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Does adding whole-breast ultrasonography to mammography improve breast cancer screening effectiveness?
In this cohort study, for women whose breast cancer risk ranged from low to very high, there were significantly higher short-interval follow-up and biopsy recommendation rates with screening mammography plus same-day ultrasonography compared with mammography alone. However, no significant increase in cancer detection or decrease in interval cancer rates was observed.
These results suggest that the benefits of supplemental ultrasonography screening may not outweigh associated harms.
Whole-breast ultrasonography has been advocated to supplement screening mammography to improve outcomes in women with dense breasts.
To determine the performance of screening mammography plus screening ultrasonography compared with screening mammography alone in community practice.
Design, Setting, and Participants
Observational cohort study. Two Breast Cancer Surveillance Consortium registries provided prospectively collected data on screening mammography with vs without same-day breast ultrasonography from January 1, 2000, to December 31, 2013. The dates of analysis were March 2014 to December 2018. A total of 6081 screening mammography plus same-day screening ultrasonography examinations in 3386 women were propensity score matched 1:5 to 30 062 screening mammograms without screening ultrasonography in 15 176 women from a sample of 113 293 mammograms. Exclusion criteria included a personal history of breast cancer and self-reported breast symptoms.
Screening mammography with vs without screening ultrasonography.
Main Outcomes and Measures
Cancer detection rate and rates of interval cancer, false-positive biopsy recommendation, short-interval follow-up, and positive predictive value of biopsy recommendation were estimated and compared using log binomial regression.
Screening mammography with vs without ultrasonography examinations was performed more often in women with dense breasts (74.3% [n = 4317 of 5810] vs 35.9% [n = 39 928 of 111 306] in the overall sample), in women who were younger than 50 years (49.7% [n = 3022 of 6081] vs 31.7% [n = 16 897 of 112 462]), and in women with a family history of breast cancer (42.9% [n = 2595 of 6055] vs 15.0% [n = 16 897 of 112 462]). While 21.4% (n = 1154 of 5392) of screening ultrasonography examinations were performed in women with high or very high (≥2.50%) Breast Cancer Surveillance Consortium 5-year risk scores, 53.6% (n = 2889 of 5392) had low or average (<1.67%) risk. Comparing mammography plus ultrasonography with mammography alone, the cancer detection rate was similar at 5.4 vs 5.5 per 1000 screens (adjusted relative risk [RR], 1.14; 95% CI, 0.76-1.68), as were interval cancer rates at 1.5 vs 1.9 per 1000 screens (RR, 0.67; 95% CI, 0.33-1.37). The false-positive biopsy rates were significantly higher at 52.0 vs 22.2 per 1000 screens (RR, 2.23; 95% CI, 1.93-2.58), as was short-interval follow-up at 3.9% vs 1.1% (RR, 3.10; 95% CI, 2.60-3.70). The positive predictive value of biopsy recommendation was significantly lower at 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, these results suggest that the benefits of supplemental ultrasonography screening may not outweigh associated harms.
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Accepted for Publication: December 7, 2018.
Published Online: March 18, 2019. doi:10.1001/jamainternmed.2018.8372
Correction: This article was corrected on April 29, 2019, to fix a typographical error in Table 3.
Corresponding Author: Janie M. Lee, MD, MSc, Seattle Cancer Care Alliance, 825 Eastlake Ave E, Seattle, WA 98109 (email@example.com).
Author Contributions: Dr Lee had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Lee, Sprague, Kerlikowske, Lehman, Smith, Henderson, Miglioretti.
Acquisition, analysis, or interpretation of data: Lee, Arao, Sprague, Kerlikowske, Lehman, Henderson, Rauscher, Miglioretti.
Drafting of the manuscript: Lee, Arao, Smith, Miglioretti.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Arao, Smith, Henderson, Miglioretti.
Obtained funding: Sprague, Kerlikowske, Lehman, Smith, Henderson, Miglioretti.
Administrative, technical, or material support: Kerlikowske.
Supervision: Lehman, Miglioretti.
Conflict of Interest Disclosures: Dr Lee reported receiving grants from the National Cancer Institute and American Cancer Society during the conduct of the study and reported receiving grants, personal fees, and nonfinancial support from GE Healthcare outside the submitted work. Dr Sprague reported receiving grants from the National Institutes of Health. Dr Kerlikowske reported receiving grants from the American Cancer Society. Dr Lehman reported receiving grants from the National Cancer Institute and the American Cancer Society and reported receiving grants and other support from and having a consulting agreement with GE Healthcare. Dr Henderson reported receiving grants from the National Institutes of Health and the National Cancer Institute. Dr Miglioretti reported receiving grants from the American Cancer Society and the National Cancer Institute and reported receiving personal fees from the Hologic Inc Scientific Advisory Board. No other disclosures were reported.
Funding/Support: This research was funded by the Breast Cancer Surveillance Consortium (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 also 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 United States. A full description of these sources is available online (http://www.bcsc-research.org/work/acknowledgement.html).
Role of the Funder/Sponsor: The funding sources 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 decision to submit the manuscript for publication.
Additional Contributions: We thank the participating women, mammography facilities, and radiologists for the data they have provided for this study. More information about the Breast Cancer Surveillance Consortium is available online (http://www.bcsc-research.org/).
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