JSM 2011 Online Program

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Abstract Details

Activity Number: 339
Type: Topic Contributed
Date/Time: Tuesday, August 2, 2011 : 10:30 AM to 12:20 PM
Sponsor: Section on Statistics in Epidemiology
Abstract - #301198
Title: Issues in the Analysis of Progression-Free Survival from a Cancer Clinical Trial
Author(s): Dianne M. Finkelstein*+
Companies: Massachusetts General Hospital/Harvard School of Public Health
Address: 50 Staniford Street, Boston, MA, 02114,
Keywords: clincial trial ; interval censoring ; dependent censoring ; PFS ; cancer
Abstract:

The use of progression free survival (PFS) as a primary endpoint in cancer trials must consider several issues to ensure validity of this outcome as a surrogate for survival. First, although a trial is designed to evaluate progression at regular prescribed time points, recurrence can be recorded at times outside these times because visits are missed, resulting in interval censored data. Second, the time that disease is evaluated may be determined by a report of symptoms, which could result in a dependent censoring pattern. Third, patients may stop or change therapy or withdraw from the study, which could result in a loss of power or a bias in the analysis. We will discuss these issues and methodology that can be used to appropriately handle these various censoring issues in the analysis of PFS in cancer clinical trials.


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