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OSNA-Assisted Molecular Staging in Colorectal Cancer: A Prospective Multicenter Trial in Japan

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

Abstract

Background

We previously reported that the one-step nucleic acid amplification (OSNA) assay provided a judgment performance for colorectal cancer equivalent to a 2-mm-interval histopathological examination of lymph nodes (concordance 97.1 %, n = 385 lymph nodes). In this prospective multicenter study, we uncovered an OSNA-assisted pathology to detect lymph node metastasis.

Methods

A total of 204 (50 stage I, 74 stage II, and 80 stage III) colorectal cancer patients. All 4324 lymph nodes were examined by the standard histology (one-slice H&E staining) and 1925 lymph nodes (44.5 %) of them were also subject to the OSNA analysis.

Results

The concordance rate between 1 slice hematoxylin/eosin and OSNA assay was 95.7 % (1,842/1925 lymph nodes). The sensitivity and specificity of the OSNA assay were 86.2 % (125/145) and 96.5 % (1717/1780), respectively. Among 124 node-negative patients (pN0), the respective upstaging rates of pStages I, IIA, IIB, and IIC were 2.0 % (1/50), 17.7 % (11/62), 12.5 % (1/8), and 25 % (1/4). OSNA-positive patients had deeper invasion to the colonic wall and severe lymphatic invasion (P = 0.048 and P = 0.004, respectively). The sum of the quantitative results of OSNA and total tumor load increased as the number of metastasized lymph nodes increased: 1550 copies/μL in pN0, 24,050 copies/μL in pN1, and 90,600 copies/μL in pN2.

Conclusions

The present study on colorectal cancer provided fundamental data regarding OSNA-assisted pathology of lymph node metastasis in Japan.

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Funding

This study was supported by Sysmex Corporation.

Author information

Author notes

    Authors and Affiliations

    1. Division of Health Sciences, Department of Molecular Pathology, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan

      Hirofumi Yamamoto MD, PhD

    2. Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan

      Hirofumi Yamamoto MD, PhD

    3. Department of Surgery, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan

      Naohiro Tomita MD, PhD

    4. Department of Gastroenterological and Pediatric Surgery, Faculty of Medicine, Oita University, Yufu, Oita, Japan

      Masafumi Inomata MD

    5. Department of Nursing School of Health Sciences, Sapporo Medical University, Sapporo, Hokkaido, Japan

      Tomohisa Furuhata MD, PhD

    6. Department of Surgery, Nishinomiya Municipal Central Hospital, Nishinomiya, Hyogo, Japan

      Yasuhiro Miyake MD, PhD

    7. Department of Surgery, Osaka Rosai Hospital, Sakai, Osaka, Japan

      Shingo Noura MD, PhD

    8. Department of Surgery, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan

      Takeshi Kato MD, PhD

    9. Department of Surgery, Suita Municipal Hospital, Suita, Osaka, Japan

      Kohei Murata MD, PhD

    10. Department of Digestive Surgery, Surugadai Nihon University Hospital, Chiyoda-ku, Tokyo, Japan

      Shigeoki Hayashi MD, PhD

    11. Division of Pathology, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan

      Seiji Igarashi MD, PhD

    12. Department of Surgery II, Tokyo Women’s Medical University, Shinjuku, Tokyo, Japan

      Michio Itabashi MD, PhD & Shingo Kameoka MD, PhD

    13. Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Osaka, Japan

      Nariaki Matsuura MD, PhD

    Authors
    1. Hirofumi Yamamoto MD, PhD
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    2. Naohiro Tomita MD, PhD
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    3. Masafumi Inomata MD
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    4. Tomohisa Furuhata MD, PhD
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    5. Yasuhiro Miyake MD, PhD
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    6. Shingo Noura MD, PhD
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    7. Takeshi Kato MD, PhD
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    8. Kohei Murata MD, PhD
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    9. Shigeoki Hayashi MD, PhD
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    10. Seiji Igarashi MD, PhD
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    11. Michio Itabashi MD, PhD
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    12. Shingo Kameoka MD, PhD
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    13. Nariaki Matsuura MD, PhD
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    Corresponding author

    Correspondence to Hirofumi Yamamoto MD, PhD.

    Additional information

    Hirofumi Yamamoto and Naohiro Tomita have contributed equally to this study.

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    Cite this article

    Yamamoto, H., Tomita, N., Inomata, M. et al. OSNA-Assisted Molecular Staging in Colorectal Cancer: A Prospective Multicenter Trial in Japan. Ann Surg Oncol 23, 391–396 (2016). https://doi.org/10.1245/s10434-015-4880-x

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    • DOI: https://doi.org/10.1245/s10434-015-4880-x

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