Pegylated interferon-alpha-2a (PEG-IFN) did not improve improve outcomes for patients with melanoma compared with IFN. Furthermore, patients receiving PEG-IFN were more likely to discontinue treatment due to toxicity, a study published in Annals of Oncology has shown.1
Because disease-free survival (DFS) was improved with adjuvant treatment with interferon-alpha-2a (IFN), and trending improved overall survival (OS) in melanoma, this trial sought to examine if PEG-IFN is superior to IFN. Primary endpoint was distant metastasis-free survival (DMFS), with DFS, OS, quality of life and tolerability were secondary end points.
For this multicenter, open-label, prospective randomized phase 3 trial, 909 patients with resected cutaneous melanoma stage 2A(T3a)-3B (AJCC 2002) were randomly assigned to receive PEG-IFN 180 mcg subcutaneously once a week for 24 months (451 patients) or IFN alpha-2a 3 MIU subcutaneously 3 times a week for 24 months (458 patients); both groups were stratified for stage, number of metastatic nodes, age, and previous interferon treatment.
No significant differences were seen between 5-year DMFS (PEG-IFN 61.0% vs IFN 67.3%; HR, 1.16; P = .21), 5-year OS (PEG-IFN 73.2% vs IFN 75.2%; HR, 1.05, P = .70), or 5-year DFS (PEG-IFN 57.3% vs IFN 60.9%; HR, 1.09, P = .40). Nor were differences found in DMFS, OS, or DFS between the treatment groups on subgroup analyses in patients ± ulcerated primaries and of different tumor stages.
Due to adverse events, 118 patients (26.2%) in the PEG-IFN group did not receive the full dosage and length of treatment; in the IFN group, 61 patients (13.3%) were affected (P < .001). Leukopenia and elevated liver enzymes were more common in the PEG-IFN arm (56% vs 23.5% LCP; 19.1% vs 9.4 % AST; 33.0% vs 16.5% ALT). Quality of life was identical for nearly all patients.
1. Eigentler TK, Gutzmer R, Hauschild A, Heinzerling L, Schadendorf D, Nashan D, et al. Adjuvant treatment with pegylated interferon alpha-2a versus low-dose interferon alpha-2a in patients with high-risk melanoma. A randomized phase III DeCOG trial [published online June 10, 2016]. Ann Oncol. doi:10.1093/annonc/mdw225.