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See Latest ArticlesAdjuvant therapy with pegylated interferon alfa-2b vs 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, 05/13/09
Bottomley A et al. - In a trial to examine the health-related quality of life (HRQOL) effects of adjuvant pegylated IFN-α-2b (PEG-IFN-α-2b) vs observation in pts with stage III melanoma, it was shown that PEG-IFN-α-2b leads to a significant and sustained improvement in recurrence-free survival (RFS). There is an expected negative effect on global HRQOL and selected symptoms when pts undergo PEG-IFN-α-2b treatment.
Methods- 1256 pts with stage III melanoma were 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 an intended total duration of 5 yrs.
- The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 was used to assess HRQOL.
- At 3.8 yrs of median follow-up, for the primary endpoint, RFS, risk was reduced by 18% in the PEG-IFN-α-2b arm compared with observation.
- Significant and clinically meaningful differences occurred with the PEG-IFN-α-2b treatment arm compared with the observation group, showing decreased global HRQOL at mo 3 (-11.6 points) and yr 2 (-10.5 points).
- Many of the other scales showed statistically 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.
ANDREW BOTTOMLEY, 06/02/09
| We believe that its is important to add that many of the side effects seen by patients undergoing PEG-IFN-?-2b could be treated, and the clinicans need to be aware of these and take a proactive approach in detailing with these problems. Clinicians could, for example, inform patients about the expected side effects and strategies on how best to manage these. For example, if the patients are suffering from appetite loss as observed in our study, oral supplements can be used, and also appetite stimulants may be helpful. Also it is important that, close monitoring by doctors could lead to dose modification, which may reduce side effects at key times in patients' treatment. This dosing to tolerance was clearly successful in our trial. |
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