In a paper by Andrew Bottomley et al. published in the Journal of Clinical Oncology, the EORTC Melanoma Group and Quality of Life Department reported the results of the effects of pegylated interferon α-2b (PEG-IFN- α-2b) on health-related quality of life (HRQOL) and symptoms in the EORTC 18991 trial (1). In this trial, 1256 patients were randomly assigned to be observed (n=629) or to receive PEG-IFN- α-2b (n=627) following lymphadenectomy, and the EORTC QOL questionnaire C30 was used to evaluate HRQOL. The HRQOL of the patients was assessed at baseline and then again at 3, 12, 24 and 36 months. Clinical results for this study were published previously by Eggermont et al. and showed that treatment with PEG-IFN- α-2b had a significant and sustained effect on recurrence free survival in this patient population after a median 3.8 years follow-up (2). For the HRQOL, however, an expected negative effect on global HRQOL was observed, and important differences were found between the observation arm and the PEG-IFN- α-2b arm for two functioning scales (social and role functioning) as well as three symptom scales (appetite loss, fatigue, and dyspnea) at each post-baseline assessment with the PEG-IFN- α-2b arm being the more impaired. These results suggest that adjuvant PEG-IFN- α-2b might not be the most appropriate therapy for patients with high-risk melanoma, but also suggest that appropriate dose reduction and symptom management approaches can be used in patients using PEG-IFN- α-2b thereby reducing the unwanted side effects of treatment.
(1) Published Ahead of Print on May 11, 2009 as 10.1200/JCO.2008.20.2069.
(2) A.M.M. Eggermont, S. Suciu, M. Santinami, A. Testori, W.H.J. Kruit, J. Marsden, C.J.A. Punt, F. Sales, M. Gore, R. Mackie, Z. Kusic, R. Dummer, A. Hauschild, E. Musat, A. Spatz, U. Keilholz, for the EORTC Melanoma Group. Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: Final results of EORTC 18991, a randomised phase III trial. Lancet 372 (9633): 117-126, 2008.