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Activity Number: 244
Type: Contributed
Date/Time: Monday, August 5, 2013 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #309198
Title: A Frailty-Based Progressive Multistate Model for Progression and Death in Cancer Studies
Author(s): Chen Hu*+ and Alex Tsodikov
Companies: American College of Radiology and University of Michigan
Keywords: Survival analysis ; Composite endpoints ; Progressive multistate model ; Semiparametric regression ; Frailty model ; Oncology
Abstract:

In advanced or adjuvant cancer studies, progression-related events (e.g., progression-free or recurrence-free survival) and cancer death are common endpoints that are sequentially observed. The relationship between covariate (e.g., therapeutic intervention), progression, and death is often of interest, as it may provide a key to optimal treatment decisions. The evaluation of this relationship is often complicated by the latency of disease progression leading to undetected or missing progression-related events. We consider a progressive multistate model with a frailty modeling the association between progression and death, and propose a semiparametric regression model for the joint distribution. An Expectation-Maximization (EM) approach is used to derive the maximum likelihood estimators of covariate effects on both endpoints, the probability of missing progression event, as well as the parameters involved in the association. The asymptotic properties of the estimators are studied. We illustrate the proposed method with Monte Carlo simulation and data analysis of a clinical trial of colorectal cancer adjuvant therapy.


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