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 PLUS ALPHA-INTERFERON

In a Nordic multi-centre trial, 583 previously untreated multiple myel oma patients were randomized to receive melphalan-prednisone or melpha lan-prednisone + interferon alpha-2b at a dose of 5 million units subc utaneously, 3 d/week. A quality-of-life study was integrated into the trial, using the EORTC QLQ C-30 questionnaire supplemented with 11 que stions concerning interferon toxicity. The questionnaire was completed prior to treatment and after 1, 6, 12, 24, 36 and 48 months. 90% of t he patients participated in the quality-of-life study, and 83% complet ed all questionnaires submitted to them. During the first year of trea tment the patients on interferon reported significantly more fever, ch ills, dry skin, fatigue, pain, nausea/vomiting and appetite loss than the control patients. There was a moderate reduction of the global qua lify-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 fr equency of dizziness in the interferon group. As only 60% of the patie nts remained on interferon after 24 months, our data probably underest imate the potential toxicity of the drug, Although there was no signif icant survival benefit for the interferon patients, a 5-6 months prolo ngation of the response and plateau phase duration was observed, Howev er, by intention-to-treat analysis, there was no late quality-of-life benefit for the interferon patients to compensate for the early impair ment. Thus, the clinical significance of the plateau-phase prolongatio n is uncertain.