Moinpour C M
Fred Hutchinson Cancer Research Center, Seattle, WA.
Semin Oncol. 1994 Oct;21(5 Suppl 10):48-60; discussion 60-3.
Quality of life (QOL) variables are increasingly included as end points in cancer therapy trials, supplementing such traditional end points as survival time in evaluating the effects of cancer treatments. Consensus has been reached that a number of QOL components (symptom status and physical, emotional, role, and social functioning) should be measured. Assessing multiple health-related QOL dimensions, as compared with a global score, provides a more detailed accounting of specific effects of cancer treatment on patient functioning. Southwest Oncology Group QOL assessment policies emphasize patient reports and the need for systematic quality control procedures. The Southwest Oncology Group QOL questionnaire comprises a battery of categorical scales with established psychometric properties. A set of generic core scales is always included in the battery, and treatment- and disease-specific scales are developed for each trial. Other frequently used QOL questionnaires, such as the European Organization for Research and Treatment of Cancer QLQ-C30, the Cancer Rehabilitation Evaluation System questionnaire, and the Functional Assessment of Cancer Therapy are alternative instruments in current use. Quality of life findings from lung cancer clinical trials indicate a prevalence of symptom distress, fatigue, and decline in functional status, although patients also experience symptom management problems without treatment. A summary of preliminary QOL findings for two vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) trials (randomized and single-arm) in patients with non-small cell lung cancer show that symptom status was as good or better for patients receiving vinorelbine compared with those receiving 5-fluorouracil/leucovorin in the randomized study. Differences in other QOL dimensions were not detected. Findings for the single-arm trial of oral vinorelbine were generally consistent with those of the randomized trial.
生活质量（QOL）变量越来越多地被纳入癌症治疗试验的终点指标，以补充诸如生存时间等传统终点指标，用于评估癌症治疗的效果。人们已达成共识，应测量一些生活质量组成部分（症状状态以及身体、情感、角色和社会功能）。与整体评分相比，评估多个与健康相关的生活质量维度能更详细地说明癌症治疗对患者功能的具体影响。西南肿瘤协作组的生活质量评估政策强调患者报告以及系统质量控制程序的必要性。西南肿瘤协作组的生活质量问卷由一系列具有既定心理测量特性的分类量表组成。该量表组始终包含一组通用核心量表，并且针对每个试验开发特定治疗和疾病的量表。其他常用的生活质量问卷，如欧洲癌症研究与治疗组织的QLQ-C30问卷、癌症康复评估系统问卷以及癌症治疗功能评估问卷，都是目前正在使用的替代工具。肺癌临床试验的生活质量研究结果表明，症状困扰、疲劳以及功能状态下降普遍存在，尽管患者在未接受治疗时也会出现症状管理问题。两项关于长春瑞滨（诺维本；百时美施贵宝公司，北卡罗来纳州三角研究园；法国皮埃尔法布尔制药公司，巴黎）治疗非小细胞肺癌患者的试验（随机试验和单臂试验）的初步生活质量研究结果总结显示，在随机研究中，接受长春瑞滨治疗的患者与接受5-氟尿嘧啶/亚叶酸钙治疗的患者相比，症状状态相当或更好。未检测到其他生活质量维度的差异。口服长春瑞滨单臂试验的结果与随机试验的结果总体一致。
