Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma: A Phase III Randomized Controlled Trial of Health-Related Quality of Life and Symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group

Bottomley, A. et al. (2009) Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma: A Phase III Randomized Controlled Trial of Health-Related Quality of Life and Symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group. Journal of Clinical Oncology, 27(18), pp. 2916-2923. (doi: 10.1200/JCO.2008.20.2069)

Abstract

PurposeInterferon (IFN) -based adjuvant therapy in melanoma is associated with significant side effects, which necessitates evaluation of health-related quality of life (HRQOL). Our trial examined the HRQOL effects of adjuvant pegylated IFN-{alpha}-2b (PEG-IFN-{alpha}-2b) versus observation in patients with stage III melanoma. MethodsA total of 1,256 patients with stage III melanoma were randomly assigned after full lymphadenectomy to receive either observation (n = 629) or PEG-IFN-{alpha}-2b (n = 627): induction 6 g/kg/wk for 8 weeks then maintenance 3 g/kg/wk for an intended total duration of 5 years. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 was used to assess HRQOL. ResultsAt 3.8 years of median follow-up, for the primary end point, recurrence-free survival (RFS), risk was reduced by 18% (hazard rate = 0.82; P = .01) in the PEG-IFN-{alpha}-2b arm compared with observation. Significant and clinically meaningful differences occurred with the PEG-IFN-{alpha}-2b treatment arm compared with the observation group, showing decreased global HRQOL at month 3 (-11.6 points; 99% CI, -8.2 to -15.0) and year 2 (-10.5 points; 99% CI, -6.6 to -14.4). Many of the other scales showed statistically significant differences between scores when comparing the two arms. From a clinical point of view, important differences were found for five scales: two functioning scales (social and role functioning) and three symptom scales (appetite loss, fatigue, and dyspnea), with the PEG-IFN-{alpha}-2b arm being most impaired. ConclusionPEG-IFN-{alpha}-2b leads to a significant and sustained improvement in RFS. There is an expected negative effect on global HRQOL and selected symptoms when patients undergo PEG-IFN-{alpha}-2b treatment

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Mackie, Professor Rona
• Authors: Bottomley, A., Coens, C., Suciu, S., Santinami, M., Kruit, W., Testori, A., Marsden, J., Punt, C., Sales, F., Gore, M., Mackie, R., Kusic, Z., Dummer, R., Patel, P., Schadendorf, D., Spatz, A., Keilholz, U., and Eggermont, A.
• College/School: College of Medical Veterinary and Life Sciences
• Journal Name: Journal of Clinical Oncology
• ISSN: 0732-183X