PROSPERO International prospective register of systematic reviews

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1 PROSPERO International prospective register of systematic reviews Meta-analysis of randomized controlled trials in first-line treatment of squamous non-small cell lung cancer Lisa Hess, Amy De Lozier, Lee Bowman, Jacqueline Brown, Luping Zhao, Fanni Natanegara, Joseph Treat, Zhanglin Lin Cui, Stephen Able Citation Lisa Hess, Amy De Lozier, Lee Bowman, Jacqueline Brown, Luping Zhao, Fanni Natanegara, Joseph Treat, Zhanglin Lin Cui, Stephen Able. Meta-analysis of randomized controlled trials in first-line treatment of squamous non-small cell lung cancer. PROSPERO 2014:CRD Available from Review question(s) This meta-analysis will investigate randomized trials of first-line treatment of squamous NSCLC. A systematic review and meta-analysis (including indirect comparisons) will be conducted of treatments used in squamous NSCLC to assess the clinical efficacy, quality of life, and safety of necitumumab compared to other treatments used in squamous NSCLC. 1. To conduct a systematic literature review of randomized trials of all relevant treatments used for the first-line treatment of squamous NSCLC. 2. To extract relevant data from the relevant published literature. 3. To perform indirect and direct comparisons of necitumumab to all identified comparators for the following outcomes: 3.1 overall survival 3.2 progression free survival 3.3 toxicity 3.4 quality of life Searches Searches will be run in PubMed, Medline and EMBASE using free text and controlled vocabulary terms (MeSH). Studies published prior to 1995 will be excluded because NSCLC histology was not consistently differentiated prior to Studies not published in English will be excluded. Additionally, conference abstracts of cancer/lung cancer focused meetings will be reviewed to identify additional trials. Link to search strategy Types of study to be included The meta-analysis is limited to randomized controlled trials. Condition or domain being studied Lung cancer is the leading cause of cancer-related deaths worldwide, accounting for 1.3 million deaths annually. 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). NSCLC is the predominant subtype form and accounts for about 85% of all lung cancers; it is further divided by cell histology into adenocarcinoma, squamous-cell carcinoma, and large-cell carcinoma with adenocarcinoma currently being the Page: 1 / 5

2 predominant lung cancer type among never smokers. Although the overall age-adjusted incidence rates for lung cancer are declining, lung cancer remains the leading cause of cancer-related deaths worldwide with an overall 5-year relative survival rate of about 15%, resulting in a significant disease burden worldwide. Participants/ population Male or female patients with histologically or cytologically confirmed squamous NSCLC. Study participants must have not received chemotherapy treatment prior to first line chemotherapy for NSCLC at the time of randomization in the study. Intervention(s), exposure(s) The study assesses a chemotherapy treatment in each of the study arms. No limits are placed on the type of chemotherapy used. Comparator(s)/ control The study assesses chemotherapy as a comparator to the experimental arm. Context Additional eligibility characteristics include: Outcomes: At least one of the following outcomes must be quantitatively reported in the publication: overall survival; progression free survival; toxicity; or quality of life. At least one of the required outcome variables is reported separately for patients with advanced or metastatic (Stage III/IV) disease that is of squamous histology Study Design: Randomized controlled trials (RCTs) Year: 1995 to present Ineligible studies include: Review articles, news, editorials, commentaries Publication date prior to 1995 Not first-line treatment with first-line defined as patients with no prior exposure to chemotherapy Radiation therapy in the absence of concurrent chemotherapy in any treatment group While systematic reviews and meta-analyses are ineligible, the references will be culled to ensure that no relevant studies have been inadvertently excluded Outcome(s) Primary outcomes Overall survival Progression free survival Toxicity Page: 2 / 5

3 Quality of life Overall survival, Hazard ratio Progression free survival, hazard ratio Toxicity, odds ratio Quality of life, mean difference Secondary outcomes Data extraction, (selection and coding) Two reviewers will independently extract data from the eligible articles. Data from both reviewers will be matched and compared. In cases of disagreement, the reviewers will meet and attempt to come to resolution. In cases of nonresolution, a third reviewer will be consulted. All rules and decisions regarding data resolution will be recorded for quality assurance and consistency in decision making. A subset of ten percent of the data will be verified for accuracy by an individual not involved in the data extraction process. In cases of error detection, the full database will be reviewed to ensure accuracy. Risk of bias (quality) assessment Risk of bias will be assessed using the Cochrane Risk of Bias Tool. Study quality will be assessed by the PEDro Scale. Sensitivity analyses will be conducted using these data. Strategy for data synthesis Aggregate data will be used for indirect comparisons using Bayesian methods. Individual hazard ratios (HR) or median time and its 95% confidence interval (90% or 99% confidence intervals will be converted to 95%) for overall survival from each study will be included in a NMA using a Bayesian approach ensuring the preservation of randomization in the network. The HR will be used as the primary unit of analysis to evaluate differences in effect size between treatment groups. Data for analysis will be directly extracted from the text of the article, calculated from data in the text, or extrapolated from the Kaplan-Meier plot according to the method of Parmar, et al. Graphs and figures will be digitized using TechDig software and/or xyscan tool if needed and digitized values will be extracted. Analysis of subgroups or subsets Percent with Stage IV disease and age will be included as covariates in a meta-regression. Dissemination plans The meta-analysis will be submitted for publication in a peer reviewed journal following completion Contact details for further information Lisa Hess Lilly Corporate Center DC 5022 Indianapolis IN USA hess_lisa_m@lilly.com Organisational affiliation of the review Eli Lilly and Company Page: 3 / 5

4 Review team Dr Lisa Hess, Eli Lilly Ms Amy De Lozier, Eli Lilly Dr Lee Bowman, Eli Lilly Dr Jacqueline Brown, Eli Lilly Dr Luping Zhao, Eli Lilly Dr Fanni Natanegara, Eli Lilly Dr Joseph Treat, Eli Lilly Dr Zhanglin Lin Cui, Eli Lilly Dr Stephen Able, Eli Lilly Collaborators Dr Maheswar Ganta, GVK Details of any existing review of the same topic by the same authors Anticipated or actual start date 29 November 2013 Anticipated completion date 29 August 2014 Funding sources/sponsors Eli Lilly and Company Conflicts of interest Eli Lilly and Company is conducting research on molecules in the area of focus of the meta-analysis Other registration details Language English Country United States of America Subject index terms status Subject indexing assigned by CRD Subject index terms Carcinoma, Non-Small-Cell Lung; Humans Stage of review Ongoing Date of registration in PROSPERO 17 March 2014 Date of publication of this revision 17 March 2014 DOI /CRD Page: 4 / 5

5 Powered by TCPDF ( Stage of review at time of this submission Started Completed Preliminary searches Yes Yes Piloting of the study selection process Yes Yes Formal screening of search results against eligibility criteria Yes Yes Data extraction Yes No Risk of bias (quality) assessment Yes No Data analysis No No PROSPERO International prospective register of systematic reviews The information in this record has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Page: 5 / 5