Ultrasonographically-guided core biopsy has been used as an adjunct to triple assessment when fine-needle aspiration cytology was inadequate or equivocal, if the overall assessment of the patient was uncertain, or if it was deemed the preferred diagnostic option. Some 143 of 2603 patients had a guided core biopsy, 125 to establish the diagnosis and 18 to obtain histology in cytologically proven malignancy. A diagnosis of malignancy was established in 43 of the 125 patients who had a diagnostic core biopsy. Some 45 patients with benign disease were either discharged or returned to follow-up on the basis of the core biopsy. The remaining 37 patients required surgical biopsy, of whom 13 had malignant and 24 benign disease. The overall positive predictive value for malignancy was 98 per cent. Experience with ultrasonographically-guided core biopsy shows that it can reduce the need for surgical biopsy in both benign and malignant conditions of the breast.

Background BI-RADS Category 4 patients have a 2–95% risk for malignancy and are generally recommended for breast biopsy with little discrimination for risk level or distinction between risk of invasive or in situ disease. Our study sought to determine if higher thresholds for biopsy based on stratifying for risk and distinguishing between risk of invasive cancer and DCIS could reduce biopsy rates and increase cancer-to-biopsy yields without missing cancers urgent for resolution. Methods 108 BI-RADS 4 cases with final outcomes data were evaluated from a prospective cohort of 215 consecutive patients seen at a same-day multidisciplinary breast clinic for women with mammograms categorized as BI-RADS 0, 4, or 5 in 2006–07. Final outcomes were determined from pathologic diagnosis or two-year follow-up. Risk estimates (RE) for DCIS and invasive cancer were collected prospectively and re-assessed by a radiologist blinded to outcomes and prior reading assessments. Cases were stratified according to the risk ranges of the BI-RADS 4 subcategories and risk of invasive or in situ disease. Biopsy rates, cancer-to-biopsy yields, and number of malignancies missed were calculated for various thresholds for intervention. Results A ROC curve for invasive cancer risk for the radiologist demonstrated a 98.5% level of accuracy (95% confidence interval [CI]: 96.9%, 100%). 60 cases had some risk for invasive cancer and 48 had some risk for DCIS. There were 14 invasive cancer and 11 DCIS outcomes, 3 of which were high-grade. Pathologic assessment from biopsy or surgery was available for 100 patients. The outcomes of 8 cases were determined by benign two-year follow-up. There are several strategies for intervention that improve biopsy yield and reduce biopsies for benign disease as shown in Table 1. If cases with RE between 2–10% for DCIS or invasive cancer were not biopsied, 23% of biopsies would be avoided and the yield would increase to 30%. If cases with invasive cancer RE between 10–95% and DCIS RE between 50–95% were biopsied, 52% of biopsies would be avoided and the yield would increase to 39%. One invasive ductal carcinoma (3 mm, Grade 2) would be missed, although with six-month follow-up, this would not be a problem. Limitations Small sample size; one radiologist providing RE may not be representative of general mammographic assessment. Conclusion Setting higher biopsy thresholds for BI-RADS 4 lesions can safely reduce biopsy rates and increase biopsy yields. Given evidence suggesting that low/intermediate grade DCIS may be overdiagnosed, distinguishing between DCIS and invasive cancer risk at screening by offering active surveillance as an alternative to biopsy for BI-RADS 4 lesions suspicious for non-high-grade DCIS may be a promising approach for reducing biopsies. This will be prospectively tested in a reader study using several radiology readers in a series of 750 cases in the Athena Breast Health Network. New biopsy thresholds can be set if the results of our study can be validated. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-09-02.

