False-Negative Rates of Breast Cancer Screening with and without Digital Breast Tomosynthesis.

Background Screening with digital breast tomosynthesis (DBT) improves breast cancer detection and recall rates compared with those obtained with digital mammography (DM); however, the impact of DBT on patient survival has not been established. False-negative (FN) screening examinations can be a surrogate for long-term outcomes, such as breast cancer morbidity and mortality. Purpose To determine if screening with DBT is associated with lower FN rates, detection of cancers with more favorable prognoses, and improved performance outcomes versus DM. Materials and Methods This retrospective study involved 10 academic and community practices. DM screening examinations 1 year prior to DBT implementation and DBT screening examinations from the start date until June 30, 2013, were linked to cancers through June 30, 2014, with data collection in 2016 and analysis in 2018-2019. Cancers after FN examinations were characterized by presentation, either symptomatic or asymptomatic. FN rates, sensitivity, specificity, cancer detection and recall rates, positive predictive values, tumor size, histologic features, and receptor profile were compared. Results A total of 380 641 screening examinations were included. There were 183 989 DBT and 196 652 DM examinations. With DBT, rates trended lower for overall FN examinations (DBT, 0.6 per 1000 screens; DM, 0.7 per 1000 screens; P = .20) and symptomatic FN examinations (DBT, 0.4 per 1000 screens; DM, 0.5 per 1000 screens; P = .21). Asymptomatic FN rates trended higher in women with dense breasts (DBT, 0.14 per 1000 screens; DM: 0.07 per 1000 screens; P = .07). With DBT, improved sensitivity (DBT, 89.8% [966 of 1076 cancers]; DM, 85.6% [789 of 922 cancers]; P = .004) and specificity (DBT, 90.7% [165 830 of 182 913 examinations]; DM, 89.1% [174 480 of 195 730 examinations]; P < .001) were observed. Overall, cancers identified with DBT were more frequently invasive (P < .001), had fewer positive lymph nodes (P = .04) and distant metastases (P = .01), and had lower odds of an FN finding of advanced cancer (odds ratio, 0.9 [95% CI: 0.5, 1.5]). Conclusion Screening with digital breast tomosynthesis improves sensitivity and specificity and reveals more invasive cancers with fewer nodal or distant metastases. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Schattner in this issue.

A Pivotal Study of Optoacoustic Imaging to Diagnose Benign and Malignant Breast Masses: A New Evaluation Tool for Radiologists.

Purpose To compare the diagnostic utility of an investigational optoacoustic imaging device that fuses laser optical imaging (OA) with grayscale ultrasonography (US) to grayscale US alone in differentiating benign and malignant breast masses. Materials and Methods This prospective, 16-site study of 2105 women (study period: 12/21/2012 to 9/9/2015) compared Breast Imaging Reporting and Data System (BI-RADS) categories assigned by seven blinded independent readers to benign and malignant breast masses using OA/US versus US alone. BI-RADS 3, 4, or 5 masses assessed at diagnostic US with biopsy-proven histologic findings and BI-RADS 3 masses stable at 12 months were eligible. Independent readers reviewed US images obtained with the OA/US device, assigned a probability of malignancy (POM) and BI-RADS category, and locked results. The same independent readers then reviewed OA/US images, scored OA features, and assigned OA/US POM and a BI-RADS category. Specificity and sensitivity were calculated for US and OA/US. Benign and malignant mass upgrade and downgrade rates, positive and negative predictive values, and positive and negative likelihood ratios were compared. Results Of 2105 consented subjects with 2191 masses, 100 subjects (103 masses) were analyzed separately as a training population and excluded. An additional 202 subjects (210 masses) were excluded due to technical failures or incomplete imaging, 72 subjects (78 masses) due to protocol deviations, and 41 subjects (43 masses) due to high-risk histologic results. Of 1690 subjects with 1757 masses (1079 [61.4%] benign and 678 [38.6%] malignant masses), OA/US downgraded 40.8% (3078/7535) of benign mass reads, with a specificity of 43.0% (3242/7538, 99% confidence interval [CI]: 40.4%, 45.7%) for OA/US versus 28.1% (2120/7543, 99% CI: 25.8%, 30.5%) for the internal US of the OA/US device. OA/US exceeded US in specificity by 14.9% (P < .0001; 99% CI: 12.9, 16.9%). Sensitivity for biopsied malignant masses was 96.0% (4553/4745, 99% CI: 94.5%, 97.0%) for OA/US and 98.6% (4680/4746, 99% CI: 97.8%, 99.1%) for US (P < .0001). The negative likelihood ratio of 0.094 for OA/US indicates a negative examination can reduce a maximum US-assigned pretest probability of 17.8% (low BI-RADS 4B) to a posttest probability of 2% (BI-RADS 3). Conclusion OA/US increases the specificity of breast mass assessment compared with the device internal grayscale US alone. Online supplemental material is available for this article. © RSNA, 2017.

