title: Sentinel-Lymph-Node-Based Management or Routine Axillary Clearance? Five-Year Outcomes of the RACS Sentinel Node Biopsy Versus Axillary Clearance (SNAC) 1 Trial: Assessment and Incidence of True Lymphedema.
abstract: OBJECTIVE
  To determine whether the benefits of sentinel-node-based management (SNBM) over routine axillary clearance (RAC) persisted to 5 years.
  
  
  METHODS
  A total of 1088 women with breast cancer less than 3 cm in diameter and clinically negative axillary nodes were randomized to SNBM with axillary clearance if the sentinel node was positive or RAC preceded by sentinel-node biopsy. The outcomes were: (1) objectively measured change in the volume of the operated and contralateral nonoperated arms; (2) the proportion with an increase in arm volume <15%; and (3) subjectively assessed arm morbidity for the domains swelling, symptoms, dysfunction, and disability. Assessments were performed at 1 and 6 months after surgery and then annually.
  
  
  RESULTS
  Limb volume increased progressively in the operated and nonoperated arms for 2 years and persisted unchanged to year 5, accompanied by weight gain. Correction by change in the nonoperated arm showed a mean volume increase of 70 mL in the RAC group and 26 mL in the SNBM group (P < 0.001) at 5 years. Only 28 patients (3.3%) had a corrected increase >15% from baseline (RAC 5.0% vs. SNBM 1.7%). Significant predictors were surgery type (RAC vs. SNBM), obesity, diabetes, palpable tumor, and weight gain exceeding 10% of baseline value.
  
  
  CONCLUSIONS
  Subjective assessments revealed persisting patient concerns about swelling and symptoms but not overall disability at 5 years. Subjective scores were only moderately correlated with volume increase. SNAC1 has demonstrated that objective morbidity and subjective morbidity persist for 5 years after surgery and that SNBM significantly lowers the risk of both.
authors.affiliation: Wesley Medical Centre, Brisbane, QLD, Australia.
authors.forename: Neil
authors.initials: N
authors.lastname: Wetzig
authors.affiliation: Breast, Endocrine & Surgical Oncology Unit, Royal Adelaide Hospital, Adelaide, SA, Australia. grantley.gill@adelaide.edu.au.|Department of Surgery, University of Adelaide, Adelaide, SA, Australia. grantley.gill@adelaide.edu.au.
authors.forename: Peter Grantley
authors.initials: PG
authors.lastname: Gill
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Espinoza
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Mister
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.|Sydney Cancer Centre, Royal Prince Alfred and Concord Hospitals, Sydney, NSW, Australia.
authors.forename: Martin R
authors.initials: MR
authors.lastname: Stockler
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
authors.forename: Val J
authors.initials: VJ
authors.lastname: Gebski
authors.affiliation: Department of Medicine, University of Queensland, Brisbane, QLD, Australia.|Centre for Breast Health, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.
authors.forename: Owen A
authors.initials: OA
authors.lastname: Ung
authors.affiliation: Waikato Hospital, Hamilton, New Zealand.
authors.forename: Ian
authors.initials: I
authors.lastname: Campbell
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Simes
mesh_terms: D001365:Axilla; D001943:Breast Neoplasms / Q000473:pathology* / Q000601:surgery; D002908:Chronic Disease; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008197:Lymph Node Excision / Q000009:adverse effects*; D008209:Lymphedema / Q000209:etiology*; D009929:Organ Size; D000071036:Sentinel Lymph Node / Q000473:pathology*; D021701:Sentinel Lymph Node Biopsy / Q000009:adverse effects*; D013997:Time Factors; D047368:Tumor Burden; D034941:Upper Extremity / Q000473:pathology*; D015430:Weight Gain