Abstract
PurposeTo 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). Patients and methodsA 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, 5days/week, 4weeks, maintenance: IFN alfa-2b, 10 MU (flat dose), SC, 3days/week for 12months (n=285); or Arm C: 2years 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 2years. 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. ConclusionA significant negative impact on HRQoL of IFN treatment was demonstrated, however the impact were reversible when treatment was stopped.
Published Version
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