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首页> 外文期刊>Journal of Clinical Oncology >Pain and emotional well-being outcomes in Southwest Oncology Group-directed intergroup trial S0205: a phase III study comparing gemcitabine plus cetuximab versus gemcitabine as first-line therapy in patients with advanced pancreas cancer.
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Pain and emotional well-being outcomes in Southwest Oncology Group-directed intergroup trial S0205: a phase III study comparing gemcitabine plus cetuximab versus gemcitabine as first-line therapy in patients with advanced pancreas cancer.

机译:西南肿瘤小组指导的小组间试验S0205的疼痛和情绪健康结果:一项III期研究,比较吉西他滨加西妥昔单抗与吉西他滨作为晚期胰腺癌患者的一线治疗。

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PURPOSE: S0205 was a randomized clinical trial that compared the therapeutic impact of gemcitabine versus gemcitabine plus cetuximab. Study results for patient-reported health-related quality of life (HRQL) outcomes are reported. PATIENTS AND METHODS: Patients completed the Brief Pain Inventory and a measure of emotional well-being (each measured on a 0 to 10 scale) at baseline and at weeks 5, 9, 13, and 17 postrandom assignment. Worst pain status was classified as palliated (worst pain scores < 5 maintained for 2 consecutive cycles) or not palliated (remaining patients) and tested with a chi(2) test. Change in emotional well-being and worst pain (exploratory analysis) were assessed over 17 weeks using generalized estimating equations with inverse probability of censoring weights. RESULTS: Seven hundred twenty of 766 enrolled patients contributed baseline HRQL data. The two treatment arms did not differ statistically in the percentage of patients with successful worst pain palliation. Longitudinal analyses showed significantly improved emotional well-being for patients on both arms by weeks 13 and 17 (P < .01 and P < .001). An exploratory longitudinal analysis of worst pain showed significant decreases at all time points for both arms (P < .01 and P < .001). Significant treatment arm differences for either worst pain or emotional well-being were not observed at any of the assessment times. CONCLUSION: We observed palliated pain and improved well-being for patients on this trial. However, these improvements were similar in both treatment arms, suggesting that the addition of cetuximab did not contribute to improvement in these HRQL outcomes.
机译:目的:S0205是一项随机临床试验,比较了吉西他滨与吉西他滨加西妥昔单抗的治疗效果。报告了患者报告的健康相关生活质量(HRQL)结果的研究结果。患者和方法:患者在基线和随机分配后的第5、9、13和17周完成了简短的疼痛清单和情绪幸福感的量度(每个量表的评分范围为0至10)。疼痛最严重的状态分类为姑息(连续2个周期维持最坏疼痛评分<5)或未姑息(其余患者),并用chi(2)测试进行测试。在17周内,使用广义估计方程对体重减轻的概率进行了评估,从而评估了情绪健康的变化和最严重的疼痛(探索性分析)。结果:766名登记患者中的720名贡献了基线HRQL数据。两个治疗组在成功缓解最严重疼痛的患者中所占的百分比没有统计学差异。纵向分析显示,在第13周和第17周时,两臂患者的情绪健康都得到了显着改善(P <.01和P <.001)。对严重疼痛的探索性纵向分析显示,在所有时间点,两臂的疼痛均明显减轻(P <.01和P <.001)。在任何评估时间均未观察到治疗疼痛严重程度或情绪健康方面的显着差异。结论:在该试验中,我们观察到疼痛减轻并改善了患者的幸福感。但是,两个治疗组的这些改善均相似,这表明西妥昔单抗的添加并未有助于这些HRQL结果的改善。

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