Accéder directement au contenu Accéder directement à la navigation
Article dans une revue

Prognostic factor of early death in phase II trials or the end of 'sufficient life expectancy' as an inclusion criterion? (predit model)

Abstract : Optimizing patient selection is a necessary step to design better clinical trials. 'Life expectancy' is a frequent inclusion criterion in phase II trial protocols, a measure that is subjective and often difficult to estimate. The aim of this study was to identify factors associated with early death in patients included in phase II studies. We retrospectively collected medical records of patients with advanced solid tumors included in phase II trials in two French Comprehensive Cancer Centers (Bordeaux, Center 1 set; Lille, Center 2 set). We analyzed patients' baseline characteristics. Predictive factors associated with early death (mortality at 3 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. Center 1 and 2 sets included 303 and 227 patients, respectively. Patients from Center 1 and 2 sets differed in tumor site, urological (26 % vs 15 %) and gastrointestinal (18 % vs 28 %) and in lung metastasis incidence (10 % vs 49 %). Overall survival (OS) at 3 months was 88 % (95 % CI [83.5; 91.0], Center 1 set) and 91 % (95 % CI [86.7; 94.2], Center 2 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 Center 2 set. Using the Center 1 set, ROC analysis shows a good discrimination to predict early death (AUC: 0.89 at 3 months and 0.86 at 6 months). Risk modeling in two independent cancer populations based on simple clinical parameters showed that baseline ECOG of 2, hyperleukocytosis and anemia are strong early-death predictive factors. This model 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.
Type de document :
Article dans une revue
Liste complète des métadonnées

Littérature citée [30 références]  Voir  Masquer  Télécharger

https://hal.univ-lille.fr/hal-02530714
Contributeur : Lilloa Université de Lille <>
Soumis le : vendredi 3 avril 2020 - 10:48:07
Dernière modification le : jeudi 11 juin 2020 - 03:21:17

Fichier

Prognostic factor.pdf
Fichiers éditeurs autorisés sur une archive ouverte

Licence


Distributed under a Creative Commons Paternité 4.0 International License

Identifiants

Collections

Citation

Thomas Grellety, Sophie Cousin, Louis Letinier, Pauline Bosco-Levy, Stephanie Hoppe, et al.. Prognostic factor of early death in phase II trials or the end of 'sufficient life expectancy' as an inclusion criterion? (predit model). BMC Cancer, BioMed Central, 2016, BMC Cancer, 16, pp.768. ⟨10.1186/s12885-016-2819-7⟩. ⟨hal-02530714⟩

Partager

Métriques

Consultations de la notice

20

Téléchargements de fichiers

27