by Mariana-Felicia Sandor, Beatrice Schwalbach, Viktoria
Hofmann, Simona-Elena Istrate, Zlatna Schuller, Elena Ionescu, Sara Heiman,
Moira Ragazzi, Michael P. Lux
The Breast: Published: October 05, 2022
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.
