Pitfalls and limitations of a single-centre, retrospectively derived prognostic score for Phase i oncology trial participants - Reply to Fussenich et al.: A new, simple and objective prognostic score for Phase i cancer patients

摘要

We read with interest the derivation of a new prognostic scoring system by Fussenich et al. which adds to efforts by several groups aiming to provide objective risk stratification and optimise patient selection for Phase I trials. As the series in the Nijmegen model comprised only 122 subjects treated at one site, and as Fussenich et al. acknowledged in their conclusion, larger studies are required in order to put their conclusions into context. For this reason, we have studied the utility of the Nijmegen score using data collected from the European Drug Development Network (EDDN~1).