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Tumor response: - No growth inhibition

± Transient response, inhibition <Td2 (=mean time for tumor volume to double) + Growth inhibition >Td2 ++ Growth inhibition >2xTd2 +++ Growth inhibition >3xTd2

++++ Growth inhibition >3 Td2+volume regression >50% +++++ Complete regression with subsequent growth

++++++ Complete regression with no regrowth of any tumors during the period of observation (>84 days)

erant to a drug, relative to human, then the mouse models will overpredict activity (Leggas et al. 2002). If the converse holds, then the mouse models may fail to identify potentially useful agents for clinical disease; thus, it is critical to determine whether drug doses inducing tumor regressions in the models achieve systemic exposures that are relevant to clinical exposures at tolerated doses (Boland et al. 1999; Zamboni et al. 1998). In most instances drug pharmacokinetic data are available from phase-I trials in adult patients prior to initiating pediatric clinical trials; hence, these comparisons can be used to prioritize or de-emphasize development of a specific agent in pediatric trials.

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