Skip directly to search Skip directly to A to Z list Skip directly to page options Skip directly to site content

NIOSHTIC-2 Publications Search

Search Results

A threshold regression mixture model for assessing treatment efficacy in a multiple myeloma clinical trial.

Authors
Lee-ML; Chang-M; Whitmore-GA
Source
J Biopharm Stat 2008 Nov; 18(6):1136-1149
NIOSHTIC No.
20034699
Abstract
A first-hitting-time (FHT) survival model postulates a health status process for a patient that gradually declines until the patient dies when the level first reaches a critical threshold. Threshold regression (TR) is a new regression methodology that incorporates the effects of covariates on the threshold and process parameters of this FHT model. In this study, we use TR to analyze data from a randomized clinical trial of treatment for multiple myeloma. The trial compares VELCADE and high-dose Dexamethasone, the former a new therapy and the latter an established therapy for this disease. Patients are switched between the two drugs based on patient response. The novel contribution of this work is the modeling of this clinical trial design using a mixture of TR models. Specifically, we propose a mixture FHT model to fit the survival distribution. The model includes a composite time scale that differentiates the rate of disease progression before and after switching. The analysis shows significant benefit from initial treatment by VELCADE. A comparison is made with a Cox proportional hazards regression analysis of the same data.
Keywords
Statistical-analysis; Mathematical-models; Analytical-methods; Analytical-models; Analytical-processes; Mortality-surveys; Treatment; Therapeutic-agents
Contact
Mei-Ling Ting Lee, Department of Epidemiology and Biostatistics, School of Public Health, University of Maryland, College Park, MD 20740, USA
CODEN
JBSTEL
Publication Date
20081101
Document Type
Journal Article
Email Address
mltlee@umd.edu
Funding Type
Grant
Fiscal Year
2009
NTIS Accession No.
NTIS Price
Identifying No.
Grant-Number-R01-OH-008649
Issue of Publication
6
ISSN
1054-3406
Source Name
Journal of Biopharmaceutical Statistics
State
MD; MA
Performing Organization
University of Maryland - College Park
TOP