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OSNA-Assisted Molecular Staging in Colorectal Cancer: A Prospective Multicenter Trial in Japan

Hirofumi Yamamoto MD, PhD, Naohiro Tomita MD, PhD, Masafumi Inomata MD, Tomohisa Furuhata MD, PhD, Yasuhiro Miyake MD, PhD, Shingo Noura MD, PhD, Takeshi Kato MD, PhD, Kohei Murata MD, PhD, Shigeoki Hayashi MD, PhD, Seiji Igarashi MD, PhD, Michio Itabashi MD, PhD, Shingo Kameoka MD, PhD, Nariaki Matsuura MD, PhD
Colorectal Cancer
Volume 23, Issue 2 / February , 2016

Abstract

Background

We previously reported that the one-step nucleic acid amplification (OSNA) assay provided a judgment performance for colorectal cancer equivalent to a 2-mm-interval histopathological examination of lymph nodes (concordance 97.1 %, n = 385 lymph nodes). In this prospective multicenter study, we uncovered an OSNA-assisted pathology to detect lymph node metastasis.

Methods

A total of 204 (50 stage I, 74 stage II, and 80 stage III) colorectal cancer patients. All 4324 lymph nodes were examined by the standard histology (one-slice H&E staining) and 1925 lymph nodes (44.5 %) of them were also subject to the OSNA analysis.

Results

The concordance rate between 1 slice hematoxylin/eosin and OSNA assay was 95.7 % (1,842/1925 lymph nodes). The sensitivity and specificity of the OSNA assay were 86.2 % (125/145) and 96.5 % (1717/1780), respectively. Among 124 node-negative patients (pN0), the respective upstaging rates of pStages I, IIA, IIB, and IIC were 2.0 % (1/50), 17.7 % (11/62), 12.5 % (1/8), and 25 % (1/4). OSNA-positive patients had deeper invasion to the colonic wall and severe lymphatic invasion (P = 0.048 and P = 0.004, respectively). The sum of the quantitative results of OSNA and total tumor load increased as the number of metastasized lymph nodes increased: 1550 copies/μL in pN0, 24,050 copies/μL in pN1, and 90,600 copies/μL in pN2.

Conclusions

The present study on colorectal cancer provided fundamental data regarding OSNA-assisted pathology of lymph node metastasis in Japan.

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