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Diagnostic performance of one‐step nucleic acid amplification for intraoperative sentinel node metastasis detection in breast cancer patients
Author(s) -
Le FrèreBelda MarieAude,
Bats AnneSophie,
Gillaizeau Florence,
Poulet Bruno,
Clough Krishna B.,
Nos Claude,
Peoc'h Michel,
Seffert Pierre,
Bouteille Catherine,
Leroux Agnès,
Guillemin François,
BlancFournier Cécile,
Crouet Hubert,
Arnould Laurent,
Cuisenier Jean,
PenaultLlorca Frédérique,
Gimbergues Pierre,
Jacquemier Jocelyne,
Houvenaeghel Gilles,
Chatellier Gilles,
Lécuru Fabrice
Publication year - 2011
Publication title -
international journal of cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.475
H-Index - 234
eISSN - 1097-0215
pISSN - 0020-7136
DOI - 10.1002/ijc.26291
Subject(s) - micrometastasis , medicine , histology , breast cancer , sentinel lymph node , metastasis , lymph node , prospective cohort study , cancer , cytology , pathology , radiology , oncology
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.