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QOL and Survival Comparisons by Race in Oncology Clinical Trials. 肿瘤临床试验中不同种族的生活质量和生存比较。
Pub Date : 2016-03-01 Epub Date: 2016-11-16
A D Tan, P J Novotny, J S Kaur, J C Buckner, R B Mowat, E Paskett, J A Sloan

Background: Significant efforts have been made to increase access and accrual to clinical trials for minority cancer patients (MP). This meta-analysis looked for differences in survival and baseline quality of life (QOL) between MP and non-minority cancer patients (NMP).

Materials and methods: Baseline QOL and overall survival times from 47 clinical trials (6513 patients) conducted at Mayo Clinic Cancer Center/North Central Cancer Treatment Group were utilized. Assessments included Uniscale, Linear Analogue Self Assessment, Symptom Distress Scale (SDS), Profile of Mood States and Functional Assessment of Cancer Therapy - General, each transformed into a 0-100 scale with higher scores indicating better outcomes. This transformation involves subtracting the lowest possible value from the assessment, dividing by the range of the scale (the maximum minus the minimum), and multiplying by 100. Analyses included Fisher's Exact tests, linear regression, Kaplan-Meier curves, and Cox proportional hazards models.

Results: Eight percent of patients self-reported as MP (0.45% American Indian/Alaskan Native, 0.7% Asian, 5% Black/African American, 1.5% Hispanic, 0.1% Native Hawaiian and 0.3% Other). MP had no meaningful deficits relative to non-MP in overall QOL but were slightly worse on FACT-G total score, physical, social/family, functional, and SDS nausea severity. MP with lung, neurological or GI cancers had significantly worse mean scores in nausea (58 vs. 69), sleep problems (34 vs. 54); emotional (53 vs. 74); and social/family (60 vs. 67), respectively. Regression models confirmed these results. After adjusting for disease site, there were no significant differences in survival.

Conclusion: MP on these clinical trials indicated small deficits in physical, social, and emotional subscales at baseline compared to NMP. Within cancer sites, MP experienced large deficits for selected QOL domains that bear further attention.

背景:为增加少数癌症患者(MP)临床试验的可及性和累积性,已经做出了重大努力。这项荟萃分析旨在寻找MP和非少数癌症患者(NMP)之间的生存和基线生活质量(QOL)的差异。材料和方法:采用Mayo Clinic Cancer Center/North Central Cancer Treatment Group进行的47项临床试验(6513例患者)的基线生活质量和总生存时间。评估包括unscale,线性模拟自我评估,症状困扰量表(SDS),情绪状态概况和癌症治疗功能评估-一般,每项都转化为0-100的量表,得分越高表明结果越好。这个转换包括从评估中减去最低可能的值,除以刻度范围(最大值减去最小值),然后乘以100。分析包括Fisher’s Exact检验、线性回归、Kaplan-Meier曲线和Cox比例风险模型。结果:8%的患者自我报告为MP(0.45%美国印第安人/阿拉斯加原住民,0.7%亚洲人,5%黑人/非裔美国人,1.5%西班牙裔,0.1%夏威夷原住民和0.3%其他)。与非MP相比,MP在总体生活质量方面没有明显的缺陷,但在FACT-G总分、身体、社会/家庭、功能和SDS恶心严重程度方面略差。MP合并肺部、神经系统或胃肠道癌症在恶心(58比69)、睡眠问题(34比54)方面的平均得分明显较差;情绪化(53比74);以及社会/家庭(60比67)。回归模型证实了这些结果。在调整疾病部位后,生存率无显著差异。结论:在这些临床试验中,与NMP相比,MP在基线时在身体、社会和情感亚量表上有较小的缺陷。在癌症部位,MP经历了大量需要进一步关注的选择的生活质量域的缺陷。
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Journal of cancer and clinical oncology
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