TY - JOUR
T1 - The potential of combined shear wave and strain elastography to reduce unnecessary biopsies in breast cancer diagnostics – An international, multicentre trial
AU - Golatta, Michael
AU - Pfob, André
AU - Büsch, Christopher
AU - Bruckner, Thomas
AU - Alwafai, Zaher
AU - Balleyguier, Corinne
AU - Clevert, Dirk André
AU - Duda, Volker
AU - Goncalo, Manuela
AU - Gruber, Ines
AU - Hahn, Markus
AU - Kapetas, Panagiotis
AU - Ohlinger, Ralf
AU - Rutten, Matthieu
AU - Togawa, Riku
AU - Tozaki, Mitsuhiro
AU - Wojcinski, Sebastian
AU - Rauch, Geraldine
AU - Heil, Joerg
AU - Barr, Richard G.
N1 - Publisher Copyright:
© 2021 Elsevier Ltd
PY - 2022/1/1
Y1 - 2022/1/1
N2 - Background: Shear wave elastography (SWE) and strain elastography (SE) have shown promising potential in breast cancer diagnostics by evaluating the stiffness of a lesion. Combining these two techniques could further improve the diagnostic performance. We aimed to exploratorily define the cut-offs at which adding combined SWE and SE to B-mode breast ultrasound could help reclassify Breast Imaging Reporting and Data System (BI-RADS) 3-4 lesions to reduce the number of unnecessary breast biopsies. Methods: We report the secondary results of a prospective, multicentre, international trial (NCT02638935). The trial enrolled 1288 women with BI-RADS 3 to 4c breast masses on conventional B-mode breast ultrasound. All patients underwent SWE and SE (index test) and histopathologic evaluation (reference standard). Reduction of unnecessary biopsies (biopsies in benign lesions) and missed malignancies after recategorising with SWE and SE were the outcome measures. Results: On performing histopathologic evaluation, 368 of 1288 breast masses were malignant. Following the routine B-mode breast ultrasound assessment, 53.80% (495 of 920 patients) underwent an unnecessary biopsy. After recategorising BI-RADS 4a lesions (SWE cut-off ≥3.70 m/s, SE cut-off ≥1.0), 34.78% (320 of 920 patients) underwent an unnecessary biopsy corresponding to a 35.35% (320 versus 495) reduction of unnecessary biopsies. Malignancies in the new BI-RADS 3 cohort were missed in 1.96% (12 of 612 patients). Conclusion: Adding combined SWE and SE to routine B-mode breast ultrasound to recategorise BI-RADS 4a patients could help reduce the number of unnecessary biopsies in breast diagnostics by about 35% while keeping the rate of undetected malignancies below the 2% ACR BI-RADS 3 definition.
AB - Background: Shear wave elastography (SWE) and strain elastography (SE) have shown promising potential in breast cancer diagnostics by evaluating the stiffness of a lesion. Combining these two techniques could further improve the diagnostic performance. We aimed to exploratorily define the cut-offs at which adding combined SWE and SE to B-mode breast ultrasound could help reclassify Breast Imaging Reporting and Data System (BI-RADS) 3-4 lesions to reduce the number of unnecessary breast biopsies. Methods: We report the secondary results of a prospective, multicentre, international trial (NCT02638935). The trial enrolled 1288 women with BI-RADS 3 to 4c breast masses on conventional B-mode breast ultrasound. All patients underwent SWE and SE (index test) and histopathologic evaluation (reference standard). Reduction of unnecessary biopsies (biopsies in benign lesions) and missed malignancies after recategorising with SWE and SE were the outcome measures. Results: On performing histopathologic evaluation, 368 of 1288 breast masses were malignant. Following the routine B-mode breast ultrasound assessment, 53.80% (495 of 920 patients) underwent an unnecessary biopsy. After recategorising BI-RADS 4a lesions (SWE cut-off ≥3.70 m/s, SE cut-off ≥1.0), 34.78% (320 of 920 patients) underwent an unnecessary biopsy corresponding to a 35.35% (320 versus 495) reduction of unnecessary biopsies. Malignancies in the new BI-RADS 3 cohort were missed in 1.96% (12 of 612 patients). Conclusion: Adding combined SWE and SE to routine B-mode breast ultrasound to recategorise BI-RADS 4a patients could help reduce the number of unnecessary biopsies in breast diagnostics by about 35% while keeping the rate of undetected malignancies below the 2% ACR BI-RADS 3 definition.
KW - BI-RADS
KW - Breast ultrasound
KW - Shear wave elastography
KW - Unclear breast lesion
UR - http://www.scopus.com/inward/record.url?scp=85120893337&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2021.11.005
DO - 10.1016/j.ejca.2021.11.005
M3 - Article
C2 - 34879299
AN - SCOPUS:85120893337
SN - 0959-8049
VL - 161
SP - 1
EP - 9
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -