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Health-related quality of life before and during adjuvant interferon-alpha treatment for patients with malignant melanoma (DeCOG-trial).

Author(s): Ziefle S, Egberts F, Heinze S, Volkenandt M, Schmid-Wendtner M, Tilgen W, Linse R, Boettjer J, Vogt T, Spieth K, Eigentler T, Brockmeyer NH, Heinz A, Hauschild A, Schaefer M

Affiliation(s): Department of Psychiatry, Charite Campus Mitte, Charite-University Medicine Berlin, Germany.

Publication date & source: 2011-05, J Immunother., 34(4):403-8.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Adjuvant treatment with interferon-alpha (IFN-alpha) 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-alpha 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-alpha-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-alpha 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.

Page last updated: 2011-12-09

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