Tomasicchio Giovanni, Mastropasqua Mauro Giuseppe, Picciariello Arcangelo, Montanaro Alda Elena, Signorile Daniela, Cirilli Alfredo, Punzo Clelia
Department of Emergency and Organ Transplantation, School of Medicine, University of Bari "Aldo Moro", Piazza G Cesare, 11, 70124 Bari, Italy.
Breast Unit Surgery, Azienda Ospedaliera Universitaria Policlinico Bari, Piazza G Cesare, 11, 70124 Bari, Italy.
Cancers (Basel). 2022 Jul 12;14(14):3384. doi: 10.3390/cancers14143384.
(1) Background: The main discriminant in breast cancer prognosis is axillary lymph node status. In a select cohort of patients, axillary lymph node dissection (ALND) may be safely spared. This study aimed to determine a new possible cut-off of cytokeratin (CK) 19 mRNA copy number in the SLN to predict cases at high risk of positive ALND. (2) Methods: Clinical records of 1339 patients were retrospectively reviewed and were separated into two groups according to the axillary status (negative: ALNs- and positive ALNs+). Receiver operative characteristic (ROC) curves were used to identify a new optimal cut-off of CK19 mRNA copy number in SLN; (3) Results: Large tumor size and high grade were found mostly in ALNs+. Results from the ROC analyses, with an AUC of 82.1%, identified a new cut-off (9150 CK19 mRNA copies) showing 94% sensitivity, 67.3% specificity, 61.2% positive, and 95.3% negative predictive values; (4) OSNA remains the most-important intra-operative tool to identify patients who can benefit from ALND but with the traditional cut-off, many patients undergo needless ALND. The results of the present study suggest a new cut-off helpful to personalize surgical treatment and avoid unnecessary invasive procedures.
(1) 背景：乳腺癌预后的主要判别因素是腋窝淋巴结状态。在特定患者队列中，腋窝淋巴结清扫术（ALND）可能可安全省略。本研究旨在确定前哨淋巴结（SLN）中细胞角蛋白（CK）19 mRNA拷贝数的一个新的可能临界值，以预测ALND阳性高危病例。(2) 方法：回顾性分析1339例患者的临床记录，并根据腋窝状态分为两组（阴性：腋窝淋巴结阴性[ALNs-]和阳性[ALNs+]）。采用受试者操作特征（ROC）曲线确定SLN中CK19 mRNA拷贝数的新最佳临界值；(3) 结果：大肿瘤大小和高级别在ALNs+组中最为常见。ROC分析结果显示曲线下面积（AUC）为82.1%，确定了一个新的临界值（9150个CK19 mRNA拷贝），其敏感性为94%，特异性为67.3%，阳性预测值为61.2%，阴性预测值为95.3%；(4) 术中核酸分析（OSNA）仍然是识别可从ALND中获益患者的最重要术中工具，但按照传统临界值，许多患者接受了不必要的ALND。本研究结果提示一个有助于个性化手术治疗并避免不必要侵入性操作的新临界值。
