Abstract

BackgroundOne-step nucleic acid amplification (OSNA) for cytokeratin 19 messenger RNA is an intraoperative diagnostic procedure for the detection of lymph node metastasis.ObjectiveThis study aimed to construct intraoperative nomograms using OSNA for the prediction of non-sentinel lymph node (NSLN) metastasis and four or more axillary lymph node (ALN) metastases.MethodsOf the 4736 breast cancer patients (T1-3, N0) who underwent sentinel lymph node (SLN) biopsy and had SLNs examined intraoperatively with OSNA, 623 with SLN metastasis treated with completion ALN dissection (cALND) were retrospectively analyzed, and were randomly divided into training (n = 312) and validation (n = 311) sets.ResultsOf the clinicopathological parameters available preoperatively and intraoperatively, the multivariate analysis of the training set revealed that clinical tumor size and total tumor load (TTL) determined by OSNA were significantly associated with NSLN metastasis, and that clinical tumor size, number of macrometastatic SLNs, and TTL were significantly associated with four or more ALN metastases. Nomograms for NSLN metastasis and four or more ALN metastases were constructed using these parameters, and their area under the receiver operating characteristic curve (AUC) of the validation set were both 0.70, with a diagnostic accuracy similar to that of previously reported postoperative nomograms.ConclusionsWe constructed intraoperative nomograms using OSNA for the prediction of NSLN metastasis and four or more ALN metastases. These nomograms are as accurate as the conventional postoperative nomograms and might be helpful for decision making regarding the indication for cALND or the choice of adjuvant chemotherapeutic regimens and radiation field.

Highlights

  • One-step nucleic acid amplification (OSNA) for cytokeratin 19 messenger RNA is an intraoperative diagnostic procedure for the detection of lymph node metastasis

  • We identified 623 of these patients as having primary invasive carcinoma (T1-3, N0, M0) based on the following criteria: successful sentinel lymph node biopsy (SLNB) with at least one positive sentinel lymph node (SLN), and completion ALN dissection (cALND) with removal of at least five nodes

  • Univariate analysis of the clinicopathological parameters available before and during surgery revealed that for the training cohort, clinical tumor size, histological grade, number of positive SLNs, number of macrometastatic SLNs, and total tumor load (TTL) were significantly associated with non-sentinel lymph node (NSLN) metastasis

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Summary

Introduction

One-step nucleic acid amplification (OSNA) for cytokeratin 19 messenger RNA is an intraoperative diagnostic procedure for the detection of lymph node metastasis. Of the 4736 breast cancer patients (T1-3, N0) who underwent sentinel lymph node (SLN) biopsy and had SLNs examined intraoperatively with OSNA, 623 with SLN metastasis treated with completion ALN dissection (cALND) were retrospectively analyzed, and were. In the current era of precision medicine, the risk of NSLN metastasis should be estimated accurately, and the indication for cALND should be personalized according to the risk of NSLN metastasis For these reasons, various prediction models for NSLN metastasis and four or more ALN metastases have been developed for SLN-positive breast cancer patients.[9,10,11,12,13,14,15,16,17,18]

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