Health-related quality of life in men with metastatic prostate cancer treated with prednisone alone or mitoxantrone and prednisone

Purpose: A combination of mitoxantrone plus prednisone is preferable to prednisone alone for reduction of pain in men with metastatic, hormone-resistant, prostate cancer. The purpose of this study was to assess the effects of these treatments on health-related qualify of life (HQL). Patients and Methods: Men with metastatic prostate cancer (n = 161) were randomized to receive either daily prednisone alone or mitoxantrone (every 3 weeks) plus prednisone. Those who received prednisone alone could have mitoxantrone added after 6 weeks if there was no improvement in pain. HQL was assessed before treatment initiation and then every 3 weeks using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (EORTC QLQ-C30) and the Quality of Life Module-Prostate 14 (QOLM-P14), a trial-specific module developed for this study. an intent-to-treat analysis was used to determine the mean duration of HQL improvement and differences in improvement duration between groups of patients. Results: at 6 weeks, both groups showed improvement several HQL domains, and only physical functioning and pain were better in the mitoxantrone-plus-prednisone group than in the prednisone-alone group. After 6 weeks,:patients taking prednisone showed no improvement in HQL scores, whereas those taking mitoxantrone plus prednisone showed significant improvements in global quality of life (P = .009), four functioning domains, and nine symptoms (.001 < P < .01), and the improvement (> 10 units on a scale of 0 to 100) lasted longer than in the prednisone-alone group (.004 < P < .05). The addition of mitoxantrone to prednisone after failure of prednisone alone was associated with improvements in pain, pain impact, pain relief, insomnia, and global quality of life (.001 < P < .003). Conclusion: Treatment with mitoxantrone plus prednisone was associated with greater and longer-casting improvement in several HQL domains and symptoms than treatment with prednisone alone. (C) 1999 by American Society of Clinical Oncology.