correlated with final pathologic reports or follow-up images. RESULTS: Among 108 lesions, 17 (15.7%) were malignant and 91 (84.3%) were benign. Sensitivity was 100% for both ultrasound (17/17) and DBT (17/17) and negative predictive value was also 100% for both ultrasound (49/49) and DBT (74/74). Specificity and positive predictive value for ultrasound were 53.9% (49/91) and 28.8% (17/59), respectively. Specificity and positive predictive value for DBT were 81.3% (74/91) and 50% (17/34), respectively. DBT showed higher diagnostic accuracy than that of breast ultrasound (DBT: 84.3%, 91/108; ultrasound: 61.1%, 66/108; p<0.001). The benign biopsy rate of DBT (50%, 17/34) was lower than that of ultrasound (71.2%, 42/59). CONCLUSION: DBT showed better diagnostic performance than breast ultrasound for dense breasts with category 0. DBT may reduce the benign biopsy rate and short term follow-up.

Role of shear-wave elastography (SWE) in complex cystic and solid breast lesions in comparison with conventional ultrasound.

OBJECTIVE: To evaluate the additional role of shear-wave elastography (SWE) in differential diagnosis of complex cystic and solid breast lesions. MATERIALS AND METHODS: From January 2013 to November 2013, 140 complex cystic and solid breast lesions from 139 consecutive patients were performed ultrasound and SWE prior to biopsy. BI-RADS ultrasound final assessment and SWE parameters were recorded for each lesion. Histopathologic diagnosis was used as the reference standard. RESULTS: Among the 140 lesions, 30 lesions (21.4%) were malignant. The mean maximum elasticity (Emax) of malignant lesions (184.3 kPa) was significantly higher than that of benign lesions (45.5 kPa) (P<0.001). Homogeneity of elasticity and color pattern were significantly different from malignancy and benign lesions (P<0.05). Emax with cutoff value at 108.5 kPa showed Az value of 0.968 (95% CI, 0.932-0.985) with sensitivity of 86.7% and specificity of 97.3%. Using this cutoff value, false-positive rate was 2.7% and false-negative rate was 13.3%. By applying an Emax value of 108.5 kPa or less as a criterion for downgrading BI-RADS category 4a lesions to category 3 lesions, 103/123 (83.7%) lesions could be downgraded to category 3 lesions. CONCLUSION: Additional use of SWE could reduce unnecessary benign biopsies in complex cystic and solid breast lesions.