title: Morbidity comparison of sentinel lymph node biopsy versus conventional axillary lymph node dissection for breast cancer patients: results of the sentinella-GIVOM Italian randomised clinical trial.
abstract: OBJECTIVE
  To compare physical morbidity and health-related quality of life (HRQOL) in breast cancer patients who received standard axillary dissection (ALND) or sentinel lymph node biopsy (SLNB), followed by axillary dissection only in the case of sentinel-node positivity, within a randomised clinical trial.
  
  
  METHODS
  Patients with early breast cancer < or =3cm and clinically negative axilla were randomly allocated to ALND or SLNB. All patients underwent physical examination every 6 months in order to assess any arm-related symptoms. A subset of patients completed the SF-36 quality of life questionnaire and the Psychological General Well Being Index (PGWBI) before randomisation, at 6 and 12 months after surgery and yearly thereafter. Results of the first 24 months are reported.
  
  
  RESULTS
  Six-hundred and seventy-seven patients were available for analysis: 341 patients randomised to the ALND group and 336 to the SLNB group. Six months after surgery, the SLNB group had significantly less lymph-oedema, movement restrictions, pain and numbness with respect to the ALND group. Lymph-oedema was also significantly reduced at 12 months and numbness remained significantly less frequent in the SLNB arm at all time points. Three-hundred and ten patients participated in the HRQOL assessment. The mean scores of the PGWB questionnaire general index and anxiety domain were significantly better in the SLNB group than in the ALND group but the difference ceased to be significant at 24 months.
  
  
  CONCLUSIONS
  The SLNB is associated with reduced arm morbidity without evidence of a negative impact on psychological well being. While waiting for long-term results of ongoing randomised clinical trials, the SLNB may be proposed for early stage breast cancer patients after adequate information on the expected advantages and the possible risks.
authors.affiliation: Clinical Trials and Biostatistics Unit, Istituto Oncologico Veneto - IRCCS, Via Gattamelata 64, Padova, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Del Bianco
authors.forename: G
authors.initials: G
authors.lastname: Zavagno
authors.forename: P
authors.initials: P
authors.lastname: Burelli
authors.forename: G
authors.initials: G
authors.lastname: Scalco
authors.forename: L
authors.initials: L
authors.lastname: Barutta
authors.forename: P
authors.initials: P
authors.lastname: Carraro
authors.forename: P
authors.initials: P
authors.lastname: Pietrarota
authors.forename: G
authors.initials: G
authors.lastname: Meneghini
authors.forename: T
authors.initials: T
authors.lastname: Morbin
authors.forename: G
authors.initials: G
authors.lastname: Tacchetti
authors.forename: P
authors.initials: P
authors.lastname: Pecoraro
authors.forename: V
authors.initials: V
authors.lastname: Belardinelli
authors.forename: G L
authors.initials: GL
authors.lastname: De Salvo
mesh_terms: D000368:Aged; D001365:Axilla / Q000601:surgery*; D001943:Breast Neoplasms / Q000453:epidemiology* / Q000401:mortality* / Q000473:pathology; D005260:Female; D006801:Humans; D007558:Italy; D008197:Lymph Node Excision / Q000706:statistics & numerical data*; D008875:Middle Aged; D009017:Morbidity; D009367:Neoplasm Staging; D011788:Quality of Life; D021701:Sentinel Lymph Node Biopsy / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires