Originally published as JCO Early Release 10.1200/JCO.2008.20.2069 on May 11 2009

This Article Full Text Full Text (PDF) Publisher's Note Erratum (v27,p4630) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Google Scholar Articles by Bottomley, A. Articles by Eggermont, A. PubMed PubMed Citation Articles by Bottomley, A. Articles by Eggermont, A. Social Bookmarking                            What's this?

Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma: A Phase III Randomized Controlled Trial of Health-Related Quality of Life and Symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group

From the European Organisation for Research and Treatment of Cancer Quality of Life Department and Headquarters; Institut Jules Bordet, Brussels, Belgium; Istituto Nazionale dei Tumori; Istituto Europeo di Oncologia, Milan, Italy; University Hospital Birmingham, Birmingham; Royal Marsden Hospital National Health Service, London; University of Glasgow, Glasgow; Nottingham City Hospital, Nottingham, United Kingdom; Radboud University Nijmegen Medical Center, Nijmegen; Erasmus University Medical Center, Rotterdam, the Netherlands; University Hospital Sestre Milosrdnice, Zagreb, Croatia; University Clinic Zürich, Zürich, Switzerland; University Hospital Essen, Essen; Charité, Benjamin Franklin Campus, Berlin, Germany; and Institute Gustave Roussy, Villejuif Cedex, France.

Corresponding author: Andrew Bottomley, PhD, Quality of Life Department, EORTC Headquarters, Av E. Mounier 83, box 11, Brussels, Belgium 1200; e-mail: andrew.bottomley{at}eortc.be.

Purpose Interferon (IFN) -based adjuvant therapy in melanoma is associated with significant side effects, which necessitates evaluation of health-related quality of life (HRQOL). Our trial examined the HRQOL effects of adjuvant pegylated IFN--2b (PEG-IFN--2b) versus observation in patients with stage III melanoma.

Methods A total of 1,256 patients with stage III melanoma were randomly assigned after full lymphadenectomy to receive either observation (n = 629) or PEG-IFN--2b (n = 627): induction 6 µg/kg/wk for 8 weeks then maintenance 3 µg/kg/wk for an intended total duration of 5 years. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 was used to assess HRQOL.

Results At 3.8 years of median follow-up, for the primary end point, recurrence-free survival (RFS), risk was reduced by 18% (hazard rate = 0.82; P = .01) in the PEG-IFN--2b arm compared with observation. Significant and clinically meaningful differences occurred with the PEG-IFN--2b treatment arm compared with the observation group, showing decreased global HRQOL at month 3 (–11.6 points; 99% CI, –8.2 to –15.0) and year 2 (–10.5 points; 99% CI, –6.6 to –14.4). Many of the other scales showed statistically significant differences between scores when comparing the two arms. From a clinical point of view, important differences were found for five scales: two functioning scales (social and role functioning) and three symptom scales (appetite loss, fatigue, and dyspnea), with the PEG-IFN--2b arm being most impaired.

Conclusion PEG-IFN--2b leads to a significant and sustained improvement in RFS. There is an expected negative effect on global HRQOL and selected symptoms when patients undergo PEG-IFN--2b treatment.

Supported by Schering Plough Research International (pegylated interferon alfa-2b provided free of charge).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				J. Glaspy, A. Ribas, and B. Chmielowski Interferon Alfa in the Postsurgical Management of High-Risk Melanoma: Is It Worth It? J. Clin. Oncol., June 20, 2009; 27(18): 2896 - 2897. [Full Text] [PDF]