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Multicenter Comparative Multimodality Surveillance of Women at Genetic-Familial High Risk for Breast Cancer (HIBCRIT Study): Interim Results¹

¹ From the University of Milan School of Medicine, Department of Medical and Surgical Sciences, Unit of Radiology, IRCCS Policlinico San Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy (F.S.); and Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, Rome, Italy (F.P.). The remaining authors and their affiliations are listed at the end of this article. From the 2004 RSNA Annual Meeting. Received December 5, 2005; revision requested January 25, 2006; revision received February 28; accepted April 3; final version accepted June 30. The HIBCRIT study was supported by the Italian Ministry of Health (Ricerca Finalizzata 1% 98/JT/T) and Istituto Superiore di Sanità (ricerca corrente C3A3/2004) and coordinated by the Istituto Superiore di Sanità, Rome, Italy. Address correspondence to F.S. (e-mail: f.sardanelli{at}grupposandonato.it).

Purpose: To prospectively compare clinical breast examination (CBE), mammography, ultrasonography (US), and contrast material–enhanced magnetic resonance (MR) imaging for screening women at genetic-familial high risk for breast cancer and report interim results, with pathologic findings as standard.

Materials and Methods: Institutional review board of each center approved the research; informed written consent was obtained. CBE, mammography, US, and MR imaging were performed for yearly screening of BRCA1 or BRCA2 mutation carriers, first-degree relatives of BRCA1 or BRCA2 mutation carriers, or women enrolled because of a strong family history of breast or ovarian cancer (three or more events in first- or second-degree relatives in either maternal or paternal line; these included breast cancer in women younger than 60 years, ovarian cancer at any age, and male breast cancer at any age).

Results: Two hundred seventy-eight women (mean age, 46 years ± 12 [standard deviation]) were enrolled. Breast cancer was found in 11 of 278 women at first round and seven of 99 at second round (14 invasive, four intraductal; eight were 10 mm in diameter). Detection rate per year was 4.8% (18 of 377) overall; 4.3% (11 of 258) in BRCA1 or BRCA2 mutation carriers and first-degree relatives of BRCA1 or BRCA2 mutation carriers versus 5.9% (seven of 119) in women enrolled because of strong family history; and 5.3% (nine of 169) in women with previous personal breast and/or ovarian cancer versus 4.3% (nine of 208) in those without. In six (33%) of 18 patients, cancer was detected only with MR imaging. Sensitivity was as follows: CBE, 50% (95% confidence interval [CI]: 29%, 71%); mammography, 59% (95% CI: 36%, 78%); US, 65% (95% CI: 41%, 83%); and MR imaging, 94% (95% CI: 82%, 99%). Positive predictive value was as follows: CBE, 82% (95% CI: 52%, 95%); mammography, 77% (95% CI: 50%, 92%); US, 65% (95% CI: 41%, 83%); and MR imaging, 63% (95% CI: 43%, 79%).

Conclusion: Addition of MR imaging to the screening regimen for high-risk women may enable detection of otherwise unsuspected breast cancers.

© RSNA, 2007

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