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European Journal of Dermatology

Safety of pegylated interferon-alpha-2a in adjuvant therapy of intermediate and high-risk melanomas Volume 18, issue 1, January-February 2008

Résumé : Pegylated (PEG)-IFN-α-2a is a modified form of recombinant human IFN-α-2a with sustained absorption and prolonged half-life. Our aim was to evaluate its safety profile in adjuvant treatment of high-risk melanoma patients in a single centre setting and to compare this safety profile with data obtained from the literature for a) low dose IFN-α and b) high dose IFN. Eighteen consecutive melanoma patients (AJCC 2002 stages IIa-IIIc) were retrospectively analyzed for toxicities associated with adjuvant PEG-IFN-α-2a (180 μg/week s.c.). The most frequently reported adverse events were constitutional side effects (78%), myelosuppression (83%) and hepatotoxicity (78%). The proportion of patients receiving PEG-IFN-α-2a and suffering from myelosuppression and liver toxicity was significantly higher than for patients reported in the literature undergoing low-dose IFN-α treatment (P = 0.008, P = 0.001 respectively), while fatigue and depression were seen less frequently with PEG-IFN-α-2a. By contrast, compared to patients treated with high-dose IFN-α, PEG-IFN-α-2a treated patients less frequently experienced fatigue (P < 0.001), neutropenia (P < 0.068) and neuropsychiatric (statistically not significant) adverse events. In conclusion, subcutaneously delivered PEG-IFN-α-2a is well tolerated in a once-weekly dose of 180 μg by most patients with high risk malignant melanoma. The frequency of side effects is increased compared to low dose, but reduced compared to high dose standard IFN-α. Due to its pharmacokinetic properties, pegylated IFN-α has, as in the treatment of hepatitis C, potential for increased efficacy in adjuvant therapy of melanoma.