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

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1-7
Number of pages7
JournalLung Cancer
Volume97
DOIs
Publication statusPublished - 2016 Jul 1

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Non-Small Cell Lung Carcinoma
Nucleic Acids
Multicenter Studies
Lymph Nodes
Prospective Studies
Neoplasm Metastasis
Keratin-19
Alveolar Epithelial Cells
Lymph Node Excision
Lung Neoplasms
Decision Making
Japan
Clinical Trials
Lung
Messenger RNA

Keywords

  • Histological examination
  • LN status
  • Lymph node metastasis
  • Non-small cell lung cancer (NSCLC)
  • One-step nucleic acid amplification (OSNA)

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

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

In: Lung Cancer, Vol. 97, 01.07.2016, p. 1-7.

Research output: Contribution to journalArticle

Nakagawa, K, Asamura, H, Tsuta, K, Nagai, K, Yamada, E, Ishii, G, Mitsudomi, T, Ito, A, Higashiyama, M, Tomita, Y, Inoue, M, Morii, E, Matsuura, N & Okumura, M 2016, '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', Lung Cancer, vol. 97, pp. 1-7. https://doi.org/10.1016/j.lungcan.2016.03.015
Nakagawa, Kazuo ; Asamura, Hisao ; Tsuta, Koji ; Nagai, Kanji ; Yamada, Eiji ; Ishii, Genichiro ; Mitsudomi, Tetsuya ; Ito, Akihiko ; Higashiyama, Masahiko ; Tomita, Yasuhiko ; Inoue, Masayoshi ; Morii, Eiichi ; Matsuura, Nariaki ; Okumura, Meinoshin. / 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. In: Lung Cancer. 2016 ; Vol. 97. pp. 1-7.
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abstract = "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.",
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T1 - 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)

T2 - Results of a multicenter prospective study

AU - Nakagawa, Kazuo

AU - Asamura, Hisao

AU - Tsuta, Koji

AU - Nagai, Kanji

AU - Yamada, Eiji

AU - Ishii, Genichiro

AU - Mitsudomi, Tetsuya

AU - Ito, Akihiko

AU - Higashiyama, Masahiko

AU - Tomita, Yasuhiko

AU - Inoue, Masayoshi

AU - Morii, Eiichi

AU - Matsuura, Nariaki

AU - Okumura, Meinoshin

PY - 2016/7/1

Y1 - 2016/7/1

N2 - 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.

AB - 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.

KW - Histological examination

KW - LN status

KW - Lymph node metastasis

KW - Non-small cell lung cancer (NSCLC)

KW - One-step nucleic acid amplification (OSNA)

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