title: Long-term assessment of quality of life in the Intergroup Exemestane Study: 5 years post-randomisation.
abstract: BACKGROUND
  The Intergroup Exemestane Study (IES) (ISRCTN11883920) demonstrated improved survival for postmenopausal women with ER-positive/unknown primary breast cancer who switched to exemestane after 2-3 years tamoxifen, compared with those continuing on tamoxifen to complete 5 years therapy. This was achieved without detriment to on-treatment quality-of-life (QoL). We report on- and post-treatment QoL impact in IES.
  
  
  METHODS
  A total of 582 patients from 8 countries participated in the QoL substudy. Functional Assessment of Cancer Therapy-Breast (FACT-B) and endocrine symptom subscale (ES) were completed at baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 months. The primary endpoint was FACT-B Trial Outcome Index (TOI); secondary endpoints included severity of individual endocrine symptoms.
  
  
  RESULTS
  Both the groups showed gradual improvement in overall QoL and lessening of total endocrine symptoms post treatment compared with baseline (P<0.002). There was no evidence of any between-group differences in TOI. Vasomotor complaints remained high on treatment. Vaginal discharge was more frequent (P<0.01) with tamoxifen up to 24 months from baseline. In both the groups, post-treatment libido did not recover to baseline levels.
  
  
  CONCLUSIONS
  Clinical benefits of switching to exemestane are accompanied by good overall QoL. Although some symptoms persist, the majority of endocrine symptoms improve after treatment completion.
authors.affiliation: Sussex Health Outcomes Research & Education in Cancer, Brighton & Sussex Medical School, University of Sussex BN1 9RX, Brighton, UK. L.J.Fallowfield@Sussex.ac.uk
authors.forename: L J
authors.initials: LJ
authors.lastname: Fallowfield
authors.forename: L S
authors.initials: LS
authors.lastname: Kilburn
authors.forename: C
authors.initials: C
authors.lastname: Langridge
authors.forename: C F
authors.initials: CF
authors.lastname: Snowdon
authors.forename: J M
authors.initials: JM
authors.lastname: Bliss
authors.forename: R C
authors.initials: RC
authors.lastname: Coombes
mesh_terms: D000730:Androstadienes / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000556:secondary; D017326:Clinical Trials, Phase III as Topic; D057915:Drug Substitution; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007989:Libido / Q000187:drug effects; D009382:Neoplasms, Unknown Primary / Q000188:drug therapy*; D017698:Postmenopause; D011788:Quality of Life; D011960:Receptors, Estrogen / Q000378:metabolism; D011795:Surveys and Questionnaires; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019522:Vaginal Discharge / Q000139:chemically induced
chemical_list: D000730:Androstadienes; D000970:Antineoplastic Agents; D047072:Aromatase Inhibitors; D011960:Receptors, Estrogen; D013629:Tamoxifen; C056516:exemestane