title: Diagnostic performance of one-step nucleic acid amplification for intraoperative sentinel node metastasis detection in breast cancer patients.
abstract: The purpose of this prospective multicenter study was to assess one-step nucleic acid amplification (OSNA) for intraoperative sentinel lymph node (SLN) metastasis detection in breast cancer patients, using final histology as the reference standard. OSNA results were also compared to intraoperative histology SLN evaluation and to standard clinicopathological risk markers. For this study, fresh SLNs were cut in four blocks, and alternate blocks were used for OSNA and histology. CK19 mRNA copy number was categorized as strongly positive, positive or negative. Positive histology was defined as presence of macrometastasis or micrometastasis. When discrepancies occurred, the entire SLNs were subjected to histological studies and the node lysates to additional molecular studies. Five hundred three SLN samples from 233 patients were studied. Mean time to evaluate two SLNs was 40 min. Sensitivity per patient was 91.4% (95% CI, 76.9-98.2%), specificity 93.3% (95% CI, 88.6-96.6%), positive likelihood ratio 13.7 and negative likelihood ratio 0.1. Sensitivity was 63.6% for frozen sections and 47.1% for touch imprint cytology. Both methods were 100% specific. Positive histology and positive OSNA were significantly associated with highest clinical stage, N1 status and vascular invasion; and OSNA results correlated with HER2/neu status and benefited patients with negative histology. These findings show that OSNA assay can allow detection of SLN metastasis in breast cancer patients intraoperatively with a good sensitivity, thus minimizing the need for second surgeries for axillary lymph node detection.
authors.affiliation: Department of Pathology, Hôpital Européen Georges Pompidou, Université Paris Descartes, France. marie-aude.le-frere-belda@egp.aphp.fr
authors.forename: Marie-Aude
authors.initials: MA
authors.lastname: Le Frère-Belda
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Bats
authors.forename: Florence
authors.initials: F
authors.lastname: Gillaizeau
authors.forename: Bruno
authors.initials: B
authors.lastname: Poulet
authors.forename: Krishna B
authors.initials: KB
authors.lastname: Clough
authors.forename: Claude
authors.initials: C
authors.lastname: Nos
authors.forename: Michel
authors.initials: M
authors.lastname: Peoc'h
authors.forename: Pierre
authors.initials: P
authors.lastname: Seffert
authors.forename: Catherine
authors.initials: C
authors.lastname: Bouteille
authors.forename: Agnès
authors.initials: A
authors.lastname: Leroux
authors.forename: François
authors.initials: F
authors.lastname: Guillemin
authors.forename: Cécile
authors.initials: C
authors.lastname: Blanc-Fournier
authors.forename: Hubert
authors.initials: H
authors.lastname: Crouet
authors.forename: Laurent
authors.initials: L
authors.lastname: Arnould
authors.forename: Jean
authors.initials: J
authors.lastname: Cuisenier
authors.forename: Frédérique
authors.initials: F
authors.lastname: Penault-Llorca
authors.forename: Pierre
authors.initials: P
authors.lastname: Gimbergues
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Jacquemier
authors.forename: Gilles
authors.initials: G
authors.lastname: Houvenaeghel
authors.forename: Gilles
authors.initials: G
authors.lastname: Chatellier
authors.forename: Fabrice
authors.initials: F
authors.lastname: Lécuru
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001365:Axilla; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000473:pathology; D005260:Female; D006801:Humans; D007432:Intraoperative Period; D053539:Keratin-19 / Q000235:genetics; D008207:Lymphatic Metastasis / Q000175:diagnosis*; D008875:Middle Aged; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy
chemical_list: D053539:Keratin-19