Optoacoustic Breast Imaging: Imaging-Pathology Correlation of Optoacoustic Features in Benign and Malignant Breast Masses.

OBJECTIVE: Optoacoustic ultrasound breast imaging is a fused anatomic and functional modality that shows morphologic features, as well as hemoglobin amount and relative oxygenation within and around breast masses. The purpose of this study is to investigate the positive predictive value (PPV) of optoacoustic ultrasound features in benign and malignant masses. SUBJECTS AND METHODS: In this study, 92 masses assessed as BI-RADS category 3, 4, or 5 in 94 subjects were imaged with optoacoustic ultrasound. Each mass was scored by seven blinded independent readers according to three internal features in the tumor interior and two external features in its boundary zone and periphery. Mean and median optoacoustic ultrasound scores were compared with histologic findings for biopsied masses and nonbiopsied BI-RADS category 3 masses, which were considered benign if they were stable at 12-month follow-up. Statistical significance was analyzed using a two-sided Wilcoxon rank sum test with a 0.05 significance level. RESULTS: Mean and median optoacoustic ultrasound scores for all individual internal and external features, as well as summed scores, were higher for malignant masses than for benign masses (p < 0.0001). High external scores, indicating increased hemoglobin and deoxygenation and abnormal vessel morphologic features in the tumor boundary zone and periphery, better distinguished benign from malignant masses than did high internal scores reflecting increased hemoglobin and deoxygenation within the tumor interior. CONCLUSION: High optoacoustic ultrasound scores, particularly those based on external features in the boundary zone and periphery of breast masses, have high PPVs for malignancy and, conversely, low optoacoustic ultrasound scores have low PPV for malignancy. The functional component of optoacoustic ultrasound may help to overcome some of the limitations of morphologic overlap in the distinction of benign and malignant masses.

Downgrading and Upgrading Gray-Scale Ultrasound BI-RADS Categories of Benign and Malignant Masses With Optoacoustics: A Pilot Study.

OBJECTIVE: False-positive findings remain challenging in breast imaging. This study investigates the incremental value of optoacoustic imaging in improving BI-RADS categorization of breast masses at ultrasound. SUBJECTS AND METHODS: The study device is an optoacoustic breast imaging device with a handheld duplex laser and internal gray-scale ultrasound probe, fusing functional and morphologic information (optoacoustic ultrasound). In this prospective multisite study, breast masses assessed as BI-RADS category 3, 4A, 4B, 4C, or 5 by site radiologists underwent both gray-scale ultrasound and optoacoustic imaging with the study device. Independent reader radiologists assessed internal gray-scale ultrasound and optoacoustic ultrasound features for each mass and assigned a BI-RADS category. The percentage of mass reads for which optoacoustic ultrasound resulted in a downgrade or upgrade of BI-RADS category relative to internal gray-scale ultrasound was determined. RESULTS: Of 94 total masses, 39 were biopsy-proven malignant, 44 were biopsy-proven benign, and 11 BI-RADS category 3 masses were stable at 12-month follow-up. The sensitivity of both optoacoustic ultrasound and internal gray-scale ultrasound was 97.1%. The specificity was 44.3% for optoacoustic ultrasound and 36.4% for internal gray-scale ultrasound. Using optoacoustic ultrasound, 41.7% of benign masses or BI-RADS category 3 masses that were stable at 12-month follow-up were downgraded to BI-RADS category 2 by independent readers; 36.6% of masses assigned BI-RADS category 4A were downgraded to BI-RADS category 3 or 2, and 10.1% assigned BI-RADS category 4B were downgraded to BI-RADS category 3 or 2. Using optoacoustic ultrasound, independent readers upgraded 75.0% of the malignant masses classified as category 4A, 4B, 4C, or 5, and 49.4% of the malignant masses were classified as category 4B, 4C, or 5. CONCLUSION: Optoacoustic ultrasound resulted in BI-RADS category downgrading of benign masses and upgrading of malignant masses compared with gray-scale ultrasound.

