Life-expectancy of patients enrolled in phase 1 clinical trials: A systematic review of published prognostic models

Life-expectancy superior to 3 months is a key-eligibility criterion for contemporary oncology phase 1 trials. Nevertheless, there is no reliable and consensual guidance for estimating this criterion. We have conducted a systematic review of published studies investigating the risk factor for 90-day mortality and the inherent generated scores. Nine studies have been published on this topic. Only two of these prognostic models have been validated on an independent dataset. Most of the models are based on a very subjective and investigator-dependent parameter: the performance status. The predictive performance of these prognostic models is poorly evaluated.

► Selection of patients for phase I clinical trials remains a critical issue.
► There is no reliable and validated guidance to estimate life-expectancy.
► Numerous scores and models for prediction of overall survival or 90-day mortality have been published. The calibration and the discrimination of these models are not explored.
► None of these models have been definitively validated on an independent cohort.
► A large multicenter study is needed.