Detection of Lymph Node Metastasis in Non-small Cell Lung Cancer Using the New System of One-step Nucleic Acid Amplification Assay

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2022 Mar 21

PMID 35312731

Authors

Naoko Ose

Yukiyasu Takeuchi

Yasushi Sakamaki

Yoshihisa Kadota

Koji Urasaki

Hiromi Tsuji

Kunimitsu Kawahara

Mayuko Noguchi

Yasushi Shintani

Affiliations

Soon will be listed here.

Abstract

Introduction: The prognosis of non-small cell lung cancer greatly depends on the presence of lymph node metastasis, which limits the need for surgery and adjuvant therapy for advanced cancer. One-step nucleic acid amplification of cytokeratin19 (CK19) mRNA was used to detect lymph node metastasis. Automated Gene Amplification Detector RD-200 and the LYNOAMP CK19 gene amplification reagent as components of the new one-step nucleic acid amplification system, which has increased gene amplification efficiency by improving the reagent composition, have shorter preprocessing and measurement times than conventional systems. We aimed to compare the clinical performance of the new system with that of histopathology and the conventional system.

Materials And Methods: 199 lymph nodes from 58 non-small cell lung cancer patients who underwent lymph node dissection were examined intraoperatively using the new system, conventional system, and histopathology.

Results: Lymph node metastasis was diagnosed in 32, 42, and 44 patients using histopathological analysis, the new system, and the conventional system, respectively. Compared with histopathological analysis, the concordance rate, sensitivity, specificity, positive predictive value, and negative predictive value of the new system were 92.0%, 90.6%, 92.2%, 69.0%, and 98.1%, respectively, and compared with the conventional system, the values were 95.0%, 86.4%, 97.4%, 90.5%, and 96.2%, respectively.

Conclusion: The clinical performance of the new one-step nucleic acid amplification system in detecting lymph node metastasis of lung cancer is comparable to that of histopathology and the conventional system; its performance was sufficient for determining the appropriate clinical treatment. The new rapid system can be effectively utilized during lung cancer treatment intraoperatively and postoperatively.

Citing Articles

The Detection of Lung Cancer Cell Profiles in Mediastinal Lymph Nodes Using a Hematological Analyzer and Flow Cytometry Method.

Kwiecien I, Rutkowska E, Raniszewska A, Sokolowski R, Bednarek J, Jahnz-Rozyk K Cancers (Basel). 2025; 17(3).

PMID: 39941799 PMC: 11816154. DOI: 10.3390/cancers17030431.

Sentinel Lymph Node Mapping in Lung Cancer: A Pilot Study for the Detection of Micrometastases in Stage I Non-Small Cell Lung Cancer.

Romano G, Zirafa C, Calabro F, Ali G, Manca G, De Liperi A Tomography. 2024; 10(5):761-772.

PMID: 38787018 PMC: 11125324. DOI: 10.3390/tomography10050058.

Diagnostic value of one-step nucleic acid amplification for sentinel lymph node metastasis in cytokeratin 19-positive tumors: evidence from bioinformatics and meta-analysis.

Li K, Meng M, Zhang W, Li J, Wang Y, Zhou C Front Oncol. 2024; 14:1370709.

PMID: 38651158 PMC: 11033366. DOI: 10.3389/fonc.2024.1370709.

Implications of ZNF334 gene in lymph node metastasis of lung SCC: potential bypassing of cellular senescence.

Khashei Varnamkhasti K, Moghanibashi M, Naeimi S J Transl Med. 2024; 22(1):372.

PMID: 38637790 PMC: 11025273. DOI: 10.1186/s12967-024-05115-9.

References

Peg V, Sansano I, Vieites B, Bernet L, Cano R, Cordoba A . Role of total tumour load of sentinel lymph node on survival in early breast cancer patients. Breast. 2017; 33:8-13. DOI: 10.1016/j.breast.2017.02.011. View

Postmus P, Kerr K, Oudkerk M, Senan S, Waller D, Vansteenkiste J . Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017; 28(suppl_4):iv1-iv21. DOI: 10.1093/annonc/mdx222. View

Itabashi M, Yamamoto H, Tomita N, Inomata M, Murata K, Hayashi S . Lymph Node Positivity in One-Step Nucleic Acid Amplification is a Prognostic Factor for Postoperative Cancer Recurrence in Patients with Stage II Colorectal Cancer: A Prospective, Multicenter Study. Ann Surg Oncol. 2019; 27(4):1077-1083. PMC: 7060165. DOI: 10.1245/s10434-019-07971-y. View

Terrenato I, DAlicandro V, Casini B, Perracchio L, Rollo F, De Salvo L . A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients. PLoS One. 2017; 12(2):e0171517. PMC: 5302783. DOI: 10.1371/journal.pone.0171517. View

Shimazu K, Miyake T, Okuno J, Naoi Y, Tanei T, Shimoda M . One-step Nucleic Acid Amplification Can Identify Sentinel Node-negative Breast Cancer Patients With Excellent Prognosis. Anticancer Res. 2019; 39(3):1447-1454. DOI: 10.21873/anticanres.13261. View

Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin D, Pineros M . Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int J Cancer. 2018; 144(8):1941-1953. DOI: 10.1002/ijc.31937. View

Guller U, Zettl A, Worni M, Langer I, Cabalzar-Wondberg D, Viehl C . Molecular investigation of lymph nodes in colon cancer patients using one-step nucleic acid amplification (OSNA): a new road to better staging?. Cancer. 2012; 118(24):6039-45. PMC: 3549559. DOI: 10.1002/cncr.27667. View

Inoue M, Hiyama K, Nakabayashi K, Morii E, Minami M, Sawabata N . An accurate and rapid detection of lymph node metastasis in non-small cell lung cancer patients based on one-step nucleic acid amplification assay. Lung Cancer. 2012; 78(3):212-8. DOI: 10.1016/j.lungcan.2012.08.018. View

Asamura H, Chansky K, Crowley J, Goldstraw P, Rusch V, Vansteenkiste J . The International Association for the Study of Lung Cancer Lung Cancer Staging Project: Proposals for the Revision of the N Descriptors in the Forthcoming 8th Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2015; 10(12):1675-84. DOI: 10.1097/JTO.0000000000000678. View

10.

Yamamoto H, Sekimoto M, Oya M, Yamamoto N, Konishi F, Sasaki J . OSNA-based novel molecular testing for lymph node metastases in colorectal cancer patients: results from a multicenter clinical performance study in Japan. Ann Surg Oncol. 2011; 18(7):1891-8. DOI: 10.1245/s10434-010-1539-5. View

11.

Escalante Perez M, Hermida Romero M, Alen B, Alvarez Martinez M, Prado R, De La Torre Bravos M . Detection of lymph node metastasis in lung cancer patients using a one-step nucleic acid amplification assay: a single-centre prospective study. J Transl Med. 2019; 17(1):233. PMC: 6647159. DOI: 10.1186/s12967-019-1974-4. View

12.

Shimazu K, Sato N, Ogiya A, Sota Y, Yotsumoto D, Ishikawa T . Intraoperative Nomograms, Based on One-Step Nucleic Acid Amplification, for Prediction of Non-sentinel Node Metastasis and Four or More Axillary Node Metastases in Breast Cancer Patients with Sentinel Node Metastasis. Ann Surg Oncol. 2018; 25(9):2603-2611. PMC: 6097722. DOI: 10.1245/s10434-018-6633-0. View

13.

Espinosa-Bravo M, Sansano I, Perez-Hoyos S, Ramos M, Sancho M, Xercavins J . Prediction of non-sentinel lymph node metastasis in early breast cancer by assessing total tumoral load in the sentinel lymph node by molecular assay. Eur J Surg Oncol. 2013; 39(7):766-73. DOI: 10.1016/j.ejso.2013.03.011. View

14.

Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antunez J, Sancho de Salas M . Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients. Breast Cancer Res Treat. 2013; 139(1):87-93. DOI: 10.1007/s10549-013-2524-z. View

15.

Osako T, Iwase T, Ushijima M, Yonekura R, Ohno S, Akiyama F . A new molecular-based lymph node staging classification determines the prognosis of breast cancer patients. Br J Cancer. 2017; 117(10):1470-1477. PMC: 5680460. DOI: 10.1038/bjc.2017.311. View

16.

Rubio I, Espinosa-Bravo M, Rodrigo M, Viguri Diaz M, Hardisson D, Sagasta A . Nomogram including the total tumoral load in the sentinel nodes assessed by one-step nucleic acid amplification as a new factor for predicting nonsentinel lymph node metastasis in breast cancer patients. Breast Cancer Res Treat. 2014; 147(2):371-80. DOI: 10.1007/s10549-014-3108-2. View

17.

Shimazu K, Tanei T, Tamaki Y, Saeki T, Osaki A, Hasebe T . Performance of a new system using a one-step nucleic acid amplification assay for detecting lymph node metastases in breast cancer. Med Oncol. 2019; 36(6):54. DOI: 10.1007/s12032-019-1277-x. View

18.

Han H, Chen H . Selective lymph node dissection in early-stage non-small cell lung cancer. J Thorac Dis. 2017; 9(7):2102-2107. PMC: 5542950. DOI: 10.21037/jtd.2017.06.04. View

19.

Deambrogio C, Castellano I, Paganotti A, Zorini E, Corsi F, Bussone R . A new clinical cut-off of cytokeratin 19 mRNA copy number in sentinel lymph node better identifies patients eligible for axillary lymph node dissection in breast cancer. J Clin Pathol. 2014; 67(8):702-6. DOI: 10.1136/jclinpath-2014-202384. View

20.

Nakagawa K, Asamura H, Tsuta K, Nagai K, Yamada E, Ishii G . 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. 2016; 97:1-7. DOI: 10.1016/j.lungcan.2016.03.015. View