Informing Women and Their Physicians about Recommendations for Adjunct Breast MRI Screening: A Cohort Study.

It is unclear how best to communicate recommendations for breast cancer screening with MRI as an adjunct to mammography for women at high risk. This study compares the rates of breast MRI screening for two different methods of communication. The retrospective IRB-approved cohort study was conducted at Invision Sally Jobe Breast Centers (ISJBC). ISJBC provided Gail model risk assessment to all women presenting for screening mammography. Women with scores ≥ 19.6% were considered to be high risk. Over 2 years, ISJBC used two different methods to inform women at elevated lifetime risk and their physicians about recommendations for adjunct MRI screening (N = 561, mean age = 52 years, s.d. = 8.7). During Window A, information was sent to referring physicians as a part of the dictated imaging report, while later, in Window B, the information was sent to referring physicians as well as to the women themselves in a letter. Analyses were stratified by mammography screening frequency. One-time screeners presented in only Window A or Window B. Repeat screeners came both in Window A and in Window B. Breast MRI screening rates were significantly higher in Window B than in Window A (one-time screeners, N = 459, 9.8% vs. 14.4%, p = 0.047; repeat screeners, N = 102, 0% vs. 6.9%, p = 0.016). Although an observational study cannot assess causality, direct communication of risk-based recommendations for adjunct breast MRI screening to women and to their referring physicians was associated with an increased rate of screening breast MRI completion at the same clinic at which the women underwent mammography.

Effect of age on breast cancer screening using tomosynthesis in combination with digital mammography.

PURPOSE: To determine the effect of tomosynthesis imaging as a function of age for breast cancer screening. METHODS: Screening performance metrics from 13 institutions were examined for 12 months prior to introduction of tomosynthesis (period 1) and compared to those after introduction of tomosynthesis (period 2, range 3-22 months). Screening metrics for women ages 40-49, 50-59, 60-69, and 70+ , included rates per 1000 screens for recalls, biopsies, cancers, and invasive cancers detected. RESULTS: Performance parameters were compared for women screened with digital mammography alone (n = 278,908) and digital mammography + tomosynthesis (n = 173,414). Addition of tomosynthesis to digital mammography produced significant reductions in recall rates for all age groups and significant increases in cancer detection rates for women 40-69. Largest recall rate reduction with tomosynthesis was for women 40-49, decreasing from 137 (95% CI 117-156) to 115 (95% CI 95-135); difference, -22 (95% CI -26 to -18; P < .001). Simultaneous increase in invasive cancer detection rate for women 40-49 from 1.6 (95% CI 1.2-1.9) to 2.7 (95% CI 2.2-3.1) with tomosynthesis (difference, 1.1; 95% CI 0.6-1.6; P < .001) was observed. CONCLUSIONS: Addition of tomosynthesis to digital mammography increased invasive cancer detection rates for women 40-69 and decreased recall rates for all age groups with largest performance gains seen in women 40-49. The similar performance seen with tomosynthesis screening for women in their 40s compared to digital mammography for women in their 50s argues strongly for commencement of mammography screening at age 40 using tomosynthesis.

