title: Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: first results of International Breast Cancer Study Group Trial 10-93.
abstract: OBJECTIVE
  Axillary clearance in early breast cancer aims to improve locoregional control and provide staging information but is associated with undesirable morbidity. We therefore investigated whether avoiding axillary surgery in older women would result in improved quality of life (QL) with similar disease-free survival (DFS) and overall survival (OS).
  
  
  METHODS
  Between 1993 and 2002, women > or = 60 years old with clinically node-negative operable breast cancer in whom adjuvant tamoxifen was considered indicated regardless of pathologic nodal status were randomly assigned to primary surgery plus axillary clearance (Sx + Ax) followed by tamoxifen (Tam) versus Sx without Ax followed by Tam for 5 consecutive years. The primary end point was QL reported by the patient and by physician assessment.
  
  
  RESULTS
  A total of 473 patients (234 to Sx + Ax, 239 to Sx) were randomly assigned. The median age was 74 years; 80% had estrogen receptor-positive disease. In both the patients' subjective assessment of their QL and the physicians' perception of the patients' QL, the largest adverse QL effects of Ax were observed from baseline to the first postoperative assessment, but the differences tended to disappear in 6 to 12 months. At a median follow-up of 6.6 years, results for Sx + Ax and Sx yielded similar DFS (6-year DFS, 67% v 66%; hazard ratio [HR] Sx + Ax/Sx, 1.06; 95% CI, 0.79 to 1.42; P = .69) and OS (6-year OS, 75% v 73%; HR Sx + Ax/Sx, 1.05; 95% CI, 0.76 to 1.46; P = .77).
  
  
  CONCLUSIONS
  Avoiding axillary clearance for women > or = 60 years old who have clinically node-negative disease and receive Tam for endocrine-responsive disease yields similar efficacy with better early QL.
authors.affiliation: West Swedish Breast Cancer Study Group, Sahlgrenska University Hospital/Mölndal, Göteborgsvägen 31, 431 80 Mölndal, Sweden. c-m.rudenstam@telia.com
authors.forename: Carl-Magnus
authors.initials: CM
authors.lastname: Rudenstam
authors.forename: David
authors.initials: D
authors.lastname: Zahrieh
authors.forename: John F
authors.initials: JF
authors.lastname: Forbes
authors.forename: Diana
authors.initials: D
authors.lastname: Crivellari
authors.forename: Stig B
authors.initials: SB
authors.lastname: Holmberg
authors.forename: Piercarlo
authors.initials: P
authors.lastname: Rey
authors.forename: David
authors.initials: D
authors.lastname: Dent
authors.forename: Ian
authors.initials: I
authors.lastname: Campbell
authors.forename: Jürg
authors.initials: J
authors.lastname: Bernhard
authors.forename: Karen N
authors.initials: KN
authors.lastname: Price
authors.forename: Monica
authors.initials: M
authors.lastname: Castiglione-Gertsch
authors.forename: Aron
authors.initials: A
authors.lastname: Goldhirsch
authors.forename: Richard D
authors.initials: RD
authors.lastname: Gelber
authors.forename: Alan S
authors.initials: AS
authors.lastname: Coates
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D001365:Axilla; D001943:Breast Neoplasms / Q000737:chemistry / Q000401:mortality / Q000473:pathology / Q000517:prevention & control / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D020847:Estrogen Receptor Modulators / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008197:Lymph Node Excision / Q000009:adverse effects; D008207:Lymphatic Metastasis; D008408:Mastectomy / Q000379:methods*; D008875:Middle Aged; D011788:Quality of Life; D018714:Radiotherapy, Adjuvant; D011960:Receptors, Estrogen / Q000032:analysis; D016019:Survival Analysis; D013629:Tamoxifen / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D020847:Estrogen Receptor Modulators; D011960:Receptors, Estrogen; D013629:Tamoxifen