title: Loco-regional morbidity after breast conservation and axillary lymph node dissection for early breast cancer with or without regional nodes radiotherapy, perspectives in modern breast cancer treatment: the Skagen Trial 1 is active.
abstract: BACKGROUND
  Axillary lymph node dissection (ALND) and adjuvant radiotherapy (RT) in early breast cancer are associated with a risk of morbidity, including lymphedema and impaired shoulder mobility. The aim of this study was to evaluate loco-regional morbidity after breast conserving surgery (BCS), ALND, taxane-based chemotherapy and whole breast irradiation (WBI) with or without regional nodes RT.
  
  
  METHODS
  Eligible patients had BCS and ALND from 2007 to 2012 followed by adjuvant taxane-based chemotherapy and if indicated, trastuzumab and endocrine treatment. The RT consisted of WBI and regional nodes RT in case of ≥ pN1 disease (group 1) and WBI only in case of pN0-1(mic) disease (group 2). The dose was 50 Gy in 25 fractions. The patients were invited to participate in a cross-sectional study evaluating morbidity.
  
  
  RESULTS
  Of the 347 eligible patients, 277 patients (79%) accepted the invitation. Of these, 185 patients (67%) belonged to group 1 and 92 patients (33%) to group 2. The median time from RT to evaluation of morbidity was 3.3 years (group 1) and 4.3 years (group 2). In group 1, 34 patients (18%) and in group 2, 15 patients (16%) had ≥2 cm enlargement in circumference of ipsilateral upper or lower arm (p = .67). The frequence of impairment of ipsilateral shoulder abduction to ≤120° was 3% in both groups and of shoulder flexion to ≤120° was 1% and 2% (group 1 versus 2). No difference in patient reported outcome measure (PROM) data regarding heaviness or enlargement of ipsilateral upper and lower arm or mobility and sensory disturbances.
  
  
  CONCLUSIONS
  The risk of lymphedema was low in patients after ALND and not related to use of regional nodes RT. Impairment of shoulder function was rare, and no differences in PROM were detected regarding use or not of regional nodes RT.
authors.affiliation: a Department of Oncology , Aarhus University Hospital , Aarhus , Denmark.
authors.forename: Hanne Melgaard
authors.initials: HM
authors.lastname: Nielsen
authors.affiliation: a Department of Oncology , Aarhus University Hospital , Aarhus , Denmark.
authors.forename: Rasmus Blechingberg
authors.initials: RB
authors.lastname: Friis
authors.affiliation: b Department of Oncology , Herning Hospital , Herning , Denmark.
authors.forename: Søren
authors.initials: S
authors.lastname: Linnet
authors.affiliation: a Department of Oncology , Aarhus University Hospital , Aarhus , Denmark.
authors.forename: Birgitte Vrou
authors.initials: BV
authors.lastname: Offersen
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001365:Axilla; D001943:Breast Neoplasms / Q000473:pathology* / Q000628:therapy; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003430:Cross-Sectional Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009017:Morbidity; D011379:Prognosis; D018714:Radiotherapy, Adjuvant; D016059:Range of Motion, Articular; D021701:Sentinel Lymph Node Biopsy; D012782:Shoulder / Q000503:physiopathology