A randomized prospective study of lumpectomy margin assessment with use of marginprobe in patients with nonpalpable breast malignancies

Freya Schnabel, Susan K. Boolbol, Mark Gittleman, Tami Karni, Lorraine Tafra, Sheldon Feldman, Alice Police, Neil B. Friedman, Scott Karlan, Dennis Holmes, Shawna C. Willey, Moshe Carmon, Kristen Fernandez, Stephanie Akbari, Jay Harness, Lisa Guerra, Thomas Frazier, Karen Lane, Rache M. Simmons, Alison Estabrook & 1 others Tanir Allweis

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1589-1595
Number of pages7
JournalAnnals of Surgical Oncology
Volume21
Issue number5
DOIs
StatePublished - 2014
Externally publishedYes

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Segmental Mastectomy
Breast
Arm
Prospective Studies
Equipment and Supplies
Neoplasms
Pathology
Israel
Multicenter Studies
Patient Care
Delivery of Health Care
Recurrence

ASJC Scopus subject areas

  • Surgery
  • Oncology
  • Medicine(all)

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A randomized prospective study of lumpectomy margin assessment with use of marginprobe in patients with nonpalpable breast malignancies. / Schnabel, Freya; Boolbol, Susan K.; Gittleman, Mark; Karni, Tami; Tafra, Lorraine; Feldman, Sheldon; Police, Alice; Friedman, Neil B.; Karlan, Scott; Holmes, Dennis; Willey, Shawna C.; Carmon, Moshe; Fernandez, Kristen; Akbari, Stephanie; Harness, Jay; Guerra, Lisa; Frazier, Thomas; Lane, Karen; Simmons, Rache M.; Estabrook, Alison; Allweis, Tanir.

In: Annals of Surgical Oncology, Vol. 21, No. 5, 2014, p. 1589-1595.

Research output: Contribution to journalArticle

Schnabel, F, Boolbol, SK, Gittleman, M, Karni, T, Tafra, L, Feldman, S, Police, A, Friedman, NB, Karlan, S, Holmes, D, Willey, SC, Carmon, M, Fernandez, K, Akbari, S, Harness, J, Guerra, L, Frazier, T, Lane, K, Simmons, RM, Estabrook, A & Allweis, T 2014, 'A randomized prospective study of lumpectomy margin assessment with use of marginprobe in patients with nonpalpable breast malignancies', Annals of Surgical Oncology, vol. 21, no. 5, pp. 1589-1595. https://doi.org/10.1245/s10434-014-3602-0
Schnabel, Freya ; Boolbol, Susan K. ; Gittleman, Mark ; Karni, Tami ; Tafra, Lorraine ; Feldman, Sheldon ; Police, Alice ; Friedman, Neil B. ; Karlan, Scott ; Holmes, Dennis ; Willey, Shawna C. ; Carmon, Moshe ; Fernandez, Kristen ; Akbari, Stephanie ; Harness, Jay ; Guerra, Lisa ; Frazier, Thomas ; Lane, Karen ; Simmons, Rache M. ; Estabrook, Alison ; Allweis, Tanir. / A randomized prospective study of lumpectomy margin assessment with use of marginprobe in patients with nonpalpable breast malignancies. In: Annals of Surgical Oncology. 2014 ; Vol. 21, No. 5. pp. 1589-1595.
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title = "A randomized prospective study of lumpectomy margin assessment with use of marginprobe in patients with nonpalpable breast malignancies",
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.",
author = "Freya Schnabel and Boolbol, {Susan K.} and Mark Gittleman and Tami Karni and Lorraine Tafra and Sheldon Feldman and Alice Police and Friedman, {Neil B.} and Scott Karlan and Dennis Holmes and Willey, {Shawna C.} and Moshe Carmon and Kristen Fernandez and Stephanie Akbari and Jay Harness and Lisa Guerra and Thomas Frazier and Karen Lane and Simmons, {Rache M.} and Alison Estabrook and Tanir Allweis",
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T1 - A randomized prospective study of lumpectomy margin assessment with use of marginprobe in patients with nonpalpable breast malignancies

AU - Schnabel, Freya

AU - Boolbol, Susan K.

AU - Gittleman, Mark

AU - Karni, Tami

AU - Tafra, Lorraine

AU - Feldman, Sheldon

AU - Police, Alice

AU - Friedman, Neil B.

AU - Karlan, Scott

AU - Holmes, Dennis

AU - Willey, Shawna C.

AU - Carmon, Moshe

AU - Fernandez, Kristen

AU - Akbari, Stephanie

AU - Harness, Jay

AU - Guerra, Lisa

AU - Frazier, Thomas

AU - Lane, Karen

AU - Simmons, Rache M.

AU - Estabrook, Alison

AU - Allweis, Tanir

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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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