Diagnostic accuracy of ultrasound in detecting pathological complete response to neoadjuvant chemotherapy in breast cancer: a systematic review and diagnostic test accuracy meta-analysis.
- 1Department of Functional Diagnostics, Xi'an Hospital of Traditional Chinese Medicine, Xi'an, China.
- 2Department of Oncology, Xi'an Hospital of Traditional Chinese Medicine, Xi'an, China.
Abstract
Pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) is a key prognostic indicator in breast cancer. Whether ultrasound can reliably distinguish pCR from residual disease, and whether advanced functional ultrasound techniques add sufficient diagnostic value over conventional B-mode imaging to influence treatment decisions, remains uncertain. Given the heterogeneity in existing evidence and the lack of consensus on optimal ultrasound modalities and assessment timing, a comprehensive synthesis is needed to guide clinical practice. This study aimed to determine the overall diagnostic accuracy of ultrasound for predicting pCR after NAC in breast cancer, compare different ultrasound modalities, and identify factors influencing predictive value. A systematic review and meta-analysis were conducted following PRISMA-DTA guidelines. We searched PubMed/MEDLINE, Embase, Web of Science, and Cochrane Library from inception to April 1, 2025. Studies evaluating any ultrasound-based modality [conventional B-mode, shear-wave elastography (SWE), contrast-enhanced ultrasound (CEUS), superb microvascular imaging (SMI), or quantitative ultrasound (QUS)] against histopathological reference standard (pCR defined as ypT0/is ypN0 or equivalent) were included. Risk of bias was assessed using QUADAS-2. Data were pooled using a bivariate random-effects model. Twelve studies (2,146 patients) were included. The overall pooled sensitivity and specificity were 0.80 [95% confidence interval (CI): 0.73-0.86] and 0.77 (95% CI: 0.70-0.83), respectively, with a diagnostic odds ratio (DOR) of 13.7 (95% CI: 8.2-22.9), positive likelihood ratio (PLR) of 3.5 (95% CI: 2.6-4.7), negative likelihood ratio (NLR) of 0.26 (95% CI: 0.19-0.36), and area under the curve (AUC) of 0.85 (95% CI: 0.82-0.88). Heterogeneity was substantial (τ2=0.58 for sensitivity, 0.43 for specificity). Advanced functional ultrasound techniques demonstrated significantly higher diagnostic accuracy (DOR =16.04, 95% CI: 12.46-20.64) compared to conventional B-mode ultrasound alone (DOR =5.26, 95% CI: 3.47-7.99; interaction P=0.003). Early assessment during NAC (after 1-2 cycles) yielded the highest predictive value (DOR =17.10, AUC =0.90). Risk of bias was generally low, though some concerns were noted in patient selection (2 retrospective studies) and flow and timing domains. Ultrasound demonstrates moderate diagnostic accuracy for predicting pCR after NAC, with substantial heterogeneity across techniques. Advanced functional ultrasound techniques, particularly when employed early during treatment, offer superior performance. However, given the moderate sensitivity and specificity, ultrasound should be considered an adjunctive tool rather than a standalone method for pCR determination. These findings support the potential role of ultrasound in guiding adaptive therapy, but further validation with standardized protocols is needed before routine clinical implementation.
Related
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- Machine learning model for the prediction of pathological complete response after neoadjuvant chemotherapy in breast cancer.
- Predictive Value of Combined Ultrasound Viscoelasticity Imaging, CEUS, AAPR, and PLR for Assessing Neoadjuvant Chemotherapy Efficacy in Breast Cancer
BibTeX
@article{fan2026diagnostic,
title = {{Diagnostic accuracy of ultrasound in detecting pathological complete response to neoadjuvant chemotherapy in breast cancer: a systematic review and diagnostic test accuracy meta-analysis.}},
author = {Liping Fan and Wentao Qu and Lintao Liu and Xiaoyuan Cui and Jinhui Zuo and Jianxu Jin},
journal = {Gland surgery},
year = {2026},
month = sep,
doi = {10.21037/gs-2026-0364},
url = {https://europepmc.org/article/MED/42996611},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Diagnostic accuracy of ultrasound in detecting pathological complete response to neoadjuvant chemotherapy in breast cancer: a systematic review and diagnostic test accuracy meta-analysis.
AU - Liping Fan
AU - Wentao Qu
AU - Lintao Liu
AU - Xiaoyuan Cui
AU - Jinhui Zuo
AU - Jianxu Jin
PY - 2026
DA - 2026/09/28
JO - Gland surgery
DO - 10.21037/gs-2026-0364
UR - https://europepmc.org/article/MED/42996611
AB - Pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) is a key prognostic indicator in breast cancer. Whether ultrasound can reliably distinguish pCR from residual disease, and whether advanced functional ultrasound techniques add sufficient diagnostic value over conventional B-mode imaging to influence treatment decisions, remains uncertain. Given the heterogeneity in existing evidence and the lack of consensus on optimal ultrasound modalities and assessment timing, a comprehensive synthesis is needed to guide clinical practice. This study aimed to determine the overall diagnostic accuracy of ultrasound for predicting pCR after NAC in breast cancer, compare different ultrasound modalities, and identify factors influencing predictive value. A systematic review and meta-analysis were conducted following PRISMA-DTA guidelines. We searched PubMed/MEDLINE, Embase, Web of Science, and Cochrane Library from inception to April 1, 2025. Studies evaluating any ultrasound-based modality [conventional B-mode, shear-wave elastography (SWE), contrast-enhanced ultrasound (CEUS), superb microvascular imaging (SMI), or quantitative ultrasound (QUS)] against histopathological reference standard (pCR defined as ypT0/is ypN0 or equivalent) were included. Risk of bias was assessed using QUADAS-2. Data were pooled using a bivariate random-effects model. Twelve studies (2,146 patients) were included. The overall pooled sensitivity and specificity were 0.80 [95% confidence interval (CI): 0.73-0.86] and 0.77 (95% CI: 0.70-0.83), respectively, with a diagnostic odds ratio (DOR) of 13.7 (95% CI: 8.2-22.9), positive likelihood ratio (PLR) of 3.5 (95% CI: 2.6-4.7), negative likelihood ratio (NLR) of 0.26 (95% CI: 0.19-0.36), and area under the curve (AUC) of 0.85 (95% CI: 0.82-0.88). Heterogeneity was substantial (τ2=0.58 for sensitivity, 0.43 for specificity). Advanced functional ultrasound techniques demonstrated significantly higher diagnostic accuracy (DOR =16.04, 95% CI: 12.46-20.64) compared to conventional B-mode ultrasound alone (DOR =5.26, 95% CI: 3.47-7.99; interaction P=0.003). Early assessment during NAC (after 1-2 cycles) yielded the highest predictive value (DOR =17.10, AUC =0.90). Risk of bias was generally low, though some concerns were noted in patient selection (2 retrospective studies) and flow and timing domains. Ultrasound demonstrates moderate diagnostic accuracy for predicting pCR after NAC, with substantial heterogeneity across techniques. Advanced functional ultrasound techniques, particularly when employed early during treatment, offer superior performance. However, given the moderate sensitivity and specificity, ultrasound should be considered an adjunctive tool rather than a standalone method for pCR determination. These findings support the potential role of ultrasound in guiding adaptive therapy, but further validation with standardized protocols is needed before routine clinical implementation.
SN - 2227-684X
SN - 2227-8575
ER -