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      One-step nucleic acid amplification assay is an accurate technique for sentinel lymph node biopsy of breast cancer patients: a meta-analysis

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          Abstract

          Background:

          To estimate the accuracy of one-step nucleic acid amplification (OSNA) assay as an intra-operative sentinel lymph node biopsy (SLNB) for sentinel lymph node (SLN) metastasis in breast cancer.

          Methods:

          PubMed, Cochrane Library and Web of Science databases were searched by two independent reviewers to retrieve literature with per-patient analysis. The deadline was up until December 2016. A meta-analysis was performed using STATA, Meta-Disc, and Revman software. A random-effects model was used and subgroup analysis was carried out to identify possible sources of heterogeneity.

          Results:

          According to the inclusion criteria, 2833 patients from 12 studies were included in this meta-analysis. The pooled sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR) and the area under the sROC curve (AUC) for detecting SLN metastasis were 0.87 (95% CI 0.81–0.91), 0.92 (95% CI 0.86–0.95), 10.65 (95% CI 6.18–18.34), 0.14 (95% CI 0.10–0.20), 75.08 (95% CI 37.77–149.22) and 0.94 (95% CI 0.91–0.95), respectively.

          Conclusions:

          The present study adds the evidence that OSNA assay is an accurate molecular diagnostic tool for intra-operatively detecting SLN metastasis in breast cancer. One-step nucleic acid amplification assay might be introduced into clinical usage for replacing traditional intro-operative diagnostic methods of SLNB.

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          Expression of luminal and basal cytokeratins in human breast carcinoma.

          David Ellis, R W Blamey, El-Sayed Mahdy … (2004)
          We have examined basal and luminal cell cytokeratin expression in 1944 cases of invasive breast carcinoma, using tissue microarray (TMA) technology, to determine the frequency of expression of each cytokeratin subtype, their relationships and prognostic relevance, if any. Expression was determined by immunocytochemistry staining using antibodies to the luminal cytokeratins (CKs) 7/8, 18 and 19 and the basal markers CK 5/6 and CK 14. Additionally, assessment of alpha-smooth muscle actin (SMA) and oestrogen receptor status (ER) was performed. The vast majority of the cases showed positivity for CK 7/8, 18 and 19 indicating a differentiated glandular phenotype, a finding associated with good prognosis, ER positivity and older patient age. In contrast, basal marker expression was significantly related to poor prognosis, ER negativity and younger patient age. Multivariate analysis showed that CK 5/6 was an independent indicator for relapse free interval. We were able to subgroup the cases into four distinct phenotype categories (pure luminal, mixed luminal/basal, pure basal and null), which had significant differences in relation to the biological features and the clinical course of the disease. Tumours classified as expressing a basal phenotype (the combined luminal plus basal and the pure basal) were in a poor prognostic subgroup, typically ER negative in most cases. These findings provide further evidence that breast cancer has distinct differentiation subclasses that have both biological and clinical relevance. Copyright 2004 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.
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            One-step nucleic acid amplification for intraoperative detection of lymph node metastasis in breast cancer patients.

            Masahiko Tsujimoto, Kadzuki Nakabayashi, Katsuhide Yoshidome … (2007)
            Detection of sentinel lymph node (SLN) metastasis in breast cancer patients has conventionally been determined by intraoperative histopathologic examination of frozen sections followed by definitive postoperative examination of permanent sections. The purpose of this study is to develop a more efficient method for intraoperative detection of lymph node metastasis. Cutoff values to distinguish macrometastasis, micrometastasis, and nonmetastasis were determined by measuring cytokeratin 19 (CK19) mRNA in histopathologically positive and negative lymph nodes using one-step nucleic acid amplification (OSNA). In an intraoperative clinical study involving six facilities, 325 lymph nodes (101 patients), including 81 SLNs, were divided into four blocks. Alternate blocks were used for the OSNA assay with CK19 mRNA, and the remaining blocks were used for H&E and CK19 immunohistochemistry-based three-level histopathologic examination. The results from the two methods were then compared. We established CK19 mRNA cutoff values of 2.5 x 10(2) and 5 x 10(3) copies/muL. In the clinical study, an overall concordance rate between the OSNA assay and the three-level histopathology was 98.2%. Similar results were obtained with 81 SLNs. The OSNA assay discriminated macrometastasis from micrometastasis. No false positive was observed in the OSNA assay of 144 histopathologically negative lymph nodes from pN0 patients, indicating an extremely low false positive for the OSNA assay. The OSNA assay of half of a lymph node provided results similar to those of three-level histopathology. Clinical results indicate that the OSNA assay provides a useful intraoperative detection method of lymph node metastasis in breast cancer patients.
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              Frozen section analysis for intraoperative margin assessment during breast-conserving surgery results in low rates of re-excision and local recurrence.

