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Annals of Surgical Oncology
Published in: Annals of Surgical Oncology 5/2014

Open Access 01-05-2014 | Breast Oncology

A Randomized Prospective Study of Lumpectomy Margin Assessment with Use of MarginProbe in Patients with Nonpalpable Breast Malignancies

Authors: Freya Schnabel, MD, Susan K. Boolbol, MD, Mark Gittleman, MD, Tami Karni, MD, Lorraine Tafra, MD, Sheldon Feldman, MD, Alice Police, MD, Neil B. Friedman, MD, Scott Karlan, MD, Dennis Holmes, MD, Shawna C. Willey, MD, Moshe Carmon, MD, Kristen Fernandez, MD, Stephanie Akbari, MD, Jay Harness, MD, Lisa Guerra, MD, Thomas Frazier, MD, Karen Lane, MD, Rache M. Simmons, MD, Alison Estabrook, MD, Tanir Allweis, MD

Published in: Annals of Surgical Oncology | Issue 5/2014

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Abstract

Background

The presence of tumor cells at the margins of breast lumpectomy specimens is associated with an increased risk of ipsilateral tumor recurrence. Twenty to 30 % of patients undergoing breast-conserving surgery require second procedures to achieve negative margins. This study evaluated the adjunctive use of the MarginProbe device (Dune Medical Devices Ltd, Caesarea, Israel) in providing real-time intraoperative assessment of lumpectomy margins.

Methods

This multicenter randomized trial enrolled patients with nonpalpable breast malignancies. The study evaluated MarginProbe use in addition to standard intraoperative methods for margin assessment. After specimen removal and inspection, patients were randomized to device or control arms. In the device arm, MarginProbe was used to examine the main lumpectomy specimens and direct additional excision of positive margins. Intraoperative imaging was used in both arms; no intraoperative pathology assessment was permitted.

Results

In total, 596 patients were enrolled. False-negative rates were 24.8 and 66.1 % and false-positive rates were 53.6 and 16.6 % in the device and control arms, respectively. All positive margins on positive main specimens were resected in 62 % (101 of 163) of cases in the device arm, versus 22 % (33 of 147) in the control arm (p < 0.001). A total of 19.8 % (59 of 298) of patients in the device arm underwent a reexcision procedure compared with 25.8 % (77 of 298) in the control arm (6 % absolute, 23 % relative reduction). The difference in tissue volume removed was not significant.

Conclusions

Adjunctive use of the MarginProbe device during breast-conserving surgery improved surgeons’ ability to identify and resect positive lumpectomy margins in the absence of intraoperative pathology assessment, reducing the number of patients requiring reexcision. MarginProbe may aid performance of breast-conserving surgery by reducing the burden of reexcision procedures for patients and the health care system.
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Metadata
Title
A Randomized Prospective Study of Lumpectomy Margin Assessment with Use of MarginProbe in Patients with Nonpalpable Breast Malignancies
Authors
Freya Schnabel, MD
Susan K. Boolbol, MD
Mark Gittleman, MD
Tami Karni, MD
Lorraine Tafra, MD
Sheldon Feldman, MD
Alice Police, MD
Neil B. Friedman, MD
Scott Karlan, MD
Dennis Holmes, MD
Shawna C. Willey, MD
Moshe Carmon, MD
Kristen Fernandez, MD
Stephanie Akbari, MD
Jay Harness, MD
Lisa Guerra, MD
Thomas Frazier, MD
Karen Lane, MD
Rache M. Simmons, MD
Alison Estabrook, MD
Tanir Allweis, MD
Publication date
01-05-2014
Publisher
Springer US
Published in
Annals of Surgical Oncology / Issue 5/2014
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-014-3602-0

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