Prospective Multicenter Diagnostic Performance of Technologist-Performed Screening Breast Ultrasound After Tomosynthesis in Women With Dense Breasts (the DBTUST)
PURPOSE: To assess diagnostic performance of digital breast tomosynthesis (DBT) alone or combined with technologist-performed handheld screening ultrasound (US) in women with dense breasts.
METHODS: In 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.
RESULTS: Mean 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).
CONCLUSION: Overall 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.
| Errataetall: |
CommentIn: AJR Am J Roentgenol. 2023 Dec;221(6):848. - PMID 37095664 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:41 |
|---|---|
| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 41(2023), 13 vom: 01. Mai, Seite 2403-2415 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Berg, Wendie A [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Journal Article |
|---|
| Anmerkungen: |
Date Completed 03.05.2023 Date Revised 02.01.2024 published: Print-Electronic ClinicalTrials.gov: NCT02643966 CommentIn: AJR Am J Roentgenol. 2023 Dec;221(6):848. - PMID 37095664 Citation Status MEDLINE |
|---|
| doi: |
10.1200/JCO.22.01445 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM351377182 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM351377182 | ||
| 003 | DE-627 | ||
| 005 | 20240108140652.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1200/JCO.22.01445 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1246.xml |
| 035 | |a (DE-627)NLM351377182 | ||
| 035 | |a (NLM)36626696 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Berg, Wendie A |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Prospective Multicenter Diagnostic Performance of Technologist-Performed Screening Breast Ultrasound After Tomosynthesis in Women With Dense Breasts (the DBTUST) |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 03.05.2023 | ||
| 500 | |a Date Revised 02.01.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02643966 | ||
| 500 | |a CommentIn: AJR Am J Roentgenol. 2023 Dec;221(6):848. - PMID 37095664 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: To assess diagnostic performance of digital breast tomosynthesis (DBT) alone or combined with technologist-performed handheld screening ultrasound (US) in women with dense breasts | ||
| 520 | |a METHODS: In 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 | ||
| 520 | |a RESULTS: Mean 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) | ||
| 520 | |a CONCLUSION: Overall 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 | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 700 | 1 | |a Zuley, Margarita L |e verfasserin |4 aut | |
| 700 | 1 | |a Chang, Thomas S |e verfasserin |4 aut | |
| 700 | 1 | |a Gizienski, Terri-Ann |e verfasserin |4 aut | |
| 700 | 1 | |a Chough, Denise M |e verfasserin |4 aut | |
| 700 | 1 | |a Böhm-Vélez, Marcela |e verfasserin |4 aut | |
| 700 | 1 | |a Sharek, Danielle E |e verfasserin |4 aut | |
| 700 | 1 | |a Straka, Michelle R |e verfasserin |4 aut | |
| 700 | 1 | |a Hakim, Christiane M |e verfasserin |4 aut | |
| 700 | 1 | |a Hartman, Jamie Y |e verfasserin |4 aut | |
| 700 | 1 | |a Harnist, Kimberly S |e verfasserin |4 aut | |
| 700 | 1 | |a Tyma, Cathy S |e verfasserin |4 aut | |
| 700 | 1 | |a Kelly, Amy E |e verfasserin |4 aut | |
| 700 | 1 | |a Waheed, Uzma |e verfasserin |4 aut | |
| 700 | 1 | |a Houshmand, Golbahar |e verfasserin |4 aut | |
| 700 | 1 | |a Nair, Bronwyn E |e verfasserin |4 aut | |
| 700 | 1 | |a Shinde, Dilip D |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, Amy H |e verfasserin |4 aut | |
| 700 | 1 | |a Bandos, Andriy I |e verfasserin |4 aut | |
| 700 | 1 | |a Berg, Jeremy M |e verfasserin |4 aut | |
| 700 | 1 | |a Lettiere, Nicole B |e verfasserin |4 aut | |
| 700 | 1 | |a Ganott, Marie A |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of clinical oncology : official journal of the American Society of Clinical Oncology |d 1986 |g 41(2023), 13 vom: 01. Mai, Seite 2403-2415 |w (DE-627)NLM012608777 |x 1527-7755 |7 nnns |
| 773 | 1 | 8 | |g volume:41 |g year:2023 |g number:13 |g day:01 |g month:05 |g pages:2403-2415 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1200/JCO.22.01445 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 41 |j 2023 |e 13 |b 01 |c 05 |h 2403-2415 | ||