Osoba D, Tannock I F, Ernst D S, Neville A J
Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
J Clin Oncol. 1999 Jun;17(6):1654-63. doi: 10.1200/JCO.1999.17.6.1654.
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 quality of life (HQL).
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.
At 6 weeks, both groups showed improvement in 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 to100) 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).
Treatment with mitoxantrone plus prednisone was associated with greater and longer-lasting improvement in several HQL domains and symptoms than treatment with prednisone alone.
对于转移性、激素抵抗性前列腺癌男性患者，米托蒽醌联合泼尼松在减轻疼痛方面优于单独使用泼尼松。本研究的目的是评估这些治疗方法对健康相关生活质量（HQL）的影响。
转移性前列腺癌男性患者（n = 161）被随机分为两组，一组每天单独服用泼尼松，另一组每3周接受米托蒽醌加泼尼松治疗。单独服用泼尼松的患者，如果疼痛没有改善，6周后可加用米托蒽醌。在治疗开始前以及之后每3周使用欧洲癌症研究与治疗组织生活质量问卷C30（EORTC QLQ - C30）和生活质量模块 - 前列腺14（QOLM - P14，为本研究专门开发的特定试验模块）评估HQL。采用意向性分析来确定HQL改善的平均持续时间以及患者组之间改善持续时间的差异。
在6周时，两组在几个HQL领域均有改善，且只有身体功能和疼痛方面，米托蒽醌加泼尼松组比单独使用泼尼松组更好。6周后，服用泼尼松的患者HQL评分没有改善，而服用米托蒽醌加泼尼松的患者在总体生活质量（P = 0.009）、四个功能领域和九个症状方面（0.001 < P < 0.01）有显著改善，且改善（在0至100分的量表上> 10分）持续时间比单独使用泼尼松组更长（0.004 < P < 0.05）。在单独使用泼尼松治疗失败后加用米托蒽醌与疼痛、疼痛影响、疼痛缓解、失眠和总体生活质量的改善相关（0.001 < P < 0.003）。
与单独使用泼尼松治疗相比，米托蒽醌加泼尼松治疗在几个HQL领域和症状方面有更大且更持久的改善。
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