Lymph Node Positivity in One-Step Nucleic Acid Amplification is a Prognostic Factor for Postoperative Cancer Recurrence in Patients with Stage II Colorectal Cancer: A Prospective, Multicenter Study.
Itabashi M; Institute of Gastroenterology, Tokyo Women's Medical University, Shinjuku, Japan.
Yamamoto H; Department of Molecular Pathology, Division of Health Sciences, Graduate School of Medicine, Osaka University, Suita, Japan. .
Tomita N; Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.
Inomata M; Department of Gastroenterological and Pediatric Surgery, Faculty of Medicine, Oita University, Oita, Japan.
Murata K; Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.
Hayashi S; Department of Digestive Surgery, Nihon University Hospital, Chiyoda, Japan.
Miyake Y; Department of Surgery, Osaka Minato Central Hospital, Osaka, Japan.
Igarashi S; Division of Pathology, Tsuboi Cancer Center Hospital, Koriyama, Japan.
Kato T; Department of Colorectal Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Noura S; Department of Surgery, Osaka Rosai Hospital, Sakai, Japan.
Furuhata T; Division of Gastroenterological and General Surgery, St. Marianna University Toyoko Hospital, Kawasaki, Japan.
Ozawa H; Department of Colorectal Surgery, Tochigi Cancer Center, Utsunomiya, Japan.
Takemasa I; Department of Surgery, Surgical Oncology and Science, Sapporo Medical University, Sapporo, Japan.
Yasui M; Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
Takeyama H; Department of Surgery, Minoh City Hospital, Minoh, Japan.
Okamura S; Department of Surgery, Suita Municipal Hospital, Suita, Japan.
Ohno Y; Department of Mathematical Health Science, Graduate School of Medicine, Osaka University, Suita, Japan.
Matsuura N; Osaka International Cancer Institute, Osaka, Japan.
Annals of surgical oncology [Ann Surg Oncol] 2020 Apr; Vol. 27 (4), pp. 1077-1083. Date of Electronic Publication: 2019 Nov 13.
Typ publikacji :
Journal Article; Multicenter Study
Imprint Name(s) :
Publication: 2005- : New York, NY : Springer
Original Publication: New York, NY : Raven Press, c1994-
MeSH Terms :
Nucleic Acid Amplification Techniques*
Neoplasm Recurrence, Local/*diagnosis
Adult ; Aged ; Aged, 80 and over ; Colorectal Neoplasms/genetics ; Colorectal Neoplasms/surgery ; Disease-Free Survival ; Female ; Humans ; Japan ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Recurrence, Local/pathology ; Neoplasm Staging ; Prognosis ; Prospective Studies ; RNA, Messenger/genetics ; Survival Rate
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Substance Nomenclature :
0 (Biomarkers, Tumor)
0 (RNA, Messenger)
Entry Date(s) :
Date Created: 20191114 Date Completed: 20201223 Latest Revision: 20210404
Update Code :
PubMed Central ID :
Background: For colorectal cancer (CRC) patients, the standard histological lymph node (LN) evaluation has low sensitivity. Our previously developed one-step nucleic acid amplification (OSNA™) assay measures cytokeratin 19 gene expression in whole LNs. We recently showed that 17.6% of pN0 stage II CRC patients were OSNA positive, suggesting a correlation between OSNA results and disease recurrence. This multicenter, prospective study investigateed the prognostic value of the OSNA assay for pStage II CRC patients.
Methods: We examined 204 CRC patients who were preoperatively diagnosed as cN0 and cN1 and surgically treated at 11 medical institutions across Japan. Nine patients were excluded, and 195 patients (Stage I: n = 50, Stage II: n = 70, Stage III: n = 75) were examined. All LNs, harvested from patients, were examined histopathologically using one-slice hematoxylin-eosin staining. Furthermore, half of the LNs was examined by the OSNA assay. Patients were classified according to the UICC staging criteria and OSNA results, and the 3-year, disease-free survival (DFS) of each cohort was analyzed.
Results: Average 21.2 LNs/patient were subject to pathological examination. Approximately half of all harvested LNs (average, 9.4 LNs/patient) were suitable for the OSNA assay. Significantly lower 3-year DFS rates were observed in pStage (pathological Stage) II OSNA-positive patients than in OSNA-negative patients (p = 0.005). Among all assessed clinical and pathological parameters, only the OSNA result significantly affected 3-year DFS rates in pStage II CRC patients (p = 0.027).
Conclusions: This study shows that OSNA positivity is a risk factor for recurrence of the patients with pStage II CRC.