Rationale and Objectives
This study aimed to determine the best screening strategy using automated whole-breast ultrasound and mammography in women with increased breast density or an elevated risk of breast cancer.
Materials and Methods
After an institutional review board waiver was obtained, a retrospective review of 122 cancer cases diagnosed in 3435 women with increased breast density or an elevated risk of breast cancer, screened with mammography and supplemental automated whole-breast ultrasound, was performed. The imaging modality on which each cancer was seen was noted. Screening strategies were postulated.
For each screening strategy, rates of advanced cancer diagnosis, with 95% confidence limits, are calculated using the Clopper-Pearson method. Differences in outcomes were calculated using Cochrane Q test and McNemar test for paired observations. Results were expressed for all stages of cancer and for invasive cancers only.
Results
When all cancer stages are considered, mammographic screening reduces advanced cancers by 31% over no screening. Ultrasound-only screening results in a 32% reduction. The combination of mammographic and ultrasound screening reduces advanced cancers by 40% ( P < .05).
Compared to mammographic screening, mammographic plus ultrasound screening reduces advanced-stage cancers by 5.7% ( P = 0.03) for all stages and 10.8% ( P = 0.02) for invasive cancers.
Conclusions
For women with increased breast density or who are at high risk of developing breast cancer, a combination of screening mammography and whole-breast automated ultrasound is superior to mammographic screening. Screening ultrasound alone is also an effective screening strategy.
Introduction
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Materials and Methods
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Screening and Supplemental Imaging
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Cancer Case Review
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Classification of Cancer Diagnoses and Postulated Screening Strategies
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Table 1
Postulated Screening Strategies
Strategy Based On No Screening Symptomatic cancers Mammogram (alone) Mammogram-detected and symptomatic cancers Ultrasound (alone) Ultrasound-detected and symptomatic cancers Mammogram and ultrasound Mammogram or ultrasound detected, and symptomatic cancers
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Statistical Considerations
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Results
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Table 2
Screened Patient Characteristics
Women screened 3435 Age 59 (28–82) Screening events Mammogram 7451 Ultrasound 5985 Both 5638 Cancers diagnosed 129 Stage 0 32 Stage 1 55 Stage 2 26 Stage 3 14 Stage 4 2 Cancers seen on Mammogram only 39 Ultrasound only 42 Both 41 Yield (asymptomatic) Mammogram 55 (7.4/1000 screened) Ultrasound only 31 (4.2/1000 screened) Recall (asymptomatic) Mammogram 11.4% Ultrasound 3.2%
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Rates of Advanced-cancer Diagnoses
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Table 3
Proportion of Advanced Cancers (Stage 2–4) Diagnosed by Screening Strategy with 95% Confidence Intervals for All Cancers and for Invasive Cancers Only
Stage 0–4 Stage 1–4 Symptomatic (no Screening) 0.73 (0.56–0.86) 0.77 (0.63–0.91) Mammogram 0.39 (0.29–0.48) 0.54 (0.42–0.66) Ultrasound only 0.42 (0.32–0.52) 0.46 (0.34–0.57) Mammogram and ultrasound 0.33 (0.25–0.41) 0.43 (0.33–0.52)
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Reduction in Advanced Cancers by Screening Strategy
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Table 4
Reduction in Advanced Cancers by Screening Strategy for All Cancers and for Invasive Cancers Only
Strategy Advanced-cancer Reduction Stage 0–4 Stage 1–4 No screening vs. mammographic screening 34.5% ( P < .01) 23.3% ( P < .01) No screening vs. ultrasound-only screening 30.6% ( P < .01) 31.6% ( P < .01) No screening vs. mammographic + sonographic screening 40.2% ( P < .01) 34.1% ( P < .01) Mammographic vs. mammographic + sonographic screening 5.7% ( P = .03) 10.8% ( P = .02) Mammographic vs. ultrasound-only screening −3.9% NS 8.3% NS
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Discussion
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Conclusion
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