Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
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SHR Neuro Krebs Kardio Lipid Stoffw Microb
Eigentler, TK; Gutzmer, R; Hauschild, A; Heinzerling, L; Schadendorf, D; Nashan, D; Hölzle, E; Kiecker, F; Becker, J; Sunderkötter, C; Moll, I; Richtig, E; Pönitzsch, I; Pehamberger, H; Kaufmann, R; Pföhler, C; Vogt, T; Berking, C; Praxmarer, M; Garbe, C; Dermatologic Cooperative Oncology Group (DeCOG).
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.
Ann Oncol. 2016; 27(8):1625-1632
Doi: 10.1093/annonc/mdw225
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- Abstract:
- 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. 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. 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. PEG-IFN did not improve the outcome over IFN. A higher percentage of patients under PEG-IFN discontinued treatment due to toxicity. NCT00204529. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Aged -
- Chemotherapy, Adjuvant - adverse effects
- Chemotherapy, Adjuvant - methods
- Disease-Free Survival -
- Dose-Response Relationship, Drug -
- Drug-Related Side Effects and Adverse Reactions - pathology
- Female -
- Humans -
- Interferon-alpha - administration & dosage
- Interferon-alpha - adverse effects
- Male -
- Melanoma - drug therapy
- Melanoma - pathology
- Middle Aged -
- Polyethylene Glycols - administration & dosage
- Polyethylene Glycols - adverse effects
- Quality of Life -
- Recombinant Proteins - administration & dosage
- Recombinant Proteins - adverse effects
- Treatment Outcome -
- Find related publications in this database (Keywords)
- adjuvant drug therapy
- interferon alpha-2a
- melanoma
- PEG-interferon alpha-2a
- randomized
- controlled trial