Estimating the dose-toxicity curve in completed phase I studies.

ABSTRACT: While there is an extensive amount of literature covering prospective designs for phase I trials, the methodology for analyzing these data is limited. Prospective designs select the maximum tolerated dose (MTD) through a dose escalation scheme based on a model or on empirical rules. For example, the '3 + 3' method (standard method: SM) assigns patients in cohorts of three and expands to six if one toxicity is observed. It has been shown previously that the MTD chosen by the SM may be low, possibly leading to a non-efficacious dose. Additionally, when deviation from the original trial design occurs, the rules for determining MTD might not be applicable. We hypothesize that a retrospective analysis would suggest an MTD that is more accurate than the one obtained by the SM. A weighted Continu

SUBMITTER: Iasonos A 

PROVIDER: S-EPMC4849410 | biostudies-literature | 2011 Jul

REPOSITORIES: biostudies-literature