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Activity Number: 412
Type: Topic Contributed
Date/Time: Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #315689
Title: Use of PFS and PFS2 in Cancer Clinical Trials
Author(s): Tommy Fu* and Marie-Laure Bravo and Chengqing Wu and Guang Chen and Zhinuan Yu and Qiang Xu
Companies: Celgene and Celgene and Celgene and Celgene and Celgene and Celgene
Keywords: PFS, PFS2, recurrent events
Abstract:

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.


Authors who are presenting talks have a * after their name.

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