title: Time-to-event endpoints in operable non-small-cell lung cancer randomized clinical trials.
abstract: No guideline for time-to-event endpoints (TTEE) definitions in lung cancer trials exists. Areas covered: The aim of the study was to evaluate the reporting of TTEE in operable non-small-cell lung cancer randomized clinical trials. Expert commentary: Sixty-two TTEE were recorded. In the Methods section, using four key points to define TTEE we observed that the 'starting point', 'events', 'information on censoring', 'assessment of events' were clearly defined for 43 (69.4%), 34 (54.8%), 6 (9.7%), 33 (53.2%) endpoints respectively. In the results section, using five key points, we observed that the 'Kaplan-Meier estimation', 'estimation of effect size', 'precision (confidence interval)', 'number of events', 'number of patients at risk', 'multivariate analysis' were clearly identified for 46 (74.2%), 31 (50%), 30 (48.4%), 37 (59.7%), 28 (45.2%), and 17 (27.4%) endpoints, respectively. A majority of articles failed to provide a complete reporting of TTEE. Guidelines for TTEE is warranted.
authors.affiliation: a Methodology and Quality of Life in Oncology Unit , University Hospital of Besançon , Besançon , France.|b Department of Medical Oncology , University Hospital of Besançon , Besançon , France.|c Medical Department , European Organisation for Research and Treatment of Cancer , Brussels , Belgium.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Fiteni
authors.affiliation: a Methodology and Quality of Life in Oncology Unit , University Hospital of Besançon , Besançon , France.|b Department of Medical Oncology , University Hospital of Besançon , Besançon , France.
authors.forename: Marie-Justine
authors.initials: MJ
authors.lastname: Paillard
authors.affiliation: d Chest disease Department , University Hospital of Besançon , Besançon , France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Westeel
authors.affiliation: a Methodology and Quality of Life in Oncology Unit , University Hospital of Besançon , Besançon , France.|b Department of Medical Oncology , University Hospital of Besançon , Besançon , France.|e EA 3181 University of Franche-Comté , Besançon , France.
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
mesh_terms: D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000601:surgery*; D023381:Endpoint Determination / Q000379:methods* / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000473:pathology / Q000601:surgery*; D015999:Multivariate Analysis; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D013997:Time Factors
keywords: Endpoint; clinical trial; guideline; lung cancer; methodology