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Performance of Screening Ultrasound as an Adjunct to Screening Mammography in Women Across the Spectrum of Breast Cancer Risk

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posted on 21.08.2019 by Janie M. Lee, Robert F. Arao, Brian L. Sprague, Karla Kerlikowske, Constance D. Lehman, Robert A. Smith, Louise M. Henderson, Garth H. Rauscher, Diana L. Miglioretti
Importance: Whole-breast ultrasound has been advocated to supplement screening mammography to improve outcomes in women with dense breasts. Objective: To determine the performance of screening mammography plus screening ultrasound compared with screening mammography alone in community practice. Design: Observational cohort study. Setting: The study was IRB approved and HIPAA compliant. Two Breast Cancer Surveillance Consortium (BCSC) registries provided prospectively collected data on screening mammography with vs. without same-day breast ultrasound from 2000-2013. Participants: 6,081 screening mammography plus same day screening ultrasound examinations in 3,385 women were propensity score matched 1:5 to 30,062 screening mammograms without screening ultrasound in 15,176 women from a sample of 113,293 mammograms. Exclusion criteria included personal history of breast cancer and self-reported breast symptoms. Exposure: Screening mammography with versus without screening ultrasound. Main Outcomes and Measures: Cancer detection rate (CDR), and rates of interval cancer, false-positive (FP) biopsy recommendation, short-interval follow-up (SIFU), and positive predictive value of biopsy recommendation (PPV2) were estimated and compared using logbinomial regression. Results: Screening mammography with vs without ultrasound examinations were performed more often in women with dense breasts (74% vs 36% in the overall sample); who were younger than 50 years (50% vs 32%), with a family history of breast cancer (43% vs 15%). While 21% of screening ultrasound examinations were performed in women with high or very high (>2.50%) BCSC 5-year risk scores, 53% had low or average (<1.67%) risk. Comparing mammography plus ultrasound to mammography alone, CDR was similar: 5.4 vs. 5.5 per 1000 examinations (adjusted relative risk [RR]=1.14 95% confidence interval [CI]: 0.76-1.68); as were interval cancer rates: 1.5 vs. 1.9 per 1,000 examinations (RR=0.67, 95%CI: 0.33-1.37); FP biopsy rates were significantly higher: 52.0 vs. 22.2 per 1000 examinations (RR=2.23, 95%CI: 1.93-2.58); as was SIFU: 3.9% vs. 1.1% (RR=3.10, 95%CI: 2.60-3.70); PPV2 was significantly lower: 9.5% vs. 21.4% (RR=0.50 95%CI: 0.35-0.71). Conclusions and Relevance: In a relatively young population of women at low, intermediate, and high breast cancer risk, our results suggest that the benefits of supplemental ultrasound screening may not outweigh associated harms.

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Conflict of Interest Disclosures: Drs. Lee and Lehman each report research grant funding and a consulting agreement with GE Healthcare. The remaining authors disclose no conflicts of interest. Funding/Support: This research was funded by the Breast Cancer Surveillance Consortium program project (P01CA154292). Additional support was provided by the American Cancer Society through a gift from the Longaberger Company’s Horizon of Hope Campaign (ACS 15922 #NHLONGGBR). Data collection for this work was additionally supported, in part, by funding from the National Cancer Institute (U54CA163303). The collection of cancer and vital status data used in this study was supported in part by several state public health departments and cancer registries throughout the U.S. For a full description of these sources, please see: http://www.bcscresearch.org/work/acknowledgement.html. We thank the participating women, mammography facilities, and radiologists for the data they have provided for this study. You can learn more about the BCSC at: http://www.bcsc-research.org/. Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication.

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Copyright @ American Medical Association

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Lee, J. M., Arao, R. F., Sprague, B. L., Kerlikowske, K., Lehman, C. D., Smith, R. A., . . . Miglioretti, D. L. (2019). Performance of Screening Ultrasonography as an Adjunct to Screening Mammography in Women Across the Spectrum of Breast Cancer Risk. JAMA Internal Medicine. doi:10.1001/jamainternmed.2018.8372

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American Medical Association

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en

issn

2168-6106

Issue date

18/03/2019

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