Hirofumi Yamamoto1,2, Naohiro Tomita3, Masafumi Inomata4, Tomohisa Furuhata5, Yasuhiro Miyake6, Shingo Noura7, Takeshi Kato8, Kohei Murata9, Shigeoki Hayashi10, Seiji Igarashi11, Michio Itabashi12, Shingo Kameoka12, Nariaki Matsuura13. 1. Division of Health Sciences, Department of Molecular Pathology, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan. hyamamoto@gesurg.med.osaka-u.ac.jp. 2. Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan. hyamamoto@gesurg.med.osaka-u.ac.jp. 3. Department of Surgery, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan. 4. Department of Gastroenterological and Pediatric Surgery, Faculty of Medicine, Oita University, Yufu, Oita, Japan. 5. Department of Nursing School of Health Sciences, Sapporo Medical University, Sapporo, Hokkaido, Japan. 6. Department of Surgery, Nishinomiya Municipal Central Hospital, Nishinomiya, Hyogo, Japan. 7. Department of Surgery, Osaka Rosai Hospital, Sakai, Osaka, Japan. 8. Department of Surgery, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan. 9. Department of Surgery, Suita Municipal Hospital, Suita, Osaka, Japan. 10. Department of Digestive Surgery, Surugadai Nihon University Hospital, Chiyoda-ku, Tokyo, Japan. 11. Division of Pathology, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan. 12. Department of Surgery II, Tokyo Women's Medical University, Shinjuku, Tokyo, Japan. 13. Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Osaka, Japan.
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.
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 cancerpatients. 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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