Abstract
Since 2007, one-step nucleic acid amplification (OSNA) has been used as a diagnostic system for sentinel lymph node (SLN) examination in patients with breast cancer. This study aimed to define a new clinical cut-off of CK19 mRNA copy number based on the calculation of the risk that an axillary lymph node dissection (ALND) will be positive. We analyzed 1529 SLNs from 1140 patients with the OSNA assay and 318 patients with positive SLNs for micrometastasis (250 copies) and macrometastasis (5000 copies) underwent ALND. Axillary non–SLNs were routinely examined. ROC curves and Youden’s index were performed in order to identify a new cut-off value. Logistic regression models were performed in order to compare OSNA categorical variables created on the basis of our and traditional cut-off to better identify patients who really need an axillary dissection. 69% and 31% of OSNA positive patients had a negative and positive ALND, respectively. ROC analysis identified a cut-off of 2150 CK19 mRNA copies with 95% sensitivity and 51% specificity. Positive and negative predictive values of this new cut-off were 47% and 96%, respectively. Logistic regression models indicated that the cut-off of 2150 copies better discriminates patients with node negative or positive in comparison with the conventional OSNA cut-off (p<0.0001). This cut-off identifies false positive and false negative cases and true-positive and true negative cases very efficiently, and therefore better identifies which patients really need an ALND and which patients can avoid one. This is why we suggest that the negative cut-off should be raised from 250 to 2150. Furthermore, we propose that for patients with a copy number that ranges between 2150 and 5000, there should be a multidisciplinary discussion concerning the clinical and bio-morphological features of primary breast cancer before any decision is taken on whether to perform an ALND or not.
Highlights
Sentinel lymph node (SLN) biopsy is currently the recommended procedure for axillary staging in clinically node-negative early breast cancer at diagnosis
In order to define a specific cut-off of CK19 mRNA copy number, we focused our study on the 318 patients with positive sentinel lymph node who underwent axillary dissection
Taking into account the entire series of patients included in our study, the percentage of cases with a positive SLN for micrometastases (OSNA+, 250–5000 copies) was 12.8% (146/1140), whereas the percentage for macrometastases (OSNA++) was 15% (172/1140)
Summary
Sentinel lymph node (SLN) biopsy is currently the recommended procedure for axillary staging in clinically node-negative early breast cancer at diagnosis. When patients are positive for SLN, complete ALND is usually performed but the non-sentinel lymph nodes (non–SLN) of 40%-70% of these patients are found not to have metastases [1,2,3]. Multiple studies have aimed to identify predictive variables of non-SLN metastases in order to select those patients who can be spared complete ALND. To this end, many nomograms [5, 6] have been proposed but all of these show some inconsistencies. Most of the variables considered in these studies are subjective and difficult to reproduce
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