title: Health-related quality of life in patients with high-risk melanoma randomised in the Nordic phase 3 trial with adjuvant intermediate-dose interferon alfa-2b.
abstract: OBJECTIVE
  To compare health-related quality of life (HRQoL) and side-effects in patients with high-risk melanoma participating in a randomised phase III trial of adjuvant interferon alfa-2b (IFN).
  
  
  METHODS
  A total of 855 patients with histologically verified resected cutaneous melanoma in AJCC stage IIb (T4 N0 M0) or stage III (Tx N1-3 M0) were randomised to: Arm A: observation only (n = 284); Arm B: 1-year treatment: induction: IFN alfa-2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks, maintenance: IFN alfa-2b, 10 MU (flat dose), SC, 3 days/week for 12 months (n = 285); or Arm C: 2 years of same treatment as Arm B. HRQoL was assessed using The European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) before randomisation and at 8 pre-defined time-points during 2 years. IFN-related side-effects were assessed by a study-specific questionnaire.
  
  
  RESULTS
  > 80% of eligible patients returned questionnaires at the different assessment points. Statistically significant interactions between randomisation arm and time after randomisation were found for almost all EORTC QLQ-30 variables. While patients in Arm A improved or remained at baseline levels; patients in Arms B and C reported decreased functioning and quality of life, and an increase in side-effects during their treatment. Patients in Arm B improved after the 12th month assessment, when IFN treatment was scheduled to end, to the 16th month assessment (p < 0.001). The same pattern of improvement was found for 5 of 7 interferon-related side-effects.
  
  
  CONCLUSIONS
  A significant negative impact on HRQoL of IFN treatment was demonstrated, however the impact were reversible when treatment was stopped.
authors.affiliation: Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. yvonne.bandberg@ki.se
authors.forename: Y
authors.initials: Y
authors.lastname: Brandberg
authors.forename: S
authors.initials: S
authors.lastname: Aamdal
authors.forename: L
authors.initials: L
authors.lastname: Bastholt
authors.forename: M
authors.initials: M
authors.lastname: Hernberg
authors.forename: U
authors.initials: U
authors.lastname: Stierner
authors.forename: H
authors.initials: H
authors.lastname: von der Maase
authors.forename: J
authors.initials: J
authors.lastname: Hansson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000473:pathology*; D008875:Middle Aged; D011788:Quality of Life; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012306:Risk; D012878:Skin Neoplasms / Q000188:drug therapy / Q000523:psychology*; D055815:Young Adult
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins