Comment in:
Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer.
Berg WA, Blume JD, Cormack JB, Mendelson EB, Lehrer D, Böhm-Vélez M, Pisano ED, Jong RA, Evans WP, Morton MJ, Mahoney MC, Larsen LH, Barr RG, Farria DM, Marques HS, Boparai K; ACRIN 6666 Investigators.Collaborators (59)Poller WR, Huerbin M, Berg WA, Levit BE, Baum JK, Fein-Zachary VJ, Kelleher SM, Lehrer DE, Ostertag MS, Soo MS, Prince BN, Morton MJ, Johnson LM, Mendelson EB, Kalata M, Reynolds H, Wheeler YS, Barr RG, Mangino MJ, Stavros AT, Valdez M, Jong RA, Lee JH, Piccoli CW, Merritt CR, Dascenzo C, Hoyt AC, Marzan R, Mahoney MC, Kamm MM, Pisano ED, Tuttle LA, Larsen LH, Kiss CE, Whitman GJ, Rice SR, Evans WP, Taylor KT, Farria DM, Bird DJ, Böhm-Vélez M, Cockroft A, Adams AM, Berns EA, Olson CB, Sabina S, Gabrielli GJ, Clabo S, DeBari J, Green JM, Crozier CL, Schloesser J, Levering AM, Fredericks NS, Brennecke CM, Schleinitz MD, LeStage BK, Sickles EA, Patterson EA.
American Radiology Services Inc, Johns Hopkins Green Spring, Lutherville, Maryland, USA. wendieberg@gmail.com
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.
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PMID: 18477782 [PubMed - indexed for MEDLINE]