Ultrasound positive predictive values by BI-RADS categories 3-5 for solid masses: An independent reader study.

OBJECTIVE: We assessed multiple readers' positive predictive values (PPVs) for ACR BI-RADS 3, 4a, 4b, 4c and 5 masses on ultrasound (US) pre- and post-proposed guidelines. METHODS: This retrospective, IRB-approved study included four American and four non-American readers who assigned BI-RADS categories for US images of 374 biopsy-proved masses. Readers were offered guidelines and re-classified the masses. We assessed readers' abilities to achieve ACR benchmarks BI-RADS categories pre- and post-guidelines. RESULTS: PPVs increased with BI-RADS category. The PPVs pre- and post-guidelines were 6.0% and 4.4% for category 3, 27.3% and 30.5% for category 4a, 49.9% and 51.5% for category 4b, 69.0% and 67.4% for category 4c, and 79.3% and 80.1% for category 5. Readers achieved the PPV benchmark for category 4c, but not for categories 3, 4a, 4b and 5, with no significant improvement after guidelines. Regular BI-RADS 4 subcategory users missed benchmarks by less than non-regular users. CONCLUSION: Pre- and post-guidelines, readers' PPVs increased with BI-RADS categories, ACR PPV benchmarks were achieved in category 4c, missed in other categories, especially in the critical 4a subcategory, where the PPV was too high. BI-RADS 4 subcategory users performed better than non-users. KEY POINTS: • Readers failed to achieve benchmarks for BI-RADS 4 subcategories, especially 4a. • USA and Brazilian readers performed similarly in ACR BI-RADS 4 subcategorization. • Proposed guidelines did not improve overall, USA or Brazilian reader performance. • Regularly BI-RADS 4 subcategory users performed better than did non-users. • US features distinguished between benign and malignant, not BI-RADS 4 subcategories.

Breast cancer screening using tomosynthesis in combination with digital mammography.

IMPORTANCE: Mammography plays a key role in early breast cancer detection. Single-institution studies have shown that adding tomosynthesis to mammography increases cancer detection and reduces false-positive results. OBJECTIVE: To determine if mammography combined with tomosynthesis is associated with better performance of breast screening programs in the United States. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of screening performance metrics from 13 academic and nonacademic breast centers using mixed models adjusting for site as a random effect. EXPOSURES: Period 1: digital mammography screening examinations 1 year before tomosynthesis implementation (start dates ranged from March 2010 to October 2011 through the date of tomosynthesis implementation); period 2: digital mammography plus tomosynthesis examinations from initiation of tomosynthesis screening (March 2011 to October 2012) through December 31, 2012. MAIN OUTCOMES AND MEASURES: Recall rate for additional imaging, cancer detection rate, and positive predictive values for recall and for biopsy. RESULTS: A total of 454,850 examinations (n=281,187 digital mammography; n=173,663 digital mammography + tomosynthesis) were evaluated. With digital mammography, 29,726 patients were recalled and 5056 biopsies resulted in cancer diagnosis in 1207 patients (n=815 invasive; n=392 in situ). With digital mammography + tomosynthesis, 15,541 patients were recalled and 3285 biopsies resulted in cancer diagnosis in 950 patients (n=707 invasive; n=243 in situ). Model-adjusted rates per 1000 screens were as follows: for recall rate, 107 (95% CI, 89-124) with digital mammography vs 91 (95% CI, 73-108) with digital mammography + tomosynthesis; difference, -16 (95% CI, -18 to -14; P < .001); for biopsies, 18.1 (95% CI, 15.4-20.8) with digital mammography vs 19.3 (95% CI, 16.6-22.1) with digital mammography + tomosynthesis; difference, 1.3 (95% CI, 0.4-2.1; P = .004); for cancer detection, 4.2 (95% CI, 3.8-4.7) with digital mammography vs 5.4 (95% CI, 4.9-6.0) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001); and for invasive cancer detection, 2.9 (95% CI, 2.5-3.2) with digital mammography vs 4.1 (95% CI, 3.7-4.5) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001). The in situ cancer detection rate was 1.4 (95% CI, 1.2-1.6) per 1000 screens with both methods. Adding tomosynthesis was associated with an increase in the positive predictive value for recall from 4.3% to 6.4% (difference, 2.1%; 95% CI, 1.7%-2.5%; P < .001) and for biopsy from 24.2% to 29.2% (difference, 5.0%; 95% CI, 3.0%-7.0%; P < .001). CONCLUSIONS AND RELEVANCE: Addition of tomosynthesis to digital mammography was associated with a decrease in recall rate and an increase in cancer detection rate. Further studies are needed to assess the relationship to clinical outcomes.

