title: Sentinel Lymph Node Biopsy Versus Axillary Dissection in Node-Negative Early-Stage Breast Cancer: 15-Year Follow-Up Update of a Randomized Clinical Trial.
abstract: Sentinel lymph node biopsy (SLNB) allows for staging of the axillary node status in early-stage breast cancer (BC) patients and avoiding complete axillary lymph node dissection (ALND) when the sentinel lymph node (SLN) is proven to be free of disease. In a previous randomized trial we compared SLNB followed by ALND (ALND arm) with SLNB followed by ALND only if the SLN presented metastasis (SLNB arm). At a mid-term of ≈ 6 years median follow-up, the two strategies appeared to ensure similar survival and locoregional control. We have revised these previous findings and update the results following a 15-year observation period.
  
  
  
  Patients were randomly assigned to either the ALND or SLNB arm. The main endpoints were event-free survival (EFS), overall survival (OS), and axillary disease recurrence. EFS and OS were assessed using Kaplan-Meier analysis and the log-rank test.
  
  
  
  The ALND and SLNB arms included 115 and 110 patients, respectively. At 14.3 years median follow-up, 39 primary BC-related recurrences occurred, 22 (19 %) of which occurred in the ALND arm and 17 (16 %) occurred in the SLNB arm (p = 0.519). No axillary relapse developed in the SLNB arm, while two were observed in the ALND arm. OS (82.0 vs. 78.8 %) and EFS (72.8 vs. 72.9 %) were not statistically different between the ALND and SLNB arms (p = 0.502 and 0.953, respectively).
  
  
  
  SLNB is a safe and efficacious component of the surgical treatment of early-stage BC patients. In the long-term, SLNB is equivalent to ALND in terms of locoregional nodal disease control and survival in this subset of patients.
authors.affiliation: Advanced Surgical Senology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.|Breast Unit, Istituto Clinico Humanitas IRCCS, Rozzano, MI, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Canavese
authors.affiliation: Clinical Epidemiology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Bruzzi
authors.affiliation: Advanced Surgical Senology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Catturich
authors.affiliation: Advanced Surgical Senology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Tomei
authors.affiliation: Pathological Anatomy and Cytohistology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Franca
authors.initials: F
authors.lastname: Carli
authors.affiliation: Clinical Epidemiology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Elsa
authors.initials: E
authors.lastname: Garrone
authors.affiliation: Advanced Surgical Senology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Spinaci
authors.affiliation: Advanced Surgical Senology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Lacopo
authors.affiliation: Breast Unit, Istituto Clinico Humanitas IRCCS, Rozzano, MI, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tinterri
authors.affiliation: Clinical Epidemiology Unit, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy. beatrice.dozin@hsanmartino.it.
authors.forename: Beatrice
authors.initials: B
authors.lastname: Dozin
mesh_terms: D000328:Adult; D000368:Aged; D001365:Axilla / Q000473:pathology*; D001943:Breast Neoplasms / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008197:Lymph Node Excision; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D009367:Neoplasm Staging; D021701:Sentinel Lymph Node Biopsy; D015996:Survival Rate