Quality of life and pain in advanced stage prostate cancer: Results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone
Quality of life and pain in advanced stage prostate cancer: Results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone
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DOI：
10.1200/jco.2005.04.8207
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发表时间：
2006-06-20
影响因子：
45.3
通讯作者：
Crawford, E. David
中科院分区：
文献类型：
--
作者：
Berry, Donna L.;Moinpour, Carol M.;Crawford, E. David
目的观察多西他赛联合雌莫司汀（DE）或米托蒽醌联合泼尼松（MP）治疗雄激素非依赖性前列腺癌患者骨痛的疗效。虽然西南肿瘤组试验99-16证明了生存改善DE MP，该研究还旨在比较姑息疾病相关symptoms.Methods疼痛缓解和全球生活质量（QOL）的两个主要患者报告的结果。采用麦吉尔疼痛量表-简表的当前疼痛强度量表测量疼痛。欧洲癌症研究和治疗组织核心生活质量问卷C30（QLQ-C30）及其前列腺癌模块（PR 25）测量QOL和症状状态。在随机分配时、8个周期的每个周期和随机分配后1年测量疼痛和镇痛药使用情况;在随机分配时、第4周期（第10周）和第8周期（第6个月）前和1年时测量QLQ-C30和PR 25。除了主要的意向治疗，在随机分析，缺失的敏感性分析，以评估鲁棒性的全球QOL的结论下替代信息缺失dataassumption.Results六百七十四个合格的患者接受DE（n = 338）或MP（n = 336）。在意向治疗分析中，DE组的中位总生存期为17.5个月，MP组为15.6个月（P = 0.02）。治疗组之间的疼痛缓解无统计学显著差异。敏感性分析表明，一致缺乏统计学显着的全球QOL差异两arms.Conclusion DE具有上级临床疗效（总生存期，时间进展，前列腺特异性抗原下降）与相似的全球QOL和疼痛缓解的MP手臂。
Purpose Palliation of bone pain can be achieved in men with androgen-independent prostate cancer treated with docetaxel and estramustine (DE) or mitoxantrone and prednisone (MP). While Southwest Oncology Group trial 99-16 demonstrated a survival improvement of DE over MP, the study also was designed to compare the palliation of disease-related symptoms.Methods Pain palliation and global quality of life (QOL) were the two primary patient-reported outcomes. Pain was measured with the Present Pain Intensity scale of the McGill Pain Questionnaire-Short Form. The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (QLQ-C30) and its Prostate Cancer Module (PR25) measured QOL and symptom status. Pain and analgesic use were measured at random assignment, every cycle for eight cycles, and 1 year from random assignment; the QLQ-C30 and the PR25 were administered at random assignment, before cycle four (week 10) and cycle eight (month 6) and at 1 year. In addition to the primary intent-to-treat, missing at random analysis, sensitivity analyses were performed to assess robustness of global QOL conclusions under alternative informative missing data assumptions.Results Six hundred seventy four eligible patients received DE (n = 338) or MP (n = 336). In an intention-to-treat analysis, median overall survival was 17.5 months for the DE arm and 15.6 months for the MP arm (P = .02). There were no statistically significant differences in pain palliation between the treatment arms. The sensitivity analyses showed a consistent lack of statistically significant global QOL differences for the two arms.Conclusion DE had superior clinical efficacy (overall survival, time-to-progression, and prostate-specific antigen declines) with similar global QOL and pain palliation in the MP arm.