Primary systemic treatment and concomitant low dose radiotherapy for breast cancer: Final results of a prospective phase II study

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-offof 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-offof 7700 (sensitivity 78%, specificity 57%). A comparison between our and the traditional cut-off(5000) was performed. Results The cut-offof 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. © 2014 by the BMJ Publishing Group Ltd & Association of Clinical Pathologists.