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Abstract Details

Activity Number: 387
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304368
Title: PFS, OS, and Multi-State Counting Processes
Author(s): Xiaolong Luo*+ and Guang Chen and Zhinuan Yu and Soo Peter Ouyang
Companies: Celgene Corporation and Celgene Corporation and Celgene Corporation and Celgene Corporation
Address: 164 Grayson Drive, Belle Mead, NJ, 08502-4933, United States
Keywords: survival analysis ; clinical trials ; PFS ; counting process
Abstract:

Chemotherapy for patients with many forms of cancer are long term interventions that often switch among lines of treatments upon disease progression or unacceptable toxicity. In clinical trials, major study endpoints such as Progression Free Survival (PFS) and Overall Survival (OS) require long term follow up for evaluation. Conventional statistical methods treat PFS and OS separately without considering their intertwining relationship and their relationship with the study drug exposure or subsequent therapies. Such overly simplified method may leave difficulty in answering many important questions such as projected longer term OS effect based on the shorter term PFS effect and potential optimal length of the study drug exposure. In this talk, we will apply multi state counting process to study PFS, OS and study drug exposure simultaneously. The inference of joint relationship will help the study design of regulatory pivotal trials in endpoint prioritization and control of type I error rate for multiple comparisons. Simulations and actual clinical trials will be used to illustrate the methodology.


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