DeLozier Amy M, Brown Jacqueline, Natanegara Fanni, Zhao Luping, Cui Zhanglin Lin, Able Stephen L, Bowman Lee, Treat Joseph, Hess Lisa M
Eli Lilly and Company, Indianapolis, IN, USA.
Syst Rev. 2014 Sep 16;3:102. doi: 10.1186/2046-4053-3-102.
There is a high unmet need for effective treatments for patients with squamous non-small cell lung cancer (NSCLC). Eli Lilly and Company is conducting a phase III, randomized, multicenter, open-label study of gemcitabine plus cisplatin plus necitumumab (GC + N) versus gemcitabine plus cisplatin (GC) for the first-line treatment of patients with stage IV squamous NSCLC. Given GC is not the only treatment commonly used for the treatment of squamous NSCLC, this study was designed to compare the survival, toxicity, and quality of life outcomes of current treatment strategies for squamous NSCLC in the first-line setting.
METHODS/DESIGN: A systematic review and meta-analysis (including indirect comparisons) of treatments used in squamous NSCLC will be conducted to assess the clinical efficacy (overall and progression-free survival), health-related quality of life (HRQoL), and safety (grade 3-4 toxicity) of GC + N compared to other treatments used in squamous NSCLC. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines will be followed for all aspects of this study. A systematic literature review will be conducted to identify randomized controlled trials evaluating chemotherapy treatment in first-line NSCLC. Eligible articles will be restricted to randomized controlled trials (RCTs) among chemotherapy-naïve advanced NSCLC cancer patients that report outcome data (survival, toxicity, or quality of life) for patients with squamous histology. Following data extraction and validation, data consistency and study heterogeneity will be assessed. A network meta-analysis will be conducted based on the available hazard ratios for overall and progression-free survival, odds ratios for published toxicity data, and mean difference of HRQoL scales. Sensitivity analyses will be conducted.
This is a presentation of the study protocol only. Results and conclusions are pending completion of this study.
PROSPERO CRD42014008968.
对于鳞状非小细胞肺癌（NSCLC）患者而言，对有效治疗方法存在着高度未满足的需求。礼来公司正在开展一项III期、随机、多中心、开放标签研究，比较吉西他滨联合顺铂加奈昔单抗（GC + N）与吉西他滨联合顺铂（GC）用于IV期鳞状NSCLC患者的一线治疗。鉴于GC并非鳞状NSCLC唯一常用的治疗方法，本研究旨在比较一线治疗中鳞状NSCLC当前治疗策略的生存、毒性和生活质量结果。
方法/设计：将对鳞状NSCLC中使用的治疗方法进行系统评价和荟萃分析（包括间接比较），以评估GC + N与鳞状NSCLC中使用的其他治疗方法相比的临床疗效（总生存期和无进展生存期）、健康相关生活质量（HRQoL）和安全性（3 - 4级毒性）。本研究的所有方面都将遵循PRISMA（系统评价和荟萃分析的首选报告项目）指南。将进行系统的文献综述，以识别评估一线NSCLC化疗治疗的随机对照试验。符合条件的文章将限于未接受过化疗的晚期NSCLC癌症患者中的随机对照试验（RCT），这些试验报告了鳞状组织学患者的结局数据（生存、毒性或生活质量）。在数据提取和验证后，将评估数据一致性和研究异质性。将基于总生存期和无进展生存期的可用风险比、已发表毒性数据的比值比以及HRQoL量表的均值差异进行网络荟萃分析。将进行敏感性分析。
这仅是研究方案的介绍。结果和结论有待本研究完成。
PROSPERO CRD42014008968
