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Reliability of Whole Sentinel Lymph Node Analysis by One-Step Nucleic Acid Amplification for Intraoperative Diagnosis of Breast Cancer Metastases

Castellano, Isabella MD*,†; Macrì, Luigia MD*,†; Deambrogio, Cristina MD*; Balmativola, Davide MD*; Bussone, Riccardo MD†,‡; Ala, Ada MD†,‡; Coluccia, Claudio MD†,‡; Sapino, Anna MD*,†

doi: 10.1097/SLA.0b013e31823000ed
Original Articles

Objective: To assess the reliability of using the One-Step Nucleic Acid Amplification (OSNA) assay as a single test on whole sentinel lymph nodes (SLN) as a method of intraoperative diagnosis and staging of SLNs in breast cancer.

Background: Combining histological and molecular assessment of metastasis on the same SLN may not fully reproduce the actual load of cancer cells present in the SLN and create problems in decisions regarding axillary dissection.

Methods: Selection criteria for the whole SLN OSNA test required that the primary tumor expressed CK19 in more than 80% of tumor cells. Imprint cytology analysis of SLNs was performed together with the OSNA.

Results: Of the 279 patients enrolled for SLN evaluation, 123 gave consent to the OSNA protocol and 156 to the standard histology. Thirteen patients were excluded from OSNA evaluation because of low CK19 gene expression in the primary tumor; only 2.3% were truly negative. The kappa of concordance between the imprint cytology and OSNA results was 0.52. The rate of macrometastases determined by OSNA was 11% versus 20% determined by histology, whereas the rate of OSNA-micrometastases (18%) was significantly higher than that determined by histology (8%). The rate of SLN-negative cases was similar between the 2 protocols. Macrometastases correlated with the presence of vascular invasion in both protocols. The rate of axillary lymph node metastases was consistent with SLN tumor load.

Conclusions: Intraoperative OSNA assay performed on the whole SLN gave objective and reproducible results that were useful for directing decisions regarding axillary dissection and for accurately defining the SLN stage.

Performing the One-Step Nucleic Acid Amplification (OSNA) assay intraoperatively on the whole sentinel node (SLN) may take advantage of a single surgical procedure by producing objective and reproducible data. Information obtained from the OSNA aids in correctly defining the SNL stage and guides decision-making regarding axillary dissection.

*Department of Biomedical Sciences and Human Oncology, University of Turin, Turin, Italy,

Division of Surgery,

Breast Unit, Azienda Ospedaliera-Universitaria San Giovanni Battista, Molinette Hospital, Turin, Italy.

Reprints: Anna Sapino, MD, Department of Biomedical Sciences and Human Oncology, University of Turin, Via Santena 7, 10126 Turin, Italy. E-mail: anna.sapino@unito.it.

Disclosure: The authors declare no conflicts of interest. Supported by Rete Oncologica Piemonte-Valle d'Aosta, PRIN 2008, AIRC 2011, Compagnia San Paolo, Cassa di Risparmio di Torino and Progetto Ricerca Sanitaria Finalizzata DD204/2009.

© 2012 Lippincott Williams & Wilkins, Inc.