title: One-step nucleic acid amplification assay for intraoperative prediction of non-sentinel lymph node metastasis in breast cancer patients with sentinel lymph node metastasis.
abstract: The aim of the present study was to construct the intra-operative prediction model of non-sentinel lymph node (non-SLN) metastasis in breast cancer patients with SLN metastasis using one-step nucleic acid amplification (OSNA). Of 833 breast cancer patients (T1-T2, N0) who underwent SLN biopsy and had their SLNs examined intra-operatively with the OSNA assay, 161 with SLN metastasis and treated with completion axillary lymph node dissection (cALND) were randomly divided into a training (n = 81) and a validation (n = 80) cohort. Non-SLN metastasis of the training cohort was associated with the number of positive SLNs (P = 0.001), CK19 mRNA copy number (P = 0.001), and clinical tumor size (P = 0.055). These parameters were used to construct the intra-operative prediction model of non-SLN metastasis. Its diagnostic accuracy (AUC of ROC curve) was 0.809 and 0.704 for the training and validation cohorts, respectively. The intra-operative prediction model using OSNA may have a diagnostic accuracy of non-SLN metastasis comparable to that of the conventional, post-operative prediction model, indicating that it might help decide the indication for cALND.
authors: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan.
authors: Atsuko
authors: A
authors: Teramoto
authors: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan.
authors: Kenzo
authors: K
authors: Shimazu
authors: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan.
authors: Yasuto
authors: Y
authors: Naoi
authors: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan.
authors: Atsushi
authors: A
authors: Shimomura
authors: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan.
authors: Masafumi
authors: M
authors: Shimoda
authors: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan.
authors: Naofumi
authors: N
authors: Kagara
authors: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan.
authors: Naomi
authors: N
authors: Maruyama
authors: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan.
authors: Seung Jin
authors: SJ
authors: Kim
authors: Department of Surgery, Osaka Police Hospital, 10-31 Kitayamacho, Tennouji-ku, Osaka-shi, Osaka 543-0035, Japan.
authors: Katsuhide
authors: K
authors: Yoshidome
authors: Department of Pathology, Osaka Police Hospital, 10-31 Kitayamacho, Tennouji-ku, Osaka-shi, Osaka 543-0035, Japan.
authors: Masahiko
authors: M
authors: Tsujimoto
authors: Department of Breast and Endocrine Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 3-3 Nakamichi 1-Chome, Higashinari-ku, Osaka-shi, Osaka 537-8511, Japan.
authors: Yasuhiro
authors: Y
authors: Tamaki
authors: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan. Electronic address: noguchi@onsurg.med.osaka-u.ac.jp.
authors: Shinzaburo
authors: S
authors: Noguchi
mesh_terms: D001365:Axilla; D014408:Biomarkers, Tumor / Q000378:metabolism*; D001943:Breast Neoplasms / Q000378:metabolism / Q000473:pathology* / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000378:metabolism / Q000473:pathology* / Q000601:surgery; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000378:metabolism / Q000473:pathology* / Q000601:surgery; D018275:Carcinoma, Lobular / Q000378:metabolism / Q000473:pathology* / Q000601:surgery; D003661:Decision Support Techniques; D005260:Female; D006801:Humans; D007430:Intraoperative Care / Q000379:methods*; D053539:Keratin-19 / Q000378:metabolism; D016015:Logistic Models; D008197:Lymph Node Excision; D008207:Lymphatic Metastasis; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D012372:ROC Curve; D012189:Retrospective Studies; D021701:Sentinel Lymph Node Biopsy; D047368:Tumor Burden
chemical_list: D014408:Biomarkers, Tumor; D053539:Keratin-19
keywords: CK19 mRNA; Intra-operative prediction model; Non-sentinel lymph node metastasis