Toward the definition of new endpoints

Abstract

Despite considerable advances in the different treatment modalities, there is no evidence-based consensus in the therapeutic management of diffuse low-grade glioma (DLGG). The typically long overall survival of patients with DLGG makes the usual methodology in oncology of randomized trials inadequate. Moreover, any evaluation of treatment efficacy on overall survival has to be associated with an analysis of functional status in these young patients, who are often not that much affected in the initial phase of their disease. In a first step, we propose a new method to compare the efficacy of the different strategies (advocated in different centers): plotting the time to malignant progression versus the time with quality of life. In a second step, new criteria of response to a single treatment are defined on morphological MRI. Contrarily to previous work, our approach takes into account not only the tumor size evolution but also the dynamic changes induced by the therapy.