Dione M. Farria

Combined Screening With Ultrasound and Mammography vs Mammography Alone in Women at Elevated Risk of Breast Cancer

CONTEXT Screening ultrasound may depict small, node-negative breast cancers not seen on mammography. OBJECTIVE To compare the diagnostic yield, defined as the proportion of women with positive screen test results and positive reference standard, and performance of screening with ultrasound plus mammography vs mammography alone in women at elevated risk of breast cancer. DESIGN, SETTING, AND PARTICIPANTS From April 2004 to February 2006, 2809 women, with at least heterogeneously dense breast tissue in at least 1 quadrant, were recruited from 21 sites to undergo mammographic and physician-performed ultrasonographic examinations in randomized order by a radiologist masked to the other examination results. Reference standard was defined as a combination of pathology and 12-month follow-up and was available for 2637 (96.8%) of the 2725 eligible participants. MAIN OUTCOME MEASURES Diagnostic yield, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) of combined mammography plus ultrasound vs mammography alone and the positive predictive value of biopsy recommendations for mammography plus ultrasound vs mammography alone. RESULTS Forty participants (41 breasts) were diagnosed with cancer: 8 suspicious on both ultrasound and mammography, 12 on ultrasound alone, 12 on mammography alone, and 8 participants (9 breasts) on neither. The diagnostic yield for mammography was 7.6 per 1000 women screened (20 of 2637) and increased to 11.8 per 1000 (31 of 2637) for combined mammography plus ultrasound; the supplemental yield was 4.2 per 1000 women screened (95% confidence interval [CI], 1.1-7.2 per 1000; P = .003 that supplemental yield is 0). The diagnostic accuracy for mammography was 0.78 (95% CI, 0.67-0.87) and increased to 0.91 (95% CI, 0.84-0.96) for mammography plus ultrasound (P = .003 that difference is 0). Of 12 supplemental cancers detected by ultrasound alone, 11 (92%) were invasive with a median size of 10 mm (range, 5-40 mm; mean [SE], 12.6 [3.0] mm) and 8 of the 9 lesions (89%) reported had negative nodes. The positive predictive value of biopsy recommendation after full diagnostic workup was 19 of 84 for mammography (22.6%; 95% CI, 14.2%-33%), 21 of 235 for ultrasound (8.9%, 95% CI, 5.6%-13.3%), and 31 of 276 for combined mammography plus ultrasound (11.2%; 95% CI. 7.8%-15.6%). CONCLUSIONS Adding a single screening ultrasound to mammography will yield an additional 1.1 to 7.2 cancers per 1000 high-risk women, but it will also substantially increase the number of false positives. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00072501.

Detection of Breast Cancer with Addition of Annual Screening Ultrasound or a Single Screening MRI to Mammography in Women with Elevated Breast Cancer Risk

CONTEXT Annual ultrasound screening may detect small, node-negative breast cancers that are not seen on mammography. Magnetic resonance imaging (MRI) may reveal additional breast cancers missed by both mammography and ultrasound screening. OBJECTIVE To determine supplemental cancer detection yield of ultrasound and MRI in women at elevated risk for breast cancer. DESIGN, SETTING, AND PARTICIPANTS From April 2004-February 2006, 2809 women at 21 sites with elevated cancer risk and dense breasts consented to 3 annual independent screens with mammography and ultrasound in randomized order. After 3 rounds of both screenings, 612 of 703 women who chose to undergo an MRI had complete data. The reference standard was defined as a combination of pathology (biopsy results that showed in situ or infiltrating ductal carcinoma or infiltrating lobular carcinoma in the breast or axillary lymph nodes) and 12-month follow-up. MAIN OUTCOME MEASURES Cancer detection rate (yield), sensitivity, specificity, positive predictive value (PPV3) of biopsies performed and interval cancer rate. RESULTS A total of 2662 women underwent 7473 mammogram and ultrasound screenings, 110 of whom had 111 breast cancer events: 33 detected by mammography only, 32 by ultrasound only, 26 by both, and 9 by MRI after mammography plus ultrasound; 11 were not detected by any imaging screen. Among 4814 incidence screens in the second and third years combined, 75 women were diagnosed with cancer. Supplemental incidence-screening ultrasound identified 3.7 cancers per 1000 screens (95% CI, 2.1-5.8; P < .001). Sensitivity for mammography plus ultrasound was 0.76 (95% CI, 0.65-0.85); specificity, 0.84 (95% CI, 0.83-0.85); and PPV3, 0.16 (95% CI, 0.12-0.21). For mammography alone, sensitivity was 0.52 (95% CI, 0.40-0.64); specificity, 0.91 (95% CI, 0.90-0.92); and PPV3, 0.38 (95% CI, 0.28-0.49; P < .001 all comparisons). Of the MRI participants, 16 women (2.6%) had breast cancer diagnosed. The supplemental yield of MRI was 14.7 per 1000 (95% CI, 3.5-25.9; P = .004). Sensitivity for MRI and mammography plus ultrasound was 1.00 (95% CI, 0.79-1.00); specificity, 0.65 (95% CI, 0.61-0.69); and PPV3, 0.19 (95% CI, 0.11-0.29). For mammography and ultrasound, sensitivity was 0.44 (95% CI, 0.20-0.70, P = .004); specificity 0.84 (95% CI, 0.81-0.87; P < .001); and PPV3, 0.18 (95% CI, 0.08 to 0.34; P = .98). The number of screens needed to detect 1 cancer was 127 (95% CI, 99-167) for mammography; 234 (95% CI, 173-345) for supplemental ultrasound; and 68 (95% CI, 39-286) for MRI after negative mammography and ultrasound results. CONCLUSION The addition of screening ultrasound or MRI to mammography in women at increased risk of breast cancer resulted in not only a higher cancer detection yield but also an increase in false-positive findings. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00072501.

