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Use of MarginProbe as an adjunct to standard operating procedure does not significantly reduce re-excision rates in breast conserving surgery

  • Clinical trial
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Abstract

Purpose

A positive margin after breast conserving surgery has consistently been shown to be a significant predictor for ipsilateral breast tumor recurrence. Currently, there is no standard for intraoperative margin assessment during lumpectomy, and up to 20% of cases result in positive margins. MarginProbe is a device that provides real-time evaluation of lumpectomy margins during surgery. The aim of this study was to evaluate the impact of MarginProbe as an adjunct to standard operating procedure (SOP).

Methods

Patients diagnosed with breast cancer scheduled for breast conserving surgery were consented for intraoperative use of MarginProbe. Shaved margins were excised based on margin assessment using the surgeon’s SOP which included specimen radiography and gross pathologic examination, and feedback from the device. The primary endpoint was re-excision rate. Secondary endpoints included sensitivity, specificity, false-positive and negative rates.

Results

Of the 60 breast cancers, initial histologically close/positive margins were identified in 18 patients (30%). The re-excision rate in the overall cohort was 6.6%, compared to a historical re-excision rate of 8.6% (p < 0.01). Based on 360 measurement sites, MarginProbe demonstrated a sensitivity of 67% and specificity of 60%, with a positive predictive value of 16%, and of negative predictive value of 94%, which was similar to the accuracy of SOP.

Conclusions

MarginProbe performs equally as well as specimen radiography and gross pathologic examination. In this setting where the baseline re-excision rate was low, the use of MarginProbe as an adjunct to SOP resulted in a small 2% absolute reduction in re-excision rate.

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Abbreviations

SOP:

Standard operating procedure

NIH:

National Institutes of Health

BCS:

Breast conserving surgery

SEER:

Surveillance epidemiology and end results

IBTR:

Ipsilateral breast tumor recurrence

EBCTG:

Early Breast Cancer Trialist’s Collaborative Group

FDA:

Federal Drug Administration

BI-RADS:

Breast imaging reporting and database system

DCIS:

Ductal carcinoma in situ

EIC:

Extensive intraductal component

ER:

Estrogen receptor

PR:

Progesterone receptor

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Funding

The authors received no research grants or outside sources funding for this study. There are no financial or non-financial interests to declare.

Author information

Authors and Affiliations

  1. Department of Surgery, Huntington Hospital, 100 W California Blvd, Pasadena, CA, 91105, USA

    Elyse LeeVan, Be Thi Ho & Jeannie Shen

  2. Department of Clinical Research, Huntington Hospital, 100 W California Blvd, Pasadena, CA, 91105, USA

    Sadie Seto

  3. Department of Surgery, University of California Los Angeles, 10833 Le Conte Ave #72, Los Angeles, CA, 90024, USA

    Jeannie Shen

  4. 625 S Fair Oaks Ave, Suite 300, Pasadena, CA, 91105, USA

    Jeannie Shen

Authors
  1. Elyse LeeVan
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  2. Be Thi Ho
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  3. Sadie Seto
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  4. Jeannie Shen
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Corresponding author

Correspondence to Jeannie Shen.

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Ethical approval

The research described was approved by institutional IRB, and all participants voluntarily signed informed consent. The study is presented following Committee on Publication Ethics guidelines and rules of good scientific practice. No animals were involved in the study.

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LeeVan, E., Ho, B.T., Seto, S. et al. Use of MarginProbe as an adjunct to standard operating procedure does not significantly reduce re-excision rates in breast conserving surgery. Breast Cancer Res Treat 183, 145–151 (2020). https://doi.org/10.1007/s10549-020-05773-5

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  • DOI: https://doi.org/10.1007/s10549-020-05773-5

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