Literature DB >> 26259493

The role of censoring on progression free survival: oncologist discretion advised.

Vinay Prasad1, Usama Bilal2.   

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. Published by Elsevier Ltd.

Entities:  

Keywords:  BOLERO-2; Censoring; Informative censoring; Progression free survival; Randomised trial design; Surrogacy

Mesh:

Substances:

Year:  2015        PMID: 26259493     DOI: 10.1016/j.ejca.2015.07.005

Source DB:  PubMed          Journal:  Eur J Cancer        ISSN: 0959-8049            Impact factor:   9.162


  6 in total

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Authors:  V Prasad; S V Rajkumar
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4.  Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis.

Authors:  Huseyin Naci; Courtney Davis; Jelena Savović; Julian P T Higgins; Jonathan A C Sterne; Bishal Gyawali; Xochitl Romo-Sandoval; Nicola Handley; Christopher M Booth
Journal:  BMJ       Date:  2019-09-18

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6.  Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?

Authors:  Robert Kemp; Vinay Prasad
Journal:  BMC Med       Date:  2017-07-21       Impact factor: 8.775

  6 in total

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