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Health-related quality of life in patients with high-risk melanoma randomized in the Nordic phase 3 trial with adjuvant intermediate-dose interferon alfa-2b
European Journal of Cancer, 01/13/2012
Brandberg Y et al. – A significant negative impact on HRQoL of IFN treatment was demonstrated, however the impact were reversible when treatment was stopped.E
Methods- 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
- >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 QOL, 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)
- Same pattern of improvement was found for 5 of 7 interferon–related side–effects
