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Effect of interferon on the health‐related quality of life of multiple myeloma patients: results of a Nordic randomized trial comparing melphalan–prednisone to melphalan–prednisone + α‐interferon
Author(s) -
WislØff Finn,
Hjorth Martin,
Kaasa Stein,
Westin Jan
Publication year - 1996
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1046/j.1365-2141.1996.d01-1802.x
Subject(s) - medicine , prednisone , chills , melphalan , nausea , quality of life (healthcare) , multiple myeloma , vomiting , alpha interferon , randomized controlled trial , surgery , interferon , immunology , nursing
In a Nordic multi‐centre trial, 583 previously untreated multiple myeloma patients were randomized to receive melphalan–prednisone or melphalan–prednisone + interferon α‐2b at a dose of 5 million units subcutaneously, 3 d/week. A quality‐of‐life study was integrated into the trial, using the EORTC QLQ C‐30 questionnaire supplemented with 11 questions concerning interferon toxicity. The questionnaire was completed prior to treatment and after 1, 6, 12, 24, 36 and 48 months. 90% of the patients participated in the quality‐of‐life study, and 83% completed all questionnaires submitted to them. During the first year of treatment the patients on interferon reported significantly more fever, chills, dry skin, fatigue, pain, nausea/vomiting and appetite loss than the control patients. There was a moderate reduction of the global quality‐of‐life score and slight, non‐significant, reductions of physical, emotional, cognitive, social and role functioning scores. After the first year there were no statistically significant differences in any toxicity, symptom or quality‐of‐life score, except for an increased frequency of dizziness in the interferon group. As only 60% of the patients remained on interferon after 24 months, our data probably underestimate the potential toxicity of the drug. Although there was no significant survival benefit for the interferon patients, a 5–6 months prolongation of the response and plateau phase duration was observed. However, by intention‐to‐treat analysis, there was no late quality‐of‐life benefit for the interferon patients to compensate for the early impairment. Thus, the clinical significance of the plateau‐phase prolongation is uncertain.