Outcomes After Accelerated Partial Breast Irradiation in Women With Triple Negative Subtype and Other "High Risk" Variables Categorized as Cautionary in The ASTRO Guidelines.

PURPOSE: To report a primary objective clinical outcome of ipsilateral breast recurrence following accelerated partial breast irradiation (APBI) in women with triple negative and other high risk breast cancer (as described in 2017 ASTRO guidelines) (i.e., age 40-49, size 2.1-3.0 cm, estrogen receptor negative and invasive lobular breast cancer). Secondary objectives of axillary and regional failure as well as overall survival are also reported. METHODS AND MATERIAL: Patients from two clinical trials (NCT01185145, NCT01185132) were treated with 38.5 Gy IMRT or 3D-CRT APBI w/3.85 Gy fraction/BID fractionation for 10 fractions. Triple negative and other high risk patients (n=269) were compared to a total of 478 low risk patients which ASTRO defined as "suitable" for APBI. High risk patients, for the purpose of this study, were defined as those who possess one or more high risk criteria: triple negative (n=30), tumor size >2 cm <3 cm (n=50), HER 2+ (n=54), age range 40-50 years (n=120), ER- (n=43), and ILC histology (n=52). RESULTS: Median follow up was 4.0 years for all patients. No significant difference was found for this high-risk cohort at 5 years for ipsilateral breast, or regional recurrences. Axillary recurrence was significantly adversely impacted by triple negative and ER- statuses (p=0.01, p=0.04). There were significant correlations between triple negative type and axillary recurrence on multivariate analysis (p=0.03). Overall survival for all patients was unaffected by any of the high-risk categories. CONCLUSION: The data from this study suggests that women possessing high risk features are at no more meaningful risk for recurrence than other patients considered to be acceptable for APBI treatment. However, the finding of axillary recurrence in patients with triple negative breast cancer does warrant a degree of caution in proceeding with accelerated partial breast irradiation technique in this patient group.

A prospective Phase III trial evaluating patient self-reported pain and cosmesis in accelerated partial breast irradiation utilizing 3-D versus intensity-modulated radiotherapy.

PURPOSE/OBJECTIVE: The primary objective is to examine patient self-assessment of breast pain and cosmesis between three-dimensional (3D-CRT) versus intensity-modulated radiotherapy (IMRT). The secondary objective is to evaluate any relationship of treatment planning conformality of both cohorts to patient-assessed pain. Assessments were performed at interim 12, 24, 36, and 48 months with a final 5-year assessment. MATERIALS/METHODS: In total, 656 patients (3D-CRT n = 328; IMRT n = 328) were randomly assigned to either IMRT or 3D-CRT accelerated partial breast radiotherapy to 38.5 Gy in 10 BID 3.85 Gy fractions. RESULTS: Median follow-up was 3 years. Multivariate analysis showed that pain severity significantly decreased from baseline to the 12-month follow-up visit (<0.001 for both 3D-CRT and IMRT) in each cohort. There was significantly less pain at 2 (p = 0.002) and 3 years (0.045) in the IMRT arm versus the 3D-CRT arm when compared to the baseline pain level. There was no difference in patient-assessed cosmesis at any follow-up point; however, although MD-assessed cosmesis showed no difference from years 1 to 4, there was significantly better cosmesis for 3D-CRT versus IMRT (p = 0.047) at 5 years. There was a significant correlation between a maximum pain score and an increase in the CI100 (indicating less conformity) in the IMRT cohort (p < 0.01) and in the IMRT subgroup when the CI100 was ≤0.37 cohort arm (p = 0.01). CONCLUSION: In the analysis of our primary objective we found that at 2 years, IMRT resulted in more interval improvement in breast pain after baseline when compared to patients treated with 3D-CRT planning. As seen in our secondary analysis, this may be due to the ability of IMRT to achieve higher conformality (as evidenced by lower CI values) resulting in less fibrosis. There were no differences in patient-assessed cosmesis or MD-assessed cosmesis for years 1-4; however, physician-assessed 5-year cosmesis was better with 3D-CRT.

