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Prediction of pathologic complete response using image-guided biopsy after neoadjuvant chemotherapy in breast cancer patients selected based on MRI findings: a prospective feasibility trial

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Abstract

Purpose

Accurate prediction of pathologic complete response (pCR) in breast cancer using magnetic resonance imaging (MRI) and ultrasound (US)-guided biopsy may aid in selecting patients who forego surgery for breast cancer. We evaluated the accuracy of US-guided biopsy aided by MRI in predicting pCR in the breast after neoadjuvant chemotherapy (NAC).

Methods

After completion of NAC, 40 patients with near pCR (either tumor size ≤ 0.5 cm or lesion-to-background signal enhancement ratio (L-to-B SER) ≤ 1.6 on MRI) and no diffused residual microcalcifications were prospectively enrolled at a single institution. US-guided multiple core needle biopsy (CNB) or vacuum-assisted biopsy (VAB) of the tumor bed, followed by standard surgical excision, was performed. Matched biopsy and surgical specimens were compared to assess pCR. The negative predictive value (NPV), accuracy, and false-negative rate (FNR) were analyzed.

Results

pCR was confirmed in 27 (67.5%) surgical specimens. Preoperative biopsy had an NPV, accuracy, and FNR of 87.1%, 90.0%, and 30.8%, respectively. NPV for hormone receptor-negative and hormone receptor-positive tumors were 83.3% and 100%, respectively. Obtaining at least 5 biopsy cores based on tumor size ≤ 0.5 cm and an L-to-B SER of ≤ 1.6 on MRI (27 patients) resulted in 100% NPV and accuracy. No differences in accuracy were noted between CNB and VAB (90% vs. 90%).

Conclusions

Investigation using stringent MRI criteria and ultrasound-guided biopsy could accurately predict patients with pCR after NAC. A larger prospective clinical trial evaluating the clinical safety of breast surgery omission after NAC in selected patients will be conducted based on these findings.

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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

cCR:

Complete clinical response

CNB:

Core needle biopsy

DCIS:

Ductal carcinoma in situ

FNR:

False negative rate

HER2:

Human epidermal growth factor receptor 2

HR:

Hormone receptor

LN:

Lymph node

L-to-B SER:

Lesion-to-background signal enhancement ratio

MMG:

Mammogram

MRI:

Magnetic resonance imaging

NAC:

Neoadjuvant chemotherapy

NPV:

Negative predictive value

pCR:

Pathologic complete response

US:

Ultrasound

VAB:

Vacuum-assisted biopsy

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Acknowledgements

The authors would like to sincerely thank Ms. Hye-Sook Kim for administrative support.

Funding

This study was supported by the Seoul National University Hospital Research Fund (30-2016-0250 to WH; sponsored by H-U Kim [Woowon Construction, Co., Ltd.]) and by the Institute for Information and Communications Technology Promotion (IITP) grant funded by the Korea government (MSIT) (2018-0-00861 to HBL).

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Authors and Affiliations

  1. Department of Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea

    Han-Byoel Lee, Wonshik Han, Kyoung-Eun Kim, Jung Hyun Park, Young Wook Ju, Eun-Shin Lee, Sung-Joon Lim, Hyeong-Gon Moon & Dong-Young Noh

  2. Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea

    Han-Byoel Lee, Wonshik Han, Hyeong-Gon Moon & Woo Kyung Moon

  3. Cancer Research Institute, Seoul National University, Seoul, Republic of Korea

    Han-Byoel Lee, Wonshik Han, Kyung-Hun Lee, Seock-Ah Im & Dong-Young Noh

  4. Department of Radiology, Seoul National University College of Medicine, Seoul, Republic of Korea

    Soo-Yeon Kim, Nariya Cho, Sung Ui Shin, Su Hyun Lee, Jung Min Chang & Woo Kyung Moon

  5. Department of Pathology, Seoul National University College of Medicine, Seoul, Republic of Korea

    Jung Ho Kim, Han Suk Ryu & In-Ae Park

  6. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea

    Dae-Won Lee, Miso Kim, Tae-Yong Kim, Kyung-Hun Lee & Seock-Ah Im

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  1. Han-Byoel Lee
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Corresponding author

Correspondence to Wonshik Han.

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Conflict of interest

Han-Byoel Lee and Wonshik Han are members on the board of directors of, and have stock and ownership interests at DCGen, Co., Ltd., outside the submitted work. Seock-Ah Im, has received research grants from AstraZeneca and Pfizer; advisory role for AstraZeneca, Eisai, Hanmi, Novartis, Roche, MedPacto and Pfizer, outside the submitted work. All other authors have no conflicts of interest to declare.

Ethical approval

All procedures performed in this trial were in accordance with the ethical standards approved by the Institutional Review Board of the Seoul National University Hospital (No. 1606-122-772) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Lee, HB., Han, W., Kim, SY. et al. Prediction of pathologic complete response using image-guided biopsy after neoadjuvant chemotherapy in breast cancer patients selected based on MRI findings: a prospective feasibility trial. Breast Cancer Res Treat 182, 97–105 (2020). https://doi.org/10.1007/s10549-020-05678-3

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