Background: Selecting patients for phase I trials in order to investigate cytotoxic agents is challenging, since there is no clear and reliable guidance to estimate life expectancy among these patients. We retrospectively assessed prognostic factors in cancer patients screened for Phase1 trials between October 1997 and October 2002.
Methods: 148 consecutive patients, screened for inclusion in phase I trials investigating cytotoxic agents, were included in the present study. 70 out of them actually received phase I trial regimens. Univariate and multivariate analysis were undertaken to determine the prognostic factors for overall survival (OS) from the date of screening.
Results: The median OS of the 148 patients was 5.7 months. Ninety-two percent of them had PS<or=1. The Cox model identified serum albumin<38 g/l [HR 2.51 (1.51-4.18), p=0.0001] and lymphocyte count<700/mm3 [HR 2.27 (1.13-4.62), p=0.024] as independent prognostic for overall survival. All patients presenting both prognostic factors died within 90 days.
Conclusions: We propose a simple model, easily obtained at the bedside, which can discriminate patients who are likely to be alive at 3 months and thus could be included in a phase 1 anti-cancer trial. This model now needs to be validated on an independent cohort.