Routine clinical use of the one‐step nucleic acid amplification assay for detection of sentinel lymph node metastases in breast cancer patients

Abstract

; and the Japanese One-Step Nucleic Acid Amplification Study Group BACKGROUND: The objective of this study was to confirm, by means of a multicenter study conducted in Japan, the reliability and usefulness of the one-step nucleic acid amplification (OSNA) assay in routine clinical use for sentinel lymph node biopsy (SLNB) of breast cancer patients. METHODS: Patients with Tis-T2N0M0 breast cancer who underwent SLNB before systemic chemotherapy comprised the study cohort. A whole sentinel lymph node (SLN) was examined intraoperatively with the OSNA assay except for a 1-mm-thick, central slice of the lymph node, which underwent pathologic examination after the operation. For patients who underwent axillary dissection, non-SLNs were examined with routine pathologic examination. RESULTS: In total, 417 SLNBs from 413 patients were analyzed. SLN metastases were detected with greater sensitivity by the OSNA assay than by pathologic examination (22.5% vs 15.8%; P < .001), as expected from the difference in size of the specimens examined. Patients who had SLN metastases assessed with the OSNA assay proved to harbor non-SLN metastases with an overall risk ratio of 33.7%. The risk of non-SLN metastasis was significantly lower for patients who had positive SLNs assessed as OSNAþ than for those who had SLNs assessed as OSNAþþ (17.6% vs 44%; P ¼ .012). CONCLUSIONS: The OSNA assay can be used for routine clinical SLNB, and its assessment for volume of metastasis may be a powerful predictive factor for non-SLN metastasis. Further studies with more patients are needed to confirm the usefulness of this assay for selection in the clinical setting of patients who do not need axillary dissection.

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

“…A second paper by Tamaki et al 63 reports another multicentre study based in Japan. Comprehensive patient clinical characteristics are given with minimal details provided on recruitment.…”

“…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 Two unpublished papers 40,66 for Metasin were identified and assessed using the Standards for the Reporting of Diagnostic Accuracy Studies (STARD) in Table 7.…”

“…A subsequent Japanese multicentre study by Tamaki et al 63 investigated the clinical use of OSNA compared with one-level histology. This study used a single-gate design and involved 198 patients and 674 ALNs and SLNs.…”

One-step Nucleic Acid Amplification (OSNA) Fits Better with Lower Cost in Breast Cancer Axillary Management

“…Hence these costsaving methods do not guarantee the avoidance of a second surgery for patients. One-Step Nucleic Acid Amplification (OSNA) assay is a rapid and standardized molecular technique, which has been largely validated in literature for intraoperative SLN analysis in comparison with standard histology, thus providing an accurate tool for immediate decisions in management of the axilla [8,9]. Aim of our study was to investigate advantages of OSNA beyond its high accuracy for the definitive assessment of nodal involvement, including the possibility of a one-step surgery for both lumpectomy and possible axillary dissection, and subsequent anticipation in the onset of systemic adjuvant therapy.…”

“…Therefore, a large lymph node in paraffin wax, taking two adjacent sections every 50 micron and staining one of them with HE and the other one with IHC for cytokeratin [1,4]. For 114 patients SLN analysis was performed intraoperatively with OSNA system (Sysmex, Kobe, Japan) obtaining a definitive result about nodal status [8,11]. Nodal involvement has been defined as reported in Table 1 [10,11].…”