title: Sentinel lymph node biopsy in breast cancer: ten-year results of a randomized controlled study.
abstract: OBJECTIVE
  Sentinel node biopsy (SNB) is widely used to stage the axilla in breast cancer. We present 10-year follow-up of our single-institute trial designed to compare outcomes in patients who received no axillary dissection if the sentinel node was negative, with patients who received complete axillary dissection.
  
  
  METHODS
  From March 1998 to December 1999, 516 patients with primary breast cancer up to 2 cm in pathologic diameter were randomized either to SNB plus complete axillary dissection (AD arm) or to SNB with axillary dissection only if the sentinel node contained metastases (SN arm).
  
  
  RESULTS
  The 2 arms were well-balanced for number of sentinel nodes found, proportion of positive sentinel nodes, and all other tumor and patient characteristics. About 8 patients in the AD arm had false-negative SNs on histologic analysis: a similar number (8, 95% CI: 3-15) of patients with axillary involvement was expected in SN arm patients who did not receive axillary dissection; but only 2 cases of overt axillary metastasis occurred. There were 23 breast cancer-related events in the SN arm and 26 in the AD arm (log-rank, P = 0.52), while overall survival was greater in the SN arm (log-rank, P = 0.15).
  
  
  CONCLUSIONS
  Preservation of healthy lymph nodes may have beneficial consequences. Axillary dissection should not be performed in breast cancer patients without first examining the sentinel node.
authors.affiliation: European Institute of Oncology, Milan, Italy. umberto.veronesi@ieo.it
authors.forename: Umberto
authors.initials: U
authors.lastname: Veronesi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Viale
authors.forename: Giovanni
authors.initials: G
authors.lastname: Paganelli
authors.forename: Stefano
authors.initials: S
authors.lastname: Zurrida
authors.forename: Alberto
authors.initials: A
authors.lastname: Luini
authors.forename: Viviana
authors.initials: V
authors.lastname: Galimberti
authors.forename: Paolo
authors.initials: P
authors.lastname: Veronesi
authors.forename: Mattia
authors.initials: M
authors.lastname: Intra
authors.forename: Patrick
authors.initials: P
authors.lastname: Maisonneuve
authors.forename: Francesca
authors.initials: F
authors.lastname: Zucca
authors.forename: Giovanna
authors.initials: G
authors.lastname: Gatti
authors.forename: Giovanni
authors.initials: G
authors.lastname: Mazzarol
authors.forename: Concetta
authors.initials: C
authors.lastname: De Cicco
authors.forename: Dario
authors.initials: D
authors.lastname: Vezzoli
mesh_terms: D000368:Aged; D001365:Axilla; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008197:Lymph Node Excision; D008207:Lymphatic Metastasis; D008875:Middle Aged; D021701:Sentinel Lymph Node Biopsy; D015996:Survival Rate