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. - Data demonstrate that pegylated IFN-α-2b (PEG-IFN-α-2b) leads to a significant and sustained improvement in recurrence-free survival (RFS). However, a negative effect on global health-related quality of life (HRQOL) and selected symptoms were observed when patients undergo this treatment. Methods- Study examines the HRQOL effects of adjuvant PEG-IFN-α-2b vs observation in pts with stage III melanoma
- 1,256 pts; randomly assigned after full lymphadenectomy to receive either:
- Observation (n=629) or
- PEG-IFN-α-2b (n=627): induction 6 g/kg/wk for 8 wks then maintenance 3 g/kg/wk for 5 yrs
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 was used to assess HRQOL
Results- At 3.8 yrs of median f/u, for the primary end point, RFS risk was reduced by 18% in the PEG-IFN-α-2b arm
- PEG-IFN-α-2b treatment arm showed decreased global HRQOL at mo 3 and yr 2
- Many of the other scales showed significant differences between scores when comparing the 2 arms
- From a clinical point of view, important differences were found for 5 scales:
- 2 functioning scales (social and role functioning) and
- 3 symptom scales (appetite loss, fatigue, and dyspnea)
with the PEG-IFN-α-2b arm being most impaired
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