Outcomes Are Not Improved With Pegylated Interferon Alpha-2a vs Interferon Alpha-2a

Outcomes Are Not Improved With Pegylated Interferon Alpha-2a vs Interferon Alpha-2a
Outcomes Are Not Improved With Pegylated Interferon Alpha-2a vs Interferon Alpha-2a

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.

Reference

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.

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