Schwentner Lukas, Helms Gisela, Nekljudova Valentina, Ataseven Beyhan, Bauerfeind Ingo, Ditsch Nina, Fehm Tanja, Fleige Barbara, Hauschild Maik, Heil J, Kümmel Sherko, Lebeau Anette, Schmatloch Sabine, Schrenk Peter, Staebler Anette, Loibl Sibylle, Untch Michael, Von Minckwitz Gunter, Liedtke Cornelia, Kühn Thorsten
Department of Gynecology and Obstetrics, University Ulm, Prittwitzstraße 43, 89075 Ulm, Germany.
Department of Gynecology and Obstetrics, University Tübingen, Calwerstraße 7, 72076 Tübingen, Germany.
Breast. 2017 Feb;31:202-207. doi: 10.1016/j.breast.2016.11.012. Epub 2016 Nov 24.
With the growing importance of neoadjuvant systemic therapy (NST) the assessment of post neoadjuvant axillary status is of increasing importance especially in patients who presented initially with suspicious nodes (cN1). This study aims to investigate the predictive value of palpation and axillary ultrasound of formerly cN1 patients following NST.
The SENTINA trial (SENTinel NeoAdjuvant) is a 4-arm prospective multicenter study designed to evaluate the role of sentinel node biopsy (SLNB) in the context of neoadjuvant systemic treatment (NST) of breast cancer patients.
1240 patients from 103 institutions entered the trial. 715 (arm C n = 592; arm D n = 123) patients, who presented initially cN1 underwent clinical evaluation of lymph node status following NST. Palpation alone demonstrated a sensitivity of 8.3%, specifity of 94.8% and a negative predictive value (NPV) of 46.6%. Ultrasound alone revealed a sensitivity of 23.9%, specificity 91.7%, and a NPV of 50.3%.The investigators combined classification (palpation and ultrasound) resulted in a sensitivity of 24.4%, specificity 91.4%, and a NPV of 50.3%. Investigators classified the axilla nodes as being unsuspicious (cN0) following NST in 592/715 patients; of them 298 (50.3%) were pN0, 151 (25.5%) had 1-2 histologically involved nodes and 143 (24.2%) had >2 histologically involved nodes.
The diagnostic accuracy of ultrasound and palpation following NST is unacceptably low and additional tools for evaluation of the axillary lymph node status following NST are urgently needed.
随着新辅助全身治疗（NST）的重要性日益增加，新辅助治疗后腋窝状态的评估变得越发重要，尤其对于最初表现为可疑淋巴结（cN1）的患者。本研究旨在探讨NST后原cN1患者触诊和腋窝超声的预测价值。
SENTINA试验（哨兵新辅助试验）是一项四臂前瞻性多中心研究，旨在评估前哨淋巴结活检（SLNB）在乳腺癌患者新辅助全身治疗（NST）中的作用。
来自103个机构的1240例患者进入试验。715例（C组n = 592；D组n = 123）最初表现为cN1的患者在NST后接受了淋巴结状态的临床评估。单独触诊显示敏感性为8.3%，特异性为94.8%，阴性预测值（NPV）为46.6%。单独超声检查显示敏感性为23.9%，特异性为91.7%，NPV为50.3%。研究者联合分类（触诊和超声）的敏感性为24.4%，特异性为91.4%，NPV为50.3%。研究者将715例患者中592例NST后的腋窝淋巴结分类为不可疑（cN0）；其中298例（50.3%）为pN0，151例（25.5%）有1 - 2个组织学受累淋巴结，143例（24.2%）有>2个组织学受累淋巴结。
NST后超声和触诊的诊断准确性低得令人无法接受，迫切需要用于评估NST后腋窝淋巴结状态的其他工具。
