Abstract Details
Activity Number:
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412
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #315689
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Title:
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Use of PFS and PFS2 in Cancer Clinical Trials
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Author(s):
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Tommy Fu* and Marie-Laure Bravo and Chengqing Wu and Guang Chen and Zhinuan Yu and Qiang Xu
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Companies:
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Celgene and Celgene and Celgene and Celgene and Celgene and Celgene
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Keywords:
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PFS, PFS2, recurrent events
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Abstract:
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When PFS is used as an endpoint in oncology trials, there is a concern on changes of tumor's drug resistance profile by experimental therapy. If survival benefit cannot be shown, EMA encourages the use of progression on next-line therapy (PFS2) defined as time from randomization to objective disease progression on next-line therapy or death from any cause. PFS2 includes all subjects in opposition of subset analyses on patient who progressed under current therapy. It is crucial to collect outcomes till the 2nd progression (or death) even a patient discontinued the current therapy. Two types of strategies are considered. The 1st strategy considers the 2nd progression (or death) as the only event of interest. Conventional time-to-event analyses approach can be used in this setting. The 2nd strategy consists of taking into account all the progressions as recurrent events and death as the terminal event. In this case recurrent event survival models should be used. Conditional approaches such as Prentice, Williams and Peterson (PWP) models is recommended. These models can be seen as a stratified Anderson-Gill model with event-specific baseline hazards and a restricted risk set.
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Authors who are presenting talks have a * after their name.
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