Professional and economic factors affecting access to mammography: a crisis today, or tomorrow? Results from a national survey.

Objective data and anecdotal reports have suggested that access to mammography may be declining because of facility closures and difficulty in recruiting and retaining radiologists and radiologic technologists. To gain insight into the practice patterns, use of emerging technologies, and concerns of breast imagers in current practice, the Society of Breast Imaging (SBI) conducted a national survey of breast imaging practices in the U.S.

Pathologic Outcomes of Nonmalignant Papillary Breast Lesions Diagnosed at Imaging-guided Core Needle Biopsy

PURPOSE To determine the upstage rate from nonmalignant papillary breast lesions obtained at imaging-guided core needle biopsy (CNB) and if there are any clinical, imaging, or pathologic features that can be used to predict eventual upstaging to malignancy. MATERIALS AND METHODS This retrospective case review was institutional review board approved and HIPAA compliant, with a waiver of informed consent. A database search (from January 2001 to March 2010) was performed to find patients with a nonmalignant papillary breast lesion diagnosed at CNB. Of the resulting 128 patients, 86 (67%) underwent surgical excision; 42 (33%) patients were observed with imaging, for a median observation time of 4.1 years (range, 1.0-8.6 years). Chart review was performed to determine pertinent features of each case. RESULTS Fourteen of 128 patients were subsequently found to have malignancy at excision, for an upstage rate of 11%. Nine (7%) of the 128 patients were subsequently found to have atypia at excision. Comparisons between patients with upstaged lesions and patients whose lesions were not upstaged demonstrated patients with upstaged lesions to be slightly older (65 vs 56 years, P=.01), more likely to have a mass than calcifications at imaging (P=.03), and to have had less tissue obtained at biopsy (three vs five cores obtained, P=.02; 14- vs 9-gauge needle used, P<.01; no vacuum assistance used, P<.01). Most strongly predictive of eventual malignancy, however, was whether the interpreting pathologist qualified the benign diagnosis at CNB with additional commentary (P<.01). CONCLUSION Given the substantial upstage rate (11%) of papillary lesions diagnosed at imaging-guided CNB, surgical excision is an appropriate management decision; however, careful evaluation in concert with an expert breast pathologist may allow for observation in appropriately selected patients.

Effect of Transition to Digital Mammography on Clinical Outcomes

PURPOSE To determine the effect of transition to digital screening mammography on clinical outcome measures, including recall rate, cancer detection rate, and positive predictive value (PPV). MATERIALS AND METHODS Institutional review board approval and the need for informed consent were waived for this HIPAA-complaint study. Practice audit data were obtained for three breast imaging radiologists from 2004 to 2009. These data were sorted by time period into the following groups: baseline (2004-2005), digital year 1 (2007), digital year 2 (2008), and digital year 3 (2009). The χ(2) and Fisher exact tests were used to assess differences in proportions among and between years. Clinical outcomes based on lesion type from 2004 to 2008 were also compared. Computer-aided detection was used. RESULTS The three radiologists interpreted 32 600 screen-film mammograms and 33 879 digital mammograms. Recall rates increased from 6.0% at baseline to 7.1% in digital year 1 (P < .0001) and continued to increase in subsequent years to 8.5%. The cancer detection rate increased from 3.3 at baseline to 5.3 in digital year 1 (P = .0061), and it remained higher than that at baseline in subsequent years. PPV after screening mammogaphy (PPV(1)) increased from 5.6% at baseline to 7.5% in digital year 1 and returned to baseline levels in digital year 3. In contrast, PPV after biopsy (PPV(3)) decreased from 44.5% at baseline to 30.3% in digital year 3 (P = .0021). From 2004 to 2008, 3444 patients with 3493 lesions were recalled. The percentage of recalls for calcifications increased from 13.8% at baseline to a peak of 23.9% in digital year 1 and 17.9% in digital year 2. Both PPV(1) and PPV(3) decreased for calcifications after the digital transition. CONCLUSION Recall rate and cancer detection rate increase for at least 2 years after the transition to digital screening mammography. PPV(3) is significantly reduced after digital transition, primarily in patients with microcalcifications.

