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Data: 16/06/2010, às 07h00

Tema:  “Dose Finding with Escalation with Overdose Control (EWOC) in Cancer Clinical Trials”

Palestrantes: 
André Rogatko

Cedars-Sinai Medical Center, Samuel Oschin
Comprehensive Cancer Institute, Los Angeles, USA

Abstract: 
Traditionally,  the major objective in phase I trials is to identify a working-dose for subsequent studies, whereas the major endpoint in phase II and III trials is treatment efficacy. The dose sought is typically referred to as the maximum tolerated dose (MTD). Several statistical methodologies have been proposed to select the MTD in cancer phase I trials. In  this manuscript, we  focus on a Bayesian adaptive design, known as EWOC. Several aspects of this design are discussed;  including  large sample properties of the sequence of doses selected in the trial, design operating characteristics, sample size determination, choice of prior distributions and use of covariates. The methodology is exemplified with  real life examples of  cancer  phase I trials.  In particular, we show in the recently completed  ABR trial that omitting an important predictor of toxicity when dose assignments to cancer patients are determined results in a high percent  of patients experiencing severe side effects and a significant proportion treated at sub-optimal doses. 

Local:  
Auditório Senador José Ermírio de Moraes - Hospital A.C.Camargo
R. Prof. Antonio Prudente, 211 - 2º SS - Liberdade