Reynolds Jonathan K, Levien Terri L
Department of Pharmacotherapy, College of Pharmacy, Washington State University, Pullman, Washington 99164-6510, USA.
Drugs Aging. 2008;25(11):893-911. doi: 10.2165/0002512-200825110-00001.
Health-related quality-of-life (QOL) endpoints in clinical trials provide decision makers with a more comprehensive picture of a specific treatment than activity-related endpoints alone. Such endpoints are increasingly being reported in cancer clinical trials. We reviewed phase III clinical trials that involved gemcitabine in the treatment of unresectable non-small-cell lung cancer. A systematic literature search was undertaken and 16 phase III clinical trials were found in which gemcitabine therapy was included in a treatment arm and QOL was an endpoint. Twelve of the 16 trials compared a gemcitabine-based treatment with a non-gemcitabine-based treatment. Not all data were reported in the trials, and the findings are mixed. However, a review of these 12 trials generally shows that gemcitabine-containing chemotherapy treatments had either no different or more favourable QOL outcomes than non-gemcitabine-containing chemotherapy treatments. Ten of the 16 trials that were reviewed had a primary endpoint or objective that was not QOL. Of these ten trials, only four concluded that one treatment arm could be therapeutically favoured over another in terms of the non-QOL primary endpoint. Two of the trials reported no difference in QOL and two reported that QOL favoured the arm that was therapeutically favoured. Many more trials will need to be conducted in order to conclude that gemcitabine-containing arms are associated with a more desirable QOL than non-gemcitabine-containing arms and that QOL necessarily favours the therapeutically favoured arm in the treatment of non-small-cell lung cancer.
临床试验中与健康相关的生活质量（QOL）终点指标，相较于仅使用与活动相关的终点指标，能为决策者提供关于特定治疗的更全面信息。此类终点指标在癌症临床试验中的报告越来越多。我们回顾了涉及吉西他滨治疗不可切除非小细胞肺癌的III期临床试验。进行了系统的文献检索，发现16项III期临床试验，其中治疗组包含吉西他滨治疗且QOL为终点指标。16项试验中有12项将基于吉西他滨的治疗与非基于吉西他滨的治疗进行了比较。并非所有试验数据都有报告，结果也参差不齐。然而，对这12项试验的回顾总体显示，含吉西他滨的化疗治疗与不含吉西他滨的化疗治疗相比，在QOL结果上要么没有差异，要么更有利。所回顾的16项试验中有10项的主要终点指标或目标不是QOL。在这10项试验中，只有4项得出结论，就非QOL主要终点指标而言，一个治疗组在治疗上比另一个治疗组更具优势。其中两项试验报告QOL无差异，两项试验报告QOL有利于在治疗上更具优势的治疗组。为了得出含吉西他滨的治疗组比不含吉西他滨的治疗组具有更理想的QOL，且在非小细胞肺癌治疗中QOL必然有利于在治疗上更具优势的治疗组这一结论，还需要进行更多试验。
