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A New Diagnostic Method for Rapid Detection of Lymph Node Metastases Using a One-Step Nucleic Acid Amplification (OSNA) Assay in Endometrial Cancer

  • Gynecologic Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

To improve lymph node (LN) metastasis identification for patients with endometrial cancer (EC), this study assessed the usefulness of molecular biologic techniques using a one-step nucleic acid amplification (OSNA) assay.

Methods

Using quantitative reverse transcription polymerase chain reaction (qRT-PCR), an optimal mRNA marker was selected, and its expression was compared between histopathologically positive and negative LNs using an OSNA assay. The authors determined copy number cutoff values and evaluated the diagnostic performance of this OSNA assay using sentinel lymph nodes (SLNs). They also investigated whether an OSNA assay could detect LN metastases with sensitivity and specificity equivalent to the 2-mm-interval histopathology method.

Results

For analysis of EC samples, cytokeratin 19 (CK19) was selected as a useful mRNA marker for the OSNA assay. When the cutoff value was set at 250 copies (using 215 LNs from 70 patients), an OSNA assay using CK19 mRNA had a sensitivity of 93.3 %, a specificity of 99.5 %, and a concordance rate of 99.1 %. For performance evaluations using SLNs (120 histopathologically negative LNs and 17 histopathologically positive LNs from 35 patients), a OSNA assay using CK19 mRNA had a sensitivity of 82.4 %, a specificity of 99.2 %, a positive predictive value of 93.3 %, and a concordance rate of 97.1 %. Thus, an OSNA assay using CK19 mRNA provided results equivalent to those with the 2-mm-interval histopathology method.

Conclusions

The study data demonstrated that an OSNA assay using CK19 mRNA was applicable for detecting LN metastases in EC. Combined analysis using an OSNA assay and SLNs may improve individualized treatments according to LN metastatic status.

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Acknowledgment

The authors thank Ms. Emi Endo, Ms. Aya Miyabe, Mr. Hiroyuki Shimizu, and Mr. Kengo Goto for their substantial support. This study was supported in part by a Grant-in-Aid for Scientific Research on Priority Areas from the Ministry of Education, Science and Culture, Japan; a Grant-in-Aid for Scientific Research (B) and (C); a Grant-in-Aid for Young Scientists (B); a Grant-in-Aid for Exploratory Research, from the Ministry of Education, Science, Sports and Culture, Japan; a Grant-in-Aid from the Ministry of Health, Labor and Welfare, Japan; the Global COE Program Special Research Grant (Tohoku University) from the Ministry of Education Science, Sports and Culture, Japan; Kurokawa Cancer Research Foundation, and the Uehara Memorial Foundation.

Conflict of interest

There are no conflicts of interest.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Tohoku University School of Medicine, Sendai, Japan

    Tomoyuki Nagai MD, Hitoshi Niikura MD, Satoshi Okamoto PhD, Hiroki Utsunomiya MD, Satoru Nagase MD & Nobuo Yaegashi MD

  2. Department of Product Development of LS Business Unit, Sysmex Corporation, Kobe, Japan

    Kadzuki Nakabayashi PhD

  3. Department of Gynecology, Cancer Institute Hospital, Tokyo, Japan

    Maki Matoda MD & Nobuhiro Takeshima MD

  4. Department of Pathology, Tohoku University Hospital, Sendai, Japan

    Mika Watanabe MD

Authors
  1. Tomoyuki Nagai MD
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  2. Hitoshi Niikura MD
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  3. Satoshi Okamoto PhD
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  4. Kadzuki Nakabayashi PhD
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  5. Maki Matoda MD
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  6. Hiroki Utsunomiya MD
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  7. Satoru Nagase MD
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  8. Mika Watanabe MD
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  9. Nobuhiro Takeshima MD
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  10. Nobuo Yaegashi MD
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Corresponding author

Correspondence to Hitoshi Niikura MD.

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Nagai, T., Niikura, H., Okamoto, S. et al. A New Diagnostic Method for Rapid Detection of Lymph Node Metastases Using a One-Step Nucleic Acid Amplification (OSNA) Assay in Endometrial Cancer. Ann Surg Oncol 22, 980–986 (2015). https://doi.org/10.1245/s10434-014-4038-2

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  • DOI: https://doi.org/10.1245/s10434-014-4038-2

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