Health-related quality of life measures in melanoma patients receiving pulsed high-dose intravenous interferon alpha 2b (IFNα2b)

Abstract

8536 Background: Major problems of high-dose interferon (HDI) in patients with malignant melanoma (MM) result from side effects and impairment of quality of life (QoL). Up to now it is unclear whether intraveneous (iv), subcutaneous (sc), or both components of HDI treatment are necessary for the efficacy in adjuvant treatment of MM. The adjuvant phase III DeCOG MM-ADJ-5 trial evaluates efficacy, safety, and tolerability of pulsed high-dose intravenous IFNa2b. In this prospective, randomized trial, 3 courses of IFNa2b 20 Mio IU/m2 iv on 5 days a week for 4 weeks repeated every 4 months are compared to the standard HDI regimen. The higher iv dosage produces more toxicity, but for a shorter period of time, since patients in the pulsed treatment arm are 9 months off treatment as compared to the conventional sc treatment with 10 Mio IU/m2 three times a week given for 11 months after 4 weeks of iv therapy. Methods: With a planned recruitment of 600 patients, an interim analysis of QoL has been performed after half of the patients completed treatment. EORTC QLQ- C30 questionnaire modified for interferon side effects was obtained before therapy, and at 4, 16, 24, and 40 weeks of treatment. The global QoL items were obtained weekly by a visual analogue scale over the whole year of treatment. Additionally, the side effects were scored using CTC- AE toxicity levels, and dose modifications were recorded. Results: A total of 300 patients were evaluated. After 4 weeks of initial iv HDI treatment the global QoL score decreased similarly in both treatment groups (35% vs. 41%). Four weeks after the initial iv pulse, the global QoL score completely recovered in the experimental arm (104%). In the conventional HDI, QoL remained reduced by an average 22% during the whole subcutaneous treatment phase. During the second and third iv-pulse in the experimental arm, QoL again decreased and completely recovered thereafter. Overall, the cumulative QoL score measured for 12 months treatment was significantly in favour of the pulsed regimen (+16% AuC value). Conclusions: Patients under pulsed adjuvant HDI treatment experience significantly less impairment of QoL and may therefore have a higher rate of completing the scheduled dosage. [Table: see text]