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A new clinical cut-off of cytokeratin 19 mRNA copy number in sentinel lymph node better identifies patients eligible for axillary lymph node dissection in breast cancer
  1. Cristina Deambrogio1,
  2. Isabella Castellano2,
  3. Alessia Paganotti3,
  4. Elisabetta Omodeo Zorini4,
  5. Fabio Corsi5,
  6. Riccardo Bussone6,
  7. Roberto Franchini7,
  8. Jlenia Antona1,
  9. Umberto Miglio1,
  10. Anna Sapino2,
  11. Concetta Antonacci4,
  12. Renzo Boldorini1
  1. 1Department of Health Science, School of Medicine, University of Eastern Piedmont “Amedeo Avogadro”, Novara, Italy
  2. 2Department of Medical Sciences, University of Turin, Turin, Italy
  3. 3Unit of Pathology, Maggiore Hospital, Novara, Italy
  4. 4Unit of Pathology, Luigi Sacco Hospital, Milan, Italy
  5. 5Department of Surgery, Luigi Sacco Hospital, University of Milan, Milan, Italy
  6. 6Breast Unit, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin, Italy
  7. 7Unit of Surgery, Maggiore Hospital, Novara, Italy
  1. Corresponding to Professor Renzo Boldorini, Dipartimento di Scienze della Salute, via Solaroli 17, Novara 28100, Italy; renzo.boldorini{at}


Aims Cytokeratin 19 (CK19) mRNA copy number predicts the probability of tumour load in axillary lymph nodes (ALN) and can help in decision-making regarding the axillary dissection. The purpose of this study was to define a new cut-off of CK19 mRNA copy number using the one-step nucleic acid amplification (OSNA) assay on metastatic sentinel lymph nodes (SLN) in order to identify cases at risk of having one or more positive ALN.

Methods 1296 SLN from 1080 patients were analysed with the OSNA assay. 194 patients with positive SLN underwent ALN dissection and the mean value of CK19 copy number (320 000) of their SLN was set as initial cut-off. Receiver operative characteristics curve identify a best cut-off of 7700 (sensitivity 78%, specificity 57%). A comparison between our and the traditional cut-off (5000) was performed.

Results The cut-off of 7700 successfully identifies patients with positive ALN (p=0.001, false- negative cases: 17%). In the range between 5000 and 7700, one patient with positive ALN would not undergo axillary dissection, whereas eight patients with negative ALN would be correctly identified.

Conclusions We suggest that the level of CK19 mRNA copy number could be the only parameter to consider in the intraoperative management of the axilla.

  • Breast Cancer
  • Lymph Nodes
  • Molecular Pathology
  • Surgery

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