Abstract
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. 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). 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 <or=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%). Addition of MR imaging to the screening regimen for high-risk women may enable detection of otherwise unsuspected breast cancers.
Highlights
When we considered the need for planning contrast-enhanced magnetic resonance (MR) imaging during the 2nd week of the menstrual cycle in premenopausal women and logistic problems, a maximum time of 1 month for performance of the four diagnostic modalities was allowed
The mean ages of patients enrolled by using the two criteria stated previously were 45.8 years Ϯ 12.0 (175 women enrolled because they were BRCA1 or BRCA2 mutation carriers or first-degree relatives of BRCA1 or BRCA2 mutation carriers) and 46.5 years Ϯ 12.0 (103 women enrolled on the basis of the family history), and there was no significant difference (Mann-Whitney U test) in mean age between them
We found no significant difference in detection rate in BRCA1 and BRCA2 mutation carriers or first-degree relatives of BRCA1 or BRCA2 mutation carriers compared with that in women enrolled only on the basis of a strong family history of breast cancer and/or ovarian cancer
Summary
Results: Conclusion: 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. Findings from two retrospective [21,22] and five prospective studies [23,24,25,26,27] indicated that contrast-enhanced MR imaging is useful in the screening of high-risk women These single- and multicenter studies differed in the number of diagnostic modalities used for comparative evaluation, in enrollment criteria, in selected age groups, and in levels of cumulative lifetime risk of breast cancer. The purpose of our multicenter trial was to prospectively compare the sensitivity of clinical breast examination (CBE), mammography, ultrasonography (US), and contrast-enhanced MR imaging for the screening of women at genetic-familial high risk for breast cancer and to report our interim results, with pathologic findings as the reference standard
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