Tanvetyanon Tawee, Soares Heloisa P, Djulbegovic Benjamin, Jacobsen Paul B, Bepler Gerold
H. Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa, Florida 33612, USA.
J Thorac Oncol. 2007 Dec;2(12):1091-7. doi: 10.1097/JTO.0b013e31815cff64.
Systemic chemotherapy is accepted as a standard of care for patients with advanced non-small cell lung cancer (NSCLC). Although survival outcomes are equivalent among standard chemotherapy regimens, it is unknown whether the quality of life (QOL) outcomes are also comparable. We evaluated available literatures to summarize the state of current knowledge and provide suggestions for future studies.
Using PUBMED/MEDLINE database, a systematic review of randomized controlled phase III trials of advanced NSCLC reporting QOL as one of the end points was conducted. Trials were included if standard chemotherapy regimens (as defined by The American Society of Clinical Oncology 2003 recommendations) were used in at least two arms of a trial. Two reviewers independently extracted data and evaluated the characteristics of QOL reporting, analyses, and results.
The search criteria identified 14 trials (6665 patients). Of these, 13 trials used validated QOL instruments and were included for review. The QOL reporting/analysis techniques were heterogeneous. We included nine trials, which reported the rate of completed baseline assessment and compliance survivors at analysis greater than 50%, for data synthesis. Of these, only one trial found a significant difference in QOL between the comparator arms: paclitaxel plus cisplatin was better than teniposide plus cisplatin.
Based on our review, it seems unlikely that a major difference exists in the global QOL associated with standard chemotherapy regimens for advanced NSCLC. Although QOL reporting format is largely acceptable, a lack of uniformity in analysis and a poor compliance to QOL assessment made between-trial comparisons difficult.
全身化疗被公认为晚期非小细胞肺癌(NSCLC)患者的标准治疗方法。尽管标准化疗方案的生存结果相当,但生活质量(QOL)结果是否也具有可比性尚不清楚。我们评估了现有文献,以总结当前的知识状况并为未来研究提供建议。
使用PUBMED/MEDLINE数据库,对将QOL作为终点之一的晚期NSCLC随机对照III期试验进行系统评价。如果一项试验的至少两个治疗组使用了标准化疗方案(按照美国临床肿瘤学会2003年的建议定义),则纳入该试验。两名研究者独立提取数据并评估QOL报告、分析和结果的特征。
检索标准确定了14项试验(6665例患者)。其中,13项试验使用了经过验证的QOL工具并纳入综述。QOL报告/分析技术存在异质性。我们纳入了9项试验进行数据合成,这些试验报告分析时完成基线评估的比例和依从性幸存者比例大于50%。其中,只有一项试验发现比较组之间的QOL存在显著差异:紫杉醇加顺铂优于替尼泊苷加顺铂。
根据我们的综述,对于晚期NSCLC,标准化疗方案相关的总体QOL似乎不太可能存在重大差异。尽管QOL报告格式在很大程度上是可接受的,但分析缺乏一致性以及QOL评估的依从性差使得试验间比较困难。