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Health-related Quality of Life Before and During Adjuvant Interferon-α Treatment for Patients With Malignant Melanoma (DeCOG-Trial)

Ziefle, Susanne*; Egberts, Friederike; Heinze, Sarah*; Volkenandt, Matthias; Schmid-Wendtner, Monika; Tilgen, Wolfgang§; Linse, Ruthild; Boettjer, Jörg; Vogt, Thomas§,♯; Spieth, Konstanze**; Eigentler, Thomas††; Brockmeyer, Norbert H.‡‡; Heinz, Andreas*; Hauschild, Axel; Schaefer, Martin*,§§

doi: 10.1097/CJI.0b013e31821b7a4b
Clinical Studies
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Adjuvant treatment with interferon-α (IFN-α) for patients with malignant melanoma can improve relapse-free and overall survival, but IFN-associated side effects may reduce patient's quality of life. The aim of the study was to prospectively evaluate health-related quality of life (HRQoL) in patients with melanoma before and during Low-Dose IFN-α therapy. In a prospective multicenter trial conducted by the Dermatologic Cooperative Oncology Group, 850 patients with cutaneous stage II malignant melanoma received a standard Low-Dose of IFN-α-2a. We evaluated HRQoL using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 questionnaire at baseline and after 3, 6, and 12 months of IFN-α treatment in 282 patients. Nine of 15 subscales showed significant poorer results after 3 months of adjuvant IFN treatment. Symptoms included reduced physical functioning, reduced cognitive functioning, fatigue, nausea, pain, dyspnea, insomnia, diarrhea, and loss of appetite. We did not find a significant change over time for role, emotional, or social functioning. Only cognitive functioning and dyspnea continuously worsened through the twelfth month. At baseline women had significantly lower scores for physical and emotional functioning and for fatigue compared with men. During treatment, women scored significantly poorer on physical functioning, emotional functioning, fatigue, pain, and constipation subscales. Patients who reported having a bad or very bad QoL before treatment were 5.8 times more likely to discontinue treatment early because of psychiatric problems. We conclude that adjuvant low-dose IFN treatment is associated with significant deterioration of HRQoL. Specific psychosocial care should be offered especially for patients who report lower HRQoL and emotional problems before treatment to prevent early discontinuation.

*Department of Psychiatry, Charité Campus Mitte, Charité-University Medicine Berlin

Department of Dermatology, University of Schleswig-Holstein, Campus Kiel

Department of Dermatology, Ludwig-Maximilians-University, Munich

§§Department of Psychiatry, Psychotherapy, and Addiction Medicine, Kliniken Essen-Mitte

§Department of Dermatology, The Saarland University Hospital, Homburg/Saar

Clinic for Skin Diseases, Helios Clinic Erfurt

Department of Dermatology, Johannes-Wesling-Klinikum Minden

Department of Dermatology, University of Regensburg

**Department of Dermatology, Johann Wolfgang Goethe-University, Frankfurt am Main

††Department of Dermatology, Eberhard-Karls-University, Tübingen

‡‡Department of Dermatology, Venerology, and Allergology, Ruhr University Bochum, Germany

A.H. received consultancy, honoraria, and study support from Schering-Plough (USA)/Essex Pharma (Germany). M.S. and N.H.B. received consultancy, honoraria, and study support from Schering-Plough (USA)/Essex Pharma (Germany) and Roche Pharma (Germany/Switzerland). M.V. received honoraria from Schering-Plough (USA)/Essex Pharma (Germany) and Roche Pharma (Germany/Switzerland). All other authors have no conflict of interest.

Supported by Hiege Foundation against Skin Cancer.

Hannah Cullup and Andy K.W. Hsu have contributed equally.

Present address of Andy K.W. Hsu is Peter MacCallum Cancer Research Institute, Melbourne, Victoria, Australia.

The present address of Monika Schmid-Wendtner is Department of Dermatology, Rheinische Friedrich-Wilhelms-Universität, Bonn, Germany.

Reprints: Martin Schaefer, Kliniken Essen Mitte, Department of Psychiatry and Psychotherapy, Henricistr. 92, 45136 Essen, Germany (e-mail: m.schaefer@kliniken-essen-mitte.de).

Received December 21, 2010

Accepted March 2, 2011

© 2011 Lippincott Williams & Wilkins, Inc.