title: An improved axillary staging system using the OSNA assay does not modify the therapeutic management of breast cancer patients.
abstract: The one-step nucleic acid amplification (OSNA) assay is a molecular procedure that can identify deposits of breast cancer (BC) cells in the sentinel lymph node (SLN). We examined the consistency of the OSNA assay with a classic hematoxylin-eosin (H&E)-based immunohistochemistry (IHC) study and evaluated how OSNA-based axillary staging might impact the therapeutic management of BC patients. SLN biopsy results were considered to be positive in 60 patients (40%) in the OSNA group (N = 148) and in 43 (28%) patients in the IHC cohort (N = 153, p = 0.023). There was no difference in the macrometastasis (22% for OSNA, 15% for H&E, p = 0.139) or micrometastasis (19% for OSNA, 13% for H&E, p = 0.166) rates, but we found statistically significant differences in the number of isolated tumor cells (1% for OSNA, 11% for H&E, p < 0.001). There were no differences in the administration rate of adjuvant systemic therapy between the OSNA (66% in the SLN(+) patients) and the H&E (74% in the SLN(+) patients) groups (p = 0.159). The OSNA assay allows for the detection of SLN metastases more precisely than conventional pathologic methods but does not alter the therapeutic management of SLN(+) BC patients.
authors.affiliation: Department of Gynecology, Dr. Josep Trueta Hospital of Girona, Girona; Catalonia, Spain.
authors.forename: Miguel Alonso
authors.initials: MA
authors.lastname: Ruano
authors.affiliation: Department of Anatomical Pathology, Dr. Josep Trueta Hospital of Girona, Girona; Catalonia, Spain.
authors.forename: Eugeni
authors.initials: E
authors.lastname: Lopez-Bonet
authors.affiliation: 1] Epidemiology Unit and Cancer Registry of Girona (UERCG), Catalan Cancer Plan, Catalan Health Government, Girona, Catalonia, Spain [2] Girona Biomedical Research Institute (IDIBGI), Girona; Catalonia, Spain [3] Nursery Department, Universitat de Girona (UdG), Girona; Catalonia, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Buxó
authors.affiliation: Department of Gynecology, Dr. Josep Trueta Hospital of Girona, Girona; Catalonia, Spain.
authors.forename: Francesc
authors.initials: F
authors.lastname: Tuca-Rodríguez
authors.affiliation: Department of Gynecology, Dr. Josep Trueta Hospital of Girona, Girona; Catalonia, Spain.
authors.forename: Ester
authors.initials: E
authors.lastname: Vila-Camps
authors.affiliation: Department of Gynecology, Dr. Josep Trueta Hospital of Girona, Girona; Catalonia, Spain.
authors.forename: Elena
authors.initials: E
authors.lastname: Alvarez
authors.affiliation: Unit of Clinical Research, Catalan Institute of Oncology, Girona; Catalonia, Spain.
authors.forename: Begoña
authors.initials: B
authors.lastname: Martin-Castillo
authors.affiliation: 1] Girona Biomedical Research Institute (IDIBGI), Girona; Catalonia, Spain [2] Translational Research Laboratory, Catalan Institute of Oncology (ICO), Girona; Catalonia, Spain.
authors.forename: Javier A
authors.initials: JA
authors.lastname: Menendez
mesh_terms: D000328:Adult; D000368:Aged; D001365:Axilla; D001943:Breast Neoplasms / Q000188:drug therapy / Q000235:genetics / Q000473:pathology*; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy / Q000235:genetics / Q000556:secondary*; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology*; D008207:Lymphatic Metastasis; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques; D009367:Neoplasm Staging / Q000379:methods; D021141:Nucleic Acid Amplification Techniques; D058996:Quality Improvement