Defining and analysing symptom palliation in cancer clinical trials: a deceptively difficult exercise.
Defining and analysing symptom palliation in cancer clinical trials: a deceptively difficult exercise.
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DOI：
10.1038/sj.bjc.6690085
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发表时间：
1999-02
影响因子：
8.8
通讯作者：
中科院分区：
文献类型：
--
作者：
症状缓解的评估是临床试验中许多治疗比较的重要组成部分，但广泛的文献检索显示对其确切定义没有达成共识，该定义可能包括症状缓解、发作时间、持续时间、程度以及症状控制和预防。为了评估这些方面的重要性并比较不同的分析方法，我们在一项大规模（>300例患者）多中心随机临床试验（由医学研究理事会肺癌工作组进行）中使用了来自患者自我评估问卷（鹿特丹症状检查表）的一种症状（咳嗽），该临床试验采用姑息化疗治疗小细胞肺癌。比较的方案是两种药物方案（2D）和四种药物方案（4D）。两种治疗方案在缓解发作时间或缓解持续时间方面无差异。缓解程度与初始严重程度密切相关：基线时中度或重度咳嗽患者中有90%报告改善，而轻度咳嗽患者中只有53%报告改善。使用不同里程碑时间点进行的分析得出了相互矛盾的结果：4D方案在1个月和3个月时表现出上级，而在2个月时2D方案表现出上级。当考虑到3个月内任何时间的改善时，4D方案显示出显著的获益（4D 79%，2D 60%，P = 0.02）。这些发现强调了在解释结果时需要谨慎，以及努力制定症状缓解的标准定义的重要性。由于目前缺乏具体的标准，很难分析和解释试验结果，也不可能进行试验间的比较。提出了一个标准的定义，用于临床试验数据的分析，其中考虑到发病，持续时间和程度的缓解，症状的改善，控制和预防方面。© 1999癌症研究运动
The assessment of symptom palliation is an essential component of many treatment comparisons in clinical trials, yet an extensive literature search revealed no consensus as to its precise definition, which could embrace relief of symptoms, time to their onset, duration, degree, as well as symptom control and prevention. In an attempt to assess the importance of these aspects and to compare different methods of analysis, we used one symptom (cough) from a patient self-assessment questionnaire (the Rotterdam Symptom Checklist) in a large (>300 patient) multicentre randomized clinical trial (conducted by the Medical Research Council Lung Cancer Working Party) of palliative chemotherapy in small-cell lung cancer. The regimens compared were a two-drug regimen (2D) and a four-drug regimen (4D). No differences were seen between the regimens in time of onset of palliation or its duration. The degree of palliation was strongly related to the initial severity: 90% of the patients with moderate or severe cough at baseline reported improvement, compared with only 53% of those with mild cough. Analyses using different landmark time points gave conflicting results: the 4D regimen was superior at 1 month and at 3 months, whereas at 2 months the 2D regimen appeared superior. When improvement at any time up to 3 months was considered, the 4D regimen showed a significant benefit (4D 79%, 2D 60%, P = 0.02). These findings emphasize the need for caution in interpreting results, and the importance of working towards a standard definition of symptom palliation. The current lack of specified criteria makes analysis and interpretation of trial results difficult, and comparison across trials impossible. A standard definition of palliation for use in the analysis of clinical trials data is proposed, which takes into account aspects of onset, duration and degree of palliation, and symptom improvement, control and prevention. © 1999 Cancer Research Campaign
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影响因子：
8.8
作者：
Ball, D;Smith, J;Bishop, J;Olver, I;Davis, S;OBrien, P;Bernshaw, D;Ryan, G;Millward, M
通讯作者：
Millward, M
影响因子：
8.8
作者：
de Haes JC;van Knippenberg FC;Neijt JP
通讯作者：
Neijt JP
影响因子：
50.5
作者：
Glimelius, B;Hoffman, K;Svensson, C
通讯作者：
Svensson, C
影响因子：
24.5
作者：
BARR, H;KRASNER, N;WALKER, RJ
通讯作者：
WALKER, RJ
影响因子：
5.7
作者：
HAIEMEDER, C;PELLAECOSSET, B;ARRIAGADA, R
通讯作者：
ARRIAGADA, R