Atypical lobular hyperplasia and classic lobular carcinoma in situ in core biopsy specimens: routine excision is not necessary.

Standardized recommendations for the management of lobular neoplasia in core biopsy specimens are not established. The aim of our study was to define morphologic features of lobular neoplasia in core biopsies that predict the finding of ductal carcinoma in situ or invasive carcinoma in the subsequent excisional specimen. We reviewed 333 cases of atypical lobular hyperplasia or lobular carcinoma in situ without ductal carcinoma in situ or invasive carcinoma diagnosed in core biopsies from 1996 to 2006. Subsequent excision was performed in 41% (136/333) of cases, including atypical lobular hyperplasia (n=48), lobular carcinoma in situ (n=39), and lobular neoplasia associated with atypical ductal hyperplasia (n=49). Upgrades were identified in 2% (1/48) of atypical lobular hyperplasia, 23% (9/39) of lobular carcinoma in situ, and 27% (13/49) of lobular neoplasia associated with atypical ductal hyperplasia cases. When further analyzed, the upgraded cases of lobular carcinoma in situ were associated with radiologic-pathologic discordance in 6/9 cases and with nonclassic pathology (two lobular carcinoma in situ with necrosis and one pleomorphic lobular carcinoma in situ) in the remaining three cases. The frequency of upgrade was 11% (3/26) in classic lobular carcinoma in situ, and 46% (6/13) in nonclassic types (pleomorphic or with necrosis). After excluding cases with discordant imaging/pathology, there was a 5% upgrade in our excisional specimens. After excluding cases where the upgrade was associated with nonclassic morphology, the upgrade in our study was 1%. Our results suggest that atypical lobular hyperplasia and classic lobular carcinoma in situ with concordant radiology and pathology can be appropriately managed with clinical follow-up without surgery.

Breast Cancer Risk Assessment Models and High-Risk Screening.

It is important to recognize that patients at high risk for breast cancer may benefit by following breast cancer screening paradigms that are more robust than those recommended for the average-risk population. Assessing individual cancer risk and using guidelines to determine if a patient is a candidate for genetic counseling and possibly genetic testing are essential components to comprehensive breast cancer screening.

Digital and screen-film mammography: comparison of image acquisition and interpretation times.

OBJECTIVE: The objective of our study was to compare acquisition times and interpretation times of screening examinations using screen-film mammography and soft-copy digital mammography. MATERIALS AND METHODS: Technologist study acquisition time from examination initiation to release of the screenee was measured for both screen-film and digital mammography (100 cases each) in routine clinical practice. The total interpretation time for screening mammography was also measured for 183 hard-copy screen-film cases and 181 soft-copy digital cases interpreted by a total of seven breast imaging radiologists, four experienced breast imagers, and three breast imaging fellows. RESULTS: Screening mammography acquisition time averaged 21.6 minutes for screen-film and 14.1 minutes for digital, a highly significant 35% shorter time for digital than screen-film (p < 10(-17)). The average number of images per case acquired with digital mammography was higher than that for screen-film mammography (4.23 for screen-film, 4.50 for digital; p = 0.047). The total interpretation time averaged 1.4 minutes for screen-film mammography and 2.3 minutes for digital mammography, a highly significant 57% longer interpretation time for digital (p < 10(-11)). In addition, technical problems delaying interpretation were encountered in none of the 183 screen-film cases but occurred in nine (5%) of the 181 digital cases. CONCLUSION: Compared with screen-film mammography, the use of digital mammography for screening examinations significantly shortened acquisition time but significantly increased interpretation time. In addition, more technical problems were encountered that delayed the interpretation of digital cases.

