Evaluation of the one-step nucleic acid amplification assay for detecting lymph node metastasis in patients with cervical and endometrial cancer: A multicenter prospective study

Shinichi Togami; Akihide Tanimoto; Shintaro Yanazume; Hideki Tokunaga; Tomoyuki Nagai; Mika Watanabe; Hideaki Yahata; Kazuo Asanoma; Hidetaka Yamamoto; Tomohito Tanaka; Masahide Ohmichi; Takashi Yamada; Yukiharu Todo; Ryutaro Yamada; Hidenori Kato; Wataru Yamagami; Kenta Masuda; Miho Kawaida; Hitoshi Niikura; Takuya Moriya; Hiroaki Kobayashi

doi:10.1016/j.ygyno.2022.12.016

Evaluation of the one-step nucleic acid amplification assay for detecting lymph node metastasis in patients with cervical and endometrial cancer: A multicenter prospective study

Gynecol Oncol. 2023 Mar:170:70-76. doi: 10.1016/j.ygyno.2022.12.016. Epub 2023 Jan 11.

Authors

Shinichi Togami¹, Akihide Tanimoto², Shintaro Yanazume¹, Hideki Tokunaga³, Tomoyuki Nagai³, Mika Watanabe⁴, Hideaki Yahata⁵, Kazuo Asanoma⁵, Hidetaka Yamamoto⁶, Tomohito Tanaka⁷, Masahide Ohmichi⁷, Takashi Yamada⁸, Yukiharu Todo⁹, Ryutaro Yamada⁹, Hidenori Kato⁹, Wataru Yamagami¹⁰, Kenta Masuda¹⁰, Miho Kawaida¹¹, Hitoshi Niikura¹², Takuya Moriya¹³, Hiroaki Kobayashi¹⁴

Affiliations

¹ Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University, Kagoshima, Japan.
² Department of Pathology, Kagoshima University Graduate School of Medical and Dental Sciences, Japan.
³ Department of Obstetrics and Gynecology, Tohoku University School of Medicine, Miyagi, Japan.
⁴ Department of Pathology, Tohoku Kosai Hospital, Sendai, Japan.
⁵ Department of Obstetrics and Gynecology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
⁶ Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
⁷ Department of Obstetrics and Gynecology, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.
⁸ Department of Pathology, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.
⁹ Division of Gynecologic Oncology, National Hospital Organization, Hokkaido Cancer Center, 4-2 Kikusui, Shiroishi-ku, Sapporo 003-0804, Japan.
¹⁰ Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan.
¹¹ Department of Pathology, Keio University School of Medicine, Tokyo, Japan.
¹² Department of Obstetrics and Gynecology, National Hospital Organization Sendai Medical Center, Miyagi, Japan.
¹³ Department of Pathology, Kawasaki Medical School, Okayama, Japan.
¹⁴ Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University, Kagoshima, Japan. Electronic address: hirokoba@m2.kufm.kagoshima-u.ac.jp.

PMID: 36638744
DOI: 10.1016/j.ygyno.2022.12.016

Abstract

Objective: This multicenter study aimed to evaluate the accuracy of the one-step nucleic acid amplification (OSNA) assay in diagnosing lymph node metastasis (LNM) in patients with cervical and endometrial cancers.

Methods: Surgically removed LNs from patients with cervical and endometrial cancer were sectioned at 2-mm intervals along the short axis direction and alternately examined using the OSNA assay and conventional histopathological examination. Ultrastaging (200-μm LN sections) was performed for metastatic LNs using hematoxylin and eosin staining and immunostaining with an anti-CK19 antibody in cases where the OSNA assay and histopathological examination (performed using 2-mm LN sections) results showed discordance.

Results: A total of 437 LNs from 133 patients were included; 61 patients (14%) showed metastasis by histopathological examination, with a concordance rate of 0.979 (95% confidence interval [CI]: 0.961-0.991) with the OSNA assay. The sensitivity and specificity of the OSNA assay were 0.918 (95% CI: 0.819-0.973) and 0.989 (95% CI: 0.973-0.997), respectively. Discordance between the two methods was observed in nine LNs (2.1%), and allocation bias of metastatic foci was identified as the major cause of discordance.

Conclusions: The OSNA assay showed equally accurate detection of LN metastasis as the histopathological examination. We suggest that the OSNA assay may be a useful tool for the rapid intraoperative diagnosis of LN metastasis in patients with cervical and endometrial cancers.

Keywords: Cervical cancer; Endometrial cancer; One-step nucleic acid amplification; Sentinel lymph node.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Breast Neoplasms* / pathology
Endometrial Neoplasms* / pathology
Female
Humans
Keratin-19 / genetics
Lymph Nodes / pathology
Lymphatic Metastasis / pathology
Nucleic Acid Amplification Techniques / methods
Nucleic Acids*
Prospective Studies
Sentinel Lymph Node Biopsy

Substances

Nucleic Acids
Keratin-19