The novel one-step nucleic acid amplification (OSNA) assay for the diagnosis of lymph node metastasis in patients with non-small cell lung cancer (NSCLC): Results of a multicenter prospective study

Kazuo Nakagawa, Hisao Asamura, Koji Tsuta, Kanji Nagai, Eiji Yamada, Genichiro Ishii, Tetsuya Mitsudomi, Akihiko Ito, Masahiko Higashiyama, Yasuhiko Tomita, Masayoshi Inoue, Eiichi Morii, Nariaki Matsuura, Meinoshin Okumura

研究成果: Article査読

20 被引用数 (Scopus)

抄録

Objectives: The precise and rapid diagnosis of the presence or absence of lymph node (LN) metastasis is essential for deciding upon an appropriate therapeutic strategy for patients with non-small cell lung cancer (NSCLC). We conducted a prospective multicenter clinical trial in Japan to evaluate a rapid, automated and objective assay system, the one-step nucleic acid amplification (OSNA) assay (Sysmex Corp), which targets cytokeratin 19 mRNA, to detect LN metastasis of NSCLC. Materials and methods: A total of 410 Lymph nodes (LNs) from 111 patients with clinical stage IB to IIIA NSCLC who underwent lung resection with LN dissection were included in this study. The LNs were divided into 4 blocks and examined by either the OSNA assay or a 3-level histological examination. The results of each method were compared and further analyses were performed for discordant cases. The primary endpoint was a concordance rate of more than 85% between the two methods. Results: The concordance rate between the two methods was 92.7% (95% CI, 89.7-95.0%), with a sensitivity of 79.7% (95% CI, 67.2-89.0%). Discordant results were observed in 30 LNs (5.8%), and were mainly due to a tissue allocation bias and/or contamination by CK19-expressing alveolar cells in LNs. Conclusion: The OSNA assay gave a diagnosis that was as accurate as a 3-level histological examination, which is more detailed than a histological examination in routine clinical practice. The OSNA assay might be useful in intraoperative decision-making in personalized lung cancer surgery based on the LN status.

本文言語English
ページ(範囲)1-7
ページ数7
ジャーナルLung Cancer
97
DOI
出版ステータスPublished - 2016 7月 1

ASJC Scopus subject areas

  • 腫瘍学
  • 呼吸器内科
  • 癌研究

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