Circulating Tumor Cell Eradication as an Intermediate Efficacy End Point for Metastatic Castration-Resistant Prostate Cancer: Is There Enough Evidence?
Menée à partir des données de cinq essais de phase III incluant au total 6 081 patients atteints d'un cancer métastatique de la prostate résistant à la castration, cette étude analyse, par rapport au niveau sérique de l'antigène prostatique spécifique, l'intérêt de différentes mesures du nombre de cellules tumorales circulantes pour évaluer précocement la réponse thérapeutique
There are four broad classes of context-specific biomarkers that may have clinical utility in oncology.1 The first relates to prognostic markers, which aid in defining disease prognosis in a particular clinical context independently of the type of therapy administered. The second is a predictive biomarker (also called a treatment-specific or treatment-selection marker), which aids the clinician in preferentially choosing one therapy over another in a given disease context. The third is a marker that can serve as an indicator of therapeutic response after a particular therapy has been started (ie, a response biomarker), and which may itself sometimes be a measure of clinical benefit. The fourth is an efficacy biomarker measured at an early time point after therapy initiation that correlates with a definitive clinical end point (such as survival), and which may serve as an intermediate end point (and in the strictest sense, a surrogate end point) of clinical benefit for the purposes of expediting drug development and regulatory approvals.
Journal of Clinical Oncology , éditorial en libre accès, 2016