文档介绍：DeLozier et al. Systematic Reviews 2014, 3:102
PROTOCOL Open Access
Study protocol: systematic review and
meta-analysis of randomized controlled trials in
first-line treatment of squamous non-small cell
lung cancer
Amy M DeLozier1, Jacqueline Brown2, Fanni Natanegara1, Luping Zhao1, Zhanglin Lin Cui1, Stephen L Able1,
Lee Bowman1, Joseph Treat1 and Lisa M Hess1*
Abstract
Background: 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 li