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.

Is intraoperative touch imprint cytology indicated in the surgical treatment of early breast cancers?

“…24 The cost for the total patient population was V362,664. Intraoperative histological examinations are less effective 4,6 and significantly increase treatment costs for patients operated on for early breast cancer.…”

A systematic review and economic evaluation of intraoperative tests [RD-100i one-step nucleic acid amplification (OSNA) system and Metasin test] for detecting sentinel lymph node metastases in breast cancer

“…The study by Le Frère-Belda et al 58 reported a sensitivity of 91.1% (95% CI 80.3% to 97.1%) and a specificity of 97.2% (95% CI 95.1% to 98.6%) for OSNA compared with five-level histology after adjustment for TAB.…”

“…Sixteen test accuracy papers were included for OSNA, [50][51][52][53][54][55][56][57][58][59][60][61][62][63][64][65] with two papers reporting the same study. Two unpublished papers 40,66 for Metasin were identified and assessed using the Standards for the Reporting of Diagnostic Accuracy Studies (STARD) in Table 7.…”

“…NIHR Journals Library www.journalslibrary.nihr.ac.uk Le Frère-Belda et al 58 reported a study assessing the intraoperative diagnostic performance of OSNA compared with extensive histological evaluation. This was a multicentre single-gate study involving eight clinical centres in France.…”

“…A single-gate study reported by Le Frère-Belda et al 58 provides a flow chart of the SLN samples as well as patient characteristics. This study investigates a reasonably heterogeneous population, although the majority had pN0 node status.…”