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

  • Gaiane M. Rauch
  • Henry M. Kuerer
  • Beatriz Adrada
  • Lumarie Santiago
  • Tanya Moseley
  • Rosalind P. Candelaria
  • Elsa Arribas
  • Jia Sun
  • Jessica W. T. Leung
  • Savitri Krishnamurthy
  • Wei T. Yang
Breast Oncology

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.

Notes

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.

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Copyright information

© Society of Surgical Oncology 2018

Authors and Affiliations

  • Gaiane M. Rauch
    • 1
  • Henry M. Kuerer
    • 2
  • Beatriz Adrada
    • 1
  • Lumarie Santiago
    • 1
  • Tanya Moseley
    • 1
  • Rosalind P. Candelaria
    • 1
  • Elsa Arribas
    • 1
  • Jia Sun
    • 3
  • Jessica W. T. Leung
    • 1
  • Savitri Krishnamurthy
    • 4
  • Wei T. Yang
    • 1
  1. 1.Department of Diagnostic RadiologyThe University of Texas MD Anderson Cancer CenterHoustonUSA
  2. 2.Department of Breast Surgical OncologyThe University of Texas MD Anderson Cancer CenterHoustonUSA
  3. 3.Department of BiostatisticsThe University of Texas MD Anderson Cancer CenterHoustonUSA
  4. 4.Department of PathologyThe University of Texas MD Anderson Cancer CenterHoustonUSA

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