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

• Published in: European journal of cancer (1990) 2012-09, Vol.48 (13), p.2012-2019
• Main Authors: Brandberg, Y, Aamdal, S, Bastholt, L, Hernberg, M, Stierner, U, von der Maase, H, Hansson, J
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Biological and medical sciences; Cancer; Cancer and Oncology; Cancer och onkologi; Chemotherapy, Adjuvant; Female; Health related quality of life; Hematology, Oncology and Palliative Medicine; High risk; Humans; Interferon; Interferon-alpha - adverse effects; Interferon-alpha - therapeutic use; Maintenance; Male; Malignant melanoma; Medical sciences; Melanoma; Melanoma - drug therapy; Melanoma - pathology; Middle Aged; Pharmacology. Drug treatments; Quality of Life; Randomised; Recombinant Proteins - adverse effects; Recombinant Proteins - therapeutic use; Risk; Side effects; Skin Neoplasms - drug therapy; Skin Neoplasms - psychology; Tumors; Young Adult
• ISSN: 0959-8049; 1879-0852; 1879-0852
• DOI: 10.1016/j.ejca.2011.11.019

Abstract Purpose 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). Patients and 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. Conclusion A significant negative impact on HRQoL of IFN treatment was demonstrated, however the impact were reversible when treatment was stopped.