1371P - PREDIT model: PRognostic factor of Early Death In phase II Trials or the end of ‘sufficient life expectancy’ as an inclusion criterion?

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Bioethics, Legal, and Economic Issues
Presenter Thomas Grellety
Citation Annals of Oncology (2016) 27 (6): 474-482. 10.1093/annonc/mdw387
Authors T. Grellety1, S. Cousin1, L. Letinier1, P. Bosco-Levy1, S. Hoppe1, D. Joly1, N. Penel2, S. Mathoulin-Pelissier1, A. Italiano1
  • 1Medical Oncology, Institute Bergonié, 33000 - Bordeaux/FR
  • 2Medical Oncology, Centre Oscar Lambret, Lille/FR



‘Life expectancy’ is a frequent inclusion criterion in phase II trials, a measure that is subjective and difficult to estimate. The aim of this study was to identify factors associated with early death in patients included in phase II trials.


We retrospectively collected medical records of patients with advanced solid tumors included in phase II trials in two French Comprehensive Cancer Centers (Bordeaux, first set; Lille, second set). We analyzed patients' baseline characteristics. Predictive factors associated with early death (mortality at three months) were identified by logistic regression. We built a model (PREDIT, PRognostic factor of Early Death In phase II Trials) based on prognostic factors isolated from the final multivariate model.


First and second sets included 303 and 227 patients, respectively. Patients from the first and second sets differed in tumor site (urological (25.7% vs 15.4%) and gastrointestinal (17.8% vs 27.8%)) and in lung metastasis incidence (9.9% vs 48.9%). Overall survival (OS) at three months was 87.8% (95%CI [83.5; 91.0], first set) and 91.2% (95%CI [86.7; 94.2], second set). Presence of a ‘life expectancy’ inclusion criterion did not improve the 3-month OS (HR 0.6, 95%CI [0.2; 1.2], p = 0.2325). Independent factors of early death were an ECOG score of 2 (OR 13.3, 95%CI [4.1; 43.4]), hyperleukocytosis (OR 5.5, 95%CI [1.9; 16.3]) and anemia (OR 2.8, 95%CI [1.1; 7.1]). Same predictive factors but with different association levels were found in the second set. Using the first set, ROC analysis shows a good discrimination to predict early death (AUC: 0.89 at 3 months and 0.86 at 6 months). In the overall population, patients with 0, 1, 2 and 3 risk factors had a rate of a 3-month early-death of 2.4% (7/292), 13.7% (24/175), 37.7% (20/53) and 60% (6/10) and a rate of 6-month early-death of 6.5% (19/292), 28% (49/175), 47.2% (25/53) and 70% (7/10), respectively.


Risk modeling in two independent cancer populations based on 3 simple clinical parameters allows identifying patients who may not benefit from a phase II trial investigational drug and may, therefore, represent a helpful tool to select patients for phase II trial entry.

Clinical trial identification

Legal entity responsible for the study

Institut Bergonié Comprehensive Cancer Center


Institut Bergonié Comprehensive Cancer Center


All authors have declared no conflicts of interest.