An introduction to economic issues in breast imaging.

Marked increases in national health care costs, along with governmental coverage of health care costs for the elderly under Medicare, have resulted in increased government regulation of medical reimbursement rates. Private insurers and HMOs now provide reimbursements that are frequently the same or lower than those from Medicare. Reimbursement rates for mammography have been particularly restricted. Although screening mammography appears to be as cost-effective as other commonly accepted medical interventions, some third-party payors have been reluctant to reimburse screening mammography because of its perceived effect on overall health care costs. An objective analysis shows that inclusion of coverage for screening mammography, however, even beginning at age 40 years, has only a slight effect on total health care costs. Adequate reimbursement for screening mammography supports an effort that provides substantial reduction in deaths from breast cancer.

The ACR/Society of Breast Imaging Resident and Fellowship Training Curriculum for Breast Imaging, Updated

The education committees of the ACR Commission on Breast Imaging and the Society of Breast Imaging have revised the resident and fellowship training curriculum to reflect the current state of breast imaging in the United States. The original curriculum, created by the Society of Breast Imaging in 2000, had been updated only once before, in 2006. Since that time, a number of significant changes have occurred in the way mammography is acquired, how adjunctive breast imaging methods are used, and how pathology is assessed. This curricular update is meant to reflect these and other changes and to offer guidance to educators and trainees in preparing those interested in providing breast imaging services.

Educational Intervention for Women Undergoing Image-Guided Breast Biopsy: Results of a Randomized Clinical Trial

BACKGROUND The process of informed consent has been examined for patients undergoing various procedures but not breast biopsy. Our study was a randomized trial that examined the effect of an educational flip chart as part of the informed consent. METHODS A total of 122 patients referred for stereotactic or ultrasound-guided core breast biopsy were randomly assigned to receive an informed consent discussion with or without an illustrated flip chart. The chart included information about breast anatomy, pathology, and diagnostic procedures. Outcome measures included objective knowledge, subjective knowledge, anxiety, and satisfaction. RESULTS Analysis showed few significant main effects of the intervention. However, results showed interactions between experimental condition and race/ethnicity, indicating that the intervention was effective in enhancing objective and subjective knowledge for African American but not Caucasian patients. Anxiety after consultation was higher among patients assigned to the flip chart condition, possibly because they were better informed about the risks of the procedure. Patients who underwent biopsy sooner after learning they needed one were more satisfied with their care. CONCLUSIONS The usual care consent process is effective for many but not all patients. Informed consent that employs visual aids may help overcome characteristics of the consent process that are ineffective for some patients.

Abstract A40: An institutional strategy to increase minority recruitment to therapeutic trials

Purpose: Participation in therapeutic clinical trials rarely reflects the race and ethnic composition of the patient population. To meet NIH-mandated goals, strategies to increase participation are required. Here, we present a framework for institutional enhancement of minority clinical trial accrual that provides linkages to other interventions. We report implementation of this framework at the Siteman Cancer Center, an NCI-designated Comprehensive Cancer Center. Methods: We implemented structural changes on four levels to induce and sustain minority accrual to clinical trials: 1) leadership support, 2) center-wide policy change, 3) infrastructural process control, data analysis and reporting and 4) follow up with clinical investigators. The Protocol Review and Monitoring Committee (PRMC) reviews studies and monitors accrual, and the Program for the Elimination Cancer Disparities (PECaD) leads efforts for proportional accrual, supporting the system through data tracking and web tools. Results: Following implementation in 2005, minority accrual to trials (therapeutic and nontherapeutic) increased from 13.7% in 2005, to 14.4% in 2006,15.9% in 2007 and 16.8% in 2008. The “rolling average” minority cancer incidence at the Cancer Center during this four-year timeframe was 17.3%. There has been an increase in the number of minorities participating in clinical trials in the years 2005 to 2008 (from 346 to 630,82%) compared to a 43% increase in the number of Caucasians during the same time period. Minority accrual in therapeutic clinical trials increased from 11.4% to 14.6%. Conclusion: Implementing a system to aid investigators in planning and establishing targets for accrual, while requiring this component as a part of annual protocol review and monitoring accrual, offers a successful strategy that can be replicated in other cancer centers. This approach may also be extendable to other clinical and translational centers. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):A40.