Imaging of lumpectomy surface with large field-of-view confocal laser scanning microscope for intraoperative margin assessment - POLARHIS study

Introduction: Breast-conserving surgery (BCS) in case of breast cancer and/or in-situ-carcinoma lesions (DCIS) intends to completely remove breast cancer while saving healthy tissue as much as possible to achieve better aesthetic and psychological outcomes for the patient. Such modality should resul...

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Main Authors: Mariana-Felicia Sandor, Beatrice Schwalbach, Viktoria Hofmann, Simona-Elena Istrate, Zlatna Schuller, Elena Ionescu, Sara Heimann, Moira Ragazzi, Michael P. Lux
Format: Article
Language:English
Published: Elsevier 2022-12-01
Series:Breast
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S0960977622001680
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author Mariana-Felicia Sandor
Beatrice Schwalbach
Viktoria Hofmann
Simona-Elena Istrate
Zlatna Schuller
Elena Ionescu
Sara Heimann
Moira Ragazzi
Michael P. Lux
author_facet Mariana-Felicia Sandor
Beatrice Schwalbach
Viktoria Hofmann
Simona-Elena Istrate
Zlatna Schuller
Elena Ionescu
Sara Heimann
Moira Ragazzi
Michael P. Lux
author_sort Mariana-Felicia Sandor
collection DOAJ
description Introduction: Breast-conserving surgery (BCS) in case of breast cancer and/or in-situ-carcinoma lesions (DCIS) intends to completely remove breast cancer while saving healthy tissue as much as possible to achieve better aesthetic and psychological outcomes for the patient. Such modality should result in postoperative tumor-free margins of the surgical resection in order to carry on with the next therapeutical steps of the patient care. However, 10–40% of patients undergo more than one procedure to achieve acceptable cancer-negative margins. A 2nd operation or further operation (re-operation) has physical, psychological, and economic consequences. It also delays the administration of adjuvant therapy, and has been associated with an elevated risk of local and distant disease relapse. In addition, a high re-operation rate can have significant economic effects - both for the service provider and for the payer. A more efficient intraoperative assessment of the margin may address these issues. Recently, a large field-of-view confocal laser scanning microscope designed to allow real-time intraoperative margin assessment has arrived on the market - the Histolog Scanner. In this paper, we present the first evaluation of lumpectomy margins assessment with this new device. Materials and methods: 40 consecutive patients undergoing BCS with invasive and/or DCIS were included. The whole surface of the surgical specimens was imaged right after the operation using the Histolog Scanner (HLS). The assessment of all the specimen margins was performed intraoperatively according to the standard-of-care of the center which consists of combined ultrasound (IOUS) and/or conventional specimen radiography (CSR), and gross surgical inspection. Margin assessment on HLS images was blindly performed after the surgery by 5 surgeons and one pathologist. The capabilities to correctly determine margin status in HLS images was compared to the final histopathological assessment. Furthermore, the potential reduction of positive-margin and re-operation rates by utilization of the HLS were extrapolated. Results: The study population included 7/40 patients with DCIS (17.5%), 17/40 patients with DCIS and invasive ductal cancer (IDC NST) (42.5%), 10/40 patients with IDC NST (25%), 4/40 with invasive lobular cancer (ILC) (10%), and 1/40 patients with a mix of IDC NST, DCIS, and ILC. Clinical routine resulted in 13 patients with positive margins identified by final histopathological assessment, resulting in 12 re-operations (30% re-operation rate). Amongst these 12 patients, 10 had DCIS components involved in their margin, confirming the importance of improving the detection accuracy of this specific lesion. Surgeons, who were given a short familiarization on HLS images, and a pathologist were able to detect positive margins in 4/12 and 7/12 patients (33% and 58%), respectively, that were missed by the intraoperative standard of care. In addition, a retrospective analysis of the HLS images revealed that cancer lesions can be identified in 9/12 (75%) patients with positive margins. Conclusion: The present study presents that breast cancer can be detected by surgeons and pathologists in HLS images of lumpectomy margins leading to a potential reduction of 30% and 75% of the re-operations. The Histolog Scanner is easily inserted into the clinical workflow and has the potential to improve the intraoperative standard-of-care for the assessment of breast conserving treatments. In addition, it has the potential to increase oncological safety and cosmetics by avoiding subsequent resections and can also have a significant positive economic effect for service providers and cost bearers. The data presented in this study will have to be further confirmed in a prospective phase–III–trial.