ACR Appropriateness Criteria Stage I Breast Cancer: Initial Workup and Surveillance for Local Recurrence and Distant Metastases in Asymptomatic Women.

Women newly diagnosed with stage 1 breast cancer have an early-stage disease that can be effectively treated. Evidence provides little justification for performing imaging to exclude metastasis in asymptomatic women with stage I breast cancer. No differences have been found in survival or quality of life in women regardless of whether they underwent initial workup for metastatic disease. These women generally prefer intensive follow-up to detect an early recurrence. However, survival rates do not differ between women who obtain intensive screening and surveillance, with imaging and laboratory studies, and women who undergo testing only as a result of development of symptoms or findings on clinical examinations. In addition, quality of life is similar for women who undergo intensive surveillance compared with those who do not. American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines state that annual mammography is the only imaging examination that should be performed to detect a localized breast recurrence in asymptomatic patients. Additional imaging may be needed if the patient has locoregional symptoms. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review by the panel include extensive analysis of current medical literature from peer-reviewed journals and application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures. When evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

ACR Appropriateness Criteria Palpable Breast Masses.

A palpable breast mass is one of the most common presenting features of breast carcinoma. However, the clinical features are frequently nonspecific. Imaging performed before biopsy is helpful in characterizing the nature of the mass. For women with clinically detected breast masses, the vast majority will require evaluation with ultrasound. Diagnostic mammography is the initial imaging modality of choice for women aged ≥ 40 years; ultrasound is typically necessary unless a definitively benign mass is identified as the etiology of the clinical finding. For evaluating women aged <30 years and women who are pregnant or lactating, ultrasound is used for initial evaluation. For women aged 30 to 39 years, either ultrasound or diagnostic mammography may be used for initial evaluation. MRI is rarely indicated to evaluate a clinically detected finding. Biopsy is indicated for masses with suspicious features. Short-term follow-up is a reasonable alternative to biopsy for solid masses with probably benign features suggesting fibroadenoma. Correlation between imaging and the clinical finding is essential. The ACR Appropriateness Criteria® are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

ACR Appropriateness Criteria Breast Cancer Screening.

Mammography is the recommended method for breast cancer screening of women in the general population. However, mammography alone does not perform as well as mammography plus supplemental screening in high-risk women. Therefore, supplemental screening with MRI or ultrasound is recommended in selected high-risk populations. Screening breast MRI is recommended in women at high risk for breast cancer on the basis of family history or genetic predisposition. Ultrasound is an option for those high-risk women who cannot undergo MRI. Recent literature also supports the use of breast MRI in some women of intermediate risk, and ultrasound may be an option for intermediate-risk women with dense breasts. There is insufficient evidence to support the use of other imaging modalities, such as thermography, breast-specific gamma imaging, positron emission mammography, and optical imaging, for breast cancer screening. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review includes an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

ACR Appropriateness Criteria® Stage I Breast Carcinoma.

Stage I breast carcinoma is classified when an invasive breast carcinoma is ≤2 cm in diameter (T1), with no regional (axillary) lymph node metastases (N0) and no distant metastases (M0). The most common sites for metastases from breast cancer are the skeleton, lung, liver, and brain. In general, women and health care professionals prefer intensive screening and surveillance after a diagnosis of breast cancer. Screening protocols include conventional imaging such as chest radiography, bone scan, ultrasound of the liver, and MRI of brain. It is uncertain whether PET/CT will serve as a replacement for current imaging technologies. However, there are no survival or quality-of-life differences for women who undergo intensive screening and surveillance after a diagnosis of stage I breast carcinoma compared with those who do not. The ACR Appropriateness Criteria® are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

ACR Appropriateness Criteria Evaluation of the Symptomatic Male Breast.

