One-Step Nucleic Acid Amplification method – what is the future of sentinel lymph node management?

Czech version

Authors: J. Kosťun ¹; M. Pešta ²; R. Slunečko ⁴; P. Vlasák ¹; J. Bouda ¹; D. Berezovskiy ¹; O. Topolčan ³; Z. Novotný ¹; J. Presl ¹
Authors‘ workplace: Gynekologicko-porodnická klinika FN a LF UK, Plzeň, přednosta doc. MUDr. Z. Novotný, CSc. ¹; Ústav biologie LF UK, Plzeň, vedoucí doc. RNDr. M. Pešta, Ph. D. ²; Oddělení imunochemické diagnostiky FN a LF UK, Plzeň, primář prof. MUDr. O. Topolčan, CSc. ³; Šiklův ústav patologie FN a LF UK, Plzeň, přednosta prof. MUDr. M. Michal ⁴
Published in: Ceska Gynekol 2018; 83(1): 57-61

Overview

Objective:
The article summarizes current possibilities of usage of the One-Step Nucleic Acid Amplification method (OSNA) in the perioperative management of sentinel lymph nodes in oncologic surgery. The principle of this method is the detection of cytokeratin 19 (CK19) in the lymphatic tissue as a marker of the metastatic spread.

Design:
Review article.

Settings:
Department of Obstetrics and Gynaecology, University Hospital Pilsen, Faculty of Medicine in Pilsen, Charles University, Prague; Department of Biology, Faculty of Medicine in Pilsen, Charles University, Prague; Department of Immunochemistry, University Hospital Pilsen, Faculty of Medicine in Pilsen, Charles University, Prague; Sikl´s Department of Pathology, University Hospital Pilsen, Faculty of Medicine in Pilsen, Charles University, Prague.

Methods:
The review of the literature published until the end of April 2017 available on the PubMed database was performed. The official abbreviation OSNA and the full name of the method One-Step Nucleic Acid Amplification was used for search in this database.

Conclusion:
The usage of the OSNA method with the detection of CK 19 in the sentinel lymph nodes as a marker of metastatic spread to the lymphatic tissue currently represents an acceptable form of perioperative sentinel lymph node management in patients with breast and colorectal cancer. Until now published data are pointing towards possible successful application of this method in sentinel lymph node management in patients with some other malignancies, such as thyroid carcinoma, gastric cancer, uterus cancer and head and neck cancer. More data is needed to establish this method also in those neoplasms.

Keywords:
OSNA, CK19, sentinel lymph node

Sources

1. Athwal, RK., Clarke D., Harries S., et al. Patient anxiety on the use of one step nucleic acid amplification (OSNA) during breast cancer surgery. Breast Disease, 2016, 36(1), p. 23–26.

2. Cabanas, RM. An approach for the treatment of penile carcinoma. Cancer, 1977, 39(2), p. 456–466.

3. Cibula, D., Oonk, MH., Abu-Rustum, NR. Sentinel lymph node biopsy in the management of gynecologic cancer. Curr Opin Obstet Gynecol, 2015, 27(1), p. 66–72.

4. Colombo, N., Creutzberg, C., Amant, F., et al. ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer: Diagnosis, Treatment and Follow-up. Inter J Gynecol Cancer, 2016, 26(1), p. 2–30.

5. Croner, RS., Schellerer, V., Demund, H., et al. One step nucleic acid amplification (OSNA) – a new method for lymph node staging in colorectal carcinomas. J Translat Med, 2010, p. 883.

6. del Carmen, S., Gatius, S., Franch-Arcas, G., et al. Concordance study between one-step nucleic acid amplification and morphologic techniques to detect lymph node metastasis in papillary carcinoma of the thyroid. Hum Pathol, 2016, p. 48132–48141.

7. Donker, M., van Tienhoven, G., Straver, ME., et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncology, 2014, 15(12), p. 1303–1310.

8. Dzvincuk, P., Pilka, R., Kudela, M., et al. [Sentinel lymph node detection using 99mTc-nanocolloid in endometrial cancer]. Ces Gynek, 2006, 71(3), s. 231–236.

9. Galimberti, V., Cole, BF., Zurrida, S., et al. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncology, 2013, 14(4), p. 297–305.

10. Giuliano, AE., Hunt, KK., Ballman, KV., et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA, 2011, 305(6), p. 569–575.

