title: The role of censoring on progression free survival: oncologist discretion advised.
abstract: Censoring is increasingly appreciated as a potential bias affecting estimates of progression free survival (PFS) in randomised trials. In this commentary, we explore the central assumption of censoring. Censored patients are considered no more or less likely to undergo the event of interest than those who remain in the analysis. Instead however, if one makes alternate assumptions, that censored patients are different than those who remain on the trial, estimates of PFS change. Using the example of the recent BOLERO-2 trial of exemestane and everolimus, we show that by altering the assumptions for censoring, the major conclusions of clinical trials may change. As such, the number of censored patients at each time interval should be routinely reported in randomised trials to better understand the implications of censoring.
authors.affiliation: Medical Oncology Service, National Cancer Institute, National Institutes of Health, 10 Center Dr. 10/12N226, Bethesda, MD 20892, United States. Electronic address: vinayak.prasad@nih.gov.
authors.forename: Vinay
authors.initials: V
authors.lastname: Prasad
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe Street, Baltimore, MD 21205, United States.
authors.forename: Usama
authors.initials: U
authors.lastname: Bilal
mesh_terms: D000730:Androstadienes / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015982:Bias; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003627:Data Interpretation, Statistical; D018572:Disease-Free Survival; D023381:Endpoint Determination; D000068338:Everolimus / Q000627:therapeutic use; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D012107:Research Design / Q000706:statistics & numerical data; D013997:Time Factors; D017211:Treatment Failure
chemical_list: D000730:Androstadienes; D000068338:Everolimus; C056516:exemestane
keywords: BOLERO-2; Censoring; Informative censoring; Progression free survival; Randomised trial design; Surrogacy