TY - JOUR
T1 - Study protocol
T2 - Systematic review and meta-analysis of randomized controlled trials in first-line treatment of squamous non-small cell lung cancer
AU - DeLozier, Amy M.
AU - Brown, Jacqueline
AU - Natanegara, Fanni
AU - Zhao, Luping
AU - Cui, Zhanglin L.
AU - Able, Stephen L.
AU - Bowman, Lee
AU - Treat, Joseph
AU - Hess, Lisa M.
N1 - Publisher Copyright:
© 2014 DeLozier et al.; licensee BioMed Central Ltd.
PY - 2014/9/16
Y1 - 2014/9/16
N2 - 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 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.DISCUSSION: This is a presentation of the study protocol only. Results and conclusions are pending completion of this study.SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014008968.
AB - 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 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.DISCUSSION: This is a presentation of the study protocol only. Results and conclusions are pending completion of this study.SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014008968.
KW - Antibodies, Monoclonal, Humanized
KW - Antibodies, Monoclonal/administration & dosage
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Carcinoma, Non-Small-Cell Lung/drug therapy
KW - Carcinoma, Squamous Cell/drug therapy
KW - Cisplatin/administration & dosage
KW - Deoxycytidine/administration & dosage
KW - Disease-Free Survival
KW - Gemcitabine
KW - Humans
KW - Lung Neoplasms/drug therapy
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Research Design
KW - Survival Rate
KW - Systematic Reviews as Topic
UR - http://www.scopus.com/inward/record.url?scp=84925405363&partnerID=8YFLogxK
U2 - 10.1186/2046-4053-3-102
DO - 10.1186/2046-4053-3-102
M3 - Article
C2 - 25227571
AN - SCOPUS:84925405363
SN - 2046-4053
VL - 3
JO - Systematic Reviews
JF - Systematic Reviews
IS - 1
M1 - 102
ER -
