| 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 |
Related Documents
:
|
21484249 - Results of a phase ii trial of s-1 as first-line treatment of metastatic pancreatic can... 11279329 - Neuropsychiatric toxicity of antiviral treatment in chronic hepatitis c. 21507189 - Critical assessment of the european association of urology guideline indications for pe... 8985519 - Angiographic response of locally advanced soft-tissue sarcoma following hyperthermic is... 21519259 - Phase 1 clinical trials for sarcomas: the cutting edge. 9216849 - Dacarbazine and interferon alpha for stage iv malignant melanoma. 8221579 - Development of a new intensive therapy for acute lymphoblastic leukemia in children at ... 1642879 - A randomized trial of neoadjuvant vs concomitant chemotherapy vs radiotherapy alone in ... 10378669 - Weekly 24-h infusion of high-dose 5-flurouracil and leucovorin in patients with advance... |
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 |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| 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
Previous Document: Diagnostic performance of whole body dual modality 18F-FDG PET/CT imaging for N- and M-staging of ma...
Next Document: Clinical and molecular studies of the effect of imatinib on advanced aggressive fibromatosis (desmoi...