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Biopsy Feasibility Trial for Breast Cancer Pathologic Complete Response Detection after Neoadjuvant Chemotherapy: Imaging Assessment and Correlation Endpoints

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Purpose

This study was designed to present the secondary imaging endpoints of the trial for evaluating mammogram (MMG), ultrasound (US) and image guided biopsy (IGBx) assessment of pathologic complete response (pCR) in breast cancer (BC) patients undergoing neoadjuvant chemotherapy (NAC).

Methods

Patients with T1–3, N0–3, M0 triple-negative or HER2-positive BC who received NAC were enrolled in an Institutional Review Board-approved prospective, clinical trial. Patients underwent US and MMG at baseline and after NAC. Images were evaluated for residual abnormality and to determine modality for IGBx [US-guided (USG) or stereotactic guided (SG)]. Fine-needle aspiration and 9-G, vacuum-assisted core biopsy (VACBx) of tumor bed was performed after NAC and was compared with histopathology at surgery.

Results

Forty patients were enrolled. Median age was 50.5 (range 26–76) years; median baseline tumor size was 2.4 cm (range 0.8–6.3) and 1 cm (range 0–5.5) after NAC. Nineteen patients had pCR: 6 (32%) had residual Ca2+ presurgery, 5 (26%) residual mass, 1 (5%) mass with calcifications, and 7 (37%) no residual imaging abnormality. Sensitivity, specificity, and accuracy of US, MMG, and IGBx for pCR were 47/95/73%, 53/90/73%, and 100/95/98%, respectively. Twenty-five (63%) patients had SGBx and 15 (37%) had US-guided biopsy (USGBx). Median number of cores was higher with SGBx (12, range 6–14) than with USGBx (8, range 4–12), p < 0.002. Positive predictive value for pCR was significantly higher for SG VACBx than for USG VACBx (100 vs. 60%, p < 0.05).

Conclusions

SG VACBx is the preferred IGBx modality for identifying patients with pCR for trials testing the safety of eliminating surgery.

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Acknowledgment

The authors thank Stephanie Deming for editing the paper.

Funding

This work was supported by the PH and Fay Etta Robinson Distinguished Professorship in Cancer Research (HMK) and a Cancer Center Support Grant from the National Institutes of Health (NIH) (CA16672).

Disclosure

The authors have no conflicts of interest to disclose.

Author information

Authors and Affiliations

  1. Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Gaiane M. Rauch MD, PhD, Beatriz Adrada MD, Lumarie Santiago MD, Tanya Moseley MD, Rosalind P. Candelaria MD, Elsa Arribas MD, Jessica W. T. Leung MD & Wei T. Yang MD

  2. Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Henry M. Kuerer MD, PhD

  3. Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Jia Sun PhD

  4. Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Savitri Krishnamurthy MD

Authors
  1. Gaiane M. Rauch MD, PhD
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  2. Henry M. Kuerer MD, PhD
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  3. Beatriz Adrada MD
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  4. Lumarie Santiago MD
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  5. Tanya Moseley MD
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  6. Rosalind P. Candelaria MD
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  7. Elsa Arribas MD
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  8. Jia Sun PhD
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  9. Jessica W. T. Leung MD
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  10. Savitri Krishnamurthy MD
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  11. Wei T. Yang MD
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Corresponding author

Correspondence to Gaiane M. Rauch MD, PhD.

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Rauch, G.M., Kuerer, H.M., Adrada, B. et al. Biopsy Feasibility Trial for Breast Cancer Pathologic Complete Response Detection after Neoadjuvant Chemotherapy: Imaging Assessment and Correlation Endpoints. Ann Surg Oncol 25, 1953–1960 (2018). https://doi.org/10.1245/s10434-018-6481-y

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  • DOI: https://doi.org/10.1245/s10434-018-6481-y

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