Rightly or wrongly, radiologists ‘own’ breast cancer screening, as it is a radiological procedure, administered by the radiology departments. As a result in the USA, radiologists are outraged at what is seen as misuse of published data showing the effectiveness of mammographic screening. In the USA, we do not have true population screening, and rely on women being informed, and having insurance coverage, to enable them to have an annual screening exam. There is no call/recall system, and we do not collect national statistics on breast screening and outcomes. Many low income women are not offered, what to many is a ‘life saving’ test, as a result of State budget cuts. In comparison with other countries, some of which have National Screening Programs (like the UK NHS BSP, the Netherlands and Sweden), there is support from epidemiology and public health departments, as screening is population based, and therefore a public health measure. The downsides with these programs are funding issues, with Cost-Benefit analysis being used, and QALYs (Quality Adjusted Life Years), to assist committees deciding affordable health policy for the nation. There are differences between Europe and the USA in recommendations for screening as a result, especially in terms of starting at 50 years and having a longer screening interval of 2 years. In late 2009, the US Preventive Services Task Force recommendations to abandon the guideline to start at age 40 for all women, and to recommend routine screening, unless high risk), until the age of 50 years, met with a storm of criticism by interested parties. The recommendations have largely been largely ignored, except by internists. However, in the current economic climate, it is becoming increasingly clear that decisions may have to be made on cost-benefit if health-care dollars are limited. The acknowledgment that health policy may have to change, is shown when compromises have to be made. This is demonstrated when screening policy is altered, for example, in the UK, where a decision was made to alter the screening target age, rather than reduce the interval between screens. (The NHS BSP is being extended in 2012 to cover women aged between 47 and 73). I will be concentrating on the screening guidelines and the different approaches taken between the USA and Europe. I will cover the screening of ‘Normal Risk’ women, and uphold the recommendations of the Society of Breast Imaging, American College of Radiology and the American Cancer Society. I will explain the ‘harms’ of screening and argue that screening recommendations should be made on evidence rather than on the numbers of lives saved. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr CSF1-1.

Purpose: To determine the agreement between expert readers on mammographic findings and calcification patterns. Materials and Methods: Ten academic radiologists from 5 centers reviewed 250 de-identified mammographic cases without prior exams which were previously assessed as BI-RADS 4 or 5 with subsequent pathologic diagnosis by percutaneous or surgical biopsy. For benign cases diagnosed by percutaneous biopsy, 1 year of benign or negative imaging follow-up was required. Using standardized forms, each radiologist assessed the presence of any suspicious mammographic findings (microcalcifications, asymmetry (1-vew), focal asymmetry (2-view), architectural distortion), and the morphology (none, round/punctate, amorphous, coarse heterogeneous, fine pleomorphic, fine linear branching) and distribution (none, diffuse, regional, grouped, linear, segmental) of any identified microcalcifications. Agreement between radiologists for presence/absence of findings, morphology, and distribution of calcifications was determined by calculating the Kappa (k) coefficient with 95% confidence interval (95% CI). The kappa coefficient proposed strength of agreement is ≤0 = poor, .01-.20 = slight, .21-.40 = fair, .41-.60 = moderate, .61-.80 = substantial, and .81-1 = almost perfect, as established by Landis and Koch.1 Results: Of the 250 lesions, 156 (62%) were benign and 94 (38%) malignant. Agreement among the 10 expert readers was strongest for recognizing the presence/absence of calcifications (k = 0.82, 95% CI: 0.80-84), “almost perfect”). There was substantial agreement among the readers for the identification of a mass (k = 0.67, 95% CI: 0.66-69), whereas agreement was fair for the presence of a focal (2-view) asymmetry (k = 0.21, 95% CI: 0.1900.23) or architectural distortion (k = 0.28, 95%CI: 0.26-0.30). Agreement for asymmetries (1-view) was slight (k = 0.09, 95%CI: 0.08-0.11). Among the 6 categories of microcalcification distribution and morphology, reader agreement was moderate (distribution k = 0.60, 95%CI:0.59-0.61; morphology k = 0.51, 95%CI: 0.50-0.52). Conclusion: When asked to characterize suspicious mammographic findings, this sampling of 10 expert academic breast imagers across 5 centers revealed varying strength of agreement for different findings, ranging from slight to almost perfect. Strongest agreement (“almost perfect”) was found for identifying the presence or absence of microcalcifications, although agreement drops to moderate when readers are asked to specify microcalcification morphology and distribution. 1 Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics.1977;33:159-174. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-01-06.