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

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 MoriyaHiroaki Kobayashi

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	70-76
Number of pages	7
Journal	Gynecologic Oncology
Volume	170
DOIs	https://doi.org/10.1016/j.ygyno.2022.12.016
Publication status	Published - 2023 Mar

Keywords

Cervical cancer
Endometrial cancer
One-step nucleic acid amplification
Sentinel lymph node

ASJC Scopus subject areas

Oncology
Obstetrics and Gynaecology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.ygyno.2022.12.016

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Togami, S., Tanimoto, A., Yanazume, S., Tokunaga, H., Nagai, T., Watanabe, M., Yahata, H., Asanoma, K., Yamamoto, H., Tanaka, T., Ohmichi, M., Yamada, T., Todo, Y., Yamada, R., Kato, H., Yamagami, W., Masuda, K., Kawaida, M., Niikura, H., ... Kobayashi, H. (2023). 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. Gynecologic Oncology, 170, 70-76. https://doi.org/10.1016/j.ygyno.2022.12.016

Togami, S, Tanimoto, A, Yanazume, S, Tokunaga, H, Nagai, T, Watanabe, M, Yahata, H, Asanoma, K, Yamamoto, H, Tanaka, T, Ohmichi, M, Yamada, T, Todo, Y, Yamada, R, Kato, H, Yamagami, W, Masuda, K, Kawaida, M, Niikura, H, Moriya, T & Kobayashi, H 2023, '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', Gynecologic Oncology, vol. 170, pp. 70-76. https://doi.org/10.1016/j.ygyno.2022.12.016

@article{c467fbf61f924a42967a448cdfc1d39e,

title = "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",

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",

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

note = "Funding Information: Sysmex Corporation (Kobe, Japan) provided research funding for this multicenter prospective study. Sysmex had no role in the data interpretation or preparation of the report. Publisher Copyright: {\textcopyright} 2023 Elsevier Inc.",

year = "2023",

month = mar,

doi = "10.1016/j.ygyno.2022.12.016",

language = "English",

volume = "170",

pages = "70--76",

journal = "Gynecologic Oncology",

issn = "0090-8258",

publisher = "Academic Press Inc.",

}

TY - JOUR

T1 - Evaluation of the one-step nucleic acid amplification assay for detecting lymph node metastasis in patients with cervical and endometrial cancer

T2 - A multicenter prospective study

AU - Togami, Shinichi

AU - Tanimoto, Akihide

AU - Yanazume, Shintaro

AU - Tokunaga, Hideki

AU - Nagai, Tomoyuki

AU - Watanabe, Mika

AU - Yahata, Hideaki

AU - Asanoma, Kazuo

AU - Yamamoto, Hidetaka

AU - Tanaka, Tomohito

AU - Ohmichi, Masahide

AU - Yamada, Takashi

AU - Todo, Yukiharu

AU - Yamada, Ryutaro

AU - Kato, Hidenori

AU - Yamagami, Wataru

AU - Masuda, Kenta

AU - Kawaida, Miho

AU - Niikura, Hitoshi

AU - Moriya, Takuya

AU - Kobayashi, Hiroaki

N1 - Funding Information: Sysmex Corporation (Kobe, Japan) provided research funding for this multicenter prospective study. Sysmex had no role in the data interpretation or preparation of the report. Publisher Copyright: © 2023 Elsevier Inc.

PY - 2023/3

Y1 - 2023/3

N2 - 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.

AB - 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.

KW - Cervical cancer

KW - Endometrial cancer

KW - One-step nucleic acid amplification

KW - Sentinel lymph node

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U2 - 10.1016/j.ygyno.2022.12.016

DO - 10.1016/j.ygyno.2022.12.016

M3 - Article

C2 - 36638744

AN - SCOPUS:85146346017

SN - 0090-8258

VL - 170

SP - 70

EP - 76

JO - Gynecologic Oncology

JF - Gynecologic Oncology

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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