Weinfurt K P, Li Y, Castel L D, Saad F, Timbie J W, Glendenning G A, Schulman K A
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA.
Ann Oncol. 2005 Apr;16(4):579-84. doi: 10.1093/annonc/mdi122. Epub 2005 Feb 25.
We examined the clinical relevance of skeletal-related events (SREs) for health state preferences, pain and health-related quality of life in patients with advanced prostate cancer and a history of bone metastases.
Data were from a clinical trial of zoledronic acid versus placebo in the treatment of SREs associated with advanced prostate cancer metastatic to bone. Patients (n=248) were included if they experienced an SRE during the study. Outcome measures were assessed at fixed intervals. We used mixed-effects models to estimate changes in outcomes after each patient's first SRE.
There were clinically meaningful and statistically significant declines in physical well-being after: radiation and pathologic fractures; functional well-being after radiation; and emotional well-being after radiation and pathologic fractures. There also were meaningful and significant declines in preference and utility scores after radiation and fracture. Pain intensity declined after radiation, but not after other SREs; no other pain measure changed substantively.
SREs have important and significant effects on measures of health-related quality of life in men with prostate cancer. Treatments that prevent SREs may not demonstrate corresponding effects on outcomes if the effects of SREs occur between scheduled outcome assessments. Implications for trial design are discussed.
我们研究了骨相关事件（SREs）对于晚期前列腺癌且有骨转移病史患者的健康状态偏好、疼痛及健康相关生活质量的临床相关性。
数据来自一项唑来膦酸对比安慰剂治疗骨转移相关晚期前列腺癌SREs的临床试验。若患者在研究期间经历了一次SREs，则纳入研究（n = 248）。在固定时间间隔评估结局指标。我们使用混合效应模型来估计每位患者首次发生SREs后结局的变化。
在发生以下情况后，身体幸福感出现了具有临床意义且在统计学上显著的下降：放疗和病理性骨折后；放疗后的功能幸福感；放疗和病理性骨折后的情绪幸福感。在放疗和骨折后，偏好和效用评分也出现了有意义且显著的下降。放疗后疼痛强度下降，但其他SREs后未下降；其他疼痛指标无实质性变化。
SREs对前列腺癌男性患者的健康相关生活质量指标有重要且显著的影响。如果SREs的影响发生在预定的结局评估之间，预防SREs的治疗可能不会在结局上显示出相应的效果。讨论了对试验设计的影响。
