title: Using ultrasound and palpation for predicting axillary lymph node status following neoadjuvant chemotherapy - Results from the multi-center SENTINA trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gynecology and Obstetrics, University Ulm, Prittwitzstraße 43, 89075 Ulm, Germany.
authors.forename: Lukas
authors.initials: L
authors.lastname: Schwentner
authors.affiliation: Department of Gynecology and Obstetrics, University Tübingen, Calwerstraße 7, 72076 Tübingen, Germany.
authors.forename: Gisela
authors.initials: G
authors.lastname: Helms
authors.affiliation: German Breast Group, Martin-Behaim-Straße 12, 63263 Neu-Isenburg, Germany.
authors.forename: Valentina
authors.initials: V
authors.lastname: Nekljudova
authors.affiliation: Department of Gynecologic Oncology, Klinikum Essen-Mitte, Henricistraße 92, 45136 Essen, Germany.
authors.forename: Beyhan
authors.initials: B
authors.lastname: Ataseven
authors.affiliation: Department of Gynecology and Obstetrics, Klinikum Landshut, Robert-Koch-Straße 1, 84034 Landshut, Germany.
authors.forename: Ingo
authors.initials: I
authors.lastname: Bauerfeind
authors.affiliation: Department of Gynecology and Obstetrics, University Munich, Marchionistraße 15, 81377 München, Germany.
authors.forename: Nina
authors.initials: N
authors.lastname: Ditsch
authors.affiliation: Department of Gynecology and Obstetrics, University Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany.
authors.forename: Tanja
authors.initials: T
authors.lastname: Fehm
authors.affiliation: Department of Pathology, Helios Klinikum Berlin Buch, Schwanebecker Chaussee 50, 13125 Berlin, Germany.
authors.forename: Barbara
authors.initials: B
authors.lastname: Fleige
authors.affiliation: Department of Gynecology and Obstetrics, Gesundheitszentrum Fricktal, Riburgerstraße 12, 4310 Rheinfelden, Switzerland.
authors.forename: Maik
authors.initials: M
authors.lastname: Hauschild
authors.affiliation: Department of Gynecology and Obstetrics, University Heidelberg, Neuenheimer Feld 440, 69120 Heidelberg, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Heil
authors.affiliation: Department of Senology, Klinikum Essen-Mitte, Henricistraße 92, 45136 Essen, Germany.
authors.forename: Sherko
authors.initials: S
authors.lastname: Kümmel
authors.affiliation: Department of Pathology, University Hamburg, Martinistraße 42, 20246 Hamburg, Germany.
authors.forename: Anette
authors.initials: A
authors.lastname: Lebeau
authors.affiliation: Breast Cancer Center, Elisabeth Krankenhausx, Weinbergstraße 7, 34117 Kassel, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Schmatloch
authors.affiliation: Department of Surgery, AKH Linz, Krankenhausstraße 9, 4020 Linz, Austria.
authors.forename: Peter
authors.initials: P
authors.lastname: Schrenk
authors.affiliation: Department of Pathology, University Tübingen, Liebermeisterstraße 8, 72076 Tübingen, Germany.
authors.forename: Anette
authors.initials: A
authors.lastname: Staebler
authors.affiliation: German Breast Group, Martin-Behaim-Straße 12, 63263 Neu-Isenburg, Germany.
authors.forename: Sibylle
authors.initials: S
authors.lastname: Loibl
authors.affiliation: Department of Gynecology and Obstetrics, Helios Klinikum Berlin Buch, Schwanebecker Chaussee 50, 13125 Berlin, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Untch
authors.affiliation: German Breast Group, Martin-Behaim-Straße 12, 63263 Neu-Isenburg, Germany.
authors.forename: Gunter
authors.initials: G
authors.lastname: Von Minckwitz
authors.affiliation: Department of Gynecology and Obstetrics, University Schleswig-Holstein, Ratzeburger Allee 160, 23538 Lübeck, Germany.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Liedtke
authors.affiliation: Department of Gynecology and Obstetrics, Hospital Esslingen, Hirschlandstraße 97, 73730 Esslingen, Germany. Electronic address: t.kuehn@klinikum-esslingen.de.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Kühn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001365:Axilla / Q000000981:diagnostic imaging; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D017024:Chemotherapy, Adjuvant; D005260:Female; D006276:Health Facility Size; D006801:Humans; D008198:Lymph Nodes / Q000000981:diagnostic imaging* / Q000473:pathology*; D008207:Lymphatic Metastasis; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D010173:Palpation; D011237:Predictive Value of Tests; D011446:Prospective Studies; D021701:Sentinel Lymph Node Biopsy; D014463:Ultrasonography; D055815:Young Adult
keywords: Axillary ultrasound; Breast cancer; Neoadjuvant chemotherapy; Sentinel-node-biopsy