Document Detail


Randomized dose-escalation study evaluating peginterferon alfa-2a in patients with metastatic malignant melanoma.
MedLine Citation:
PMID:  16505439     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: A pegylated interferon, peginterferon alfa-2a (PEG-IFNalpha-2a; 40 kd), has the potential for improved tumor response and survival with lower toxicity than IFNalpha. This open-label, randomized study evaluated the safety, tolerability, and efficacy of subcutaneous PEG-IFNalpha-2a in patients with metastatic malignant melanoma (stage IV American Joint Committee on Cancer staging system). PATIENTS AND METHODS: PEG-IFNalpha-2a was administered subcutaneously at 180 (n = 48), 360 (n = 53), or 450 mug (n = 49) once weekly for 24 weeks, with maintenance therapy for responders. Efficacy was assessed by the proportion of patients with complete response (CR) or partial response (PR). RESULTS: The major response rate (CR or PR) was 6% in the 180-mug group (CR, 2%; PR, 4%), 8% in the 360-mug group (CR, 2%; PR, 6%), and 12% in the 450-mug group (CR, 6%; PR, 6%). The times to achieve a major response, duration of major response, rate of disease progression, and 12-month survival were similar between groups, although overall median survival was significantly different among the three groups (P = .0136). More patients required dose adjustment for safety reasons in the higher dose groups, but PEG-IFNalpha-2a was generally well tolerated, with few withdrawals because of adverse events (6%, 19%, and 16% in the 180-, 360-, and 450-mug groups, respectively). The most common adverse events were fatigue, pyrexia, and nausea. CONCLUSION: PEG-IFNalpha-2a at doses up to 450 mug once weekly has shown good tolerability and similar efficacy to conventional IFNalpha and monochemotherapy in stage IV metastatic melanoma.
Authors:
Reinhard Dummer; Claus Garbe; John A Thompson; Alexander M Eggermont; Kisook Yoo; Tanja Maier; Bengt Bergstrom
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.    
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  24     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2006 Mar 
Date Detail:
Created Date:  2006-02-28     Completed Date:  2006-03-16     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1188-94     Citation Subset:  IM    
Affiliation:
Department of Dermatology, University Hospital of Zürich, Zürich, Switzerland. reinhard.dummer@usz.ch
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Antineoplastic Agents / administration & dosage*,  adverse effects*
Disease Progression
Fatigue / chemically induced
Female
Fever / chemically induced
Humans
Interferon Alfa-2a / administration & dosage*,  adverse effects*
Male
Melanoma / drug therapy*,  secondary*
Middle Aged
Nausea / chemically induced
Polyethylene Glycols / administration & dosage*,  adverse effects*
Skin Neoplasms / drug therapy,  pathology*
Survival Analysis
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antineoplastic Agents; 0/Polyethylene Glycols; 0/peginterferon alfa-2a; 76543-88-9/Interferon Alfa-2a

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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