纳入临床试验的癌症相关性疲劳的晚期癌症患者和转诊至姑息治疗门诊患者的特征。
Characteristics of advanced cancer patients with cancer-related fatigue enrolled in clinical trials and patients referred to outpatient palliative care clinics.
机构信息
Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
出版信息
J Pain Symptom Manage. 2013 Mar;45(3):534-41. doi: 10.1016/j.jpainsymman.2012.02.013. Epub 2012 Aug 20.
CONTEXT
Limited published data exist on whether characteristics of patients with advanced cancer enrolled in cancer-related fatigue clinical trials (CCTs) differ from patients in outpatient palliative care clinics (OPCs).
OBJECTIVES
The primary aim of this study was to compare the characteristics of two groups of patients with advanced cancer and moderate-to-severe fatigue: patients in CCTs and patients at an OPC.
METHODS
We retrospectively reviewed the records of 337 patients who were enrolled in one of five CCTs for advanced cancer patients at The University of Texas M. D. Anderson Cancer Center as well as the records of 1896 consecutive patients who were referred to our OPC from January 2003 through December 2010. Patients with fatigue scores of ≥4/10 (measured by the Edmonton Symptom Assessment System [ESAS]) were eligible (1252 OPC patients and 337 CCT patients). Patient characteristics, ESAS scores, and survival times were compared using Chi-square tests, Wilcoxon rank sum tests, and the Kaplan-Meier method.
RESULTS
Compared with the CCT patients, OPC patients were more likely to be older (58 vs. 59 years; P=0.009) and male (38% vs. 52%; P<0.001). The most common primary cancer type was breast cancer (22%) in the CCT patients and lung cancer (23%) in the OPC patients (P<0.001). The median ESAS scores in the OPC and CCT groups, respectively, were 6 and 4 for pain (P<0.001), 7 and 7 for fatigue (P=0.525), 3 and 2 for depression (P=0.004), 3 and 2 for anxiety (P<0.001), 3 and 2 for dyspnea (P<0.001), and 43 and 32 for the symptom distress score (P<0.001). The median overall survival times were 17.9 months (95% CI 13.5-22.3 months) in the CCT group and 3.8 months (95% CI 3.5-4.1 months) in the OPC group (P<0.001).
CONCLUSION
Baseline characteristics and overall survival times significantly differed between patients enrolled in the CCT and OPC groups. Therefore, we conclude that the results of CCTs cannot be generalized to patients being treated in OPCs.
背景
关于入组癌症相关性乏力临床试验（CCTs）的晚期癌症患者的特征是否与门诊姑息治疗门诊（OPCs）的患者不同，目前仅有有限的文献报道。
目的
本研究的主要目的是比较两组患有晚期癌症和中重度乏力的患者的特征：入组 CCTs 的患者和 OPC 患者。
方法
我们回顾性分析了在德克萨斯大学 MD 安德森癌症中心的五个 CCT 中入组的 337 例晚期癌症患者的记录，以及在 2003 年 1 月至 2010 年 12 月期间转诊到我们的 OPC 的 1896 例连续患者的记录。乏力评分≥4/10（采用埃德蒙顿症状评估系统[ESAS]测量）的患者符合入组标准（1252 例 OPC 患者和 337 例 CCT 患者）。使用卡方检验、Wilcoxon 秩和检验和 Kaplan-Meier 法比较患者特征、ESAS 评分和生存时间。
结果
与 CCT 患者相比，OPC 患者更可能年龄较大（58 岁比 59 岁；P=0.009）和为男性（38%比 52%；P<0.001）。在 CCT 患者中最常见的原发癌类型为乳腺癌（22%），而在 OPC 患者中为肺癌（23%）（P<0.001）。OPC 和 CCT 组的中位 ESAS 评分分别为疼痛 6 分和 4 分（P<0.001），疲劳 7 分和 7 分（P=0.525），抑郁 3 分和 2 分（P=0.004），焦虑 3 分和 2 分（P<0.001），呼吸困难 3 分和 2 分（P<0.001），症状困扰评分 43 分和 32 分（P<0.001）。CCT 组的中位总生存时间为 17.9 个月（95%CI 13.5-22.3 个月），OPC 组为 3.8 个月（95%CI 3.5-4.1 个月）（P<0.001）。
结论
入组 CCT 和 OPC 组的患者的基线特征和总生存时间有显著差异。因此，我们得出结论，CCT 的结果不能推广到 OPC 治疗的患者。
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