Most male breast problems are benign, and men with typical symptoms of gynecomastia or pseudogynecomastia do not usually need imaging. When a differentiation between benign disease and breast cancer cannot be made on the basis of clinical findings or when the clinical findings are suspicious for breast cancer, imaging is indicated. Mammography is useful in both identifying cancer and obviating the need for biopsy in patients for whom a benign mammographic impression confirms the clinical impression. However, because of the relationship of breast cancer to increasing age, age-based protocols that do not include mammography have been developed. For men with an indeterminate palpable mass, begin with ultrasound if the patient is <25 years of age, because breast cancer is highly unlikely. Mammography should be performed if ultrasound is suspicious. For men ≥25 years of age or having a highly concerning physical examination, usually begin with mammography; ultrasound is useful if mammography is inconclusive or suspicious. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals, and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

External beam accelerated partial breast irradiation yields favorable outcomes in patients with prior breast augmentation.

PURPOSE: To report outcomes in breast cancer patients with prior breast augmentation treated with external beam accelerated partial breast irradiation (EB-APBI) utilizing intensity-modulated radiotherapy or 3-dimensional conformal radiotherapy, both with IGRT. MATERIALS AND METHODS: Sixteen stage 0/1 breast cancer patients with previous elective bilateral augmentation were treated post-lumpectomy on institutional EB-APBI trials (01185132 and 01185145 on clinicaltrials.gov). Patients received 38.5 Gy in 10 fractions over five consecutive days. Breast/chest wall pain and cosmesis were rated by patient; cosmesis was additionally evaluated by physician per RTOG criteria. RESULTS: The median follow-up from accelerated partial breast irradiation (APBI) completion was 23.9 months (range, 1.2-58.6). Little to no change in cosmesis or pain from baseline was reported. Cosmetic outcomes at last follow-up were judged by patients as excellent/good in 81.2% (13/16), and by physicians as excellent/good in 93.8% (15/16). Ten patients (62.5%) reported no breast/chest wall pain, five (31.2%) reported mild pain, and one (6.2%) reported moderate pain. All patients remain disease free at last follow-up. The median ipsilateral breast, planning target volume (PTV), and implant volumes were 614, 57, and 333 cm(3). The median ratios of PTV/ipsilateral breast volume (implant excluded) and PTV/total volume (implant included) were 9 and 6%. CONCLUSION: These 16 breast cancer cases with prior bilateral augmentation treated with EB-APBI demonstrate favorable clinical outcomes. Further exploration of EB-APBI as a treatment option for this patient population is warranted.

ACR Appropriateness Criteria stage I breast cancer: initial workup and surveillance for local recurrence and distant metastases in asymptomatic women.

Women newly diagnosed with stage 1 breast cancer have an early-stage disease that can be effectively treated. Evidence provides little justification for performing imaging to exclude metastasis in asymptomatic women with stage I breast cancer. No differences have been found in survival or quality of life in women regardless of whether they underwent initial workup for metastatic disease. These women generally prefer intensive follow-up to detect an early recurrence. However, survival rates do not differ between women who obtain intensive screening and surveillance, with imaging and laboratory studies, and women who undergo testing only as a result of development of symptoms or findings on clinical examinations. In addition, quality of life is similar for women who undergo intensive surveillance compared with those who do not. American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines state that annual mammography is the only imaging examination that should be performed to detect a localized breast recurrence in asymptomatic patients. Additional imaging may be needed if the patient has locoregional symptoms. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review by the panel include extensive analysis of current medical literature from peer-reviewed journals and application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures. When evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.