Abstract
BackgroundThere 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/DesignA 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.DiscussionThis is a presentation of the study protocol only. Results and conclusions are pending completion of this study.Systematic review registrationPROSPERO CRD42014008968
Highlights
There is a high unmet need for effective treatments for patients with squamous non-small cell lung cancer (NSCLC)
This is a presentation of the study protocol only
It is defined as cancer that forms in the tissues of the lung, usually in the cells lining air passages, and is divided into two main subtypes: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)
Summary
There is a high unmet need for effective treatments for patients with squamous non-small cell lung cancer (NSCLC). NSCLC is the predominant subtype form and accounts for about 85% of all lung cancers [2]; it is further divided by cell histology into adenocarcinoma, squamous cell carcinoma, and large-cell carcinoma, with adenocarcinoma the currently predominant histology. Adjuvant chemotherapy is increasingly used in those with stage II disease and occasionally for those with stage IB, depending on the size of the tumor. For those with stage III lung cancer, chemoradiotherapy alone or in addition to surgery is used to treat patients; while treatment is administered with a curative intent, the 5-year survival for patients with regional disease is approximately 26%, which decreases to 3.9% for patients with metastatic disease [3]. The standard first-line drug treatments for advanced NSCLC, neoadjuvant, adjuvant, or chemoradiotherapy, are generally based on the combination of a second- or third-generation cytotoxic drug with a platinum agent (cisplatin or carboplatin)
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