2548 Background: Selection of pts entering in phase trials remains difficult. An international network of expert centers had validated the efficacy of the RMS as selection tool in such context. Nevertheless, RMS have been developed (Arkenau EJC 2008) and validated (Olmos et al. JCO 2012) in cohorts of already enrolled pts, whereas that the question of eligibility is crucial at the time of screening. We have then implemented and measured the efficacy of the RMS in 453 pts entering in the screening process in 4 expert centers. Methods: We have analyzed pts having signed the PIS/IC. RMS (0 to 3) is sum of the following prognostic factors: LDH>ULN, met. sites>2 and albumin <35 g/L. We have established the rates of enrolled pts, of pts dying within 90 days, of pts having completed PK/PD analysis, with accurate tumor assessment, having to be replaced according to RMS value. Results: Score was as follows: 0 (122/453, 27.0%), 1 (147/453, 32.4%), 2 (79/453, 17.4%), 3 (20/354, 4.4%) & not assessable (84/453, 19.2%). OS according to RMS value were 615, 299, 239 & 136 days (p=0.0001). The rates of 90-day mortality were 5.3%, 12.6%, 26.6% & 41.1% (p=0.0001). The rates of enrolled pts were 79.5%, 77.5%, 60.7% & 50.0% (p=0.001). Among enrolled pts, the rates of pts having completed the PK/PD analysis were 87.6%, 79.8%, 70.8% & 50.0% (p=0.007). Among enrolled pts, the rates of tumor assessment available were 95.8%, 88.6%, 89.5% & 70.0% (p=0.006). The rates of pts having to being replaced 4.1%, 5.2%, 2.0% & 50.0% (p=0.04). The time under study was 118, 81, 56 and 62 days (p=0.005). Conclusions: We confirm that the RMS is a reliable, easily obtained tool for selecting pts in such context. The enrollment of pts with RMS=3 is associated with a high risk of attribution rate & risk to be replaced. The time under study was significantly lower in cases of RMS =[2-3].
Metholology for the selection of LWR safety R and D projects. Phase I, status report