Health-related quality of life (HRQOL) in the Nordic randomized trial of adjuvant intermediate-dose interferon alfa-2b in high-risk melanoma.

Abstract

Listen

Translate article

8547 Background: 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 randomized to: Arm A: Observation only (n=284), to Arm B: One year treatment - Induction: IFN-α2b, 10 MU (flat dose), SC, 5 days/w, 4 weeks, Maintenance: IFN-α2b, 10 MU (flat dose), SC, 3 days/w for 12 months (n=285), or to Arm C: Two years treatment - Induction: Same as arm B Maintenance: IFN- α2b, 10 MU (flat dose), SC, 3 days/w for 24 months (n=286). Adjuvant intermediate-dose IFN-a2b was delivered with moderate and expected toxicities in both 1- and 2 year treatment arms. No significant effect of adjuvant IFN treatment on overall survival was observed (J Hansson et al. Lancet Oncol, 12: 144-152, 2011). Aim: To compare HRQOL between the three randomization arms during two years from inclusion in the study. Methods: HRQOL was assessed by the EORTC-QLQ C30 questionnaire before randomization, and at 3, 6, 9, 12, 16, 20 and 24 months after inclusion. Questionnaire completion rate was high at all points of assessment (>80%). Results: Overall, Arm A improved or remained at the same level as at inclusion, while functioning and quality of life decreased and symptoms increased during treatment in Arms B and C. Arm B improved, reaching levels comparable to Arm A, between months’ 12 and 16 assessments when IFN alfa-2b treatment was stopped. In the longitudinal analyses, statistical significant interactions between randomization arm and time were found for all the HRQOL scales, indicating that treatment effect differed over time (p<0.001). Conclusions: The results of this study revealed significant effects of IFN alfa-2b treatment on HRQOL. The impact on HRQOL is important to consider as part of the decision process on whether or not to use adjuvant Interferon.