              T P Olson, J. Harter, A. Munoz … (2007)
              Negative surgical margins minimize the risk of local recurrence after breast-conserving surgery. Intraoperative frozen section analysis (FSA) is one method for margin evaluation. We retrospectively analyzed records of patients who received breast-conserving therapy with intraoperative FSA of the lumpectomy cavity to assess re-excision rates and local control. Records were retrospectively reviewed for individuals who underwent breast-conserving surgery for ductal carcinoma in situ (DCIS) or invasive carcinoma between 1993 and 2003. Inclusion criteria were a minimum of 2 years follow-up and intact tumor at the time of operation. The major outcome measure was local recurrence. The Kaplan-Meier test was used to evaluate local recurrence rates between groups. 290 subjects with an average age of 57.2 years (range 27-89) underwent 292 lumpectomies with FSA. 11.3% had DCIS, 73.3% had infiltrating ductal, 5.8% had infiltrating lobular, and 9.6% exhibited other forms of invasive carcinoma. 70 subjects underwent additional resection at the time of breast surgery, 16 underwent subsequent re-excision, and 17 underwent subsequent mastectomy. At a median follow-up of 53.4 months (range 5.8-137.8), there were six local recurrences (2.74%) in patients who had breast-conserving procedures and two local recurrences in patients who underwent mastectomy. There were no statistically significant associations among local recurrence rate, tumor size, nodal status, or overall stage. Local recurrences were higher in patients with DCIS compared with invasive carcinoma, and tumors >2cm. Intraoperative FSA allows resection of suspicious or positive margins at the time of lumpectomy and results in low rates of local recurrence and re-excision. The low local recurrence rate reported here is comparable to those reported with other margin assessment techniques.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Br J Cancer
                Journal ID (iso-abbrev): Br. J. Cancer
                Title: British Journal of Cancer
                Publisher: Nature Publishing Group
                ISSN (Print): 0007-0920
                ISSN (Electronic): 1532-1827
                Publication date (Print): 10 October 2017
                Publication date (Electronic): 10 August 2017
                Volume: 117
                Issue: 8
                Pages: 1185-1191
                Affiliations
                [1 ]Department of Epidemiology and Statistics, School of Public Health, Jilin University , No. 1163, Xinmin Avenue, Changchun 130021, China
                Author notes
                Article
                Publisher Item ID: bjc2017262
                DOI: 10.1038/bjc.2017.262
                PMC ID: 5674095
                PubMed ID: 28797030
                SO-VID: becd0f21-3760-4351-9224-e4430e14d68b
                Copyright © Copyright © 2017 Cancer Research UK
                License:

                From twelve months after its original publication, this work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/4.0/

                History
                Date received : 27 April 2017
                Date revision received : 01 June 2017
                Date accepted : 13 July 2017
                Categories
                Subject: Molecular Diagnostics

                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: one-step nucleic acid amplification,sentinel lymph node biopsy,metastasis,breast cancer,cytokeratin 19,meta-analysis
                Data availability:
                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: one-step nucleic acid amplification, sentinel lymph node biopsy, metastasis, breast cancer, cytokeratin 19, meta-analysis

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