Our multi-centric trial using the OSNA assay for sentinel node evaluation in breast cancer demonstrates that this is a highly sensitive, specific and reproducible technique that allows for standardization of the SN diagnostic procedure, a necessary, and until now unresolved, issue.

Several models have been developed to predict non-sentinel nodes (NSLN) metastasis in patients with a positive sentinel node (SLN) that incorporates a standard pathology examination of the SLN. It has been reported that total tumoral load (TTL) in the SLNs assessed by one-step nucleic acid amplification (OSNA) is a predictive factor for additional NSLN metastasis in the axillary lymph node dissection (ALND). The objective was to develop a nomogram that predicts patient´s risk of additional NSLN metastasis incorporating TTL in the SLNs assessed by OSNA. Six hundred and ninety-seven consecutive patients with positive SLN evaluation by OSNA and a completion ALND were recruited. Pathologic features of the primary tumor and SLN metastases, including TTL were collected. Multivariate logistic regression identified factors predictive of non-SLN metastasis. A nomogram was developed with these variables and validated in an external cohort. On multivariate logistic regression analysis, tumor size, number of affected SLN, Her2 overexpression, lymphovascular invasion, and TTL were each associated with the likelihood of additional NSLN metastasis (p < 0.05). The overall predictive accuracy of the nomogram, as measured by the AUC was 0.7552 (95 %CI 0.7159-0.7945). When applied to the external cohort the nomogram was accurate with an AUC = 0.678 (95 %CI 0.621-0.736). This novel nomogram that incorporates TTL assessed by OSNA performs well and may help clinicians to make decisions about ALND for individual patients. Moreover, the standardization of pathologic assessment by OSNA may help to achieve interinstitutional reproducibility among nomograms.

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Tumour molecular subtyping defines different pCR to neoadjuvant chemotherapy (NC) but has no impact over DFS in patients with LABC. Although no significant correlation between HER2 status and trastuzumab therapy with pCR was found, probably due to the small number of patients, a favourable trend was observed in the group of HER2+ tumours treated with T.