11. Goda, H., Nakashiro, K., Oka, R., et al. One-step nucleic acid amplification for detecting lymph node metastasis of head and neck squamous cell carcinoma. Oral Oncol, 2012, 48(10), p. 958–963.

12. Inoue, M., Hiyama, K., Nakabayashi, K., et al. 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), p. 212–218.

13. Khoury-Collado, F., St Clair, C., Abu-Rustum, NR. Sentinel lymph node mapping in endometrial cancer: an update. Oncologist, 2016, 21(4), p. 461–466.

14. Kumagai, K., Yamamoto, N., Miyashiro, I., et al. Multicenter study evaluating the clinical performance of the OSNA assay for the molecular detection of lymph node metastases in gastric cancer patients. Gastric Cancer, 2014, 17(2), p. 273–280.

15. Lopez-Ruiz, ME., Diestro, MD., Yebenes, L., et al. One-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node metastasis in endometrial cancer. Gynecol Oncol, 2016, 143(1), p. 54–59.

16. Nagai, T., Niikura, H., Okamoto, S., et al. A new diagnostic method for rapid detection of lymph node metastases using a one-step nucleic acid amplification (OSNA) assay in endometrial cancer. Ann Surg Oncol, 2015, 22(3), p. 980–986.

17. Nakagawa, K., Asamura, H., Tsuta, K., et al. 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, p. 971–977.

18. Network, NCC. Uterine Neoplasms. 2017; https://www.nccn.org/professionals/physician_gls/f_guidelines.asp#uterine, 2017.

19. Okamoto, S., Niikura, H., Nakabayashi, K., et al. Detection of sentinel lymph node metastases in cervical cancer: assessment of KRT19 mRNA in the one-step nucleic acid amplification (OSNA) method. Gynecol Oncol, 2013, 130(3), p. 530–536.

20. Raia-Barjat, T., Trombert, B., Khaddage, A., et al. OSNA (one-step nucleic acid amplification) sentinel lymph node intraoperative molecular analysis in breast cancer: a cost-benefit analysis. Medical Oncol, 2014, 31(12), p. 322.

21. Robova, H., Charvat, M., Strnad, P., et al. Lymphatic mapping in endometrial cancer: comparison of hysteroscopic and subserosal injection and the distribution of sentinel lymph nodes. Inter J Gynecol Cancer, 2009, 19(3), p. 391–394.

22. Robova, H., Rob, L., Halaska, MJ., et al. Current status of sentinel lymph node mapping in the management of endometrial cancer. Expert Rev Anticancer Ther, 2013, 13(1), p. 55–61.

23. Saruta, Y., Puig-Junoy, J. Cost and budget impact analysis of an accurate intraoperative sentinel lymph node diagnosis for breast cancer metastasis. Appl Health Econ Health Policy, 2016, 14(3), p. 323–335.

24. Slama, J., Dundr, P., Dusek, L., et al. High false negative rate of frozen section examination of sentinel lymph nodes in patients with cervical cancer. Gynec Oncol, 2013, 129(2), p. 384–388.

25. Slama, J., Zikan, M., Fischerova, D., et al. [Contribution of sentinel lymph-node biopsy to treatment of locally advanced stages of cervical cancers]. Ces Gynek, 2016, 81(3), s. 165–170.

26. Sysmex. OSNA – molecular detection of metastases in lymph nodes. 2017. https://www.sysmex-europe.com/products/oncology/sentinel-lymph-node-analysis-osna/clinical-evidence-osna.html

27. Tamaki, Y. One-step nucleic acid amplification (OSNA): where do we go with it? Int J Clin Oncol, 2017, 22(1), p. 3–10.

28. Terrenato, I., D‘Alicandro, V., Casini, B., et al. 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), p. e0171517.

29. Tsujimoto, M., Nakabayashi, K., Yoshidome, K., et al. One-step nucleic acid amplification for intraoperative detection of lymph node metastasis in breast cancer patients. Clin Cancer Res, 2007, 13(16), p. 4807–4816.

30. Yamamoto, H., Tomita, N., Inomata, M., et al. OSNA-Assisted Molecular Staging in Colorectal Cancer: A prospective multicenter trial in Japan. Ann Surg Oncol, 2016, 23(2), p. 391–396.