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spelling doaj.art-297bdd49ae6c47528f3ca6b890910efb2022-12-22T03:03:24ZengElsevierBreast1532-30802022-12-0166118125Imaging of lumpectomy surface with large field-of-view confocal laser scanning microscope for intraoperative margin assessment - POLARHIS studyMariana-Felicia Sandor0Beatrice Schwalbach1Viktoria Hofmann2Simona-Elena Istrate3Zlatna Schuller4Elena Ionescu5Sara Heimann6Moira Ragazzi7Michael P. Lux8Department of Gynecology and Obstetrics, Women's Hospital St. Louise, Paderborn, Women′s Hospital, St. Josefs, Salzkotten, St. Vincenz-Krankenhaus GmbH, Husener Str. 81, 33098, Paderborn, GermanyDepartment of Gynecology and Obstetrics, Women's Hospital St. Louise, Paderborn, Women′s Hospital, St. Josefs, Salzkotten, St. Vincenz-Krankenhaus GmbH, Husener Str. 81, 33098, Paderborn, GermanyDepartment of Gynecology and Obstetrics, Women's Hospital St. Louise, Paderborn, Women′s Hospital, St. Josefs, Salzkotten, St. Vincenz-Krankenhaus GmbH, Husener Str. 81, 33098, Paderborn, GermanyDepartment of Gynecology and Obstetrics, Women's Hospital St. Louise, Paderborn, Women′s Hospital, St. Josefs, Salzkotten, St. Vincenz-Krankenhaus GmbH, Husener Str. 81, 33098, Paderborn, GermanyDepartment of Gynecology and Obstetrics, Women's Hospital St. Louise, Paderborn, Women′s Hospital, St. Josefs, Salzkotten, St. Vincenz-Krankenhaus GmbH, Husener Str. 81, 33098, Paderborn, GermanyDepartment of Gynecology and Obstetrics, Women's Hospital St. Louise, Paderborn, Women′s Hospital, St. Josefs, Salzkotten, St. Vincenz-Krankenhaus GmbH, Husener Str. 81, 33098, Paderborn, GermanyDepartment of Gynecology and Obstetrics, Women's Hospital St. Louise, Paderborn, Women′s Hospital, St. Josefs, Salzkotten, St. Vincenz-Krankenhaus GmbH, Husener Str. 81, 33098, Paderborn, GermanyPathology Unit, Azienda USL – IRCCS di Reggio Emilia, 42123, Reggio Emilia, ItalyDepartment of Gynecology and Obstetrics, Women's Hospital St. Louise, Paderborn, Women′s Hospital, St. Josefs, Salzkotten, St. Vincenz-Krankenhaus GmbH, Husener Str. 81, 33098, Paderborn, Germany; Corresponding author. Klinik für Gynäkologie und Geburtshilfe, Frauenklinik St. Louise, Paderborn, St. Josefs-Krankenhaus, Salzkotten, Husener Str. 81, 33098, Paderborn, Germany.Introduction: Breast-conserving surgery (BCS) in case of breast cancer and/or in-situ-carcinoma lesions (DCIS) intends to completely remove breast cancer while saving healthy tissue as much as possible to achieve better aesthetic and psychological outcomes for the patient. Such modality should result in postoperative tumor-free margins of the surgical resection in order to carry on with the next therapeutical steps of the patient care. However, 10–40% of patients undergo more than one procedure to achieve acceptable cancer-negative margins. A 2nd operation or further operation (re-operation) has physical, psychological, and economic consequences. It also delays the administration of adjuvant therapy, and has been associated with an elevated risk of local and distant disease relapse. In addition, a high re-operation rate can have significant economic effects - both for the service provider and for the payer. A more efficient intraoperative assessment of the margin may address these issues. Recently, a large field-of-view confocal laser scanning microscope designed to allow real-time intraoperative margin assessment has arrived on the market - the Histolog Scanner. In this paper, we present the first evaluation of lumpectomy margins assessment with this new device. Materials and methods: 40 consecutive patients undergoing BCS with invasive and/or DCIS were included. The whole surface of the surgical specimens was imaged right after the operation using the Histolog Scanner (HLS). The assessment of all the specimen margins was performed intraoperatively according to the standard-of-care of the center which consists of combined ultrasound (IOUS) and/or conventional specimen radiography (CSR), and gross surgical inspection. Margin assessment on HLS images was blindly performed after the surgery by 5 surgeons and one pathologist. The capabilities to correctly determine margin status in HLS images was compared to the final histopathological assessment. Furthermore, the potential reduction of positive-margin and re-operation rates by utilization of the HLS were extrapolated. Results: The study population included 7/40 patients with DCIS (17.5%), 17/40 patients with DCIS and invasive ductal cancer (IDC NST) (42.5%), 10/40 patients with IDC NST (25%), 4/40 with invasive lobular cancer (ILC) (10%), and 1/40 patients with a mix of IDC NST, DCIS, and ILC. Clinical routine resulted in 13 patients with positive margins identified by final histopathological assessment, resulting in 12 re-operations (30% re-operation rate). Amongst these 12 patients, 10 had DCIS components involved in their margin, confirming the importance of improving the detection accuracy of this specific lesion. Surgeons, who were given a short familiarization on HLS images, and a pathologist were able to detect positive margins in 4/12 and 7/12 patients (33% and 58%), respectively, that were missed by the intraoperative standard of care. In addition, a retrospective analysis of the HLS images revealed that cancer lesions can be identified in 9/12 (75%) patients with positive margins. Conclusion: The present study presents that breast cancer can be detected by surgeons and pathologists in HLS images of lumpectomy margins leading to a potential reduction of 30% and 75% of the re-operations. The Histolog Scanner is easily inserted into the clinical workflow and has the potential to improve the intraoperative standard-of-care for the assessment of breast conserving treatments. In addition, it has the potential to increase oncological safety and cosmetics by avoiding subsequent resections and can also have a significant positive economic effect for service providers and cost bearers. The data presented in this study will have to be further confirmed in a prospective phase–III–trial.http://www.sciencedirect.com/science/article/pii/S0960977622001680Breast conserving surgeryConfocal microscopyDuctal carcinoma in-situHistolog scannerRe-excisionFresh tissue imaging
spellingShingle Mariana-Felicia Sandor
Beatrice Schwalbach
Viktoria Hofmann
Simona-Elena Istrate
Zlatna Schuller
Elena Ionescu
Sara Heimann
Moira Ragazzi
Michael P. Lux
Imaging of lumpectomy surface with large field-of-view confocal laser scanning microscope for intraoperative margin assessment - POLARHIS study
Breast
Breast conserving surgery
Confocal microscopy
Ductal carcinoma in-situ
Histolog scanner
Re-excision
Fresh tissue imaging
title Imaging of lumpectomy surface with large field-of-view confocal laser scanning microscope for intraoperative margin assessment - POLARHIS study
title_full Imaging of lumpectomy surface with large field-of-view confocal laser scanning microscope for intraoperative margin assessment - POLARHIS study
title_fullStr Imaging of lumpectomy surface with large field-of-view confocal laser scanning microscope for intraoperative margin assessment - POLARHIS study
title_full_unstemmed Imaging of lumpectomy surface with large field-of-view confocal laser scanning microscope for intraoperative margin assessment - POLARHIS study
title_short Imaging of lumpectomy surface with large field-of-view confocal laser scanning microscope for intraoperative margin assessment - POLARHIS study
title_sort imaging of lumpectomy surface with large field of view confocal laser scanning microscope for intraoperative margin assessment polarhis study
topic Breast conserving surgery
Confocal microscopy
Ductal carcinoma in-situ
Histolog scanner
Re-excision
Fresh tissue imaging
url http://www.sciencedirect.com/science/article/pii/S0960977622001680
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