One-Step Nucleic Acid Amplification System in Comparison to the Intraoperative Frozen Section and Definitive Histological Examination Among Breast Cancer Patients: A Retrospective Survival Study

Serena Bertozzi; Ambrogio P Londero; Michela Bulfoni; Luca Seriau; Diane Agakiza; Alberto Pasqualucci; Michela Andretta; Maria Orsaria; Laura Mariuzzi; Carla Cedolini

doi:10.3389/fonc.2022.847858

One-Step Nucleic Acid Amplification System in Comparison to the Intraoperative Frozen Section and Definitive Histological Examination Among Breast Cancer Patients: A Retrospective Survival Study

Front Oncol. 2022 May 18:12:847858. doi: 10.3389/fonc.2022.847858. eCollection 2022.

Authors

Serena Bertozzi^{1

2

3}, Ambrogio P Londero^{2

4}, Michela Bulfoni⁵, Luca Seriau¹, Diane Agakiza³, Alberto Pasqualucci^{6

7}, Michela Andretta¹, Maria Orsaria⁵, Laura Mariuzzi^{3

5}, Carla Cedolini^{1

2}

Affiliations

¹ Breast Unit, University Hospital of Udine, Udine, Italy.
² Ennergi Research, Lestizza, Italy.
³ Department of Medical Area (DAME), University of Udine, Udine, Italy.
⁴ Academic Unit of Obstetrics and Gynaecology, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Infant Health, University of Genoa, Genova, Italy.
⁵ Institute of pathology, University Hospital of Udine, Udine, Italy.
⁶ Department of Surgical and Biomedical Science, University of Perugia, Perugia, Italy.
⁷ Rashid Hospital, Trauma and Emergency Center, Dubai Health Authority, Dubai, United Arab Emirates.

Abstract

Simple summary: Implementing intraoperative assessment of sentinel lymph nodes by one-step nucleic acid amplification in early breast cancer can reduce the surgical burden to the patient and the costs to the health system. However, only limited data are available in terms of long-term disease-free survival and overall survival. Therefore, this study aims to compare disease-free survival and overall survival between one-step nucleic acid amplification, frozen section, and definitive histology. These results could impact the healthcare community, adding further proof to the body of evidence supporting the broader adoption of this innovative technology that enables a safe reduction in patient surgical burden and healthcare costs.

Background: The one-step nucleic acid amplification (OSNA) system is a novel molecular technique, which consents to quick intraoperative detection of sentinel lymph node metastases by the amplification of cytokeratin 19 mRNA. Our study aims to evaluate the OSNA method in comparison with frozen section (FS) and definitive histological examination of the sentinel lymph node biopsy among early breast cancer patients considering disease-free survival (DFS) and overall survival (OS).

Methods: In this study, we included all women who underwent sentinel lymph node biopsy (SLNB) for breast cancers classified as TNM stage I and II in our center between January 2005 and January 2017, and the follow-up was collected up to January 2019. We divided patients among three groups based on SLNB evaluation: definitive histological examination, intra-operative FS, or OSNA.

Results: We included 2412 SLNBs: 727 by definitive histological examination, 697 by FS, and 988 by OSNA. Isolated tumor cells were found in 2.32% of cases, micrometastasis in 9.12%, and macrometastases in 13.64%. Surgical procedure duration was significantly shorter in OSNA than in FS (42.1 minutes ±5.1 vs. 70.1 minutes ±10.5, p <0.05). No significant differences have been observed among the three groups regarding OS, DSF, cumulative local, or distant metastases. In particular 5-year DFS was 96.38% in definitive histology (95% C.I. 95.02-97.75%), 96.37% in FS (95% C.I. 94.98-97.78%), and 96.51% in OSNA group (95% C.I. 95.32-97.72%).

Conclusions: No difference in OS and DFS was found comparing OSNA, FS, and definitive histology. Furthermore, reduced operative time was found in the OSNA group.

Keywords: Keywords sentinel lymph node biopsy; OSNA; breast cancer; frozen section; survival.