Adjuvant treatment with pegylated interferon α-2a versus low-dose interferon α-2a in patients with high-risk melanoma: a randomized phase III DeCOG trial.

BACKGROUND: Adjuvant treatment with interferon (IFN)-α-2a improved disease-free survival (DFS) and showed a trend for improving overall survival (OS) in melanoma. This trial was designed to examine whether PEG-IFN is superior to IFN with regard to distant metastasis-free survival (DMFS), DFS and OS. PATIENTS AND METHODS: In this multicenter, open-label, prospective randomized phase III trial, patients with resected cutaneous melanoma stage IIA(T3a)-IIIB (AJCC 2002) were randomized to receive PEG-IFN (180 µg subcutaneously 1×/week; 24 months) or IFN α-2a (3MIU subcutaneously 3×/week; 24 months). Randomization was stratified for stage, number of metastatic nodes, age and previous IFN treatment. The primary end point was DMFS; secondary end points were OS, DFS, quality of life (QoL) and tolerability. RESULTS: A total of 909 patients were enrolled (451 PEG-IFN versus 458 IFN). Neither 5-year DMFS [PEG-IFN 61.0% versus IFN 67.3%; hazard ratio (HR) 1.16, P = 0.21] nor 5-year OS (PEG-IFN 73.2% versus IFN 75.2%; HR 1.05, P = 0.70) nor 5-year DFS (PEG-IFN 57.3% versus IFN 60.9%; HR 1.09, P = 0.40) showed significant differences. Subgroup analyses in patients ± ulcerated primaries and of different tumor stages did not find differences in DMFS, OS or DFS between the treatment groups. One hundred and eighteen patients (26.2%) in the PEG-IFN and 61 patients (13.3%) in the IFN population did not receive the full dosage and length of treatment due to adverse events (P < 0.001). Leukopenia and elevation of liver enzymes were more common in the PEG-IFN arm (56% versus 23.5% LCP; 19.1% versus 9.4% AST; 33.0% versus 16.5% ALT). QoL was identical for nearly all domains. CONCLUSION: PEG-IFN did not improve the outcome over IFN. A higher percentage of patients under PEG-IFN discontinued treatment due to toxicity. CLINICAL TRIALSGOV IDENTIFIER: NCT00204529.

Evaluating a superabsorbent hydropolymer dressing for exuding venous leg ulcers.

A new hydropolymer dressing was compared with an alginate dressing in a multicentre, prospective, controlled, randomised, stratified, open label trial of 113 patients with exuding venous leg ulcers. The study aimed to evaluate the performance of the dressings in terms of their ability to handle exudate, patient and user acceptability and cost-effectiveness. Patients were stratified according to volume of wound exudate (moderate/heavy) and randomised to the hydropolymer dressing or the alginate plus a secondary dressing. A statistically significant difference between treatment groups was observed in mean wear time, with a longer wear time observed in the hydropolymer group (3.91 days) compared with the alginate group (3.09 days, p = 0.001). In terms of patient and user acceptability, all 10 overall evaluations made by both patient and investigator were markedly in favour of the hydropolymer dressing (p < 0.001 to p = 0.020). The use of the hydropolymer dressing for patients with moderate to heavily exuding venous leg ulcers has statistically significant advantages over the alginate dressing in terms of wear time and investigator and patient acceptability. It is anticipated that this reduction in dressing frequency will translate into a cost-effective wound treatment.