New graphic AUC-based method to estimate overall survival benefit: pomalidomide reanalysis

Summary What is known and objective Difference in median survival is an erratic measure and sometimes does not provide a good assessment of survival benefit. The aim of this study was to reanalyse the overall survival benefit of pomalidomide from pivotal clinical trial using a new area under curve (...

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Veröffentlicht in:Journal of clinical pharmacy and therapeutics 2016-02, Vol.41 (1), p.1-3
Hauptverfasser: Fenix-Caballero, S., Diaz-Navarro, J., Prieto-Callejero, B., Rios-Sanchez, E., Alegre-del Rey, E. J., Borrero-Rubio, J. M.
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Sprache:eng
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Zusammenfassung:Summary What is known and objective Difference in median survival is an erratic measure and sometimes does not provide a good assessment of survival benefit. The aim of this study was to reanalyse the overall survival benefit of pomalidomide from pivotal clinical trial using a new area under curve (AUC)‐based method. Comment In the pivotal trial, pomalidomide plus low‐dose dexamethasone showed a significant survival benefit over high‐dose dexamethasone, with a difference between medians of 4·6 months. The new AUC method applied to the survival curves, obtained an overall survival benefit of 2·6 months for the pomalidomide treatment. This average difference in OS was calculated for the 61·5% of patients for whom the time to event is reliable enough. What is new and conclusion This 2‐month differential would have major clinical and pharmacoeconomic implications, on both cost‐effectiveness studies and on the willingness of the healthcare systems to pay for this treatment.
ISSN:0269-4727
1365-2710
DOI:10.1111/jcpt.12338