JSM 2012 Home

JSM 2012 Online Program

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

Online Program Home

Abstract Details

Activity Number: 408
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
Sponsor: Section on Bayesian Statistical Science
Abstract - #306337
Title: Multivariate Kth-Order Markov Models for the Conditional Probability of Toxicity in Phase II Trials
Author(s): Laura Fernandes*+ and Jeremy Michael George Taylor and Susan Murray
Companies: University of Michigan and University of Michigan and University of Michigan
Address: 327 S Division, Ann Arbor, MI, 48104, United States
Keywords: adaptive ; oncology ; clinical trial ; dose escalation

Prior to designing a Phase II trial, a Phase I trial often has narrowed interest to two doses that will be moved forward. In addition to getting a preliminary idea of efficacy,an important goal of a phase II trial is to determine dose(s) that have an acceptable toxicity pro file over repeated cycles. We model the conditional probability of toxicity during a cycle conditional on not seeing toxicity in any of the previous cycles; a kth-order Markov model where k is the number of previous cycles. Our model allows the conditional probability of toxicity to depend on randomized dose group, cumulative dose from prior cycles, a measure of how consistently a patient responds to the same dose exposure on subsequent cycles as well as individual risk factors influencing the ability to tolerate the treatment regimen. Simulations studying finite sample properties of the model are given. Finally, the approach is demonstrated in a phase II trial studying two dose levels of ifosfamide plus doxorubicin and granulocyte colony-stimulating factor in soft tissue sarcoma patients.

The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.

Back to the full JSM 2012 program

2012 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.