Early Assessment Window for Predicting Breast Cancer Neoadjuvant Therapy using Biomarkers, Ultrasound, and Diffuse Optical Tomography
Purpose The purpose of the study was to assess the utility of tumor biomarkers, ultrasound (US) and US-guided diffuse optical tomography (DOT) in early prediction of breast cancer response to neoadjuvant therapy (NAT). Methods This prospective HIPAA compliant study was approved by the institutional...
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| Published in: | Breast cancer research and treatment Vol. 188; no. 3; pp. 615 - 630 |
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| Main Authors: | , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
New York
Springer US
01-08-2021
Springer Springer Nature B.V |
| Subjects: | |
| Online Access: | Get full text |
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| Summary: | Purpose
The purpose of the study was to assess the utility of tumor biomarkers, ultrasound (US) and US-guided diffuse optical tomography (DOT) in early prediction of breast cancer response to neoadjuvant therapy (NAT).
Methods
This prospective HIPAA compliant study was approved by the institutional review board. Forty one patients were imaged with US and US-guided DOT prior to NAT, at completion of the first three treatment cycles, and prior to definitive surgery from February 2017 to January 2020. Miller-Payne grading was used to assess pathologic response. Receiver operating characteristic curves (ROCs) were derived from logistic regression using independent variables, including: tumor biomarkers, US maximum diameter, percentage reduction of the diameter (%US), pretreatment maximum total hemoglobin concentration (HbT) and percentage reduction in HbT (%HbT) at different treatment time points. Resulting ROCs were compared using area under the curve (AUC). Statistical significance was tested using two-sided two-sample student
t
-test with
P
< 0.05 considered statistically significant. Logistic regression was used for ROC analysis.
Results
Thirty-eight patients (mean age = 47, range 24–71 years) successfully completed the study, including 15 HER2 + of which 11 were ER + ; 12 ER + or PR + /HER2−, and 11 triple negative. The combination of HER2 and ER biomarkers, %HbT at the end of cycle 1 (EOC1) and %US (EOC1) provided the best early prediction, AUC = 0.941 (95% CI 0.869–1.0). Similarly an AUC of 0.910 (95% CI 0.810–1.0) with %US (EOC1) and %HbT (EOC1) can be achieved independent of HER2 and ER status. The most accurate prediction, AUC = 0.974 (95% CI 0.933–1.0), was achieved with %US at EOC1 and %HbT (EOC3) independent of biomarker status.
Conclusion
The combined use of tumor HER2 and ER status, US, and US-guided DOT may provide accurate prediction of NAT response as early as the completion of the first treatment cycle.
Clinical Trial Registration number:
NCT02891681.
https://clinicaltrials.gov/ct2/show/NCT02891681
, Registration time: September 7, 2016 |
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| Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Author contributions QZ: designed and conducted all aspects of the ultrasound-guided optical tomography data acquisition, image reconstruction and data analysis and contributed to the manuscript preparation and literature review. SPP: designed and conducted patient imaging studies, data analysis, and contributed to the manuscript preparation and literature review. FOA and CM: coordinated and recruited patients to the study, and contributed to the manuscript review and literature review. CY, CA, MFC: contributed to the imaging studies, imaging interpretations, and manuscript review. SS and ISH: contributed to the pathological data evaluations, interpretations, manuscript review. AM and K.M.S.U: contributed to the development of optical tomography system hardware and software as well as imaging algorithm. IG: coordinated, consented all study patients, and data analysis. AEF and LFH: contributed to patient recruitments. All authors read and approved the final manuscript. |
| ISSN: | 0167-6806 1573-7217 |
| DOI: | 10.1007/s10549-021-06239-y |