JSM 2004 - Toronto

Abstract #301612

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Activity Number: 90
Type: Contributed
Date/Time: Monday, August 9, 2004 : 9:00 AM to 10:50 AM
Sponsor: Biopharmaceutical Section
Abstract - #301612
Title: Modeling Tumor Growth in Cancer Clinical Trial
Author(s): Jun Wu*+
Companies: Eli Lilly and Company
Address: Lilly Corporate Center, Indianapolis, IN, 46285,
Keywords: cancer ; time-to-tumor progression ; clinical trial ; growth curve ; survival time
Abstract:

In clinical trial settings, tumor growth is followed by measuring the size of tumors by common diagnostic imaging method on a regular basis. The sum of all tumors at post-baseline measurement is compared with that at baseline. Tumor progression is determined if the sum increases by a clinically significant proportion over that at baseline. Time from randomization to tumor progression (TTP) is a common clinical endpoint that will be compared between treatment arms with time-to-event method. Malignant tumor progression tends to occur in short time frame relative to the interval between measurements, which may affect the analysis. Effect of augmenting the TTP analysis with growth curve (linear, exponential and Gompertz) of individuals' tumors on hypothesis testing will be studied on simulated data. The correlation of modeling tumor growth with survival time will also be discussed.

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Revised March 2004