Prospective multicenter cohort study to refine management recommendations for women at elevated familial risk of breast cancer: the EVA trial.
OBJECTIVE
We investigated the respective contribution (in terms of cancer yield and stage at diagnosis) of clinical breast examination (CBE), mammography, ultrasound, and quality-assured breast magnetic resonance imaging (MRI), used alone or in different combination, for screening women at elevated risk for breast cancer.


METHODS
Prospective multicenter observational cohort study. Six hundred eighty-seven asymptomatic women at elevated familial risk (> or = 20% lifetime) underwent 1,679 annual screening rounds consisting of CBE, mammography, ultrasound, and MRI, read independently and in different combinations. In a subgroup of 371 women, additional half-yearly ultrasound and CBE was performed more than 869 screening rounds. Mean and median follow-up was 29.18 and 29.09 months.


RESULTS
Twenty-seven women were diagnosed with breast cancer: 11 ductal carcinoma in situ (41%) and 16 invasive cancers (59%). Three (11%) of 27 were node positive. All cancers were detected during annual screening; no interval cancer occurred; no cancer was identified during half-yearly ultrasound. The cancer yield of ultrasound (6.0 of 1,000) and mammography (5.4 of 1,000) was equivalent; it increased nonsignificantly (7.7 of 1,000) if both methods were combined. Cancer yield achieved by MRI alone (14.9 of 1,000) was significantly higher; it was not significantly improved by adding mammography (MRI plus mammography: 16.0 of 1,000) and did not change by adding ultrasound (MRI plus ultrasound: 14.9 of 1,000). Positive predictive value was 39% for mammography, 36% for ultrasound, and 48% for MRI.


CONCLUSIONS
In women at elevated familial risk, quality-assured MRI screening shifts the distribution of screen-detected breast cancers toward the preinvasive stage. In women undergoing quality-assured MRI annually, neither mammography, nor annual or half-yearly ultrasound or CBE will add to the cancer yield achieved by MRI alone.
Kuhl
Christiane
C
Department of Radiology, University of Bonn, Sigmund-Freud-Str 25, D-53105 Bonn, Germany. kuhl@uni-bonn.de
Weigel
Stefanie
S
Schrading
Simone
S
Arand
Birke
B
Bieling
Heribert
H
König
Roy
R
Tombach
Bernd
B
Leutner
Claudia
C
Rieber-Brambs
Andrea
A
Nordhoff
Dennis
D
Heindel
Walter
W
Reiser
Maximilian
M
Schild
Hans H
HH
D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000235:genetics*; D015331:Cohort Studies; D005260:Female; D020022:Genetic Predisposition to Disease; D006801:Humans; D008279:Magnetic Resonance Imaging; D008327:Mammography; D008403:Mass Screening; D008875:Middle Aged; D010808:Physical Examination; D011446:Prospective Studies; D012307:Risk Factors; D014463:Ultrasonography