JSM 2004 - Toronto

Abstract #301660

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Activity Number: 182
Type: Topic Contributed
Date/Time: Tuesday, August 10, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #301660
Title: Clinical Trial Analyzed with Cox Proportional Hazards Models (Stratified over Covariables) for Progression-Free and Overall Survival of Patients with a Progressive Disease
Author(s): Harry F. Bushar*+
Companies: U.S. Food and Drug Administration
Address: DHHS/PHS/FDA/CDRH/OSB/DBS/DX, Rockville, MD, 20850,
Keywords: Cox Proportional Hazards ; progression-free survival ; overall survival
Abstract:

A multicenter, longitudinal clinical trial was conducted to determine whether trends in marker level correlate with Progression-Free Survival (PFS) or Overall Survival (OS). Patients with a specific progressive disease, who were about to start a new line of therapy were enrolled. Initially, three ad hoc methods for interpretation of longitudinal changes in marker level were applied, under the naïve assumption that time segments within a patient would be independent, and data were collapsed into 2x2 tables of marker level changes by progression. However, the independence assumption was difficult to justify. Therefore, following selection of the optimal marker cut-off level, three patient populations were defined and SAS PROC PHREG (Cox Proportional Hazards Regression) was used to predict PFS or OS from marker level, based on patients with available data, with PFS stratified over one covariable and with OS stratified over two covariables. The results of these analyses demonstrate that marker level successfully predicts both PFS and OS, with distinct results for each of the three patient populations, without requiring the naïve assumption that time segments within a patient would be independent.

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Revised March 2004