TY - JOUR
T1 - Prospective Multicenter Diagnostic Performance of Technologist-Performed Screening Breast Ultrasound after Tomosynthesis in Women with Dense Breasts (the DBTUST)
AU - Berg, Wendie A.
AU - Zuley, Margarita L.
AU - Chang, Thomas S.
AU - Gizienski, Terri Ann
AU - Chough, Denise M.
AU - Böhm-Vélez, Marcela
AU - Sharek, Danielle E.
AU - Straka, Michelle R.
AU - Hakim, Christiane M.
AU - Hartman, Jamie Y.
AU - Harnist, Kimberly S.
AU - Tyma, Cathy S.
AU - Kelly, Amy E.
AU - Waheed, Uzma
AU - Houshmand, Golbahar
AU - Nair, Bronwyn E.
AU - Shinde, Dilip D.
AU - Lu, Amy H.
AU - Bandos, Andriy I.
AU - Berg, Jeremy M.
AU - Lettiere, Nicole B.
AU - Ganott, Marie A.
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/5/1
Y1 - 2023/5/1
N2 - PURPOSETo assess diagnostic performance of digital breast tomosynthesis (DBT) alone or combined with technologist-performed handheld screening ultrasound (US) in women with dense breasts.METHODSIn an institutional review board-approved, Health Insurance Portability and Accountability Act-compliant multicenter protocol in western Pennsylvania, 6,179 women consented to three rounds of annual screening, interpreted by two radiologist observers, and had appropriate follow-up. Primary analysis was based on first observer results.RESULTSMean participant age was 54.8 years (range, 40-75 years). Across 17,552 screens, there were 126 cancer events in 125 women (7.2/1,000; 95% CI, 5.9 to 8.4). In year 1, DBT-alone cancer yield was 5.0/1,000, and of DBT+US, 6.3/1,000, difference 1.3/1,000 (95% CI, 0.3 to 2.1; P =.005). In years 2 + 3, DBT cancer yield was 4.9/1,000, and of DBT+US, 5.9/1,000, difference 1.0/1,000 (95% CI, 0.4 to 1.5; P <.001). False-positive rate increased from 7.0% for DBT in year 1 to 11.5% for DBT+US and from 5.9% for DBT in year 2 + 3 to 9.7% for DBT+US (P <.001 for both). Nine cancers were seen only by double reading DBT and one by double reading US. Ten interval cancers (0.6/1,000 [95% CI, 0.2 to 0.9]) were identified. Despite reduction in specificity, addition of US improved receiver operating characteristic curves, with area under receiver operating characteristic curve increasing from 0.83 for DBT alone to 0.92 for DBT+US in year 1 (P =.01), with smaller improvements in subsequent years. Of 6,179 women, across all 3 years, 172/6,179 (2.8%) unique women had a false-positive biopsy because of DBT as did another 230/6,179 (3.7%) women because of US (P <.001).CONCLUSIONOverall added cancer detection rate of US screening after DBT was modest at 19/17,552 (1.1/1,000; CI, 0.5-to 1.6) screens but potentially overcomes substantial increases in false-positive recalls and benign biopsies.
AB - PURPOSETo assess diagnostic performance of digital breast tomosynthesis (DBT) alone or combined with technologist-performed handheld screening ultrasound (US) in women with dense breasts.METHODSIn an institutional review board-approved, Health Insurance Portability and Accountability Act-compliant multicenter protocol in western Pennsylvania, 6,179 women consented to three rounds of annual screening, interpreted by two radiologist observers, and had appropriate follow-up. Primary analysis was based on first observer results.RESULTSMean participant age was 54.8 years (range, 40-75 years). Across 17,552 screens, there were 126 cancer events in 125 women (7.2/1,000; 95% CI, 5.9 to 8.4). In year 1, DBT-alone cancer yield was 5.0/1,000, and of DBT+US, 6.3/1,000, difference 1.3/1,000 (95% CI, 0.3 to 2.1; P =.005). In years 2 + 3, DBT cancer yield was 4.9/1,000, and of DBT+US, 5.9/1,000, difference 1.0/1,000 (95% CI, 0.4 to 1.5; P <.001). False-positive rate increased from 7.0% for DBT in year 1 to 11.5% for DBT+US and from 5.9% for DBT in year 2 + 3 to 9.7% for DBT+US (P <.001 for both). Nine cancers were seen only by double reading DBT and one by double reading US. Ten interval cancers (0.6/1,000 [95% CI, 0.2 to 0.9]) were identified. Despite reduction in specificity, addition of US improved receiver operating characteristic curves, with area under receiver operating characteristic curve increasing from 0.83 for DBT alone to 0.92 for DBT+US in year 1 (P =.01), with smaller improvements in subsequent years. Of 6,179 women, across all 3 years, 172/6,179 (2.8%) unique women had a false-positive biopsy because of DBT as did another 230/6,179 (3.7%) women because of US (P <.001).CONCLUSIONOverall added cancer detection rate of US screening after DBT was modest at 19/17,552 (1.1/1,000; CI, 0.5-to 1.6) screens but potentially overcomes substantial increases in false-positive recalls and benign biopsies.
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U2 - 10.1200/JCO.22.01445
DO - 10.1200/JCO.22.01445
M3 - Article
C2 - 36626696
AN - SCOPUS:85159246647
SN - 0732-183X
VL - 41
SP - 2403
EP - 2415
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 13
ER -