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Personalized Treatment of Breast Cancer pp 93–102Cite as

One-Step Nucleic Acid Amplification (OSNA) Assay for Primary Breast Cancer

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Abstract

Recently, sentinel lymph node biopsy (SLNB) has become a standard procedure for N0 breast cancer. OSNA (one-step nucleic acid amplification, SYSMEX) is an automated assay system using cytokeratin 19 mRNA to detect lymph node metastasis of breast cancer in 30–40 min. OSNA has already been approved by health insurance in Japan since 2008.

For the next step, the feasibility of the OSNA assay in breast cancer patients treated by PST has been confirmed under multicenter trial; we compared the judgment of the OSNA assay and of pathological examination on lymph nodes dissected after receiving PST to evaluate the performance of the OSNA assay. The overall concordance rate between the OSNA assay and pathological examination was 91.1 % (275/302) with sensitivity of 88.3 % (53/60) and specificity of 91.7 % (222/242) (Osako et al. British Journal of Cancer (2013) 109, 1693–1698). These results are very similar to those of the Japanese clinical validation study in breast cancer patients without receiving PST which was conducted by the almost same protocol (Tamaki Y, et al. Clin Cancer Res, 2009, 15: 2879–2884). These results indicate the OSNA assay can be applicable for breast cancer patients after receiving PST as well as breast cancer patients without receiving PST.

The status of residual cancer burden in SLN after PST has been assumed as one of prognostic factors. Therefore, the accurate measurement of cancer burden using OSNA is a promising method especially in the setting of PST.

At the present, the prospective clinical trial has been conducted to assess local recurrence rate and disease-free survival (DFS) of patients with OSNA negative without ALND after PST. The study is also focusing on the inclusion criteria for SNB among the cases of positive to negative change in preoperative imaging.

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Authors and Affiliations

  1. Department of Surgery, Division of Breast Surgical Oncology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan

    Seigo Nakamura & Katsutoshi Enokido

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  1. Seigo Nakamura
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  2. Katsutoshi Enokido
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Correspondence to Seigo Nakamura .

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Editors and Affiliations

  1. Department of Breast Surgery Graduate Sc, Kyoto University, Kyoto, Kyoto, Japan

    Masakazu Toi

  2. Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA

    Eric Winer

  3. Addenbrooke’s Hospital, Cambridge University Hospitals, Cambridge, Cambridgeshire, United Kingdom

    John Benson

  4. University of Arkansas for Medical Scien, Little Rock, Arkansas, USA

    Suzanne Klimberg

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Nakamura, S., Enokido, K. (2016). One-Step Nucleic Acid Amplification (OSNA) Assay for Primary Breast Cancer. In: Toi, M., Winer, E., Benson, J., Klimberg, S. (eds) Personalized Treatment of Breast Cancer. Springer, Tokyo. https://doi.org/10.1007/978-4-431-55552-0_7

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  • DOI: https://doi.org/10.1007/978-4-431-55552-0_7

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  • Online ISBN: 978-4-431-55552-0

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